On February 20, 2020 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") reported financial results and a business update for the full fiscal year ended December 31, 2019 (Press release, VolitionRX, FEB 20, 2020, View Source [SID1234554580]). Volition management will host a conference call tomorrow, February 21, at 8:30 a.m. U.S. Eastern Time to discuss these results. Conference call details may be found below.

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Cameron Reynolds, President and Chief Executive Officer of Volition, upon releasing these results commented, "During 2019, we, together with our collaborators, have made very strong progress, particularly in assay and platform development, with our Nu.Q(TM) Capture program and epigenetic toolkit, Nu.Q(TM) Vet in collaboration with Texas A&M University and, most recently, with the acquisition of the epigenetics reagents company, Octamer GmbH. It is very encouraging that our field of epigenetics is now getting what we believe is long overdue recognition."

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An interview with Cameron Reynolds, President and Chief Executive Officer.

Mr. Reynolds added "We strengthened our balance sheet throughout 2019 with existing investors exercising over $16 million in outstanding warrants to purchase shares of our common stock, receipt of additional non-dilutive funding and maintaining a low cash burn rate and therefore start the new year in a strong position to achieve our key 2020 milestones."

Company Highlights

Financial

Cash and cash equivalents as of December 31, 2019 totalled $17 million compared to $13.4 million as of the end of 2018.
Existing investors exercised $16.5 million in aggregate amount of outstanding warrants to purchase shares of our common stock.
Received additional $3.3 million in non-dilutive funding taking our total non-dilutive funding (grants and loans) to date to over $7.5 million.
Continue to manage cash carefully with a monthly burn (or cash used in operating activities) of approximately $1.2 million during 2019.
Assay Development

Volition has completely re-engineered its Nu.Q(TM) assays to now use a magnetic particle-based assay format leading to a step-change improvement in analytical performance. Volition expects this enhanced analytical performance to translate into improved clinical performance in the studies to be carried out and reported in the coming months.

Relative to Volition’s ELISA plate Nu.Q(TM) assay format, the magnetic particle-based assay format demonstrates:

A 10 to 20-fold improvement in analytical sensitivity of the assays.
Typical within-day reproducibility of quantitative test results below 3% (previously <10%).
Decrease in test result turnaround time from 6 hours to approximately 1 hour and 20 minutes, allowing much higher throughput.
The ability to be developed and processed on fully-automated Random-Access platforms (enabling the use of a wide range of commercial automated platforms).
In terms of clinical accuracy, over the past twelve months as we have been working on the aforementioned assay development, we have completed some proof of concept studies to assess clinical performance. While this work is yet to be completed for the finalized assays, preliminary results were extremely encouraging that for even the development assays we saw our highest ever Area Under the Curve performance in Blood Cancer at 91% and in Lung Cancer at 85% in addition to reporting positive data in colorectal cancer.

Epigenetic Toolbox

Volition has developed and is seeking patents on its novel Nu.Q(TM) Capture based epigenetic tools, in addition to its ongoing efforts regarding its bead-based Nu.Q(TM) assay format, to decipher the epigenetic and environmental profiles of cancer nucleosomes with the aim of using:

Nu.Q(TM) Capture methods to enrich cancer nucleosomes and simplify sequencing based "liquid biopsies".
Nu.Q(TM) Capture methods to isolate intact nucleosomes from plasma for mass spectrometry analysis in the framework of both biomarker discovery and clinical diagnostics.
Nu.Q(TM) Capture to measure global methylation patterns in a simple platform.
Nu.Q(TM) Capture to concentrate nucleosomal markers prior to our Nu.Q(TM) assays to increase accuracy.
Nu.Q(TM) platform to detect and measure circulating nucleosomes and transcription factors with potential to be tissue specific, and therefore cancer specific. This, if successful could result in a simple blood test for multiple cancers.
Volition is using these tools to expand diagnostic developments that focus on circulating DNA fragment analysis, to a broader and potentially more powerful investigation of the epigenetic status of a patient’s circulating chromosome fragments, in addition to its ongoing work with its assay-based format in a range of cancers.

Organization

Our laboratory team expanded appreciably to include, among others, the appointment of an Assay Validation Expert who has been instrumental in taking our assays forward.
We added two new operating subsidiaries with the formation of Volition Veterinary Diagnostics in June 2019 and the acquisition of our epigenetics reagents subsidiary, Octamer Gmbh, in the early part of 2020.
In connection with the formation of Volition Veterinary Diagnostics, we welcomed Nathan Dewsbury as its Chief Executive Officer and, Dr. Heather Wilson-Robles DVM, as its Chief Medical Officer.
In connection with the acquisition of Octamer we expanded our Scientific Advisory Board to include Dr. Adrian Schomburg, one of the world’s leading experts on Nucleosomes and founder and CEO of Octamer.
We also welcomed Dr. Phillip Barnes to our Board of Directors.
Upcoming Milestones

We expect to achieve the following milestones during 2020 :

Release a range of clinical data with our new optimised bead-based assays in colorectal, lung and other cancers.
Advance our previously announced large-scale colorectal and lung cancer trials in Europe, Asia and the U.S.
Advance the development of Nu.Q(TM) Capture by determining the level of discrimination of tumor associated nucleosomes using mass spectrometry and/or sequencing.
Announce patient data demonstrating the wide utility of Volition’s epigenetic toolbox.
Complete pre-analytical and clinical studies for Nu.Q(TM) Vet with the aim of launching our first product in 2020.
Publish several abstracts and peer reviewed articles with clinical results as well as showing the robustness and utility of our Nu.Q(TM) platform.
Mr. Reynolds concluded, "We are extremely proud of the accomplishments we have achieved thus far. I thank the dedicated Volition team for their tireless efforts. I, along with the rest of the Board and indeed the whole company, look forward to sharing the results of key studies over the coming year."

For further details please contact [email protected]

VolitionRx Limited Fourth Quarter & Full Year 2019 Earnings and Business Update Conference Call

Date: Friday, February 21, 2020
Time: 8:30 a.m. Eastern time
U.S. & Canada Dial-in: 1-877-407-9716 (toll free)
U.K. Dial-in: 0 800 756 3429 (toll free)
Toll/International: 1-201-493-6779
Conference ID: 13699351

Cameron Reynolds, President and Chief Executive Officer of Volition, will host the call along with David Vanston, Chief Financial Officer and Scott Powell, Executive Vice President, Investor Relations.

A live audio webcast of the conference call will also be available on the investor relations page of Volition’s corporate website at View Source In addition, a telephone replay of the call will be available until March 6, 2020. The replay dial-in numbers are 1-844-512-2921 (toll-free) in the U.S. and Canada and 1-412-317-6671 (toll) internationally. Please use replay pin number 13699351.

On February 19, 2020 Deciphera Pharmaceuticals, Inc. (Nasdaq:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, reported the closing of its previously announced registered underwritten public offering. 3,181,818 shares of the Company’s common stock at a price to the public of $55.00 per share were issued and sold in the offering (Press release, Deciphera Pharmaceuticals, FEB 19, 2020, View Source [SID1234554492]). The gross proceeds to Deciphera from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses, are expected to be approximately $175.0 million. In addition, the Company has granted the underwriters a 30-day option to purchase up to 477,272 additional shares of its common stock.

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J.P. Morgan, Piper Sandler and Jefferies acted as joint book-running managers for the offering. Guggenheim Securities acted as lead manager for the offering. SunTrust Robinson Humphrey acted as co-manager for the offering.

Deciphera intends to use the net proceeds from the offering to fund continued growth of its commercial and medical affairs capabilities to support its transition from a development-stage company toward a commercial-stage company including pursuing development and potential commercialization in second-line GIST; clinical trials for ripretinib, including the expansion stage of its current Phase 1 clinical trial, its ongoing pivotal Phase 3 clinical trial, and additional clinical trials, as well as clinical research outsourcing and manufacturing of clinical trial material, and pre-commercialization manufacturing process development and validation; clinical trials for DCC-3014, including the expansion stage of its current Phase 1 clinical trial, and additional clinical trials as well as clinical research outsourcing and manufacturing of clinical trial material; clinical trials for rebastinib, including its current Phase 1b/2 clinical trials, and additional clinical trials as well as clinical research outsourcing and manufacturing of clinical trial material; IND-enabling studies and the potential development of DCC-3116; new and ongoing research activities for future drug candidates using its proprietary kinase switch control inhibitor platform; and working capital purposes, including general operating expenses.

The offering was made only by means of a prospectus supplement and accompanying prospectus forming part of an automatic shelf registration statement on Form S-3 previously filed with the Securities and Exchange Commission (SEC) on February 12, 2020. The final prospectus supplement and the accompanying prospectus was filed with the SEC and is available on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from J.P. Morgan Securities LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, Attention: Prospectus Department, by telephone at (800) 747-3924 or by email at [email protected]; and Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388 or by email at [email protected].

On February 19, 2020 NantHealth, Inc. (NASDAQ: NH), a next-generation, evidence-based, personalized healthcare company and NantOmics, LLC, the leader in molecular analysis, reported Real-world data for differential expression of immunoregulatory molecules and targetable cancer genes may provide therapeutic insights into agnostic-driven trial designs during an oral presentation at the Real World Evidence in Immunotherapy Session at the Clinical Immuno-Oncology Symposium, sponsored by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and the Society for Immunotherapy in Cancer (SITC) (Free SITC Whitepaper) (Press release, NantHealth, FEB 19, 2020, View Source [SID1234554509]).

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The Symposium, held at Rosen Shingle Creek in Orlando, FL from February 6-8, 2020 provides cutting-edge translational science and relevant clinical results to a diverse audience of leaders in oncology education, doctors and care teams.

"Our analysis shows that commonly evaluated mutations are associated with therapeutic targets for immunotherapy," said Sandeep "Bobby" Reddy, MD, Chief Medical Officer, NantHealth. "For example we saw high IDO expression in in patient samples with FBXW7 mutations. IDO has failed in clinical trials in the past but perhaps the wrong patient population was assessed. This data may help design better clinical trials which match the molecular phenotype with the best possible combination of therapies."

IDO1 (i.e. IDO) is the molecular target for several immunotherapy drugs (e.g. Epacadostat) that have failed in trials that selected patients based on tissue-type. FBXW7 mutants are significantly higher in IDO1 expression regardless of which tissue they show up in, and FXBW7 mutations are found in many tissue types. Agnostic-driven clinical trial designs using strategies to identify FBXW7 tumors that have higher expression of IDO1 may be a good strategy for these types of drugs.

In the study, authors utilized TCGA data and data collected from NantHealth’s GPS Cancer database on whole exome (WES) DNA tumor and paired normal and matched deep whole transcriptomic sequencing (RNA-Seq) to identify novel associations between oncogenic mutations and immune checkpoint therapeutic targets.

"CDKN2A mutation status was identified as associated with increased PD1 and CTLA4 expression while KRAS and APC mutations were assessed as associated with decreased PDL1/2 expression," said Christopher Szeto, Director of Machine Learning. "These mutation associations remained significant after accounting for tissue-specific expression patterns."

Title: "Real-world data validation for differential expression of immunoregulatory molecules and targetable cancer genes may provide therapeutic insights into agnostic-driven trial designs," Abstract #10
Authors: Jacob J. Adashek, Christopher Szeto, Sandeep K. Reddy, Philippe E. Spiess
Poster Session and Number:
Who: NantHealth, Inc. and NantOmics, LLC
What: Real World Evidence in Immunotherapy Session
When: February 6-8, 2020
Location: Rosen Shingle Creek

On February 19, 2020 Cycle for Survival, the movement to beat rare cancers, made history by topping $250 million raised since it was founded in 2007 (Press release, Memorial Sloan-Kettering Cancer Center, FEB 19, 2020, View Source [SID1234554526]). The grassroots fundraising effort includes donations from more than one million individuals across all 50 states. This milestone reflects the determination and generosity of a passionate community uniting to fight rare cancers. Every dollar raised goes to clinical trials, research studies and groundbreaking technologies pioneered by Memorial Sloan Kettering (MSK).

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MEMORIAL SLOAN KETTERING’S CYCLE FOR SURVIVAL EXCEEDS $250 MILLION FOR RARE CANCER RESEARCH With support from founding partner Equinox, the Cycle for Survival community surpasses a major fundraising milestone to help rare cancer patients with every dollar raised
MEMORIAL SLOAN KETTERING’S CYCLE FOR SURVIVAL EXCEEDS $250 MILLION FOR RARE CANCER RESEARCH With support from founding partner Equinox, the Cycle for Survival community surpasses a major fundraising milestone to help rare cancer patients with every dollar raised
Maximizing their success with the peer-to-peer fundraising model, Cycle for Survival has grown consistently over the past 14 years, with significant growth in the previous few years. More than half of the $250 million total was raised in the past three years.

Equinox, Cycle for Survival’s founding partner and host, has been essential to the fundraising achievements since the beginning. In celebration of the $250 million raised, Equinox provided a $500,000 donation match yesterday to help drive Cycle for Survival over the extraordinary quarter of a billion dollars mark.

In honor of this milestone, and to celebrate the 11th year of Cycle for Survival events in Chicago, Willis Tower lit its iconic antennas orange on February 8 during the local rides.

Starting as a single indoor cycling ride in New York City with just 230 people on 50 bikes, Cycle for Survival now has more than 37,000 participants on 9,000 bikes, and 250,000 donors annually. Participating teams include more than 1,100 corporate teams from 610 companies rallying colleagues to ride together. Cycle for Survival’s signature stationary cycling events, led by instructors from Equinox, take place in 17 cities across the country this January, February and March.

The $250 million raised by Cycle for Survival has allowed hundreds of MSK physicians, scientists and research teams to pursue bold ideas to change the way cancer is diagnosed and treated. Their investigations have made a direct impact on patient care, including FDA-approved drugs and effective experimental therapies. Cycle for Survival donations often provide vital seed funding for new research endeavors.

All of the money raised is allocated within the six months following the close of fundraising annually. The funds go directly to research and clinical trials for rare cancers, which affect about half of all cancer patients and include thyroid, brain, ovarian, pancreatic, all pediatric cancers and many others. As doctors and researchers pursue new treatments, Cycle for Survival provides urgently needed resources. Visit www.CycleforSurvival.org to learn more.

On February 19, 2020 DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported it has enrolled and begun dosing the final patient in its ongoing Phase 2 clinical study investigating the first-line treatment of VAL-083 with radiation therapy in newly-diagnosed, MGMT-unmethylated glioblastoma multiforme (GBM) (Press release, DelMar Pharmaceuticals, FEB 19, 2020, View Source [SID1234554493]). The trial, which is being conducted at the Sun Yat-sen University Cancer Center (SYSUCC) in Guangzhou, China, and in collaboration with Guangxi Wuzhou Pharmaceutical Company, is designed to enroll up to 30 patients to determine whether first-line therapy with VAL-083 treatment improves progression free survival (PFS). The current standard of care is first-line temozolomide (TMZ) with radiation.

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"We are very pleased to have enrolled and started dosing our final patient in this important study. This earlier than predicted full enrollment is encouraging and will allow an earlier topline data readout," commented Professor Zhong-ping Chen, founder chairman of the Department of Neurosurgery/Neuro-oncology at Sun Yat-sen University Cancer Center, and who is also the study’s principal investigator. "The enrollment of the final patient also provides us the opportunity to corroborate the preliminary data we’ve recently published, which supports the possibility that VAL-083 can provide a new and valuable treatment option in this difficult-to-treat indication."

The Phase 2 trial is a single-arm, open-label study testing VAL-083 in combination with standard radiotherapy in GBM patients who have an unmethylated promoter of the methylguanine DNA-methyltransferase (MGMT) gene. The clinical trial in newly-diagnosed GBM patients is designed to determine if first-line treatment with VAL-083 plus radiotherapy can provide improvements over the historical efficacy of standard of care TMZ plus radiotherapy. Efficacy will be measured based on tumor response to treatment, progression-free survival, progression-free survival at six months, and overall survival compared to historical results in the target population.

"Having completed enrollment of our first-line study ahead of schedule, we expect to complete analysis for the topline data in our most important Phase 2 trial for first-line GBM patients earlier than anticipated. We are optimistic that we will receive the initial data readout before the end of August 2020," commented Saiid Zarrabian, DelMar’s Chief Executive Officer. "In the meantime, we continue to rapidly advance our other Phase 2 program in the adjuvant and recurrent settings for VAL-083 at MD Anderson Cancer Center and look forward to providing further updates on the progress of our ongoing open label GBM trials at upcoming scientific meetings."

DelMar has been monitoring the coronavirus situation in China. Based on discussions with our principal investigator at SYSUCC, we believe the coronavirus outbreak will not have a significant impact on our patient treatment timeline.

In addition to the Phase 2 clinical trial in first-line treatment, DelMar is conducting an additional two-arm Phase 2 clinical trial in GBM. The adjuvant arm, which initiated in late 2019 will enroll up to 24 newly-diagnosed patients who have undergone surgery and chemoradiation with TMZ but will now receive VAL-083 in place of standard of care TMZ for adjuvant therapy. The second arm treats patients with recurrent disease, administering VAL-083 in patients who have been heavily pre-treated with TMZ prior to disease recurrence. The recurrent arm will allow a total of 83 patients to be enrolled. Both arms are being conducted at the University of Texas MD Anderson Cancer Center.

About VAL-083

VAL-083 (dianhydrogalactitol) is a "first-in-class", bifunctional DNA-targeting agent that introduces inter-strand DNA cross-links at the N7-position of guanine leading to DNA double-strand breaks and cancer cell death. VAL-083 has demonstrated clinical activity against a range of cancers including GBM and ovarian cancer in historical clinical trials sponsored by the U.S. National Cancer Institute (NCI). DelMar has demonstrated that VAL-083’s anti-tumor activity is unaffected by common mechanisms of chemoresistance, including MGMT, in cancer cell models and animal studies. Further details regarding these studies can be found at:

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