On August 11, 2021 Heat Biologics, Inc. ("Heat") (NASDAQ: HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, reported that financial, clinical and operational updates for the second quarter ended June 30, 2021 (Press release, Heat Biologics, AUG 11, 2021, View Source [SID1234586334]).

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Jeff Wolf, Chief Executive Officer of Heat, commented, "This quarter we achieved several meaningful clinical, research and business milestones. First, we presented favorable survival data of HS-110 in previously treated non-small cell lung cancer (NSCLC) patients at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Based on these results, we believe HS-110, in combination with a checkpoint inhibitor (CPI), holds significant potential to improve survival benefit for patients with non-small cell lung cancer. We are continuing to evaluate possible Phase 3 registration pathways with the FDA and potential partners. At the same time, we are exploring a variety of paths forward related to our infectious disease efforts. We look forward to providing further near-term updates."

"This quarter we also announced the groundbreaking for our biomanufacturing/bioanalytic facility in San Antonio, TX and the expansion of our current research and development (R&D) facilities at our corporate headquarters in Morrisville, NC. This expansion will support enhanced R&D capabilities including in-house synthesis and production of antibodies and other drugs/reagents, as well as an expanded vivarium for onsite pre-clinical studies. We believe that this expansion will allow us to accelerate R&D timelines and generate cost savings on research and development by bringing more of our development activities in-house."

"Moreover, we have maintained a strong balance sheet with approximately $122.5 million of cash, cash equivalents and short-term investments which should allow us to augment our clinical programs as well as enhance and expand our therapeutic pipeline."

Second Quarter 2021 Financial Results

●Recognized $0.5 million of grant revenue for qualified expenditures under the CPRIT grant compared to $0.6 million for the quarter ended June 30, 2020. The decrease in grant revenue in the current-year period primarily reflects the expected timing of completion of deliveries under the current phase of the contracts. As of June 30, 2021, we had a grant receivable balance of $0.4 million for CPRIT proceeds not yet received but for which the costs had been incurred or the conditions of the award had been met. We continue our efforts to secure future non-dilutive grant funding to subsidize ongoing research and development costs.
●Research and development expense was $4.2 million and $2.8 million for the three months ended June 30, 2021 and 2020, respectively.
●General and administrative expense was $2.9 million and $1.8 million for the three months ended June 30, 2021 and 2020. The increase was primarily due to an increase in stock-based compensation expense.
●Net loss attributable to Heat Biologics was approximately $6.5 million, or ($0.26) per basic and diluted share for the quarter ended June 30, 2021 compared to a net loss of approximately of $4.5 million, or ($0.35) per basic and diluted share for the quarter ended June 30, 2020.
●As of June 30, 2021, the Company had approximately $122.5 million in cash, cash equivalents and short investments.

On August 11, 2021 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported its financial results for the second quarter 2021 (Press release, Cyclacel, AUG 11, 2021, View Source [SID1234586333]). The quarter’s business highlights included an update on the Company’s progress with fadraciclib and CYC140, Cyclacel’s novel CDK2/9 and PLK1 inhibitors, respectively.

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"After announcing In July that the first patient had been dosed with oral fadraciclib, two additional patients with advanced solid tumors have been treated, completing enrolment of the first dose level," said Spiro Rombotis, President and Chief Executive Officer. "We are encouraged by investigator interest in our fadraciclib 065-101 solid tumor study. In earlier clinical studies fadraciclib has demonstrated single-agent activity, including durable PR. We believe that fadraciclib is a leading, transcriptionally-active CDK inhibitor with a differentiated product profile. Pipeline momentum will continue to build with the planned opening of protocol 065-102, an oral fadraciclib study in patients with hematological malignancies, and later with the initiation of two similar protocols in solid tumors and hematological malignancies for our novel PLK1 inhibitor, CYC140. The second half of 2021 is an exciting period for Cyclacel, as we expand our clinical programs and increase our visibility as an oncology leader focused on cell cycle inhibition for the treatment of cancer. We look forward to reporting further updates as data from these studies become available."

Key Corporate Highlights

Oral fadraciclib – First three patients with advanced solid tumors dosed in the 065-101 Phase 1/2, registration-directed trial. The study includes multiple cohorts defined by histology thought to be sensitive to the drug’s mechanism of action and informed by the clinical activity of fadraciclib in MCL1, MYC and/or cyclin E amplified cancers. The cohorts include breast (metastatic, hormone receptor positive, post-CDK4/6 inhibitor; HER-2 refractory; or triple negative), cholangiocarcinoma, colorectal (including KRAS mutant), endometrial, hepatocellular, ovarian cancers and certain lymphomas. The study design also includes a basket cohort which will enroll patients with relevant biomarkers to the drug’s mechanism regardless of histology. Previously single agent, intravenous fadraciclib has demonstrated durable suppression of MCL1 and other mechanistically-related proteins, including cyclin E and MYC, at tolerated doses.

Oral CYC140 – continued progress with IND-directed activities and manufacturing of clinical trial supplies. Initial data in preclinical models show that KRAS mutant cancers are sensitive to oral CYC140 inhibition. The Company expects to begin a study in patients with solid tumors in the second half of 2021. Similar to the fadraciclib clinical program, the CYC140 Phase 1/2 study will be a registration-directed trial using a streamlined design that will first determine the recommended Phase 2 dose (RP2D) for single-agent CYC140. Once the RP2D has been established, the trial will immediately enter into a proof-of-concept, cohort stage, using a Simon 2-stage design, where single agent CYC140 will be administered to patients across multiple cohorts based upon those histologies thought to be sensitive to the drug’s mechanism of action.
Key Near-Term Business Objectives and Expected Timeline

2H 2021

First patient to be dosed with oral fadraciclib in 065-102 Phase 1/2 leukemia study
FDA clearance of IND filing; begin oral CYC140 Phase 1/2 advanced solid tumor study
1H 2022

First patient to be dosed with oral CYC140 in Phase 1/2 leukemia study
Phase 1 data with oral fadraciclib in advanced solid tumor 065-101 study
Financial Highlights

As of June 30, 2021, cash and cash equivalents totaled $43.6 million, compared to $47.8 million as of March 31, 2021. The decrease of $4.2 million was primarily due to net cash used in operating activities. The Company estimates that the cash resources will fund currently planned programs through early 2023.

Research and development expenses were $4.1 million for the three months ended June 30, 2021 as compared to $1.2 million for the same period in 2020. Research and development (R&D) expenses relating to fadraciclib increased by approximately $1.9 million for the three months ended June 30, 2021 with the start of the CYC065-101 study of fadraciclib in solid tumors and preparations for opening the 065-102 study of fadraciclib in leukemias. Additionally, R&D expenses related to CYC140 increased $1.0 million for the quarter as IND-directed activities are approaching completion and clinical trial supplies are being manufactured.

General and administrative expenses for the three months ended June 30, 2021 were $2.0 million, compared to $1.3 million for the same period of the previous year due to costs of approximately $0.4 million related to exiting a long-term facility lease, increased legal and professional expenses and recruitment costs.

United Kingdom research & development tax credits were $1.0 million for the three months ended June 30, 2021, as compared to $0.3 million for the same period in 2020 due to the increase in R&D expenditure.

Net loss for the three months ended June 30, 2021 was $5.1 million, compared to $2.2 million for the same period in 2020.

On August 11, 2021 Biomea Fusion, Inc. ("Biomea") (Nasdaq: BMEA), a preclinical-stage biopharmaceutical company focused on the discovery and development of irreversible small molecules to treat patients with genetically defined cancers, reported financial results for the second quarter of 2021 (Press release, Biomea Fusion, AUG 11, 2021, View Source [SID1234586332]).

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"We continue to make notable progress as we rapidly advance BMF-219 toward a planned entry into the clinic and continue to grow our company and pipeline," said Thomas Butler, Biomea’s CEO and Chairman of the Board. "In the second quarter, we successfully completed IND-enabling studies for BMF-219 and are now in the final stages of completing our IND submission to the FDA to advance BMF-219 to a Phase I study for the treatment of patients with menin-dependent AML and ALL. We also continued to make important progress pursuing our broad, ambitious, preclinical strategy focused on exploring the potential of this novel irreversible small molecule across a number of menin-dependent liquid and solid tumors, including DLBCL."

Mr. Butler continued, "While our primary focus is oncology drug development, there are multiple diseases where the menin pathway is implicated and where an irreversibly binding small molecule approach may have an important impact, including for patients with type 2 diabetes. At our core, we feel a profound responsibility to help patients with our novel chemistry. To that end, we look forward to seeing the results of our exploratory pathway validation in type 2 diabetes next year."

Business Highlights

Completed IND-enabling studies with irreversibly binding menin inhibitor BMF-219. Biomea successfully conducted IND-enabling studies with BMF-219, an irreversible menin inhibitor for the treatment of patients with menin-dependent AML and ALL. Biomea anticipates submitting the IND during the second half of 2021.

Continued preclinical studies of BMF-219 in DLBCL. Biomea continues to explore the potential of BMF-219 for a number of menin-dependent liquid and solid tumor cancers, including a subset of DLBCL, with a number of preclinical studies currently underway. The Company plans to report its findings in DLBCL in the first quarter of 2022. Despite the high dependency of several cancers on menin, Biomea Fusion is not aware of any menin inhibitors currently in clinical development for these cancer types.

Initiated pathway validation studies in diabetes. Based on a growing body of internal and external scientific evidence, Biomea has initiated key preclinical studies to explore the potential of its irreversible menin inhibitors as a treatment for type 2 diabetes. The Company plans to report its findings in the first quarter of 2022. Biomea Fusion is not aware of any menin inhibitors currently in clinical development for diabetes.
Expanded team and in-house research capabilities to support long-term growth and clinical and preclinical development plans. Biomea strengthened its executive team with the appointments of Franco Valle as Chief Financial Officer, Alex Cacovean, M.D. as Executive Medical Director and Sasha Blaug Ph.D. as Senior VP of Corporate Development. Biomea has successfully grown its headcount this year to date by 29 for a total of 41 current team members. The Company has also completed the buildout of its own laboratory facilities to further support the research and preclinical pipeline development of its irreversible platform.
Strengthened the Company’s Board of Directors. In the second quarter Biomea appointed Sumita Ray J.D., Chief Legal and Administrative Officer at Calithera Biosciences, Inc., to its Board. Ms. Ray is an industry veteran with over 20 years of expertise in FDA regulatory law, global health care law and compliance, brand support, product launches, collaborations and alliances.
Financial Highlights

Second Quarter 2021 Year to Date Financial Results

Biomea reported a net loss attributable to common stockholders of $14.3 million for the first six months of 2021, compared to a net loss of $0.7 million for the same period in 2020.

Research and development expenses were $9.0 million for the first six months of 2021, compared to $0.6 million for the same period in 2020. The increase of $8.4 million was primarily due to an increase in personnel-related expenses, as well as an increase in pre-clinical development costs, including manufacturing and external consulting, related to the IND-enabling studies for BMF-219.

General and administrative expenses were $5.3 million for the first six months of 2021, compared to $0.1 million for the same period in 2020. The increase of $5.2 million was primarily due to higher personnel-related expenses and other corporate costs to support the Company’s expanding operations, including legal and accounting.

As of June 30, 2021, the Company had cash, cash equivalents, restricted cash, and investments of $203.0 million.

On August 11, 2021 Histogen Inc. (NASDAQ: HSTO), a clinical-stage company focused on developing potential first-in-class restorative therapeutics that ignite the body’s natural process to repair and maintain healthy biological function, reported financial results for the second quarter ended June 30, 2021 and provided an update on its clinical pipeline and other corporate developments (Press release, Conatus Pharmaceuticals, AUG 11, 2021, View Source [SID1234586331]).

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"In the second quarter, we charted a more strategic course for our restorative therapeutics pipeline with a focus on orthopedic indications that we believe sit at the crossroads of pre-clinical and clinical proof-of-concept, significant commercial opportunity and unmet medical needs," said Richard W. Pascoe, President and Chief Executive Officer. "Moreover, we believe that there is a significant value-creating opportunity for emricasan as a COVID-19 therapeutic given the positive safety and efficacy signals we reported in the recently completed Phase 1 study in mild symptomatic patients. Looking forward, we will concentrate our efforts on achieving meaningful regulatory, pre-clinical and clinical milestones for our pipeline assets in an effort to create long-term value for the benefit of patients, the healthcare community and our shareholders."

Highlights from the Second Quarter Ended June 30, 2021 and Business Updates

Technology and Pipeline Focus – In June 2021, we completed a strategic evaluation of our regenerative medicine platform technology and announced that our pipeline focus will be on what we believe to be high-value orthopedic indications, creating pipeline synergies and maximizing resources in an effort to further drive long-term shareholder value. Our current orthopedic development programs include HST 003 for cartilage regeneration in the knee and HST 004 for spinal disk repair. Histogen is also evaluating the potential for additional pipeline opportunities targeting other soft tissues such as the tendon and ligament.

HST 003 – In June 2021, we initiated our Phase 1/2 clinical study of HST 003 to evaluate the safety and efficacy of human extracellular matrix (hECM) implanted within microfracture interstices and the cartilage defect in the knee to regenerate hyaline cartilage in combination with a microfracture procedure. We anticipate having top-line results from this study in the second quarter of 2022.
HST 004 – We recently initiated investigational new drug application (IND) enabling activities for HST 004, a CCM solution intended to be administered through an intradiscal injection for spinal disc repair. Our initial preclinical research has shown that HST 004 stimulates stem cells from the spinal disc to proliferate and secrete aggrecan and collagen II, regenerate normal matrix and cell tissue structure and restore disc height. HST 004 was also shown to both reduce inflammation and protease activity and upregulate aggrecan production in an ex vivo spinal disc model. We anticipate filing an IND for HST 004 in the second quarter of 2022.
Emricasan – In June 2021, we, along with our partner Amerimmune, announced positive results from the Phase 1 study of emricasan in mild symptomatic COVID-19 patients. Emricasan was shown to be safe and well-tolerated during the 14 days of dosing and at the day 45 follow up, as compared to placebo with no reports of serious adverse events. Patients who completed treatment with emricasan had a complete resolution of the symptoms most commonly associated in mild COVID-19, such as a cough, headache, and fatigue at day 7 and continued through Day 45. Patients in the placebo arm who completed the study did not experience COVID-19 symptom resolution at any time point out to day 45. We, along with our partner Amerimmune, are currently evaluating our clinical development plans for the emricasan program and expect to complete our evaluation in the third quarter of 2021.
Second Quarter 2021 Financial Highlights

Second Quarter Ended June 30, 2021 and 2020

License and Service Revenues in the second quarter of 2021 decreased nearly 100% to $5 thousand from $0.1 million in the second quarter of 2020. The decrease is primarily related to the completion of technology transfer obligations of Histogen under the Allergan Agreements. During both periods, $5 thousand of deferred revenue was recognized in relation to the Potential Future Improvements remaining performance obligation currently being amortized over the remaining 9-year patent life.

Cost of Professional Services Revenues for the three months ended June 30, 2021 and 2020 were zero and $0.1 million, respectively.

Acquired In-Process Research and Development for the three months ended June 30, 2021 and 2020 were zero and $7.1 million, respectively. Histogen incurred $7.1 million for in-process research and development acquired during the three months ended June 30, 2020 in connection with the merger.

Research and Development Expenses for the three months ended June 30, 2021 and 2020 were $2.4 million and $1.4 million, respectively. The net increase of $1.0 million for the three months ended June 30, 2021 as compared to the three months ended June 30, 2020 was primarily due to increases in expanded development costs of our product candidates partially offset by $0.2 million in qualifying expenses in connection with the Department of Defense grant and increases in personnel-related expenses.

General and Administrative Expenses for the three months ended June 30, 2021 and 2020 were $1.8 million and $1.6 million, respectively. The $0.2 million increase for the three months ended June 30, 2021 as compared to the three months ended June 30, 2020 was primarily due to increases in personnel-related expenses and insurance fees offset by other expenses, such as legal and accounting fees.

Cash and Cash Equivalents as of June 30, 2021 were $23.1 million. We believe that Histogen’s existing cash and cash equivalents and cash inflow from operations will be sufficient to meet its anticipated cash needs into the fourth quarter of 2022.

On August 11, 2021 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") reported financial results and a business update for the second quarter ended June 30, 2021 (Press release, VolitionRX, AUG 11, 2021, View Source [SID1234586330]). Volition management will host a conference call tomorrow, August 12 at 8:00 a.m. U.S. Eastern Time to discuss these results. Conference call details may be found below.

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"We have made significant progress on many fronts during the first half of 2021, in particular on all four of the Company’s key pillars: Nu.Q, Nu.Q Vet, Nu.Q NETs and Nu.Q Capture," commented Cameron Reynolds, President and Chief Executive Officer of Volition. "We have also significantly strengthened our balance sheet, our intellectual property portfolio, and our executive team to drive our commercial focus."

View Source

An interview with Cameron Reynolds, President and Chief Executive Officer of Volition, Terig Hughes, Chief Financial Officer of Volition, and Dr. Tom Butera, Chief Executive Officer of Volition Veterinary Diagnostics Development LLC

Mr. Reynolds continued, "I am delighted that the Nu.Q Vet beta launch has not only been very successful in providing invaluable real-world learnings for our first veterinary product but has also generated a high level of interest in both the licensing and distribution of our veterinary products, and we are actively negotiating potential arrangements on multiple fronts."

Company Highlights

Financial

Cash and cash equivalents as of June 30, 2021, totalled approximately $27.9 million compared with $19.4 million as of December 31, 2020.
Net loss for the second quarter of 2021 was $5.6 million and net cash used in operating activities was $5.4 million for the quarter.
Grant income earned in the second quarter of 2021 was approximately $0.4 million.
Volition received approximately $0.9 million of net proceeds through its at-the-market equity distribution program during the second quarter of 2021.
Continued to manage expenditures carefully with a cash burn rate of approximately $2 million per month.
Personnel

On May 1, Dr. Tom Butera, a seasoned veterinary executive with an extensive commercial track record, and former Non-Executive Director of Volition, joined the team full time as Chief Executive Officer of Volition’s veterinary subsidiary to drive its product launches.
Intellectual Property

27 patent families (plus three in-licensed families) covering both human and animal use of Volition’s Nucleosomics platform.
71 granted patents (ten in the U.S., 14 in Europe and 47 rest of world).
89 patents pending.
Continued focus on filings during the second quarter of 2021 and expect portfolio to grow in the quarters and years ahead.
Publications

Volition’s list of publications and abstracts continues to grow.
Year to date data for Nu.Q has been presented at three international conferences and Volition has collaborated on four clinical papers, three of which have already been published with the other pending publication.
These publications are another very important step forward for the Company.
Nu.Q Vet Cancer Screening Test Beta Launch

Volition has received strong indications of interest in the whole Nu.Q Vet platform, from a range of smaller and very large companies, and it is progressing potential licensing negotiations with several well-known major players in the veterinary space around the world.
The Company aims to have a very meaningful deal signed before the end of 2021.
Clinical – NETosis including COVID-19

Volition believes that the versatility of the Nu.Q platform and the range of applications for which these assays can be leveraged may help increase diagnostic power and monitor disease progression and potentially treatment response across a broad range of diseases that involve the over production of NETs, such as COVID-19, pneumonia, influenza and sepsis.
Volition previously reported preliminary results demonstrating that its Nu.Q NETs assay correlated well with current COVID-19 disease severity.  
Recently published posters (at the International Society on Thrombosis and Haemostasis Congress) showed that results on admission using the same Nu.Q NETs assay could predict future COVID-19 disease severity and that serial results correlate with disease progression including 28-day mortality.
From a sepsis product development perspective, to date Volition has completed animal studies in the monitoring of disease progress and treatment efficacy which have demonstrated the effective use of Nu.Q NETs.
The Company has additional large studies in progress related to COVID-19, sepsis and other diseases, some due for completion soon, with the publication of further data expected in the coming months.
Clinical – Cancer

Volition has also been in active and continuing negotiations in Asia this year on its first human cancer launch in China.
The Company has completed preliminary analysis of the lung cancer study conducted with the National Taiwan University and looks forward to reviewing the data with Professor Chen and his team ahead of publication either through clinical paper or conference abstract. Collection has also been completed for the colorectal cancer study also conducted with the National Taiwan University. Volition anticipates the data will be analysed this year, with findings to be presented at a conference in 2022.
After a 15 month pause, EDRN (a large-scale U.S. colorectal cancer study) re-initiated enrolment in June and aims to be enrolling at full capacity in September 2021. The study collection completion date has been extended to the fourth quarter of 2022.
With regards to Volition’s two U.S. blood cancer studies, the timing of expected completion for each has been impacted by the COVID-19 pandemic due to sample collection and protocol issues.
– For the 1,500 subject NHL diagnostic study, all preliminary protocol development and study preparation has been completed. The Company aims to begin collection in late 2021, protocols and pandemic permitting, and to submit the first data to the FDA in late 2022.
– COVID-19 restrictions have also made sequential therapy-matched specimen collections exceptionally difficult in the DLBCL Treatment Monitoring Study. The Company aims to issue interim analysis results later this year.
Volition has installed a Service Lab in Silver One, which will undertake sample processing for external parties such as pharmaceutical companies, biotech companies and academic researchers. This service, branded as Nu.Q Discover, has already generated interest and the Company has provided quotes to multiple pharma and biotech companies. Volition anticipates that it will generate revenue from this activity in 2021 with continued growth in the future.
Upcoming Milestones

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

Drive revenue in the coming quarters in the following key areas:
– Licensing of its technology, with a particular but not exclusive focus on Nu.Q Vet, with the aim of signing the first deal this year,
– Processing samples at Silver One using its Nu.Q Discovery assays, and
– Disease monitoring tests (e.g. COVID-19, Sepsis).
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 its 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 its Nu.Q platform.
Advance the development of Nu.Q Capture.
Continue to file patents to expand and extend its intellectual property portfolio.
VolitionRx Limited Second Quarter 2021 Financial Results and Business Update

Cameron Reynolds, President and Chief Executive Officer of Volition, will host the call along with Terig Hughes, Chief Financial Officer of Volition, Dr. Tom Butera, Chief Executive Officer of Volition Veterinary Diagnostics Development LLC, and Scott Powell, Executive Vice President, Investor Relations of Volition.

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 August 26, 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 13722250.