On August 4, 2022 Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, reported recent business progress and financial results for the second quarter June 30, 2022 (Press release, Aligos Therapeutics, AUG 4, 2022, View Source [SID1234617544]).

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"In the second quarter, we continued to make strong progress in advancing our drug candidates and discovery programs," said Lawrence Blatt, PhD, MBA, CEO and Chairman of the Board at Aligos. "We completed enrollment in multiple cohorts across our Phase 1 CAM-2 and NASH studies and presented posters for these and other drug candidates and discovery programs at the recent International Liver Congress meeting hosted by the European Association for the Study of the Liver (EASL). We are similarly off to a strong start in Q3, where we have initiated enrollment in a 12-week cohort evaluating the safety and chronic suppressive activity of ALG-000184 in chronic hepatitis B (CHB) patients. We also remain on track to submit a clinical trial application (CTA) this quarter to evaluate our siRNA drug candidate, ALG-125755, in healthy volunteers and CHB patients. We believe our siRNA, which is designed to lower HBsAg levels, is an important addition to our clinical portfolio and has the potential to be a cornerstone of our functional cure strategy."

Recent Business Progress

Aligos Portfolio of Drug Candidates

HBV Programs

ALG-000184 (CAM-2): Enrollment of HBeAg positive subjects in 28-day and 12-week cohorts evaluating various dose levels is ongoing. We plan to share data from HBeAg positive cohorts at a scientific conference in Q4 2022.
ALG-125755 (siRNA): Phase 1 enabling nonclinical studies are nearly complete. We are on track to file a CTA in Q3 2022 to enable the evaluation of the safety, tolerability, pharmacokinetics, and antiviral activity of ALG-125755. Dosing is planned to begin in healthy volunteers in Q4 2022 and in CHB subjects
in Q1 2023.
NASH

ALG-055009: Enrollment of hyperlipidemic subjects in all 4 cohorts of the multiple ascending dose portion of our Phase 1 study is now complete. We are currently analyzing these data and remain on track to share top line data from the single and multiple ascending dose portions of this study in Q3 2022.

COVID-19 3CL Protease Inhibitor (PI) Program

ALG-097558: Evaluation of ALG-097558 in the hamster SARS-CoV-2 infection model indicates that when dosed prior to infection or up to 24 hours post-infection, the compound causes a significant reduction in the levels of infectious virus in the lungs.
Phase 1 enabling nonclinical studies are on track to be initiated in H2 2022. A subsequent CTA filing for a Phase 1 study evaluating the safety and pharmacokinetics of ALG-097558 in healthy volunteers is planned for Q1 2023.
COVID-19 3CL Protease Inhibitor Resistance Profiling

The potential for the emergence of viral resistance to 3CL protease inhibitors used to treat COVID-19 is of considerable concern. Together with our collaborators at KU Leuven, including its Centre for Drug Design and Discovery (CD3), a drug discovery unit and investment fund of KU Leuven, and the Rega Institute for Medical Research, we have begun to investigate the viral resistance profile of our 3CL protease inhibitors. A resistant mutant was derived by incubating SARS-CoV-2 infected cells with an early lead compound, ALG-097161. We identified a combination of 3 amino acid substitutions in the 3CL protease (L50F E166A L167F) that are associated with a greater than 50-fold increase in the EC50 values for ALG-097161 and PF-07321332 (nirmatrelvir) when assessed in a biochemical assay. In contrast, when ALG-097558 was profiled against the L50F E166A L167F resistant mutant, only a 3-fold shift in the EC50 value was observed. Experiments to further evaluate the viral resistance profile of ALG-097558 are currently ongoing.

Financial Results for the Second Quarter 2022

Cash, cash equivalents and investments totaled $159.3 million as of June 30, 2022, compared with $205.8 million as of December 31, 2021. We continue to believe our cash balance provides sufficient cash to fund planned operations into the first half of 2024.

Net losses for the three months ended June 30, 2022, were $19.9 million or basic and diluted net loss per common share of ($0.47), compared to net losses of $29.8 million or basic and diluted net loss per common share of $(0.79) for the three months ended June 30, 2021.

Research and development (R&D) expenses for the three months ended June 30, 2022, were $16.5 million compared with $24.6 million for the same period of 2021. The decrease in R&D expenses for this comparative period is primarily attributable to our continued wind-down related to the discontinuation of our STOPS and ASO programs offset by our expenditures related to the ongoing development and manufacturing activities associated with our CAM and NASH clinical program activities. Total R&D stock-based compensation expense incurred for the three months ended June 30, 2022, was $2.2 million compared with $2.0 million for the same period of 2021.

General and administrative (G&A) expenses for the three months ended June 30, 2022, were $7.6 million compared with $6.6 million for the same period of 2021. The increase in G&A expenses for this comparative period is primarily attributable to routine employee and facility related costs. Total G&A stock-based compensation expense incurred for the three months ended June 30, 2022, was $1.8 million compared with $1.5 million for the same period of 2021.

On August 4, 2022 Tyra Biosciences, Inc. (Nasdaq: TYRA), a precision oncology company focused on developing purpose-built therapies to overcome tumor resistance and improve outcomes for patients with cancer, reported financial results for the quarter ended June 30, 2022 and highlighted recent corporate progress (Press release, Tyra Biosciences, AUG 4, 2022, View Source [SID1234617560]).

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"It’s been a very productive second quarter at TYRA, highlighted by the FDA clearance to proceed with our SURF301 study of TYRA-300. I couldn’t be more pleased with the execution our team has demonstrated and we look forward to moving our first precision oncology therapy into the clinic," said Todd Harris, CEO of TYRA. "We also remain on track to submit an IND for TYRA-200 in the second half of 2022 and continue to advance our pipeline."

Recent Corporate Highlights

IND Clearance Received for TYRA-300. The U.S. Food and Drug Administration (FDA) cleared TYRA to proceed with its Phase 1/2 SURF301 clinical study of TYRA-300, an FGFR3-selective inhibitor, in patients with metastatic urothelial carcinoma of the bladder and urinary tract. SURF301 is a two-part study designed to determine the optimal and maximum tolerated doses (MTD) and the recommended Phase 2 dose (RP2D) of TYRA-300.

IND for TYRA-200 on Track. TYRA continued to advance TYRA-200, an FGFR2 inhibitor with an initial focus on patients with intrahepatic cholangiocarcinoma. TYRA remains on track to submit an IND with the FDA for TYRA-200 in the second half of 2022.

Pipeline Progression. TYRA continued to progress its pipeline including programs targeting achondroplasia and other FGFR3-related skeletal dysplasias, FGFR4-related cancers, and REarranged during Transfection kinase (RET).

Strengthened Leadership Team with Key Hires. During the second quarter of 2022, TYRA made key senior appointments to its leadership team of Sarah Honig as Vice President, Corporate Development and Strategy, and Ali Fawaz as General Counsel and Secretary.
Second Quarter 2022 Financial Results

Second quarter 2022 net loss was $15.1 million compared to $5.5 million for the same period in 2021.
Second quarter 2022 research and development expenses were $12.0 million compared to $4.4 million for the same period in 2021.
Second quarter 2022 general and administrative expenses were $3.4 million compared to $1.1 million for the same period in 2021.
As of June 30, 2022, TYRA had cash and cash equivalents of $275.1 million.

On August 4, 2022 Omega Therapeutics, Inc. (Nasdaq: OMGA) ("Omega"), a clinical-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as a new class of programmable epigenetic medicines by leveraging its OMEGA Epigenomic Programming platform, reported financial results for the second quarter ended June 30, 2022, and highlighted recent Company progress (Press release, Omega Therapeutics, AUG 4, 2022, View Source [SID1234617576]).

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"This has been an exciting second quarter for Omega, in which we were thrilled to receive FDA clearance of our first IND application for OTX-2002, representing the first ever Omega Epigenomic ControllerTM, a new class of programmable mRNA therapeutics. This is a critical milestone for Omega as we enter our next phase of growth and reflects our pioneering work to realize the potential of epigenomic programming," said Mahesh Karande, President and Chief Executive Officer of Omega Therapeutics. "Additionally, we were also pleased to share exciting, new supportive preclinical data, both from our lead program OTX-2002 in hepatocellular carcinoma, as well as from another program in our pipeline focused on non-small cell lung cancer, a potential future indication. We look forward to continuing this momentum as we enter the clinic in the second half of this year and further exploring the broad ranging capabilities of our novel platform in additional therapeutic areas."

Recent Business Highlights

Development Pipeline and Platform

Received FDA Clearance of Investigational New Drug (IND) application for OTX-2002, the First Omega Epigenomic ControllerTM (OEC), for MYC driven Hepatocellular Carcinoma (HCC): OTX-2002 is a novel, engineered, and programmable mRNA therapeutic designed to downregulate c-Myc (MYC) expression pre-transcriptionally through epigenetic modulation while potentially overcoming MYC autoregulation. This represents the first ever epigenomic controller, a new class of programmable mRNA therapeutics, to receive IND clearance.
On Track to Launch a Phase 1/2 Clinical Trial Under the MYCHELANGELOTM Clinical Trial Program in HCC patients in the 2H’22: The study consists of Part 1 (OTX-2002 as monotherapy) and Part 2 (OTX-2002 combined with standards of care in HCC). The Phase 1/2 trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of OTX-2002 as a monotherapy and in combination with standard of care therapies in patients with relapsed or refractory HCC and other solid tumor types known for association with the MYC oncogene. The study is expected to enroll approximately 190 patients at clinical trial sites in the United States, Asia, and Europe and the Company expects to dose the first patient during the fourth quarter of 2022.
Part 1: This dose escalation portion of the trial will evaluate OTX-2002 monotherapy in patients with relapsed or refractory HCC and other solid tumors. Investigators will utilize a 3+3 design to identify the following primary endpoints of any dose limiting toxicities (DLTs), maximum tolerated dose (MTD), incidence of treatment emergent adverse events (TEAEs), and the recommended dose for expansion (RDE). There will then be a monotherapy expansion for patients with relapsed or refractory HCC who have received at least 1 prior line of systemic anticancer treatment and are without available subsequent standards of care. These patients will receive the RDE of OTX-2002. The primary endpoints of the monotherapy expansion will be overall response rate (ORR) and duration of response (DOR).
Part 2: This portion of the trial will evaluate OTX-2002 in combination with standard of care therapies and will consist of safety run-in and expansion cohorts. During the safety run-in, patients with relapsed or refractory HCC will receive OTX-2002 at the selected dose in combination with one of three current standard of care therapies. These combination partners will be one of two types of tyrosine kinase inhibitors (TKIs) or an immune checkpoint inhibitor (ICI). The primary endpoints of the safety run-in will be DLT, MTD, and incidence of TEAEs. Once the combination therapies have been determined to be tolerable in the safety run-in, patients with relapsed or refractory HCC will be enrolled into the expansion cohorts for each of the combination therapies, with the primary endpoints of ORR and DOR.
New OTX-2002 Preclinical Data Presented at Three Major Medical Meetings Show Robust In Vivo Efficacy and In Vitro Loss of Cancer Cell Viability:
Non-Human Primate (NHP) Data for OTX-2002 in HCC Presented at ESMO (Free ESMO Whitepaper)-GI 2022: Results showed that treatment with OTX-2002 resulted in robust in vivo efficacy in xenograft tumor models and successfully achieved pre-transcriptional downregulation of hepatocyte MYC gene expression in NHPs. These data support the clinical potential of OTX-2002 in combination with existing standard of care therapies for HCC, including ICIs. The ESMO (Free ESMO Whitepaper)-GI poster presentation is available here.
In Vivo Data for OTX-2002 in HCC Presented at AACR (Free AACR Whitepaper) 2022: Results demonstrated that OTX-2002 suppresses MYC gene expression resulting in a loss of cancer cell viability in vitro and a reduction in tumor growth in in vivo xenograft models. These data support the potential of Omega’s platform to engineer programmable mRNA therapeutics that successfully regulate gene expression. The AACR (Free AACR Whitepaper) poster presentation is available here.
In Vivo OEC Data in Models of Non-Small Cell Lung Cancer (NSCLC) Presented at ASGCT (Free ASGCT Whitepaper) 2022: Results demonstrated that regulation of MYC gene expression via epigenomic programming resulted in decreased viability of cancer cells in vitro and reduced tumor burden in in vivo xenograft models. These data support the potential of OECs to precisely and durably regulate gene expression and their potential as a future treatment for NSCLC. The ASGCT (Free ASGCT Whitepaper) poster presentation is available here.
Additional OEC Development: Beyond HCC and NSCLC, the Company is advancing multiple programs through preclinical studies spanning oncology, multigenic diseases including immunology, regenerative medicine, and select monogenic diseases.
OMEGA Epigenomic ProgrammingTM Platform: Omega is creating a new generation of programmable mRNA medicines that are designed to control the fundamental epigenetic processes to correct the root cause of disease by restoring aberrant gene expression to normal levels without altering native nucleic acid sequences. Omega has developed a highly rational and deterministic approach to drug design that enables the Company to rapidly develop and optimize novel OECs with high target specificity to durably tune the expression of single or multiple genes. Omega is advancing multiple preclinical development programs spanning oncology, multigenic diseases including immunology, regenerative medicine, and select monogenic diseases.
Corporate

Joshua Reed Appointed Chief Financial Officer. Mr. Reed brings over 25 years of successful and diverse corporate and financial operations experience including capital raising, business development, and investor relations.
Second Quarter 2022 Financial Results

As of June 30, 2022, the Company had cash, cash equivalents and marketable securities totaling $173.7 million.

Research and development (R&D) expenses for the second quarter of 2022 were $19.4 million, compared to $11.2 million for the second quarter of 2021. The $8.2 million increase in R&D expense was primarily driven by an increase in personnel-related expenses, external manufacturing costs, and study costs in support of the advancement of our programs

General and administrative (G&A) expenses for the second quarter of 2022 were $6.2 million, compared to $3.6 million for the second quarter of 2021. The $2.6 million increase in G&A expense was primarily driven by an increase in personnel-related expenses to support business growth.

Net loss for the second quarter of 2022 was $25.9 million, compared to $15.4 million for the second quarter of 2021, driven predominantly by increased R&D and G&A expenses to support the Company’s growth and operations as a public company.

On August 4, 2022 KemPharm, Inc. (NasdaqGS: KMPH) (KemPharm, or the Company), a specialty pharmaceutical company focused on the discovery, development and commercialization of novel treatments for rare central nervous system (CNS), neurodegenerative and lysosomal storage diseases, reported that the Company will host a conference call and live audio webcast on Thursday, August 11, 2022, at 5:00 p.m. ET, to discuss its corporate and financial results for the second quarter 2022 (Press release, KemPharm, AUG 4, 2022, View Source [SID1234617592]).

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The audio webcast with slide presentation will be accessible via the Investor Relations section of the Company’s website, View Source An archive of the webcast and presentation will be available for 90 days beginning at approximately 6:00 p.m. ET, on August 11, 2022.

On August 4, 2022 Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid"), a commercial-stage, cancer prevention medical diagnostics company, and majority-owned subsidiary of PAVmed Inc. (Nasdaq: PAVM, PAVMZ) ("PAVmed"), reported that a recently published American Gastroenterological Association ("AGA") clinical practice update supports esophageal precancer ("Barrett’s Esophagus," "BE") screening to prevent highly lethal esophageal cancer ("EAC") utilizing its EsoGuard Esophageal DNA Test ("EsoGuard") on samples collected with its EsoCheck Cell Collection Device ("EsoCheck") (Press release, Lucid Diagnostics, AUG 4, 2022, View Source [SID1234617607]).

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The clinical practice update entitled "AGA Clinical Practice Update on New Technology and Innovation for Surveillance," the first such update since 2011, was recently published online in the journal, Clinical Gastroenterology and Hepatology. The expert review was commissioned by the AGA’s Clinical Practice Update Committee, its Center for GI Innovation and Technology, and Governing Board to "provide timely guidance on a topic of high clinical importance…" Senior author Srinadh Komanduri M.D., M.S., Professor of Medicine and Surgery, Associate Chief, Division of Gastroenterology and Hepatology and Director of Endoscopy at the Feinberg School of Medicine, Northwestern University, is a member of Lucid’s Medical Advisory Board.

The AGA update mirrors the recently updated American College of Gastroenterology ("ACG") clinical guideline on the same topic, by acknowledging the "significant need for noninvasive screening tools that are easy to administer, patient friendly, and cost-effective for the detection of BE," and endorsing, for the first time, such tools as an acceptable alternative to endoscopy to directly address this need.

Best Practice Advice 2: Non-Endoscopic Cell Collection Devices may be considered as an option to screen for BE.

The clinical practice update specifically mentions EsoCheck, along with Lucid’s EsophaCap device, as such "Non-endoscopic Cell Collection Devices" – the only such devices commercially available in the United States – indicating that they "have demonstrated excellent tolerability, safety, and sensitivity for the diagnosis of BE." The authors cite the seminal NIH-funded multicenter, case-control study published in 2018 in Science Translational Medicine, which demonstrated that EsoGuard is highly accurate at detecting esophageal precancer and cancer, including on samples collected with EsoCheck.

"We are gratified that the AGA has joined the ACG in updating their clinical practice guidelines to recognize the role that groundbreaking technologies, such as EsoGuard and EsoCheck, can play in driving widespread esophageal precancer screening to prevent esophageal cancer deaths," said Lishan Aklog M.D., Lucid’s Chairman and Chief Executive Officer. "We now have a consensus. The two leading gastroenterology professional associations support the use of our nonendoscopic tools as an acceptable alternative to endoscopy – which has unequivocally failed as a screening tool despite over a decade of clinical guidelines recommending screening of at-risk patients. This ongoing failure to screen makes the thousands of esophageal deaths in the U.S. each year a profound and preventable tragedy, which we are determined to eliminate."

The clinical practice update also significantly expands the target population for esophageal precancer screening, including for EsoGuard and EsoCheck, by recommending, for the first time, screening in at-risk patients without symptoms of reflux. The AGA does so by adding a history of chronic gastroesophageal disease ("GERD," commonly known as chronic heartburn) as merely an additional, seventh, risk factor to the six risk factors for BE and EAC that have traditionally identified at-risk symptomatic patients recommended for screening. As a result, chronic symptomatic GERD is no longer a mandatory prerequisite and asymptomatic patients with three other risk factors are now considered appropriate for screening.

Best Practice Advice 1: Screening with standard upper endoscopy may be considered in individuals with at least 3 established risk factors for Barrett’s esophagus (BE) and esophageal adenocarcinoma (EAC), including individuals who are male, non-Hispanic White, age >50 years, have a history of smoking, chronic GERD, obesity or a family history of BE or EAC.

It is estimated that approximately 40% of GERD patients have "silent GERD" without classic symptoms of heartburn, representing an estimated thirty million persons in addition to the estimated fifty million U.S. adults with weekly symptoms of GERD. The AGA experts based their expansion of the target screening population on a growing consensus, driven by data indicating that over 50% of U.S. patients diagnosed with esophageal cancer would not have qualified for screening per traditional clinical practice guidelines – nearly all because they lacked symptoms of GERD. A recently launched NIH-funded and Lucid-supported study, Detection of Barrett s Esophagus in Patients Without GERD Symptoms, seeks to directly demonstrate that EsoGuard performed by Lucid on samples collected with EsoCheck can detect esophageal precancer in such asymptomatic patients.

"We applaud this bold move by the AGA, which represents a profound paradigm shift in how we view screening for esophageal precancer," said Dr. Aklog. "Based on data its experts cite, removing symptomatic GERD as a mandatory prerequisite for screening has the potential to dramatically increase our ability to prevent esophageal cancer deaths through esophageal precancer screening. We believe that ongoing studies, including the NIH-funded ‘non-GERD’ study we are supporting, will provide additional clinical evidence to support the use of EsoGuard and EsoCheck in asymptomatic at-risk patients."

About EsoGuard and EsoCheck

Millions of patients with GERD are at risk of developing esophageal precancer and a highly lethal form of esophageal cancer ("EAC"). Over 80% of EAC patients die within five years of diagnosis, making it the second most lethal cancer in the U.S. The mortality rate is high even in those diagnosed with early stage EAC. The U.S. incidence of EAC has increased 500% over the past four decades, while the incidences of other common cancers have declined or remained flat. In nearly all cases, EAC silently progresses until it manifests itself with new symptoms of advanced disease. All EAC is believed to arise from esophageal precancer, which occurs in approximately 5% to 15% of at-risk GERD patients. Early esophageal precancer can be monitored for progression to late esophageal precancer which can be cured with endoscopic esophageal ablation, reliably halting progression to cancer.

Esophageal precancer screening is already recommended by clinical practice guidelines in millions of GERD patients with multiple risk factors, including age over 50 years, male gender, White race, obesity, smoking history, and a family history of esophageal precancer or cancer. Unfortunately, fewer than 10% of those recommended for screening undergo traditional invasive endoscopic screening. The profound tragedy of an EAC diagnosis is that likely death could have been prevented if the at-risk GERD patient had been screened and then undergone surveillance and curative treatment.

The only missing element for a viable esophageal cancer prevention program has been the lack of a widespread screening tool that can detect esophageal precancer. Lucid believes EsoGuard, performed on samples collected with EsoCheck, is the missing element – the first and only commercially available test capable of serving as a widespread screening tool to prevent esophageal cancer deaths through the early detection of esophageal precancer in at-risk GERD patients. An updated American College of Gastroenterology clinical practice guideline and an American Gastroenterological Association clinical practice update both endorse nonendoscopic biomarker tests as an acceptable alternative to costly and invasive endoscopy for esophageal precancer screening. EsoGuard is the only such test currently available in the United States.

EsoGuard is a bisulfite-converted NGS DNA assay performed on surface esophageal cells collected with EsoCheck, which quantifies methylation at 31 sites on two genes, Vimentin (VIM) and Cyclin A1 (CCNA1). The assay was evaluated in a 408-patient, multicenter, case-control study published in Science Translational Medicine and showed greater than 90% sensitivity and specificity at detecting esophageal precancer and cancer.

EsoCheck is an FDA 510(k) and CE Mark cleared noninvasive swallowable balloon capsule catheter device capable of sampling surface esophageal cells in a less than five-minute office procedure. It consists of a vitamin pill-sized rigid plastic capsule tethered to a thin silicone catheter from which a soft silicone balloon with textured ridges emerges to gently swab surface esophageal cells. When vacuum suction is applied, the balloon and sampled cells are pulled into the capsule, protecting them from contamination and dilution by cells outside of the targeted region during device withdrawal. Lucid believes this proprietary Collect+Protect technology makes EsoCheck the only noninvasive esophageal cell collection device capable of such anatomically targeted and protected sampling. The sample is sent by overnight express mail to Lucid’s CLIA-certified, CAP-accredited laboratory, LucidDx Labs, for EsoGuard testing.