On February 23, 2018 Fate Therapeutics, Inc. (NASDAQ:FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that the California Institute for Regenerative Medicine (CIRM) awarded the Company a $4.0 million grant to advance FT516 into a first-in-human clinical trial (Press release, Fate Therapeutics, FEB 23, 2018, View Source [SID1234524183]). FT516 is being developed by Fate Therapeutics as an off-the-shelf engineered NK cell cancer immunotherapy. The NK cell product candidate is derived from a clonal master induced pluripotent stem cell (iPSC) line engineered to uniformly express a novel CD16 Fc receptor.

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"CIRM is pleased to support the continued development of FT516 and Fate Therapeutics’ first-of-kind approach to off-the-shelf cancer immunotherapy using clonal master iPSC lines, which can serve as a renewable cell source for large-scale, cost-effective manufacture of well-characterized, uniform cell products," said Maria T. Millan, M.D., President and CEO of CIRM. "The adoptive transfer of healthy allogeneic donor NK cells has been shown to be well tolerated in patients and has not been associated with the known risks of allogeneic T-cell immunotherapy such as graft-versus-host disease. This suggests that FT516 can be reliably administered without individual patient matching restrictions and used off-the-shelf to treat a large patient population."

NK cells play a critical role in the prevention and treatment of cancer. NK cells naturally express CD16, a potent activating receptor that enables binding of NK cells to the Fc portion of IgG antibodies. Once activated through CD16, NK cells can lyse antibody-coated tumor cells and can secrete immune signaling cytokines, such as interferon gamma, to orchestrate a broad adaptive immune response. Unfortunately, the expression of CD16 on NK cells can undergo considerable down-regulation in cancer patients, which can lead to loss of NK cell anti-tumor activity.

FT516 expresses a novel CD16 Fc receptor that has been modified to prevent the receptor’s down-regulation and to enhance its binding affinity to IgG antibodies. In preclinical studies conducted by the Company, FT516 exhibited potent and persistent anti-tumor activity in vitro and in vivo in multiple tumor cell recognition and killing assays, including in combination with various IgG antibodies.

"FT516 has the potential to address a significant unmet need for more efficacious treatments across multiple solid-tumor types by restoring a patient’s immune cell function and enhancing the therapeutic effect of monoclonal antibody therapy," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "We are honored that CIRM has recognized the potential therapeutic value of FT516 as well as the unique advantages of using clonal master iPSC lines to manufacture a well characterized, uniformly engineered cell product in large batches for off-the-shelf use."

The Company plans to develop FT516 for the treatment of multiple tumor types, both as a monotherapy and in combination with tumor-targeting monoclonal antibody therapy. The first-in-human study is expected to evaluate the safety and tolerability of multiple dosing cycles of FT516 in combination with FDA-approved monoclonal antibody therapy.

Fate Therapeutics has built an extensive intellectual property portfolio broadly covering the generation and engineering of iPSCs and the production of NK and T-cell cancer immunotherapies from clonal master iPSC lines. Its proprietary portfolio includes compositions and methods for making iPSCs, including engineering their biological properties using CRISPR and other nucleases, and for producing cells of the hematopoietic lineage, including NK cells, from iPSCs. In addition, the Company has an exclusive license from the University of Minnesota covering iPSC-derived NK cells expressing targeting receptors, including modified CD16 Fc receptors and chimeric antigen receptors for human therapeutic use.

About Fate Therapeutics’ iPSC Product Platform
The Company’s proprietary induced pluripotent stem cell (iPSC) product platform enables large-scale generation of off-the-shelf, engineered, homogeneous cell products that can be administered in repeat doses to mediate more effective pharmacologic activity, including in combination with cycles of other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event, and selecting a single iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used for the manufacture of monoclonal antibodies, clonal master iPSC lines can serve as a renewable cell source for the consistent and repeated manufacture of homogeneous cell products with the potential to treat many different diseases and many thousands of patients in an off-the-shelf manner. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 90 issued patents and 100 pending patent applications.

On February 23, 2018 Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA), an Australian oncology-focused biotechnology company, reported that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Kazia’s investigational new drug, GDC-0084, for the treatment of glioblastoma multiforme, the most common and most aggressive form of primary brain cancer (Press release, Kazia Therapeutics, FEB 23, 2018, View Source [SID1234526005]). The company received
written notification from FDA on Friday 23rd February 2018.

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Key Points

• Orphan Drug Designation (ODD) is a special status accorded to drugs which are considered promising potential treatments for rare (‘orphan’) diseases, generally defined as those which affect less than 200,000 cases per annum in the United States

• ODD can provide drug developers with up to seven years of Orphan Drug Exclusivity (ODE), extending the effective life of a commercial product. It also provides opportunities for grant funding, protocol assistance, and financial benefits, such as a waiver of New Drug Application fees, and tax credits

• Licensed from Genentech in October 2016, GDC-0084 is due to commence a phase II clinical trial in glioblastoma in late March or early April of 2018 Glioblastoma multiforme (GBM) is an area of significant unmet medical need. More than 130,000 patients are diagnosed worldwide each year, and the prognosis remains poor, with median survival of 12-15 months on best available care. Existing drug treatments are largely ineffective in almost two-thirds of patients, and there remains an urgent need for new therapies
.
GDC-0084 was licensed from Genentech in late 2016, after demonstrating favourable results in a phase I study of 47 patients with advanced brain cancer. Kazia intends to shortly commence an international phase II clinical study to provide definitive evidence of clinical efficacy. This phase II study will initially be conducted predominantly at leading centres in the United States, and is anticipated to provide an initial data read-out in early calendar 2019.

Kazia CEO, Dr James Garner, commented, "we are very pleased to have successfully completed this important regulatory step in the development of GDC-0084. We share FDA’s recognition of the need for new treatments in this very challenging disease, and we believe that GDC-0084 has great promise as a potential new therapy. We anticipate an imminent start of the phase II clinical study, and look forward to working closely with the participating
clinicians

On February 22, 2018 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of autoimmune diseases, asthma and allergic diseases and cancer, reported that the first patient has been dosed in a Phase 1 clinical trial of XmAb18087, a bispecific antibody for the treatment of neuroendocrine tumors (NET) and gastrointestinal stromal tumors (GIST) (Press release, Xencor, FEB 22, 2018, View Source [SID1234524359]).

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"XmAb18087 engages the immune system against tumors by binding to somatostatin receptor 2 (SSTR2) and CD3," said Paul Foster, M.D., chief medical officer at Xencor. "In preclinical studies, XmAb18087 has shown potent killing of human tumor cell lines in vitro and in vivo and the stimulation of target-dependent T-cell activation. This is our first bispecific antibody targeting solid tumors to enter into clinical trials, and we expect to file INDs for three more bispecific antibodies for solid tumors this year."

The trial is a multiple ascending dose study to determine the safety and tolerability, pharmacokinetics and immunogenicity, and preliminary anti-tumor activity of weekly intravenous administration of XmAb18087 and to determine the maximally tolerated dose and regimen in patients with advanced NET or GIST.

For more information about the XmAb18087 clinical trial please visit to View Source (identifier: NCT03411915).

About Neuroendocrine Tumors
Neuroendocrine tumors (NETs) are abnormal growths that begin in neuroendocrine cells, which are distributed widely throughout the body. Most neuroendocrine tumors occur in the lungs, appendix, small intestine, rectum and pancreas. It is estimated that more than 12,000 people in the United States are diagnosed with a neuroendocrine tumor each year. For more information visit www.cancer.net.

About Gastrointestinal Stromal Tumors
Gastrointestinal stromal tumors (GISTs) are soft-tissue sarcomas, cancers that grow from cells of the body’s connective or supportive tissues, that can be located in any part of the digestive system. The most common sites of GISTs are the stomach and small intestine. Each year, as many as 3,500 to 4,000 adults in the United States will be diagnosed with a GIST. For more information visit www.cancer.net.

About Xencor’s XmAb Bispecific Technology
As opposed to traditional monoclonal antibodies that target and bind to a single antigen, bispecific antibodies are designed to elicit multiple biological effects that require simultaneous binding to two different antigen targets. Xencor’s XmAb bispecific Fc domain technology is designed to maintain full-length antibody properties in a bispecific antibody, potentially enabling favorable in vivo half-life and simplified manufacturing.

On February 22, 2018 Emergent BioSolutions Inc. (NYSE:EBS) reported financial results for the quarter and twelve months ended December 31, 2017 (Press release, Emergent BioSolutions, FEB 22, 2018, View Source;p=RssLanding&cat=news&id=2334205 [SID1234524127]).

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2017 FINANCIAL HIGHLIGHTS

(in millions) 4Q 2017
(unaudited) 4Q 2016 (1)
(unaudited)
Total Revenues $ 193.8 $ 151.7
Net Income $ 33.9 $ 32.3
Adjusted Net Income (2) $ 37.8 $ 36.6
EBITDA (1) $ 65.2 $ 61.3

(in millions) Full Year 2017
(unaudited) Full Year 2016 (1)
Total Revenues $ 560.9 $ 488.8
Net Income $ 82.6 $ 62.5
Adjusted Net Income (2) $ 95.7 $ 77.5
EBITDA (1) $ 166.0 $ 141.7

(1) Financial results for 4Q 2016 and Full Year 2016 are presented on a continuing operations basis.

(2) See "Reconciliation of Net Income to Adjusted Net Income and EBITDA" for a definition of terms and a reconciliation table.

4Q 2017 BUSINESS ACCOMPLISHMENTS

Acquisitions

Completed the acquisition of Sanofi’s ACAM2000 business, including ACAM2000 (Smallpox (Vaccinia) Vaccine, Live), the only smallpox vaccine licensed by the U.S. Food and Drug Administration (FDA), related manufacturing facilities and employees, and an existing 10-year, $425 million contract with the Centers for Disease Control and Prevention (CDC) with a remaining value at acquisition of up to approximately $160 million for deliveries of ACAM2000 to the Strategic National Stockpile (SNS)
Completed the acquisition of Raxibacumab, an FDA-approved anthrax monoclonal antibody, from GSK and assumed responsibility for a multi-year contract with the Biomedical Advanced Research and Development Authority (BARDA), with a remaining value at acquisition of up to approximately $130 million, to supply Raxibacumab to the SNS
Procurement Contracts

Awarded a contract valued at up to approximately $25 million by the U.S. Department of State to supply Trobigard(3) (Atropine Sulfate [2mg]/Obidoxime Chloride [220mg]) auto-injector, a drug and device combination product for emergency use outside of the U.S. in the event of nerve agent or organophosphate poisoning
Awarded a contract by the Department of National Defence, valued at approximately $8 million, to deliver Anthrasil (Anthrax Immune Globulin Intravenous [human]) to the Canadian government
Capital Structure

Converted approximately $239.4 million, or 95.8%, of the $250 million 2.875% Convertible Senior Notes due 2021 (the Notes) for approximately 8.5 million shares of the company’s common stock by holders of the Notes.
Repurchased 788,894 shares of its common stock in the fourth quarter of 2017 under a board-approved share repurchase program
(3) Trobigard is not currently approved or cleared by the U.S. Food and Drug Administration or any similar regulatory body, and is only distributed to authorized government buyers for use outside the U.S. This product is not distributed in the U.S.

2017 FINANCIAL PERFORMANCE

(I) Quarter Ended December 31, 2017 (Unaudited)

Revenues

Total Revenues

For Q4 2017, total revenues were $193.8 million, an increase of 28% as compared to 2016. The increase is primarily driven by increased product sales of $74.1 million mainly due to a $63.2 million increase in BioThrax sales as well as sales of products acquired in Q4 2017, partially offset by a $31.6 million reduction in contracts and grants revenue.

Product Sales

For Q4 2017, product sales were $161.6 million, an increase of 85% as compared to 2016. The increase is principally attributable to a $63.2 million increase in BioThrax (Anthrax Vaccine Adsorbed) sales as well as a $10.9 million increase primarily due to sales of products acquired in Q4 2017.

(in millions)
(unaudited) Three Months Ended
December 31,
2017 2016 % Change
Product Sales
BioThrax $ 107.0 $ 43.8 145 %
Other 54.6 43.7 25 %
Total Product Sales $ 161.6 $ 87.5 85 %

Contract Manufacturing

For Q4 2017, revenue from the Company’s contract manufacturing operations was $16.2 million, a decrease of 3% as compared to 2016.

Contracts and Grants

For Q4 2017, contracts and grants revenue was $15.9 million, a decrease of 66% as compared to 2016. The decrease primarily reflects a reduction in revenue associated with the successful completion of multiple U.S. government contracts as well as reduced R&D activities related to certain ongoing funded development programs.

Operating Expenses

Cost of Product Sales and Contract Manufacturing

For Q4 2017, cost of product sales and contract manufacturing was $70.3 million, an increase of 84% as compared to 2016. The increase primarily reflects the impact of higher product sales.

Research and Development (Gross and Net)

For Q4 2017, gross R&D expenses were $28.5 million, an increase of 5% as compared to 2016. The increase primarily reflects increased contract development services performed for NuThraxTM and the EV-035 series of molecules, offset by reduced services related to the task orders performed by the Center for Innovation in Advanced Development and Manufacturing (CIADM).

For Q4 2017, net R&D expense (calculated as gross research and development expenses less contracts and grants revenue) was $12.6 million. For Q4 2016, contracts and grants revenue exceeded gross R&D expense, resulting in a net contribution from funded development programs of $20.4 million.

(in millions)
(unaudited) Three Months Ended
December 31,
2017 2016 % Change
Research and Development Expenses $ 28.5 $ 27.1 5 %
Adjustments:
– Contracts and grants revenue $ 15.9 $ 47.5 (66 %)
Net Research and Development Expenses (Income) $ 12.6 $ (20.4 ) –

Selling, General and Administrative

For Q4 2017, selling, general and administrative expenses were $42.0 million, an increase of 19% as compared to 2016. The increase is attributable to higher compensation expense and professional services fees during the period.

Net Income & Adjusted Net Income

For Q4 2017, net income was $33.9 million, or $0.67 per diluted share, versus $32.3 million, or $0.67 per diluted share, in 2016.

Net income per diluted share is computed using the "if-converted" method prior to November 14, 2017, the date the company terminated conversion rights associated with the company’s 2.875% Convertible Senior Notes due 2021 (the Notes). This method requires net income to be adjusted to add back interest expense and amortization of debt issuance cost, both net of tax, associated with the Notes. The following table details the adjustments made in this calculation.

(in millions, except per share value)
(unaudited) Three Months Ended
December 31,
2017 2016
Net Income $ 33.9 $ 32.3
Adjustments:
+ Interest expense, net of tax 0.2 0.9
+ Amortization of debt issuance costs, net of tax 0.1 0.2
Net Income, adjusted ("if converted") $ 34.2 $ 33.4
Net Income Per Diluted Share, adjusted ("if converted") $ 0.67 $ 0.67
Weighted Average Diluted Shares 51.0 49.6

For Q4 2017, adjusted net income, a non-GAAP measure, was $37.8 million, or $0.74 per diluted share, versus $36.6 million, or $0.74 per diluted share, in 2016. See "Reconciliation of Net Income to Adjusted Net Income and EBITDA" for a definition of terms and a reconciliation table.

(II) Year Ended December 31, 2017 (Unaudited)

Revenues

Total Revenues

For the twelve months of 2017, total revenues were $560.9 million, an increase of 15% as compared to 2016. The increase is attributable to significantly increased product sales, notably Other product sales, and contract manufacturing services revenue offset by a decrease in contracts and grants revenue.

Product Sales

For the twelve months of 2017, product sales were $421.5 million, an increase of 42% as compared to 2016. The increase is principally attributable to higher BioThrax sales to the SNS and higher Other product sales, specifically timing of BAT [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) – (Equine)] deliveries to the SNS, international sales of VIGIV and Trobigard and sales of ACAM2000 to the CDC and Raxibacumab to BARDA.

(in millions) Twelve Months Ended
December 31,
2017
(unaudited) 2016 % Change
Product Sales
BioThrax $ 286.6 $ 237.0 21 %
Other $ 134.9 $ 59.3 128 %
Total Product Sales $ 421.5 $ 296.3 42 %

Contract Manufacturing

For the twelve months of 2017, revenue from the Company’s contract manufacturing operations was $68.9 million, an increase of 40% as compared to 2016. The increase primarily reflects an increase in fill/finish and manufacturing services to commercial entities.

Contracts and Grants

For the twelve months of 2017, contracts and grants revenue was $70.4 million, a decrease of 51% as compared to 2016. The decrease primarily reflects a reduction in revenue associated with the successful completion of multiple U.S. government contracts as well as reduced R&D activities related to certain ongoing funded development programs.

Operating Expenses

Cost of Product Sales and Contract Manufacturing

For the twelve months of 2017, cost of product sales and contract manufacturing was $195.7 million, an increase of 49% as compared to 2016. The increase primarily reflects the impact of higher product sales and increased costs associated with the expansion of our contract manufacturing business.

Research and Development (Gross and Net)

For the twelve months of 2017, gross R&D expenses were $97.4 million, a decrease of 10% as compared to 2016. The decrease primarily reflects lower contract development services costs associated with reduced contract development services performed during the period.

For the twelve months of 2017, net R&D expense (calculated as gross research and development expenses less contracts and grants revenue) was $27.0 million. For the twelve months of 2016, contracts and grants revenue exceeded gross R&D expense, resulting in a net contribution from funded development programs of $35.1 million.

(in millions) Twelve Months Ended
December 31,
2017
(unaudited) 2016 % Change
Research and Development Expenses $ 97.4 $ 108.3 (10 %)
Adjustments:
– Contracts and grants revenue $ 70.4 $ 143.4 (51 %)
Net Research and Development Expenses (Income) $ 27.0 $ (35.1 ) –

Selling, General and Administrative

For the twelve months of 2017, selling, general and administrative expenses were $143.5 million, unchanged as compared to 2016.

Net Income & Adjusted Net Income

For the twelve months of 2017, net income was $82.6 million, or $1.71 per diluted share, versus $62.5 million, or $1.35 per diluted share, in 2016.

Net income per diluted share is computed using the "if-converted" method prior to November 14, 2017, the date the company terminated conversion rights associated with the company’s 2.875% Convertible Senior Notes due 2021 (the Notes). This method requires net income to be adjusted to add back interest expense and amortization of debt issuance cost, both net of tax, associated with the Notes. The following table details the adjustments made in this calculation.

(in millions, except per share value) Twelve Months Ended
December 31,
2017
(unaudited) 2016
Net Income $ 82.6 $ 62.5
Adjustments:
+ Interest expense, net of tax 2.6 3.3
+ Amortization of debt issuance costs, net of tax 0.7 0.8
Net Income, adjusted ("if converted") $ 85.9 $ 66.6
Net Income Per Diluted Share, adjusted ("if converted") $ 1.71 $ 1.35
Weighted Average Diluted Shares 50.3 49.3

For the twelve months of 2017, adjusted net income, a non-GAAP measure, was $95.7 million, or $1.90 per diluted share, versus $77.5 million, or $1.57 per diluted share, in 2016. See "Reconciliation of Net Income to Adjusted Net Income and EBITDA" for a definition of terms and a reconciliation table.

2018 FINANCIAL & OPERATIONAL GOALS

2018 Financial Forecast:

Total revenue of $715 to $755 million
Pre-Tax income of $120 to $140 million
Net income of $95 to $110 million
Adjusted net income of $110 to $125 million (2)
EBITDA of $175 to $190 million (2)
(2) See "Reconciliation of Net Income to Adjusted Net Income and EBITDA" for a definition of terms and a reconciliation table.

2018 Operational Goals:

Advance NuThrax development to enable Emergency Use Authorization filing with the FDA in 2018
Complete ACAM2000 deliveries; establish a multi-year follow-on contract with the U.S. government
Deliver Raxibacumab doses under current contract; advance tech transfer to the company’s CIADM Bayview facility in Baltimore, Maryland
Progress pipeline to have at least four product candidates in advanced development
Complete an acquisition that generates revenue within 12 months of closing
1Q 2018 Financial Forecast (Revised):

Total revenue of $125 to $150 million; previous forecast was $145 to $160 million; the revision primarily reflects the timing of deliveries of BioThrax
2020 FINANCIAL & OPERATIONAL GOALS

The Company is targeting the following 2020 financial and operational goals:

Total Revenue: $1 billion
Revenue Mix: at least 10% of total revenue from ex-US customers
Expense Discipline: Net R&D <15% of net revenue (4); SG&A <25% of total revenue
Net Income: at least 14% of total revenue
Product Development Pipeline: Six products in clinical or advanced development (with at least three dual-market opportunities)
(4) Computed as Total Revenue less Contracts & Grants Revenue.

CONFERENCE CALL AND WEBCAST INFORMATION

Company management will host a conference call at 5:00 pm (Eastern Time) today, February 22, 2018, to discuss these financial results. This conference call can be accessed live by telephone or through Emergent’s website:

Live Teleconference Information:
Dial in number: (855) 766-6521
International dial in: (262) 912-6157
Conference ID: 93325042

Live Webcast Information:
Visit edge.media-server.com/m6/p/qhvnyd93 for the live webcast feed.

A replay of the call can be accessed on Emergent’s website emergentbiosolutions.com under "Investors."

On February 22, 2018 Provectus Biopharmaceuticals, Inc. (OTCQB: PVCT, www.provectusbio.com) ("Provectus" or the "Company"), a clinical-stage biotechnology company developing the first small molecule oncolytic immunotherapy for solid tumor cancers, reported an update on the Company’s gastrointestinal ("GI") cancer clinical development program for its lead investigational drug PV-10, which is administered percutaneously when targeting GI cancer tumors (Filing, 8-K, Provectus Biopharmaceuticals, FEB 22, 2018, View Source [SID1234524118]).

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Provectus’ Phase 1 study of patients with hepatic lesions (a "basket study" open to patients with different hepatic tumor types and entitled A Study to Assess PV-10 Chemoablation of Cancer of the Liver, NCT00986661) has treated 18 patients at four U.S. sites to date: six patients with hepatocellular carcinoma ("HCC"), six patients with metastatic colorectal cancer ("mCRC") metastatic to the liver, and six patients with breast cancer, lung cancer, melanoma, ovarian cancer or pancreatic cancer liver metastases. A fifth U.S. site is currently projected to enroll patients in the first half of 2018 and focus on uveal melanoma metastatic to the liver.

The most recent data from this basket study was presented at the 9th Annual Symposium of Clinical Interventional Oncology ("CIO") in Hollywood, Florida on February 4-5, 2017 (a similar presentation was made at the 26th Conference of the Asian Pacific Association for the Study of the Liver in Shanghai, China on February 15-19, 2017). Results included:

● Two of six patients with HCC who remained alive for 58 and 75 months after treatment, the latter with no evidence of disease;

● Four of five patients with mCRC liver metastases who remained alive 9 to 73 months after treatment, including one patient with no evidence of disease at 73 months; and

● One patient with pancreatic cancer liver metastases who remained alive 12 months after treatment.

Evidence of tumor destruction in both target (injected) and bystander (non-injected) lesions was displayed. A copy of the CIO poster presentation is available on Provectus’ website. Provectus currently plans to present updated data from this basket study at a medical conference in the second half of 2018.

In February 2017, researchers at the University of Illinois at Chicago published work elucidating PV-10’s mechanism of action in colon cancer, whereby PV-10 may induce immunogenic cell death that contributes to specific antitumor immunity.1

In April 2017, the first patient was treated in the Company’s first expansion trial of the GI cancer program (A Phase 1 Study of PV-10 Chemoablation of Neuroendocrine Tumors Metastatic to the Liver, NCT02693067). The patient, who had multifocal disease refractory to Lutate (177Lu-DOTA-octreotate, a radio-labelled somatostatin analog; also known as LUTATHERA, which was approved earlier this month by the U.S. Food and Drug Administration), received percutaneous PV-10 to a single neuroendocrine tumor ("NET") metastasis, and subsequently received a second injection of PV-10 to a second NET metastasis.2 Since then, a second patient received a first injection.2 Provectus currently plans to present preliminary data from this study at a medical conference in the second half of 2018.

Provectus is planning to initiate a second expansion of its GI cancer program focused on metastatic pancreatic cancer. This new study will be the first clinical combination use of PV-10 in GI cancer:

● The study, with the preliminary title A Phase 1b/2 study of percutaneous PV-10 neoadjuvant to chemotherapy for metastatic pancreatic cancer, builds on the data from the Company’s hepatic basket and NET trials to address pancreatic cancer that has metastasized to the liver. Prior preclinical work by Moffitt Cancer Center established that PV-10 has therapeutic activity in pancreatic cancer murine models as both a single agent and in combination with gemcitabine, a standard chemotherapeutic agent used to treat this disease.3

Dominic Rodrigues, Chairman of the Company’s Board of Directors, said, "GI cancers as a group are responsible for more deaths than any other disease type. Provectus and its research collaborators have independently established PV-10 as an oncolytic immunotherapy in melanoma4, colon cancer, and pancreatic cancer. We will expand our GI cancer clinical development program by continuing to initiate trials where PV-10, either as a single agent or in combination with another class of agent, may address multiple different indications with substantial unmet need or that are rare diseases."