On August 13, 2020 Lumos Pharma, Inc. (NASDAQ:LUMO), a clinical-stage biopharmaceutical company focused on therapeutics for rare diseases, reported financial results for the second quarter ended June 30, 2020 and provided an update on clinical activities (Press release, NewLink Genetics, AUG 13, 2020, View Source [SID1234563600]).

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"The second quarter continued to be a busy and productive one for Lumos Pharma," commented Rick Hawkins, Chairman, CEO and President. "Most notably, the efforts of our team during this period culminated in the sale of our Priority Review Voucher in line with our expectations, further strengthening our balance sheet. With a Study May Proceed letter from the FDA in hand, we are progressing toward our goal of initiating the Phase 2b trial of LUM-201, our oral therapeutic candidate for PGHD, prior to the end of this year. In addition, we continue to engage in activities to expand our pipeline through the licensure of other rare disease assets. With our strong balance sheet and non-dilutive funds from the monetization of our PRV, we believe Lumos Pharma is well positioned to execute on our clinical and business development plans."
Corporate Update
Sale of Priority Review Voucher (PRV) – On July 27, 2020, Lumos Pharma announced that it had entered into a definitive agreement to sell its PRV to Merck, known as MSD outside the United States and Canada. The PRV was granted in conjunction with the approval by the U.S. Food and Drug Administration (FDA) of ERVEBO, a vaccine developed by the Company’s licensee, Merck, for the prevention of the Zaire Ebola virus disease.
Under the terms of the original license agreement, Lumos Pharma is entitled to retain 60% of the value of the PRV. Based upon an agreed valuation of $100 million, Merck will pay Lumos $60 million. The $60 million will be received in two non-contingent payments, $34 million anticipated in the third quarter of 2020, and $26 million in the first quarter of 2021. The transaction remains subject to customary closing conditions including anti-trust review. The non-dilutive funds from this transaction will provide additional capital to support the expansion of the Company’s pipeline through the in-licensing or acquisition of another novel therapeutic candidate for those suffering from rare diseases.
Clinical Update and COVID-19 Impact
Phase 2b trial of LUM-201 in PGHD – Lumos Pharma continues to prioritize the clinical development of LUM-201, its orally administered therapeutic candidate for a significant subset of children with PGHD. The Company continues to anticipate the initiation of its Phase 2b trial in PGHD prior to the end of 2020. This trial will evaluate three dose levels of LUM-201 in PGHD patients against a comparator arm of standard-of-care injectable growth hormone therapy. Dosing will be administered over six months, with annualized growth height velocity as the primary clinical outcome measure. The purpose of this trial will be to prospectively confirm our Predictive Enrichment Marker strategy and to identify the optimal dose of LUM-201 to be used in a registration trial.
While the coronavirus pandemic initially caused pervasive interruptions to clinical trials industrywide, clinical sites have begun to reopen, and numerous trials have restarted. A resurgence of the coronavirus pandemic may cause further

Exhibit 99.1

delays or shutdowns of clinical trials, including our own. Our Phase 2b site selection, however, spans a broad geographic base across the US and multiple other countries and includes both private clinics and academic centers, which we believe should help mitigate the impact of a resurgence of this pandemic.
Pharmacokinetic/Pharmacodynamic Study of LUM-201 in PGHD – Lumos also plans to initiate a second concurrent trial of LUM-201 in PGHD by Q1 2021. This trial is intended to further explore the effects of the mechanism of action of LUM-201 in amplifying the natural pulsatile secretion of growth hormone. The study will focus on pharmacodynamic and pharmacokinetic endpoints at two different doses in a limited number of children with PGHD, corroborating the amplified pulsatile secretion demonstrated in prior LUM-201 studies in adults. The trial will be conducted at a single specialized pediatric center with the capacity to conduct the more frequent sample acquisition and monitoring required for these types of clinical trials. This study will run in parallel with our announced Phase 2b trial with the intention that the data will be supportive in any future regulatory filings.
Pipeline Expansion – The Company continues to pursue business development opportunities to expand its rare disease portfolio. With a team possessing deep experience in the rare disease sector, we believe we are well-positioned to be successful in our pursuit of opportunities to expand our pipeline and build shareholder value.
Financial Results for the Three-Month Period Ended June 30, 2020 and Updated Cash Guidance
Cash Position: Lumos Pharma ended the quarter on June 30, 2020, with cash and cash equivalents totaling $72.7 million compared to Lumos Pharma prior to its merger with NewLink Genetics cash of $5.0 million on December 31, 2019 and pro forma cash, including NewLink Genetics, of $95.5 million on December 31, 2019. The Company expects its cash on hand will be sufficient to fund current operations through the Phase 2b LUM-201 trial read-out.
R&D Expenses: Research and development expenses for the three months ended June 30, 2020 were $2.8 million, an increase of $882,000 from $1.9 million for the same period in 2019. The increase is primarily due to an increase of $877,000 in personnel-related and stock compensation expense, an increase of $480,000 in clinical trial expense and an increase of $310,000 in supplies and other expense, offset by a decrease of $430,000 in contract manufacturing expense, and a decrease of $355,000 in legal and consulting expense.
G&A Expenses: General and administrative expenses for the three months ended June 30, 2020 were $4.1 million, an increase of $3.4 million from $714,000 for the same period in 2019. The increase was due primarily to increases of $1.2 million in personnel-related and stock compensation expense, $1.2 million due to increased operating expenses for insurance, rent, supplies and depreciation, and $969,000 in legal and consulting expense.
Net Loss: The net loss for the three months ended June 30, 2020 was $5.4 million compared to a net loss of $2.6 million for the same period in 2019.
Lumos Pharma ended Q2 2020 with 8,293,312 shares outstanding.
Conference Call and Webcast Details
The Company has scheduled a conference call and webcast for 4:30 p.m. ET today to discuss its financial results and to give an update on clinical and business development activities. There will also be a question and answer session following management’s prepared remarks.
Access to the live conference call is available five minutes prior to the start of the call by dialing (855) 469-0612 (U.S.) or (484) 756-4268 (international). The conference call will be webcast live and a link to the webcast can be accessed through the Lumos Pharma website at www.lumos-pharma.com in the "Investors & Media" section under "Events and Presentations" or through this link: View Source To ensure a timely connection, it is recommended that users register at least 10 minutes prior to the scheduled webcast. A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and using the passcode 9585725. The replay will be available for two weeks from the date of the call.

On August 13, 2020 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported the enrollment and dosing of the first patient in the amended Stage 2 of the Phase 2 clinical study of prexigebersen (BP1001), a liposomal Grb2 antisense, for the treatment of acute myeloid leukemia (AML), in combination with frontline therapy decitabine and venetoclax (Press release, Bio-Path Holdings, AUG 13, 2020, View Source [SID1234563599]).

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As previously reported, Phase 2 clinical development of prexigebersen in AML commenced with Stage 1 of the Phase 2 clinical trial, which was open label and treated de novo AML patients with a combination of prexigebersen and low dose cytarabine (LDAC). The combination of prexigebersen and LDAC was shown to be safe and more efficacious to treat this class of patients than with LDAC alone. Despite the superior combination treatment results with LDAC, the new drug decitabine was favored by oncologists. As a result, Stage 2 of the Phase 2 trial in AML dropped the combination treatment of prexigebersen and LDAC and replaced it with the combination treatment prexigebersen and decitabine. In addition, a second cohort of relapsed/refractory AML patients was added.

The recent approval of the frontline therapy venetoclax provided an opportunity for adding prexigebersen to the newly approved frontline, two-drug combination of venetoclax and decitabine for the treatment of AML patients.

Prior to finalizing plans to include prexigebersen with the frontline treatment combination of decitabine and venetoclax, the Company performed preclinical testing in AML cancer cell lines to assess prexigebersen’s increased benefit to efficacy. Preclinical testing of prexigebersen with the frontline treatment of decitabine and venetoclax demonstrated the potential to enhance efficacy of the frontline treatment combination. In the studies, four AML cancer cell lines were treated with three different combinations of decitabine, venetoclax and prexigebersen (BP1001). Decrease in AML cell viability was the primary measure of efficacy. The triple combination of decitabine, venetoclax and BP1001 showed significant improvement in efficacy in three of the four AML cell lines. Based on these results, the Company believes that adding prexigebersen to the treatment combination of decitabine and venetoclax could lead to improved efficacy in AML patients.

% Decrease in Cell Viability
AML Cell Lines BP1001 + decitabine BP1001 + decitabine + venetoclax Controla + decitabine + venetoclax
KG-1 64 90 46
MOLM-13 86 100 88
MV-4-11 67 95 79
Kasumi-1 33 50 47

a Empty liposomes control

Bio-Path’s approved amended Stage 2 for this Phase 2 clinical trial has three cohorts of patients, which the Company believes provides for several potential regulatory pathways. The first two cohorts will treat patients with the triple combination of prexigebersen, decitabine and venetoclax. The first cohort will include untreated AML patients, and the second cohort will include relapsed/refractory AML patients. Finally, the third cohort will treat relapsed/refractory AML patients who are venetoclax resistant or intolerant with the two-drug combination of prexigebersen and decitabine.

The first step in establishing the amended Stage 2 of the Phase 2 trial in AML was demonstrating the safety of treating patients with the two-drug combination of prexigebersen and decitabine, which the Company previously reported has been successfully completed. Importantly, results from patients who were previously treated with the two-drug combination of prexigebersen and decitabine prior to the amendment to Stage 2 of the Phase 2 trial in AML and who meet the criteria for enrollment in the third cohort of the amended Stage 2 of the Phase 2 trial in AML can be included in the third cohort results. This represents a beneficial head-start in the third cohort enrollment. This third cohort represents a significant, unmet opportunity in clinical treatment, as options are limited for AML patients who fail frontline therapy.

The first six evaluable patients in the amended Stage 2 of the Phase 2 trial in AML will be treated with the triple combination of prexigebersen, decitabine and venetoclax to test the safety of this treatment combination. As noted previously, the enrollment and dosing of the first patient in the amended Stage 2 of the Phase 2 clinical study has occurred. This patient is in the relapsed/refractory cohort being treated with the triple combination of prexigebersen, decitabine and venetoclax.

"Despite recent advances in the field, AML continues to be a challenging malignancy with unmet medical need as most patients unfortunately eventually succumb to their disease. The potential for prexigebersen in combination with new standard of care treatments seems particularly promising. We look forward to the execution of this trial and, hopefully, to bringing another tool to bear in the fight against this deadly disease," said Jorge Cortes, M.D., Director of the Georgia Cancer Center and Chairman of the Bio-Path Scientific Advisory Board.

"We are excited to be testing prexigebersen in this promising triple combination. Given our preclinical data, which support treating AML patients with this triple combination, we believe there is strong potential for improved outcomes for patients with AML who otherwise have limited treatment options," said Peter Nielsen, President and Chief Executive Officer of BioPath Holdings.

"We believe that this unique trial design provides us with several definable registration pathways. We believe that prexigebersen, with its promising efficacy and safety profile, has the potential to be an ideal combination candidate with frontline therapy," concluded Mr. Nielsen.

Study Design

The amended Stage 2 of this Phase 2 trial in AML is an open label Phase 2, two-stage, multicenter study of prexigebersen in combination with decitabine and venetoclax in two cohorts of patients with previously untreated AML and relapsed/resistant AML. A third cohort includes treating relapsed/refractory AML patients who are venetoclax resistant or intolerant with the two-drug combination of prexigebersen and decitabine.

The full trial design-plans have approximately 54 evaluable patients for the cohort treating relapsed/refractory AML patients with the triple combination treatment of prexigebersen, decitabine and venetoclax and the cohort treating AML patients who are venetoclax resistant or intolerant with the two-drug combination of prexigebersen and decitabine, with a review of both cohorts performed after 19 evaluable patients.

The full trial design-plans have approximately 98 evaluable patients for the cohort treating untreated AML patients with the triple combination treatment of prexigebersen, decitabine and venetoclax, with a preliminary review for the cohort performed after 19 evaluable patients and a formal interim analysis after 38 evaluable patients. The higher number of patients in the full trial design for the untreated AML patient cohort is due to the higher baseline response of the frontline therapy.

The primary endpoint for this study will be the number of patients who achieve complete remission ("CR"), which includes complete remission with incomplete hematologic recovery ("CRi"), and complete remission with partial hematology recovery ("CRh").

An interim analysis will be performed on each cohort to assess the safety and efficacy of the treatment. In the event these results exceed the primary endpoint in a number of patients that meets or exceeds statistically determined thresholds, the Company plans to seek to convert the trial into a registration trial for accelerated approval.

The study is anticipated to be conducted at ten clinical sites in the U.S., and Gail J. Roboz, M.D., will be the national coordinating Principal Investigator for the Phase 2 trial. Dr. Roboz is professor of medicine and director of the Clinical and Translational Leukemia Program at the Weill Medical College of Cornell University and the New York-Presbyterian Hospital in New York City. For more information on the Phase 2 study, visit www.clinicaltrials.gov.

On August 13, 2020 SELLAS Life Sciences Group, Inc. (Nasdaq:SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported financial results for the quarter ended June 30, 2020 (Press release, Sellas Life Sciences, AUG 13, 2020, View Source [SID1234563598]).

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"We are pleased that our ongoing studies for galinpepimut-S (GPS) – our Phase 3 REGAL study in patients with acute myeloid leukemia (AML) who have achieved complete remission after second-line anti-leukemic therapy (CR2), our Phase 1/2 basket study of GPS in combination with Merck’s pembrolizumab (KEYTRUDA), and the Phase 1 investigator-sponsored clinical trial (IST) of GPS in combination with Bristol-Myers Squibb’s anti-PD-1 therapy, nivolumab (Opdivo), in patients with malignant pleural mesothelioma (MPM) – are all proceeding on track despite these challenging times," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "During the second quarter of 2020, we established the independent Data Monitoring Committee (DMC) for the REGAL study comprised of esteemed members of the medical, scientific and biostatistical communities as well as a Steering Committee for the study."

Dr. Stergiou added, "We are also pleased to have strengthened our balance sheet with the closing of our private placement financing in early August, as the proceeds will be used to continue to progress our GPS program."

Second Quarter 2020 Pipeline Highlights

Galinpepimut-S (GPS) Program
In May 2020, SELLAS announced the formation of the Independent Data Monitoring Committee (DMC) for its pivotal Phase 3 REGAL clinical trial in AML CR2 patients. The DMC, comprised of an independent group of medical, scientific and biostatistics experts, is responsible for reviewing and evaluating patient safety and efficacy data for the REGAL study. The DMC currently consists of four members: Moshe Talpaz, M.D., Associate Director of Translational Research and Associate Chief of the Division of Hematology/Oncology at the University of Michigan Comprehensive Cancer Center and Chair of the DMC; Thomas Fleming, Ph.D., Professor and former department chair of the University of Washington Department of Biostatistics, Member of the Fred Hutchinson Cancer Research Center, former Director of the Statistical Center for HIV/AIDS Prevention Trial Network, NIAID, Special Government Employee for the FDA, and for more than 25 years, a regular member of several FDA Advisory Committees; Miguel-Angel Perales, M.D., Chief, Adult Bone Marrow Transplant Service at Memorial Sloan Kettering Cancer Center (MSKCC); and Stephane de Botton, M.D., Head of the Hematology Department at the Gustave Roussy Cancer Campus in Paris, France.
In April 2020, the Company announced the formation of the Steering Committee for the REGAL study. The Steering Committee currently consists of three members: Dr. Hagop Kantarjian, MD, Professor and Chair of the Department of Leukemia at The University of Texas MD Anderson Cancer Center, and Principal Investigator at MD Anderson for the REGAL study and Chair of the REGAL Steering Committee; Dr. Javier Pinilla-Ibarz, MD, PhD, Director of Immunotherapy for Malignant Hematology at the H. Lee Moffitt Cancer Center and member of the SELLAS Scientific Advisory Board; and Dr. Moshe Yair Levy, MD, Director of Hematologic Malignancies at the Texas Oncology – Baylor Charles A. Sammons Cancer Center.
Initial data readout from the MPM IST is expected by the end of 2020; initial data from the Phase 1/2 basket study is expected in the first half of 2021; and the planned interim safety and futility analysis in the REGAL study is expected to occur by the end of 2021.
Recent Corporate Highlights

In July 2020, SELLAS announced a private placement priced at-the-market of 2,744,078 shares of its common stock and accompanying warrants to purchase an aggregate of up to 2,744,078 shares of common stock, at a combined purchase price of $3.335 per share and accompanying warrant, to certain institutional and accredited investors, with gross proceeds to the Company of approximately $9.2 million before deducting the placement agent fee and related offering expenses.
Second Quarter 2020 Financial Results

R&D Expenses: Research and development expenses were $2.3 million for the second quarter of 2020, as compared to $1.4 million for the second quarter of 2019. Research and development expenses for the first half of 2020 were $4.1 million, as compared to $3.2 million for the same period in 2019. The increases in research and development expenses during the second quarter and first half of 2020 compared to the same periods in 2019 were primarily due to clinical trial expenses incurred for the REGAL study commencing in 2020.

G&A Expense: General and administrative expenses were $2.0 million for the second quarter of 2020, as compared to $2.6 million for the second quarter of 2019. General and administrative expenses for the first half of 2020 were $4.2 million, as compared to $5.1 million for the same period in 2019. The decreases during the second quarter and first half of 2020 compared to the same periods in 2019 were primarily due a reduction in legal fees and personnel related expenses.

Net Loss: Net loss attributable to common stockholders was $4.4 million for the second quarter of 2020, or a basic and diluted loss per share attributable to common stockholders of $0.66, as compared to a net loss attributable to common stockholders of $4.1 million for the second quarter of 2019, or a basic and diluted loss per share attributable to common stockholders of $6.33. Net loss attributable to common stockholders was $8.6 million for the first half of 2020, or a basic and diluted loss per share attributable to common stockholders of $1.32, as compared to a net loss attributable to common stockholders of $9.1 million for the first half of 2019, or a basic and diluted loss per share attributable to common stockholders of $16.56.

Cash Position: As of June 30, 2020, cash and cash equivalents totaled approximately $3.3 million. Following the end of the quarter, on August 4, 2020, the Company received gross proceeds of approximately $9.2 million from the Company’s sale, through a private placement priced at-the-market, of shares of common stock and accompanying common stock warrants to purchase shares of common stock.

On August 13, 2020 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") reported financial results and a business update for the second quarter ended June 30, 2020 (Press release, VolitionRX, AUG 13, 2020, View Source [SID1234563597]). Volition management will host a conference call tomorrow, August 14 at 8:30 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.
An interview with Cameron Reynolds, President and Chief Executive Officer.
Cameron Reynolds, President and Chief Executive Officer of Volition, upon releasing these results commented, "During the second quarter, given the persistence of the COVID-19 pandemic, we focused on two key areas to try and mitigate the effects of lockdowns and allow us to keep moving towards our first commercial products utilizing our cutting edge Nu.Q platform. Firstly, we significantly strengthened our balance sheet to ensure we have sufficient capital to work on our many programs concurrently, and launch products where possible during the pandemic. Secondly, we have increased the flexibility of our supply chain of key components and are moving towards producing our key components in house. Cancer remains our core disease focus, however, we have discovered that our technology potentially has applications beyond just cancer, for example with COVID-19."

View Source

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

Mr. Reynolds added, "I am proud of the way our team has adapted to the different world we find ourselves in and kept on working at full speed, their fantastic efforts have put us in an excellent position as we move towards the launch of our first products expected later this year and early next year."

Company Highlights

Financial

Cash and cash equivalents as of June 30, 2020 totalled approximately $21.3 million compared with $12 million the previous quarter.
Raised $13.8 million in gross proceeds in an underwritten public offering.
Periodically sold shares of our common stock pursuant to our previously disclosed "At The Market" equity offering program, or "ATM", under our existing registration statement along with our Rule 10b5-1 plan. Through the end of the second quarter of 2020 we had raised approximately $1.7 million in gross proceeds under the ATM.
During July and the first week of August we raised an additional approximately $4.7 million in gross proceeds through the ATM.
Volition was added to both the Russell 3000 and Russell Microcap Indexes in June.
Product Production Facility

Submitted an offer to purchase a neighboring facility in Belgium known as "Silver One". We expect this facility to be the production hub of all of our products and components, to both secure our own supply at a lower cost, and to drive reagent revenue building on our purchase of Octamer GmbH (now called Volition Germany) earlier this year.
Clinical – COVID-19

The preliminary study results reported in May demonstrated the Area Under the Curve (AUC) for a single Nu.Q assay was 98.7% PCR positive versus control subjects, with 100% sensitivity at 94% specificity. A second Nu.Q assay also showed promising results with an AUC of 86.2%.
To date we have now tested two independent cohorts of COVID-19 positive patients with quantitative nucleosome immunoassays and found that nucleosomes were highly elevated in plasma of severe COVID-19 patients relative to healthy control subjects and importantly, that both histone 3.1 variant and citrullinated nucleosomes increased with disease severity.
Given that the highest levels of nucleosomes were found in patients requiring artificial ventilation or extracorporeal oxygenation, we believe that nucleosomes could serve as a guiding biomarker for disease severity in COVID-19 positive patients.
These data imply that Nu.Q could have strong prognostic potential, and so we are now focused on the completion of larger longitudinal studies that would be needed to support a potential COVID-19 product launch.
Our collaborators have submitted this data for peer-review and we look forward to its publication.
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 product to help in the battle against the COVID-19 global pandemic and potentially other diseases such as influenza and pneumonia.
Clinical- Veterinary

In a proof of concept study conducted by Texas A&M University, a single Nu.Q Vet assay detected almost 70% of both Canine Hemangiosarcoma and Canine Lymphoma with AUCs of 84.5% and 83.1% cancer versus healthy, respectively, at a specificity of 90%. These two cancers alone represent almost a third of all canine cancers.
Based on the results of this study, we plan to move forward with other Nu.Q Vet assays in our pipeline, and with the larger range of cohorts and trials that we have collected and planned.
The first Nu.Q Vet products expected to be launched late in 2020 are likely to be for blood and lymphoma remission monitoring and we then aim to target additional uses (such as remission monitoring for other cancers and for diagnosis itself) in 2021.
Assay Development and Clinical Studies (Cancer)

We exceeded our target of 12 assays being finalized by the end of the second quarter with respect to our fully-automated magnetic bead-based chemiluminescent format. To date, 13 assays have been developed and are being tested in our clinical research programs. We plan to reach a total of 20 by the end of 2020.
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 on track with our milestones) but many issues are not within our control.
We have now successfully completed 8 assays on subsets of both of our National Taiwan University studies – colorectal and lung cancers – and are working on data analysis. We expect over this coming quarter to run an additional number of assays and to submit the data at upcoming conferences.
Epigenetic Toolbox

We have developed and are seeking patents on our novel Nu.Q Capture-based epigenetic tools. We are using these tools to expand diagnostic developments that focus on circulating DNA fragment analysis, leading to a broader and potentially more powerful investigation of the epigenetic status of a patient’s circulating chromosome fragments. We have made significant progress with this work and will continue to publicise data as it is completed in the coming quarters.
Publications

The second quarter was the best quarter ever from a publications point of view.
We had three abstracts published at ASCO (Free ASCO Whitepaper), the American Society for Clinical Oncology, including data in both lung and blood cancers.
We have received acceptance for oral presentation of two abstracts at the Veterinary Cancer Society Meeting in October this year.
A Nu.Q Vet paper regarding pre-analytics has been submitted for peer review and accepted for publication.
Three papers have been submitted by collaborators using our Nu.Q technology, for lung disease, for complications during pregnancy and for COVID-19, yet again showing the wide adaptability of our platform.
We have other papers in process, including a pre-analytics paper for humans that we expect to submit over the next couple of months, and two papers from the Nu.Q Capture program on mass spectrometry and also sequencing.
Upcoming Milestones

Volition expects to achieve the following milestones during 2020 and beyond:

We will focus on driving revenue in the coming quarters, where possible during the pandemic, in 4 key areas:
Our four potential triage tests (3 cancers and COVID-19);
Nu.Q Vet products;
Reagent sales; and
Licensing of our technology for others to commercialize.
Continue to advance our previously announced large-scale colorectal and lung cancer trials in Europe, Asia and the U.S.
Commission and complete longitudinal studies for COVID-19.
Publish several abstracts and peer reviewed scientific papers with clinical results as well as showing the robustness and utility of our Nu.Q platform.
Advance the development of Nu.Q Capture
Announce patient data demonstrating the wide utility of our epigenetic toolbox.
Complete the purchase and fit out of "Silver One", to serve as our manufacturing hub and service lab in Belgium.
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 especially given the challenging circumstances we all face during the COVID-19 pandemic. 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 Second Quarter 2020 Earnings

and Business Update Conference Call Date: Friday, August 14, 2020

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 August 28, 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 13707978.

On August 13, 2020 Histogen Inc. (NASDAQ: HSTO), a clinical-stage therapeutics 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, 2020 and provided an update on its clinical pipeline and other corporate developments (Press release, Conatus Pharmaceuticals, AUG 13, 2020, View Source [SID1234563596]).

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Key Second Quarter 2020 Highlights and Subsequent Updates

Filed Investigational Device Exemption (IDE) for HST-002. In April, Histogen filed an IDE application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical trial of HST-002 as a dermal filler for the treatment of moderate to severe nasolabial folds. If the application is approved, Histogen plans to initiate the clinical trial in fourth quarter of 2020.

Closed Reverse Merger with Conatus. In May, Histogen closed the reverse merger transaction with Conatus. The transaction included approximately $13.0 million in cash resources, which when combined with existing resources, is expected to fund Histogen’s current operating plan into the second quarter of 2021. The combined company changed its name from Conatus Pharmaceuticals Inc. to Histogen Inc. and began trading on the Nasdaq Capital Market under the ticker symbol "HSTO" on May 27, 2020.
Appointed Susan A. Knudson as Chief Financial Officer. In May, Ms. Knudson joined Histogen as its Executive Vice President and Chief Financial Officer. With over 20 years of experience in the biopharmaceutical industry, she brings a wealth of financial and corporate strategy expertise to Histogen. Ms. Knudson most recently served as Chief Financial Officer at Pfenex Inc. and prior to Pfenex, she held the position of Chief Financial Officer of Neothetics, Inc.

Completed Enrollment for HST-001 Phase 1a/2b trial for Androgenic Alopecia in Men with Topline Data Expected in the fourth quarter 2020. Histogen announced that it initiated the trial in June, completed enrollment in July and expects to report topline results in the fourth quarter of 2020.

Entered into Common Stock Purchase Agreement for Up to $10 Million. In July, Histogen entered into a common stock purchase agreement for up to $10 million with Lincoln Park Capital Fund, LLC. Upon execution of the purchase agreement, Lincoln Park made an initial purchase of $1.0 million of common stock.
"Throughout the second quarter of this year, we focused on transforming Histogen into a leading restorative therapeutics development company through the completion of the reverse merger, obtaining a NASDAQ listing, strengthening the executive team and advancing our innovative therapeutics pipeline," said Richard W. Pascoe, Histogen’s President and Chief Executive Officer. "In the remaining months of 2020, we will focus on achieving a number of near-term clinical and regulatory value-inflection points, such as filing an IND for our HST-003 program focused on knee cartilage repair, initiating a Phase 1 trial for HST-002 for the treatment of moderate to severe nasolabial folds and reporting topline results from our HST-001 Phase 1a/2b trial for androgenic alopecia in men. Moreover, I want to take this opportunity to commend the entire Histogen team for their tireless efforts, in the midst of a global pandemic, to position the company for success in 2020 and beyond."

Expected Second Half 2020 Milestones

Submit HST-003 IND for the regeneration of cartilage in the knee
Initiate HST-002 Phase 1 trial for the treatment of moderate to severe nasolabial folds, if IDE is approved
Report topline data for HST-001 Phase 1a/2b trial for androgenic alopecia in men
Financial Highlights for the Second Quarter 2020

Revenues for the three months ended June 30, 2020 and 2019 were $0.1 million and $1.4 million, respectively. The year-over-year decrease of $1.3 million was primarily due to a decrease in the fulfillment of supply orders of CCM to Allergan and one additional customer.

Cost of revenues for the three months ended June 30, 2020 and 2019, were $0 million and $0.5 million, respectively. The decrease of $0.5 million for the three months ended June 30, 2020 as compared to the three months ended June 30, 2019 was due to a decrease in fulfillment of supply orders of CCM to Allergan and one additional customer.

For both the three months ended June 30, 2020 and 2019, we recognized costs of professional services of $0.1 million related to our Allergan License Agreements.

In-process research and development expenses for the three months ended June 30, 2020 and 2019 were $7.1 million and $2.3 million, respectively. In the three months ended June 30, 2020, we incurred $7.1 million for in-process research and development acquired in connection with the reverse merger with Conatus and in the three months ended June 30, 2019, we incurred $2.3 million for in-process research and development related to the acquisition of HST-003 and HST-004 from PUR Biologics LLC.

Research and development expenses for the three months ended June 30, 2020 and 2019 were $1.4 million and $1.0 million, respectively. The increase of $0.4 million for the three months ended June 30, 2020 was primarily due to an increase in development costs for our product candidates.

General and administrative expenses for both the three months ended June 30, 2020 and 2019 were $1.6 million. The three months ended June 30, 2019 included success-based fees of approximately $0.8 million related to $7.5 million of license revenue received in the three months ended June 30, 2019 for which there was no comparable expense incurred in the three months ended June 30, 2020. This decrease for the three months ended June 30, 2020 was offset by increases in personnel related expenses, legal and accounting fees in the three months ended June 30, 2020.

Cash and cash equivalents as of June 30, 2020 were $10.4 million. Histogen believes that its existing cash and cash equivalents and cash inflow from operations will be sufficient to meet Histogen’s anticipated cash needs into the second quarter of 2021.