On May 11, 2021 Pulmatrix, Inc. (NASDAQ: PULM), a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and non-pulmonary disease using its patented iSPERSE technology, reported its first quarter 2021 financial results and provides a business update (Press release, Pulmatrix, MAY 11, 2021, View Source [SID1234579674]).

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

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

                  Schedule Your 30 min Free Demo!

Q1 and Recent Highlights:

PUR1800

Pulmatrix regained full rights to its narrow spectrum kinase inhibitor (NSKI) portfolio, including PUR1800, following Johnsons & Johnson’s Enterprise Innovation’s (JJEI) decision to terminate the Company’s license, development and commercialization agreement. JJEI’s termination of the agreement had no material impact on our financial projections.
Pulmatrix intends to continue the development of PUR1800, with ongoing clinical and toxicology studies to support programs in acute exacerbations in COPD (AECOPD) and other chronic airway diseases.
Initiated the Phase 1b clinical study of PUR1800, dosing 5 of 15 patients to date. Study endpoints include safety, tolerability and exploratory biomarkers to demonstrate target engagement and anti-inflammatory effect. Ph1b top-line data is expected in Q4 2021, shortly after data from 6 and 9-month toxicology studies.
With existing 28-day toxicology results, the Company expects that completion of the PUR1800 Phase 1b will enable a Ph2 efficacy trial in AECOPD. The results from 6 and 9-month toxicology studies underway may expand the PUR1800 opportunity to additional indications which require chronic dosing.
PUR3100

PUR3100 development candidate, a dry powder iSPERSE formulation of dihydroergotamine (DHE) for pulmonary delivery in acute migraine.
Completed dog PK study of PUR3100, demonstrated similar exposure kinetics to modelled kinetics from published data with MAP0004, the MAP Pharmaceuticals pMDI inhaled formulation of DHE.
Pulmazole

Successfully completed a Type C Meeting with the U.S. FDA for the further clinical development of Pulmazole.
On May 10, 2021, we sent a letter to Cipla Technologies LLC ("Cipla") notifying Cipla that it is in material breach of our Development and Commercialization Agreement (the "Cipla Agreement"), dated April 15, 2019, due to Cipla’s anticipatory breach of its obligation under the Cipla Agreement to fund 50% of the development costs for Pulmazole. We have given Cipla 30 days from the date of the letter to reaffirm that it will perform the Agreement in accordance with its terms or we will exercise our contractual right to terminate the agreement for Cipla’s material breach and reacquire all rights to Pulmazole for 25% of its fair market value. In either outcome, Pulmatrix intends to advance Pulmazole clinically to Ph2b.
Hosted KOL investor event featuring presentations by Stewart J. Tepper, M.D., F.A.H.S, Geisel School of Medicine at Dartmouth and Stephen Silberstein, M.D., F.A.C.P., Thomas Jefferson University, detailing the current landscape and unmet need for acute migraine, the potential of novel DHE therapies, and the development plan and preclinical data for PUR3100
Progressing IND-enabling studies with Phase 1/Phase 2 clinical study anticipated to begin Q1 2022.
Corporate:

Completed a registered direct offering with gross proceeds of $40 million extending the Company’s cash runway to fully fund data readouts across its development pipeline including PUR1800 Phase 1b and PUR3100 Phase 1 / Phase 2 studies.
"The first quarter of 2021 has marked a number of significant milestones for Pulmatrix," said Ted Raad, Chief Executive Officer of Pulmatrix. "Each of our iSPERSE enabled programs, ranging from asthma, COPD, and migraine, represents an opportunity to address significant unmet needs of large patient populations. We are pleased to now have the kinase inhibitor portfolio back in our proprietary pipeline following the termination of the development and licensing agreement with Johnson & Johnson. We also remain steadfast in our objective to bring Pulmazole to market and address significant unmet need of patients suffering from ABPA. Our recent notice to Cipla Technologies demonstrates that commitment. With our strong balance sheet, we believe that we can fund operations through planned data milestones for PUR1800 and PUR3100 and, if we ultimately re-acquire Pulmazole from Cipla, begin our Ph2b study."

Financials

As of March 31, 2021, Pulmatrix had $63.4 million in cash and cash equivalents, compared to $31.7 million for the year ended December 31, 2020.

Revenue for the first quarter of 2021 was $1.4 million, compared to $2.8 million for the same period in 2020. The revenue for the first quarter of 2021 and 2020 was the result of the collaboration and licensing agreements with Cipla and JJEI.

Research and development expense was $3.9 million in the first quarter of 2021 compared to $5.3 million for the same period in 2020. The decrease year–over-year was primarily attributable to decreased costs associated with the PUR1800 program and clinical study costs incurred for the Phase 2 Pulmazole study partially offset by preclinical and manufacturing costs for the PUR3100 program.

General and administrative expense was $1.6 million for the first quarter of 2021 compared to $2.2 million for the same period in 2020. The decrease year–over-year was primarily attributable to decreased employment, patent, and consulting costs.

Net loss was $4.1 million for the first quarter of 2021 compared to a net loss of $4.7 million for the same period of 2020.

On May 11, 2021 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology," Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, reported an update on recent company developments and reported first quarter financial results for the period ended March 31, 2021 (Press release, Olema Oncology, MAY 11, 2021, View Source [SID1234579673]).

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

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

                  Schedule Your 30 min Free Demo!

"The first quarter of 2021 was very productive for Olema as we continued to advance our wholly-owned lead candidate, OP-1250, a complete estrogen receptor (ER) antagonist (CERAN), through dose escalation in the ongoing Phase 1/2 clinical trial in ER+ / HER2- breast cancer, and made substantial progress in building our organization," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "Looking ahead, we remain on track to share initial clinical data at a medical meeting later this year and advance OP-1250 into Phase 2 monotherapy expansion. We also plan to initiate a Phase 1b study to evaluate OP-1250 in combination with a CDK4/6 inhibitor in the second half of 2021. We are in a strong financial position to execute on our strategy and are committed to working toward advancing the standard of care for people living with breast cancer."

Recent Corporate Highlights

Presented nonclinical data on OP-1250 in a late-breaking poster session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, held virtually from April 10-15, 2021. Data presented showed that 10 mg/kg OP-1250, a complete estrogen receptor (ER) antagonist (CERAN), was superior to tamoxifen, fulvestrant and ovariectomy in shrinking mutant ESR1-Y537S tumors in an intracranial model of ER+ breast cancer brain metastasis.
Appointed Yi Larson to Olema’s Board of Directors in April 2021. Ms. Larson currently serves as Chief Financial Officer at LianBio and brings significant biotech operational leadership and global healthcare banking expertise.
Strengthened Olema’s research and discovery capabilities with the opening of new laboratory facilities in San Francisco, CA.
Financial Highlights

Cash, cash equivalents and marketable securities as of March 31, 2021 were $327.0 million. Olema anticipates that this balance of cash will be sufficient to fund operations through the end of 2023.
Net loss for the quarter ended March 31, 2021 was $15.3 million, compared to $1.7 million for the same period of the prior year.
Research and development (R&D) expenses were $10.7 million for the quarter ended March 31, 2021, compared to $0.8 million for the same period of the prior year. The increase in R&D expenses was primarily related to the increase in nonclinical development activities, execution of the ongoing Phase 1/2 clinical trial of OP-1250 and higher non-cash stock-based compensation expenses.
General and administrative (G&A) expenses were $4.8 million for the quarter ended March 31, 2021, compared to $0.2 million for the same period of the prior year. The increase in G&A expenses was primarily related to an increase in personnel, public company-related expenses, other corporate costs and higher non-cash stock-based compensation expenses.

On May 11, 2021 Aileron Therapeutics (NASDAQ:ALRN), a chemoprotection oncology company focused on fundamentally transforming the experience of chemotherapy for cancer patients, reported business highlights and financial results for the first quarter ended March 31, 2021 (Press release, Aileron Therapeutics, MAY 11, 2021, View Source [SID1234579672]).

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

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

                  Schedule Your 30 min Free Demo!

"We continue to work diligently to initiate our first randomized, double-blind, placebo-controlled clinical trial of ALRN-6924 as a novel therapeutic to protect non-small cell lung cancer (NSCLC) patients receiving first-line chemotherapy against various chemotherapy-induced toxicities. Approximately 50% of NSCLC patients have a p53 mutation, suggesting the broad potential impact of ALRN-6924 in this indication alone," said Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer.

Dr. Aivado further commented, "Simultaneously, we are actively planning for the rapid advancement of ALRN-6924 into late-stage development for patients with p53-mutated NSCLC pending the outcome of the Phase 1b trial. Bolstered by our successful capital raises in the first quarter of 2021, we are making near-term strategic investments in CMC, p53 companion diagnostic development, and team scale-up which we expect will not only enable the future advancement of our NSCLC clinical program, but also will provide foundational support for future clinical programs of ALRN-6924 across multiple p53-mutated cancer indications."

Aileron is developing ALRN-6924 to selectively protect healthy cells in patients with cancers that harbor p53 mutations, which are present in over half of all cancer patients, to reduce or eliminate chemotherapy-induced side effects while not interfering with chemotherapy’s attack on cancer cells. This novel concept is known as chemoprotection. By reducing or eliminating multiple chemotherapy-induced side effects, ALRN-6924 may improve patients’ quality of life and help them better tolerate chemotherapy. Enhanced tolerability may result in fewer dose reductions or delays of chemotherapy and the potential for improved efficacy as a result. Given Aileron’s p53 biomarker approach, designed to ensure selective chemoprotection only in healthy cells, coupled with the high prevalence of p53-mutated cancers, the company’s strategy is to ultimately pursue a tumor-agnostic label for ALRN-6924 as a chemoprotective agent in p53-mutated cancers.

First Quarter 2021 Highlights and Recent Updates

Aileron to host upcoming KOL Fireside Chat, "Protecting Cancer Patients from Chemotherapy-Induced Toxicities – A New Paradigm". Moderated by Soumit Roy, Ph.D., Vice President, Healthcare Analyst with JonesTrading Institutional Services LLC, the event will include a discussion on the unmet need and potential for chemoprotection with Alan List, M.D. and Lodovico Balducci, M.D. Dr. List, who recently was appointed Chief Medical Officer of Precision Biosciences, is a renowned hematologist with extensive academic and clinical experience in the research and development of hematology and oncology products. Dr. List is also a member of Aileron’s Scientific Advisory Board. Dr. Balducci, a prominent geriatric oncologist, previously served as Senior Member of the Senior Adult Oncology Program and Medical Director of Affiliates and Referring Physician Relations at the Moffitt Cancer Center. Link here to register for the event, which will take place on Wednesday, May 26, 2021.
Abstract co-authored by Aileron and Foundation Medicine, Inc. to be presented at 2021 ASCO (Free ASCO Whitepaper) Annual Meeting. The abstract, titled, "Gene Sequencing of Serial Tumor Biopsies from a Large Cohort of Cancer Patients Shows Longitudinal Changes in TP53 Mutation Status Are Uncommon" (Abstract #3124), was accepted as a poster presentation at the meeting. Additional details will be announced upon ASCO (Free ASCO Whitepaper)’s online publication of this year’s abstracts later this month.
Announced enrollment expansion for upcoming Phase 1b clinical trial of ALRN-6924 in patients with advanced NSCLC. In February 2021, Aileron announced a 50% expansion of its enrollment target for its upcoming Phase 1b clinical trial of ALRN-6924 in patients with NSCLC undergoing chemotherapy. Aileron plans to enroll 60 patients with advanced p53-mutated NSCLC undergoing treatment with first-line carboplatin plus pemetrexed (with or without immune checkpoint inhibitors). Aileron anticipates this enrollment expansion will enable a more robust exploration of ALRN-6924 as a novel chemoprotective agent to prevent chemotherapy-induced toxicities in the NSCLC patient population and better position the company to rapidly advance ALRN-6924 into late-stage clinical development for NSCLC following the Phase 1b trial.

In the Phase 1b NSCLC trial, patients will be randomized 1:1 to receive either carboplatin/pemetrexed plus 0.3 mg/kg ALRN-6924 or carboplatin/pemetrexed plus placebo for at least four 21-day treatment cycles. Evaluations will include the proportion of treatment cycles free of severe hematological and other toxicities, transfusions and the use of growth factors, as well as the impact on quality of life. Aileron plans to initiate the NSCLC trial in the second quarter of 2021 and anticipates reporting early interim data at the end of 2021 and topline results in mid-2022.
During the first quarter, Aileron completed its Phase 1b evaluation of ALRN-6924 at the recommended phase 2 dose of 0.3 mg/kg in patients with SCLC receiving ALRN-6924 24-hours prior to topotecan and conducted preliminary evaluation of data from additional cohorts. These preliminary findings from 11 additional patients (n=7 patients receiving 0.3 mg/kg ALRN-6924 six hours before topotecan and n=4 patients receiving 0.2 mg/kg ALRN-6924 twenty-four hours before topotecan) were in line with data presented last October and with Aileron’s expectation that administering ALRN-6924 at 0.3mg/kg and 24 hours before topotecan remains the optimal dose and schedule in this patient population. Aileron expects to present results of the Phase 1b SCLC trial at a scientific conference in the second half of 2021.

Raised $55.7 million in aggregate proceeds from the sale of common stock during first quarter 2021, which based on Aileron’s current operating plan, is expected to provide funding into the second half of 2023 and approximately 12 months beyond the anticipated topline results from the NSCLC trial. In January 2021, Aileron completed a registered direct offering of common stock, for a purchase price of $1.10 per share, raising $33.1 million in aggregate net proceeds, after deducting placement agent fees and other offering expenses payable by Aileron. New fundamental and institutional investors, including Acorn Bioventures, BVF Partners, L.P., Maven Investment Partners and Grand Oaks Capital, participated in the offering, in addition to several existing Aileron investors, including Satter Medical Technology Partners and Lincoln Park Capital Fund, LLC. In addition to the registered direct offering, since January 1, 2021, Aileron sold an aggregate of 13,775,399 shares of its common stock for an average purchase price of $1.64 per share, for aggregate net proceeds of $22.6 million, after deducting fees and offering expenses, in "at the market" offerings and under its structured equity line with Lincoln Park Capital Fund, LLC.
Continuing healthy volunteer study to support long-term clinical development strategy for ALRN-6924. The ongoing study, initiated in November 2020, is designed to characterize the time to onset, magnitude, and duration of cell cycle arrest in human bone marrow relative to ALRN-6924 administration. Another goal of the study is to develop a universal dosing regimen for ALRN-6924 for use as a chemoprotection agent across a range of chemotherapies and p53-mutated tumor indications. Aileron expects to present results from the healthy volunteer study at a scientific conference in the second half of 2021.
First Quarter 2021 Financial Results

Cash Position: Cash, cash equivalents and investments at March 31, 2021 were $63.4 million, compared to $13.8 million at December 31, 2020. The company expects, based on its current operating plan, that its existing cash, cash equivalents and investments will fund operations into the second half of 2023.

Research and Development (R&D) Expenses: R&D expenses for the quarter ended March 31, 2021 were $4.3 million, compared to $4.1 million for the corresponding quarter in 2020. The increase of $0.2 million is primarily a result of increased spending on clinical development of ALRN-6924 in connection with the preparation for the upcoming Phase 1b clinical trial in patients with advanced NSCLC patients being treated with first-line chemotherapy of carboplatin and pemetrexed and is partially offset by the effect of cost savings measures implemented in 2020 resulting in decreased spending on employee, facility and other development expenses.

General and Administrative (G&A) Expenses: G&A expenses for the quarter ended March 31, 2021 were $2.7 million, compared to $2.8 million for the corresponding quarter in 2020. The decrease in general and administrative expense is the result of lower headcount and facility costs during the three months ended March 31, 2021 as a result of cost savings measures as compared to the three months ended March 31, 2020 and is partially offset by increased spending on professional services.

Net Loss: Net loss for the quarter ended March 31, 2021 was $7.0 million, compared to $6.7 million for the corresponding quarter in 2020. The basic and diluted net loss per share for the first quarter of 2021 was $0.08 compared to $0.24 for the first quarter of 2020. The change in basic and diluted net loss per share is primarily a result of increased shares outstanding in connection with sales of common stock during the first quarter of 2021.

On May 11, 2021 Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage biopharmaceutical company utilizing proprietary genetic engineering platform technologies to create cell and gene therapeutics with the capacity to cure, reported program updates and financial results for the first quarter ended March 31, 2021 (Press release, Poseida Therapeutics, MAY 11, 2021, View Source [SID1234579671]).

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

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

                  Schedule Your 30 min Free Demo!

"We are encouraged by our continued progress in first quarter of 2021, building on the accomplishments from the prior year as we moved multiple programs forward to important inflection points, including our ongoing P-BCMA-101 and P-PSMA-101 CAR-T programs, on which we plan to provide further clinical updates later in the year," said Eric Ostertag, M.D., Ph.D., Chief Executive Officer of Poseida. "Additionally, we intend to advance two INDs in our allogeneic CAR-T portfolio this year, one for P-BCMA-ALLO1, targeting BCMA in relapsed/refractory multiple myeloma; and the other for P-MUC1C-ALLO1, targeting MUC1-C in a variety of solid tumor indications, including triple negative breast cancer and ovarian cancer. Though still early, initial clinical activity in patients with prostate cancer following treatment with P-PSMA-101 increases our excitement and confidence in the probability of success for this pan-solid tumor program."

Program Updates

BCMA Program

P-BCMA-101 is an autologous CAR-T product candidate in an ongoing Phase 1 dose expansion trial and Phase 2 trial in development for the treatment of relapsed/refractory multiple myeloma. Phase 1 dose expansion enrollment continues, with an expected update on this program later in 2021.

P-BCMA-ALLO1, the Company’s first allogeneic CAR-T product candidate, is in development for the treatment of relapsed/refractory multiple myeloma and is designed to be fully allogeneic, with genetic edits intended to reduce or eliminate both host-vs-graft and graft-vs-host alloreactivity. The program is proceeding toward an IND filing. Due to a suspected equipment failure at the contract manufacturer for P-BCMA-ALLO1, the IND is now expected in the third quarter of 2021.

PSMA Program

P-PSMA-101 is a solid tumor autologous CAR-T product candidate being developed to treat patients with metastatic castrate resistant prostate cancer (mCRPC) currently in an ongoing Phase 1 dose escalation trial. Following a previously disclosed serious adverse event in cohort 1 (0.75X10E6 cells/kg), the Company elected to de-escalate dosing and treat at least three patients at the protocol preestablished cohort -1 (0.25X10E6 cells/kg) dose. All three patients have been treated, with significant improvements in activity measures seen in the first two patients, one with a >50% decline in prostate-specific antigen (PSA) at about two weeks post CAR-T treatment; and the second with >96% decline in PSA and a 70% reduction in standard uptake value in PSMA PET imaging of target lesions at four weeks post CAR-T treatment. The third patient was only recently treated. One patient demonstrated Grade 1 cytokine release syndrome, or CRS. Assuming no dose limiting toxicities are observed, re-escalation to the cohort 1 dose and beyond is expected. The Company intends to provide an additional update on this program in the second half of 2021.

MUC1-C Program

P-MUC1C-ALLO1 is an allogeneic CAR-T product candidate in preclinical development with the potential to treat a wide range of solid tumors, including breast and ovarian cancers. P-MUC1C-ALLO1 is proceeding as planned, with an anticipated IND filing and initiation of Phase 1 clinical trial by the end of 2021.

Liver-Directed Gene Therapy Programs

P-OTC-101 is the Company’s first liver-directed gene therapy program for the in vivo treatment of urea cycle disease caused by congenital mutations in the ornithine transcarbamylase (OTC) gene, a condition characterized by high unmet medical need. The Company expects an IND submission and initiation of a Phase 1 clinical trial in 2022.

Early-Stage Development Programs

For programs in early development, including P-FVIII-101, a liver-directed gene therapy for the in vivo treatment of hemophilia A, preclinical studies are ongoing that will inform the development plans and timelines to IND filings.

For discovery programs, the Company may seek partnerships or collaborations to advance development in the near term.

Other Operational Updates and Upcoming Events

Launch of Immuno-Oncology Scientific Advisory Board (SAB)

In March, the Company announced the appointment of distinguished scientist and pioneer in the field of CAR-T therapy, Carl June, M.D., to chair the newly expanded immuno-oncology scientific advisory board, which will provide advice and counsel on the research and development efforts that drive the Company’s innovative cell and gene therapies.

Dr. June has since been joined by Luca Gattinoni, M.D., Chair for Functional Immune Cell Modulation at the Regensburg Center for Interventional Immunology at the University of Regensburg in Germany; Christine Brown, Ph.D., Heritage Provider Network Professor of Immunotherapy at City of Hope Comprehensive Cancer Center; and J. Joseph Melenhorst, Ph.D., Adjunct Associate Professor of Pathology & Laboratory Medicine at the Perelman School of Medicine at the University of Pennsylvania.

The Company is also in the process of establishing a second SAB focused on additional applications for its proprietary gene therapy platform technologies.

American Society of Gene and Cell Therapy 2021 Virtual Annual Meeting

The Company gave multiple oral and poster presentations earlier today, May 11, 2021, at the American Society of Gene and Cell Therapy 2021 Virtual Annual Meeting. The Company’s oral presentation highlighted new data demonstrating the potential of its proprietary piggyBac DNA Delivery System for the treatment of genetic liver disorders in children and infants. Two additional presentations highlighted preclinical data supporting Poseida’s first allogeneic CAR-T product candidate, P-BCMA-ALLO1 for R/R multiple myeloma, as well as preclinical data supporting the Company’s anti-c-kit CAR-T program as a potentially safer preconditioning regimen for hematopoietic stem cell transplantation in patients with AML. The presentation materials can be accessed on the Poseida website.

BofA Securities 2021 Virtual Health Care Conference

The Company is participating in a virtual conference at 2:45pm ET/11:45am PT on Wednesday, May 12, 2021. The audio recording of the presentation, formatted as a fireside chat, will be made available on the Company’s website.

BofA Securities 2021 Napa Biopharma Virtual Conference

The Company is participating in a virtual conference at 4:30pm ET/1:30pm PT on Monday, June 14, 2021. The audio recording of the presentation, formatted as a fireside chat, will be made available on the Company’s website.

Financial Results for the First Quarter 2021

Research and Development Expenses

Research and development expenses were $29.1 million for the first quarter ended March 31, 2021, compared to $23.4 million for the same period in 2020. The increase was primarily due to increased headcount, external costs related to our preclinical programs and clinical stage programs, including the ongoing enrollment and manufacturing associated with our P-BCMA-101 and P-PSMA-101 clinical trials, and internal costs related to facilities development.

General and Administrative Expenses

General and administrative expenses were $8.4 million for the first quarter ended March 31, 2021, compared to $4.9 million for the same period in 2020. The increase was primarily due to increased headcount and professional fees associated with becoming a publicly traded company.

Net Loss

Net loss was $38.3 million for the first quarter ended March 31, 2021 compared to $28.8 million for the first quarter ended March 31, 2020.

Cash Position

As of March 31, 2021, cash, cash equivalents and short-term investments were $270.0 million.

On May 11, 2021 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") reported financial results and a business update for the first quarter ended March 31, 2021 (Press release, VolitionRX, MAY 11, 2021, View Source [SID1234579670]). Volition management will host a conference call tomorrow, May 12 at 8:00 a.m. U.S. Eastern Time to discuss these results. Conference call details may be found below.

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

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

                  Schedule Your 30 min Free Demo!

"We have made significant progress on many fronts during 2021 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 commercial focus."

View Source

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

Mr. Reynolds continued, "Silver One, our manufacturing facility and service lab, is proving to have been an excellent addition to Volition’s commercialization efforts and is now producing finished product and components at commercial scale for our anticipated product launches. I am delighted that the Nu.Q Vet beta launch has not only provided revenue but also invaluable real-world learnings allowing us to move ahead soon with our expected national U.S. and international launches. We are also seeing a high level of interest in both the licensing and distribution of our products and are actively negotiating multiple agreements."

Company Highlights

Financial

Cash and cash equivalents as of March 31, 2021 totaled approximately $33.1 million compared with $19.4 million as of December 31, 2020.
During the first quarter of 2021, added an aggregate of approximately $20.3 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 Volition’s 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.
Continued to manage expenditures carefully with a cash burn rate of approximately $2 million per month.
Personnel

As Volition transitions from a research and development company to a commercial company, it strengthened the leadership team with the appointment of a new Chief Financial Officer, Mr. Terig Hughes, as well as the appointment of Mr. Gael Forterre as Chief Commercial Officer. In addition, Volition promoted Dr. Gaetan Michel to Chief Operating Officer and Dr. Mark Eccleston to Chief Technology Officer.
Volition announced the appointment of two Independent Directors to its main Board – Kim Nguyen, an HR executive with global expertise at Google, and Richard Brudnick, a pharmaceutical business executive with extensive commercial know-how.
As of May 1, Dr. Tom Butera, a seasoned veterinary executive with an extensive commercial track record, joined the team as Chief Executive Officer of Volition’s Veterinary subsidiary to drive its product launches.
Intellectual Property

28 patent families covering both human and animal use of Volition’s Nucleosomics platform.
64 granted patents (ten in the U.S., 14 in Europe and 42 rest of world).
93 patents pending.
Continued focus on filings during the first quarter and expect portfolio to grow in the quarters and years ahead.
Publications

Volition’s list of publications and abstracts is growing.
Year to date data for Nu.Q has been presented at two international conferences and Volition has collaborated on three clinical paper publications.
These publications are another very important step forward for the Company.
Nu.Q Vet Cancer Screening Test Beta Launch

Beta launch of the Nu.Q Vet Cancer Screening Test in late November 2020 in Texas. This beta launch is facilitating real-world learnings to help shape the marketing mix before Volition’s planned launch nationally across the U.S. expected in the next few months.
Volition has received strong indications of interest in the whole Nu.Q Vet platform, from a range of small and very large companies, and it is progressing potential licensing discussions with several well-known major players in the veterinary space around the world.
In addition to the Texas beta launch, Volition is finalizing beta launch planning in both Asia and Europe.
Nu.Q Capture

The clinical paper published in Nature’s Scientific Reports in March highlighted for the first time that histone H2A1R3 citrulline is, in plasma, upregulated in colorectal cancer patients and so could be a biomarker Volition targets for future Nu.Q immunoassay development.
It showed that the use of Nu.Q Capture may open up the possibility of using mass spectrometry not only for biomarker discovery but also as a high throughput platform for screening and/or diagnostics.
Volition aims for Nu.Q Capture to be an important enabling technology in the liquid biopsy space and expects to launch its first product with this technology in 2022.
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.
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.
Human studies in the monitoring of disease progress and treatment efficacy in sepsis are now underway at a leading UK hospital.
From a COVID-19 product development perspective, Volition has conducted studies of serial testing of COVID-19 patients at leading UK hospitals to determine the predictive value of its test, with further data due to be presented at upcoming conferences and potentially additional studies and collaborations as well.
Clinical – Cancer

As previously reported, due to the pandemic collection for the U.S. EDRN study for colorectal cancer has been paused, and collection for the blood cancer studies in the U.S. have been delayed with an updated timeline expected in the near future.
In Asia, Volition has reached its target patient cohorts for both colorectal cancer studies and the lung cancer study, all collected in conjunction with the National Taiwan University, notwithstanding the pandemic. Volition expects to run the assays and finalize the analysis over the coming months with data due to be reported at future conferences.
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 Volition expects to see initial revenue from this during 2021.
Volition is producing recombinant nucleosomes in-house and at large-scale, building a library for sale through Nu.Q Discover and also for internal R&D use.
Volition is still in active discussions on its first potential licensing deal with a large healthcare company.
Upcoming Milestones

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

National launch of the Nu.Q Vet Cancer Screening Test in the U.S.
Beta launches of the Nu.Q Vet Cancer Screening Test in Asia and Europe.
Continue to focus on driving revenue in the coming quarters in four key areas:
– Nu.Q Vet products,
– Disease monitoring tests (e.g. Nu.Q NETs for COVID-19, sepsis),
– Nu.Q Discover, and
– Licensing of its 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 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 First 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 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 May 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 13719633.