On November 25, 2016 Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs being developed to treat inflammatory diseases, cancer and sexual dysfunction, reported financial results for the nine months ended September 30, 2016 and updates on its drug development programs (Filing, Q3, Can-Fite BioPharma, 2016, NOV 25, 2016, View Source [SID1234516799]).

Clinical Development Program and Corporate Highlights Include:

● Piclidenoson (CF101) – EMA Clearance Received for Phase III Trials in Rheumatoid Arthritis & Psoriasis to Commence in 2017

Rheumatoid Arthritis: Piclidenoson is being developed as a first line therapy and replacement for the current gold standard, Methotrexate (MTX), the most widely used drug for rheumatoid arthritis. The Company plans to submit its study protocol to Institutional Review Boards (IRBs) of clinical sites in the first quarter of 2017.

Rheumatoid arthritis is a treatment market forecast to reach $38.5 billion by 2017.

Psoriasis: Can-Fite reached an agreement with the European Medicines Agency (EMA) on the final design of a global pivotal Phase III trial for Piclidenoson in the treatment of psoriasis. The Phase III trial, expected to commence enrollment in the second half of 2017, will investigate the efficacy and safety of Piclidenoson compared to placebo as its primary endpoint and as compared to apremilast (Otezla) as its secondary endpoint in approximately 400 patients with moderate-to-severe plaque psoriasis.

During the third quarter, Can-Fite received a Notice of Allowance from the European Patent Office indicating the patent titled, "Pharmaceutical Composition Comprising A3 Adenosine Receptor Agonist (IB-MECA/CF-101) for Treatment of Psoriasis" will be granted.

The Journal of Drugs in Dermatology published data in August from Can-Fite’s Phase II/III trial of Piclidenoson in the treatment of moderate to severe psoriasis. The study is titled "Treatment of Plaque-Type Psoriasis With Oral CF101: Data from a Phase II/III Multicenter, Randomized, Controlled Trial."

The psoriasis market is forecast to be $8.9 billion in 2018.

● Namodenoson (CF102) – Distribution deal in South Korea; Ongoing Phase II in Liver Cancer & Phase II NAFLD/NASH Protocol Submitted to IRB

In October, Can-Fite signed a distribution agreement with Chong Kun Dang Pharmaceuticals (CKD) for the exclusive right to distribute Namodenoson for the treatment of liver cancer in South Korea. The deal includes up to $3,000,000 in upfront and milestone payments, plus a percentage of royalties on net sales in the low twenties. CKD also negotiated for a right of first refusal to distribute Namodenoson for other indications for which Can-Fite develops Namodenoson.

Liver Cancer: Can-Fite continues to enroll and dose patients in its global Phase II study of Namodenoson in the treatment of hepatocellular carcinoma, the most common form of liver cancer. A total of approximately 78 patients are expected to be enrolled in the U.S., Europe, and Israel.

Molecular Medicine Report published an article titled, "A3 adenosine receptor agonist, CF102, protects against hepatic ischemia/reperfusion injury following partial hepatectom" during the third quarter. The article reports the results of preclinical studies conducted by Can-Fite, showing Namodenoson protects the liver from ischemia/reperfusion injury and regenerates liver cells following partial hepatectomy.

Liver cancer drugs are expected to generate $1.4 billion in sales in 2019.

NAFLD/NASH: In conjunction with world renowned Key Opinion Leaders in the field of liver diseases, Can-Fite completed the study design of its upcoming Phase II trial of Namodenoson in the treatment of non-alcoholic fatty liver disease (NAFLD), the precursor to non-alcoholic steatohepatitis (NASH).

This Phase II clinical trial protocol was submitted to leading Institutional Review Boards (IRB) in Israel. Top medical centers in Israel, including Hadassah Medical Center and Rabin Medical Center are expected to participate in the planned study by enrolling and treating patients.

By 2025, the addressable pharmaceutical market for NASH is estimated to reach $35-40 billion.

● CF602 – Broad Patent Estate in Sexual Dysfunction & Other Indications

A Notice of Allowance was granted to Can-Fite by the U.S. Patent and Trademark Office in November for the Company’s patent application covering A3 adenosine receptor (A3AR) ligands for use in the treatment of erectile dysfunction. The patent addresses methods for treating erectile dysfunction with different A3AR ligands including Can-Fite’s erectile dysfunction drug candidate, CF602. With this new broader patent protection, Can-Fite has made a strategic decision to investigate additional compounds, owned by the Company, for the most effective and safest profile in this indication. As such, the Company will postpone its planned Investigational New Drug (IND) submission for this indication.

"Today Can-Fite stands poised to enter two pivotal Phase III trials in autoimmune disease where there is a clear need for an effective oral drug that can be taken safely, on a long-term basis. In the treatment of liver diseases, we look forward to completing our Phase II trial in liver cancer and commencing a Phase II trial in NAFLD/NASH. We believe our small molecule oral drug candidates offer very clear advantages over other drugs on the market that patients cannot tolerate longer term due to safety and IV administration issues. Along with benefits to patients, it is our strong belief that our drug candidates will improve healthcare economics and create growing value for our shareholders," stated Can-Fite CEO Dr. Pnina Fishman.

Revenues for the nine months ended September 30, 2016 were NIS 0.64 million (U.S. $0.17 million) compared to NIS 0.54 million (U.S. $0.14 million) in the first nine months of 2015. The increase in revenue was due to the recognition of a portion of the NIS 5.14 million (U.S. $1.36 million) upfront payment received in March 2015 under the distribution agreement with Cipher Pharmaceuticals.

Research and development expenses for the nine months ended September 30, 2016 were NIS 15.45 million (U.S. $4.11 million) compared with NIS 9.58 million (U.S. $2.55 million) for the same period in 2015. Research and development expenses for the first nine months of 2016 comprised primarily of expenses associated with the Phase II study for CF102, preclinical study for CF602, as well as expenses for ongoing studies of CF101. The increase is due to costs associated with preparations of the aforementioned studies.

General and administrative expenses were NIS 7.88 million (U.S. $2.1 million) for the nine months ended September 30, 2016 compared to NIS 6.79 million (U.S. $1.81 million) for the same period in 2015. The increase is primarily due to an increase in share based compensation expense.

Financial income, net for the nine months ended September 30, 2016 aggregated NIS 3.12 million (U.S. $0.83 million) compared to financial expenses, net of NIS 4.7 million (U.S. $1.25 million) for the same period in 2015. The increase in financial income, net in the first nine month of 2016 was mainly due to a decrease in the fair value of warrants that are accounted for as financial liability as compared to an increase in the fair value of these warrants in the same period in 2015. In addition, the increase in financial income, net in the first nine months of 2016 was offset by an increase in financial expenses due to exchange rate differences as compared to insignificant financial income from exchange rate differences and capital issuance expenses for the same period in 2015.

Can-Fite’s net loss for the nine months ended September 30, 2016 was NIS 19.56 million (U.S. $5.2 million) compared with a net loss of NIS 20.53 million (U.S. $5.46 million) for the same period in 2015. The decrease in net loss for the first nine month of 2016 was primarily attributable to an increase in financial income, net offset by an increase in research and development expenses.

As of September 30, 2016, Can-Fite had cash and cash equivalents of NIS 37.57 million (U.S. $10 million) as compared to NIS 66.03 million (U.S. $17.57 million) at December 31, 2015. The decrease in cash during the nine months ended September 30, 2016 is due to operating expenses.

For the convenience of the reader, the reported NIS amounts have been translated into U.S. dollars, at the representative rate of exchange on September 30, 2016 (U.S. $1 = NIS 3.758).

The Company’s consolidated financial results for the nine months ended September 30, 2016 are presented in accordance with International Financial Reporting Standards.

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On November 24, 2016 Kymab Group Limited ("Kymab"), a leading monoclonal antibody biopharmaceutical group, reported that it has successfully secured a US$100 million (£81 million) Series C financing (Press release, Kymab, NOV 24, 2016, View Source [SID1234537010]). The financing was led by new investors ORI Healthcare Fund L.P. ("ORI Fund") with participation by Shenzhen Hepalink Pharmaceutical Co., Ltd ("Hepalink") as well as follow-on investments from existing shareholders: Wellcome Trust, Bill & Melinda Gates Foundation, Malin Corporation plc, CF Woodford Equity Income Fund and Woodford Patient Capital plc.

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The funds will enable Kymab to advance its proprietary pipeline of first-in-class therapeutic human monoclonal antibodies the first of which is commencing clinical development in 2017.

"We are delighted to welcome new investors ORI Fund and Hepalink and would like to thank our existing investors for their continued support in our goal of building Kymab into a sustainable global biopharmaceutical company with a pipeline of products in four main therapeutic areas: immuno-oncology, auto-immunity, haematology and infectious disease," says Dr Dave Chiswell, CEO of Kymab.

"ORI Fund and Hepalink bring deep experience of the pharmaceutical industry. Hepalink has a global reach for their products and have biologics manufacturing capability in the US. This investment will help us maximise the potential of the Kymab pipeline as we develop and commercialise monoclonal antibody medicines for patients world-wide."

"We are very fortunate to have the opportunity to invest in Kymab which is equipped with world class technologies, world class programs, a world class team and world class investors," says Ms Simone Song, Senior Partner of ORI Fund. "We look forward to working with Dave and his team to fully realise the potential of Kymab as it enters into the clinic with a global presence."

"We have had a biologics strategy for a number of years and believe Kymab has one of the most comprehensive humanised transgenic antibody platforms which is already delivering first-in-class antibodies," explains Mr Li Li, President and Chairman of Hepalink. "We are pleased to invest in a world leading antibody company and look forward to potential collaborative opportunities with Kymab"

Kymab is using the Kymouse transgenic human antibody platform to discover and develop fully human monoclonal antibody drugs. Data published in Nature Biotechnology demonstrate that the Kymouse technology yields an antibody library constituted from 100 trillion different antibodies. From this deep library rare high-quality antibodies can be selected and developed into therapeutics.

Five of the top ten best-selling drugs are antibodies. This is because antibodies are natural products with exquisite specificity and potency, and generally have superior safety profiles. The challenge has been to capture the full human antibody repertoire and to recapitulate all its attributes.

The Series C follows the US$120 million Series A and B financings.

Notes to Editors
Issued 24 November, 2016

On November 23, 2019 Xenetic Biosciences, Inc. (NASDAQ: XBIO) ("Xenetic" or the "Company"), a clinical-stage biopharmaceutical company focused on the discovery, research and development of next-generation biologic drugs and novel orphan oncology therapeutics, reported that the Company’s management team will host a quarterly update conference call with a live webcast for investors, analysts and other interested parties (Press release, Xenetic Biosciences, NOV 23, 2016, View Source [SID1234537808]).

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During the conference call, the Company will provide a corporate update and discuss the clinical and regulatory progress for its in-house product candidates, as well as those being developed with Xenetic’s biotechnology and pharmaceutical partners. Xenetic’s current in-house product pipeline includes Virexxa (sodium cridanimod), which is being evaluated for the treatment of endometrial cancer and triple negative breast cancer, and ErepoXen, a polysialylated form of erythropoietin (EPO), a hormone created by the kidneys to maintain red blood cell production and prevent anemia. Xenetic is also currently evaluating OncoHist for the treatment of acute myeloid leukemia (AML) in refractory patients and refractory non-Hodgkin lymphoma (NHL).

Conference Call and Webcast Information

Xenetic management will host a conference call for investors, analysts and other interested parties on Wednesday, November 30, 2016 at 8:30 a.m. ET. The conference call and live webcast will be accompanied by presentation slides.

To participate in the call, please dial (877) 407-6914 (domestic) or (201) 493-6709 (international). The live webcast and accompanying slides will be available by accessing the IR Calendar in the Investors section of Xenetic’s website (www.xeneticbio.com). A replay of the webcast will be available for 90 days, starting approximately two hours after the presentation ends.

On November 23, 2016 Navidea Biopharmaceuticals (NYSE MKT: NAVB) reported that it has entered into a definitive asset purchase agreement with Cardinal Health (NYSE: CAH) (Press release, Navidea Biopharmaceuticals, NOV 23, 2016, View Source;p=RssLanding&cat=news&id=2225596 [SID1234516774]). Pursuant to the purchase agreement, Cardinal Health will purchase Navidea’s Lymphoseek product for lymphatic mapping, lymph node biopsy and the diagnosis of metastatic spread to lymph nodes for the staging of cancer in North America. Navidea will receive $80 million at closing, plus the opportunity to earn up to $230 million of contingent consideration based on certain milestones through 2026, with $20.1 million of that amount guaranteed over the next 3 years.

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As part of the transaction, Cardinal Health will license a portion of the acquired intellectual property back to Navidea to allow Navidea to develop and sell new immunodiagnostic and immunotherapeutic products for specific purposes in North America, and to continue to produce and sell Lymphoseek, mostly under a different brand, outside of North America.

Michael M. Goldberg, M.D., President and Chief Executive Officer, Navidea Biopharmaceuticals said, "This transaction is very exciting for Navidea and its shareholders as it will enable the company to extinguish the CRG debt and to focus the company on several attractive development efforts. With our proven delivery system and broad pipeline of clinical and preclinical products addressing very large commercial opportunities, we intend to build a world-class and highly focused development effort. We will leverage our team and financial resources by continuing to seek non-dilutive grant funding and partnerships with leading academic and commercial entities. We have successfully completed two grant-funded clinical studies in Rheumatoid Arthritis and Cardiovascular disease with academic collaborators and have continued our progress with other successful preclinical studies with candidates from our proprietary Macrophage Therapeutics pipeline."

The proposed transaction has been approved by the Board of Directors of each company, but remains subject to customary conditions, including approval by Navidea’s shareholders, receipt of applicable regulatory approvals and the absence of a material adverse effect. The transaction is expected to close in the first quarter of 2017.

Proxy materials are being drafted and will be distributed to shareholders as soon as Navidea receives regulatory clearance.

On November 22, 2016 BioLineRx Ltd. (NASDAQ: BLRX; TASE: BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, reported its financial results for the third quarter ended September 30, 2016 (Press release, BioLineRx, NOV 22, 2016, View Source;p=RssLanding&cat=news&id=2225224 [SID1234516761]).

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Highlights and achievements during third quarter of 2016 and to date:

Signing of significant immuno-oncology collaboration with Genentech, a member of the Roche Group, for several Phase 1b studies for BL-8040 in combination with Genentech’s Atezolizumab, in multiple solid tumor indications and AML
Steady progress in existing immuno-oncology collaboration with MSD (known as Merck in the US and Canada), with initiation of a Phase 2a study in pancreatic cancer for BL-8040 in combination with Merck’s KEYTRUDA
Signing of immuno-oncology collaboration with MD Anderson Cancer Center for additional Phase 2a combination study in pancreatic cancer, as part of strategic clinical research immunotherapy collaboration between MSD and MD Anderson Cancer Center
In-licensing of three new projects under strategic collaboration with Novartis, including two novel liver fibrosis/failure projects, and a novel anti-inflammatory treatment for dry eye syndrome
Presentation of growing body of clinical evidence surrounding BL-8040 at leading medical and scientific conferences, including an oral presentation at the upcoming ASH (Free ASH Whitepaper) 2016
Expanded geographic reach with new joint venture in China for development of novel drug candidates
Expected upcoming significant milestones for 2017:

Partial results from Phase 2 study for BL-8040 in stem-cell mobilization for allogeneic transplantation expected by Q1 2017
Partial results in immuno-oncology Phase 2a study for pancreatic cancer for BL-8040 in combination with Merck’s KEYTRUDA expected by H2 2017
Phase 1b immuno-oncology studies for BL-8040 in combination with Genentech’s Atezolizumab, in multiple solid tumor indications and AML, expected to commence during 2017
Philip A. Serlin, Chief Executive Officer of BioLineRx, remarked, "The third quarter of 2016 demonstrated our continued ability to leverage our leading BL-8040 oncology platform, as well as our access to cutting edge technologies. In particular, our immunotherapy collaboration efforts continued to bear fruit, with the signing of a significant agreement with Genentech to carry out multiple clinical trials in a variety of oncology indications, as well as a collaboration agreement with MD Anderson Cancer Center. Meanwhile, our immunotherapy collaboration with Merck, announced earlier in the year, steadily progressed, with our Phase 2a clinical trial in pancreatic cancer now in active enrollment. Further, following extensive due diligence, we are now pleased to roll out three programs under our Novartis collaboration, including two in the exciting field of liver fibrosis. We expect a number of additional novel assets to enter our pipeline in 2017, including several within the framework of the Novartis collaboration. Finally, we continue to highlight growing clinical evidence supporting our lead oncology program, BL-8040, which is regularly featured at leading medical and scientific conferences."

"We are excited about our prospects ahead and are focused on achieving our expected milestones for 2017 and beyond. With $39 million of cash on hand, we remain well positioned to carry out our operational plans for the next few years," Mr. Serlin concluded.

Financial Results for the Third Quarter Ended September 30, 2016

Research and development expenses for the three months ended September 30, 2016 were $3.0 million, an increase of $0.4 million, or 14.7%, compared to $2.6 million for the comparable period in 2015. The increase resulted primarily from spending on new projects and from increased spending on BL-8040 in the 2016 period. Research and development expenses for the nine months ended September 30, 2016 were $8.2 million, a decrease of $0.4 million, or 5.1%, compared to $8.7 million for the comparable period in 2015. The decrease resulted primarily from lower expenditures for BL-7010 during the 2016 period and conclusion of one of the clinical trials for BL-8040 in 2015, partially offset by increased spending on a new project.

Sales and marketing expenses for the three months ended September 30, 2016 were $0.41 million, an increase of $0.14 million, or 54.3%, compared to $0.27 million for the comparable period in 2015. The increase resulted primarily from consultancy and legal expenses related to increased business development activity in the 2016 period. Sales and marketing expenses for the nine months ended September 30, 2016 were $0.9 million, an increase of $0.1 million, or 12.6%, compared to $0.8 million for the nine months ended September 30, 2015. The reason for the increase is similar to the one discussed above in the three-month comparison.

General and administrative expenses for the three months ended September 30, 2016 were $1.1 million, an increase of $0.4 million, or 47.6%, compared to $0.8 million for the comparable period in 2015. The increase resulted primarily from an increase in non-cash share-based compensation. General and administrative expenses for the nine months ended September 30, 2016 were $3.0 million, an increase of $0.4 million, or 14.4%, compared to $2.6 million for the nine months ended September 30, 2015. The reason for the increase is similar to the one discussed above in the three-month comparison.

The Company’s operating loss for the three months ended September 30, 2016 amounted to $4.5 million, compared with an operating loss of $3.6 million for the corresponding 2015 period. The Company’s operating loss for the nine months ended September 30, 2016 amounted to $12.1 million, similar to the comparable period in 2015.

Non-operating income (expenses) for the three and nine months ended September 30, 2016 and 2015 primarily relate to fair-value adjustments of warrant liabilities on the Company’s balance sheet. These fair-value adjustments, which were material in the 2015 periods, but not material in the 2016 periods, are highly influenced by the Company’s share price at each period end (revaluation date).

Net financial income (expenses) for the three and nine months ended September 30, 2016 and 2015 primarily relate to investment income earned on bank deposits, as well as banking fees.

The Company’s net loss for the three months ended September 30, 2016 amounted to $4.3 million, compared with a net loss of $1.6 million for the corresponding 2015 period. The Company’s net loss for the nine months ended September 30, 2016 amounted to $11.6 million, compared with a net loss of $10.7 million for the corresponding 2015 period.

The Company held $38.9 million in cash, cash equivalents and short-term bank deposits as of September 30, 2016.

Net cash used in operating activities was $10.4 million for the nine months ended September 30, 2016, compared with net cash used in operating activities of $11.0 million for the comparable period in 2015. The $0.6 million decrease in net cash used was primarily the result of an increase in other receivables.

Net cash provided by investing activities for the nine months ended September 30, 2016 was $7.3 million, compared to net cash used in investing activities of $18.7 million for the comparable period in 2015. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits and other investments during the respective periods.

Net cash provided by financing activities for the nine months ended September 30, 2016 was $1.5 million, compared to net cash provided by financing activities of $29.3 million for the comparable period in 2015. The decrease in cash flows from financing activities reflects the underwritten public offering which was completed in March 2015.