On January 13, 2019 Editas Medicine, Inc. (Nasdaq: EDIT), a leading genome editing company, and Sandhill Therapeutics, Inc., a cellular immuno-oncology company, reported a strategic research collaboration, license, and option agreement to combine their respective genome editing and cell therapy technologies to discover, develop, and manufacture allogeneic engineered natural killer (NK) cells and non-alpha beta T cell medicines for the treatment of cancer (Press release, Editas Medicine, FEB 13, 2020, View Source [SID1234553822]).

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This collaboration brings together Editas Medicine’s leading genome editing technology and Sandhill’s BINATE product process, a novel universal donor technology to extract, isolate, and expand NK cells and non-alpha beta T cells, to develop novel medicines for the treatment of solid tumor cancers.

"We are excited to work with Sandhill, combining CRISPR-based genome editing with BINATE cells to accelerate the development of numerous, transformative medicines for people with cancer and improve patient outcomes," said Charles Albright, Ph.D., Executive Vice President and Chief Scientific Officer, Editas Medicine. "We continue to increase our commitment to oncology, and we believe our portfolio of multiple immune system cell types, including T cells, NK cells, and induced pluripotent stem cells (iPSCs), will be effective in making the next generation of allogeneic medicines to fight many common cancers."

"The team at Editas Medicine has one of the most innovative technology platforms, and we look forward to combining our technologies to create new medicines for the treatment of cancer. Together, we are dedicated to transforming cellular immuno-oncology and developing new therapies," said Annemarie Moseley, M.D., Ph.D., Chief Executive Officer, Sandhill Therapeutics, Inc.

Under the terms of the agreement, Editas Medicine obtains an exclusive license to Sandhill’s technology to research, develop and commercialize immuno-oncology engineered cell medicines for solid tumors originating within a given area of the body and an option to expand such license to two additional areas. In return, Sandhill will receive an upfront payment, development and sales-based milestone payments, and royalties on sales of resulting Editas products.

RBC Capital Markets acted as exclusive financial advisor to Sandhill for the transaction.

On February 13, 2020 Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, reported its operating and financial results for the fourth quarter and fiscal year ended December 31, 2019 (Press release, Genocea Biosciences, FEB 13, 2020, View Source [SID1234554264]).

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Genocea presented new inhibigen (inhibitory antigen) data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2019 in National Harbor, Maryland. In one presentation, preclinical data demonstrated that the presence of an inhibigen reversed anti-tumor responses of an otherwise protective neoantigen vaccine, confirming the importance of excluding inhibigens from neoantigen cancer immunotherapies. A separate presentation showed data suggesting that the ratio of a patient’s inhibigens to stimulatory (anti-tumor) neoantigens may predict response to immune checkpoint inhibitor (ICI) therapy. Only Genocea’s proprietary neoantigen discovery platform, ATLAS, can systematically find inhibigens. As previously disclosed, GEN-009 immunogenicity data confirm that ATLAS identifies neoantigens optimized both to patients’ T cell responses and their tumors. These new data offer an additional dimension to the advantages of ATLAS for neoantigen selection.

The company also completed patient dosing in Part A of its GEN-009 neoantigen vaccine phase 1/2a trial with no disease recurrence in vaccinated study participants to date. GEN-009 was highly immunogenic and well-tolerated by the entire cohort. Genocea has begun dosing patients for Part B, testing GEN-009 in combination with standard-of-care ICI therapy, with preliminary clinical results expected in Q2/Q3 2020.

Genocea also made important progress developing a robust manufacturing process for GEN-011, an adoptive T cell therapy using T cells derived from peripheral blood against ATLAS-identified neoantigens. The company intends to file an Investigational New Drug Application (IND) for GEN-011 in Q2 2020 with preliminary clinical results expected in 1H 2021.

"Genocea made critical scientific and clinical progress in the last quarter," said Chip Clark, President and Chief Executive Officer, Genocea. "The discovery and understanding of inhibigens has the potential to transform the process of antigen discovery for cancer immunotherapies, and even the therapeutic landscape for cancer. The GEN-009 immunogenicity results are unprecedented in neoantigen vaccines. Meanwhile, GEN-011 is progressing rapidly toward the clinic. We look forward to continuing – and capitalizing on – this strong progress in 2020."

Genocea also appointed Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer of Exelixis to its board of directors effective February 14, 2020. "I am delighted to welcome Gisela to our board. Her broad oncology drug development expertise and her proven company-building track record will provide us valued counsel and insights in the coming years," said Clark.

Fourth Quarter 2019 Financial Results

Cash position: As of December 31, 2019, cash and cash equivalents were $40.1 million versus $26.4 million as of December 31, 2018.

Research and Development (R&D) expenses: R&D expenses were $6.8 million for the quarter ended December 31, 2019, compared to $6.3 million for the same period in 2018.

General and Administrative (G&A) expenses: G&A expenses were $3.0 million for the quarter ended December 31, 2019, compared to $2.6 million for the same period in 2018.

Net income/loss: Net loss was $9.4 million for the quarter ended December 31, 2019, compared to a net income of $0.4 million for the same period in 2018.

Guidance
Genocea expects that its existing cash and cash equivalents are sufficient to support its operations into the first quarter of 2021.

Conference Call
Genocea will host a conference call and webcast today at 8:30 a.m. EST. Interested participants may access the conference call by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and referring to conference ID number 7319557. To join the live webcast, please visit the presentation page of the investor relations section of the Genocea website at View Source A webcast replay of the conference call will be available on the Genocea website beginning approximately two hours after the event and will be archived for 90 days.

On February 13, 2020 DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported its financial results for the three and six months ended December 31, 2019 and provided a corporate update (Press release, DelMar Pharmaceuticals, FEB 13, 2020, https://ir.delmarpharma.com/news/detail/925/delmar-pharmaceuticals-announces-fiscal-second-quarter-2020-financial-results-and-recent-corporate-updates [SID1234554288]).

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"We are pleased with the pace of progress of both trials, which in some cases have enrolled patients faster than our previous forecasts. We are seeing rapid progress with encouraging survival benefits in both our Phase 2 trials per recent announcements and publications, and look forward to sharing our upcoming update of clinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held in San Diego April 24 to 29," commented Saiid Zarrabian, DelMar’s President and Chief Executive Officer. "Following a productive quarter, we continue to believe that our cash position will provide the runway to enable us to achieve topline results for two of our three patient groups in our two Phase 2 trials."

RECENT CORPORATE UPDATES

January 2020 – Announced the publication of previously released interim clinical data in the February 2020 issue of peer-reviewed journal, Glioma. The article highlights results from the first 22 patients of our ongoing Phase 2 clinical study investigating the first-line treatment of VAL-083 with radiation therapy in newly-diagnosed, MGMT-unmethylated glioblastoma multiforme ("GBM") being conducted at Sun Yat-sen University Cancer Center ("SYSUCC") in China.
November 2019 – Provided positive interim clinical data and held Key Opinion Leader GBM summit at the Society for Neuro-Oncology annual meeting. The updated clinical data in two poster sessions included the following:
The first poster outlined the open-label, Phase 2 study of VAL-083 as a first-line treatment in newly-diagnosed, unmethylated GBM being conducted at SYSUCC.
The second poster outlined interim data from two groups of patients receiving VAL-083 in the open-label, Phase 2 study in recurrent and adjuvant unmethylated GBM settings being conducted at M.D. Anderson Cancer Center.
SUMMARY OF FINANCIAL RESULTS FOR THE QUARTER ENDED DECEMBER 31, 2019

For the three months ended December 31, 2019, the Company reported a net loss of approximately $1.7 million, or $0.15 per share, compared to a net loss of approximately $1.8 million, or $0.75 per share, for the same period of 2018.

For the six months ended December 31, 2019, the Company reported a net loss of approximately $3.3 million, or $0.35 per share, compared to a net loss of approximately $3.8 million, or $1.63 per share, for the same period of 2018.

Basic and fully diluted loss per share

At December 31, 2019, the Company had cash and cash equivalents of approximately $6.3 million. In August 2019, the Company completed an underwritten public offering for net proceeds of approximately $6.6 million. The cash and cash equivalents at December 31, 2019 are expected to be sufficient to fund the Company’s planned operations into the fourth quarter of calendar year 2020.

DelMar’s financial statements as filed with the U.S. Securities Exchange Commission can be viewed on the Company’s website at: View Source

ABOUT DELMAR PHARMACEUTICALS, INC.

Located in San Diego, California, DelMar is focused on the development and commercialization of new therapies for cancer patients who have limited or no treatment options. By focusing on understanding tumor biology and mechanisms of treatment resistance, the Company identifies biomarkers to personalize new therapies in indications where patients are failing, or are unable to tolerate, standard-of-care treatments.

The Company’s current pipeline is based around VAL-083, a "first-in-class", small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g. NSCLC, bladder cancer, head & neck) in U.S. clinical trials sponsored by the National Cancer Institute (NCI). Based on DelMar’s internal research programs and these prior NCI-sponsored clinical studies, the Company is conducting clinical trials to support the development and commercialization of VAL-083 to solve significant unmet medical needs.

VAL-083 is being studied in two collaborator-supported, biomarker-driven Phase 2 clinical trials for MGMT-unmethylated GBM. Overcoming MGMT-mediated resistance represents a significant unmet medical need in the treatment of GBM. In addition, DelMar has announced the allowance of a separate IND for VAL-083 as a potential treatment for platinum-resistant ovarian cancer.

Further information on DelMar’s clinical trials can be found on clinicaltrials.gov: View Source;term=val-083&cntry1=&state1=&recrs

For additional information, please visit View Source; or contact DelMar Pharmaceuticals Investor Relations: [email protected] / (604) 629-5989.

On February 13, 2020 Pacira BioSciences, Inc. (NASDAQ:PCRX) reported that it will report its fourth quarter and year ended December 31, 2019 financial results before the open of the U.S. markets on Thursday, February 20, 2020 (Press release, Pacira Pharmaceuticals, FEB 13, 2020, View Source [SID1234554304]). Following the release, the company will host a live conference call and webcast at 8:30 a.m. ET.

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To participate in the conference call, dial 1-877-845-0779 and provide the passcode 8765839. International callers may dial 1-720-545-0035 and use the same passcode. In addition, a live audio of the conference call will be available as a webcast. Interested parties can access the event through the "Events" page on the Pacira website at investor.pacira.com.

For those unable to participate in the live call, a replay will be available at 1-855-859-2056 (domestic) or 1-404-537-3406 (international) using the passcode 8765839. The replay of the call will be available for one week from the date of the live call. The webcast will be available on the Pacira website for approximately two weeks following the call.

On February 13, 2020 AMN Healthcare Services, Inc. (NYSE: AMN), the leader and innovator in healthcare total talent solutions, reported its fourth quarter and full year 2019 financial results (Press release, AMN Healthcare Services, FEB 13, 2020, View Source [SID1234554320]). Financial highlights are as follows:

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Dollars in millions, except per share amounts.

* See "Non-GAAP Measures" below for a discussion of our use of non-GAAP items and the table entitled "Non-GAAP Reconciliation Tables" for a reconciliation of non-GAAP items.

2019 & Recent Highlights

Fourth quarter results exceeded expectations, with the Nurse and Allied Solutions segment delivering higher revenue from the support of labor disruption events and rapid response staffing
Nurse and Allied segment recorded 6% year-over-year organic growth in the fourth quarter
Full year operating cash flow was $225 million, reflecting strong performance and a nine-day reduction in days’ sales outstanding
Acquired b4health, an innovative float pool management technology solution and vendor management system, in December
The previously announced acquisition of Stratus Video, the leading provider of healthcare video remote language interpretation services, is expected to close on February 14, 2020
The Stratus acquisition is expected to be immediately margin-accretive and strengthens AMN’s position as healthcare’s leading total talent solutions partner
"Throughout the last year and decade, AMN Healthcare achieved many important milestones and dramatically enhanced our ability to positively impact patient care and our communities," said Susan R. Salka, Chief Executive Officer of AMN. "During 2019, our business reached new highs in revenue and earnings, while also making critical investments in our people, processes and solutions for our healthcare professionals and clients. AMN furthered our ability to serve our clients’ total talent needs with the acquisition of Advanced Medical, Silversheet and b4health, along with the imminent acquisition of Stratus Video.

"As we enter 2020, demand for our services remains strong, and we are excited about the partnerships we are building with clients to address their workforce challenges and ensure they deliver high-quality patient care. Equally critical to our purpose at AMN, we will continue to take an active leadership role in governance and social issues such as diversity, equality and inclusion," Ms. Salka added.

Fourth Quarter 2019 Results

Consolidated revenue for the quarter was $587 million, an 11% increase over prior year and 3% higher than prior quarter. Revenue for the Nurse and Allied Solutions segment was $389 million, up 18% year over year (6% organic) and 7% sequentially. Travel Nurse revenue increased 9% year over year (2% organic). Allied division revenue increased 45% year over year with 7% organic growth.

The Locum Tenens Solutions segment reported revenue of $78 million, down by 5% year over year due to slightly lower volume and a mix shift to specialties with lower bill rates. Volume metrics were on par with prior year in December, which we believe reflects stability and future growth opportunity as we enter the new year. Other Workforce Solutions segment revenue was $120 million reflecting an increase of 2% year over year, driven primarily by growth in our physician permanent placement, interim leadership and VMS businesses, offset partly by a decline in our revenue cycle solutions division.

Gross margin was 33.6%, higher by 100 basis points year over year and higher by 10 basis points sequentially. The year-over-year variance stemmed from an increase in higher-margin labor disruption activities in our Nurse and Allied segment and a favorable mix shift in our Other Workforce Solutions segment.

SG&A expenses were $133 million or 22.7% of revenue, compared with $111 million, or 21.0% of revenue, in the same quarter last year. SG&A was $133 million, or 23.5% of revenue, in the previous quarter. Higher SG&A expenses from our acquired businesses coupled with higher acquisition and integration-related costs caused the year-over-year increase in expense margin.

Income from operations was $47 million, or 8.0% of revenue, compared with $50 million, or 9.5% of revenue, in the same quarter last year. Adjusted EBITDA was $75 million, with a year-over-year increase of 14%. Adjusted EBITDA margin was 12.9%, higher by 30 basis points year over year and an increase of 70 basis points sequentially. The higher-than-expected adjusted EBITDA margin was driven primarily by the higher labor disruption revenue.

Net income was $27 million, or $0.58 per diluted share, compared with $36 million, or $0.74 per diluted share, in the same quarter last year. Adjusted diluted EPS was $0.85.

Full Year 2019 Results

Full year 2019 consolidated revenue was $2,222 million, a 4% increase from prior year. Nurse and Allied Solutions segment revenue was $1,420 million, a year-over-year increase of 9%. The Locum Tenens Solutions segment recorded revenue of $325 million, down by 17% compared with the prior year. Other Workforce Solutions segment revenue was $477 million, 9% higher year over year.

Full year gross margin was 33.5% compared with 32.6% for the prior year. The gross margin for the year was positively impacted by higher-than-average gross margins in our Nurse and Allied Solutions segment and a favorable segment mix shift. These positive factors were partially offset by a lower margin in our Locum Tenens Solutions segment.

Full year SG&A expenses were $508 million, representing 22.9% of revenue as compared to $452 million, representing 21.2% of revenue, for the prior year. The year-over-year increase in SG&A expenses was primarily due to additional expenses from the acquired businesses, a $22 million increase related to acquisition, integration, changes in the fair value of earn-out liabilities from acquisitions and extraordinary legal expenses, and a $5 million increase in share-based compensation expense. The increase was partially offset by a $12 million increase in legal reserves in 2018.

Full year income from operations was $177 million, or 8.0% of revenue, compared with $203 million, or 9.5% of revenue, in the prior year. Adjusted EBITDA was $277 million, a year-over-year increase of 3%. Adjusted EBITDA margin was 12.5%, representing a decrease of 20 basis points year over year.

Full year net income was $114 million, or $2.40 per diluted share, compared with $142 million, or $2.91 per diluted share, in the prior year. Adjusted diluted EPS was $3.18.

At December 31, 2019 cash and cash equivalents totaled $83 million. Cash flow from operations was $79 million for the quarter and $225 million for the full year. Capital expenditures were $10 million in the quarter and $35 million for the year. The Company ended the year with total debt outstanding of $625 million with a leverage ratio of 2.0 to 1 as calculated in accordance with the Company’s credit agreement.

Stratus Video Acquisition

In January 2020, AMN signed a definitive agreement to acquire Stratus Video, the largest healthcare remote video language interpretation company. Qualified healthcare interpretation, which is mandated by federal and many state regulations, is a service that many healthcare organizations do not have the resources to provide for themselves. AMN received regulatory approval for the acquisition, which is expected to close tomorrow. The purchase price for the transaction is $475 million and will be funded with borrowings under our credit facility and cash on hand.

"Stratus Video is a compelling addition to the AMN total talent solutions strategy and a wonderful opportunity to strengthen and diversify our leadership and broader talent team," said Ms. Salka. "Stratus is the clear leader in the fastest-growing segment of the language interpretation market for healthcare. They bring a highly regarded service to a growing and important patient population, and Stratus also brings an attractive financial profile."

First Quarter 2020 Outlook

*Note: Guidance percentage metrics are approximate. For a reconciliation of adjusted EBITDA margin, see the table entitled "Reconciliation of Guidance Operating Margin to Guidance Adjusted EBITDA Margin" below.

Projected year-over-year revenue growth in the first quarter of 2020 is 12-14%. On an organic basis, revenue is projected to increase 2-3%. Nurse and Allied segment revenue is expected to be up by 14-16% compared with prior year, with organic growth of 2-4%. Locum Tenens revenue in the first quarter is expected to be flat to up 1% compared with prior year. Stratus Video revenue is expected to be approximately $15 million reflecting anticipated results from the date of acquisition. Guidance assumes no labor disruption revenue in the quarter.

Conference Call on February 13, 2020

AMN Healthcare Services, Inc. (NYSE: AMN), healthcare’s leader and innovator in total talent solutions, will host a conference call to discuss its fourth quarter and full year 2019 financial results and first quarter 2020 outlook on Thursday, February 13, 2020, at 5:00 p.m. Eastern Time. A live webcast of the call can be accessed through AMN Healthcare’s website at View Source Please log in at least 10 minutes prior to the conference call in order to download the applicable audio software. Interested parties may participate live via telephone by dialing (844) 721-7241 in the U.S. or (409) 207-6955 internationally. Following the conclusion of the call, a replay of the webcast will be available at the Company’s website. Alternatively, a telephonic replay of the call will be available starting at 6:30 p.m. Pacific Time on February 13, 2020, and can be accessed until 11:59 p.m. Eastern Time on February 27, 2020, by calling (866) 207-1041 in the U.S. or (402) 970-0847 internationally, with access code 2857669.