On August 1, 2023 Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, reported that the company generated revenue of $622.1 million for the second quarter ended June 30, 2023, compared to $521.6 million for the same period of 2022 (Press release, Exact Sciences, AUG 1, 2023, View Source [SID1234633582]).

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"The team at Exact Sciences is powering the most innovative growth engine in cancer diagnostics," said Kevin Conroy, chairman and CEO. "Led by our best-in-class scientific team, we’ll continue to enhance our current tests and develop new tests that help meaningfully improve patient outcomes. The second-quarter results demonstrate how our scale and commercial teams will help those tests impact millions of patients while improving profitability."

Second-quarter 2023 financial results

For the three-month period ended June 30, 2023, as compared to the same period of 2022 (where applicable):

Total revenue was $622.1 million, an increase of 19 percent
Core revenue was $617.5 million, an increase of 24 percent
Screening revenue was $462.8 million, an increase of 31 percent
Precision Oncology revenue was $157.2 million, an increase of 2 percent, or 7 percent on a core revenue basis
COVID-19 testing revenue was $2.1 million, a decrease of 84 percent
Gross margin including amortization of acquired intangible assets was 71 percent, and non-GAAP gross margin excluding amortization of acquired intangible assets was 75 percent
Net loss was $81.0 million, or $0.45 per share, compared to a net loss of $166.1 million, or $0.94 per share
EBITDA was $(21.7) million and adjusted EBITDA was $66.9 million
Cash provided by operating activities was $100.4 million and free cash flow was $65.7 million
Cash, cash equivalents, and marketable securities were $775.7 million at the end of the quarter
Screening primarily includes laboratory service revenue from Cologuard tests and PreventionGenetics. Precision Oncology includes laboratory service revenue from global Oncotype DX products and therapy selection products.

2023 outlook

The company anticipates revenue of $2.441-$2.466 billion during 2023, assuming:

Screening revenue of $1.820-$1.835 billion,
Precision Oncology revenue of $615-$625 million, and
COVID-19 testing revenue of $6 million.
Revenue guidance has been raised from the previously expected range of $2.380-$2.420 billion, which assumed:

Screening revenue of $1.770-$1.795 billion,
Precision Oncology revenue of $605-$620 million, and
COVID-19 testing revenue of $5 million.
Second -quarter 2023 conference call & webcast
Company management will host a conference call and webcast on Tuesday, August 1, 2023, at 5 p.m. ET to discuss second-quarter 2023 results. The webcast will be available at exactsciences.com. Domestic callers should dial 888-330-2384 and international callers should dial +1-240-789-2701. The access code for both domestic and international callers is 4437608.

An archive of the webcast will be available at exactsciences.com. A replay of the conference call will be available by calling 800-770-2030 domestically or +1-647-362-9199 internationally. The access code for the replay of the call is 4437608. The webcast, conference call, and replay are open to all interested parties.

Non-GAAP disclosure

In addition to the company’s financial results determined in accordance with U.S. GAAP, the company provides non-GAAP measures that it determines to be useful in evaluating its operating performance and liquidity. The company presents EBITDA, adjusted EBITDA, non-GAAP gross margin, non-GAAP gross profit, core revenue, and free cash flow. EBITDA and adjusted EBITDA consist of net loss after adjustment for those items shown in the table below. The company defines non-GAAP gross profit and non-GAAP gross margin as GAAP gross profit and GAAP gross margin, respectively, excluding amortization of acquired intangible assets. The amortization of acquisition-related intangible assets used in the calculation of non-GAAP gross profit and non-GAAP gross margin pertain only to the amortization associated with developed technology acquired and recorded through purchase accounting transactions. The amortization of these intangible assets will recur in future periods until such intangible assets have been fully amortized. Core revenue is calculated to adjust for recent divestitures, COVID-19 testing revenue and foreign currency exchange rate fluctuations. To exclude the impact of change in foreign currency exchange rates from the prior period under comparison, the Company converts the current period non-U.S. dollar denominated revenue using the prior year comparative period exchange rates. The company considers free cash flow to be a liquidity measure and is calculated as net cash used in or provided by operating activities, reduced by purchases of property, plant and equipment. Management believes that presentation of non-GAAP financial measures provides useful supplemental information to investors and facilitates the analysis of the company’s core operating results and comparison of operating results across reporting periods. The company uses this non-GAAP financial information to establish budgets, manage the company’s business, and set incentive and compensation arrangements. The company believes free cash flow provides useful information to management and investors since it measures our ability to generate cash from business operations. Non-GAAP financial information, when taken collectively, may be helpful to investors because it provides consistency and comparability with past financial performance. However, non-GAAP financial information is presented for supplemental information purposes only, has limitations as an analytical tool and should not be considered in isolation or as a substitute for financial information presented in accordance with U.S. GAAP. For example, non-GAAP gross margin and non-GAAP gross profit exclude the amortization of acquired intangible assets although such measures include the revenue associated with the acquisitions. Additionally, adjusted EBITDA excludes a number of expense items that are included in net loss. As a result, positive adjusted EBITDA may be achieved while a significant net loss persists. For a reconciliation of these non-GAAP measures to GAAP, see below "EBITDA and Adjusted EBITDA Reconciliations", "Non-GAAP Gross Profit and Non-GAAP Gross Margin Reconciliations", "Reconciliation of Core Revenue" and "Condensed Consolidated Statements of Cash Flows and Reconciliation of Free Cash Flow". The company presents certain forward-looking statements about the company’s future financial performance that include non-GAAP measures. These non-GAAP measures include adjustments like stock-based compensation, acquisition and integration costs including gains and losses on contingent consideration liabilities that are difficult to predict for future periods because the nature of the adjustments pertain to events that have not yet occurred. Additionally management does not forecast many of the excluded items for internal use. Information reconciling forward-looking non-GAAP measures to U.S. GAAP measures is therefore not available without unreasonable effort, and is not provided. The occurrence, timing, and amount of any of the items excluded from GAAP to calculate non-GAAP could significantly impact the company’s GAAP results.

About Cologuard

The Cologuard test was approved by the FDA in August 2014, and results from Exact Sciences’ prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. The Cologuard test is included in the American Cancer Society’s (2018) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2021) and National Comprehensive Cancer Network (2016). The Cologuard test is indicated to screen adults 45 years of age and older who are at average risk for colorectal cancer by detecting certain DNA markers and blood in the stool. Do not use the Cologuard test if you have had precancer, have inflammatory bowel disease and certain hereditary syndromes, or have a personal or family history of colorectal cancer. The Cologuard test is not a replacement for colonoscopy in high risk patients. The Cologuard test performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older. The Cologuard test performance in repeat testing has not been evaluated.

The Cologuard test result should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for colonoscopy. A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their doctor when they need to be tested again. Medicare and most major insurers cover the Cologuard test. For more information about the Cologuard test, visit cologuardtest.com. Rx only.

On August 1, 2023 Champions Oncology, Inc. (Nasdaq: CSBR), a leading global preclinical and clinical research services provider that offers end-to-end oncology R&D solutions, reported an agreement to adopt BioVolume’s leading 3D imaging and thermal technology as their primary means of capturing efficacy results (Press release, Champions Oncology, AUG 1, 2023, View Source [SID1234633581]). Through this multi-year agreement Champions Oncology will incorporate BioVolume’s cutting-edge thermal and 3D imaging platform into its broad portfolio of in vivo preclinical offerings. In alignment with Champions’ consistent focus on delivering the highest quality data and scientific excellence, the adoption of BioVolume technology will enable the achievement of greater accuracy, reduced variability, and the generation of reliable insights to advance oncology drug development programs across different therapeutic modalities.

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BioVolume is advancing global preclinical oncology by providing greater study accuracy and helping strengthen drug filings for clinical trials with a digital record of preclinical efficacy. Specifically, BioVolume detects, segments, and measures subcutaneous tumor growth in rodents. By providing traceable imaging for each volume measurement alongside the additional capture of tumor height, ensures greater reproducibility of study data and offers a statistically significant reduction in variability compared to calipers which rely on manual measurement. In silico modeling of BioVolume data demonstrates that reducing variability can decrease the chance of missing a therapeutic effect by a factor of seven in comparison to existing caliper-based processes.

Maria Mancini, Chief Operating Officer at Champions Oncology said, "We are excited to announce our partnership with BioVolume. Adopting innovative technologies to digitize preclinical lab processes is critical to generating new breakthroughs in cancer research. The partnership will enable us to provide full transparency in study data collection and analysis, more accurate and consistent data, and greater scientific confidence to the pharma and biotech research community."

"Champions Oncology and BioVolume are both forward-looking companies committed to advancing science, and we look forward to working together to enable faster, smarter, and more confident decisions to be made in the identification and development of new cancer therapeutics," said Karl Turley, BioVolume Chief Operating Officer. "Cancer research is affected by a reproducibility crisis, and we believe our unique imaging platform will help tackle this challenge by transforming reproducibility in preclinical efficacy assessments."

On August 1, 2023 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported that Scott Hutton, Chief Executive Officer of Biodesix, will present and host in-person 1×1 investor meetings at the Canaccord Genuity 43rd Annual Growth Conference, which will be held from August 7-10, 2023 (Press release, Biodesix, AUG 1, 2023, View Source [SID1234633579]).

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

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Canaccord Genuity 43rd Annual Growth Conference
Fireside Chat Date: Wednesday, August 9, 2023
Fireside Chat Time: 4:00 PM ET
Location: InterContinental Boston, Boston, MA

The fireside chat will be webcast live and available for replay under "News & Events" in the Investors section of Biodesix’s website at Biodesix.com.

On August 1, 2023 – Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported interim data from Stage 2 of the Company’s Phase 2 study of prexigebersen in combination with decitabine and venetoclax for the treatment of acute myeloid leukemia (AML) (Press release, Bio-Path Holdings, AUG 1, 2023, View Source [SID1234633578]). Prexigebersen continues to be well-tolerated and has now shown compelling efficacy results in two reporting cohorts including evaluable newly diagnosed AML patients and evaluable refractory/relapsed AML patients, which exceed outcomes with frontline therapy. The protocol for the Phase 2 study allows Bio-Path to conduct an interim efficacy analysis on each cohort at its discretion. Additional data will become available as final efficacy reviews are conducted.

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"We are delighted to report these positive interim data as they represent a potential breakthrough for these very sick patients who face a complicated disease with limited treatment options," said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "Based on these favorable results, we plan to file for regulatory designations that could accelerate our ability to bring this potentially lifesaving therapeutic to patients with the greatest of unmet medical needs."

Stage 2 of the Phase 2 clinical trial is a multi-center, open label study designed with three patient cohorts that offer Bio-Path three pathways to registration:

• Newly diagnosed AML patients treated with prexigebersen in combination with decitabine plus venetoclax;
• Refractory/relapsed AML patients treated with prexigebersen in combination with decitabine plus venetoclax; and
• Refractory/relapsed AML patients, resistant or intolerant to venetoclax, treated with prexigebersen in combination with decitabine.

The primary objective of the study is to assess whether prexigebersen in combination with decitabine plus venetoclax provides higher response rates than decitabine plus venetoclax in AML patients and whether prexigebersen in combination with decitabine provides higher response rates than decitabine alone in AML patients.

Data Highlights

Fourteen newly diagnosed patients were evaluable in Cohort 1 and treated with at least one cycle of the prexigebersen, decitabine and venetoclax combination therapy. All patients in this cohort (median age 75) were adverse risk by 2017 European LeukemiaNet (ELN) guidelines (n=10) or secondary AML (n=4). Prexigebersen was well-tolerated, and adverse events (AEs) were generally consistent with decitabine and venetoclax treatment and/or for AML. Twelve of the fourteen evaluable patients (86%) achieved complete remission (CR/CRi) and two (14%) achieved partial remission (PR). In total, 100% of the evaluable patients had a response to treatment. The complete remission rate (CR/CRi) of (86%) for the evaluable patients in Cohort 1 is significantly higher than complete remission (CR/CRi) rates (62%) for newly diagnosed patients treated with the frontline combination treatment of decitabine and venetoclax. This result is further highlighted by the high-risk rating of Bio-Path’s Cohort 1 evaluable patients and the inclusion of secondary AML patients (29%), both of which are classes of patients with very difficult to treat disease.

Fourteen refractory/relapsed evaluable AML patients in Cohort 2 were treated with at least one cycle of the prexigebersen, decitabine and venetoclax combination therapy. All patients in this cohort (median age 56.5) were adverse risk by 2017 ELN guidelines (n=11) or secondary AML (n=2). Prexigebersen was well-tolerated, and AEs were generally consistent with decitabine and venetoclax treatment and/or for AML. Eight of the fourteen evaluable patients (57%) achieved complete remission (CR/CRi), two (14%) achieved partial remission (PR) and three (22%) achieved stable disease. In total, 93% of the evaluable patients had a response to treatment. The complete remission rate (CR/CRi) of (57%) for the evaluable refractory and relapsed patients in Cohort 2 is significantly higher than complete remission (CR/CRi) rate (21%) for refractory/relapsed patients treated with the combination treatment of decitabine and venetoclax. As with newly diagnosed patients in Cohort 1, this result is further highlighted by the high-risk rating of Bio-Path’s Cohort 2 evaluable patients and the inclusion of secondary AML patients (15%).

Next Steps

Efficacy data from the initial interim analysis of Cohort 1 and Cohort 2 are compelling and show that prexigebersen-based combination therapy was not only safely administered in Cohort 1 and Cohort 2 to high-risk newly diagnosed and refractory/relapsed AML patients considered unsuitable for standard chemotherapy, but also demonstrated efficacy signals significantly better than current therapies. This is particularly encouraging as refractory/relapsed patients are a challenging population in which current treatment options are suboptimal.

As a result of the interim review, Bio-Path has demonstrated superiority of prexigebersen combination therapy in treating AML patients and currently plans to pursue U.S. Food and Drug Administration (FDA) expedited programs for Fast Track and Breakthrough Therapy designations. Fast Track Designation is designed to expedite the development and review of drugs to treat serious conditions and to fulfill an unmet medical need. Breakthrough Therapy Designation is a process designed to expedite the development and review of drugs that may demonstrate substantial improvement over available therapies.

The next steps for Bio-Path are to conduct an administrative review to affirm the cohorts that will continue with enrollment. Nineteen patients had been chosen as an initial sample size for a cohort to provide interim efficacy data, however, the protocol for the Phase 2 allows Bio-Path to conduct interim efficacy analysis sooner at its discretion.

Operations in the United States are expected to remain unchanged with an expected six to ten treatment sites. In addition, Bio-Path is evaluating whether to seek to expand Stage 2 of the Phase 2 clinical trial by pursuing operations in Europe, as it believes there are more potential patients for Stage 2 of the Phase 2 clinical trial there, which could meaningfully enhance enrollment and accelerate completion of clinical trial milestones.

About Prexigebersen (BP1001)

Prexigebersen is a neutral liposome incorporated with nuclease-resistant, hydrophobic Pethoxy antisense oligodeoxynucleotides targeted to Grb2 mRNA. Grb2 is an adaptor protein that links oncogenic tyrosine kinases with downstream kinases, such as ERK and AKT, which are critical to cell proliferation and survival.

On August 1, 2023 Ayala Pharmaceuticals, Inc. (OTCQX: ADXS), a publicly-traded clinical-stage oncology company, reported that it will present posters on its gamma secretase inhibitors AL102 and AL101 at the European Society for Molecular Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023, to be held in Madrid, Spain 20-24 October 2023 (Press release, Ayala Pharmaceuticals, AUG 1, 2023, View Source [SID1234633577]).

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Poster Presentation Details
Title: Phase 2 Results from the RINGSIDE Phase 2/3 Trial of AL102 for Treatment of Desmoid Tumors
Presenter Prof. Robin Jones (The Institute of Cancer Research and Royal Marsden, UK)
Presentation # 1929P
Abstract # 4578

Title AL101 therapy in patients with recurrent/metastatic (R/M) adenoid cystic carcinoma (ACC): Final ACCURACY trial results and meta-analysis of clinical outcomes
Presenter Renata Ferrarotto MD (M.D. Anderson Cancer Center, Houston TX)
Presentation # 903P
Abstract # 4549
About AL102

AL102 is an investigational small molecule gamma secretase inhibitor (GSI) that is designed to potently and selectively inhibit Notch 1, 2, 3 and 4, and is currently being evaluated in the Phase 2/3 RINGSIDE clinical studies in patients with progressing desmoid tumors. AL102 is designed to inhibit the expression of Notch gene targets by blocking the final cleavage step by the gamma secretase required for Notch activation. Ayala obtained an exclusive, worldwide license to develop and commercialize AL102 from Bristol-Myers Squibb Company in November 2017. AL102 was granted U.S. Food and Drug Administration (FDA) Fast Track Designation for the potential treatment of desmoid tumors.

About AL101

AL101 is a novel, injectable, potent and selective small molecule gamma secretase inhibitor. It is currently being studied in the Phase 2 ACCURACY trial for the treatment of patients with recurrent/metastatic adenoid cystic carcinoma (R/M ACC).The FDA granted Orphan Drug Designation and Fast Track Designation for AL101 for the potential treatment of ACC.