On July 29, 2019 Medpace Holdings, Inc. (Nasdaq: MEDP) ("Medpace") reported financial results for the second quarter ended June 30, 2019 (Press release, Medpace, JUL 29, 2019, View Source [SID1234537859]).

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"In the second quarter, the business environment remained strong, and our competitive win rate remained healthy," said August J. Troendle, President & Chief Executive Officer. "Cancellations in the quarter returned to an anticipated historical range from elevated levels the past two quarters."

Second Quarter 2019 Financial Results

Revenue for the three months ended June 30, 2019 increased 25.8% to $214.1 million, compared to $170.1 million for the comparable prior-year period. On a constant currency organic basis, revenue for the second quarter of 2019 increased 26.0% compared to the second quarter of 2018.

Backlog as of June 30, 2019 grew 19.6% to $1.2 billion from $979.7 million as of June 30, 2018. Net new business awards were $279.2 million, representing a net book-to-bill ratio of 1.30x for the second quarter of 2019, as compared to $239.9 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 second quarter of 2019, total direct costs were $150.3 million, compared to total direct costs of $116.7 million in the second quarter of 2018. Selling, general and administrative (SG&A) expenses were $23.6 million, compared to SG&A expenses of $20.5 million in the second quarter of 2018.

GAAP net income for the second quarter of 2019 was $27.5 million, or $0.73 per diluted share, versus GAAP net income of $16.6 million, or $0.45 per diluted share, for the second quarter of 2018. This resulted in a net income margin of 12.8% and 9.7% for the second quarter of 2019 and 2018, respectively.

EBITDA for the second quarter of 2019 increased 20.3% to $40.2 million, or 18.8% of revenue, compared to $33.4 million, or 19.7% of revenue, for the comparable prior-year period. On a constant currency basis, EBITDA for the second quarter of 2019 increased 18.2% from the second quarter of 2018.

Adjusted Net Income for the second quarter of 2019 increased 35.7% to $30.4 million compared to $22.4 million for the comparable prior-year period. Adjusted Net Income per diluted share for the second quarter of 2019 was $0.81, representing an increase of 32.8%, compared to Adjusted Net Income per diluted share of $0.61 for the comparable prior-year period.

A reconciliation of the Company’s non-GAAP financial measures, including EBITDA, EBITDA margin, Adjusted Net Income, and Adjusted Net Income per diluted share to the corresponding GAAP measures is provided below.

Balance Sheet and Liquidity

The Company’s Cash and cash equivalents were $20.1 million at June 30, 2019, and the Company generated $46.6 million in cash flow from operating activities during the second quarter of 2019. Additionally, the Company paid off its remaining outstanding obligations against its term loan during the second quarter of 2019.

Financial Guidance

The Company forecasts 2019 revenue in the range of $840.0 million to $860.0 million, representing growth of 19.2% to 22.1% over 2018 revenue of $704.6 million. GAAP net income for full year 2019 is forecasted in the range of $93.4 million to $97.4 million. Additionally, full year 2019 EBITDA is expected in the range of $144.0 million to $150.0 million.

Based on forecasted 2019 revenue of $840.0 million to $860.0 million and GAAP net income of $93.4 million to $97.4 million, diluted earnings per share (GAAP) is forecasted in the range of $2.49 to $2.60. Adjusted Net Income for 2019 is forecasted in the range of $105.7 million to $109.7 million, compared to Adjusted Net Income of $95.5 million for 2018. Furthermore, Adjusted Net Income per diluted share for 2019 is expected in the range of $2.82 to $2.93 per share.

Conference Call Details

Medpace will host a conference call at 9:00 a.m. ET, Tuesday, July 30, 2019, to discuss its second quarter 2019 results.

To participate in the conference call, dial 800-219-7113 (domestic) or 574-990-1030 (international) using the passcode 6197355.

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, July 30, 2019 until 12:00 p.m. ET on Tuesday, August 13, 2019. To hear this recording, dial 855-859-2056 (domestic) or 404-537-3406 (international) using the passcode 6197355.

On July 29, 2019 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage biopharmaceutical company focused on creating innovative cancer immunotherapies, reported that members of the management team will participate in the following upcoming investor conferences (Press release, Arcus Biosciences, JUL 29, 2019, View Source [SID1234537858]):

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BTIG Biotechnology Conference on Monday, August 12, 2019, at 12:00 pm Eastern Time in New York. Juan Jaen, Ph.D., President, will participate in a panel discussion entitled, "Solid Tumors Beyond PD-1 Monotherapy."
2019 Wedbush PacGrow Healthcare Conference on Tuesday, August 13, 2019, at 8:35 am Eastern Time in New York. Juan Jaen, Ph.D., President, and Rekha Hemrajani, Chief Operating Officer and Chief Financial Officer, will participate in a fireside chat. To access the live audio webcast of the fireside chat, please visit the "Investors" section of the Arcus website at www.arcusbio.com. A replay of the webcast will be available for 30 days following the live event.

On July 29, 2019 Verastem, Inc. (Nasdaq: VSTM) (Verastem Oncology or the Company), a biopharmaceutical company focused on developing and commercializing medicines seeking to improve the survival and quality of life of cancer patients, reported that Brian Stuglik, a member of the Board of Directors, has been named Chief Executive Officer (CEO) (Press release, Verastem, JUL 29, 2019, View Source [SID1234537857]).

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"Brian brings deep commercial and biopharmaceutical leadership experience that we believe will accelerate the growth of COPIKTRA and progress overall company goals," said Michael G. Kauffman, MD, PhD, Verastem Oncology’s Lead Director. "Throughout his career, Brian has demonstrated an ability to deliver results through a clear strategic vision, focused teams and excellent execution. We are confident that he will capitalize on the significant opportunities in front of the company on behalf of patients, customers and our shareholders."

Mr. Stuglik has more than three decades of experience in US and International pharmaceutical development, product strategy and commercialization, with a focus on Oncology. He spent the majority of his career at Eli Lilly and Company, culminating in his role as Global Vice President and Chief Marketing Officer, Oncology Global Marketing, advancing Lilly Oncology from a single approved product to a portfolio of marketed or late-stage compounds across more than 10 cancer types. In May of this year, he took on a strategic oversight and advisory role to Verastem Oncology’s commercial organization.

"I am honored to join the Verastem Oncology team as CEO and am energized to build on our commitment to patients as we realize the full potential of COPIKTRA and the pipeline," said Mr. Stuglik. "Being a member of the Board of Directors and, more recently, serving as a strategic partner to the team, I have great confidence in Verastem Oncology’s ability to rapidly progress our mission to improve the lives of cancer patients."

Mr. Stuglik will continue to serve as a member of the Board of Directors and will lead the company’s executive team. As recently announced, Dan Paterson, formerly the Chief Operating Officer has assumed the role of President and Chief Operating Officer and Rob Gagnon has expanded his role to Chief Business and Financial Officer.

As previously announced, the Company will host a conference call and webcast on Thursday, August 1, 2019 at 4:30 p.m. Eastern Time to discuss corporate updates and financial results for the second quarter ended June 30, 2019.

On July 29, 2019 Rainier Therapeutics, Inc., a privately held clinical stage drug development company, reported that updated interim results from the FIERCE-22 trial evaluating vofatamab in combination with pembrolizumab in metastatic bladder cancer will be presented at the upcoming European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Annual Congress, which will take place September 27 to October 1, 2019 in Barcelona, Spain (Press release, Rainier Therapeutics, JUL 29, 2019, View Source [SID1234537856]).

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"We look forward to presenting updated interim results on clinical activity from our FIERCE-22 trial at ESMO (Free ESMO Whitepaper)," said Scott Myers, Chairman and CEO of Rainier Therapeutics. "This includes longer term follow-up of vofatamab in combination with pembrolizumab in patients with metastatic urothelial carcinoma (bladder cancer), providing a preliminary look at overall survival."

Poster Presentation Details:

Clinical Activity of Vofatamab (V), an FGFR3 Selective Antibody in Combination with Pembrolizumab (P) in Metastatic Urothelial Carcinoma (mUC), Updated Interim Analysis of FIERCE-22

Abstract: 2673

Poster Display Session 3
Presentation Number: 917P
Date: Monday, September 30, 2019
Presentation Time: 12:00 p.m. to 1 p.m.
Location: Poster Area Hall 4

Presenter: Arlene O. Siefker-Radtke, MD, The University of Texas MD Anderson Cancer Center

About FIERCE-22

FIERCE-22 is a Phase 1b/2 trial evaluating vofatamab, a FGFR3-targeted antibody, in combination with pembrolizumab, an immune checkpoint inhibitor, to determine safety, tolerability and preliminary efficacy in the treatment of patients with locally advanced or metastatic bladder cancer who have progressed following platinum-based chemotherapy and who have not received prior immune checkpoint inhibitor therapy.

About Vofatamab

Vofatamab (formerly B-701) is an antibody specifically targeted against the fibroblast growth factor receptor 3 (FGFR3), a known driver of bladder and potentially other FGFR-driven cancers. Vofatamab is the most advanced targeted antibody specific for FGFR3 known by Rainier Therapeutics to be in clinical development. Vofatamab is currently being evaluated in two clinical trials: FIERCE-22 and FIERCE-21.

On JUly 29, 2019 Biodesix Inc. and Immodulon Therapeutics Limited, the immune-oncology company, reported that they have entered into a biomarker research collaboration (Press release, Biodesix, JUL 29, 2019, View Source [SID1234537855]). The partnership will focus on the analysis of the circulating proteome of advanced pancreatic cancer patients treated with IMM-101 using the Biodesix Diagnostic Cortex machine learning platform.

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The Biodesix proprietary machine learning platform builds on recent advances in the artificial intelligence field to uncover clinically relevant and elaborate biomarker patterns and relationships. This enables personalized approaches to therapy selection and a better understanding of complex diseases like cancer. IMM-101 is Immodulon’s investigational immunotherapeutic candidate under development for various tumour types, including advanced pancreatic cancer.

Dr Jaap Kampinga, Immodulon’s CEO, said, "In the IMAGE 1 randomised clinical trial, metastatic pancreatic cancer patients receiving IMM-101 and gemcitabine benefitted from a 59 percent increase in median overall survival compared to those receiving gemcitabine alone. There was considerable variability, as is typical in pancreatic cancer, with some patients surviving much longer than others. From this collaboration and by utilizing the Biodesix Diagnostic Cortex in identifying blood-based proteomic biomarkers, we hope to facilitate selection of those patients most likely to respond to IMM-101. This could improve the efficiency of treatment and patient care, and accelerate our clinical trial programmes."

"Our proprietary Diagnostic Cortex machine learning-based biomarker discovery platform is well suited to advancing the clinical research for IMM-101," said David Brunel, Biodesix CEO. "This research collaboration with Immodulon builds on our track record of developing companion diagnostics to optimize treatments with the potential to deliver much needed therapies to critically ill patients."