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GILEAD SCIENCES ANNOUNCES FOURTH QUARTER AND FULL YEAR 2016 FINANCIAL RESULTS

On February 7, 2017 Gilead Sciences, Inc. (Nasdaq: GILD) reported its results of operations for the fourth quarter and full year 2016 (Press release, Gilead Sciences, FEB 7, 2017, View Source [SID1234517656]).

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Total revenues for the fourth quarter of 2016 were $7.3 billion, compared to $8.5 billion for the same period in 2015. Net income for the fourth quarter of 2016 was $3.1 billion, or $2.34 per diluted share, compared to $4.7 billion, or $3.18 per diluted share for the same period in 2015. Non-GAAP net income, which excludes amounts related to acquisition-related, up-front collaboration, stock-based compensation and other expenses, for the fourth quarter of 2016 was $3.6 billion, or $2.70 per diluted share, compared to $4.9 billion, or $3.32 per diluted share for the same period in 2015.

Full year 2016 total revenues were $30.4 billion, compared to $32.6 billion for 2015. Net income for 2016 was $13.5 billion, or $9.94 per diluted share, compared to $18.1 billion, or $11.91 per diluted share for 2015. Non-GAAP net income for 2016, which excludes amounts related to acquisition-related, up-front collaboration, stock-based compensation and other expenses, was $15.7 billion, or $11.57 per diluted share, compared to $19.2 billion, or $12.61 per diluted share for 2015.

Three Months Ended Twelve Months Ended
December 31, December 31,
(In millions, except per share amounts) 2016 2015 2016 2015
Product sales $ 7,216 $ 8,409 $ 29,953 $ 32,151
Royalty, contract and other revenues 104 97 437 488
Total revenues $ 7,320 $ 8,506 $ 30,390 $ 32,639

Net income attributable to Gilead $ 3,108 $ 4,683 $ 13,501 $ 18,108
Non-GAAP net income* $ 3,585 $ 4,889 $ 15,713 $ 19,174

Diluted earnings per share $ 2.34 $ 3.18 $ 9.94 $ 11.91
Non-GAAP diluted earnings per share* $ 2.70 $ 3.32 $ 11.57 $ 12.61
* Non-GAAP net income and non-GAAP diluted earnings per share exclude acquisition-related, up-front collaboration, stock-based compensation and other expenses. A reconciliation between GAAP and non-GAAP financial information is provided in the tables on pages 7 and 8.

Product Sales

Total product sales for the fourth quarter of 2016 were $7.2 billion, compared to $8.4 billion for the same period in 2015. Product sales for the fourth quarter of 2016 were $4.9 billion in the United States, $1.4 billion in Europe, $314 million in Japan and $556 million in other locations. Product sales for the fourth quarter of 2015 were $4.8 billion in the United States, $1.7 billion in Europe, $1.4 billion in Japan and $565 million in other locations.

Total product sales during 2016 were $30.0 billion, compared to $32.2 billion in 2015. For 2016, product sales were $19.3 billion in the United States, $6.1 billion in Europe, $2.5 billion in Japan and $2.1 billion in other locations. For 2015, product sales were $21.2 billion in the United States, $7.2 billion in Europe, $1.9 billion in Japan and $1.9 billion in other locations.

Antiviral Product Sales

Antiviral product sales, which include sales of our HIV and other antiviral products and our chronic hepatitis C (HCV) products, were $6.6 billion for the fourth quarter of 2016, compared to $7.9 billion for the same period in 2015. For 2016, antiviral product sales were $27.7 billion, compared to $30.2 billion in 2015.

HIV and other antiviral product sales for the fourth quarter of 2016 were $3.4 billion, compared to $3.0 billion for the same period in 2015 and $12.9 billion for the full year 2016, compared to $11.1 billion in 2015. The increases were primarily due to the continued uptake of our tenofovir alafenamide (TAF)-based products, Genvoya (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg), Descovy (emtricitabine 200 mg/tenofovir alafenamide 25 mg) and Odefsey (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg), partially offset by decreases in sales of tenofovir disoproxil fumarate (TDF)-based products.
HCV product sales, which consist of Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg), Sovaldi (sofosbuvir 400 mg) and Epclusa (sofosbuvir 400 mg/velpatasvir 100 mg), were $3.2 billion for the fourth quarter of 2016, compared to $4.9 billion for the same period in 2015 and $14.8 billion for the full year 2016, compared to $19.1 billion in 2015. The declines were due to lower sales of Harvoni and Sovaldi, partially offset by sales of Epclusa, which was launched in 2016 across various locations.
Other Product Sales

Other product sales, which include Letairis (ambrisentan), Ranexa (ranolazine) and AmBisome (amphotericin B for liposome injection), were $621 million for the fourth quarter of 2016, compared to $523 million for the same period in 2015. For 2016, other product sales were $2.2 billion, compared to $1.9 billion in 2015.

Operating Expenses

Three Months Ended Twelve Months Ended
December 31, December 31,
(In millions) 2016 2015 2016 2015
Research and development (R&D) expenses $ 1,208 $ 757 $ 5,098 $ 3,014
Non-GAAP R&D expenses* $ 959 $ 779 $ 3,749 $ 2,845

Selling, general and administrative (SG&A) expenses $ 992 $ 1,066 $ 3,398 $ 3,426
Non-GAAP SG&A expenses* $ 938 $ 1,013 $ 3,194 $ 3,224
* Non-GAAP R&D and SG&A expenses exclude acquisition-related, up-front collaboration, stock-based compensation and other expenses. A reconciliation between GAAP and non-GAAP financial information is provided in the tables on pages 7 and 8.

During the fourth quarter of 2016, compared to the same period in 2015:

R&D expenses and non-GAAP R&D expenses* increased primarily due to the overall progression of Gilead’s clinical studies, including ongoing milestone payments.
R&D expenses for the fourth quarter of 2016 also include an impairment charge related to in-process R&D (IPR&D).
For 2016 compared to 2015:

R&D expenses and non-GAAP R&D expenses* increased primarily due to the overall progression of Gilead’s clinical studies, including ongoing milestone payments, and Gilead’s purchase of a U.S. Food and Drug Administration (FDA) priority review voucher.
R&D expenses for 2016 also include up-front collaboration expenses related to Gilead’s license and collaboration agreement with Galapagos NV, purchase of Nimbus Apollo, Inc. and impairment charges related to IPR&D.
SG&A expenses and non-GAAP SG&A expenses* decreased primarily due to lower branded prescription drug fee expense, partially offset by higher costs to support Gilead’s product launches and the geographic expansion of its business.
Cash, Cash Equivalents and Marketable Securities

As of December 31, 2016, Gilead had $32.4 billion of cash, cash equivalents and marketable securities, compared to $26.2 billion as of December 31, 2015, primarily due to the issuance of $5.0 billion aggregate principal amount of senior unsecured notes in September 2016. During 2016, Gilead generated $16.7 billion in operating cash flow, utilized $11.0 billion to repurchase 123 million shares of its stock and paid cash dividends of $2.5 billion.

Full Year 2017 Guidance

Gilead provided its full year 2017 guidance:

(In millions, except percentages and per share amounts) Provided
February 7, 2017
Net Product Sales $22,500 – $24,500
Non-HCV Product Sales $15,000 – $15,500
HCV Product Sales $7,500 – $9,000
Non-GAAP*
Product Gross Margin 86% – 88%
R&D Expenses $3,100 – $3,400
SG&A Expenses $3,100 – $3,400
Effective Tax Rate 25.0% – 28.0%
Diluted EPS Impact of Acquisition-related, Up-front Collaboration, Stock-Based Compensation and Other Expenses $0.84 – $0.91
* Non-GAAP product gross margin, R&D and SG&A expenses and effective tax rate exclude acquisition-related, up-front collaboration, stock-based compensation and other expenses. A reconciliation between GAAP and non-GAAP full year 2017 guidance is provided in the tables on page 9.

Corporate Highlights

Announced the promotion of James R. Meyers to Executive Vice President, Worldwide Commercial Operations, in November 2016.
Product & Pipeline Updates announced by Gilead during the Fourth Quarter of 2016 include:

Antiviral and Liver Diseases Programs

Announced that FDA and Japanese Ministry of Health, Labour and Welfare approved Vemlidy (tenofovir alafenamide) 25mg, a once-daily treatment for adults with chronic hepatitis B virus (HBV) infection with compensated liver disease. Additionally, the Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Agency, adopted a positive opinion on Gilead’s Marketing Authorization Application for Vemlidy.
Announced the submission of a New Drug Application (NDA) to FDA for an investigational, once-daily single-tablet regimen containing sofosbuvir 400 mg, velpatasvir 100 mg, and voxilaprevir 100 mg for the treatment of direct-acting antiviral (DAA)-experienced HCV-infected patients. The data submitted in the NDA support the use of the regimen for 12 weeks in DAA-experienced patients with genotype 1 to 6 HCV infection without cirrhosis or with compensated cirrhosis.
Announced positive results from an open-label Phase 2 trial evaluating the investigational apoptosis signal-regulating kinase 1 inhibitor selonsertib (formerly GS-4997) alone or in combination with the monoclonal antibody simtuzumab in patients with nonalcoholic steatohepatitis and moderate to severe liver fibrosis (fibrosis stages F2 or F3). The data demonstrate regression in fibrosis that was, in parallel, associated with reductions in other measures of liver injury in patients treated with selonsertib for 24 weeks. These data were presented in a late-breaking abstract session at the Liver Meeting 2016.
Announced positive two-year (96-week) data from a Phase 3 study and 48-week data from two Phase 3b studies evaluating the safety and efficacy of switching virologically suppressed HIV-1-infected patients from regimens containing Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) to regimens containing Descovy. Results demonstrated regimens containing Descovy to be statistically non-inferior to regimens containing Truvada, with improvements in certain renal and bone laboratory parameters among patients receiving Descovy-based regimens.

Aura Biosciences Receives FDA Clearance of Investigational New Drug Application for Light-activated AU-011 for the Treatment of Ocular Melanoma

On February 6, 2017 Aura Biosciences, a biotechnology company developing a new class of therapies to target and selectively destroy cancer cells using viral nanoparticle conjugates, reported that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug application (IND) for the company’s lead program, light-activated AU-011 in ocular melanoma (OM) (Press release, Aura Biosciences, FEB 6, 2017, View Source [SID1234517651]). This active IND enables Aura to begin initial clinical testing of AU-011, a unique targeted therapy that could transform the primary treatment of patients with OM, a rare and life-threatening disease.

"Early detection of ocular melanoma, combined with the administration of AU-011 as a potential vision-sparing therapy, could transform the treatment of patients with this devastating disease," said Brian Marr, M.D., Director of the Ophthalmic Oncology Service at Columbia University Medical Center. Dr. Marr is the principal investigator for the AU-011 clinical trial and also is a member of Aura’s Clinical Advisory Board.

"Receiving IND clearance to enter the clinic for AU-011 is an important step in the development pathway for this novel class of drugs, and I’m thankful to our team of dedicated employees, as well as to our distinguished scientific and clinical advisors, for their contributions that have propelled us to this point," said Elisabet de los Pinos, Ph.D., founder and CEO of Aura. "With the advancement of AU-011, we are opening the door for innovation in a completely new therapeutic area where there are no FDA drugs approved today. Our hope is that AU-011 could be used to treat small primary melanomas early, with the potential to eliminate the tumor and preserve vision for patients."

The Phase 1b open-label, single ascending dose clinical trial currently enrolling is designed to evaluate the safety, immunogenicity and preliminary efficacy of two dose levels of AU-011 for the treatment of small-to-medium primary OM. Screening procedures for eligible patients are underway at five clinical trial sites across the country. For more information, visit www.clinicaltrials.gov or contact [email protected].
About ocular melanoma (OM)
Ocular melanoma (OM), also known as uveal or choroidal melanoma, develops in the uvea, or uveal tract, of the eye, and is an aggressive and rare eye cancer. No targeted therapies are currently available, and current treatments are associated with serious morbidities. The most common treatment today is placing an invasive radioactive plaque against the exterior of the eye near the tumor, which requires multiple surgeries and can lead to cataracts, retinopathy and loss of vision. The alternative is enucleation, the removal of the eye. OM metastasizes to the liver in about half of all cases (source: OMF), and only 15 percent of patients whose OM has metastasized survive beyond five years after diagnosis (source: ACS).

About light-activated AU-011
AU-011 is a first-in-class targeted therapy in development for the primary treatment of ocular melanoma (OM), also known as uveal or choroidal melanoma, a rare and life-threatening disease. The therapy consists of viral nanoparticle conjugates that bind selectively to cancer cells in the eye. AU-011 has a necrotic mechanism of action and is administered through an intravitreal injection into the eye. Upon activation with an ophthalmic laser, the drug rapidly and specifically destroys the membranes of tumor cells while sparing key eye structures, which may allow for the potential of preserving patients’ vision. AU-011 for OM has been granted orphan drug designation by the U.S. Food and Drug Administration and is currently in clinical testing.

FDA Grants Cellectis IND Approval to Proceed with the Clinical Development of UCART123, the First Gene Edited Off-the-Shelf CAR T-Cell Product Candidate developed in the U.S.

On February 6, 2017 Cellectis (Alternext: ALCLS; Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene edited CAR T-cells (UCART), reported it has received an Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) to conduct Phase 1 clinical trials with UCART123, the Company’s most advanced, wholly owned TALEN gene-edited product candidate, in patients with acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN) (Press release, Cellectis, FEB 6, 2017, View Source [SID1234517650]). This marks the first allogeneic, "off-the-shelf" gene-edited CAR T-cell product candidate that the FDA has approved for clinical trials. Cellectis intends to initiate Phase 1 trials in the first half of 2017.

UCART123 is a gene-edited T-cell investigational drug that targets CD123, an antigen expressed at the surface of leukemic cells in AML, tumoral cells in BPDCN. The clinical research for AML will be led, at Weill Cornell, by principal investigator Dr. Gail J. Roboz, Director of the Clinical and Translational Leukemia Programs and Professor of Medicine. The UCART123 clinical program for BPDCN will be led, at the MD Anderson Cancer Center, by Dr. Naveen Pemmaraju, MD, Assistant Professor, and Professor Hagop Kantarjian, MD, Department Chair, Department of Leukemia, Division of Cancer Medicine.

AML is a devastating clonal hematopoietic stem cell neoplasm that is characterized by uncontrolled proliferation and accumulation of leukemic blasts in bone marrow, peripheral blood and, occasionally, in other tissues. These cells disrupt normal hematopoiesis and rapidly cause bone marrow failure and death. In the U.S. alone, there are an estimated 19,950 new AML cases per year, with 10,430 estimated deaths per year.

BPDCN is a very rare and aggressive hematological malignancy that is derived from plasmacytoid dendritic cell precursors. BPDCN is a disease of bone marrow and blood cells but also often affects skin and lymph nodes.

"The FDA’s approval of Cellectis’ UCART123 – the first "off-the-shelf" CAR T-cell product candidate to enter clinical trials in the U.S. – is a major milestone not only for the Company but also for the medical community, global biotech and pharmaceutical industries at large," said Dr. Loan Hoang-Sayag, Cellectis Chief Medical Officer. "Cellectis’ allogeneic UCART products have the potential to create an important shift with regard to availability, and cost-effectiveness, to make these therapies widely accessible to patient population across the world."

"After the National Institutes of Health’s Recombinant DNA Advisory Committee (RAC)’s unanimous approval of two Phase 1 study protocols for Cellectis’ UCART123 in December 2016, the FDA’s approval of Cellectis’ IND is a new major regulatory milestone achieved, for having UCART123 proceed into clinical development and reaching cancer patients in need," added Stephan Reynier, Chief Regulatory and Compliance Officer, Cellectis.

Information about ongoing clinical trials are publically available on dedicated websites such as:

www.clinicaltrials.gov in the U.S.

www.clinicaltrialsregister.eu in Europe

Kiadis Pharma issues clinical and regulatory progress update on ATIR101™ and ATIR201™

On February 6, 2017 Kiadis Pharma N.V. ("Kiadis Pharma" or the "Company") (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company developing innovative T-cell immunotherapy treatments for blood cancers and inherited blood disorders, reported a progress update on the clinical and regulatory status of ATIR101, the Company’s lead product to address the key risks and limitations of hematopoietic stem cell transplantation (HSCT) in blood cancer (Press release, Kiadis, FEB 6, 2017, View Source [SID1234517649]).

Initiation of pivotal Phase III trial with ATIR101
Following regulatory approval from the national authority in Canada (Health Canada), the Company is pleased to announce the initiation of its randomized, controlled, transatlantic Phase III trial with ATIR101 (CR-AIR-009). Approximately 195 patients with acute leukemia will be enrolled in total in the Phase III trial and randomized 1:1 to receive a haploidentical allogeneic HSCT using either the Kiadis Pharma approach with a single dose of ATIR101 or the post-transplant cyclophosphamide approach (also known as the Baltimore Protocol). The trial protocol has also been submitted for approval and is being evaluated by the United States FDA (Food and Drug Administration) as well as several European regulatory authorities. Following approval the trial will be rolled out to additional study centers in the United States and Europe.

CTI Clinical Trial and Consulting Services, Inc., an international clinical contract research organization, has been appointed to work with Kiadis Pharma to support the clinical part of the trial and PCT, LLC, A Caladrius Company, a leading external manufacturing partner to the cell therapy industry, will manufacture ATIR101 for the United States and Canada. The German Red Cross Blood Donor Service, Baden-Wuerttemberg-Hessen, will remain the manufacturer in Europe. All 15 study centers that participated in the Company’s Phase II trials with ATIR101 (CR-AIR-007 and CR-AIR-008) have confirmed their intention to participate in the Phase III trial (CR-AIR-009). Kiadis Pharma is actively and rapidly aligning more sites with the aim of having more than 40 sites in North America and Europe participating in the Phase III trial.

Ongoing CR-AIR-008 trial continues to confirm safety profile of ATIR101
Infusing a single dose of ATIR101 continues to be safe in the ongoing Phase II trial with ATIR101 (CR-AIR-008) which, as previously announced, is continuing to treat patients with a single dose of ATIR101 according to the clinical protocol and the recommendation of the Independent Data Monitoring Committee (IDMC). Five patients in this trial have now been treated with a single dose of ATIR101 of which three were infused more than 120 to 150 days ago. None of these patients have shown any symptoms of severe Graft-versus-Host-Disease (GVHD), with none having received any prophylactic immunosuppression.

MAA submission to EMA for ATIR101 progressing well
Following the Company’s decision to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the use of ATIR101 in blood cancers, Kiadis Pharma confirms that the preparations for submitting the dossier are progressing well. The MAA will be based on the results from the Company’s successful single dose Phase II trial (CR-AIR-007) which confirmed that ATIR101 can be safely infused and shows statistically significant benefits on overall survival and reducing death from GVHD and infections, compared to an observational control group of patients having received a similar T-cell depleted stem cell transplant from a haploidentical family member but without the addition of ATIR101.

Kiadis Pharma has previously received an Advanced Therapy Medicinal Product (ATMP) certificate from EMA for manufacturing quality and pre-clinical data, recognizing that this data generated for ATIR101 meets the stringent standards imposed by the agency in evaluating an MAA.

Contingent on approval from EMA, Kiadis Pharma anticipates launching ATIR101 in to the European market in 2018.

Phase I/II trial with ATIR201
As previously announced, the Company’s Phase I/II clinical trial with its product ATIR201 for thalassemia (CR-BD-001) has received regulatory approval from the national authority in the United Kingdom (the MHRA, the Medicines and Healthcare products Regulatory Agency) as well as approval from the Ethics Committees of the Royal Manchester Children’s Hospital and the Birmingham Children’s Hospital. In addition, approval from the Ethics Committee of the University of Regensburg in Germany has now been received, with regulatory approval from the national authority in Germany pending. Kiadis Pharma expects the first clinical trial data to become available in the second half of 2017.

Manfred Rüdiger, PhD, Chief Executive Officer of Kiadis Pharma, commented: "I am very excited that we have initiated our pivotal Phase III trial with ATIR101. We have significant momentum now and the preparation of our MAA submission to EMA is progressing well. This work will bring our potentially life-saving treatment, which is also protected by Orphan Drug Designations in both Europe and the US, one step closer to patients with an anticipated launch in Europe in 2018."

About ATIR101
For patients suffering from blood cancers, an allogeneic hematopoietic stem cell transplantation (HSCT) is generally regarded as the most effective curative approach. During an HSCT treatment, the bone marrow, harboring the diseased cancer cells, is completely destroyed and subsequently replaced by stem cells in the graft from a healthy donor. After an HSCT treatment it usually takes the patient at least six to twelve months to recover to near-normal blood cell levels and immune cell functions. During this period, the patient is highly vulnerable to infections caused by bacteria, viruses and fungi but also to disease relapse.

ATIR101 (Allodepleted T-cell ImmunotheRapeutics) provides for a safe donor lymphocyte infusion (DLI) from a partially matched (haploidentical) family member without the risk of causing severe Graft-versus-Host-Disease (GVHD). The T-cells in ATIR101 will help fight infections and remaining tumor cells and thereby bridge the time until the immune system has fully re-grown from stem cells in the transplanted graft.

In ATIR101, T-cells that would cause GVHD are eliminated from the donor lymphocytes using Kiadis Pharma’s photodepletion technology, minimizing the risk of GVHD and eliminating the need for prophylactic immune-suppression. At the same time, ATIR101 contains potential cancer killing T-cells from the donor that could eliminate residual cancer cells and help prevent relapse of the disease, known as the Graft-versus-Leukemia (GVL) effect.

Therefore, ATIR101, administered as an adjunctive immuno-therapeutic on top of HSCT, provides the patient with functional, mature immune cells from a partially matched family donor that can fight infections and tumor cells but that do not cause GVHD. ATIR101 thus has the potential to make curative HSCT a viable option to many more patients.

The Company estimates that approximately 35% of patients who are eligible and in urgent need of HSCT will not find a matching donor in time. A partially matched (haploidentical) family donor, however, will be available to over 95% of patients.

ATIR101, consisting of donor T-cells that fight infections and residual tumor cells while not eliciting severe GVHD, is designed to result in low relapse rates and low rates of death due to infections, in the absence of severe acute GVHD.

TapImmune Completes Scale-Up and GMP Manufacturing of TPIV 200 Vaccine to Supply Additional Phase 2 Clinical Trials

On February 2, 2017 TapImmune, Inc. (NASDAQ: TPIV), a clinical-stage immuno-oncology company specializing in the development of innovative peptide and gene-based immunotherapeutics and vaccines for the treatment of cancer and metastatic disease, reported it has successfully completed a multi-gram scale-up and GMP manufacturing of a second clinical lot of TPIV 200, the company’s multi-epitope T-cell vaccine targeting folate receptor alpha (Press release, TapImmune, FEB 6, 2017, View Source;orderby=date&order=DESC [SID1234517648]). The manufactured vaccine product will be used to supply an ongoing Phase 2 study of TPIV 200 for the treatment of platinum-sensitive ovarian cancer, as well as a planned Phase 2 study sponsored by the Mayo Clinic for treating triple-negative breast cancer.

"The successful release of our second lot of TPIV 200 represents another important milestone in the progression of our product pipeline and technologies," said Dr. Glynn Wilson, Chairman and CEO of TapImmune. "Improvements to the manufacturing process include a process change to improve scalability and a formulation change to improve the physical appearance and consistency of the final vialed product. The end result is a superior formulation that is more amenable to large scale manufacturing and commercialization."

"Our first TPIV 200 lot was manufactured in early 2016 to fully supply a TapImmune-sponsored Phase 2 trial evaluating the vaccine for the treatment of triple-negative breast cancer as well as a Phase 2 trial evaluating the vaccine in combination with a checkpoint inhibitor for platinum-resistant ovarian cancer, both of which are currently enrolling patients," said Dr. John Bonfiglio, President and COO of TapImmune. "The current, larger clinical batch of TPIV 200 will fully supply the first TapImmune-sponsored Phase 2 trial in platinum-sensitive ovarian cancer, for which a number of clinical sites are currently being screened and initiated. The batch will also supply a planned Mayo Clinic-sponsored Phase 2 trial for triple-negative breast cancer, which is fully funded by a grant from the Department of Defense."