Xenetic Bio Share Discussion Threads

[ashthorpedo] 18/11/2014 16:53

I would have thought that this would have been the reason
"The Company estimates that as of the date of the filing of this Form 10-Q, the Company has working capital available to fundits current business plan to the middle of the first quarter of 2015. Since its inception, the Company has incurred, and continues to incur, significant losses from operations. The Company has historically relied upon the proceeds of public and non-public financing activities to support the working capital requirements necessary to pursue the on-going research, development and commercialization of its intellectual property and know-how.
During September 2014, the Company entered into a non-exclusive financial advisory and placement agent agreement with an investment bank firm. Through introductions made by that firm and through other sources, the Company has met with and presented its business plan to potential investors for the purpose of raising working capital through a private placement transaction.
Based upon the progress of on-going discussions, the Company has a reasonable expectation that it will raise sufficient working capital to meet its obligations over the next twelve months, and therefore has prepared the financial statements on the going concern basis. The Company’s planned capital raise is expected to be through debt (convertible or otherwise), by means of an
equity-based instrument, or a combination thereof. The amount of capital the Company will be able to raise in that timeframe will determine to what extent the Company will be able to continue to fund its core programs and related operating costs, and/or accelerate programs as they relate to its preferred level of discretionary spend on pre-clinical developments and clinical trials
delivered by external service providers.
While these financial statements have been prepared on a going concern basis, if the Company does not raise additional working capital by the end of 2014, there is no assurance that the Company would be able to continue its operations as now currently planned beyond the middle of the first quarter of 2015 and could raise substantial doubt over the Company’s ability to continue as a going concern. Under such circumstances the Company would first expect to reduce the scale of its pre-clinical programs from the current planned levels, which would likely compel it to reduce general and administrative expenses, defer or
cease research and development projects, and delay or cease the purchase of significant clinical research services until it is able to
obtain sufficient financing."

So the share price has dropped to 30c to sell which is 6p old money which starts to make the following statements seem terribly silly.

Xenetic Biosciences is finally embarking on the process of "serious value"
growth, according to its chief executive.

Chief executive Scott Maguire recently colourfully compared this process as being like a "battleship leaving the dock".

Maguire said the long term benefits of being a US-centric organisation will become apparent as US markets give "significantly" greater value to firms like Xenetic with its broad proprietary drug pipeline.

"When I present at conferences in the US, they think our market cap is five to ten times higher than it actually is and they are quite shocked that it's US$35 million and not US$250/350 million," said Maguire.

It would seem that the US doesn't place anymore value on the company that the UK market. In fact the only difference is that I can't sell a single share.

[heyho2] 18/11/2014 16:29

Must be a move to NASDAQ coming soon the way this one's being walked down to try to inject some liquidity!

[trotterstrading] 17/10/2014 15:38

tick toc, tick toc... my other favourite hobby is watching paint dry!

[trotterstrading] 02/10/2014 09:48

The Price quoted means nothing a 50k trades can move the share price 60% and the bid/offer spread is crazy c.40%

Wish they would get a move on, but cant see much happening before Xmas

[buywell2] 01/10/2014 11:03

Nope its a Yahoo finance chart

I await $2 in 2 years

[daytraders] 30/9/2014 11:54

chart shows these went up 60% yesterday, is that wrong ?

[holly_dog] 30/9/2014 07:31

It's an absolute shambles that won't be solved until we issue new shares that institutions over there can trade. No liquidity at all and no major buying interest from US institutions at high prices to coax shares out of current holders so we must endure 40% spreads and farcical volatility.

[trotterstrading] 29/9/2014 21:17

Not liking this otcqb market, silly little sales have hammered the share price 50% in 6 months! Who is selling at these levels the bid/offer spread is ridiculous!
The board need to get the Nasdaq listing ASAP before the share price drops to single digits!

[digger18] 25/9/2014 20:46

Trotters, I agree with your comments but I was surprised by the level of Scott's salary for a non revenue earning company at £500k when we were on Aim, so who knows what it is now. A serious cash burn for all salaries at present, so hopefully shareholders will benefit from their investment. Next year Rodney will hopefully be a turning point.

[trotterstrading] 25/9/2014 12:46

Never tried to buy, but I hear the spreads are horrendous, would be interested to know what you can buy @ what price

I agree Oncahist is a little secretive for my liking, I'm not clear what has been tested and what has not? I thought Phase1 human trials had been performed in Russia and they were due to report back by now? I know Scott is very excited about Oncohist, when I met him he said Oncohist has the potential to be a $Bln molecule. He must believe it and obviously has access to clinical progress we are not privvy to. He did say we have NO Clinical issues for ANY candidate, I take that to be a hint that Oncohist is working, Scott also told me he has invested over $1mn of his own money in Xenetic, thats what I call putting your money where your mouth is!

Bodes well IMO.

Good luck

[digger18] 24/9/2014 21:58

The capital raising timing is the unknown here but it is clear that there will be no Nasdaq without a much larger free float allowing US institutional investors in.
However I am sure that the Russian share holders will not want to be diluted too much so how many new shares ?

I also got the impression that the ERepoxen out licensing could happen any time but I tend to agree that it will likely be H1 2015.

Oncohist is all very secretive where the talk is good but without much meat on the bone in the public domain. However, Scott seems very excited by it.

Has anyone tried to actually buy any shares on the OTC markets ?

[trotterstrading] 24/9/2014 15:14

Anyone attend the conference call with Scott and Colin?

Whilst it seems there are yet more delays (No suprise to long term Xentic PI's) I did get a general sense that we are making progress, I cant help feeling we are on the cusp of unlocking real shareholder value (although it has to be said, not for the first time!)

Some points I noted from the call

1) PSA-EPO 2nd cohort results expected by year-end
2) Oncohist Aus/NZ clinical trials to commence Q1 215
3) Q1 '15 additional FDA Oncohist filing orphan drug treatment
3) PSA EPO 3rd Cohort results due Q2 2015 (at which point seek to out license)
4) Nasdaq uplift sometime 1st half of 2015 (expect a combined annoucement on clinical trials and captial raise)

Anyone else have a different view or additional points that I missed?

[ashthorpedo] 23/9/2014 09:31

Xenetic Biosciences to Hold Business Update Conference Call September 23 at 6:00 a.m. Eastern Time

LEXINGTON, Mass. (September 22, 2014) — Xenetic Biosciences, Inc. (OTCBB: XBIO), a biopharmaceutical company focused on developing next-generation biologic drugs and novel oncology therapeutics, today announced that it will hold a business update conference call on Tuesday, September 23, 2014 at 11:00 a.m. GMT (6:00 a.m. EDT). M. Scott Maguire, chief executive officer, and Colin Hill, U.K. chief financial officer and board member, will provide a business update and answer questions.

To access the conference call, U.K.-based participants should call 0800 368 0649; London-based participants should call 020 3059 8129; and, participants in all other locations should call [phone]. A telephone replay will be available for seven days following the call's conclusion. Replay dial-in numbers are as follows: United Kingdom 0121 260 4861; United States 866-268-1947; and all other locations + 44 121 260 4861. Please provide conference ID 7591229 when accessing the replay. In addition, a replay of the call will be posted to the Investor Relations section of www.xeneticbio.com in the "Events and Presentations" tab.

About Xenetic Biosciences
Xenetic Biosciences is a biopharmaceutical company developing next-generation biologic drugs and novel oncology therapeutics. Xenetic's proprietary drug technology platforms include PolyXen® for creating next generation biologic drugs by extending the efficacy, safety and half-life of biologic drugs and OncoHist® for the development of novel oncology drugs focused on orphan indications. Xenetic's lead product candidates include ErepoXen®, an improved, polysialylated form of erythropoietin (EPO) for the treatment of anemia in pre-dialysis patients with chronic kidney disease and OncoHist®, a recombinant human histone H1.3 molecule which Xenetic is developing for the treatment of refractory Acute Myeloid Leukemia (AML). Xenetic is developing a novel series of polysialylated blood coagulation factors through its license agreement with Baxter International Inc. Xenetic is also developing a broad pipeline of clinical candidates for next generation biologics and novel oncology therapeutics in a number of orphan disease indications. For more information, please visit the company's website at www.xeneticbio.com.

[heyho2] 19/9/2014 21:20

Been a while since I've looked in on Xenetic having put my holding into the bottom draw for a while.Anyway, new broker initiates with a BUY rating today.

[trotterstrading] 16/9/2014 13:55

sent an email to Xenetic to ask what is causing the delays and when they are likely to be resolved, lets see if their Shareholder relations are better than their newsflow!

[ashthorpedo] 15/9/2014 11:31

Yes TrottersTrading delays, delays and more delays. It would seem that this is the price that has been paid for de-risking biotech. Loss of control.

Serum Institute started a 6 month trial with Erepoxen on 13/2/12. 2yrs 7mths later and we have heard nothing Re these trials. An article written on Proactive Investors last year on 17 July said Re: Oncohist "The firm continues to test the efficacy of this drug and crucial phase 2 data is expected this summer." Scott at the Marcum MicroCap Conference also said that the results would be in the first half of the year. Still we have heard nothing.

In the recent accounts under Going Concern they state,
"Recent developments relating to the supply of clinical material are causing the Company to bring forward a major pre-clinical program spend in order to achieve what management considers to be a pivotal clinical milestone in the development of a key productcandidate."
My guess is because of these delays the company will have to undertake the testing itself.

On 29 January the Company agreed to use its best efforts to have its common stock listed on the NASDAQ Stock Market on or prior to October 29, 2014. I would be very surprised if this was achieved.

Yes the battleship is definitely still moored up in the dock.

[trotterstrading] 14/9/2014 22:04

Fed up of these Russian and Indian delays, we should have had an update on Oncohist by now. Nasdaq by year end but that is likely to slip too IMO

[alasdair100new] 11/9/2014 14:14

All gone a bit quiet on here now.... What's our timetable for Nasdaq?

[buywell2] 26/8/2014 10:24

BAXTER have a two tiered approach to haemophilia, the news in the post was expected








Baxter and Xenetic Biosciences restructure collaborative partnership
31 January 2014 10:42 in Pharmaceutical Company Product News




Baxter and Xenetic Biosciences restructure collaborative partnership

Baxter has announced a restructuring of its long-running partnership with Xenetic Biosciences as it seeks to strengthen its capabilities in the important field of haemophilia.

The companies previously established an exclusive worldwide agreement to develop novel forms of polysialylated blood coagulation factors - including the Factor VIII therapy BAX 826 - using Xenetic's proprietary polysialic acid technology.

Under the newly agreed terms, Baxter will make an equity investment in the common stock of Xenetic and has committed to make contingent milestone payments, as well as pay royalties on future sales.

BAX 826 is currently under investigation to assess its potential to extend its half-life and duration of effectiveness. The company continues to expect to file for regulatory approval for BAX 855 in the US by the end of 2014.

Brian Goff, head of Baxter's global haemophilia organisation, said: "Through our Xenetic partnership, we are seeking to identify and develop a treatment that the majority of haemophilia patients could administer less frequently, potentially at once-weekly intervals, without compromising efficacy."

This comes after the firm allied with Cell Therapeutics on the development and commercialisation of a promising new cancer drug called pacritinib earlier this month.ADNFCR-8000103-ID-801688685-ADNFCR

[buywell2] 26/8/2014 10:11

I see it as forwards

I don't think Baxter would have bought 10% of XEN if it did not have plans for the company


Jan 30, 2014

Next Release » PDF Add to Briefcase File is in Briefcase

Xenetic Biosciences Announces Restructured Licensing Agreement With Baxter Now Totaling Up to $100 Million, in Addition to $10 Million Equity Investment




LEXINGTON, Mass., Jan. 30, 2014 (GLOBE NEWSWIRE) -- Xenetic Biosciences, Inc. (OTCBB:GAIFD), a biopharmaceutical company developing next-generation biologic drugs and novel oncology therapeutics, today announced that it has received a direct investment of $10 million from Baxter International, Inc. and has agreed to a restructuring of certain financial and timing aspects of its existing licensing deal with Baxter. The amended license agreement includes increased contingent milestone payments, now totaling up to $100 million, as well as increased royalties on sales.

"We are extremely pleased by Baxter's commitment to Xenetic and to our longstanding collaboration to develop polysialylated blood coagulation factors using Xenetic's unique technology," said Scott Maguire, Chief Executive Officer of Xenetic. "The new terms in our agreement represent enhanced economics for Xenetic. Additionally, we expect to utilize the capital resulting from Baxter's equity investment to further advance our development pipeline programs, particularly in the orphan drug arena, which feature a number of potential near-term, value-creating clinical milestones. This important new investment from our leading license partner is a genuinely dynamic development for the Company as we start our new life in the United States and it augurs well for our future in the world's leading economy and pharmaceutical market."

Brian Goff, head of Baxter's hemophilia organization, commented, "Through our Xenetic partnership, we are seeking to identify and develop a treatment that the majority of hemophilia patients could administer less frequently, potentially at once weekly intervals, without compromising efficacy. Our investment in Xenetic reflects our continued commitment to the hemophilia community and to our pursuit of a bleed-free world."

In August 2005, Xenetic and Baxter established an exclusive worldwide agreement to develop novel forms of polysialylated blood coagulation factors, including Factor VIII, using Xenetic technology to conjugate polysialic acid (PSA) to therapeutic blood-clotting factors. The goal of the program is to improve the pharmacokinetic profile and extend the active life of these factors, thereby improving upon existing therapies and increasing quality of life of patients.

[digger18] 26/8/2014 10:06

Buywell

Do you see this as a synergistic step forward or backwards ? I assume that this is not under our collaboration with them ? How do you read this ?

[buywell2] 23/8/2014 08:09

Baxter's Hemophilia Drug Hits Phase 3 Endpoint

Fri, 08/22/2014 - 4:05pm




Baxter International Inc. announced positive results from its Phase 3 pivotal clinical trial of BAX 855, an investigational, extended half-life recombinant factor VIII (rFVIII) treatment for hemophilia A based on ADVATE [Antihemophilic Factor (Recombinant)], which met its primary endpoint in reducing annualized bleed rates (ABR) in the prophylaxis arm compared to the on-demand arm.



Top-line results from the prospective, global, multi-center Phase 3 study demonstrated that BAX 855 met its primary endpoint in the control and prevention of bleeding, routine prophylaxis and perioperative management for patients who were 12 years or older. Patients in a twice-weekly prophylaxis arm experienced a 95 percent reduction in median ABR as compared to those in the on-demand arm (1.9 vs. 41.5, respectively). BAX 855 was also effective in treating bleeding episodes, 96 percent of which were controlled with one or two infusions. The half-life of BAX 855 was 1.4 to 1.5 times that of ADVATE, consistent with the findings from the Phase 1 study. No patients developed inhibitors to BAX 855 and no treatment-related serious adverse events, including hypersensitivity, were reported. The most common (three patients) product-related adverse event was headache.



"The positive results of the BAX 855 study reflect our ongoing, long-term commitment to drive innovation and expand treatment options for patients with hemophilia," said John Orloff, vice president and global head of research and development for Baxter BioScience. "We look forward to advancing the BAX 855 program to U.S. regulatory submission by the end of this year."



The multi-center, open-label study evaluated BAX 855 among 138 adolescent and adult patients with previously-treated hemophilia A. Patients received treatment twice weekly (45 IU/kg) or on-demand, and were followed for six months. The primary objective of the study was the reduction in ABR during the treatment period compared to on-demand treatment. The study also evaluated the safety and immunogenicity of the compound when administered on either prophylaxis or on-demand treatment regimens.



Baxter expects to submit a Biologics License Application (BLA) for BAX 855 to the U.S. Food and Drug Administration (FDA) before the end of 2014 and will present additional data in the coming months. In addition to an ongoing continuation study for patients who have completed the pivotal trial, the company is initiating a Phase 3, prospective, open-label, multi-center study to evaluate the safety and efficacy of BAX 855 among 60 previously treated patients under the age of 12 with severe hemophilia A. Consistent with guidelines published by the European Medicines Agency (EMA) that require a study in children less than 12 years of age prior to filing, Baxter expects to file a Marketing Authorization Application with the EMA upon the completion of the pediatric study.



BAX 855 is based on ADVATE, a full-length FVIII molecule with more than 10 years of real-world experience. Through a collaboration with Nektar Therapeutics (NASDAQ: NKTR), BAX 855 leverages proprietary PEGylation technology designed to extend the duration of activity of proteins in the body. This proprietary technology has been used for over 10 years in a number of approved medicines that treat chronic or serious conditions.



Date: August 21, 2014

Source: Baxter














Jan 2014

Xenetic Biosciences Announces Restructured Licensing Agreement With Baxter Now Totaling Up to $100 Million, in Addition to $10 Million Baxter Equity Investment






Press releases

Baxter Announces Restructured Agreement with Xenetic BioSciences, Further Bolstering Its Broad Bleeding Disorder Pipeline


DEERFIELD, Ill., January 30, 2014 - Baxter International Inc. (NYSE:BAX) has restructured its ongoing agreement with Xenetic Biosciences, Inc. (OTCBB: GAIFD) for the development of BAX 826, a recombinant Factor VIII treatment for hemophilia A under investigation to assess its potential to extend the half-life and duration of effectiveness. This program complements the company's current development programs, which are focused on improving the pharmacokinetic profile and extending the half-life of blood coagulation factors, including Factor VIII.

"Through our Xenetic partnership, we are seeking to identify and develop a treatment that the majority of hemophilia patients could administer less frequently, potentially at once-weekly intervals, without compromising efficacy," said Brian Goff, head of Baxter's global hemophilia organization. "We are focusing our efforts on using a range of technologies to introduce new therapies and enhancements to existing therapies, each designed to improve the patient experience as we pursue our vision of a bleed-free world."

Xenetic and Baxter previously established an exclusive worldwide agreement to develop novel forms of polysialylated blood coagulation factors, including Factor VIII, using Xenetic's proprietary polysialic acid (PSA) technology. Under the terms of the restructured arrangement, Baxter will make an equity investment in the common stock of Xenetic and has agreed to make contingent milestone payments as well as pay royalties on future sales.

This agreement further demonstrates Baxter's long-standing commitment to innovation in hemophilia, and bolsters the company's broad R&D pipeline focused on a variety of challenging bleeding disorders. For example, Baxter recently announced the completion of enrollment in a Phase III clinical trial of BAX 855, its investigational, extended half-life, recombinant Factor VIII (rFVIII) treatment for hemophilia A. The company continues to expect to file for regulatory approval for BAX 855 in the United States by the end of 2014.

The company is also advancing a number of other treatments and early-stage R&D programs, including the study of BAX 335, an investigational Factor IX gene therapy treatment for hemophilia B. The vector-based technology, which provides a mechanism for the patient's own liver to begin producing Factor IX following a single dose of the genetically engineered treatment, has the potential to re-define the concept of longer-acting therapy. A Phase I/II open-label clinical trial to assess the safety and optimal dosing schedule of BAX 335 is underway and the first patients have been dosed.

About Baxter in Hemophilia
Baxter has more than 60 years experience in hemophilia and has introduced a number of therapeutic firsts for hemophilia patients. Baxter has the broadest portfolio of hemophilia treatments in the industry and is able to meet individual therapy choices, providing a range of options at each treatment stage. The company's work focuses on optimizing hemophilia care and improving the lives of people worldwide living with bleeding disorders.

About Baxter International Inc.
Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.

This release includes forward-looking statements concerning developments to Baxter's R&D pipeline, including the development agreement between Baxter International Inc. and Xenetic Biosciences, Inc. Such statements include expectations with regard to clinical trials, regulatory filings, the impact of new treatments to patients, and potential payments under the development agreement. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; clinical trial results; changes in laws and regulations; product quality or patient safety issues; and other risks identified in Baxter's most recent filings on Form 10-K and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements.