On August 10, 2022 Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, reported financial results for the second quarter ended June 30, 2022, and provided a clinical and corporate update (Press release, Milestone Pharmaceuticals, AUG 10, 2022, View Source [SID1234618052]).

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"Progress continues across our Phase 3 PSVT clinical program. Notably with the recent crossing of the 180th event in the RAPID trial, we now focus on the final stages of data cleaning and analysis and look forward to reporting top line data in the middle of the second half of this year," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals.

Recent Updates

Achieved Required Number of PSVT Events Treated with Double Blind Study Medication to Initiate Preparation for the Primary Efficacy Analysis for RAPID Trial; Company Remains on Track to Report RAPID Topline Data in Mid-Second Half 2022. In July 2022, the RAPID trial, in which patients are randomized 1:1 to receive either etripamil or placebo, reached the pre-specified target of 180 confirmed PSVT events, adjudicated by a blinded, independent expert committee, required for the primary efficacy analysis. Data from RAPID is now in the process of being cleaned, verified, and analyzed, and the Company continues to expect to unblind RAPID results and report topline data in the middle of the second half of 2022. The primary efficacy analysis for the RAPID trial and the post hoc analysis of the NODE-301 trial will be time to conversion of supraventricular tachycardia (SVT) over the first 30 minutes following initial study drug administration. The RAPID and NODE-301 trials could potentially serve to fulfill the efficacy requirement for a future New Drug Application submission to the United States Food and Drug Administration for etripamil in patients with PSVT.
Milestone’s Partner, Ji Xing Pharmaceuticals Limited, Enrolled First Patient in Phase 3 Study of Etripamil in China. In July 2022, Milestone’s partner, Ji Xing Pharmaceuticals Limited (Ji Xing), announced that it enrolled its first patient in its Phase 3 study of etripamil for the treatment of PSVT in China. The study is designed to evaluate the efficacy and safety of self-administered etripamil nasal spray as a treatment for PSVT with the eventual goal of generating clinical data potentially supportive of a new drug application in China. In May 2021, Milestone and Ji Xing entered into an exclusive license agreement to develop and commercialize etripamil for PSVT in Greater China.
Data from Phase 3 NODE-302 Open-Label Extension Study of Etripamil for the Treatment of PSVT Presented at Heart Rhythm 2022. In April 2022, data from NODE-302, Milestone’s Phase 3 open-label extension of the NODE-301 study evaluating a single, 70 mg dose of self-administered, intranasal etripamil in patients with PSVT, was presented at the Heart Rhythm Society’s Heart Rhythm 2022 conference. The data demonstrated the potential for patients to self-treat recurrent SVT episodes with etripamil. Of 188 positively-adjudicated episodes observed in the trial, the PSVT conversion rate at 30 minutes following etripamil administration was 60.2%, and the need for emergency department (ED) intervention to terminate a PSVT episode was low (13% of patients and 8.5% of positively adjudicated PSVT episodes). Etripamil was generally well-tolerated, with adverse events (AEs) consistent with those observed in previous trials and largely confined to local and brief nasal AEs at the administration site. A copy of the presentation is available on request from Milestone Pharmaceuticals.
Hosted Virtual KOL Event on Etripamil for the Treatment of PSVT. In April 2022, Milestone hosted a virtual Key Opinion Leader (KOL) event focused on etripamil for the possible treatment of PSVT. Members of management were joined by Bruce Stambler, M.D., FHRS, Director of Cardiac Arrhythmia Research and Education, Piedmont Heart Institute, Atlanta, GA, and Sean Pokorney, M.D., MBA, Director of the Arrhythmia Core Laboratory, Duke Clinical Research Institute, Assistant Professor of Medicine, Duke University School of Medicine, Durham, NC. The event featured an overview of PSVT, including disease prevalence, the current treatment landscape, patient and healthcare system burdens and a discussion of the potential commercial opportunity. A recording of the event is currently available under the News & Events of Milestone’s website at www.milestonepharma.com.
New Clinical Analysis Evaluating the Drug Characteristics and Safety of Etripamil Presented at the American College of Cardiology (ACC) 71st Annual Scientific Session and Expo. In April 2022, new analyses on the safety, tolerability, pharmacokinetics, and pharmacodynamics of etripamil in healthy Japanese and non-Japanese adults was presented at the ACC 71st Annual Scientific Session and Expo. The data demonstrate a comparable safety and tolerability profile in both Japanese and non-Japanese male and female adults, indicating no ethnic differences, and treatment-related AEs consistent with the safety and tolerability profile of etripamil seen to date. A copy of the presentation is available in the Publications section of the Milestone Pharmaceuticals website.
Second Quarter 2022 Financial Results

As of June 30, 2022, Milestone had cash, cash equivalents, and short-term investments of $86.2 million and 29.9 million common shares and 12.3 million common shares issuable upon exercise of pre-funded warrants outstanding.
Research and development (R&D) expense for the second quarter of 2022 was $10.7 million, compared with $9.4 million for the prior year period. The difference is primarily the result of an increase in clinical personnel related costs, clinical consulting fees and contract research organization (CRO) costs due to advancing the RAPID Phase 3 efficacy and safety trial in etripamil for the treatment of PSVT. For the six months ended June 30, 2022, R&D expense was $19.4 million compared with $18.0 million for the prior year period. The $1.4 million increase in R&D expense in the six months ended June 30, 2022 is the result of clinical personnel related costs, clinical consulting fees and CRO costs due to advancing the RAPID Phase 3 efficacy and safety trial in etripamil for the treatment of PSVT. These increases were offset by lower drug formulation and manufacturing costs. Additionally, regulatory costs increased primarily due to personnel-related costs.
General and administrative (G&A) expense for the second quarter of 2022 was $3.9 million, compared with $3.0 million for the prior year period. The difference is primarily the result of an increase in personnel-related costs and consulting fees for general and administrative expenses. For the six months ended June 30, 2022, G&A expense was $7.6 million compared with $5.7 million for the prior year period. The $1.9 million increase in G&A expense in the six months ended June 30, 2022 is primarily the result of personnel-related costs and consulting fees for general and administrative expenses.
Commercial expense for the second quarter of 2022 was $2.2 million, compared with $1.8 million for the prior year period. The difference is primarily the result of an increase in consulting and marketing analytics. For the six months ended June 30, 2022, commercial expense was $3.9 million compared with $3.2 million for the prior year period. The $0.7 million increase in commercial expense in the six months ended June 30, 2022 is the result of personnel-related costs.
For the second quarter of 2022, operating loss was $16.8 million, compared to operating income of $0.7 million for the prior year period. For the six months ended June 30, 2022, Milestone’s operating loss was $30.9 million, compared to $11.9 million in the prior year period. Included in the operating income for the second quarter of 2021 and operating loss for the six months ended June 30, 2021 was primarily the one-time upfront payment of $15.0 million, recognized as revenue, generated from Milestone’s License Agreement with Ji Xing.
About Paroxysmal Supraventricular Tachycardia

Paroxysmal supraventricular tachycardia (PSVT) is a condition characterized by intermittent episodes of a rapid heartbeat that starts and stops suddenly that affects approximately two million Americans. Episodes of supraventricular tachycardia (SVT) are often associated with symptoms including palpitations, sweating, chest pressure or pain, shortness of breath, sudden onset of fatigue, lightheadedness or dizziness, fainting, and anxiety. Certain intravenous medications, including adenosine, beta-blockers and calcium channel blockers, have long been used for the acute treatment of PSVT. However, these medications must be administered under medical supervision, usually in an emergency department or other acute care setting.

About Atrial Fibrillation with Rapid Ventricular Rate

Atrial fibrillation (AFib) is a common arrhythmia marked by an irregular and often rapid heartbeat. AFib is estimated to affect five million patients in the United States, a prevalence projected by the Centers for Disease Control to increase to twelve million patients within the next 10 years. Atrial fibrillation with rapid ventricular rate (AFib-RVR) is a condition that some patients with AFib experience and includes episodes of abnormally high heart rate, often with symptoms such as palpitations, shortness of breath, dizziness and weakness. Oral calcium channel blockers and/or beta blockers are commonly used to reduce the heart rate in this condition. When AFib-RVR occurs, symptoms often cause patients to seek acute care in the emergency department, where standard-of-care procedures include intravenous administration of calcium channel blockers or beta blockers under medical supervision. Milestone’s market research indicates that 30-40% of patients with AFib experience one or more symptomatic episodes of RVR per year that require treatment, suggesting a target addressable market of approximately three to four million patients in 2030 for etripamil in patients with AFib.

About Etripamil

Etripamil, a new chemical identity being Milestone’s lead investigational product, is a novel calcium channel blocker designed to be a rapid-response therapy for episodic cardiovascular conditions. As a nasal spray that is self-administered by the patient, etripamil has the potential to shift the current treatment experience for many patients from the emergency department to a medically-unsupervised setting. Milestone is conducting a comprehensive development program for etripamil, with Phase 3 trials ongoing in paroxysmal supraventricular tachycardia (PSVT) and a Phase 2 proof-of-concept trial underway in patients with atrial fibrillation with rapid ventricular rate (AFib-RVR).

On August 10, 2022 Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, reported financial results for the second quarter ended June 30, 2022 and provided a corporate update (Press release, Decibel Therapeutics, AUG 10, 2022, View Source [SID1234618051]).

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"We are very pleased to report substantial progress made thus far in 2022, notably the announcement of positive top-line results from the interim analysis of our ongoing Phase 1b clinical trial of DB-020 for patients with cisplatin-induced hearing loss. We believe these positive data showcase the integrated capabilities that Decibel has implemented to develop innovative therapeutics for conditions of the inner ear. As we continue to advance our gene therapy pipeline, we believe this achievement strengthens our position as leaders in the hearing loss and balance disorder space. We are further poised to submit one or more regulatory filings for our lead gene therapy product candidate, DB-OTO and to announce a product candidate for our AAV.103 program in the second half of 2022," said Laurence Reid, Ph.D., Chief Executive Officer of Decibel.

Pipeline Highlights and Upcoming Milestones:

Gene Therapies for Congenital, Monogenic Hearing Loss

Anticipated IND/CTA Filing for DB-OTO Product Candidate: Decibel is continuing to prepare for submission of an investigational new drug application (IND) to the U.S. Food and Drug Administration and/or a Clinical Trial Application (CTA) in Europe for DB-OTO in the second half of 2022. Decibel has commenced trial site startup activities and, subject to the clearance of its IND or CTA, expects to initiate a Phase 1/2 clinical trial of DB-OTO for pediatric patients with congenital hearing loss due to an otoferlin deficiency in the first half of 2023. Decibel is developing DB-OTO in collaboration with Regeneron Pharmaceuticals and retains global commercial rights to the product candidate.
Product Candidate Selection for AAV.103 Program: In 2022, Decibel also plans to select a product candidate for further development in its AAV.103 program to restore hearing to individuals with a gap junction beta-2 (GJB2) deficiency, the most common cause of autosomal recessive, non-syndromic, congenital hearing loss. Decibel is developing the AAV.103 program in collaboration with Regeneron Pharmaceuticals and retains global commercial rights to the AAV.103 program.
Otoprotection Therapeutic

Reported Positive Data from Interim Analysis of Ongoing Phase 1b Clinical Trial of DB-020 in Patients Receiving Cisplatin Chemotherapy: In June 2022, Decibel reported positive top-line results from the interim analysis of its ongoing Phase 1b clinical trial of DB-020, a novel, proprietary formulation of sodium thiosulfate, designed to protect against hearing loss in cancer patients receiving cisplatin chemotherapy. Patients enrolled in the Phase 1b clinical trial were randomized to receive one of two doses of DB-020 in one ear while the contralateral ear received placebo, enabling each patient to serve as their own control. Patients were administered DB-020 and placebo up to three hours prior to each cisplatin infusion. Consistent with the results of a Phase 1 clinical trial of DB-020 previously completed by the Company in healthy volunteers, data from the interim analysis demonstrated that DB-020 was well tolerated, with adverse events generally mild to moderate and no significant safety issues observed. In the data from the interim analysis, 88% of patients experienced ototoxicity in their placebo-treated ear, and of these patients, 87% were partially or completely protected from ototoxicity in their DB-020-treated ears.
Board Update:

Announced planned change to the Board of Directors: In June 2022, Matthew Foy, a partner at SR One, departed Decibel’s Board of Directors due to the expiry of his three-year term. "We thank Matt for his service and are appreciative of key contributions he has made to the evolution of Decibel’s strategy," said Laurence Reid.
Second Quarter 2022 Financial Results:

Cash Position: As of June 30, 2022, cash, cash equivalents and available-for-sale securities were $125.6 million, compared to $162.3 million as of December 31, 2021.
Research and Development Expenses: Research and development expenses were $11.2 million for the second quarter of 2022, compared to $6.8 million for the same period in 2021. The increase in research and development expenses for the second quarter of 2022 was primarily due to higher development costs incurred to advance our DB-OTO product candidate, higher research costs related to our other pre-clinical gene therapy programs and higher personnel-related costs due to increased headcount, wages and stock-based compensation.
General and Administrative Expenses: General and administrative expenses were $5.9 million for the second quarter of 2022, compared to $4.9 million for the same period in 2021. The increase in general and administrative expenses for the second quarter of 2022 was primarily due to higher professional fees including external consulting, advisory, legal and audit services, as well as higher personnel-related costs due to increased headcount, wages and stock-based compensation.
Financial Guidance:

Based on its current operating and development plans, Decibel believes that its existing cash, cash equivalents and available-for-sale securities will enable it to fund its pipeline programs and operating expenses into 2024.

On August 10, 2022 Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, reported that the Journal of Clinical Oncology has published results from its INTRIGUE Phase 3 study of QINLOCK (ripretinib) in patients with advanced gastrointestinal stromal tumor (GIST) previously treated with imatinib (Press release, Deciphera Pharmaceuticals, AUG 10, 2022, View Source [SID1234618050]). Although QINLOCK did not offer a statistically significant improvement in progression-free survival (PFS) compared to sunitinib, QINLOCK showed meaningful clinical activity with fewer Grade 3/4 treatment-emergent adverse events (TEAEs) and improved tolerability.

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The article, titled "Ripretinib versus sunitinib in patients with advanced gastrointestinal stromal tumor after treatment with imatinib (INTRIGUE): A randomized, open-label, phase III trial" is now available online and will be published in a future print issue of the Journal of Clinical Oncology.

"These full Phase 3 INTRIGUE study results continue to deepen our understanding of QINLOCK and its place in the GIST treatment landscape," said Matthew L. Sherman, M.D., Chief Medical Officer of Deciphera. "Although the INTRIGUE study did not meet its primary endpoint of superiority in PFS compared to sunitinib for patients in the post-imatinib setting, the efficacy of QINLOCK was comparable to sunitinib. In addition, QINLOCK had a more favorable safety profile than sunitinib with fewer Grade 3/4 adverse events and patients in the QINLOCK arm reported less deterioration in role functioning and better outcomes on several other key patient-reported outcome measures of tolerability compared to sunitinib."

INTRIGUE is an international, multi-center study conducted in 122 active sites across 22 countries, where 453 patients with second-line GIST were randomized to receive ripretinib (n=226) or sunitinib (n=227). Key study results include:

In patients with a KIT exon 11 primary mutation, ripretinib demonstrated a median PFS (mPFS) of 8.3 months compared to 7.0 months for the sunitinib arm (Hazard Ratio [HR] 0.88, p=0.36). In the intention-to-treat (ITT) population (n=453), ripretinib demonstrated an mPFS of 8.0 months compared to 8.3 months for the sunitinib arm (HR 1.05, nominal p value=0.72).
In patients with a KIT exon 11 primary mutation, ripretinib demonstrated an objective response rate (ORR) of 23.9% (n=39 of 163) compared to 14.6% (n=24 of 164) for sunitinib (nominal p value=0.03). In the ITT population, ripretinib demonstrated an ORR of 21.7% (n=49 of 226) compared to 17.6% (n=40 of 227) for sunitinib (nominal p value=0.27).
Ripretinib was generally well tolerated. Fewer patients in the ripretinib arm experienced Grade 3/4 treatment-emergent adverse events compared to sunitinib (41.3% vs 65.6%).
Patients receiving sunitinib were three times more likely to develop Grade 3 hypertension compared to patients receiving ripretinib (26.7% vs. 8.5%) and patients receiving sunitinib were seven times more likely to develop Grade 3 palmar-plantar erythrodysesthesia compared to patients receiving ripretinib (10.0% vs. 1.3%).
Patient reported outcome measures also showed a more favorable tolerability profile for patients receiving ripretinib compared to patients receiving sunitinib. Patients receiving ripretinib experienced less deterioration in their ability to engage in either work or leisure activities during treatment, and fewer patients receiving ripretinib experienced moderate to extremely large impact on their lives due to skin toxicity across treatment cycles compared to patients receiving sunitinib.
QINLOCK is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with advanced GIST who have received prior treatment with three or more kinase inhibitors, including imatinib. The new drug application (NDA) for QINLOCK was based on positive results from the Phase 3 INVICTUS trial in patients with fourth-line and fourth-line plus GIST1.

About QINLOCK (ripretinib)
QINLOCK is a switch-control tyrosine kinase inhibitor that was engineered to broadly inhibit KIT and PDGFRA mutated kinases by using a dual mechanism of action that regulates the kinase switch pocket and activation loop. QINLOCK inhibits primary and secondary KIT mutations in exons 9, 11, 13, 14, 17, and 18 involved in GIST, as well as the primary exon 17 D816V mutation2,3. QINLOCK also inhibits primary PDGFRA mutations in exons 12, 14, and 18, including the exon 18 D842V mutation, involved in a subset of GIST2,3.

On August 10, 2022 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") reported financial results and a business update for the second quarter ended June 30, 2022 (Press release, VolitionRX, AUG 10, 2022, View Source [SID1234618049]). Volition management will host a conference call tomorrow, August 11 at 8:30 a.m. U.S. Eastern Time to discuss these results. Conference call details can be found below.

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"I am delighted with the progress we are making, and in particular could not be prouder of the team’s achievement in securing a CE Mark for Nu.Q NETs in Europe and in announcing new clinical studies for NETosis, or NETs, in the U.S. with both MD Anderson and with Diagnostic Oncology CRO LLC, or DXOCRO. As the only analytically validated test for NETs currently available, we believe that there is enormous potential for Nu.Q NETs to support clinical decision-making, enabling physicians to act quickly, and improve patient outcomes," commented Cameron Reynolds, President and Chief Executive Officer of Volition.

"Following the execution of our global licensing and supply agreement for the Nu.Q Vet Cancer Screening Test with Heska Corporation, the team has been hard at work with the technology transfer program and launch preparation. We also continue to make good progress with other potential licensing and supply partners. Finally, we have recently executed a number of contracts for Nu.Q Discover."

Company Highlights

Financial

Cash and cash equivalents as of June 30, 2022, totaled approximately $16.7 million compared with $20.6 million as of December 31, 2021.
Subsequent to quarter end, Volition received approximately $6.4 million net of underwriter’s fees and expenses in cash through an underwritten public offering of its common stock that closed on August 2.
Secured a further $1.5 million in non-dilutive funding from Namur Invest Capital Risk in Belgium to fund an early access program for Volition’s Nu.Q product portfolio at key sites across the EU, UK, and U.S.
Continued to manage expenditures carefully with net cash used in operating activities averaging approximately $2.1 million per month in the quarter.
Personnel/ Operational

Appointed Sharon Ballesteros as U.S. Head of Quality and Development Process to spearhead Volition’s clinical product development program in the U.S. and expanded her team and operations in California.
Nu.Q NETs

Nu.Q NETs test has been CE marked for the detection and evaluation of NETosis, enabling clinical use in Europe in both ELISA (enzyme-linked immunoassay) and automated ChLIA (ChemiLuminescence ImmunoAssay) formats.
Announced a sponsored research agreement with The University of Texas MD Anderson Cancer Center to evaluate the role of NETS in cancer patients with sepsis.
Appointed DXOCRO to undertake development and clinical validation studies for Volition’s Nu.Q product portfolio in the United States.
DXOCRO will conduct large-scale finding studies across multiple sites in the U.S. using Volition’s Nu.Q NETs and Nu.Q Cancer tests to determine clinical utility in sepsis and cancer.
Volition anticipates that subsequent studies will investigate the chosen intended use claims of the tests, with the objective to gain clearance, authorization, or approval from the United States Food and Drug Administration (the "FDA") and allow the tests to be marketed in the U.S.
These multi-site development studies will help demonstrate how Volition’s Nucleosomics technology can directly benefit patients and support our application to the FDA’s Breakthrough Devices Program and a Pre-submission anticipated in 2023.
In collaboration with researchers at the University of Namur and QUALIblood in Belgium, published:
a clinical paper entitled "NETosis and Nucleosome Biomarkers in Septic Shock and Critical COVID-19 Patients: An Observational Study", and
a poster presentation entitled "Evaluation and comparison of NETosis biomarkers in sepsis and COVID-19 patients" at the International Society on Thrombosis and Haemostasis (ISTH) Congress in July.
Subsequent to quarter end, sponsored a GenomeWeb webinar titled ‘The Promise of Neutrophil Extracellular Traps (NETs) as Biomarkers in Inflammatory Disease’. To watch on demand, visit the GenomeWeb website.
Commenced a Market Access Program with European Key Opinion Leaders and early adopters.
Volition Veterinary

Following the execution of a global licensing and supply agreement with one of the industry’s leading companies, Heska Corporation, started the technology transfer and launch preparations with Heska.
SAGE Healthcare launched the Nu.Q Vet Cancer Test in Singapore.
Advanced negotiations with other potential licensing and supply partners in efforts to make Nu.Q Vet products as accessible as possible worldwide and anticipate further announcements in 2022.
Expanded product claims with the presentation of new clinical data at:
the European Society of Veterinary Oncology Congress in May. To view click here.
the American College of Veterinary Internal Medicine (ACVIM) in June. To view click here.
Expanded access to a larger clinical research laboratory at Texas A&M University and appointed a veterinary emergency criticalist to commence work in non-cancer indications in addition to developing our clinical research network in Europe.
Nu.Q Capture

Nu.Q Capture, when used in combination with either sequencing, mass spectrometry and/or Volition’s Nu.Q assays could potentially aid diagnosis, treatment selection, and both treatment and disease monitoring in addition to aiding biomarker discovery.
The Nu.Q Capture program now has several strands of technology which:
essentially remove background noise, thereby amplifying the signal,
look to identify the signal in a novel way including through mass spectrometry, or
isolate various chromatin fragments, including nucleosomes and transcription factors.
Sponsored a GenomeWeb webinar entitled "Novel Proteomics Approach to Epigenetic Profiling of Circulating Nucleosomes" featuring Professor Axel Imhof. To watch on demand, visit the GenomeWeb website.
Nu.Q Discover

Progressing projects with a range of customers.
Recently signed contracts with three bio-pharmaceutical companies who are accessing our assay portfolio for rapid epigenetic profiling of their drugs in development.
Upcoming Priorities

Drive near term revenue in the following key areas:
Licensing of its technology, with a particular but not exclusive focus on Nu.Q Vet.
Complete Heska Corporation agreement milestones in order to receive further milestone payments.
Sales of key components of Point of Care test with Heska.
Sales of kits from non-exclusive agreements for the use of Nu.Q Vet via central reference labs.
Ongoing and new Nu.Q Discover agreements.
Sales of its disease monitoring tests (e.g. COVID-19, sepsis).
Continue to progress the research program for the use of Nu.Q NETs, in monitoring disease progression of COVID-19, sepsis, and potentially other diseases and as a possible companion diagnostic for the treatment of 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.

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. The call will provide an update on important events which have taken place in the second quarter of 2022 and upcoming milestones.

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 25, 2022. 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 13732149.

On August 10, 2022 MaxCyte, Inc., (NASDAQ: MXCT; LSE: MXCT), a leading commercial cell-engineering company focused on providing enabling platform technologies to advance innovative cell-based research as well as next-generation cell therapeutic discovery, development and commercialization, reported financial results for the second quarter and six months ended June 30, 2022 (Press release, MaxCyte, AUG 10, 2022, View Source [SID1234618048]).

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Second Quarter and Recent Highlights

Total revenue of $9.6 million in the second quarter of 2022, an increase of 35% over the second quarter of 2021 driven by strong growth in the cell therapy market; core business revenues grew 45% led by revenue from cell therapy customers which increased 61%, with drug discovery revenues growing by 4%.
Raising 2022 revenue guidance for core business revenue growth to approximately 30%.
Expecting SPL Program-related revenue to be approximately $4 million for the full year.
Total cash, cash equivalents and short-term investments were $240.9 million as of June 30, 2022.
Signed the Company’s 17th SPL agreement in July 2022; LG Chem licensed the use of MaxCyte’s Flow Electroporation ExPERT platform to advance cellular research and development of engineered cell-based therapies.
"We are pleased with these strong second quarter 2022 results, with 45% year-over-year core business revenue growth, highlighted by 61% growth in revenues from Cell Therapy customers. We remain encouraged by the ongoing growth of our SPL portfolio with the addition of LG Chem, our 17th SPL partner, and second SPL agreement signed in 2022, as well as the continued progress of our existing partnerships. Importantly, our LG Chem partnership broadens the reach of our SPL portfolio into Asia," said Doug Doerfler, President and CEO of MaxCyte.

"Overall, our optimism about the potential for the development programs covered by our existing partners to generate growing revenue in both pre-clinical research and clinical progress remains high. Our ExPERT platform continues to be used to enable a broad range of cell types and approaches targeting a wide array of indications, and its adoption is increasing within the industry. We are making ongoing investments to drive revenue growth, support and expand the widening array of applications for our technology, while also strengthening our team and expanding our ability to support customers through in-house manufacturing and robust infrastructure. These investments should allow us to take advantage of expanding markets and support our partners as they move forward in development and commercialization."

Second Quarter 2022 Financial Results

Total revenue for the second quarter of 2022 was $9.6 million, compared to $7.1 million in the second quarter of 2021, representing growth of 35%.

Core business revenue was $9.6 million, including 61% revenue growth from cell therapy customers and 4% from drug discovery customers, compared to core business revenue of $6.6 million in the same period last year.

We did not have any material SPL Program-related revenue in the second quarter of 2022, as compared to $0.5 million in the second quarter of 2021.

Gross profit for the second quarter of 2022 was $8.5 million (88% gross margin), compared to $6.3 million (89% gross margin) in the same period of the prior year.

Operating expenses for the second quarter of 2022 were $17.2 million, compared to operating expenses of $10.7 million in the second quarter of 2021. The overall increase in operating expenses was primarily driven by increased staff in field sales and science, manufacturing, and lab teams to support our customers’ and partners’ growth. The increase also included additional public company-related, stock-based compensation, and marketing expenses compared with the same period a year ago.

Second quarter 2022 net loss was $8.3 million compared to net loss of $4.4 million for the same period in 2021. EBITDA, a non-GAAP measure, was a loss of $8.2 million for the second quarter of 2022, compared to a loss of $4.1 million for the second quarter of the prior year. Stock-based compensation expense was $3.0 million for the second quarter versus $1.9 million for the same period in the prior year.

Total cash, cash equivalents and short-term investments were $240.9 million as of June 30, 2022.

First Half 2022 Financial Results

Total revenue for the first half of 2022 was $21.2 million, compared to $13.6 million in the first half of 2021, representing growth of 56%. Overall sales to the cell therapy (up 59%) and the drug discovery (up 13%) markets were sources of strength in the first half.

The Company recognized $2.0 million of program-related revenue in the first half of 2022, as compared to $0.5 million in program-related revenue in the first half of 2021.

Gross profit for the first half of 2022 was $19.0 million (90% gross margin), compared to $12.1 million (89% gross margin) in the same period of the prior year.

Operating expenses for the first half of 2022 were $31.9 million, compared to operating expenses of $22.9 million in the first half of 2021. The overall increase in operating expenses was primarily driven by increased staff in field sales and science, manufacturing, and lab teams to support our customers’ and partners’ growth. The increase also included additional stock-based compensation, public company-related, and marketing expenses compared with the same period a year ago.

First half 2022 net loss was $12.3 million compared to net loss of $11.5 million for the same period in 2021. EBITDA was a loss of $11.9 million for the first half of 2022, compared to a loss of $10.5 million for the same period of the prior year. Stock-based compensation expense was $5.4 million for the first half of 2022 versus $3.2 million for the same period in the prior year.

2022 Revenue Guidance

We expect core business revenue (instruments and disposables to cell therapy and drug discovery customers and excluding program-related revenue) in 2022 to grow approximately 30% compared to 2021. We continue to expect SPL Program-related revenue to be approximately $4 million in 2022.

Webcast and Conference Call Details

MaxCyte will host a conference call today, August 10, 2022, at 4:30 p.m. Eastern Time. Investors interested in listening to the conference call are required to register online. A live and archived webcast of the event will be available on the "Events" section of the MaxCyte website at View Source