On February 20, 2020 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported financial results for the fourth quarter and full year ended December 31, 2019 (Press release, Compugen, FEB 20, 2020, View Source [SID1234554542]).

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"2019 was a transformative year for Compugen and we are incredibly proud of the progress we have made in advancing COM701 and COM902," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "We are excited about our unique position in the immuno-oncology space as to our knowledge we are the only company with two clinical programs that address PVRIG and TIGIT, parallel inhibitory pathways of the DNAM axis. This differentiator is particularly important given the increasing excitement and growing recognition of the DNAM axis in cancer immunotherapy as evidenced by the development of other TIGIT antibodies in pharma. In addition, the encouraging initial signals of anti-tumor activity with COM701 monotherapy in an extremely challenging, refractory, all-comer population, has bolstered our conviction that targeting PVRIG as a newly discovered inhibitory pathway in the larger DNAM axis, has the potential to expand the reach of cancer immunotherapy."

Dr. Cohen-Dayag continued, "We are also thrilled to expand our clinical collaboration with Bristol-Myers Squibb and to initiate a Phase 1/2 study evaluating a triple combination of COM701 in combination with Opdivo and BMS-986207, Bristol-Myers Squibb’s TIGIT inhibitor. This will allow us to immediately move COM701 to a triple combination study blocking three immune checkpoint pathways – PVRIG, TIGIT and PD-1 – and accelerate the evaluation of our hypothesis that simultaneous blockade of the DNAM axis in addition to PD-1 will enable robust activation of T cells, potentially leading to enhanced anti-tumor responses in certain patients who are not responsive to PD-1 blockers alone. We look forward to our continued evolution with important milestones in our clinical programs."

Recent and 2019 Corporate Highlights

Announced plans to expand the Bristol-Myers Squibb collaboration with a Phase 1/2 triple combination study to evaluate COM701 in combination with Opdivo and BMS-986207, Bristol-Myers Squibb’s TIGIT inhibitor. The study is expected to begin in 2H 2020.

Presented initial clinical findings from ongoing Phase 1 trial of COM701 in patients with advanced solid tumors at the annual meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2019)

COM701 was well-tolerated with no dose-limiting toxicities observed.

Initial signals of anti-tumor activity were observed in the heavily pretreated, all-comers patient population enrolled in the study.

Presented trial-in-progress data at ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium from the Phase 1 study evaluating COM701 as a monotherapy and in combination with Opdivo (nivolumab)

Enrollment in the eighth dose level patient cohort of 20mg/kg at Q4 weekly dosing schedule is ongoing in the monotherapy dose escalation study.

Enrollment in the fourth dose level patient cohort at Q4 weekly dosing schedule in the combination dose escalation study of COM701 with Opdivo has been completed. No dose-limiting toxicities have been reported.

Announced Investigational New Drug application clearance by the U.S. Food and Drug Administration for COM902. A Phase 1 trial in patients with advanced malignancies is expected to begin in early 2020.

Presented new preclinical data on COM902 at SITC (Free SITC Whitepaper) 2019, supporting its potential best-in-class binding affinity and clinical use as a cancer immunotherapy treatment in combination with COM701 and PD-1 inhibitors.

Strengthened intellectual property portfolio related to COM701 and COM902

Granted U.S. Patent No. 10,213,505, covering the composition of COM701 and backup antibodies.

Granted U.S. Patent No. 10,227,408, covering the composition of an anti-PVRIG antibody having complementarity-determining regions (CDRs) of COM701 and backup antibodies.

Granted U.S. Patent No. 10,351,625, covering the method of use of COM701 or backup antibody in combination with anti-PD-1 antibodies.

Granted EPO Patent No. EP3347379, covering the composition of matter of COM902, alone or with second antibody that binds to a human checkpoint receptor protein, including PD-1 and its use.

Granted EPO Patent No. EP3258951, covering the use of any anti-PVRIG antibody that activates T cells and/or NK cells, in the treatment of cancer.

Granted U.S. Patent No. 10,550,173, covering methods of screening for anti-PVRIG antibodies that inhibit the binding of PVRIG with PVRL2.

Financial Results

Research and development expenses for the fourth quarter and year ended December 31, 2019, were $4.3 million, and $19.8 million, respectively, compared with $7.5 million and $30.3 million for the prior periods in 2018. The decrease in both cases is attributed mostly to the restructuring process we announced at the end of the first quarter of 2019, as well as preclinical activities related to COM902, most of which were concluded in 2018. This reduction was offset by an increase in expenses associated with clinical-related activities of the COM701 Phase 1 trial, which began in the second half of 2018.

Net loss for the fourth quarter of 2019 was $6.5 million, or $0.10 per basic and diluted share, compared with a net loss of $9.4 million, or $0.16 per basic and diluted share, in the comparable period of 2018. Net loss for the year ended December 31, 2019 was $27.3 million, or $0.43 per basic and diluted share, compared with a net loss of $22.6 million, or $0.41 per basic and diluted share, for the year ended December 31, 2018.

As of December 31, 2019, cash, cash related accounts, short-term and long-term bank deposits totaled approximately $43.9 million, compared with approximately $45.7 million as of December 31, 2018. The Company has no debt.

Conference Call and Webcast Information
The Company will hold a conference call today, February 20, 2020, at 8:30 AM ET to review its fourth quarter and full year 2019 results. To access the conference call by telephone, please dial 1-888-407-2553 from the United States, or +972-3-918-0610 internationally. The call will also be available via live webcast through Compugen’s website, located at the following link. Following the live audio webcast, a replay will be available on the Company’s website.

On February 20, 2020 PRA Health Sciences, Inc. ("PRA" or the "Company") (NASDAQ: PRAH) reported financial results for the quarter and year ended December 31, 2019 (Press release, PRA Health Sciences, FEB 20, 2020, View Source [SID1234554560]).

"We are pleased with our financial results for the quarter and are delighted to have delivered double digit constant currency revenue growth and double digit adjusted earnings growth," said Colin Shannon, PRA’s Chief Executive Officer. "During the year, we strengthened our leadership in Strategic Solutions, Product Registration, and Symphony Health and we believe we are very well positioned for the coming year. In 2020, we will continue to focus on our key strategic initiatives and to providing broad and flexible services to our clients."

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Net new business for our Clinical Research segment for the three months ended December 31, 2019 was $658.9 million, representing a net book-to-bill ratio of 1.21 for the period. This net new business contributed to an ending backlog of $4.7 billion at December 31, 2019.

For the three months ended December 31, 2019, revenue was $800.2 million, which represents growth of 9.7%, or $70.6 million, compared to the fourth quarter of 2018 at actual foreign exchange rates. On a constant currency basis, revenue grew $74.5 million, an increase of 10.2% compared to the fourth quarter of 2018. By segment, the Clinical Research segment generated revenues of $725.1 million, while the Data Solutions segment generated revenues of $75.1 million.

Direct costs, exclusive of depreciation and amortization, were $386.1 million during the three months ended December 31, 2019 compared to $365.7 million for the three months ended December 31, 2018 at actual foreign exchange rates. On a constant currency basis, direct costs increased by $24.7 million compared to the fourth quarter of 2018. The increase in direct costs continues to be driven by increased labor costs in our Clinical Research segment and increased data costs in our Data Solutions segment. Direct costs were 48.2% of revenue during the fourth quarter of 2019 compared to 50.1% of revenue during the fourth quarter of 2018.

Selling, general and administrative expenses were $103.5 million during the three months ended December 31, 2019 compared to $96.4 million for the three months ended December 31, 2018. Selling,

general and administrative costs were 12.9% of revenue during the fourth quarter of 2019 compared to 13.2% of revenue during the fourth quarter of 2018.

GAAP net income attributable to PRA was $74.8 million for the three months ended December 31, 2019, or $1.16 per share on a diluted basis, compared to $71.5 million for the three months ended December 31, 2018, or $1.07 per share on a diluted basis.

EBITDA was $124.9 million for both the three months ended December 31, 2019 and December 31, 2018. Adjusted EBITDA was $148.5 million for the three months ended December 31, 2019, representing growth of 9.0% compared to the three months ended December 31, 2018.

Adjusted net income was $98.7 million for the three months ended December 31, 2019, representing 13.6% growth compared to the three months ended December 31, 2018. Adjusted net income for the three months ended December 31, 2019 includes the effects of a reduction in our effective tax rate from 24% to 23%. The decrease in our effective tax rate is primarily attributable to the geographic distribution of our pre-tax earnings. Adjusted net income per diluted share was $1.54 for the three months ended December 31, 2019, representing 17.6% growth compared to the three months ended December 31, 2018.

Full Year 2019 Financial Highlights

For the twelve months ended December 31, 2019, revenue was $3,066.3 million, which represents growth of 6.8%, or $194.3 million, compared to the twelve months ended December 31, 2018 at actual foreign exchange rates. On a constant currency basis, revenue grew $225.2 million, representing growth of 7.8% compared to the twelve months ended December 31, 2018. By segment, the Clinical Research segment generated revenues of $2,813.0 million, while the Data Solutions segment generated revenues of $253.3 million.

GAAP income from operations was $363.9 million. GAAP net income attributable to PRA was $243.0 million, or $3.68 per share on a diluted basis, for the twelve months ended December 31, 2019.

Adjusted net income was $341.0 million for the twelve months ended December 31, 2019, an improvement of 20.0% compared to the twelve months ended December 31, 2018. Adjusted net income per diluted share was $5.17 for the twelve months ended December 31, 2019, up 20.8% compared to the twelve months ended December 31, 2018.

Full Year 2020 and Q1 2020 Guidance

For full year 2020, the Company expects to achieve total revenues between $3.23 billion and $3.36 billion, representing as reported and constant currency growth of 5.0% to 9.5%.

We expect GAAP net income per diluted share of between $4.01 and $4.21 per share and adjusted net income per diluted share of between $5.77 and $5.97 per share, representing growth of 12% to 15%. We anticipate an annual effective income tax rate estimate of 23%.

Our effective tax rate may differ from this estimate, due to, among other things, changes to estimates of the geographic allocation of our pre-tax income as well as changes in interpretations, analysis, and additional guidance that may be issued by regulatory agencies.

For Q1 2020, the Company expects to achieve total revenues between $765.0 million and $787.0 million, representing as reported and constant currency growth of 6% to 9%. The Company expects GAAP net

income per diluted share of between $0.59 and $0.69 per share, adjusted net income per diluted share between $1.05 and $1.15 per share, and an annual effective income tax rate of 23%.

Our 2020 guidance assumes a EURO rate of 1.15 and a GBP rate of 1.30 with all other foreign currencies using a rate as of January 31, 2020.

A reconciliation of our non-GAAP measures, EBITDA, adjusted EBITDA, adjusted net income, adjusted net income per share and our 2020 guidance, to the corresponding GAAP measures is included in this press release.

Conference Call Details

PRA will host a conference call at 9:00 a.m. ET on February 21, 2020, to discuss the contents of this release and other relevant topics. To participate, please dial (877) 930-8062 within the United States or (253) 336-7647 outside the United States approximately 10 minutes before the scheduled start of the call. The conference ID for the call is 5667733. The conference call will also be accessible, live via audio broadcast, on the Investor Relations section of the PRA website at investor.prahs.com. A replay of the conference call will be available online at investor.prahs.com. In addition, an audio replay of the call will be available for one week following the call and can be accessed by dialing (855) 859-2056 within the United States or (404) 537-3406 outside the United States. The replay ID is 5667733.

Additional Information

A financial supplement with fourth quarter 2019 results, which should be read in conjunction with this press release, may be found in the Investor Relations section of our website at investor.prahs.com in a document titled "Q4 2019 Earnings Presentation."

On February 20, 2020 Danaher Corporation (NYSE: DHR) reported that its Board of Directors has approved a regular quarterly cash dividend of $0.18 per share of its common stock, payable on April 24, 2020 to holders of record on March 27, 2020 (Press release, Danaher, FEB 20, 2020, View Source [SID1234554578]). In addition, Danaher announced today that its Board of Directors has approved a quarterly cash dividend of $11.875 per share of its 4.75% Series A Mandatory Convertible Preferred Stock, payable on April 15, 2020 to holders of record on March 31, 2020.

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On February 20, 2020 Montis Biosciences reported its launch with €8,4 million in seed financing from an international investor syndicate to investigate interactions between perivascular macrophages and tumor vasculature (Press release, Montis Biosciences, FEB 20, 2020, View Source [SID1234568646]). The company’s mission is to exploit these cellular interactions with therapeutics to drive and sustain immune reactions against solid tumors.

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Montis was founded by Droia Ventures, VIB and KU Leuven based on the foundational science discovered by the labs of Peter Carmeliet (VIB-KU Leuven) and Massimiliano Mazzone (VIB-KU Leuven). For the seed financing, the founders were joined by new investors Polaris Partners, ALSA Ventures and Pfizer Ventures, the venture capital arm of Pfizer Inc. (NYSE: PFE).

Blood vessels regulate the influx of immune cells into tumors. They do so under direction of perivascular macrophages, which can stimulate blood vessels to attract immune cells and let them pass into the tumor, or can induce blood vessel dysfunction and create an immune-compromised environment or suppressive environment in the tumor. Montis’ proprietary insights into how these two classes of cells interact now allows for modulation of these interactions to ensure a strong influx of fresh immune cells into the tumor. The seed financing will allow Montis to prioritize among a set of targets and to validate its lead programs for further development towards clinical studies. Montis will also expand its unique screening and assay platform to identify and validate additional promising targets.

"It is becoming increasingly clear that endothelial cells in the tumor vasculature play a major role in immune reactions to cancer and that their interaction with immune cells shapes this response. Historical therapies targeting the tumor vasculature largely ignored this role and instead destroyed the vessels to starve the tumor," says professor Peter Carmeliet. "Our research is showing that rather than destroying blood vessels, we can use them to herd the correct immune cells to the tumor and get much more potent and sustainable effects."

"Our approach with single-cell RNA-sequence data finally allows us to investigate the communication between immune cells and the tumor vasculature," adds professor Massimiliano Mazzone. "Montis is the step forward to translate this concept into therapeutic applications."

Montis’ Board of Directors will be composed of Executive Chairman and Droia Partner, Luc Dochez, and VIB Head New Ventures, Griet Vanpoucke, who will be joined by Ellie McGuire (Polaris Partners), Sohaib Mir (ALSA Ventures) and Rana Al-Hallaq (Pfizer Ventures).

"We’re very pleased to have been able to bring together the world-class science from the VIB-KU Leuven labs of Peter Carmeliet and Massimiliano Mazzone with an investor syndicate that is excellently positioned to ensure the long-term success of the company," says Luc Dochez, Partner at Droia Ventures and Executive Chairman at Montis. "Montis has a unique approach to target solid tumors that should be able to really shift the paradigm on multiple indications."

"We are excited to work with Droia Ventures in this oncology focused company co-creation effort," comments Johan Cardoen, managing director of VIB. "Montis is a prime example of how scientific excellence complemented with an entrepreneurial mindset and hands-on early stage investors can result in a promising new venture."

On February 20, 2020 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform, reported fourth quarter 2019 financial results on Thursday, February 27, 2020, after the close of U.S. markets (Press release, CytomX Therapeutics, FEB 20, 2020, View Source [SID1234554543]). Following the announcement, the company will host a conference call beginning at 5:00 p.m. ET to discuss its results.

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Participants may access the live audio webcast of the teleconference from the "Investors & News" section of CytomX’s website at View Source Please access the website 15 minutes prior to the start of the call to download and install any necessary audio software.

Audio Conference Call:

U.S. Dial-in Number: (877) 809-6037

International Dial-in Number: (615) 247-0221

Conference ID: 1686972
An archived webcast replay will be available on the Company’s website from February 27, 2020, until March 5, 2020.