On March 22, 2021 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") reported financial results and a business update for the full fiscal year ended December 31, 2020 (Press release, VolitionRX, MAR 22, 2021, View Source [SID1234576953]). Volition management will host a conference call tomorrow, March 23 at 8:00 a.m. U.S. Eastern Time to discuss these results. Conference call details may be found below.

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An interview with Cameron Reynolds, President and Chief Executive Officer, Terig Hughes, Chief Financial Officer and Jake Micallef, Chief Scientific Officer.
An interview with Cameron Reynolds, President and Chief Executive Officer, Terig Hughes, Chief Financial Officer and Jake Micallef, Chief Scientific Officer.
"We made significant progress on many fronts throughout 2020, culminating in the launch of our first product, the Nu.Q Vet Cancer Screening Test in the fourth quarter. This was a pivotal moment for Volition, demonstrating that our platform has the reliability and reproducibility to launch in an independent laboratory," commented Cameron Reynolds, President and Chief Executive Officer of Volition. "Despite the persistence of the COVID-19 pandemic, we kept our laboratory operational throughout the year and completed the fit out and opening of our new Silver One production facility in Namur, Belgium. I am proud of the way our team has adapted to the different world we find ourselves in and has kept working at full speed. It is their efforts and tenacity that have made possible these milestones and the many others that we achieved during 2020."

View Source

An interview with Cameron Reynolds, President and Chief Executive Officer, Terig Hughes, Chief Financial Officer and Jake Micallef, Chief Scientific Officer.

Mr. Reynolds continued, "We added to our already extensive intellectual property portfolio and at year end held 64 patents with a further 90 patents pending. We have made considerable progress in our human studies with data released in blood cancer, lung cancer, Nu.Q Capture, COVID-19 and most recently sepsis. Currently we are in our strongest-ever financial position to support the pursuit of our many milestones and look forward to providing updates throughout the year."

Company Highlights

Financial

Cash and cash equivalents as of December 31, 2020 totaled approximately $19.4 million compared with $17 million as of December 31, 2019.
Continued to manage our expenditures carefully with a burn rate of approximately $1.5 million per month throughout 2020.
During the first quarter of 2021 to date added an aggregate of approximately $20.5 million in cash mostly through an underwritten public offering of our common stock that closed in February, as well as through periodic sales of common stock under our at-the-market equity distribution program.
Secured a further $4 million in non-dilutive funding consisting of a cash grant of $1.3 million and loans totalling $2.7 million from the Walloon Regional Government and associated agencies.
Following the public offering in February, our cash and cash equivalents totaled approximately $40 million before deducting expenses incurred thus far in 2021, by far our strongest cash position ever.
Nu.Q Vet Cancer Screening Test Commercial Launch

Launched the Nu.Q Vet Cancer Screening Test in late November.
We are very happy with the sales progress to date. We received the first order from the GI lab at Texas A&M University late last year and have already received three additional orders from them in 2021.
The test is positioned for use in the annual health check of older dogs (those that are seven years and older). It may also be a complimentary test for younger dogs of breeds at high risk for developing cancer in their lifetimes such as Golden Retrievers.
This beta launch will facilitate real-world learnings and help shape the marketing mix before our planned launch nationally across the U.S. in the next few months.
The beta launch also provides us an opportunity to showcase the product to the large multinational companies we are in active discussions with, regarding the distribution and/or sales of our tests in the veterinary market.
In addition to the Texas beta launch we are finalizing beta launch planning in both Asia and Europe.
Clinical – New U.S. Regulatory Study

Engaged Diagnostic Oncology CRO LLC, the largest U.S. Contract Research Organization specializing in oncology purposed in-vitro diagnostic device clinical trials, to conduct a U.S. regulatory clinical trial for Non-Hodgkin’s Lymphoma (NHL).
The trial is designed to obtain multiple FDA-approved adjunct tests to aid in the diagnosis of the five most common and aggressive forms of NHL.
The trial will enroll up to 1,500 subjects across 10 major U.S. healthcare institutions over 22 months.
This extensive program will cost approximately $2.9 million over two years assuming the completion of numerous projects and includes not only the clinical study but also data analysis and regulatory and reimbursement submission preparation.
Existing data suggests Nu.Q technology will greatly aid physicians in distinguishing NHL from common conditions, fulfilling what we believe is a critical unmet clinical need and which represents a major market opportunity.
We expect our first FDA 510(k) submission will be possible approximately 10-12 months into the trial.
In addition, we are also conducting a proof-of-concept study for the monitoring of treatment response for the most aggressive NHL cancer, diffuse large B-cell lymphoma (DLBCL). We expect the results from this trial in the first half of 2021.
Clinical – NETosis including COVID-19

We have made great progress on a research program for the use of our Nu.Q technology in NETosis and in particular in monitoring disease progression of COVID-19 and sepsis and, as announced last week, as a potential companion diagnostic for a treatment for sepsis. We are seeking to broaden this further into influenza and potentially other diseases associated with NETosis.
Several studies have been collected, processed and are now either being analyzed or have been submitted to conferences for publication. This program has taken longer than we expected as the hospitals we are working with have, understandably, been focused on caring for the very high numbers of patients admitted during the 2nd wave of COVID-19.
We are negotiating a large FDA trial for use of our assays in diseases associated with neutrophil extracellular traps (NETs) such as sepsis, COVID-19 and influenza in the U.S. and will announce the full details once they have been finalized.
We have filed a novel patent for this application and plan to utilise results of these trials and other ongoing studies to further our aim of developing a clinically useful Nu.Q NETs product.
Clinical – Cancer

In various ways our "marquee trials" have now been affected by the continued pandemic either by slower or paused collection, or a host of other supply chain or travel and communication issues. We believe we have successfully managed those areas under our direct control (such as assay development and running samples – both of which are on track with our milestones) but many issues are not within our control.
An abstract regarding Nu.Q performance in lung cancer detection was presented at the WCLC conference in January 2021. The key message from the presentation is that, based on an interim analysis of a subset of subjects in the ongoing study with the National Taiwan University, Nu.Q assays could help identify non-cancerous nodules following a scan thereby reducing unnecessary biopsies by as much as 32%.
We hope to complete this large 1,200 subject lung cancer study and share findings at upcoming conferences later this year.
If the data continues to be encouraging, we are planning to initiate a 510(k) regulatory study in the U.S. for lung cancer, as we have for NHL.
Expansion

As we transition from a research and development company to a commercial company, we strengthened the leadership team with the appointment of a new Chief Financial Officer, Mr. Terig Hughes, Mr. Gael Forterre as Chief Commercial Officer, in addition to the promotion of Dr. Gaetan Michel as Chief Operating Officer and Dr. Mark Eccleston as Chief Technology Officer.
We completed the purchase and fit-out of "Silver One", the production hub for our products and key components located in Namur, Belgium. With this new facility we can provide a service for clinical trial purposes and produce CE-marked products for Europe and beyond.
We have also opened a small, shared laboratory at California State University in San Marcos, California where we will focus on blue-sky innovation and discovery research.
Upcoming Milestones

Volition expects to achieve the following milestones during 2021 and beyond:

Beta launches of the Nu.Q Vet Cancer Screening Test in Asia and Europe.
National launch of the Nu.Q Vet Cancer Screening Test in the U.S.
Focus on driving revenue in the coming quarters, where possible during the pandemic, in four key areas:
– Nu.Q Vet products,
– Disease monitoring tests (e.g. Nu.Q NETs for COVID-19, sepsis and other diseases),
– Reagent sales, and
– Licensing of our technology for others to commercialize in both humans and animals.

Continue to progress the research program for the use of Nu.Q in NETosis, in monitoring disease progression of COVID-19, sepsis and potentially other diseases and as a possible companion diagnostic for a treatment for sepsis.
Continue to advance our previously announced large-scale blood, lung and colorectal cancer trials in Europe, Asia and the U.S.
Publish several abstracts and peer-reviewed scientific papers with clinical results showing the robustness and utility of our Nu.Q platform.
Advance the development of Nu.Q Capture.
Continue to file patents to expand and extend our intellectual property portfolio.
VolitionRx Limited Full Fiscal 2020 Financial Results and Business Update

Date: Tuesday, March 23, 2021
Time: 8:00 a.m. U.S. 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: 13717672

Cameron Reynolds, President and Chief Executive Officer of Volition, will host the call along with Terig Hughes, Chief Financial Officer, Jake Micallef, Chief Scientific 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 April 6, 2021. 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 13717672.

On March 22, 2021 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported the publication of results from its RUN-HN study, a Phase 2 open-label, single-arm trial of tipifarnib in patients with HRAS mutant head and neck squamous cell carcinoma (HNSCC) whose disease had progressed after prior therapy (Press release, Kura Oncology, MAR 22, 2021, View Source [SID1234576952]). The paper, titled "Tipifarnib in Head and Neck Squamous Cell Carcinoma with HRAS Mutations," was published online in the Journal of Clinical Oncology earlier today.

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As of the April 10, 2020 data cutoff, a total of 22 HNSCC patients with high HRAS mutant variant allele frequency1 were enrolled, of whom 20 were evaluable for response. Eleven of the 20 evaluable patients met RECIST v1.1 criteria for confirmed partial response (PR) and, for an objective response rate (ORR) of 55% (95% CI, 31.5 to 76.9).

Median progression-free survival (PFS) of 5.6 months (95% CI, 3.6 to 16.4) on tipifarnib was a statistically significant improvement over the median PFS of 3.6 months (95% CI, 1.3 to 5.2) on last prior therapy (p=0.0012). The median overall survival (OS) was 15.4 months (95% CI, 7.0 to 29.7). Robust activity was seen despite resistance to chemotherapy, immunotherapy and/or cetuximab.

The ORR for three FDA-approved therapies for treatment of HNSCC in the second line range from 13-16%, with median PFS of 2-3 months and median OS of 5-8 months.

"We are encouraged by the compelling efficacy and safety profile of tipifarnib in patients with recurrent or metastatic HRAS mutant head and neck squamous cell carcinoma," said Alan Ho, M.D., Ph.D., of Memorial Sloan Kettering Cancer Center and principal investigator of the trial. "Importantly, these patients experienced limited benefit on prior therapies, including immunotherapies, which demonstrates the high unmet need for this disease. These data also reinforce the relevance of genomic testing for HRAS mutations to identify patients who could potentially benefit from tipifarnib treatment."

Tipifarnib was generally well-tolerated in the trial. The most common grade 3 or 4 adverse events (AEs) seen in at least 10% of patients, were anemias and lymphopenias. Patients had received a median of two prior lines of systemic therapy (range 0-6; one patient received prior radiotherapy only), with 64% receiving prior immunotherapy, 50% receiving prior cetuximab, and 23% receiving both.

"We are pleased to see our data from the Phase 2 RUN-HN trial of tipifarnib published in the Journal of Clinical Oncology for review by the broader clinical community," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "The highlighted data from the RUN-HN trial comes on the heels of our Breakthrough Therapy Designation from the FDA and we continue to advance the ongoing AIM-HN registration-directed trial in patients with HRAS mutant HNSCC, for whom there is an urgent unmet need."

The AIM-HN registration-directed trial of tipifarnib, in patients with recurrent or metastatic HRAS mutant HNSCC, is currently recruiting at more than 100 clinical sites in the U.S., Europe, Russia/Ukraine and Asia/Pacific. Patients interested in participating in this trial may talk to their doctor to have their tumor tested for the HRAS mutation for eligibility to enroll in this trial. Further details regarding the trial are available at clinicaltrials.gov (NCT03719690).

HRAS mutations occur in 4%-8% of patients with recurrent and/or metastatic HNSCC. The HRAS biomarker can be found on most commercially available genomic panels. More information about HRAS and biomarker testing is available at uncoverhras.com

About HNSCC

Head and neck squamous cell carcinoma (HNSCC) is the seventh most common cancer worldwide, accounting for more than 500,000 new cases each year. Despite advances in immunotherapy, the prognosis for advanced HNSCC patients remains poor, with an estimated median overall survival of 13-15 months in patients when stratified by PD-L1 expression. Although the anti-epidermal growth factor receptor (EGFR) antibody, cetuximab, was approved more than a decade ago, development of biomarker-directed therapies in HNSCC has been stymied by the limited number of druggable targets in the genomic landscape and the challenge of managing drug refractory recurrent/metastatic HNSCC.

About Tipifarnib

Tipifarnib, is a potent, selective and orally bioavailable inhibitor of farnesyl transferase in-licensed from Janssen. Previously, tipifarnib was studied in more than 5,000 cancer patients and showed compelling and durable anti-cancer activity in certain patient subsets; however, no molecular mechanism of action had been determined that could explain its clinical activity across a range of solid tumor and hematologic indications. Leveraging advances in next generation sequencing as well as emerging information about cancer genetics and tumor biology, the Company is seeking to identify those patients most likely to benefit from tipifarnib. In addition to Breakthrough Therapy Designation, tipifarnib has been granted Fast Track designation by the FDA for the treatment of patients with HRAS mutant HNSCC. In addition to HNSCC, tipifarnib has demonstrated encouraging clinical activity in multiple additional genetically defined tumor types. Kura has received multiple issued patents for tipifarnib, providing patent exclusivity in the U.S. and foreign countries.

On March 22, 2021 iCo Therapeutics Inc. (TSXV: ICO) (OTCQB: ICOTF) ("iCo") and Satellos Bioscience Inc. ("Satellos"), a private Canadian corporation, reported to announce the execution of a definitive agreement, dated March 21, 2021 (the "Arrangement Agreement"), providing for the business combination of iCo and Satellos by way of a plan of arrangement (the "Arrangement") in accordance with Section 192 of the Canada Business Corporations Act (the "CBCA") (Press release, iCo Therapeutics, MAR 22, 2021, View Source [SID1234576951]). Pursuant to the Arrangement, Satellos will become a wholly-owned subsidiary of iCo, and the parties expect to complete an amalgamation of iCo and Satellos, with the resulting entity named "Satellos Bioscience Inc." (the "Resulting Issuer"), operating in the life sciences industry. Following the Arrangement, and the Concurrent Financing (described below) shareholders of iCo will hold an approximately 27.7% ownership interest, and the shareholders of Satellos will hold approximately 58.8.% of the outstanding common shares of the Resulting Issuer (the "Resulting Issuer Common Shares"). Prior to completion of the Arrangement, iCo, which is formed under the Business Corporations Act (British Columbia) is expected to continue under the CBCA and the Resulting Issuer will exist as a CBCA corporation. The completion of the Arrangement will result in a reverse takeover of iCo as defined in the policies of the TSX Venture Exchange (the "Exchange"). Completion of the Arrangement is subject to, among other things, the approval of the Exchange and approval from iCo and Satellos’ shareholders.

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Recommendation of the Board of Directors and Support Agreements

The board of directors of each of iCo and Satellos have: (a) determined that the Arrangement is in the best interests of iCo and Satellos, respectively; (b) recommended that its respective shareholders vote in favour of the resolutions approving the Arrangement; and (c) authorized the execution of the Arrangement Agreement and the performance of iCo’s and Satellos’ respective obligations under the Arrangement Agreement.

The directors and officers of iCo and Satellos, and certain other shareholders of iCo and Satellos representing an aggregate of 1,692,756 (0.9%) iCo common shares ("iCo Shares") and 8,138,400 (66.7%) Satellos common shares ("Satellos Shares"), respectively, in each case on a non-diluted basis, entered into voting support agreements pursuant to which they agreed to vote their eligible securities in favour of the Arrangement.

Bloom Burton & Co. Inc. ("Bloom Burton") is acting as exclusive financial advisor to iCo on the Arrangement. Bloom Burton, through Bloom Burton Development Corp., owns approximately 31.4% of the outstanding Satellos Shares on a fully diluted basis and certain Bloom Burton employees are directors of Satellos. For the purposes of considering and approving the Arrangement, such Bloom Burton directors have declared their conflict and recused themselves from the activities of the Satellos board in accordance with the requirements of the CBCA.

In coming to its recommendation with respect to the Arrangement, the board of directors of iCo reviewed and considered a fairness opinion from Evans & Evans, Inc., financial advisors to the board of directors of iCo in connection with the Arrangement, which report provides that, as of the date of such opinion, and subject to the assumptions, limitations and qualifications set forth therein, the consideration to be received by the iCo shareholders pursuant to the Arrangement is fair from a financial point of view.

In addition, in coming to its recommendation with respect to the Arrangement, the board of directors of Satellos also reviewed and considered a fairness opinion from Leede Jones Gable, financial advisors to the board of directors of Satellos in connection with the Arrangement, which report provides that, as of the date of such opinion, and subject to the assumptions, limitations and qualifications set forth therein, the consideration to be received by the Satellos shareholders pursuant to the Arrangement is fair from a financial point of view.

On March 22, 2021 Genmab A/S reported the initiation of a share buy-back program to mitigate dilution from warrant exercises and to honor our commitments under our Restricted Stock Units program (Press release, Genmab, MAR 22, 2021, View Source [SID1234576950]).

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The share buy-back program is expected to be completed no later than June 30, 2021 and comprises up to 200,000 shares.

The following transactions were executed under the program from March 15, 2021 to March 19, 2021:

Details of each transaction are included as an appendix to this announcement.

Following these transactions, Genmab holds 167,477 shares as treasury shares, corresponding to 0.26% of the total share capital and voting rights.

The share buy-back program is undertaken in accordance with Regulation (EU) No. 596/2014 (‘MAR’) and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the "Safe Harbour Regulation." Further details on the terms of the share buy-back program can be found in our company announcement no. 11 dated February 23, 2021.

On March 22, 2021 ProMIS Neurosciences Inc. (TSX: PMN) (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, reported that the completion of an US$7M (CDN$8.75M) private placement of convertible unsecured debentures (the "Debentures") (Press release, ProMIS Neurosciences, MAR 22, 2021, View Source [SID1234576949]).

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The investors include Mike Gordon of Fenway Sports Group, the Kraft Group, Henry McCance, co-founder of the Cure Alzheimer’s Fund, and Jeremy Sclar of WS Development Group. "After conducting diligence with a number of experts in the field, we are impressed with the tremendous potential of ProMIS Neurosciences and its unique platform of drug candidates to have a profound impact in the fight against Alzheimer’s and other neurodegenerative diseases. Our group is pleased to provide funding for the next phase of the company’s exciting future", stated Mike Gordon of Fenway Sports Group.

"We are honored to have the support of such a distinguished group of investors, all of whom are accomplished leaders in the business and life sciences arenas" said Gene Williams, ProMIS Executive Chairman.

Debenture Terms

The Debentures are convertible into ProMIS common shares at the option of the holder at a conversion price of US$0.10 per share and accrue interest at 1% per annum, which is payable annually. At the company’s election, accrued interest may be paid in cash or common shares (such number of shares determined by dividing the interest due by the 5-day volume-weighted average trading price or "VWAP" of the common shares).

The Debenture mature on March 22, 2026. Prior to the maturity date, the Company may force conversion of the Debentures at the conversion price upon raising US$50M in equity and/or debt cumulatively. On the maturity date, the Company may redeem the outstanding principal amount of the Debentures in either cash or common shares (at the then 5-day VWAP less a 10% discount) or a combination thereof at its election. Amounts redeemed in common shares on the Maturity Date will be subject to TSX acceptance.

The investors were granted a right to participate, on a pro rata basis, in subsequent company offerings of equity securities for cash consideration pursuant to a public offering or a private placement.

The Debentures and any common shares issued on conversion are subject to a four-month hold period that expires on July 22, 2021. Net proceeds will be used for working capital and general corporate purposes.

ProMIS plans to accelerate progress toward a number of top priorities, including:

Advancing the PMN310 monoclonal antibody, our potential "best in class" next generation Alzheimer’s treatment, into clinical testing;
Enhancing our partnering prospects for programs under active discussion by allowing us to invest in additional validation data;
Expanding our portfolio of products and intellectual property into new target areas, using our proprietary discovery platform;
Advancing our partnered diagnostic programs;
Achieving NASDAQ listing;
Expanding our Board of Directors; and
Expanding our management team, capitalizing on the talent pool in Boston, to support a growing and ambitious scope of activity.
Retirement of our CEO

Finally, a note of great appreciation for our CEO, Dr. Elliot Goldstein. Elliot, who just turned 70, has announced his intention to retire from a full time role by the end of 2021. Even though Elliot is irreplaceable, ProMIS has initiated a search for a new CEO to help us achieve our potential. "Elliot has been a close friend and valued business partner for decades," said Gene Williams, "without his significant contributions, we would not have been able to take ProMIS from just a great science idea to a company with a growing portfolio of therapies that have the potential to be life-altering for patients. On behalf of the entire ProMIS community, and patients who in the future may benefit from our therapies, I offer Elliot our sincere thanks and gratitude".

"ProMIS Neurosciences was launched six years ago based on a world class scientific platform from our CSO and scientific founder, Dr. Neil Cashman. Playing a key role in this endeavor has been one of the most challenging yet rewarding experiences of my 40 odd years in pharmaceutical drug development. I am delighted for this exciting new phase of the Company", stated Dr. Elliot Goldstein, ProMIS CEO.