On October 26, 2020 Medpace Holdings, Inc. (Nasdaq: MEDP) ("Medpace") reported financial results for the third quarter ended September 30, 2020 (Press release, Medpace, OCT 26, 2020, View Source [SID1234569067]).

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Third Quarter 2020 Financial Results

Revenue for the three months ended September 30, 2020 increased 6.5% to $230.4 million, compared to $216.2 million for the comparable prior-year period. On a constant currency organic basis, revenue for the third quarter of 2020 increased 5.8% compared to the third quarter of 2019.

Backlog as of September 30, 2020 grew 16.7% to $1.4 billion from $1.2 billion as of September 30, 2019. Net new business awards were $315.4 million, representing a net book-to-bill ratio of 1.37x for the third quarter of 2020, as compared to $285.4 million for the comparable prior-year period. The Company calculates the net book-to-bill ratio by dividing net new business awards by revenue.

For the third quarter of 2020, total direct costs were $156.2 million, compared to total direct costs of $152.1 million in the third quarter of 2019. Selling, general and administrative (SG&A) expenses were $22.8 million in the third quarter of 2020, compared to SG&A expenses of $29.1 million in the third quarter of 2019.

GAAP net income for the third quarter of 2020 was $41.5 million, or $1.09 per diluted share, versus GAAP net income of $24.0 million, or $0.63 per diluted share, for the third quarter of 2019. This resulted in a net income margin of 18.0% and 11.1% for the third quarter of 2020 and 2019, respectively.

EBITDA for the third quarter of 2020 increased 49.4% to $51.9 million, or 22.5% of revenue, compared to $34.8 million, or 16.1% of revenue, for the comparable prior-year period. On a constant currency basis, EBITDA for the third quarter of 2020 increased 49.9% from the third quarter of 2019.

A reconciliation of the Company’s non-GAAP financial measures, including EBITDA and EBITDA margin to the corresponding GAAP measures is provided below.

Balance Sheet and Liquidity

The Company’s Cash and cash equivalents were $219.2 million at September 30, 2020, and the Company generated $59.8 million in cash flow from operating activities during the third quarter of 2020. The Company did not repurchase any shares during the third quarter.

The Company had $49.2 million remaining under its authorized share repurchase program at the end of the quarter. Additionally, the Company’s Board of Directors has authorized new share repurchases of the Company’s common stock in the open market or negotiated transactions, at the discretion of management, which brings the total current authorization back to $100 million. The extent and timing of repurchases depends on market conditions, applicable regulatory requirements, and other considerations. The share repurchase authorization does not obligate the Company to acquire any minimum amount of common stock and any repurchase program may be modified, limited, extended, suspended or terminated at any time at the Company’s discretion. The Company currently expects that any repurchases under the program would be made in compliance with the SEC’s Rules 10b-5 and 10b-18.

2020 Financial Guidance

The Company forecasts 2020 revenue in the range of $880.0 million to $920.0 million, representing growth of 2.2% to 6.9% over 2019 revenue of $861.0 million. GAAP net income for full year 2020 is forecasted in the range of $136.0 million to $144.0 million. Additionally, full year 2020 EBITDA is expected in the range of $180.0 million to $190.0 million. Based on forecasted 2020 revenue of $880.0 million to $920.0 million and GAAP net income of $136.0 million to $144.0 million, diluted earnings per share (GAAP) is forecasted in the range of $3.62 to $3.83. This guidance assumes a full year 2020 tax rate of 15.0% to 16.0% and does not reflect the potential impact of any share repurchases the Company may make pursuant to the share repurchase program.

2021 Financial Guidance

The Company forecasts 2021 revenue in the range of $1.050 billion to $1.125 billion. Full year 2021 EBITDA is expected in the range of $200.0 million to $220.0 million. The Company expects a 2021 full year tax rate of 16.0% to 20.0%.

Conference Call Details

Medpace will host a conference call at 9:00 a.m. ET, Tuesday, October 27, 2020, to discuss its third quarter 2020 results.

To participate in the conference call, dial 800-219-7113 (domestic) or 574-990-1030 (international) using the passcode 6989449.

To access the conference call via webcast, visit the "Investors" section of Medpace’s website at medpace.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A supplemental slide presentation will also be available at the "Investors" section of Medpace’s website prior to the start of the call.

A recording of the call will be available at 12:00 p.m. ET on Tuesday, October 27, 2020 until 12:00 p.m. ET on Tuesday, November 10, 2020. To hear this recording, dial 855-859-2056 (domestic) or 404-537-3406 (international) using the passcode 6989449.

On October 26, 2020 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported that it will release its financial results for the third quarter ended Sept. 30, 2020, after the close of market on Monday, Nov. 9, 2020 (Press release, Castle Biosciences, OCT 26, 2020, View Source [SID1234569066]).

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Company management will host a conference call and webcast to discuss its financial results and provide a corporate update at 4:30 p.m. Eastern time on the same day.

Conference Call and Webcast Details

A live webcast of the conference call can be accessed at View Source or via the webcast link on the Investor Relations page of the Company’s website (www.castlebiosciences.com). Please access the webcast at least 10 minutes before the conference call start time. An archive of the webcast will be available on the Company’s website until Nov. 30, 2020.

To access the live conference call via phone, please dial 877-282-2581 from the United States and Canada, or +1 470-495-9479 internationally, at least 10 minutes prior to the start of the call, using the conference ID 3586364.

There will be a brief Question & Answer session following the corporate update.

On October 26, 2020 Boundless Bio, a biotechnology company developing innovative therapeutics directed to extrachromosomal DNA (ecDNA) in aggressive cancers, reported that it will present research highlighting powerful components of its proprietary Spyglass platform at the 2020 American Society of Human Genetics (ASHG) Annual Meeting (Press release, Boundless Bio, OCT 26, 2020, View Source [SID1234569065]).

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The poster, titled "A Robust Imaging and Single-Cell Sequencing Platform to Characterize Tumor Extrachromosomal DNA (ecDNA) in Response to Therapeutic Intervention," describes elements of Boundless Bio’s broad platform for interrogating ecDNA biology. These elements couple automated cellular imaging with comprehensive single-cell genomic sequencing. The tools are part of an essential toolkit for understanding how ecDNA responds when cancers are treated with various therapeutic pressures and can be broadly applied to track how oncogenes amplify and where they are expressed following therapeutic intervention. Tumors driven by oncogene amplification are aggressive, have poor prognosis, and have proven elusive for targeted therapies. ecDNA frequently harbor oncogene amplifications and promote resistance to cancer treatment by enhancing genomic diversity and enabling cancer cells to rapidly adapt in response to therapeutic pressures.

"We are building our Spyglass platform to serve as the first robust, objective, and high-resolution tool for characterizing ecDNA and how they respond to therapeutic pressures," said Jason Christiansen, Chief Technology Officer of Boundless Bio. "This new research presented at ASH (Free ASH Whitepaper)G demonstrates that our platform can successfully track how the behavior of ecDNA in cancer shifts in the face of treatment; these insights are enabling us to develop more effective, highly-targeted treatments for patients with cancers driven by ecDNA."

Study Details

Utilizing key analytical tool elements of the Spyglass platform, scientists studied colorectal cancer cells with amplified oncogenes in the presence and absence of cytotoxic chemotherapy, demonstrating the ability to robustly characterize changes in ecDNA and chromosomally-amplified genes at the phenotypic and molecular level.

The researchers studied Colo320DM cells, containing a mixture of the MYC oncogene on ecDNA and chromosomally amplified gene populations; Colo320HSR cells with a pure chromosomally amplified MYC population; and DLD1 cells as a non-amplified control. Each arm was treated for 2 weeks with a cytotoxic chemotherapeutic agent. Cells in metaphase were collected, stained with DAPI and probed for the MYC oncogene by Fluorescence In Situ Hybridization (FISH). Whole-slide images (~10mm2) were collected using automated imaging; and custom-built software was used to automatically identify and quantify ecDNA in individual metaphase spreads. Relative changes in MYC FISH signal and localization were used to quantify the changes in ecDNA and chromosomal amplification populations before and after drug treatment.

In addition, single-cell sequencing techniques revealed molecular level information about the amplified gene regions that is complementary to the spatial information provided by image analysis. Regions of increased gene expression and open chromatin around the MYC gene are indicative of ecDNA and were not identified in the chromosomally amplified line. Further, although chromosomally amplified regions exist in both model lines, molecular level evidence demonstrated divergence in this region not discernable by imaging. When treated with cytotoxic chemotherapy, the ecDNA population was reduced and the chromosomally amplified region was selected. Together these tools demonstrated Boundless Bio’s ability to monitor and quantify dynamic changes in ecDNA in cancer cells under selective pressure.

About ecDNA
Extrachromosomal DNA, or ecDNA, are distinct circular units of DNA containing functional genes, including oncogenes, that are separated from tumor cell chromosomes. ecDNA rapidly replicate within cancer cells, causing high numbers of oncogene copies and can be passed to daughter cells asymmetrically during cell division, driving tumor heterogeneity. Cancer cells have the ability to increase or decrease copy number of oncogenes located on ecDNA to enable survival under selective pressures, including chemotherapy, targeted therapy, immunotherapy, or radiation, making ecDNA one of cancer cells’ primary mechanisms of recurrence and treatment resistance. ecDNA are rarely seen in healthy cells but are found in many solid tumor cancers. They are a key driver of the most aggressive and difficult-to-treat cancers, specifically those characterized by high copy number amplification of oncogenes.

On October 26, 2020 NANOBIOTIX (Euronext : NANO – ISIN : FR0011341205 – the ‘‘Company’’) reported updates to the Company’s global development plan for first-in-class radioenhancer NBTXR3 at the 2020 American Society for Radiation Oncology (ASTRO) Annual Meeting (Press release, Nanobiotix, OCT 26, 2020, View Source [SID1234569064]).

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While the COVID-19 crisis and subsequent measures to curtail the spread of the virus have created challenges in clinical trial recruitment, a sharpened focus on the Company’s priority pathways in head and neck cancer and immunotherapy has led to the continued achievement of necessary milestones for the development of lead product candidate NBTXR3. Moreover, diligent efforts in collaboration with The University of Texas MD Anderson Cancer Center (MD Anderson) in the United States (US) has helped to advance expansion of the development plan across new indications.

Priority Development in Head and Neck Cancer and Immunotherapy

Pathway to Global Registration in Head and Neck Cancer On Track

Nanobiotix has presented an update on the expansion part of the Company’s phase I study evaluating NBTXR3 activated by radiation therapy for patients with head and neck cancer (Study 102) at ASTRO 2020. In 31 evaluable patients, positive results confirmed the target lesion objective response rate presented earlier this year at 83.9% and showed an increase in target lesion complete response rate at 67.7%. The target lesion complete response rate is an increase over previously reported data (60%) with additional follow up (7.8-month median follow up vs. 5 months). Additionally, data showed an overall objective response rate of 83.9% and an overall complete response rate of 48.4%, which were also increases over previously reported data (83% and 43% respectively).

The trial has recruited 44 patients in total (31 evaluable to date), and will remain ongoing until reaching 44 evaluable patients. The next update on the study is expected in the second quarter of 2021.

Preparation for the Company’s pivotal phase III trial evaluating NBTXR3 activated by radiation therapy for patients with head and neck cancer (NANORAY-312) is ongoing as planned. The trial is expected to commence after the financing to fund the trial is secured.

As previously announced, NBTXR3 activated by radiation therapy for the population in NANORAY-312 received Fast Track designation from the US Food and Drug Administration (FDA) in February 2020. Fast Track is a process designed to facilitate the development and accelerate the review of drugs for serious conditions and that have the potential to address unmet medical needs. The purpose is to expedite the availability of new treatment options for patients.

First Clinical Data in Immunotherapy to be Presented in Coming Weeks

Nanobiotix will present the first clinical results from a phase I study evaluating NBTXR3 activated by radiation therapy in combination with pembrolizumab or nivolumab for patients with head and neck cancer, lung metastasis and/or liver metastasis (Study 1100) by the end of 2020.

Nine patients have been injected in the trial thus far and recruitment remains ongoing. After the release of first results, the next step for the trial will be establishment of the recommended phase II dose (RP2D) by mid year 2021 for the head and neck cancer cohort and the lung metastasis cohort, and in the second half of 2021 for the liver metastasis cohort.

Early-Stage Development Across Other Solid Tumor Indications and with Collaborators

Nanobiotix Trials in Additional Solid Tumor Indications

The dose escalation part of the Company’s phase I/II trial evaluating NBTXR3 activated by radiation therapy for the treatment of patients with hepatocellular carcinoma (HCC) or liver metastasis (Study 103) has completed successfully and final data has been presented at ASTRO 2020. Data showed that the product candidate continues to be safe and well tolerated with no dose-limiting toxicities (DLTs). Early efficacy data showed a target lesion objective response rate of 90.9% in evaluable patients with hepatocellular carcinoma (HCC) and a target lesion objective response rate of 71.4% in evaluable patients with liver metastasis. Further development in this indication will proceed after the launch of the Company’s phase III head and neck cancer trial.

The Company’s phase I trial evaluating NBTXR3 activated by radiation therapy for the treatment of patients with prostate cancer (Study 104) has administered NBTXR3 to five patients, with no serious adverse events and no DLTs reported. At present the Company has paused development in this indication to focus resources on the head and neck cancer and immunotherapy pathways.

In soft tissue sarcoma, the final patient follow up visit has been completed in the phase III Act.In.Sarc study. The planned post-registrational trial is expected to launch in 2021.

Trials with Collaborators

The Company’s clinical collaboration with MD Anderson continues to move forward with the launch of a phase I trial evaluating NBTXR3 activated by radiation therapy for patients with pancreatic cancer. FDA ‘Safe to Proceed’ notifications have been received for four additional trials in the collaboration and are pending activation.

About NBTXR3

NBTXR3 is a first-in-class radioenhancer composed of functionalized hafnium oxide nanoparticles that is administered via one-time intra-tumoral injection and activated by radiation therapy. The physical and universal mode of action (MoA) of NBTXR3 is designed to trigger cellular destruction death and adaptive immune response.

NBTXR3 is being evaluated in locally advanced head and neck squamous cell carcinoma (HNSCC) of the oral cavity or oropharynx in elderly patients unable to receive chemotherapy or cetuximab with limited therapeutic options. Promising results have been observed in the phase I trial regarding local control. In the United States, the Company has started the regulatory process to commence a phase III clinical trial in locally advanced head and neck cancers. In February 2020, the United States Food and Drug Administration granted the regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced head and neck squamous cell cancer who are not eligible for platinum-based chemotherapy.

Nanobiotix is also running an Immuno-Oncology development program. The Company has launched a Phase I clinical trial of NBTXR3 activated by radiotherapy in combination with anti-PD-1 checkpoint inhibitors in locoregional recurrent (LRR) or recurrent and metastatic (R/M) HNSCC amenable to re-irradiation of the HN and lung or liver metastases (mets) from any primary cancer eligible for anti-PD-1 therapy.

Other ongoing NBTXR3 trials are treating patients with hepatocellular carcinoma (HCC) or liver metastases, locally advanced or unresectable rectal cancer in combination with chemotherapy, head and neck cancer in combination with concurrent chemotherapy, and pancreatic cancer. The Company is also engaged in a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to further expand the NBTXR3 development program.

On October 26, 2020 Anpac Bio-Medical Science Co., Ltd. ("Anpac Bio," the "Company" or "we") (ANPC), a biotechnology company with operations in China and the United States focused on early cancer screening and detection, reported that it has completed over 200,000 cancer detection tests as of September 30, 2020 using its biophysics based cancer screening technology, Cancer Differentiation Analysis ("CDA") (Press release, Anpac Bio, OCT 26, 2020, View Source [SID1234569063]).The CDA technology allows cancer screening for close to 60 types of cancer, including certain cancer types such as esophageal cancer and brain tumors which do not yet have other more-established blood based testing methods.

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As of June 30, 2020, the Company completed an accumulated number of CDA-based tests to 180,673. Since then, Company has carried out over 20,000 additional tests by the end of September, bringing the total number of tests over 200,000.

Dr. Chris Yu, CEO and Chairman of Anpac Bio commented, "We are very pleased to have achieved this milestone of over 200,000 completed biophysics based CDA tests. The rapid increasing number of tests we have achieved indicates the viability and popularity of our products, and indicates that biophysics based cancer screening technology can be an effective alternative approach to traditional cancer screening methods due to its advantages in a number of critical areas, including the detection of multiple cancer types at earlier stages due to a high level of sensitivity and specificity and low cost approach."