On August 4, 2022 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that financial results for the second quarter ended June 30, 2022 (Press release, Puma Biotechnology, AUG 4, 2022, View Source [SID1234617612]). Unless otherwise stated, all comparisons are for the second quarter of 2022 compared to the second quarter of 2021.

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Product revenue, net consists entirely of sales revenue from NERLYNX, Puma’s first commercial product. Product revenue, net in the second quarter of 2022 was $51.3 million, compared to $48.9 million in the second quarter of 2021. Product revenue, net in the first six months of 2022 was $92.0 million, compared to $94.7 million in the first six months of 2021.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported net income of $9.4 million, or $0.21 per basic and diluted share, for the second quarter of 2022, compared to a net loss of $5.1 million, or $0.13 per share, for the second quarter of 2021. Net income for the first six months of 2022 was $6.0 million, or $0.14 per basic and diluted share, compared to net income of $11.3 million, or $0.28 per basic and diluted share, for the first six months of 2021.

Non-GAAP adjusted net income was $12.6 million, or $0.28 per basic and diluted share, for the second quarter of 2022, compared to non-GAAP adjusted net income of $13.1 million, or $0.32 per basic and diluted share, for the second quarter of 2021. Non-GAAP adjusted net income for the first six months of 2022 was $12.4 million, or $0.28 per basic and diluted share, compared to non-GAAP adjusted net income of $35.4 million, or $0.88 per basic share and $0.87 per diluted share, for the first six months of 2021. Non-GAAP adjusted net income excludes stock-based compensation expense. For a reconciliation of GAAP net income (loss) to non-GAAP adjusted net income and GAAP net income (loss) per share to non-GAAP adjusted net income per share, please see the financial tables at the end of this news release.

Net cash used in operating activities for the second quarter of 2022 was $13.9 million, compared to net cash used in operating activities of $0.1 million in the second quarter of 2021. Net cash used in operating activities for the first six months of 2022 was $40.8 million, compared to net cash provided by operating activities of $15.6 million in the first six months of 2021. At June 30, 2022, Puma had cash, cash equivalents and marketable securities of $60.8 million, compared to cash, cash equivalents and marketable securities of $82.1 million at December 31, 2021.

"We are very pleased to report positive net income and earnings per share for the second quarter of 2022," said Alan H. Auerbach, Chairman, Chief Executive Officer, and President of Puma. "This is being driven by the worldwide commercial revenues and royalties from NERLYNX, coupled with our ongoing efforts to reduce operating expenses. Our commercial execution strategy is designed to support increased patient access to NERLYNX, and we are pleased to continue to move forward with our goal of improving the lives of patients battling cancer.

"As per our earlier guidance, in June we reported top line data from the randomized cohort of the Phase II SUMMIT trial of neratinib in hormone receptor positive breast cancer that has a HER2 mutation, as well as final results from the biliary tract cohort of the Phase II SUMMIT ‘basket’ trial at the 2022 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), enabling us to move forward in our goal of demonstrating the effect of NERLYNX across various types of cancer."

Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) reporting Phase II data from the cohort of patients in the SUMMIT basket trial of neratinib in non-small cell lung cancer patients with EGFR exon 18 mutations (H2 2022); (ii) conducting a meeting with the FDA to discuss the registration pathway of neratinib in HER2-mutated HR-positive breast cancer (H2 2022); (iii) conducting a meeting with the FDA to discuss the registration pathway for neratinib in non-small cell lung cancer patients with EGFR exon 18 mutations who have previously been treated with an EGFR tyrosine kinase inhibitor (2022); (iv) reporting Phase II TBCRC-022 trial data from Cohort 4B and 4C of the combination of Kadcyla plus neratinib in patients with HER2-positive breast cancer with brain metastases who have previously been treated with Kadcyla (H2 2022); and (v) reporting Phase II data from the SUMMIT trial of neratinib in cervical cancer patients with HER2 mutations (H2 2022)."

Revenue

Total revenue consists of product revenue, net from sales of NERLYNX, Puma’s first commercial product, license revenue from Puma’s sub-licensees and royalty revenue. For the second quarter of 2022, total revenue was $59.5 million, of which $51.3 million was net product revenue and $8.2 million was royalty revenue. This compares to total revenue of $53.4 million in the second quarter of 2021, of which $48.9 million was net product revenue, $0.2 million was license revenue received from Puma’s sub-licensees, and $4.3 million was royalty revenue. For the first six months of 2022, total revenue was $105.3 million, of which $92.0 million was net product revenue and $13.3 million was royalty revenue. This compares to total revenue for the first six months of 2021 of $151.6 million, of which $94.7 million was net product revenue, $50.3 million was license revenue received from Puma’s sub-licensees, which included a $50 million upfront payment for providing development, manufacturing, and commercial rights to NERLYNX in Greater China to Pierre Fabre, and $6.6 million was royalty revenue.

Operating Costs and Expenses

Total operating costs and expenses were $47.4 million for the second quarter of 2022, compared to $70.0 million for the second quarter of 2021. Operating costs and expenses in the first six months of 2022 were $94.0 million, compared to $148.1 million in the first six months of 2021.

Cost of Sales

Cost of sales was $14.9 million for the second quarter of 2022, compared to $12.0 million for the second quarter of 2021. Cost of sales was $25.8 million for the first six months of 2022, compared to $41.5 million for the first six months of 2021, of which $20.0 million was for a termination fee paid to a former sub-licensee for the return of commercial rights to NERLYNX in Greater China.

Selling, General and Administrative Expenses

Selling, general and administrative (SG&A) expenses were $20.6 million for the second quarter of 2022, compared to $39.4 million for the second quarter of 2021. SG&A expenses for the first six months of 2022 were $41.0 million, compared to $67.7 million for the first six months of 2021. The $26.7 million year-over-year decrease for the first six months resulted primarily from a decrease in payroll and related costs of approximately $7.2 million, consisting of approximately $5.2 million from lower headcount and a $2.0 million payroll tax credit under the CARES Act; a $4.0 million decrease in consultants fees related to marketing and commercialization support; and a decrease in stock-based compensation expense of approximately $16.0 million, primarily due to the $13.6 million incremental expense resulting from the modification to the term of Mr. Auerbach’s warrant in 2021, and approximately $2.4 million due to lower headcount.

Research and Development Expenses

Research and development (R&D) expenses were $11.9 million for the second quarter of 2022, compared to $18.6 million for the second quarter of 2021. R&D expenses for the first six months of 2022 were $27.2 million, compared to $38.9 million for the first six months of 2021. The $11.7 million year-over-year decrease for the first six months resulted primarily from a decrease in clinical trial expense of $2.8 million; a decrease in internal R&D expense of $5.3 million, which reflects a $3.6 million decrease from reduced headcount and clinical trial activity and a decrease of $1.8 million for a payroll tax credit under the CARES Act; a decrease in consultant and contractors’ expense of $1.8 million, primarily due to the close of the CONTROL study and a reduction in the number of patients being treated in the SUMMIT study; and a decrease in stock-based compensation expense of $1.7 million, primarily due to the impact of headcount reductions in 2021.

Total Other Income (Expenses)

Total other expenses were $2.6 million for the second quarter of 2022, compared to total other income of $11.5 million for the second quarter of 2021. Total other expenses were $5.2 million for the first six months of 2022, compared to total other income of $7.9 million for the first six months of 2021. The $13.1 million year-over-year increase in other expenses for the first six months of 2022 resulted primarily from the recognition of $14.9 million in legal verdict contra-expense in the first six months of 2021, which represented an adjustment to the amount originally recorded for the Eshelman v. Puma Biotechnology, Inc., et al. judgment due to a subsequent ruling on the matter, partially offset by an estimate of service fees incurred related to the class action administrator and pre-judgment interest as a result of the Hsu v. Puma Biotechnology, Inc., et al. claims process.

Conference Call

Puma Biotechnology will host a conference call to report its second quarter 2022 financial results and provide an update on the Company’s business and outlook at 1:30 p.m. PDT/4:30 p.m. EDT on Thursday, August 4, 2022. The call may be accessed by dialing (877) 709-8150 (domestic) or (201) 689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available shortly after completion of the call and will be archived on Puma’s website for 90 days.

On August 4, 2022 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company, reported financial results for the second quarter ended June 30, 2022 (Press release, Repare Therapeutics, AUG 4, 2022, View Source [SID1234617611]).

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"The worldwide license and collaboration agreement we signed with Roche this quarter represents a major step in the broad global development and commercialization of camonsertib, and validates our strategy to build value into our pipeline by developing innovative drugs that target specific synthetic-lethal genomic alterations as we recently demonstrated at AACR (Free AACR Whitepaper)," said Lloyd M. Segal, President and Chief Executive Officer of Repare. "We have made substantial progress in our Phase 1 clinical trial evaluating RP-6306 as a monotherapy and in combination with camonsertib and two chemotherapy agents for the treatment of molecularly selected advanced solid tumors. We have also advanced our polymerase theta inhibitor, RP-2119, to IND-enabling studies. We look forward to providing an initial clinical data readout from the Phase 1 RP-6306 trial in the first half of 2023."

Second Quarter 2022 Review and Operational Updates:

Announced closing of its worldwide license and collaboration agreement with Roche for the development and commercialization of camonsertib (also known as RP-3500), a potent and selective oral small molecule inhibitor of ATR (Ataxia-Telangiectasia and Rad3-related protein kinase) for the treatment of tumors with specific synthetic-lethal genomic alterations.
In connection with the closing of the collaboration agreement, Repare received an upfront payment of $125 million from Roche in July 2022.
Under the collaboration, Roche will assume the development of camonsertib with the potential to expand development into additional tumor indications and multiple combination studies.
In addition to the $125 million upfront payment, Repare is eligible to receive up to $1.172 billion in potential clinical, regulatory, commercial and sales milestones, including up to $55 million in potential near-term payments, and royalties on global net sales ranging from high-single-digits to high-teens. The collaboration also provides Repare with the ability to opt-in to a 50/50 U.S. co-development and profit share arrangement, including participation in U.S. co-promotion if U.S. regulatory approval is received. If Repare chooses to exercise its co-development and profit share option, it will continue to be eligible to receive certain clinical, regulatory, commercial and sales milestone payments, in addition to full ex-U.S. royalties.
Advanced RP-6306, a first-in-class, oral PKMYT1 inhibitor as a monotherapy and in combinations
Phase 1 clinical trials are currently evaluating RP-6306 as a monotherapy (MYTHIC) as well as in combination with gemcitabine (MAGNETIC) for the treatment of molecularly selected advanced solid tumors. In January 2022, the Company initiated an additional Phase 1 clinical trial of RP-6306 in combination with FOLFIRI (MINOTAUR), also for the treatment of molecularly selected advanced solid tumors.
In May 2022, Repare initiated patient recruitment in a new arm of the Phase 1 MYTHIC clinical trial, which is designed to evaluate the safety and tolerability of RP-6306 in combination with camonsertib in patients with advanced solid tumors.
Initial Phase 1 clinical data readout for RP-6306 is now expected in the first half of 2023 for monotherapy (previously expected in the second half 2022) and potentially for combination therapies, due to disruptions in global trial site activation and enrollment resulting from the ongoing COVID-19 pandemic, as well as an expanded requirement for dose escalations that are ongoing.
Initiated IND-enabling studies for Repare’s Polθ inhibitor (now designated RP-2119), and plan to initiate clinical trials in the summer of 2023.
Repare also expects to initiate IND-enabling studies in the first half of 2023 for an additional small molecule against an undisclosed target.
Second Quarter 2022 Financial Results:

Cash and cash equivalents and marketable securities: Cash and cash equivalents and marketable securities as of June 30, 2022 were $282.1 million, which excludes the $125 million now received from Roche and extends cash runway into 2026.
Revenue: Repare recognized revenue of $0.7 million and $1.1 million for the three and six-month periods ended June 30, 2022, respectively, in connection with the Bristol Myers Squibb agreement and research activities performed.
Research and development expenses, net of tax credits (Net R&D): Net R&D expenses were $31.5 million and $57.9 million for the three- and six-month periods ended June 30, 2022, respectively, as compared to $20.2 million and $36.7 million for the three- and six-month periods ended June 30, 2021. The increase in R&D expenses for the three- and six-month periods were primarily due to an increase in direct external costs, primarily for development activities as a result of increased efforts towards advancing the development of the RP-3500 and RP-6306 programs; personnel-related costs, primarily related to increased headcount in support of discovery and development activities; and other research and development costs.
General and administrative (G&A) expenses: G&A expenses were $7.9 million and $16.7 million for the three- and six-month periods ended June 30, 2022, respectively, as compared to $6.7 million and $12.0 million for the three- and six-month periods ended June 30, 2021. The increase in G&A expenses for the three- and six-month periods were primarily due to increases in personnel related costs including share-based compensation; professional costs; and other general and administrative costs.
Net loss: Net loss was $38.1 million, or $0.91 per share, and $72.9 million, or $1.74 per share, in the three- and six-month periods ended June 30, 2022, respectively, and $26.3 million, or $0.71 per share and $47.7 million, or $1.29 per share, in the three-month and six-month periods ended June 30, 2021, respectively.
About Repare Therapeutics’ SNIPRx Platform

Repare’s SNIPRx platform is a genome-wide CRISPR-based screening approach that utilizes proprietary isogenic cell lines to identify novel and known synthetic lethal gene pairs and the corresponding patients who are most likely to benefit from the Company’s therapies based on the genetic profile of their tumors. Repare’s platform enables the development of precision therapeutics in patients whose tumors contain one or more genomic alterations identified by SNIPRx screening, in order to selectively target those tumors in patients most likely to achieve clinical benefit from resulting product candidates.

On August 4, 2022 SQZ Biotechnologies (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, reported second quarter 2022 financial results and recent portfolio updates (Press release, SQZ Biotech, AUG 4, 2022, View Source [SID1234617609]).

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"We are excited by meaningful progress in our clinical trials and also the receipt of FDA Fast Track Designation for our APC clinical candidate across HPV16+ tumors," said Armon Sharei, Ph.D., CEO and Founder at SQZ Biotechnologies. "We also highlighted the progress in developing our Point-of-Care manufacturing system which supports our long-term vision to enable broad accessibility of cell therapies. Finally, I am delighted by the addition of our newest senior team member, Dr. Marshelle Smith Warren as our Chief Medical Officer, and the elevation of Micah Zajic to Chief Financial Officer."

Second Quarter 2022 and Recent Portfolio Updates

SQZ Antigen Presenting Cell ("APC") Platform in Oncology

Granted FDA Fast Track Designation for SQZ-PBMC-HPV, our APC clinical candidate, for HPV16+ advanced or metastatic tumors
Continued enrollment of high dose monotherapy and combination with checkpoint inhibitors in the Phase 1/2 (SQZ-PBMC-HPV) trial
SQZ Enhanced Antigen Presenting Cell ("eAPC") Platform in Oncology

Presented SQZ eAPC preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting demonstrating that delivery of multiple mRNAs encoding for disease-specific antigens and immune stimulators had a synergistic effect that substantially increased killer T cell activity in humanized mouse models
Initiated enrollment and opened additional sites for the monotherapy stage of the COMMANDER-001 Phase 1/2 (SQZ-eAPC-HPV) trial
SQZ Activating Antigen Carriers ("AAC") Platform in Oncology

Published trial in progress poster at the AACR (Free AACR Whitepaper) annual meeting highlighting the SQZ AAC platforms potential to drive robust CD8 T cell activation and tumor killing
Continued enrollment and opened additional sites for the monotherapy stage of the ENVOY-001 Phase 1/2 (SQZ-AAC-HPV-101) trial
SQZ Tolerizing Antigen Carriers ("TAC") Platform in Immune Tolerance

Published comprehensive preclinical research in Frontiers in Immunology
Progressed studies supporting anticipated TAC IND submission for celiac disease in the first half of 2023; company’s POC manufacturing system intended to produce clinical batches
SQZ Point-of-Care Manufacturing

Presented non-clinical POC manufacturing performance data at the American Society for Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) annual meeting demonstrating reduced manufacturing time and comparable or improved product specifications relative to current cleanroom-based processes
Recent Corporate Highlights

Appointed two experienced executives to leadership roles: Marshelle Smith Warren, M.D. joined as Chief Medical Officer, and Micah Zajic was elevated to Chief Financial Officer
Second Quarter 2022 Financial Highlights

Revenue for the quarter ended June 30, 2022, was $3.2 million compared to $4.5 million for the same period in 2021
Research and development expenses for the quarter ended June 30, 2022, were $18.8 million compared to $17.7 million for the same period in 2021; the increase was primarily due to higher personnel-related costs including stock-based compensation expense, to support continued progress with the company’s pipeline
General and administrative expenses for the quarter ended June 30, 2022, were $7.0 million compared to $5.9 million for the same period in 2021; the increase was primarily due to higher personnel and other corporate-related costs, including stock-based compensation expense and other costs
Net loss for the quarter ended June 30, 2022, was $22.2 million, compared to $19.1 million for the same period in 2021
As of June 30, 2022, the Company had cash and cash equivalents of $105.6 million and anticipates this will be sufficient to fund operating expenses and capital expenditure requirements into the fourth quarter of 2023

On August 4, 2022 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) [("Merrimack" or the "Company")] reported its second quarter 2022 financial results for the period ended June 30, 2022 (Press release, Merrimack, AUG 4, 2022, View Source [SID1234617608]).

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"We are pleased to report continued reductions in operating expenses as we remain focused on conserving cash to ensure that we have sufficient financial resources to capture future potential milestone payments from Ipsen Pharmacology and Elevation Oncology" said Gary Crocker, Chairman of Merrimack’s Board of Directors. "We will continue to monitor developments in Ipsen’s Onivyde (irinotecan liposomal injection) program and Elevation’s seribantumab program."

Second Quarter 2022 Financial Results

Merrimack reported a net loss of $478 thousand for the second quarter ended June 30, 2022, or $0.04 per basic and diluted share on a fully diluted basis, compared to a net loss of $759 thousand, or $0.06 per basic and diluted share on a fully diluted basis, for the same period in 2021.

General and administrative expenses for the second quarter ended June 30, 2022, were $486 thousand, compared to $778 thousand for the same period in 2021.

As of June 30, 2022, Merrimack had cash and cash equivalents of $13.4 million, compared to $14.2 million as of December 31, 2021.

As of June 30, 2022, Merrimack had 13.4 million shares of common stock outstanding.

Updates on Programs Underlying Potential Milestone Payments

Ipsen

– On August 3, 2022, Ipsen announced results from its Phase III RESILIENT trial evaluating Onivyde in second-line monotherapy for small cell lung cancer. The announcement indicated that "the primary endpoint OS was not met in patients treated with Onivyde versus topotecan. However, a doubling of the secondary endpoint of objective response rate (ORR) in favor of Onivyde was observed. The safety and tolerability of Onivyde was consistent with its already-known safety profile, and no new safety concerns emerged. The clinical study results will be communicated with the regulatory agency." Ipsen indicated in its update that it will analyze the data further before making decisions about next steps.

– On July 28, 2022, Ipsen provided a public update on its sales performance for the first half of 2022 and indicated that top line data from its continuing Phase 3 study of ONIVYDE in first line pancreatic ductal adenocarcinoma were anticipated to be available during the second half of 2022.

Elevation Oncology

– On May 26, 2022, Elevation Oncology released to the public initial proof-of-concept data from its phase 2 CRESTONE Study evaluating the HER3 monoclonal antibody seribantumab in patients with tumors harboring NRG1 fusions at ASCO (Free ASCO Whitepaper) 2022. The most recent corporate presentation from Elevation indicates that top line data from this trial are expected in 2024.

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.