On October 30, 2019 NewLink Genetics Corporation (NASDAQ:NLNK) reported it will host its third quarter 2019 conference call and webcast at 8:30 AM ET on Wednesday, November 6, 2019, to discuss its third quarter financial results and provide an update on corporate activities (Press release, NewLink Genetics, OCT 30, 2019, View Source [SID1234550043]). There will also be a question and answer session following the prepared remarks.

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Investors and the general public are invited to listen to a live audio webcast of the conference call, which can be accessed five minutes prior to the start of the call by dialing (855) 469-0612 (U.S.) or (484) 756-4268 (international). The conference call will be webcast live and a link can be accessed through the NewLink Genetics website at View Source A replay of the call will be available for two weeks from the date of the call and can be accessed by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and using the passcode: 3794399.

On October 30, 2019 Refuge Biotechnologies, Inc. ("Refuge"), a synthetic biology company developing intelligent cell therapeutics for cancer immunotherapy, reported that Francesco M. Marincola, M.D., chief scientific officer of Refuge, will present during the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting & Pre-Conference Programs (SITC 2019) (Press release, Refuge Biotechnologies, OCT 30, 2019, View Source [SID1234550059]).

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Dr. Marincola will deliver a scientific overview detailing Refuge’s platform technology during the Novel Multi-Targeted Therapeutic Platform program, held November 6 at the Gaylord National Hotel & Convention Center in Maryland. The overview will include recent data from Refuge’s proprietary receptor-dCas platform and its multi-functional therapeutic applications.

"The work being done at Refuge Biotechnologies builds upon the promise of CRISPR interference and CRISPR activation, and has demonstrated the ability to develop a novel therapy that induces gene modulation of multiple genes simultaneously without making permanent edits to the genome," said Dr. Marincola. "This capability has the potential to be combined with numerous therapeutic mechanisms in a single customizable treatment. We look forward to sharing progress as we advance towards the clinic."

Details of the presentation are as follows:

Title: Contextual reprogramming of T cells for multi-targeted therapeutics: checkpoint blockade, immune resilience, and stemness to overcome immune resistance and reduce toxicity, all in one cell product
Presenter: Francesco M. Marincola, M.D.
Date and Time: Wednesday, November 6, 2019 at 4:15 p.m. ET
Session 2: Novel Platforms and Innovation

On October 30, 2019 PDL BioPharma, Inc. ("PDL" or "the Company") (NASDAQ: PDLI) reported that it will release its third quarter 2019 financial results for the period ended September 30, 2019, on Wednesday, November 6, 2019, after market close (Press release, PDL BioPharma, OCT 30, 2019, View Source [SID1234550075]). PDL’s management will host a conference call and webcast that day at 4:30 p.m. Eastern time to discuss the operating and financial results and recent developments. A slide presentation relating to the call will be available via the webcast link on the PDL website at View Source

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Conference Call Details
To access the live conference call via phone, please dial (844) 535-4071 from the United States and Canada or (706) 679-2458 internationally. The conference ID is 3195828. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available for one week following the call and may be accessed by dialing (855) 859-2056 from the United States and Canada or (404) 537-3406 internationally. The replay passcode is 3195828.

To access the live and subsequently archived webcast of the conference call, go to the Company’s website and go to "Events & Presentations." Please connect to the website at least 15 minutes prior to the call to allow for any software download that may be necessary.

On October 30, 2019 AIVITA Biomedical, Inc., a biotechnology company specializing in innovative stem cell applications, reported the publication of an article titled "Genomic, Proteomic, and Immunologic Associations with a Durable Complete Remission of Measurable Metastatic Melanoma Induced by a Patient-Specific Dendritic Cell Vaccine" in the journal Human Vaccines and Immunotherapeutics (Press release, AIVITA Biomedical, OCT 30, 2019, View Source [SID1234550028]). Robert O. Dillman, M.D., Chief Medical Officer at AIVITA, Gabriel Nistor, M.D., Chief Science Officer, and Aleksandra J. Poole, Ph.D., Vice President, Research & Development, authored the article.

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The article focuses on a melanoma patient treated in a prior Phase 2 study with AIVITA’s immunotherapy, autologous dendritic cells loaded with autologous tumor antigens derived from tumor-initiating cells. The analyses concern the immune mechanism of action that led to a complete response in the patient with progressive, refractory, metastatic melanoma. The analyses included elucidation of the genes in the patient’s tumor cells and normal cells, more than 100 blood markers before and after vaccination, and the patient’s immune cells.

The article is available at Taylor & Francis Online here: View Source

CLINICAL TRIAL DETAIL

OVARIAN CANCER

AIVITA’s ovarian Phase 2 double-blind study is active and enrolling approximately 99 patients who are being randomized in a 2:1 ratio to receive either the autologous cancer stem cell-targeting immunotherapy or autologous monocytes as a comparator.

Patients eligible for randomization and treatment will be those (1) who have undergone debulking surgery, (2) for whom a cell line has been established, (3) who have undergone leukapheresis from which sufficient monocytes were obtained, (4) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), and (5) who have completed primary therapy. The trial is not open to patients with recurrent ovarian cancer.

For additional information about AIVITA’s AVOVA-1 trial patients can visit: www.clinicaltrials.gov/ct2/show/NCT02033616

GLIOBLASTOMA

AIVITA’s glioblastoma Phase 2 single-arm study is active and is enrolling approximately 55 patients to receive the cancer stem cell-targeting immunotherapy.

Patients eligible for treatment will be those (1) who have recovered from surgery such that they are about to begin concurrent chemotherapy and radiation therapy (CT/RT), (2) for whom an autologous tumor cell line has been established, (3) have a Karnofsky Performance Status of > 70 and (4) have undergone successful leukapheresis from which peripheral blood mononuclear cells (PBMC) were obtained that can be used to generate dendritic cells (DC). The trial is not open to patients with recurrent glioblastoma.

For additional information about AIVITA’s AV-GBM-1 trial please visit: www.clinicaltrials.gov/ct2/show/NCT03400917

MELANOMA

AIVITA’s melanoma Phase 1B open-label, single-arm study will establish the safety of administering anti-PD1 monoclonal antibodies in combination with AIVITA’s cancer stem cell-targeting immunotherapy in patients with measurable metastatic melanoma. The study will also track efficacy of the treatment for the estimated 14 to 20 patients. This trial is not yet open for enrollment.

Patients eligible for treatment will be those (1) for whom a cell line has been established, (2) who have undergone leukapheresis from which sufficient monocytes were obtained, (3) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), (4) who have either never received treatment for metastatic melanoma or were previously treated with enzymatic inhibitors of the BRAF/MEK pathway because of BRAF600E/K mutations and (5) are about to initiate anti-PD1 monotherapy.

On October 30, 2019 PRA Health Sciences, Inc. ("PRA," "we," "us" or the "Company") (NASDAQ: PRAH) reported financial results for the quarter ended September 30, 2019 (Press release, PRA Health Sciences, OCT 30, 2019, View Source [SID1234550044]).

"Our third quarter financial results produced solid revenue growth and double digit earnings growth," said Colin Shannon, PRA’s Chief Executive Officer. "During the quarter we finalized a $500.0 million stock repurchase plan and repurchased and retired $300.0 million of common stock in connection with KKR’s clean-up trade. We are excited for our next chapter and I would like to thank KKR for their partnership. Our focus will remain on delivering shareholder returns and also delivering broad and flexible services to our clients. We look forward to continuing to position PRA for success in the future."

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Net new business for our Clinical Research segment for the three months ended September 30, 2019 was $669.4 million, representing a net book-to-bill ratio of 1.22 for the period. This net new business contributed to an ending backlog of $4.6 billion at September 30, 2019.

For the three months ended September 30, 2019, revenue was $780.7 million, which represents growth of 8.8%, or $63.1 million, compared to the three months ended September 30, 2018 at actual foreign exchange rates. On a constant currency basis, revenue grew $69.3 million, an increase of 9.7% compared to the third quarter of 2018. By segment, the Clinical Research segment generated revenues of $719.0 million, while the Data Solutions segment generated revenues of $61.7 million.

Direct costs, exclusive of depreciation and amortization, were $389.3 million during the three months ended September 30, 2019 compared to $371.4 million for the three months ended September 30, 2018 at actual foreign exchange rates. On a constant currency basis, direct costs increased $24.6 million compared to the third 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 49.9% of revenue during the third quarter of 2019 compared to 51.8% of revenue during the third quarter of 2018.

Selling, general and administrative expenses were $95.5 million during the three months ended September 30, 2019 compared to $92.6 million for the three months ended September 30, 2018. Selling,

general and administrative costs were 12.2% of revenue during the third quarter of 2019 compared to 12.9% of revenue during the third quarter of 2018.

GAAP net income was $83.0 million for the three months ended September 30, 2019, or $1.25 per share on a diluted basis, compared to GAAP net income of $1.5 million for the three months ended September 30, 2018, or $0.02 per share on a diluted basis.

Adjusted net income was $87.2 million for the three months ended September 30, 2019, representing growth of 16.6% compared to the three months ended September 30, 2018. Adjusted net income per diluted share was $1.32 for the three months ended September 30, 2019, representing growth of 16.8% compared to the three months ended September 30, 2018.

EBITDA was $128.6 million for the three months ended September 30, 2019, representing an increase of 99.6% compared to the three months ended September 30, 2018. Adjusted EBITDA was $137.8 million for the three months ended September 30, 2019, representing growth of 14.0% compared to the three months ended September 30, 2018.

A reconciliation of our non-GAAP measures, including EBITDA, adjusted EBITDA, adjusted net income, adjusted net income per diluted share and our 2019 guidance, to the corresponding GAAP measures is included in this press release.

Nine Months Ended September 30, 2019 Financial Highlights

For the nine months ended September 30, 2019, revenue was $2,266.0 million, which represents growth of 5.8%, or $123.7 million, compared to the nine months ended September 30, 2018 at actual foreign exchange rates. On a constant currency basis, revenue grew $150.7 million, representing growth of 7.0% compared to the nine months ended September 30, 2018.

Reported GAAP income from operations was $262.5 million, reported GAAP net income was $168.2 million and reported GAAP net income per diluted share was $2.53 for the nine months ended September 30, 2019.

Adjusted Net Income was $242.3 million for the nine months ended September 30, 2019, an improvement of 22.9% compared to the same period in 2018. Adjusted Net Income per diluted share was $3.64 for the nine months ended September 30, 2019, up 22.1% compared to the same period in 2018.

Guidance

The Company is maintaining its 2019 revenue guidance between $3.02 billion and $3.10 billion, representing as reported growth of 5% to 8% and constant currency growth of 6% to 8%. We are updating our GAAP net income per diluted share to between $3.58 and $3.64 and Adjusted Net Income per diluted share to between $5.07 and $5.12, representing growth of 18% to 20%.

We continue to estimate our annual effective income tax rate at approximately 24%. 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 guidance from regulatory agencies related to interpretation, analysis and guidance of the U.S. Tax Cuts and Jobs Act.

Our guidance assumes a EURO rate of 1.15 and a GBP rate of 1.30. All other foreign currency exchange rates are as of September 30, 2019.

Conference Call Details

PRA will host a conference call at 9:00 a.m. ET on October 31, 2019, 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 6427745. 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 6427745.

Additional Information

A financial supplement with third 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 "Q3 2019 Earnings Presentation."