On November 12, 2020 Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs), reported financial and operating results for its second quarter ended September 30, 2020 (Press release, TYME, NOV 12, 2020, View Source [SID1234570830]). During the quarter, TYME revealed a potential new therapeutic approach in the fight against COVID-19; was granted orphan drug designation for SM-88 as a potential treatment for patients with pancreatic cancer; expanded its body of peer-reviewed publications on SM-88 and clinical significance in treating advanced cancers; continued enrolling patients in multiple studies including, second and third-line pancreatic cancer trials and the HopES Sarcoma Phase II trial; advanced planning for clinical trials in metastatic breast cancer and hematological cancers; and continued ongoing preclinical studies.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our second quarter performance accurately reflects TYME’s commitment to achieve our corporate goals and objectives in the interest of all stakeholders as we navigate the unknown impact of the ongoing COVID-19 pandemic." said Steve Hoffman, Chairman and Chief Executive Officer of TYME. "We continue to make important progress across our cancer metabolism pipeline and in the critical work at hand to advance the development of TYME-19 as a potential new therapeutic approach for patients in need in the fight against COVID-19."

Second Quarter Fiscal 2021 Financial Results

As of the second quarter ended September 30, 2020, the Company had approximately $19.4 million in cash and cash equivalents compared to $21.3 million as of the first quarter ended June 30, 2020.

TYME’s operational cash burn rate for the second quarter of fiscal year 2021 was $6.6 million compared to $6.7 million for the first quarter of fiscal year 2021 and $4.2 million for the second quarter of fiscal year 2020. The burn rate was generally consistent with our previous projections and predominantly reflected costs associated with the ongoing clinical trials in pancreatic and sarcoma cancers as well as the increased supply build to support these ongoing trials. Based on active clinical trials and other business developments, TYME continues to anticipate that its quarterly cash usage, or "cash burn rate", will average between $6.0 to $7.0 million per quarter for fiscal year 2021.

Anticipated Upcoming Key Events

The extent to which COVID-19 impacts TYME’s development of product candidates and business, including patients’ willingness to participate and/or remain in clinical trials, the timing of meeting enrollment expectations, the ability of third-party partners to remain operational and TYME’s access to capital markets and financing sources depends on numerous evolving factors that are highly uncertain and cannot be accurately predicted. To that end, TYME currently expects the following key events in fiscal year 2021:

Initiate the proof-of-concept RESPOnD trial to evaluate TYME-19 as a potential new approach against COVID-19; expect data readout in first half of calendar year 2021
Continue to advance enrollment in TYME-88-Panc pivotal study; primarily because of unpredictable pandemic-related delays, full enrollment and data readout are not expected before calendar year 2022
Continue to advance enrollment in the HopES Sarcoma Phase II Trial; expect data readout in calendar year 2021
Continue to advance enrollment in PanCAN’s Precision PromiseSM adaptive randomized Phase II/III registration-intent trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy; expect data readout in calendar year 2022
Publish preclinical findings on TYME-19
Initiate plans for SM-88 clinical programs into other tumor types potentially including metastatic breast, recurrent prostate and/or hematological cancers
Present and/or publish data from Part 1 of TYME-88-Panc study
Continue proof-of-concept and IND-enabling activities for TYME-18
Evaluate opportunity in PanCAN’s Precision PromiseSM adaptive Phase II/III trial investigating SM-88 in patients with first-line pancreatic cancer in combination with gemcitabine and Abraxane
Corporate Developments

On August 19, 2020, the Company announced the appointment of John Rothman Ph.D. as Executive Vice President, Product Development. Dr. Rothman has more than 30 years of experience in product development across many disciplines and markets. He was a clinical scientist at the pharmaceutical companies, Schering Plough and Roche, where he was also a clinical director for a number of different therapeutic areas and senior director for all of Roche’s data acquisition, statistical analysis and report writing for all experimental and approved drugs in the Roche portfolio. His work on Interferon-α in AIDs-related Kaposi’s Sarcoma resulted in the approval of first recombinant drug and AIDS treatment called Referon-A.

Dr. Rothman later held R&D director positions at Roche and was associated with a number of development programs that resulted in marketed drugs, including Rocephin, Coactin, Rimadyl, Larotid, Dalmane, Rimantidine, Gantrisin, Versed and more. Dr. Rothman was later an executive vice president of science and operations at the biotech company, Advaxis, where he was responsible for R&D, toxicology, regulatory, chemistry, data management, manufacturing and intellectual property. Dr. Rothman has since held chief executive roles with several biopharmaceutical companies. Also, previously, during his career, Dr. Rothman filed numerous patents and managed a portfolio of over 80 issued patents and patent applications.

On September 15, 2020, Ben R. Taylor gave notice of his decision to resign as President and Chief Financial Officer of the Company. Mr. Taylor’s resignation was effective September 30, 2020, and he is currently serving in a consulting role with the Company until November 30, 2020, providing certain financing and strategic consulting4 services.

Summary of Recent Developments

TYME’s Phase II Prostate Cancer Study Evaluating SM-88 in Patients with Non-Metastatic Recurrent Prostate Cancer Published in the Journal, Investigational New Drugs

On September 15, 2020, TYME announced that the final results of its SM-88 Phase II Prostate Cancer study designed to evaluate the safety, tolerability and efficacy of SM-88 in patients with non-metastatic biochemical recurrent prostate cancer, were published on September 13, 2020 in the peer-reviewed journal Investigational New Drugs. The article, titled "Phase II Trial of SM-88, a Cancer Metabolism Based Therapy, in Non-Metastatic Biochemical Recurrent Prostate Cancer," is available online at View Source

The study demonstrated that SM-88 had promising efficacy and safety outcomes for prostate cancer patients while sparing testosterone. The study also demonstrated a reduction of circulating tumor cells (CTCs), an important prognostic indicator, that may prove to be a better surrogate for patient outcomes than prostate-specific antigen (PSA), particularly for SM-88. Highlights of the study were as follows:

The Phase II Prostate Cancer study demonstrated that oral SM-88 (racemetyrosine) was associated with disease control while maintaining quality of life
Based on study results, SM-88 may have a clinically meaningful role in postponing medical castration in prostate cancer patients with rising PSA
At 6 months, 100% of patients (23/23) were free of metastatic progression, and 87% of patients (20/23) remained free of any radiographic progression
After 12 weeks, 78% of patients (18/23) demonstrated a 65% decrease in median Circulating Tumor Cells from baseline
52% of patients (12/23) showed improvement in median PSA doubling time
No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months
TYME is evaluating regulatory strategies in the interest of advancing SM-88 for patients with non-metastatic recurrent prostate cancer

TYME’s Oncology Research Reveals Potential New Oral Therapy TYME-19 in the Fight Against COVID-19

On August 26, 2020, TYME announced a potential new approach to treating COVID-19 using a metabolic agent, TYME-19. TYME-19 is a synthetic bile acid, a family of metabolic agents that the Company also uses in its anticancer compound, TYME-18. Because of its expertise in metabolic therapies, the Company was able to quickly identify TYME-19 as a potent, well characterized antiviral bile acid and has performed preclinical experiments establishing effectiveness against COVID-19. Bile acids have primarily been used for liver disease; however, they represent a family of critical cellular regulators across cardiovascular, neurologic, and metabolic systems1,2, with some also having antiviral properties.

In preclinical testing, TYME-19 repeatedly prevented COVID-19 viral replication without cytotoxicity to the treated cells. Previous preclinical research has also shown select bile acids like TYME-19 have had broad antiviral activity. TYME-19 is part of a family of metabolic agents called bile acids that have formerly been associated with liver disease but are becoming recognized for their potential utility to treat multiple diseases. TYME believes it is emerging as a leader in the development of bile acids as potential therapies for cancer and COVID-19.1

TYME has partnered with physicians from Massachusetts General Hospital and the Weill Cornell Medical Center to design a trial for recently diagnosed, symptomatic patients. The proof-of-concept trial is expected to start as soon as customary trial site approvals are completed.

HopES Sarcoma Phase II Study Interim Futility Review Outcome

On August 11, 2020, TYME announced a positive outcome of an interim futility review for the investigator-initiated HopES Sarcoma Phase II clinical trial, sponsored by the Sarcoma Oncology Research Center, that is evaluating TYME’s lead cancer metabolism-based candidate, SM-88, as a potential oral treatment for patients with Ewing’s Sarcoma and other high-risk sarcomas.

The interim futility review was completed in late July and, based on the analysis of the data and recommendations of Sant Chawla, M.D., founder of the Sarcoma Oncology Center, Santa Monica, CA and principal investigator for the HopES Sarcoma trial, the study will proceed with the current trial design as planned. The next major milestone in the HopES Sarcoma trial is expected in calendar year 2021. Sarcomas represents a great unmet medical need and significant opportunity for all stakeholders. There are more than 12,000 patients diagnosed each year without meaningful treatment options.

The HopES Sarcoma trial is a prospective open-label Phase II trial evaluating the efficacy and safety of SM-88, with the conditioning agents methoxsalen, phenytoin and sirolimus, in two cohorts of patients. Up to 24 evaluable patients (12 per cohort) will be enrolled. The trial’s primary objectives are to measure efficacy events, including overall response, stable disease and progression free survival. Secondary objectives include duration of response, overall survival, clinical benefit rate using response evaluation criteria in solid tumors (RECIST 1.1), and incidence of treatment-emergent adverse events.

TYME Announced Orphan Drug Designation for SM-88 as Potential Treatment for Patients with Pancreatic Cancer

On August 3, 2020, TYME announced that the U.S. Food and Drug Administration ("FDA") had granted it Orphan Drug Designation for its lead pipeline candidate, SM-88 (racemetyrosine), as a potential treatment for patients with pancreatic cancer.

The FDA’s Office of Orphan Drug Products grants orphan status to support development of medicines for underserved patient populations, or rare disorders, that affect fewer than 200,000 people in the United States. Orphan Drug Designation provides certain benefits, including market exclusivity upon regulatory approval, if received, exemption of FDA application fees and tax credits for qualified clinical trials.

About SM-88

SM-88 is an oral investigational modified proprietary tyrosine derivative that is believed to interrupt the metabolic processes of cancer cells by breaking down the cells’ key defenses and leading to cell death through oxidative stress and exposure to the body’s natural immune system. Clinical trial data have shown that SM-88 has demonstrated encouraging tumor responses across 15 different cancers, including pancreatic, lung, breast, prostate and sarcoma cancers with minimal serious grade 3 or higher adverse events. SM-88 is an investigational therapy that is not approved for any indication in any disease. Learn more.

About TYME-18

TYME-18 is composed of a proprietary surfactant delivery agent with a specific sulfonic acid component.3 It is designed for intra-tumoral administration of difficult to treat tumors and leverages the acidic tumor microenvironment and signaling pathways to kill cancer cells. TYME-18 is distinct in composition, but like SM-88, aims to leverage susceptibilities of a cancer that are related to its altered metabolism. Initial preclinical data for TYME-18 in animal tumor models demonstrate rapid and complete tumor regression, with no reported local or systemic toxicities. TYME-18 continues to be studied as a potential therapy for difficult to treat tumors that may not be eligible for surgical or other interventions. Learn more.

About TYME-19

TYME-19 is a potent, well characterized synthetic antiviral bile acid that is being evaluated as a potential oral therapy for COVID-19. In preclinical testing, TYME-19 repeatedly prevented COVID-19 viral replication without attributable cytotoxicity in treated cells. Viruses, including COVID-19 hijack a cell’s ability to make proteins and lipids and divert these processes to make viral proteins and lipids in order to reproduce. Viruses accomplish this by inducing stress in the endoplasmic reticulum (ER), where cells process proteins, which enables a virus to remodel protein and lipid synthesis. In preclinical testing, TYME-19 has been shown to counteract these effects, preventing viral replication, by reducing ER stress.4,5 TYME-19 is believed to physically degrade viruses by solubilizing the protective lipid layer and other structural components, which prevent a virus from binding to and infecting a cell.

About TYME-88-Panc Pivotal Trial

The TYME-88-Panc pivotal trial applies the latest advances in the field of cancer metabolism by evaluating the efficacy and safety of an oral investigational compound that targets the metabolic mechanisms of the disease at its source. A prospective, open label pivotal trial in metastatic pancreatic cancer for patients who have failed two lines of any prior systemic therapy. The trial is designed to evaluate the safety and efficacy of SM-88 used with MPS (methoxsalen, phenytoin and sirolimus) in advanced pancreatic cancer and will measure multiple endpoints, including overall survival, progression free survival, relevant biomarkers, quality of life, safety, and overall response rate. Learn more.

On November 12, 2020 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that it will create a new Oncology Business Unit, effective April 1, 2021, aligning U.S and European oncology businesses, global oncology functions of marketing, market access and pricing, medical affairs as well as alliance management under one team singularly devoted to people with cancer (Press release, Daiichi Sankyo, NOV 12, 2020, https://www.businesswire.com/news/home/20201112005188/en/Daiichi-Sankyo-Creates-New-Business-Unit-to-Unify-Major-Oncology-Markets-into-One-Streamlined-Organization-Dedicated-to-Patients-with-Cancer [SID1234570829]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Ken Keller, currently leading the U.S. Business and CEO of the Company’s U.S. affiliates Daiichi Sankyo, Inc. and American Regent, Inc., will lead this new team as Head of the Oncology Business Unit, effective, April 1, 2021, and will remain President and CEO of Daiichi Sankyo, Inc. Paul Diolosa, currently Senior Vice President of Operations of American Regent, Inc., will succeed Mr. Keller as President and CEO of American Regent, Inc. as of April 1, 2021.

As oncology business growth will be driven primarily by the U.S. and Europe in the near-term, the Company will launch the Oncology Business Unit by combining these two markets.

"Daiichi Sankyo will accelerate one of the boldest strategies we have embarked upon – to realize our 2025 Vision "Global Pharma Innovator with competitive advantage in Oncology," said Sunao Manabe, President and CEO, Daiichi Sankyo Company, Ltd. "With our oncology portfolio putting this vision within reach, we must evolve our global management structure into one that will usher us into a successful long-term business dedicated to improving patients’ lives."

"The Oncology Business Unit will allow us to bring an unprecedented focus to respond to the rapid changes we see in standards of care, treatment and diagnoses patterns, and payer dynamics from both perspectives of business and science," said Ken Keller.

Ken Keller, who joined Daiichi Sankyo in 2014, has more than 30 years of experience in the pharmaceutical industry in general management, commercial, international and joint venture leadership, as well as chief operating officer experience in several therapeutic areas, including oncology, bone health, rheumatology, dermatology and primary care. Prior to joining the Daiichi Sankyo Group, Mr. Keller was the president and chief operating officer at Spectrum Pharmaceuticals and prior to that spent 21 years at Amgen. At Amgen, Keller was Vice President and General Manager leading a number of highly successful, high profile business units in the United States. Keller held roles of advancing responsibilities including Vice President of Oncology marketing and has significant international experience, having been Amgen’s Managing Director, UK and Ireland. Keller started his career as a professional sales representative.

On November 12, 2020 Australian clinical-stage drug development company Noxopharm (ASX: NOX) reported it has joined with Bristol Myers Squibb (NYSE: BMY) in an Australian pilot study investigating the ability of Noxopharm’s immunotherapy drug candidate, Veyonda, to overcome resistance to Bristol Myers Squibb’s nivolumab (Opdivo) in the treatment of cancer (Press release, Noxopharm, NOV 12, 2020, View Source [SID1234570828]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Veyonda is a first-in-class sphingosine-1-phosphate inhibitor with high selectivity for cancer cells. This mechanism of action yields a range of immunotherapeutic effects including restoration of immune function in tumors, commonly referred to as converting tumors from cold to hot.

The study, called IONIC-1, will investigate the ability of Veyonda to sensitize tumors to the PD-1 inhibiting actions of Opdivo. Approximately 30 cancer patients (e.g., melanoma, lung, and bladder cancers) will be involved, including those who have progressed on Opdivo, as well as Opdivo-naive patients (e.g., breast, ovarian, prostate cancers and sarcoma). It is anticipated that the first patients will be recruited early in the new year.

Immune checkpoint inhibitors such as Opdivo have revolutionized the treatment of some cancers with what can be dramatic, lifesaving benefits. However, most cancer types have proven to be resistant. Research points to a key limiting factor — the lack of competent immune function within cancer — with individual tumors actively expelling immune cells. Restoring that immune function is a major current goal within the pharmaceutical industry.

"I’m excited to be working with Noxopharm and Bristol Myers Squibb on this study," said principal investigator professor Paul De Souza, dean of medicine at the University of Wollongong. "Checkpoint inhibitors have made a tremendous difference to some patients with advanced cancer. If we can increase the number of patients that respond through the addition of Veyonda to their treatment regimen, we will make a significant impact — not only to those individuals, but also on the oncology landscape."

The checkpoint inhibitor market is a multi-billion-dollar market with rapid year-on-year growth, currently dominated by two major global pharmaceutical companies, one of which is Bristol Myers Squibb.

On November 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 third quarter ended September 30, 2020 and provides an update on its clinical and operational progress (Press release, IMV, NOV 12, 2020, View Source [SID1234570827]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Biomarkers predictive of responses can be game-changing in the development of new treatments for cancer. We are extremely happy to share our success this week in finding a potential predictive biomarker that is associated with a very high level of clinical efficacy in patients with relapsed/refractory DLBCL. The PD-L1 biomarker is well recognized and already approved for multiple cancer indications and this finding brings us closer to an accelerated path to market for DPX-Survivac in this high unmet medical need patient population."

"In addition to this significant milestone, we continued to make progress across our pipeline and corporate development objectives steadily advancing development in other cancer indications as well as our vaccine against COVID-19," said Fred Ors, Chief Executive Officer at IMV.

Third quarter 2020 and Recent Operational Highlights:

DPX-Survivac

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

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.

As of October 30, 2020, 24 patients have been enrolled across six clinical sites in Canada. As reported in May 2020, the study has already met its primary efficacy endpoint.

On November 11, 2020, Dr. Berinstein delivered a poster presentation at The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting. As of the data cut-off date of this presentation, 18 pre-treatment samples from 18 patients enrolled in the SPiReL study were available for biomarker analysis and thirty-nine percent (7/18) of these patients had pre-treatment tumors that were classified as PD-L1 positive.

Key findings for this population include:

6/7 subjects demonstrated a partial response (PR) or complete response (CR), resulting in an Objective Response Rate (ORR) of 86% (3 CR and 3 PR) and no clinical response (PR or CR) has been observed in the PD-L1 negative population (n=11); and
Observed 100% Disease Control Rate (DCR) defined as Stable Disease, PR or CR.
On the strength of these results, IMV is working on the design of the next clinical study in r/r DLBCL. The Company plans to engage with the U.S. Food and Drug Administration (FDA) as soon as possible to identify the best path toward registration.

Phase 2 DeCidE1 Study in Advanced Recurrent Ovarian Cancer

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

IMV intends to present top line data during a virtual key opinion leader meeting on December 3, 2020 at 8:00 am ET.

Phase 2 Basket Trial in Multiple Advanced Metastatic Solid Tumors

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.

As of October 30, 2020, a total of 106 patients out of the planned 184 patients have been 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 verification from this study. The Company intends to report results in the first quarter of 2021 to coincide with seasonal healthcare industry conferences.

DPX-COVID-19

In October 2020, IMV announced that in consultation with Health Canada, it intends to combine its original Phase 1 and 2 studies into a single trial with the potential to accelerate the clinical development and the timeline of the overall project. The design of this study will incorporate the same two-age strata cohorts (18-55 years old and over 55 years old) as originally planned.

Subject to the approval of Health Canada and after the completion and submission of the preclinical safety, GLP toxicology and challenge studies, the Phase 1/2 trial is expected to be approved and initiated before the end of 2020.

Additional funding and Increased Manufacturing Capacity

In October 2020, IMV announced that the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP) will provide advisory services and up to $5.4 million in funding to support the continuation of clinical trials for its DPX-COVID-19 vaccine candidate. This funding is milestone based and will be dependent upon the achievement of certain objectives. To date, IMV has secured more than $10 million to fund its DPX-COVID-19 development efforts and other non-dilutive funding requests are ongoing.

To increase its current manufacturing capacity, IMV has entered a collaboration with a global manufacturing partner and initiated transfer and scale-up activities of DPX-COVID-19. This collaboration has the potential to bring two additional production sites in India and Europe with capacity to produce several hundred million doses of DPX-COVID-19.

Corporate Update

On November 10, 2020, Andrew Hall joined IMV as Chief Business Officer. Mr. Hall was previously Executive Director, Business Development and Global Alliances at Celgene.

In July 2020, Michael P. Bailey was appointed to the board of directors. Mr. Bailey currently serves as President and Chief Executive Officer and a member of the board of directors at AVEO Oncology.

Upcoming Milestones

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

DPX-Survivac
Additional Phase 2 clinical results from the DLBCL combination at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting to be held virtually on December 6, 2020
Top line Phase 2 clinical results from the ovarian cancer trial on December 3, 2020
Updated Phase 2 clinical results from the basket trial in Q1 2021
DPX-COVID-19
Initiation of Phase 1/2 clinical trial with DPX-COVID-19 in 2020
Preliminary Phase 1/2 results in Q1 2021
Overview of Third quarter 2020 Financial Results

On September 30, 2020, the Company had cash and cash equivalents of $54,700,000 and working capital of $55,875,000, compared with $14,066,000 and $13,199,000, respectively at December 31, 2019. This primarily reflects proceeds from the $25,100,000 private placement completed on May 7th, the 6,841,773 common shares issued for gross proceeds of US$30 million (CAD$40.8 million) under its March and June At-The-Market facilities and $2,276,000 from the exercise of 611,888 common share warrants. Based on its current operating 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 $889,000 during the quarter ended September 30, 2020, compared to Q3 2019. These increases are mainly due to pre-clinical development for DPX-COVID-19, which is offset 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, DPX-SurMAGE preclinical development 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 $1,064,000 for the quarter ended September 30, 2020 compared to Q3 2019. This increase is explained by an increase in insurance premium and to a lesser extent is also attributable to an increase in foreign exchange loss. This increase is partly offset by a decrease of $223,000 in legal and professional fees and a decrease of $170,000 in travel due to COVID-19 travel restrictions.

The net loss and comprehensive loss of $8,327,000 ($0.13 per share) for the quarter ended September 30, 2020 was $431,000 higher than the net loss and comprehensive loss of $7,896,000 ($0.16 per share) for the quarter ended September 30, 2019.

For the nine-month period ended September 30, 2020, the net loss and comprehensive loss of $25,259,000 was $6,369,000 higher than the net loss and comprehensive loss for the nine-month period ended September 30, 2019. This relates mainly to a $5,161,000 increase in R&D expenses and a $3,000,000 increase in general and administrative expenses partly compensated by a $1,556,000 increase in government assistance mainly towards COVID-19 vaccine development.

For the nine months ended September 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 $23,566,000.

As of November 11, 2020, the number of issued and outstanding common shares was 67,093,547 and a total of 4,490,791 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 September 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, November 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# 6146758. Other interested parties will be able to access the live audio webcast at this link.

On November 12, 2020 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported the presentation of data on two of its skin cancer gene expression profile tests during the 57th Meeting of The American Society of Dermatopathology (ASDP) (Press release, Castle Biosciences, NOV 12, 2020, View Source [SID1234570826]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

DecisionDx-Melanoma:

"Identifying predictors of sentinel lymph node metastasis in cutaneous melanoma patients using molecular and clinicopathologic high-risk features" was presented by Federico Monzon, M.D.

DecisionDx-Melanoma is Castle’s gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node (SLN) positivity, independent of traditional staging factors.

"DecisionDx-Melanoma uses primary tumor biology to delineate patient metastatic risk, including the risk of SLN metastasis," said Monzon. "In this study, among all features evaluated, DecisionDx-Melanoma was the most significant factor in predicting rates of SLN positivity, justifying a role for the test alongside other commonly used features in considering the sentinel lymph node biopsy surgical procedure."

Study methods and findings:

Authors modeled decision trees using the statistical R package for a cohort of 3,093 patients with cutaneous melanoma to determine which molecular and clinicopathologic features could best stratify the risk of patients’ receiving a positive result from a sentinel lymph node biopsy (SLNB).
DecisionDx-Melanoma was the most significant factor in distinguishing between high and low SLN-positivity rates (p<0.001).
Patients with a Class 2 (high-risk) DecisionDx-Melanoma result under age 75 or with a very high mitotic rate (>10/mm2) had the highest SLN-positivity rates (>20%).
Conversely, patients with a Class 1A result over age 47 with tumors with no mitoses and those age 47 or younger with a Breslow thickness of 0.85mm or less had the lowest positivity rates (<5%), indicating they could potentially forego SLNB.
Patients of all ages and Breslow thicknesses with a Class 2 result had a greater than 10% risk of SLN positivity, indicating that a Class 2 DecisionDx-Melanoma result can be considered a high-risk factor when considering the SLNB procedure for individual patients.
DecisionDx DiffDx-Melanoma:

"Development and validation of a diagnostic gene expression profile test for ambiguous or difficult-to-diagnose pigmented skin lesions" was presented by Sarah Estrada, M.D., FCAP.

DecisionDx DiffDx-Melanoma is designed to aid dermatopathologists in characterizing difficult-to-diagnose melanocytic lesions.

"Approximately 300,000 melanocytic lesions biopsied each year cannot be confidently identified as either malignant or benign, so the nature of these lesions remains ambiguous with discordant rates of diagnoses ranging from 25-43%," said Estrada. "The accuracy metrics shown in the development and validation study suggest DecisionDx DiffDx-Melanoma could help alleviate uncertainty in difficult-to-diagnose lesions, leading to decreased unnecessary procedures while appropriately identifying at-risk patients."

Study methods and findings:

DecisionDx DiffDx-Melanoma was designed to refine diagnoses of melanocytic neoplasms by providing clinicians with an objective ancillary tool with high accuracy.
A total of 503 formalin-fixed paraffin-embedded (FFPE) tissue samples sourced from primary cutaneous melanoma tumors and melanocytic nevi were used, of which 273 were benign and 230 were malignant lesions. Samples underwent quantitative polymerase chain reaction (qPCR) to evaluate expression of 76 genes with potential diagnostic utility.
Artificial intelligence approaches were used to select and prioritize gene sets, ultimately identifying 32 differentially expressed genes that reliably classified benign versus malignant melanocytic lesions.
The resulting 35-gene expression profile (GEP) test, DecisionDx DiffDx-Melanoma, (32 discriminant genes and 3 control genes) accurately diagnosed malignant and benign cases with 99.1% sensitivity, 94.3% specificity, 93.6% positive predictive value (PPV) and 99.2% negative predictive value (NPV).
About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 5,700 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in four archival risk of recurrence studies of 901 patients and six prospective risk of recurrence studies including more than 1,600 patients. Prediction of the likelihood of sentinel lymph node positivity has also been validated in two prospective multicenter studies that included more than 3,000 patients. Impact on patient management plans for one of every two patients tested has been demonstrated in four multicenter and single-center studies including more than 560 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. Through September 30, 2020, DecisionDx-Melanoma has been ordered more than 64,560 times for use in patients with cutaneous melanoma.

More information about the test and disease can be found at www.SkinMelanoma.com.

About DecisionDx DiffDx-Melanoma

DecisionDx DiffDx-Melanoma is designed to aid dermatopathologists in characterizing difficult-to-diagnose melanocytic lesions. Of the 2 million suspicious pigmented lesions biopsied annually in the U.S., Castle estimates that approximately 300,000 of those cannot be confidently classified as either benign or malignant through traditional histopathology methods. DecisionDx DiffDx-Melanoma classifies these lesions as: benign (gene expression profile suggestive of benign neoplasm); intermediate-risk (gene expression profile cannot exclude malignancy); or malignant (gene expression profile suggestive of melanoma). Interpreted in the context of other clinical, laboratory and histopathologic information, DecisionDx DiffDx-Melanoma is designed to add diagnostic clarity and confidence for dermatopathologists while helping dermatologists deliver more informed patient management plans.

More information about the test and disease can be found at www.CastleTestInfo.com.