On August 4, 2020 Cerus Corporation (Nasdaq: CERS) reported financial results for the second quarter ended June 30, 2020 (Press release, Cerus, AUG 4, 2020, View Source [SID1234562785]).

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Recent developments and highlights include:

Q2 2020 Total Revenue of $26.8 million – driven by robust year-over-year platelet kit sales growth in the U.S. and strong plasma and illuminator sales in our EMEA region. Total revenue comprised of (in millions, except %):

Reaffirming 2020 full year product revenue guidance range of $89 million to $93 million – an approximately 20% to 25% increase over 2019 reported product revenue.
Submitted a pre-market approval supplement (PMA-S) to the FDA for pathogen reduced cryoprecipitated fibrinogen complex with 5-day post-thaw storage.
Finalized INTERCEPT Red Cell CE Mark modular submission schedule, in agreement with our notified body, under new MDR submission pathway, providing clarity on the timing and pathway for red blood cells, the most frequently transfused blood component globally.
Reached agreement with FDA on chronic transfusion clinical data required for PMA submission and submitted clinical protocol amendment for the existing Phase 3 RedeS study to allow for enrollment of sickle cell and thalassemia patients.
Announced study results demonstrating that the INTERCEPT Blood System inactivates SARS-CoV-2, the causative agent for COVID-19, in plasma components intended for transfusion.
Awarded a five-year tender by the Hong Kong Red Cross Blood Transfusion Services for INTERCEPT Blood System for platelets.
Cash, cash equivalents, and short-term investments of $136.5 million at June 30, 2020.
"The benefits of pathogen reduced blood products have never been so prominent as they are now during the COVID-19 pandemic. Our Q2 results reflect the highest quarterly product revenue we have recorded to date at $21.5 million. This pandemic has made clear to us not only the resilience of our business during this time, but also the essential role that pathogen inactivation plays in helping ensure the security and safety of the blood supply chain. It has also resulted in greater focus on strategic planning and pandemic preparedness by blood centers," said William ‘Obi’ Greenman, Cerus’ president and chief executive officer. "Demand for INTERCEPT platelet kits continued to be strong in the U.S. as blood centers and hospitals adopt pathogen reduction to be compliant with the FDA guidance document on platelet safety, which has a compliance deadline that is now less than 8 months away."

"Our development programs continued to make progress during the quarter. In May, we submitted our PMA-S for pathogen-reduced cryoprecipitated fibrinogen complex, which could result in potential FDA approval by the end of this year. In addition, meetings with the European and U.S. regulatory agencies in the quarter resulted in more expedited and clear pathways to potentially gain regulatory approvals of the INTERCEPT red blood cell system," continued Greenman.

Revenue

Product revenue during the second quarter of 2020 was $21.5 million, compared to $18.2 million during the same period in 2019. Revenue growth in the quarter benefited from robust year-over-year platelet kit sales in the U.S., in addition to strong plasma kit demand and an increase in illuminator sales in our EMEA region. Year-to-date product revenue totaled $40.1 million, an increase of 12% compared to the same period in 2019.

Government contract revenue from the Company’s Biomedical Advanced Research and Development Authority (BARDA) agreement was $5.3 million during the second quarter of 2020, compared to $4.3 million during the same period in 2019, as a result of increasing INTERCEPT red blood cell clinical and development activities. Year-to-date government contract revenue totaled $11.4 million, compared to $8.7 million in the first half of 2019. The total potential value of the current BARDA agreement is $214 million with $55 million recognized as revenue to date.

BARDA is part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services. The development of the INTERCEPT red blood cell program has been funded partially with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201600009C.

Gross Margins

Gross margins on product revenue during the second quarter of 2020 were 55% and consistent with the prior year period. Gross margins during the first half of 2020 were 55% compared to 54% reported in the first half of 2019.

Operating Expenses

Total operating expenses for the second quarter of 2020 were $31.7 million compared to $31.2 million for the same period the prior year. Year-to-date, operating expenses totaled $63.5 million compared to $60.8 million for the first half of 2019.

Selling, general, and administrative (SG&A) expenses for the second quarter of 2020 totaled $16.1 million, compared to $16.7 million for the second quarter of 2019. The year-over-year decline was due to lower travel and marketing related expenses as a result of the COVID-19 pandemic. Year-to-date SG&A expenses totaled $32.0 million compared to $32.9 million for the first half of 2019.

Research and development (R&D) expenses for the second quarter of 2020 were $15.6 million, compared to $14.4 million for the second quarter of 2019. The increase in year-over-year R&D expenses was due to higher expenses associated with initiatives to expand platelet label claims and development of our INTERCEPT red blood cell system. Year-to-date R&D expenses totaled $31.4 million compared to $27.9 million for the first half of 2019.

Net Loss

Net loss for the second quarter of 2020 was $14.9 million, or $0.09 per diluted share, compared to a net loss of $17.6 million, or $0.13 per diluted share, for the second quarter of 2019. Year-to-date net loss was $31.3 million, or $0.19 per diluted share, compared to $36.4 million, or $0.26 per diluted share, in the first half of 2019.

Cash, Cash Equivalents and Investments

At June 30, 2020, the Company had cash, cash equivalents and short-term investments of $136.5 million, compared to $85.7 million at December 31, 2019.

At June 30, 2020, the Company had approximately $39.5 million in outstanding term loan debt, compared to $39.4 million in outstanding term loan debt at December 31, 2019.

2020 Product Revenue Guidance

The Company expects 2020 product revenue to be in the range of $89 million to $93 million, unchanged from the guidance originally provided on January 13, 2020. The guidance range represents approximately 20% to 25% growth compared to 2019 reported product revenue.

QUARTERLY CONFERENCE CALL

The Company will host a conference call and webcast at 4:30 P.M. EDT this afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook. To listen to the live webcast and view the presentation slides, please visit the Investor Relations page of the Cerus website at View Source Alternatively, you may access the live conference call by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).

A replay will be available on the Company’s website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 6681405. The replay will be available approximately three hours after the call through August 18, 2020.

On August 4, 2020 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage company developing highly differentiated agents that target the underlying mechanisms of cancer, reported financial results and corporate update for the three months ended June 30, 2020 (Press release, Aptose Biosciences, AUG 4, 2020, View Source [SID1234562865]).

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The net loss for the quarter ended June 30, 2020 was $15.8 million ($0.21 per share) compared with $6.2 million ($0.13 per share) for the quarter ended June 30, 2019. Total cash and cash equivalents and investments as of June 30, 2020 were $82.7 million. Based on current operations, we expect that cash on hand and proceeds from the recent public offering provide the Company with sufficient resources to fund all planned operations including research and development into 2023.

"Aptose’s two distinctive clinical assets, CG-806 and APTO-253, are advancing well through dose escalation in their respective clinical trials, both with signs of pharmacologic activity and favorable safety and tolerability to date," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer. "For CG-806 in particular, we believe these higher doses provide momentum toward the goal of delivering responses in R/R-CLL patients. Plus, with the FDA’s recent allowance of our IND for CG-806 in AML patients at a potentially therapeutic starting dose of 450 mg BID, we continue to execute on our broad strategic plan and are hopeful that CG-806 will deliver benefit to yet another fragile patient population in great need of new therapies."

Key Corporate Highlights

CG-806 Phase 1 a/b B-cell Malignancy Clinical Study – Aptose has completed dose level four (600 mg BID dose cohort) of the CG-806 trial in patients with CLL and other B-cell malignancies. The safety review committee then advanced CG-806 to the fifth dose level of 750 mg BID, and potential patients are being screened for enrollment into this cohort. To date, CG-806 continues to be well-tolerated, and initial indications of desired pharmacologic activity continue to be observed, including strong inhibition of multiple oncogenic driver kinases and a robust increase in peripheral blood lymphocytes – or lymphocytosis – classically ascribed as a response to the inhibition of BTK. Currently, 23 U.S. sites are open for screening and enrolling patients for the study, and more information is available at www.clinicaltrials.gov.

FDA Allowance of IND for CG-806 in AML – In June, Aptose announced that the U.S. Food and Drug Administration (FDA) allowed the company’s Investigational New Drug (IND) application for the initiation of a Phase 1a/b clinical study of CG-806, the company’s highly potent, oral FLT3/BTK inhibitor, in patients with acute myeloid leukemia (AML). Importantly, the desired starting dose of 450mg BID was allowed, as this dose is expected to be pharmacologically active in patients with FLT3 mutated AML. Aptose is working with key AML sites to start enrollment for this study (NCT04477291) in late Q3. Despite recent advances in the treatment of AML, many patients continue to have a poor overall prognosis. CG-806 is the only BTK inhibitor that also possesses strong FLT3 inhibitory activity and is applicable therefore to both lymphoid and myeloid malignancies.

APTO-253 Phase 1b Clinical Study – Aptose recently completed dose level four (100 mg/m2) of the APTO-253 study in patients with AML and MDS and the safety review committee then escalated dosing to 150 mg/m2. Approval of the current protocol amendment with accelerated dosing will allow enrollment at 8 sites. APTO-253 is the only known clinical-stage molecule that can directly target and inhibit expression of the MYC oncogene, shown to reprogram survival signaling pathways and contribute to drug resistance in many malignancies, including AML and B cell malignancies. In the ongoing Phase 1b trial, Aptose has observed MYC suppression in the peripheral blood mononuclear cells (PBMCs) from treated patients with AML and MDS. More information is available at www.clinicaltrials.gov.

Public Offering of Common Shares – In July, Aptose completed an underwritten public offering of 10,500,000 common shares (the "Offering") at the public offering price of US$5.25 per share. Piper Sandler & Co. acted as the sole active book-running manager for the Offering and has been granted a 30-day option to purchase up to an additional 1,575,000 common shares in the Offering, under the same terms and conditions. Gross proceeds from the Offering, before deducting underwriting discounts and commissions and estimated offering expenses payable by Aptose, are approximately US$55.125 million.

The net loss for the three-month period ended June 30, 2020 increased by $9.5 million to $15.8 million as compared with $6.2 million for the comparable period in 2019, primarily as a result of an increase of $7.1 million in stock-based compensation in the current period, a combined increase in program costs and related labor costs of approximately $2.6 million on our CG-806 and APTO-253 development programs, and offset by lower general and administrative expenses, after adjusting for stock option compensation, of $185 thousand.

The net loss for the six-month period ended June 30, 2020 increased by $15.6 million to $27.3 million as compared with $11.7 million for the comparable period, primarily as a result of an increase of $10.9 million in stock-based compensation in the current period, a combined increase in program costs and related labor costs of approximately $4.5 million on our CG-806 and APTO-253 development programs, and higher cash-based general and administrative expenses of $384 thousand. These expenses were partially offset by an increase in net finance income of $217 thousand in the current period compared to the comparative period, mostly as a result of higher interest earned on larger balances of cash equivalents and investments held during the six-month period ended June 30, 2020.

Research and development expenses increased by $3.4 million to $6.9 million for the three-month period ended June 30, 2020 as compared with $3.5 million for the comparative period. Changes to the components of our research and development expenses presented in the table above are primarily as a result of the following events:

Program costs for CG-806 increased by approximately $2.1 million, mostly as a result of higher manufacturing costs, including costs to scale up manufacturing and research costs associated with optimizing the formulation, higher costs associated with the CG-806 Phase 1a/b trial, and the costs associated with start-up for the CG-806 AML trial.

Personnel-related expenses increased by $392 thousand, mostly related to new positions hired since the second quarter of 2019 to support the conduct of the CC-806 Phase 1a/b and APTO-253 Phase 1b clinical trials, and start-up of the CG-806 AML Phase 1 a/b clinical trial.

Stock-based compensation increased by approximately $776 thousand in the three months ended June 30, 2020, compared with the three months ended June 30, 2019, mostly related to an increase in the number of options granted during the six months ended June 30, 2020 and a higher grant date fair value of options as compared with the six months ended June 30, 2019.
Research and development expenses increased by $6.0 million to $12.8 million for the six-month period ended June 30, 2020 as compared with $6.8 million for the comparative period for the same reasons as described above for the three-month period ended June 30, 2020.

General and administrative expenses for the three-month period ended June 30, 2020 were $9.0 million as compared with $2.9 million for the comparative period, an increase of approximately $6.2 million. The increase was primarily as a result of the following:

General and administrative expenses, other than stock-based compensation and depreciation of equipment, decreased by approximately $185 thousand in the three months ended June 30, 2020, primarily as a result of lower financing costs in the current period, offset by higher personnel related costs mostly related to two additional hires, including a Chief Business Officer, in the second quarter of 2019, higher insurance and professional and regulatory costs, and higher office administrative costs.

Stock-based compensation increased by approximately $6.4 million in the three months ended June 30, 2020, compared with the three months ended June 30, 2019 mostly related to an increase in the number of restricted share units (RSUs) and options granted during the six-month period ended June 30, 2020, and a higher grant date fair value of options as compared with June 30, 2019.
General and administrative expenses for the six-month period ended June 30, 2020 were $14.9 million as compared with $5.1 million for the comparative period, an increase of approximately $9.8 million. The increase was primarily as a result of the following:

General and administrative expenses, other than stock-based compensation and depreciation of equipment, increased by approximately $384 thousand in the six months ended June 30, 2020 primarily as a result of higher personnel related costs mostly related to two additional hires, including a Chief Business Officer, in the second quarter of 2019, higher insurance and professional and regulatory costs, and higher office administrative costs.

Stock-based compensation increased by approximately $9.4 million in the six months ended June 30, 2020, compared with the six months ended June 30, 2019 for the same reasons as described above for the three-month period ended June 30, 2020.
COVID-19 did not have a significant impact on our results of operations for the quarter ended June 30, 2020; although the pandemic did necessitate reconfiguration of office space and the introduction of numerous policies and processes to ensure safety of employees and guests. We have not experienced and do not foresee material delays to the enrollment of patients or timelines for the CG-806 Phase 1a/b trial due to the variety of clinical sites that we have actively recruited for this trial. APTO-253 is administered intravenously, which requires the need for hospital / clinical site resources to assist and monitor patients during each infusion and based on the current conditions caused by COVID-19, future enrollment of patients on this trial is likely to be negatively impacted. Monitoring across all ongoing and planned studies will be impacted by COVID-19, necessitating more remote visits versus on-site; risk-based monitoring plans will minimize the impact on deliverables. As of the date of this report, we have not experienced material delays in the manufacturing of CG-806 or APTO-253 related to COVID-19. Should our manufacturers be required to shut down their facilities due to COVID-19 for an extended period of time, our trials may be negatively impacted.

Conference Call and Webcast

Aptose will host a conference call to discuss results for the quarter ended June 30, 2020 today, Tuesday, August 4, 2020 at 5:00 PM ET. Participants can access the conference call by dialing 1-844-882-7834 (North American toll-free number) and 1-574-990-9707 (international/toll number) and using conference ID # 8367033. The conference call can be accessed here and will also be available through a link on the Investor Relations section of Aptose’s website at View Source An archived version of the webcast along with a transcript will be available on the Company’s website for 30 days. An audio replay of the webcast will be available approximately two hours after the conclusion of the call for seven days by dialing 1-855-859-2056 (toll free number) and 1-404-537-3406 (international/toll number), using the conference ID # 8367033.

On August 4, 2020 Menarini Silicon Biosystems, the pioneer of liquid biopsy technology, reported two new studies describing genetic changes in circulating cancer cells that may improve cancer prognosis and help guide treatment (Press release, Menarini Silicon Biosystems, AUG 4, 2020, View Source [SID1234562854]). These studies were presented as posters at the June 22-24 virtual annual meeting II of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) . Menarini’s CELLSEARCH and DEPArrayTM NxT technologies were used to capture and isolate the circulating tumor cells for analysis. In one study, Massimo Cristofanilli, M.D., F.A.C.P., Associate Director of Translational Research at the Robert H. Lurie Cancer Center of Northwestern University, and colleagues collected blood samples from 239 patients with stage III/IV breast cancer, then isolated and selected more than 200 individual tumor cells from patients with HER2+ cells*. The scientists then sequenced the genetic codes of each of those cells.

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Previously, Dr. Cristofanilli had shown that one specific genetic change in circulating tumor cells, the overexpression of a gene called HER2, was associated with more aggressive metastatic cancer and a worse prognosis. The new study revealed additional genetic alterations that occur more frequently in metastatic breast cancer cells, the most important being a genetic variant called the PTPN1 mutation.

"The new findings are exciting because they deepen our understanding of the mechanisms underlying the critical process of cancer metastasis," said Dr. Cristofanilli. "The genetic alterations we found also could lead to the development of drugs that specifically target the mutations to improve the treatment of this deadly disease."

In the second study, scientists led by Claudio Forcato, PhD, head of the Bioinformatics Unit at Menarini Silicon Biosystems, captured, isolated, and sequenced circulating cancer cells from three patients with multiple myeloma*. They then looked for a genetic phenomenon called "loss-of-heterozygosity" (LoH), in which one of the two alleles that are normally found at a specific spot in the genetic code is lost. They found such LoH events in the cancer cells from all of the multiple myeloma patients. "Our results suggest that loss-of-heterozygosity may be pervasive in multiple myeloma, and may offer a prognostic and predictive biomarker for the disease," explained Dr. Forcato.

"These two new studies show how our technologies are advancing the understanding of cancers like metastatic breast cancer and multiple myeloma, and may lead to improved, more personalized treatment options for patients with these diseases," said Fabio Piazzalunga, President and CEO of Menarini Silicon Biosystems, Inc.

CELLSEARCH** is the first and only clinically validated blood test cleared by the U.S. Food & Drug Administration (FDA) for detecting and counting CTCs to aid physicians in managing patients with metastatic breast, prostate, and colorectal cancers when used in conjunction with other clinical methods of monitoring. The test is also approved by the China Food & Drug Administration for use in monitoring patients with Metastatic Breast Cancer (MBC). The CELLSEARCH System is the most extensively studied CTC technology, with research published in more than 650 peer-reviewed publications.

DEPArray NxT is an image-based digital cell-sorting and isolation platform that enables clinical researchers to conduct molecular analyses on live or fixed cells with single-cell precision.

On August 4, 2020 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported its financial results and operational highlights for the quarter ended June 30, 2020 (Press release, Oncolytics Biotech, AUG 4, 2020, View Source [SID1234562853]). All dollar amounts are expressed in Canadian currency unless otherwise noted.

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"I’m thrilled with the progress made by Oncolytics last quarter, as we achieved numerous value-creating clinical milestones despite the unpredictable challenges presented by COVID-19," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech Inc. "Importantly, we collected critical mechanistic, biomarker, and proof of concept data that advanced our lead breast cancer program. We initiated dosing in our phase 2 BRACELET-1 trial and are enrolling patients in our AWARE-1 study following an expansion in the number of study sites. I am particularly pleased with recent AWARE-1 data presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Breast Cancer Meeting, which confirm pelareorep’s mechanism of action and highlight its potential to synergistically combine with checkpoint inhibitors and increase the number of patients responding to such therapies. Notably, these data provide strong support for the anticipated success of our BRACELET-1 trial and our recently announced phase 2 IRENE trial, which aims to demonstrate the applicability of pelareorep to an additional disease subtype by evaluating the safety and efficacy of pelareorep-anti-PD-1 combination treatment in triple-negative breast cancer patients."

Dr. Coffey continued, "Alongside the progress made in breast cancer, we also advanced our hematological and gastrointestinal cancer programs. Clinical proof-of-concept data presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting showed that pelareorep-carfilzomib combination therapy led to a compelling association between clinical and anti-tumor inflammatory response in multiple myeloma patients. When considered with earlier data, these results support our ongoing multiple myeloma trial investigating pelareorep-carfilzomib-checkpoint inhibitor combination therapy. Further, we announced encouraging clinical results in second-line pancreatic cancer patients demonstrating pelareorep-induced expansion and creation of T cell clones in the peripheral blood. Taken together, these compelling data demonstrate the significant progress made last quarter to deepen Oncolytics’ pipeline as we target the broad commercial opportunity offered by pelareorep’s continued development."

Second Quarter Highlights

Clinical Highlights

Presented Clinical Findings of Pelareorep-Induced Immune Responses in Multiple Breast Cancer Subtypes

Newly announced AWARE-1 data presented at the ESMO (Free ESMO Whitepaper) Breast Cancer Meeting showed that systemic pelareorep administration increased tumor PD-L1 expression, infiltration of tumor immune lymphocytes, and CelTIL (a measurement of tumor-associated cellularity and tumor-infiltrating lymphocytes). These data demonstrate that pelareorep induces adaptive as well as innate immune responses and support the observed survival benefit in a previous randomized phase 2 study of pelareorep in metastatic breast cancer patients. Data also showed that changes in the tumor microenvironment and CelTIL (which is associated with favorable clinical response) correlated with peripheral T cell clonality, supporting its potential as a biomarker of pelareorep response that may aid in future registrational trial study design and patient selection.

Key Opinion Leader Call Highlighting Compelling AWARE-1 Data

The call featured Dr. Aleix Prat, M.D., Ph.D., Head of Medical Oncology at the Hospital Clínic of Barcelona, Associate Professor of the University of Barcelona, Head of the Translational Genomics and Targeted Therapeutics in Solid Tumors Group at August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Chair of SOLTI and lead translational investigator of the AWARE-1 study. On the call, Dr. Prat highlighted how AWARE-1 data showing a pelareorep-induced increase in tumor PD-L1 expression demonstrate the synergistic potential between pelareorep and checkpoint inhibitor therapies. Dr. Prat also noted how such data addresses a critical unmet need, as many patients are ineligible for (and fail to respond to) checkpoint inhibitor-based therapies due to an immunosuppressive tumor microenvironment and low PD-L1 expression.

Initiation of Dosing in Phase 2 BRACELET-1 Study

Oncolytics advanced its lead breast cancer program with the dosing of the first patient in BRACELET-1, a randomized phase 2 study being conducted under a co-development agreement with Merck KGaA (Darmstadt, Germany) and Pfizer. BRACELET-1 is designed to generate mechanistic data supporting the results of a prior successful phase 2 trial that showed a near doubling of overall survival with pelareorep treatment and to evaluate the ability of pelareorep-induced immune responses to enhance anti-PD-L1 therapy. Importantly, the study also seeks to validate peripheral T cell clonality as a biomarker of pelareorep response in HR+/HER2- metastatic breast cancer, which may aid in future registrational trial study design and patient selection.

Announced Investigator Sponsored Phase 2 Trial in Triple-Negative Breast Cancer (TNBC)

The newly announced multi-center study represents an expansion of Oncolytics’ lead breast cancer program into a new disease subtype. The trial, known as IRENE, will investigate the use of pelareorep in combination with Incyte’s anti-PD-1 checkpoint inhibitor retifanlimab (INCMGA00012) in patients with unresectable locally advanced or metastatic TNBC. In addition to investigating the safety and efficacy of pelareorep-anti-PD-1 combination treatment in TNBC patients, the study will also evaluate changes in PD-L1 expression and correlations between treatment outcomes and peripheral T cell clonality.

Presented New Clinical Proof-of-Concept Data at the ASCO (Free ASCO Whitepaper) Virtual Meeting

The recently announced phase 1b data showed that pelareorep when combined with carfilzomib, activated a profound inflammatory response accompanied by a 50% overall response rate and an 83% clinical benefit rate in patients with challenging to treat carfilzomib-refractory multiple myeloma. The data also showed the first reported incidence of cytokine stimulation associated with tumor response in multiple myeloma, highlighting the ability of pelareorep to induce robust immune cell activation and tumor lysis. Taken together with earlier data from the trial demonstrating pelareorep-induced upregulation of PD-L1 expression, the recently announced results support the success of Oncolytics’ ongoing trial investigating pelareorep-carfilzomib-checkpoint inhibitor combination therapy for the treatment of multiple myeloma.

Reported Encouraging Clinical Results in Second-line Pancreatic Cancer Patients

An abstract published as part of the 2020 ASCO (Free ASCO Whitepaper) Annual Meeting showed that pelareorep-pembrolizumab combination therapy was well tolerated and resulted in tumor-specific replication, a high degree of T cell repertoire turnover, and the creation of new T cell clones in the peripheral blood of second-line pancreatic cancer patients. Oncolytics plans to publish detailed translational and biomarker data from the study in the first half of 2021.

Upcoming & Anticipated Milestones

Dosing of the first patient in phase 2 IRENE study in TNBC: H2 2020
Announcement of final data from Phase 2 NU 18I01 second line pancreatic cancer study*: H1 2021
Oncolytics expects to provide updates on the timing of the following milestones over the coming months:

Announcement of interim data from Phase 1 WINSHIP 4398-18 multiple myeloma study
Interim safety update for phase 2 BRACELET-1 metastatic breast cancer study
Final biomarker data for AWARE-1 breast cancer study
Complete enrollment in phase 2 BRACELET-1 metastatic breast cancer study
Final data for phase 2 BRACELET-1 metastatic breast cancer study
*Guidance provided by clinical investigators

Corporate Highlights

Established New At-The-Market (ATM) Facility

The ATM provides Oncolytics with the option to efficiently approach financial markets as needed to support ongoing business development activities and clinical trials while bolstering management’s ability to negotiate potential business development agreements from a position of financial strength. The company has no obligation to sell any shares pursuant to the ATM.

Update on COVID-19

Company Continues to Efficiently Execute Business Continuity Plan

Oncolytics has developed a robust business continuity plan to ensure the safety of patients, employees, and investigators, as well as the productivity of our clinical programs. We expect that the continued execution of this plan will allow the Company to build on the positive momentum of last quarter, despite any COVID-19-related challenges that may arise. Moving forward, we will remain in contact with relevant stakeholders and will keep the market apprised of any new information that may impact clinical timelines.

Subsequent to Quarter End

Appointed Thomas C. Heineman, M.D., Ph.D., as Global Head of Clinical Development and Operations

On August 1, 2020, Oncolytics appointed Thomas C. Heineman, M.D., Ph.D., as the Company’s Global Head of Clinical Development and Operations. Dr. Heineman has extensive experience leading clinical development at biotech companies, most recently serving as Senior Vice President and Head of Clinical Development at Denovo Biopharma. Prior to his time at Denovo, Dr. Heineman served as Vice President and Head of Clinical Development at Genocea Biosciences and Halozyme Therapeutics, where he was also the Head of Translational Medicine. Dr. Heineman’s experience further extends into big pharma and academia, as he has previously held roles as Senior Director, Global Clinical Research and Development at GlaxoSmithKline and as an Associate Professor at the Saint Louis University School of Medicine. At Oncolytics, Dr. Heineman will be taking over the responsibilities of former Chief Medical Officer Dr. Rita Laeufle, who is no longer with the Company.

Financial Highlights

As of June 30, 2020, the Company reported $29.9 million in cash and cash equivalents. The Company raised $6.4 million during the second quarter through the issuing of common stock through our ATM facility.
Operating expense for the second quarter of 2020 was $3.0 million, compared to $1.8 million in the second quarter of 2019.
R&D expense for the second quarter of 2020 was $2.5 million, compared to $3.4 million in the second quarter of 2019.
Net cash used in operating activities for the second quarter of 2020 was $6.3 million, compared to $4.7 million for the second quarter of 2019.
The net loss for the second quarter of 2020 was $6.8 million, compared to a net loss of $5.3 million in the second quarter of 2019. The basic and diluted loss per share was $0.17 in the second quarter of 2020, compared to a basic and diluted loss per share of $0.26 in the second quarter of 2019.
Webcast and Conference Call

Management will host a conference call for Analysts and Institutional Investors at 4:30 pm ET, today, August 4, 2020. To access the call please dial (866)-269-4261 (United States) or (323)-347-3612 (international) and provide the Conference ID 2366778. A live webcast of the call will also be available on the Investor Relations page of Oncolytics’ website (LINK) and will be archived for three months.

About BRACELET-1

The BRACELET-1(BReast cAnCEr with the Oncolytic Reovirus PeLareorEp in CombinaTion with anti- PD-L1 and Paclitaxel) study is an open-label, phase 2, randomized study in patients with HR+/HER2-, endocrine-refractory metastatic breast cancer being conducted under a co-development agreement with Merck KGaA, Darmstadt, Germany and Pfizer. PrECOG LLC, a leading cancer research network, is managing the study. The study will take place at 20 trial sites and enroll 45 patients randomized into three cohorts. A three patient safety run-in will be conducted with patients receiving pelareorep, paclitaxel, and avelumab prior to randomization. The three cohorts will be treated as follows:

Cohort 1 (n=15): paclitaxel
Cohort 2 (n=15): paclitaxel + pelareorep
Cohort 3 (n=18): paclitaxel + pelareorep + avelumab (Bavencio)
Patients in cohort 1 will receive paclitaxel on days 1, 8, and 15 of a 28-day cycle. Patients in cohort 2 will receive the same paclitaxel regimen as cohort 1, plus pelareorep on days 1, 2, 8, 9, 15 and 16 of the 28-day cycle. Patients in cohort 3 will receive the same combination and dosing regimen as cohort 2, plus avelumab on days 3 and 17 of the 28-day cycle. The primary endpoint of the study is overall response rate. Exploratory endpoints include peripheral and tumor T cell clonality, inflammatory markers, and safety and tolerability assessments.

For more information about the BRACELET-1 study, refer to clinicaltrials.gov (NCT04215146).

About AWARE-1

AWARE-1 is an open label window-of-opportunity study in early-stage breast cancer enrolling 38 patients into five cohorts:

Cohort 1 (n=10), HR+ / HER2- (pelareorep + letrozole)
Cohort 2 (n=10), HR+ / HER2- (pelareorep + letrozole + atezolizumab (Tecentriq))
Cohort 3 (n=6), TNBC (pelareorep + atezolizumab)
Cohort 4 (n=6), HR+ / HER2+ (pelareorep + trastuzumab + atezolizumab)
Cohort 5 (n=6), HR- / HER2+ (pelareorep + trastuzumab + atezolizumab)
The study combines pelareorep with the standard of care according to breast cancer subtype and atezolizumab. Patients are biopsied on day one followed immediately by treatment, then again on day three, and a final biopsy after three weeks, on the day of their mastectomy. Data generated from this study is intended to confirm that the virus is acting as a novel immunotherapy and to provide comprehensive biomarker data by breast cancer subtype. The primary endpoint of the study is overall CelTIL (a measurement of cellularity and tumor-infiltrating lymphocytes). Secondary endpoints for the study include CelTIL by breast cancer subtype, safety and tumor, and blood-based biomarkers.

For more information about the AWARE-1 study, refer to clinicaltrials.gov (NCT04102618).

About IRENE

The IRENE (INCMGA00012 and the oncolytic virus pelareorep in metastatic triple-negative breast cancer) study is a single-arm, open-label, phase 2 study evaluating the combination of pelareorep and INCMGA00012 for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer. The study will enroll 25 patients and will be conducted at the Rutgers Cancer Institute of New Jersey and The Ohio State University Comprehensive Cancer Center.

Study participants will receive pelareorep intravenously on days 1, 2, 15, and 16 of 28-day treatment cycles. INCMGA00012 will be administered on day 3 of each cycle, with treatment cycles continuing until disease progression is observed. The co-primary endpoints of the study are safety and objective response rate. Secondary endpoints include progression free survival, overall survival, and duration of response. Exploratory endpoints include peripheral T cell clonality and pre- vs. post-treatment change in tumor PD-L1 expression.

For more information on the IRENE study, refer to clinicaltrials.gov (NCT04445844).

About Breast Cancer

Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent of all cancers in women. Incidence rates vary widely across the world, from 27 per 100,000 in Middle Africa and Eastern Asia to 85 per 100,000 in Northern America. It is the fifth most common cause of death from cancer in women globally, with an estimated 522,000 deaths.

Breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The malignant tumor (cancer) is getting worse when the cells grow into (invade) surrounding tissues or spread (metastasize) to distant areas of the body.

About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

On August 4, 2020 Oxford Biomedica plc (LSE:OXB) ("Oxford Biomedica" or "the Group"), a leading gene and cell therapy group, reported that it has signed a new Development, Manufacture & License Agreement ("DMLA") with Beam Therapeutics Inc. ("Beam") (Nasdaq: BEAM), a Cambridge, Mass.-based biotechnology company developing precision genetic medicines through the use of base editing (Press release, Oxford BioMedica, AUG 4, 2020, View Source [SID1234562852]). The DMLA grants Beam a non-exclusive license to Oxford Biomedica’s LentiVector platform for its application in next generation CAR-T programmes in oncology and puts in place a three year Clinical Supply Agreement.

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Under the terms of the DMLA, Oxford Biomedica will receive an undisclosed upfront payment, as well as payments related to development and manufacturing of lentiviral vectors for use in clinical trials, and certain development and regulatory milestones for products sold by Beam that utilise Oxford Biomedica’s LentiVector platform and an undisclosed royalty on the net sales of products sold by Beam that utilise the Group’s LentiVector platform.

Oxford Biomedica is currently working on one pre-clinical programme with Beam, and the Agreement allows for the Parties to initiate additional projects in the future.

John Dawson, Chief Executive Officer of Oxford Biomedica, said: "Beam Therapeutics is one of the leading next-generation CAR-T developers who deploy a wide range of innovative technologies to bring innovative CAR-T products into development. We are proud to be working with a leader in the field of gene editing technologies, including base editing, and this provides us another valuable opportunity for our LentiVector platform to support innovative product development of CAR-T products.

"This is our third announced partnership with leaders in the CAR-T field, building on our longstanding partnership with Novartis and our more recently announced partnership with Bristol Myers Squibb earlier this year. We look forward to supporting the next generation CAR-T programmes at Beam."