ampliphi biosciences

Phages & the Superbugs War
A specialist team of scientists from the University of Leicester has isolated viruses that eat bacteria - called phages - to specifically target the highly infectious hospital superbug Clostridium difficile (C. diff).

The future impact of antibiotics is dwindling at a pace that no one anticipated, with more and more bacteria out-smarting and 'out-evolving' these miracle drugs. This has re-energized the search for new treatments.

"One alternative to antibiotics is bacteriophages, known as phages, which unlike antibiotics, are specific in what they kill and will generally only infect one particular species, or even strain of bacteria, referred to as the 'host'. Following attachment to their hosts, they inject their DNA into the bacterium, which then replicates many times over, ultimately causing the bacterial cell to burst open. The phages released from the dead bacterium can then infect other host cells."

Dr. Clokie and her team have achieved the remarkable feat of isolating and characterizing the largest known set of distinct C. diff phages that infect clinically relevant strains of C. diff. Of these, a specific mixture of phages have been proved, through extensive laboratory testing, to be effective against 90% of the most clinically relevant C. diff strains currently seen in the U.K.

As a testament to their therapeutic potential, these phages, that are the subject of a patent application, have been licensed by AmpliPhi Biosciences Corporation, a US-based biopharmaceutical company and pioneers in developing phage-based therapeutics. AmpliPhi have already made progress in developing phages targeted against Pseudomonas aeruginosa, a pathogen that causes acute, life-threatening lung infections in cystic fibrosis patients. They were also the first biopharmaceutical company to demonstrate the effectiveness of Pseudomonas phages in controlled and regulated human clinical trials.

 

 

NYSE Listing coming - NOTICE OF SPECIAL MEETING OF SHAREHOLDER, Tuesday, February 11, 2014

Volume up significantly today and positive based on the pending NYSE and upcoming shareholder special meeting. Just with the announcement Ampliphi is already getting the Streets attention. Phil Young is doing a tremendous job as CEO since coming aboard in building shareholder value, raising awareness, partnering and this is just the beginning. Brought an approx. $5 mil. market cap company on the Pink Sheets a couple years ago to a $100 mil. plus market cap company with key partnerships. APHB's largest shareholder Intrexon is one of the hottest stocks on the NASDAQ in 2014.

1. PROPOSAL FOR APPROVAL OF MERGER AGREEMENT AND REINCORPORATION FROM WASHINGTON TO DELAWARE.
2. PROPOSAL FOR AUTHORIZATION OF THE REVERSE STOCK SPLIT.
3. PROPOSAL TO ENTER INTO THE INDEMNIFICATION AGREEMENTS.
4. PROPOSAL TO ADOPT AND ASSUME THE STOCK INCENTIVE PLAN  

http://uk.news.yahoo.com/...-risk-real-experts-042134071.html#BhxLp30  

mfg  

uniQure to pay APHB up to $4.9 in milestones, $100k annual fee, low single digital % net sales Royalties, FDA filing

Excerpt from uniQure's IPO SEC filing. APHB royalty stream to commence in first half of 2014 in EU. Also great new, they'll file an Investigational New Drug application, or IND, with the FDA for Glybera in the first half of 2014

We have to date paid to AmpliPhi a one-time up-front payment of $1,750,000. We have agreed to pay AmpliPhi annual fees of $100,000, a total of $4,950,000 in development and regulatory milestone payments, and a royalty equal to a low single-digit percentage of net sales, if any, of licensed products sold by us or Chiesi.

We met with the Food and Drug Administration, or FDA, to discuss the regulatory pathway for Glybera in the United States, We plan to file an Investigational New Drug application, or IND, with the FDA for Glybera in the first half of 2014.  

von leytonorientfan



New analyst coverage : $1 price target

New analyst coverage of APHB last night from Roth Capital Partners, with a $1 target price...

I completely agree about the derisked nature of APHB's products, and the faster development timelines, but the valuation is further derisked by APHB's legacy investments/programs, which they don't mention:

"Roth starts AmpliPhi Biosciences at buy
February 13, 2014 by mcapraro ·

Roth Capital Partners has initiated coverage of AmpliPhi Biosciences (OTC:APHB) with a “buy” rating and price target of $1. The stock closed at 59 cents on Wednesday.

AmpliPhi is developing a validated approach, phage, to combat bacterial infections through its laser guided “smart bomb” approach to address this unmet medical need.

Phage are naturally occurring viruses that infect and kill bacteria but are benign and non-infective to eukaryotic human cells. They are abundant in the natural environment. Bacteriophage have been used for over a century throughout parts of the world as a treatment for bacterial infections, but have not been widely commercially developed for this purpose in the Western World due to the heavy reliance on antibiotics.

AmpliPhi is developing several bacteriophage therapies and has the platform in place to develop many more, writes analyst Joseph Pantginis.

“We see compelling value in AmpliPhi currently, namely because its products are early stage,” he said. “However, due to extensive historical use, we believe this is an unusually de-risked early-stage company.”

Mr. Pantginis figures the development programs at AmpliPhi could be accelerated due to both the unmet medical need and potentially faster development timelines. “We also believe that as the product candidates move forward the partnering potential is high,” he added."  

gain good find/posting & great news for APHB shareholders. More to come.

I too agree 100% with your comment that analysts have yet to quantify the value of the legacy assets, especially Glybera since revenue and milestone payments start revenue flowing into APHB mid year 2014. I believe Roth would of at least doubled their price target if they knew this de-risked company had royalties and milestones coming in this year and for the foreseeable future.

The pending NYSE listing in Q.1 (expected) will have Buy Analysts lining up similar to Roth, and I expect with significantly higher price targets.

I too don't think the market and analysts haven't yet understood the significant upside valuation associated with APHB collaboration with Unilever PLC (NYSE: UL) to exploit novel genomic information to develop next generation, specific, natural antimicrobials for use in the personal care industry. Even though it's an early stage development effort, Unilever is a UK/Dutch based $110 billion market cap. multinational  

pressekonferenz montag 4.3.2014

mfg  

Summary of last night's presentation

Excellent 20 minute presentation by the CEO last night - he stated that 2014 is a "major year" for APHB, and there will be "multiple value-driving events coming up this year".

Main points:

- APHB are "by far the leader in the world in developing bacteriophage"
- APHB have had "positive feedback" from both the FDA re the US Army programme for Staph.aureus and the MHRA re the pseudomonas programme

For 2014:

- 001 : this is the lead programme re pseudomonas and CF patients. A Phase 1 study will be initiated this year in the UK
- 002 : Staph.aureus/MRSA with the US Army. An in-human study will be initiated in Q3/Q4
- 004 : C.diff - data will be reported in the next few quarters

Endorsements/partnerships are ongoing with:

- Intrexon (working with APHB's R&D dept)
- University of Leicester in the UK
- Prince Charles Hospital, Brisbane
- Royal Brompton Hospital in the UK
- Institute Pasteur in Paris
- US Army (at Walter Reed Medical Centre)

The extensive patent portfolio covers:

- phages containing therapeutic agents
- sequential use of phage to enhance subsequent antibiotic application
- formulation and delivery  

p25162 • Mar 10, 2014 9:44 PM

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$20 Billion addressable market for Ampliphi's initial 3 Phage programs - NYSE listing soon

Impressive presentation by CEO Phil Young today at the 26th Annual ROTH Conference. It was well received by institutional investors/analysts. I recommend listening and viewing the webcast presentation link at their website. "2014 transformational year: multiple valuation driving milestones."  

Agreed - NYSE listing coming up before 30th June it seems, plus lots of further news flow this year per slides 23 and 12, with:

P001 - phase 1/2a study initiated in H2'14 with data in H1'15
P002 - initiate phase 1 study in H2'14
P004 - non-clinical proof of date in H2'14

amongst others:

http://wsw.com/webcast/roth28/aphb/  

p25162 • 20 hours ago

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RA Capital Management ($850 mil. fund)- loaded up on APHB - recent 13G filing

RA Capital Management, LLC – 26,785,712 shares = 9.9% ownership
Peter Kolchinsky – 26,785,712 shares = 9.9% ownership
RA Capital Healthcare Fund, L.P. – 21,428,575 shares = 7.9% ownership

RA Capital manages approximately $850 mil. The clearly like what they see with Ampliphi. I especially like the fact that Peter K. took a personal (individual) stake as well in Ampliphi with a 9.9% stake.

Peter Kolchinsky graduated from Harvard with a Ph.D. in virology in 2001. After graduation he got $4 Million from Vertex Pharma co-founder Rich Aldrich and started picking biotech stocks at RA Capital. In 2002 he broke even when the S&P 500 index lost 22%. By the end of 2003, the initial $4 Million investment became $13 Million. Boston-based RA Capital invests in companies with promising drugs and technologies.  

   ce259 • Apr 5, 2014 12:32 AM
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   10-K

   The Company intends to file the 2013 10-K by April 15, 2014,
   Hopefully this will start the upward trend toward $1
 

This is one of the challenges from transitioning to SEC full reporting (disclosure) company and moving to the NYSE. Bottom line APHB's audit team caught the complex Derivatives and Hedging issue dealing with estimated fair value of the derivative instruments that should be recorded as non-cash income or expense in the statement of operations.

Most important point, the non-cash adjustments to the financial statements as of September 30, 2013, do not impact the amounts previously reported for the Company's cash and cash equivalents, operating expenses, or total operating, investing or financing cash flows. No material impact.  

Billionaire, CEO of Intrexon Randal Kirk, SEC 13G filing (2-14-15) owns 67.6% of APHB

Randal Kirk (CEO of Intrexon) has a track record of significant investment returns for himself and investors that follow. Based on last weeks 13G filing, Mr. Kirk, Third Security, NRM VII Holdings and Intrexon (all controlled by Kirk), own 67.6% of AmpliPhi. Randal didn't buy all these APHB shares as a tax write off.

e.g. Randal recently purchased an additionally 555k Intrexon (XON) shares in a secondary at $27. Stock closed at $39.30, equating to approx. $7 mil. return in less a month. Plus he already owned 61 mil. shares of Intrexon.  

Gestern wieder 2.600.000 stk. Irgendwas läuft da?!  

It looks like we are a few short days or weeks from the beginning of a very interesting timeline for shareholders.

AmpliPhage-002: S. aureus (MRSA)
• IND Enabling Preclinical Studies Q2 2015
• cGMP Product Release Q2 2015
• IND Filing Q3 2015
• Phase 1 Clinical Study FPFV Q4 2015
AmpliPhage-001: P. aeruginosa Cystic Fibrosis
• Product qualification Q2 2015
• cGMP Product Manufacturing Q3 2015
• Nebulizer Qualification Q4 2015
• Inhalation Toxicology Q4 2015
AmpliPhage-004: C. difficile(CDI/ CDAD)
• Preclinical efficacy data Q2 2015
• Product qualification Q4 2015  

Next 90 days

Events in the next 90 days;
IND Enabling Preclinical Studies for MRSA and cGMP Product Release
Cystic Fibrosis product qualification
C. difficile (CDI/ CDAD) preclinical efficacy data
 

hoch bei 0,30$  

Bis jetzt!!  

war nicht normal! bin in der Aktie schon lange drinn, war immer sehr volatil. otc halt. aber so wie gestern war schon lange nicht.

mfg  

toegar2000 yahoo



AmpliPhi Granted European Patent for Bacteriophage Therapy to Fight Biofilm-related Bacterial Infections!!!
This should rocket upward big time today! Good luck longs.  

@  

OTC Markets Group Congratulates AmpliPhi Biosciences on NYSE MKT Listing