On August 14, 2019 Neptune Wellness Solutions Inc. ("Neptune" or the "Corporation") (NASDAQ: NEPT) (TSX: NEPT), reported its financial and operating results for the three-month period ended June 30, 2019. All amounts are in Canadian dollars except specified otherwise (Press release, Neptune Technologies et Bioressources inc, AUG 14, 2019, View Source [SID1234538752]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Corporate Highlights:

On June 7, 2019, Neptune announced a three-year contract with Tilray Inc. for the extraction of cannabinoids from cannabis and hemp biomass. Tilray has committed to provide minimum biomass volumes of 125,000 kg over a three-year period.
On June 12, 2019, Neptune announced a three-year contract with The Green Organic Dutchman (TGOD) for a minimum of 230,000 kg of cannabis and hemp biomass. Neptune will provide extraction services as well as turnkey formulation, manufacturing and packaging solutions to TGOD covering a range of finished products.
On June 17, 2019, Neptune’s wholly owned subsidiary, 9354-7537 Québec Inc., received license amendments covering additional rooms where Neptune will perform encapsulation and cold ethanol extraction which will increase Neptune’s extraction capacity from 30,000 kg to 200,000 kg of biomass annually.
On July 8, 2019, Michael Cammarata, a successful entrepreneur and innovator in the wellness industry, was appointed as Chief Executive Officer and Member of the Board of Directors of Neptune. Jim Hamilton stepped down from his role as CEO and Director but remains an advisor to the Board.
On July 18, 2019, Neptune announced a successful private placement of US$41 million of which US$12 million has been used to fund the initial cash consideration for the acquisition of the assets of SugarLeaf Labs.
Michael Cammarata, CEO of Neptune stated, "Since joining Neptune, I have been listening to key stakeholders and evaluating the company its strategy and vision. I have been impressed by our significant IP that can applied to the fast-paced cannabis industry. Our extraction expertise can set us apart as we ramp up production of both raw material and finished products. I have recently implemented initiatives to address the near-term operational and capacity constraints that have impacted the growth of our cannabis extraction services, as well as put several building blocks in place to support that growth, including private placement funding and boosting production at the Sherbrooke facility. We expect to see positive impacts from these actions beginning in the second quarter."

"We expect that our new contracts with Tilray and TGOD will offer strong and consistent revenue over the next three years. The health and wellness market provides a significant opportunity in which cannabis and hemp extracts will play an important role in fulfilling customers’ needs for improved quality of life. Neptune Wellness is well positioned to benefit from this large global market opportunity, and we will continue to raise the bar when it comes to transparency, quality and industry standards," continued Mr. Cammarata.

"Mario Paradis, VP & CFO, has decided to leave Neptune. We are very grateful for all of Mario’s hard work during his time at the company. We have begun a search for a new CFO and Mario will remain CFO of Neptune to help with the transition. We are poised for strong growth and I have no doubt we’ll find the right talent to help us achieve that growth."

Financial Results

Total revenues reached $4.4 million for the three-month ended June 30, 2019, down versus last year’s revenues of $5.2 million. The majority of the revenues during the quarter were generated in the Nutraceutical segment. The decline in total revenues is explained by the timing of contracts in the Nutraceutical segment. Commercial production of cannabis extracts during the quarter was impacted by constrained operations and extraction capacity.

Neptune reported a net loss of $6.5 million for the three-month ended June 30, 2019, an increase compared to a net loss of $4.1 million last year.

For the three-month ended June 30, 2019, Adjusted EBITDA1 was a loss of $3.6 million compared with a loss of $2.3 million last year. The increased Adjusted EBITDA1 loss is due to investments made to support the growing cannabis operations.

Cash and cash equivalents were $5.4 million as of June 30, 2019. On a pro-forma basis, including the net proceeds from the private placement completed on July 18, and the initial cash consideration paid to acquire SugarLeaf, Neptune’s cash and cash equivalent would have been $39 million as at June 30, 2019.

Completion of the SugarLeaf acquisition

On July 24, 2019, Neptune announced the closing of the acquisition of the assets of U.S.-based hemp processor SugarLeaf Labs and Forest Remedies LLC (collectively, "SugarLeaf"). The initial consideration paid at closing consisted of US$18 million or US$12 million in cash and US$6 million in common shares. By achieving certain annual adjusted EBITDA and other performance targets, an additional consideration of up to US$132 million would be paid over each of the next three years as a combination of cash and shares for a maximum aggregate purchase price of up to US$150 million, reflecting a valuation multiple below 5x EBITDA.

The extraction capacity of SugarLeaf is expected to reach an annual run rate of 1,500,000 kg of biomass by the end of 2019 with opportunities to further expand capacity. The company is using a cutting-edge cold ethanol processing technology producing high-quality broad-spectrum extracts and refined full spectrum extracts. SugarLeaf has established strategic and well diversified sourcing, with multiple local and large regional hemp farmer partners, ensuring traceability of finished product directly back to the farms. The acquisition of SugarLeaf, combined with Neptune creates a leading North American extraction platform with significant capacity available to serve customers in both Canada and the United States. The acquisition also offers an opportunity to participate in both B2B and B2C hemp-derived CBD markets in the United States.

Launch of Neptune Ventures

Today, Neptune Wellness also announces the creation of Neptune Ventures, a strategic investment arm and technology incubator which is expected to stimulate innovation and partnerships in the cannabis and wellness industry. Neptune Ventures will support Neptune’s growth into the consumer market with investments in Forest Remedies, SugarLeaf’s consumer brand which includes hemp-derived CBD balms and oils.

"We are excited to launch Neptune Ventures, which will allow us to invest alongside our customers in innovative new products and technology to offer additional value to our customers and shareholders," said Mr. Cammarata. "Our venture arm will be an opportunity to get us closer to our customers by developing new intellectual property, innovations and creative solutions."

Outlook

In Canada, near-term capacity constraints are expected to be resolved in September with the commissioning of ethanol extraction equipment, which should increase Neptune’s capacity from current levels of 30,000 kg of biomass to 200,000 kg of biomass processed annually. Furthermore, Phase IIIA expansion is progressing as planned with completion expected before the end of calendar 2019 with Health Canada licensing expected thereafter. With the Phase IIIA expansion, Neptune expects to have the industry’s lowest extraction costs, translating into potentially healthy margin.

In the United States, the capacity of our SugarLeaf plant is expected to reach 1,500,000 kg by the end of December, providing Neptune with substantial capacity to supply our B2B customers with hemp extracts ingredients and finished products. SugarLeaf is expected to contribute to Neptune’s revenue growth starting in the second quarter of fiscal 2020.

Our Nutraceutical division has recently seen an increase in demand for hemp-derived CBD sourcing and formulations which could stimulate sales in the second half of fiscal 2020.

"Once the expansion phases are complete, we expect Neptune’s two extraction facilities to have impressive earnings potential. Given that we only recently acquired SugarLeaf and are still in the process of integrating those operations, we estimate that, based on a conservative capacity utilization scenario of 50%, our two facilities could support in excess of $450 million in annual revenues. In addition, our highly automated operations are expected to translate into low production costs benefiting margins, which have the potential to exceed 40% at the EBITDA level. With a focus on bringing the highest quality products to market sustainably, we believe these developments can help us achieve and surpass these scenarios. There can, of course, be no assurance that the integration of SugarLeaf will be successfully implemented, that our utilization capacity will achieve anticipated levels, or that operational costs and margins will benefit from these developments to the extent anticipated at this time." concluded Mr. Cammarata.

On August 14, 2019 Onconova Therapeutics, Inc. (NASDAQ: ONTX), a Phase 3 stage biopharmaceutical company discovering and developing novel products to treat cancer, with a focus on Myelodysplastic Syndromes (MDS), provided a corporate update and reported financial results for the second quarter ended June 30, 2019 (Press release, Onconova, AUG 14, 2019, View Source [SID1234538737]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Steven M. Fruchtman, M.D., President and Chief Executive Officer, stated, "Enrollment in our global Phase 3 INSPIRE Trial with IV rigosertib in second-line, higher-risk MDS patients is progressing. Our goal is to complete enrollment by the end of 2019 and we anticipate reporting top-line data in the first half of 2020 following full enrollment and 288 death events. If the INSPIRE Trial is successful, we believe rigosertib could be the first new treatment for higher-risk MDS in more than 15 years, and based on its unique mechanism of action, has the potential to provide clinical benefit in other Ras mutated cancers."

Dr. Fruchtman continued, "In addition to advancing the INSPIRE Trial, our Special Protocol Assessment (SPA) request to the FDA for a Phase 3 combination trial of oral rigosertib plus azacitidine in first-line higher-risk MDS patients is being pursued. We also have plans to target cancers driven by mutated Ras genes. Ras-mutated cancers represent about a third of all human cancers, and a Phase 1 study of rigosertib in combination with a PD-1 inhibitor for patients with progressive K-Ras mutated non-small cell lung cancer is expected to commence in 2019 as an investigator-initiated study. We are also working toward filing an IND for a Phase 1 trial of ON 123300, our investigational, first-in-class, dual inhibitor of CDK4/6 + ARK5, which we believe has the potential to treat various cancers including refractory metastatic breast cancer."

Second Quarter 2019 and Recent Highlights

On March 25, the Company announced that it had passed the 75 percent enrollment mark in the Phase 3 INSPIRE Trial. Onconova remains focused on our primary goal of completing enrollment by the end of 2019 and expects to report top-line survival data following full enrollment and 288 death events.

• More than 140 trial sites in 24 countries across four continents are open, including 21 sites in Japan. The Company opened new clinical trial sites in already participating countries. Additional geographies, including Brazil, are being opened during the coming months to add approximately 25 more sites. This strategy is designed to support the goal of achieving full accrual to the INSPIRE Trial in 2019. The Company anticipates reporting top-line data in the first half of 2020 following full enrollment and 288 death events.
The Company entered into a license agreement with HanX Biopharmaceuticals (HanX) for the development and commercialization of rigosertib in Greater China. The agreement provides for $4 million of upfront payments to Onconova, including a $2 million cash upfront fee and an investment totaling $2 million in shares purchased at a premium to market. In addition, HanX agreed to place $2 million in escrow in local currency for rigosertib clinical development expenses in Greater China. HanX will make additional regulatory, developmental, and sales-based milestone payments to Onconova of up to $45.5 million and will pay Onconova tiered royalties up to double digits on net sales in Greater China. If approval is received, Onconova will supply rigosertib to HanX for development and commercialization. HanX also will support Onconova’s other clinical trial initiatives in Greater China.
Onconova and Mission Bio have entered into a collaboration to utilize the Mission Bio Tapestri Platform for targeted single-cell DNA analysis to study rigosertib as part of planned clinical trials. Single-cell genomics may identify mutations with far better resolution than that of traditional sequencing methods, allowing a view into each patient’s disease at a level never before achieved. Tapestri will be utilized to identify mutations, including those of the Ras pathway, to monitor a patient’s response in clinical trials, supporting the advancement of rigosertib. By adding the Tapestri Platform to its research and development program, Onconova is including the opportunity to study single cell clones in MDS and determine the sequence of genetic events and the influence of rigosertib on these events along with clinical outcomes.

In December 2018, Onconova applied to the FDA for a Special Protocol Assessment (SPA) for a Phase 3 trial of oral rigosertib in combination with azacitidine for treatment of first-line higher-risk MDS patients. The Company expects completion of the FDA’s SPA decision before the end of 2019.

Results from the Phase 2 trial were reported in December 2018 in an oral presentation at the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) meeting and updated at the 2019 European Hematology Association (EHA) (Free EHA Whitepaper) Meeting.
Additional Progress for Rigosertib and Pipeline Products

ON 123300, an investigational first-in-class dual inhibitor of CDK4/6 + ARK5 with the potential to treat a variety of cancers, continues to make progress toward clinical development in the U.S. and China in partnership with HanX. HanX has conducted toxicology studies to support an IND filing in the U.S.

The collaboration with the National Cancer Institute as well as one with a Center of Excellence in Juvenile Myelomonocytic Leukemia, or JMML, for preclinical studies of rigosertib for treatment of pediatric cancer associated RASopathies are ongoing.

Onconova continues to participate in important medical and investment conferences. During the second quarter, presentations related to rigosertib development and clinical trials were made at:
• 15th Annual International Symposium on MDS/Copenhagen
• Acute Leukemia Forum/Shanghai
• BIO International Forum/Philadelphia
• European Hematology Association (EHA) (Free EHA Whitepaper)/Amsterdam
Upcoming 2019 conferences include:

RAS-Targeted Drug Discovery Summit (Boston, September 17-19)
Brazilian Association of Hematology, Hemotherapy and Cellular Therapy Congress (Rio de Janeiro, November 6-9)
The American Society of Hematology (ASH) (Free ASH Whitepaper) Conference in (Orlando, December 7-10)
Second Quarter 2019 Financial Results

Cash and cash equivalents as of June 30, 2019, totaled $5.9 million compared to $17.0 million at December 31, 2018. The Company believes that cash and cash equivalents at June 30, 2019, along with additional funds to be received from the HanX license in the third quarter, will be sufficient to fund ongoing trials and operations late into the fourth quarter of 2019. The Company was notified by Nasdaq on July 26 that Nasdaq has accepted the Company’s plan to regain compliance with the stockholders’ equity listing requirement by November 18, 2019.

Net loss was $3.6 million for the quarter ended June 30, 2019, compared to $4.3 million for the second quarter ended June 30, 2018. Research and development expenses were $3.9 million for the quarter ended June 30, 2019, and $4.1 million for the comparable period in 2018. General and administrative expenses were $1.8 million for the quarter ended June 30, 2019, and $2.1 million for the comparable period in 2018.

Conference Call and Webcast Information

The Company will host a conference call today, August 14, 2019, at 9 a.m. Eastern Time, to provide a corporate update and discuss second quarter 2019 financial results. Interested parties may access the call by dialing toll-free (855) 428-5741 from the U.S., or internationally (210) 229-8823 and using conference ID 90141175. The call will also be webcast live. Please click here to access the webcast. A replay will be available following the live webcast.

About Myelodysplastic Syndromes

Myelodysplastic syndromes (MDS) are conditions that can occur when the blood-forming cells in the bone marrow become dysfunctional and thus produce an inadequate number of circulating blood cells. It is frequently associated with the presence of blasts or leukemic cells in the marrow. This leads to low numbers of one or more types of circulating blood cells, and to the need for blood transfusions. In MDS, some of the cells in the bone marrow are abnormal (dysplastic) and may have genetic abnormalities associated with them. Different cell types can be affected, although the most common finding in MDS is a shortage of red blood cells (anemia). Patients with higher-risk MDS may progress to the development of acute leukemia.

On August 13, 2019 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported financial results for the six months ended June 30, 2019 (Press release, Trillium Therapeutics, AUG 13, 2019, View Source [SID1234538647]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We made excellent progress in the second quarter toward achieving two key near-term milestones," said Robert L. Kirkman, M.D., Executive Chair of Trillium Therapeutics. "We have secured a meeting with the U.S. Food and Drug Administration later this quarter to discuss a proposed pivotal trial of intratumoral TTI-621 in patients with cutaneous T-cell lymphoma. We have enrolled patients under our amended TTI-621 intravenous protocol that will allow us to dose cutaneous T-cell lymphoma patients beyond 0.5 mg/kg."

Second Quarter 2019 Financial Results:

As of June 30, 2019, Trillium had a combined cash and cash equivalents and marketable securities balance of $42.8 million, compared to $45.4 million at December 31, 2018. The June 30, 2019 working capital balance was $31.4 million, compared to $34.2 million at December 31, 2018. The decrease in cash and cash equivalents and marketable securities, and the decrease in working capital was due mainly to cash used in operations, partially offset by the cash received from the February 2019 public offering.

Net loss for the six months ended June 30, 2019 of $17.2 million was lower than the loss of $20.9 million for the six months ended June 30, 2018. The net loss was lower due mainly to a net warrant liability revaluation gain of $6.1 million and lower clinical trial related expenses, which were partially offset by a net foreign currency loss of $1.1 million in the current year compared to a net foreign currency gain of $3.0 million in the prior year, and higher manufacturing costs.

On August 13, 2019 ASLAN Pharmaceuticals (Nasdaq:ASLN, TPEx:6497), a clinical-stage oncology and immunology focused biopharma company, reported financial results for the quarter ended 30 June 2019 and provided an update on its clinical activities (Press release, ASLAN Pharmaceuticals, AUG 13, 2019, View Source [SID1234538833]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr Carl Firth, Chief Executive Officer, ASLAN Pharmaceuticals, said: "ASLAN made significant progress through the second quarter of this year, highlighted by our agreement with K-MASTER investigating varlitinib in metastatic gastric cancer patients, updated results from the ongoing clinical program studying ASLAN003 in AML, as well as results from our ASLAN004 single ascending dose study supporting differentiation versus other IL4/IL13 receptor inhibitors. Based on this exciting new data, we amended the agreement with CSL Limited to include full global rights to develop, manufacture, and commercialise this first in class therapeutic antibody for atopic dermatitis and other indications. Looking forward to the remainder of the year, we await topline data from our pivotal TreeTopp trial as second line treatment for biliary tract cancer, in the fourth quarter."

Second quarter 2019 and recent business highlights

Clinical development Varlitinib

Signed an agreement with the Korean Cancer Diagnosis & Treatment Enterprise (K-MASTER) to investigate varlitinib in a phase 1b/2 multi-centre umbrella study to evaluate the safety and efficacy of varlitinib in combination with weekly paclitaxel as a second-line treatment in HER1/HER2 co-expressing advanced or metastatic gastric cancer patients. The open label, multi-centre study will recruit approximately 400 patients, divided between four experimental arms and a common control arm based on biomarker profiling.

ASLAN003

The first part of a phase 2 clinical trial with ASLAN003 in patients with advanced relapsed/refractory acute myeloid leukaemia (AML) was fully recruited and four doses of ASLAN003 (100mg QD, 200mg QD, 100mg BID and 200mg BID) have been tested as monotherapy. Significant reductions in peripheral blood blast cells of up to 98% and fast onset of blast cell reduction were observed in a number of patients. ASLAN003 has been well-tolerated in AML patients with only one patient out of 24 experiencing febrile neutropenia and tumor lysis syndrome, which were classified as drug-related serious adverse events. ASLAN is now evaluating next steps in the development of ASLAN003.

ASLAN004

Completed a single ascending dose (SAD) study testing ASLAN004 in healthy volunteers and announced the updated data from the second part of the study that tested a subcutaneous formulation of ASLAN004. The results from the single ascending dose study confirmed ASLAN004’s favourable tolerability profile, complete inhibition of downstream mediators and potential for monthly dosing.

Amended license agreement with CSL Limited (CSL) so that ASLAN has full global rights to develop, manufacture and commercialise ASLAN004 in all indications. The amended agreement replaces the licensing agreement ASLAN and CSL signed in May 2014. Under the terms of the amended agreement,

ASLAN will make a first payment of US$30 million to CSL upon commencement of a phase 3 study of ASLAN004. CSL is also eligible to receive up to US$95 million of regulatory milestones, US$655 million of sales milestones and tiered royalties on net sales between mid-single digits and 10%.

Corporate updates

Elected Andrew Howden as non-executive Chairman of the Board. Dr Carl Firth, who has held the positions of Chairman and CEO since founding the company in 2010, will continue to serve as CEO and as a Director. This planned separation of the Chairman and CEO roles was conducted to align to best corporate governance practices.

Anticipated upcoming milestones

Presentation of new phase 1 data for varlitinib in combination with mFOLFIRI chemotherapy in advanced solid tumours at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2019 in late September.

Initiation of a multiple ascending dose trial for ASLAN004 in patients with moderate to severe atopic dermatitis in the second half of 2019.

Topline global pivotal trial (TreeTopp) data on varlitinib as second line treatment for biliary tract cancer in the fourth quarter of 2019.

Second quarter 2019 financial results

Cash used in operations for the quarter ended 30 June 2019 was US$6.5 million compared to US$10.0 million in the same period in 2018.

Research and development (R&D) expense was US$5.3 million and general and administrative (G&A) expense was US$1.9 million for the second quarter of 2019, compared to US$8.3 million and US$3.1 million, respectively, in the same period in 2018. The decrease in R&D expense was due to the completion of clinical studies and lower manufacturing expenses. The decrease in G&A expense in the period resulted from the restructuring implemented in January 2019.

Net loss for the second quarter of 2019 was US$7.9 million compared to a net loss of US$11.0 million for the second quarter of 2018.

Cash, cash equivalents and short-term investments totaled US$15.1 million as of 30 June 2019 compared to US$28.9 million as of 31 December 2018. Weighted average shares outstanding for the second quarter of 2019 was 160.2 million compared to 147.9 million for the second quarter of 2018. One American Depositary Share is the equivalent of five ordinary shares.

On August 13, 2019 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, reported its proof of concept clinical trial to evaluate its p-STAT3 inhibitor, WP1220, for the topical treatment of Cutaneous T-Cell Lymphoma (CTCL) has reached full enrollment (Press release, Moleculin, AUG 13, 2019, View Source [SID1234538648]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors.

"We believe there continues to be an unmet need for an improved topical therapy for Stage I-III CTCL skin lesions," commented Walter Klemp, Moleculin’s Chairman and CEO, "especially one that may avoid significant unwanted side effects. CTCL is known to frequently involve the upregulation of the activated form of STAT3 (p-STAT3), which has been linked to a range of tumor-related transcriptional activity. This proof of concept, if successful, could be an important first demonstration of a therapeutic effect in humans from such a p-STAT3 inhibitor. We are pleased with how quickly this trial reached full recruitment and we are hopeful to be able to announce results from this trial yet this year. This trial represents one of four clinical trials that we have underway."

Mr. Klemp concluded: "Notwithstanding the relatively rare nature of CTCL, we believe showing activity with one of our STAT3 inhibitors, within our WP1066 family of molecules, could be an indicator of both the value of p-STAT3 as a target and the potential for our drugs in other cancers where STAT3 is highly activated."