On August 12, 2020 Akoya Biosciences, Inc., The Spatial Biology Company, reported the application of the CODEX platform to a recent Cell publication titled "Coordinated Cellular Neighborhoods Orchestrate Antitumoral Immunity at the Colorectal Cancer Invasive Front (Press release, Akoya Biosciences, AUG 12, 2020, View Source [SID1234563530])." The paper was published online in early August (Schürch et al* from the laboratory of Professor Garry Nolan, Ph.D., Stanford University).

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In a seminal approach to studying the spatial biology of colorectal cancer, the authors have established a robust analytical framework to analyze highly multiplexed imaging data and, in doing so, discovered unique spatial relationships between "neighborhoods" of cells in the tumor microenvironment. Understanding the interactions between these cellular aggregates and their impact on antitumor immunity could advance our understanding of tumor progression and immunotherapy response.

The research team at Stanford and the University of Bern used the CODEX system for deep profiling of FFPE tissues from 35 advanced-stage colorectal cancer patients with more than 50 protein markers simultaneously, and at single cell resolution. As a result, the team discovered nine distinct cellular neighborhoods, each uniquely composed of certain immune and cancer cell types. These cellular neighborhoods were found to interact with one another in a manner that correlated with disease progression and prognosis.

Most recent studies have focused on the network of interactions between different cell types and their spatial context. This study places an emphasis on analyzing tissue biology at two different levels, the interacting cell types as well as the tissue regions within which they are organized. A detailed study of both levels of tissue architecture and behavior is now possible with a high dimensional imaging platform such as the CODEX System.

"The results from our study contribute to the growing body of biological knowledge needed to improve the development of immunotherapies," said Garry Nolan, Ph.D., the Rachford and Carlota A. Harris Professor in the Department of Microbiology and Immunology at Stanford University School of Medicine. "Using CODEX technology for highly multiplexed imaging to study cell aggregates in situ and their impact on disease pathology and progression, we were able to gain valuable insights about how tumors can disrupt immune functionality and how antitumoral immunity requires organized, spatially-nuanced interactions between cellular neighborhoods in the tumor microenvironment. The results point to potential diagnostics and new targets for therapeutic intervention."

Brian McKelligon, CEO of Akoya, said, "This study demonstrates not only the continued scientific leadership of the Nolan Lab in the application of advanced technologies for deep cancer profiling but also how the CODEX technology can be used to advance biological research and improve our understanding of disease mechanisms in cancer."

On August 12, 2020 IMV Inc. (the "Company" or "IMV") (TSX: IMV; NASDAQ: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of cancer immunotherapies and vaccines against infectious diseases, reported financial results for the second quarter ended June 30, 2020 and provided an update on its clinical and operational progress (Press release, IMV, AUG 12, 2020, View Source [SID1234563529]).

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"This quarter, we greatly strengthened our financial position and made continued progress across our portfolio with the rapid advancement of our vaccine program against SARS-CoV-2. This includes the selection of our clinical candidate, DPX-COVID-19, which demonstrated strong immunogenicity including its binding on target to the spike protein and viral neutralization in preclinical studies. In addition, Health Canada agreed with the design of our Phase 1 study, that will enroll across two clinical sites including in elderly subjects. We also confirmed non-dilutive government funding, expected to cover development costs through Phase 1.

We believe the DPX technology, combined with the thoughtful selection of non-overlapping, immunogenic peptides, offers meaningful clinical potential and we look forward to reporting preliminary Phase 1 results later this fall for DPX-COVID-19," stated Frederic Ors, Chief Executive Officer at IMV. "In parallel, we continue to advance DPX-Survivac, our lead program, currently being evaluated in multiple phase 2 studies. On the heels of our recent announcement that SPiReL, a Phase 2 study of a DPX-Survivac combination regimen in patients with r/r DLBCL, met its primary efficacy endpoint, we presented data demonstrating deepening responses in ovarian cancer at ASCO (Free ASCO Whitepaper) 2020. We look forward to reporting updated data from both studies later this year, and to engaging with regulators on the path forward for DPX-Survivac."

Second Quarter 2020 and Recent Operational Highlights:

DPX-COVID-19

IMV continues to rapidly advance its vaccine candidate for COVID-19. A summary of recent progress is outlined below:

In May 2020, IMV announced the selection of DPX-COVID-19 as its clinical candidate for COVID-19. DPX-COVID-19 is formulated within the Company’s DPX delivery platform, with four complementary peptide antigens selected for their high immunogenicity and ability to bind non-overlapping areas on the virus spike. These four peptides are independent of the 614 gene mutation, which may increase the virus’ ability to infect cells in vitro, reduce vaccine-induced immunity and avoid mutation resistance. Additionally, areas on the virus spike identified as potentially responsible for vaccine-enhanced disease have been excluded from target selection to minimize safety risk.
In July 2020, IMV received agreement with Health Canada on the design of its Phase 1 clinical study. This study is a randomized, controlled study, assessing the safety and immunogenicity of DPX-COVID-19, in 84 healthy adults across two age cohorts: (1) adults age 18-55; and (2) adults age 56 and older. To support the initiation of clinical trials, the Company completed the current good manufacturing practice (cGMP) formulation and manufacturing process development for DPX-COVID-19 and multiple batches have been successfully produced. Two dose levels of DPX-COVID-19 will be tested across both cohorts (25μg or 50μg). IMV anticipates preliminary results of the Phase 1 clinical study in the fall of 2020.
In August 2020, the Company confirmed that it will receive non-dilutive funding of $4.75 M from the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP), the Innovation Assistance Program (NRC IAP), the Atlantic Canada Opportunities Agency (ACOA), and from Next Generation Manufacturing Canada (NGen) to support upcoming clinical trials and the rapid scale-up of DPX-COVID-19. This provides sufficient capital to fund clinical development through a Phase 1 study of DPX-COVID-19.
DPX-Survivac

Phase 2 SPiReL Study in Recurrent / Refractory Diffuse Large B-Cell Lymphoma (r/r DLBCL)

In March 2020, the Company announced that the study had met its primary efficacy endpoint with 64% (7/11) of evaluable patients demonstrating a clinical response so far. The study remains ongoing and IMV anticipates presenting topline data at a scientific conference later in 2020.

Additionally, the Company plans to engage with the U.S. Food and Drug Administration (FDA) later this year, to identify the path forward in r/r DLBCL.

As of August 3, 2020, 22 patients have been enrolled across five different clinical sites in Canada.

SPiReL is an investigator-initiated Phase 2 study evaluating DPX-Survivac/CPA in combination with Keytruda (pembrolizumab) in r/r DLBCL. The study is led by Dr. Neil Berinstein, MD, FFCP©, ABIM, hematologist-oncologist at the Odette Cancer Centre at Sunnybrook Health Sciences Centre in Toronto, Ontario.

Phase 2 DeCidE1 Study in Advanced Recurrent Ovarian Cancer

In May 2020, IMV presented a poster as part of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Scientific Program. Results from the ongoing study showed prolonged durable clinical responses, continued favorable tolerability and strong translational data linking the observed clinical benefit with DPX-Survivac’s mechanism of action.

As of the data cut-off date on May 2, 2020, 19 patients were evaluable for efficacy with four patients (21%) still receiving treatment. 5/19 patients (26%) achieved a partial regression (PR) on target lesions with tumor regression >30% on target lesions. These results compare favorably to with historical data with single agent chemotherapy standard of care (12% clinical response rate) and warrant further clinical development.

Translational analyses link observed clinical benefit and survivin-specific T cells, showing treatment generated a survivin-specific CD8+ T cell response in PBMC samples of 14/16 (87%) evaluable patients and induced an immune response with survivin-specific T cell clones infiltrating tumors as early as day 56 following treatment. More data, including the poster, are available here.

DeCidE1 is a Phase 2 multicenter, randomized, open-label study to evaluate the safety and efficacy of DPX-Survivac with intermittent low dose cyclophosphamide (CPA). This Phase 2 arm enrolled 22 patients with recurrent, advanced platinum-sensitive and/or resistant ovarian cancer.

Phase 2 Basket Trial in Multiple Advanced Metastatic Solid Tumors

As of August 3, 2020, a total of 100 patients out of the planned 184 patients were enrolled across all five indications at 19 clinical sites in Canada and the US.

As noted previously, the COVID-19 pandemic has impacted data collection and validation processes from this study. However, the Company remains on track to report updated results from this study in the second half of 2020.

The Basket Trial is an open label, multi-center Phase 2 study, evaluating the safety and efficacy of DPX-Survivac/CPA in combination with Keytruda across five cohorts of patients with bladder cancer, liver cancer (hepatocellular carcinoma), ovarian cancer (with and without CPA), NSCLC and tumors shown to be positive for the microsatellite instability high (MSI-H) biomarker.

Upcoming Milestones

Over the course of upcoming quarters, the Company expects to deliver the following milestones:

DPX-COVID-19
Initiation of Phase 1 Clinical trial with DPX-COVID-19 in summer 2020
Preliminary Phase 1 results in fall 2020
DPX-Survivac
Top line Phase 2 clinical results from the DLBCL combination trial in 2020
Top line Phase 2 clinical results from the ovarian monotherapy trial in 2020
Updated Phase 2 clinical results from the basket trial in 2020
Overview of Second Quarter 2020 Financial Results

At June 30, 2020, the Company had cash and cash equivalents of $28,251,000 and working capital of $29,501,000, compared with $14,066,000 and $13,199,000, respectively at December 31, 2019. This primarily reflects proceeds from the CDN $25,100,000 private placement completed on May 7th. Subsequent to June 30th, the Company sold 4,770,890 common shares for gross proceeds of US$24.5 million (CAD$33.5 million) under its At-The-Market facility resulting in pro-forma cash and cash equivalents of $61,751,000 as of June 30, 2020. Based on its current plan, IMV expects its current cash position will be sufficient to fund operations for more than the next 12 months.

Research and development expenses increased by $1,457,000 during the quarter ended June 30, 2020, compared to Q2 2019. These increases are mainly due to increased enrollment for the ongoing basket trial prior to the onset of the pandemic, pre-clinical development for DPX-COVID-19, which is offset fully by an increase in government assistance, and to a lesser extent, also attributable to personnel costs due to an increase in headcount. The increase in research and development expenses is partly offset by a decrease in travel and costs related to the DeCidE1 Phase 2 study of DPX-Survivac/CPA, in patients with advanced recurrent ovarian cancer.

General and administrative expenses increased by $863,000 for the quarter ended June 30, 2020 compared to Q2 2019. This increase is explained by an increase in insurance premium and is also attributable to non-cash DSU compensation caused by share price fluctuation and legal and professional fees. The Company expects reduced comparative volatility in the DSU compensation expense from Q3 2020 onward as a result of electing to settle all future DSU redemptions in shares effective August 8, 2019. This increase is partly offset by a decrease of $180,000 in travel due to COVID-19 travel restrictions.

The net loss and comprehensive loss of $7,268,000 ($0.13 per share) the quarter ended June 30, 2020 was $2,217,000 higher than the net loss and comprehensive loss for the quarter ended June 30, 2020.

For the six-month period ended June 30, 2020, the net loss and comprehensive loss of $16,936,000 was $5,942,000 higher than the net loss and comprehensive loss for the six-month period ended June 30, 2019. This relates mainly to a $4,269,000 increase in R&D expenses and a $1,938,000 increase in general and administrative expenses partly compensated by a $476,000 increase in government assistance during the six-month period ended June 30, 2020.

For the six months ended June 30, 2020, IMV’s cash burn rate, defined as net loss for the period adjusted for operations not involving cash (interest on lease obligation, depreciation, accretion of long-term debt, stock-based compensation and DSU compensation), was $15,047,000. IMV expects the cash burn for the remainder of 2020 to be approximately $6,000,000 per quarter.

As of August 11, 2020, the number of issued and outstanding common shares was 66,481,659 and a total of 5,037,425 stock options, deferred share units and warrants were outstanding.

The Company’s unaudited interim condensed consolidated results of operations, financial condition and cash flows for the quarter ended June 30, 2020 and the related management’s discussion and analysis (MD&A) are available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar.

Conference Call and Webcast Information

Management will host a conference call and webcast today, August 12, 2020, at 8:00 a.m. ET. Financial analysts are invited to join the conference call by dialing (866) 211-3204 (U.S. and Canada) or (647) 689-6600 (international) using the conference ID# 2593517 Other interested parties will be able to access the live audio webcast at this link: View Source

On August 12, 2020 Ikena Oncology, a clinical-stage biotechnology company that discovers and develops patient-directed, biomarker-driven therapies, reported the publication in Nature Communications of a preclinical collaboration with the Jedd Wolchok and Taha Merghoub team at Memorial Sloan Kettering Cancer Center (MSK) (Press release, Ikena Oncology, AUG 12, 2020, View Source [SID1234563528]). The manuscript, titled, "Blockade of the AHR restricts a Treg-Macrophage suppressive axis induced by L-Kynurenine," (Campesato, et al) describes the preclinical activity of aryl hydrocarbon receptor (AHR) blockade, alone and in combination with anti-PD-1 immunotherapy. It further supports the potential of IK-175, Ikena’s internally developed, orally administered, selective AHR antagonist currently in Phase 1 clinical development.

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"AHR is known to be expressed by several cell types within the tumor microenvironment (TME), to play an important role in modulation of the body’s immune response to tumors, and to be activated in tumor and immune cells," said Jason Sager, M.D., Chief Medical Officer of Ikena Oncology. "These newly published data notably establish that selective AHR inhibition overcomes those immunosuppressive features in the TME and can additionally sensitize otherwise immune resistant tumors to clinically approved anti-PD-1 inhibitors. Collectively, it supports our recently initiated Phase 1 study evaluating IK-175 as a single-agent in patients with urothelial carcinoma and other advanced solid tumors. These data also point towards the potential for evaluating IK-175 in combination with an anti-PD-1 inhibitor."

In this preclinical study, which includes use of an Ikena AHR antagonist similar to IK-175, researchers demonstrated that AHR blockade reverses IDO/TDO-mediated immunosuppression. This immunosuppression allows a tumor to evade the immune system and is a key driver of tumor growth and progression. Moreover, the study supports a previously undescribed role for AHR signaling in regulatory T cells to modulate tumor associated macrophages and mediate immune resistance. The data also demonstrated that AHR inhibition, in combination with immune checkpoint blockade, led to prolonged survival in tumor-bearing mice when compared to single-agent anti-PD-1 treatment.

Mark Manfredi, Ph.D., President and Chief Executive Officer of Ikena Oncology, commented, "We are honored to collaborate with Jedd Wolchok and his research team at MSK. The findings published today are especially compelling because they suggest that blocking the AHR pathway has the potential to overcome the limitations of prior IDO targeting agents. We believe this research provides important rationale for implementing a personalized approach to immunotherapy. Together, with key Ikena translational findings to identify which patients may benefit most, the data presented in this manuscript is significant in informing the design of future clinical trials investigating single-agent and combination strategies with IK-175."

The manuscript can be accessed online here.

About IK-175

IK-175 (formerly known as KYN-175) is an internally-developed, orally-administered, selective aryl hydrocarbon receptor (AHR) antagonist which prevents AHR-modulated tumor promotion through its influence on both the tumor and the immune system. Ikena Oncology has commenced a first-in-human, single-arm, open-label, dose-escalation and expansion Phase 1 clinical study (NCT04200963) designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of IK-175 as a single-agent in patients with locally advanced or metastatic solid tumors, including urothelial carcinoma. US Patent 10,570,138 with claims directed to IK-175 has been issued by the United States Patent and Trademark Office. The AHR antagonist program is the subject of a global strategic collaboration with Bristol Myers Squibb (formerly Celgene).

On August 12, 2020 Seattle Genetics, Inc. (Nasdaq:SGEN) reported that Australian regulatory authorities have approved TUKYSA (tucatinib) in combination with trastuzumab and capecitabine for the treatment of patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting (Press release, Seattle Genetics, AUG 12, 2020, View Source [SID1234563527]). Australia joins U.S., Switzerland, Canada and Singapore that approved TUKYSA under Project Orbis, an initiative of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology drugs among participating international regulatory agencies.

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In April, TUKYSA became the first new medicine approved in the United States under Project Orbis, and its approval is currently under review in the European Union. TUKYSA is an oral, small molecule tyrosine kinase inhibitor (TKI) of HER2, a protein that contributes to cancer cell growth.1,2

"The rapid approval of concurrent global reviews under FDA’s Project Orbis for TUKYSA will allow for accelerated market entry of this new best-in-class treatment to HER2-positive breast cancer patients in need," said Clay Siegall, Ph.D., Chief Executive Officer at Seattle Genetics. "As our company continues to expand globally, we look forward to bringing TUKYSA to patients around the world."

The approvals are based on results from the pivotal trial HER2CLIMB, a randomized (2:1), double-blind, placebo-controlled trial that enrolled 612 patients with HER2-positive unresectable locally advanced or metastatic breast cancer who had previously received, either separately or in combination, trastuzumab, pertuzumab, and ado-trastuzumab emtansine (T-DM1). The study results were published inThe New England Journal of Medicinein December 2019. The company is pursuing a broad development strategy for TUKYSA in earlier stage HER2-positive breast cancer and other solid tumors.

About HER2-Positive Breast Cancer

Patients with HER2-positive breast cancer have tumors with high levels of a protein called human epidermal growth factor receptor 2 (HER2), which promotes the growth of cancer cells. In 2018, more than two million new cases of breast cancer were diagnosed worldwide, including nearly 523,000 in Europe.3 Between 15 and 20 percent of breast cancer cases are HER2-positive.4 Historically, HER2-positive breast cancer tends to be more aggressive and more likely to recur than HER2-negative breast cancer.5,6,7 Up to 50 percent of metastatic HER2-positive breast cancer patients develop brain metastases over time.8,9,10

About TUKYSA (tucatinib)

TUKYSA is an oral medicine that is a tyrosine kinase inhibitor of the HER2 protein. In vitro (in lab studies), TUKYSA inhibited phosphorylation of HER2 and HER3, resulting in inhibition of downstream MAPK and AKT signaling and cell growth (proliferation), and showed anti-tumor activity in HER2-expressing tumor cells. In vivo (in living organisms), TUKYSA inhibited the growth of HER2-expressing tumors. The combination of TUKYSA and the anti-HER2 antibody trastuzumab showed increased anti-tumor activity in vitro and in vivo compared to either medicine alone.11 In the U.S., TUKYSA is approved in combination with trastuzumab and capecitabine for adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases (disease that has spread to the brain), who have received one or more prior anti-HER2-based regimens in the metastatic setting.

TUKYSA is approved in the U.S., Switzerland, Canada, Singapore and Australia and is under review for approval in the EU.

U.S. Important Safety Information

Warnings and Precautions

Diarrhea – TUKYSA can cause severe diarrhea including dehydration, hypotension, acute kidney injury, and death. In HER2CLIMB, 81% of patients who received TUKYSA experienced diarrhea, including 12% with Grade 3 diarrhea and 0.5% with Grade 4 diarrhea. Both patients who developed Grade 4 diarrhea subsequently died, with diarrhea as a contributor to death. The median time to onset of the first episode of diarrhea was 12 days and the median time to resolution was 8 days. Diarrhea led to dose reductions of TUKYSA in 6% of patients and discontinuation of TUKYSA in 1% of patients. Prophylactic use of antidiarrheal treatment was not required on HER2CLIMB.
If diarrhea occurs, administer antidiarrheal treatment as clinically indicated. Perform diagnostic tests as clinically indicated to exclude other causes of diarrhea. Based on the severity of the diarrhea, interrupt dose, then dose reduce or permanently discontinue TUKYSA

Hepatotoxicity – TUKYSA can cause severe hepatotoxicity. In HER2CLIMB, 8% of patients who received TUKYSA had an ALT increase >5 × ULN, 6% had an AST increase >5 × ULN, and 1.5% had a bilirubin increase >3 × ULN (Grade ≥3). Hepatotoxicity led to dose reduction of TUKYSA in 8% of patients and discontinuation of TUKYSA in 1.5% of patients.
Monitor ALT, AST, and bilirubin prior to starting TUKYSA, every 3 weeks during treatment, and as clinically indicated. Based on the severity of hepatoxicity, interrupt dose, then dose reduce or permanently discontinue TUKYSA.

Embryo-Fetal Toxicity – TUKYSA can cause fetal harm. Advise pregnant women and females of reproductive potential risk to a fetus. Advise females of reproductive potential, and male patients with female partners of reproductive potential, to use effective contraception during TUKYSA treatment and for at least 1 week after the last dose.
Adverse Reactions

Serious adverse reactions occurred in 26% of patients who received TUKYSA. Serious adverse reactions in ≥2% of patients who received TUKYSA were diarrhea (4%), vomiting (2.5%), nausea (2%), abdominal pain (2%), and seizure (2%). Fatal adverse reactions occurred in 2% of patients who received TUKYSA including sudden death, sepsis, dehydration, and cardiogenic shock.

Adverse reactions led to treatment discontinuation in 6% of patients who received TUKYSA; those occurring in ≥1% of patients were hepatotoxicity (1.5%) and diarrhea (1%). Adverse reactions led to dose reduction in 21% of patients who received TUKYSA; those occurring in ≥2% of patients were hepatotoxicity (8%) and diarrhea (6%).

The most common adverse reactions in patients who received TUKYSA (≥20%) were diarrhea, palmar-plantar erythrodysesthesia, nausea, fatigue, hepatotoxicity, vomiting, stomatitis, decreased appetite, abdominal pain, headache, anemia, and rash.

Lab Abnormalities

In HER2CLIMB, Grade ≥3 laboratory abnormalities reported in ≥5% of patients who received TUKYSA were: decreased phosphate, increased ALT, decreased potassium, and increased AST. The mean increase in serum creatinine was 32% within the first 21 days of treatment with TUKYSA. The serum creatinine increases persisted throughout treatment and were reversible upon treatment completion. Consider alternative markers of renal function if persistent elevations in serum creatinine are observed.

Drug Interactions

Strong CYP3A or Moderate CYP2C8 Inducers: Concomitant use may decrease TUKYSA activity. Avoid concomitant use of TUKYSA.
Strong or Moderate CYP2C8 Inhibitors: Concomitant use of TUKYSA with a strong CYP2C8 inhibitor may increase the risk of TUKYSA toxicity; avoid concomitant use. Increase monitoring for TUKYSA toxicity with moderate CYP2C8 inhibitors.
CYP3A Substrates: Concomitant use may increase the toxicity associated with a CYP3A substrate. Avoid concomitant use of TUKYSA where minimal concentration changes may lead to serious or life-threatening toxicities. If concomitant use is unavoidable, decrease the CYP3A substrate dosage.
P-gp Substrates: Concomitant use may increase the toxicity associated with a P-gp substrate. Consider reducing the dosage of P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicity.
Use in Specific Populations

Lactation: Advise women not to breastfeed while taking TUKYSA and for at least 1 week after the last dose.
Renal Impairment: Use of TUKYSA in combination with capecitabine and trastuzumab is not recommended in patients with severe renal impairment (CLcr < 30 mL/min), because capecitabine is contraindicated in patients with severe renal impairment.
Hepatic Impairment: Reduce the dose of TUKYSA for patients with severe (Child-Pugh C) hepatic impairment.

On August 12, 2020 Trillium Therapeutics Inc. ("Trillium" or the "Company") (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported financial and operating results for the six months ended June 30, 2020 (Press release, Trillium Therapeutics, AUG 12, 2020, View Source [SID1234563526]).

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"We had a strong quarter, further advancing dose escalation of our lead candidates TTI-621 and TTI-622. After an initial slow-down in TTI-621 patient enrollment due to Covid-19, we successfully completed safety assessment of the 1.4 mg/kg cohort at the end of July, and moved up to 2.0 mg/kg dosing", said Jan Skvarka, Trillium’s President and Chief Executive Officer. "In May, we provided a data update for TTI-622 at ASCO (Free ASCO Whitepaper). We are very encouraged by the molecule’s emerging clinical profile, which combines strong safety with early evidence of monotherapy activity. For both molecules the next updates are planned for the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2020."

TTI-622 Study Update at ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program:

On May 29, 2020, Trillium presented updated clinical data on 19 relapsed/refractory lymphoma patients in the first 5 cohorts of the TTI-622 study at the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program annual meeting. These data highlight strong tolerability, with both drug exposure and target engagement showing dose response relationships. Objective responses, including one complete response, were observed in two heavily pretreated diffuse large B-cell lymphoma patients.

Second Quarter 2020 Financial Results:

As of June 30, 2020, Trillium had cash and cash equivalents and marketable securities of $130.8 million, compared to $22.7 million at December 31, 2019. The increase in cash and cash equivalents and marketable securities was due mainly to proceeds from an underwritten public offering completed in January 2020.

Net loss for the six months ended June 30, 2020 of $122.5 million was higher than the loss of $12.9 million for the six months ended June 30, 2019. The net loss was higher due mainly to a net warrant liability revaluation loss of $88.0 million, a loss of $22.1 million on the revaluation of the deferred share unit (DSU) liability (reclassified from a liability to equity effective June 30, 2020 on adoption of the new omnibus incentive plan), and higher manufacturing costs. This was partially offset by lower clinical trial, intangible assets amortization, share-based compensation, and salary expenses, as well as a net foreign currency gain.

Trillium’s outstanding warrants are a non-cash liability, and revaluation losses on the Company’s warrant liability balance are of a non-cash nature. On June 30, 2020, shareholders approved the 2020 Omnibus Equity Incentive Plan at the Annual General and Special Meeting of Shareholders. As Trillium intends to settle all outstanding DSUs issued for director compensation in equity, accordingly all previously existing cash-settled DSUs accounted for as a liability was reclassified to equity as of June 30, 2020.