0001144204-15-033061.txt : 20150522 0001144204-15-033061.hdr.sgml : 20150522 20150522080437 ACCESSION NUMBER: 0001144204-15-033061 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20150519 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20150522 DATE AS OF CHANGE: 20150522 FILER: COMPANY DATA: COMPANY CONFORMED NAME: AmpliPhi Biosciences Corp CENTRAL INDEX KEY: 0000921114 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 911549568 STATE OF INCORPORATION: WA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-23930 FILM NUMBER: 15884530 BUSINESS ADDRESS: STREET 1: 4870 SADLER ROAD STREET 2: SUITE 300 CITY: GLEN ALLEN STATE: VA ZIP: 23060 BUSINESS PHONE: 804-205-5069 MAIL ADDRESS: STREET 1: 4870 SADLER ROAD STREET 2: SUITE 300 CITY: GLEN ALLEN STATE: VA ZIP: 23060 FORMER COMPANY: FORMER CONFORMED NAME: TARGETED GENETICS CORP /WA/ DATE OF NAME CHANGE: 19940331 8-K 1 v411480_8k.htm 8-K

 

 

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

Form 8-K

 

 

Current Report

 

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

 

Date of report (Date of earliest event reported): May 19, 2015

 

 

AMPLIPHI BIOSCIENCES CORPORATION

(Exact name of Registrant as specified in its charter)

 

 
         
Washington   000-23930   91-1549568
         

(State or other jurisdiction of

incorporation or organization)

 

 

(Commission

File Number)

 

 

(I.R.S. Employer

Identification No.)

 

800 East Leigh Street, Suite 209

Richmond, Virginia 23219

(Address of principal executive offices) (Zip code)

 

(804) 827-2524

(Registrant’s telephone number, including area code)

 

(Former name or former address, if changed since last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

  
¨Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 
 

 

Item 7.01 Regulation FD Disclosure.

 

On May 19, 2015, AmpliPhi Biosciences Corporation issued a press release announcing its first quarter 2015 financial results.

 

A copy of the press release is furnished as Exhibit 99.1 to this report

 

  Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

  99.1 Press release, dated May 19, 2015

  

 

 
 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

  AmpliPhi Biosciences Corporation  
     
       
Date: May 22, 2015 By: /s/ David E. Bosher  
    David E. Bosher  
    Chief Financial Officer

  

 
 

 

EXHIBIT INDEX

 

Exhibit
Number
  Description
99.1   Press release, dated May 19, 2015.

 

 

 

EX-99.1 2 v411480_ex99-1.htm EXHIBIT 99.1

Exhibit 99.1

 

AmpliPhi BioSciences Corporation
800 East Leigh Street
 Richmond, VA 23219

 

Press Release

 

 

AmpliPhi Provides Corporate Update and Reports First Quarter 2015 Financial Results

 

San Diego and Richmond, VA, USA, Ljubljana, Slovenia, and Sydney, Australia, May 19 2015 AmpliPhi BioSciences Corporation (OTCQB: APHB), a global leader in the development of bacteriophage-based antibacterial therapies to treat drug resistant infections, today provided a corporate update and announced financial results for the first quarter ended March 31, 2015.

 

Corporate Update

 

·Completed $13 million private placement of common stock from existing and new investors, including strategic alliance partner Intrexon (NYSE: XON).

 

·Appointed industry veteran M. Scott Salka as the new Chief Executive Officer.

 

·Granted European patent for proprietary bacteriophage preparations for use in combination with antibiotics for the treatment of biofilm related infections caused by the bacterium Pseudomonas aeruginosa.

 

·Advanced plans to report nebulizer qualification study data from the AmpliPhage-001 program for treating Pseudomonas aeruginosa in mild to moderate cystic fibrosis patients at an upcoming scientific congress.

 

·Progressed plans to commence clinical trials at the Walter Reed Clinical Trial Center in the second half of 2015 for AmpliPhage-002, for treating multi-drug resistant strains of Staphylococcus aureus.

 

·Continued collaboration with Intrexon to focus on AmpliPhage-001 and AmpliPhage-004 (for Clostridium difficile).

 

·Confirmed the Company remains on track for a major national stock exchange listing following recent improvements to corporate balance sheet.

 

Reflecting on the progress made to date in 2015, Jeremy Curnock Cook, Chairman of AmpliPhi said, “Over the past few months, AmpliPhi has made a number of significant advancements in reinforcing our foundation, through new appointments to the executive leadership team, continued positive progress with our planned clinical trial programs and securing critical intellectual property that will protect our platform technologies. AmpliPhi is well-positioned to move forward with plans to further establish itself as the leading phage company in the world, and I am encouraged by the exciting prospects for the year ahead.”

 

First Quarter 2015 Financial Results:

 

As a result of the $13 million financing, the Company has significantly improved it overall liquidity and balance sheet strength in preparation for both executing on its R&D activities and preparing for an anticipated listing on a major national stock exchange.

 

·Total revenue, consisting of legacy AAV-1 licensing maintenance fees, for the first quarter of 2015 was $102,000. This compared to total revenue of $104,000 in the same quarter last year.

 

·First quarter 2015 R&D expenses totaled $972,000, down 3.9% from $1,011,000 for the same period of 2014, as the Company continues preparations for its upcoming clinical studies for AmpliPhage-002, which are expected to commence in the second half of 2015.

 

 

 

1 | P a g e

 
 

 

AmpliPhi BioSciences Corporation
800 East Leigh Street
 Richmond, VA 23219

 

Press Release

 

 

·First quarter 2015 G&A expenses totaled $1,397,000, down 14.1% from $1,627,000 in the first quarter of 2014.

 

·Net loss from operations for the first quarter 2015 was $2,267,000, down 10.5% from $2,534,000 in the same period of 2014.

 

·Cash and cash equivalents as of March 31, 2015 totaled $16.6 million, reflecting the net proceeds from our March 2015 financing.

 

·On May 8, 2015, the Company negotiated and executed an amendment with holders representing more than two- thirds of its June 2013, July 2013, and December 2013 warrants to eliminate certain down-round price protection features included in these warrants agreements. As a result of this amendment and subject to the Company authorizing sufficient shares of common stock to allow for their exercise, the June 2013, July 2013 and December 2013 warrants will be reclassified from liability instruments to equity instruments.

 

·The Company anticipates its current financial resources will provide sufficient cash to fund operations through several milestones, which include the commencement and completion of the AmpliPhage-002 clinical trial being conducted at Walter Reed Clinical Trial Center.

 

“With a significantly improved balance sheet, AmpliPhi remains in a favorable position to continue our development of novel bacteriophage-based therapies to address the growing global epidemic of treatment-resistant bacteria,” said M. Scott Salka, CEO of AmpliPhi. “Furthermore, through a combination of a strong product pipeline, established intellectual property protection and existing collaborations with world-class research institutions, I am confident that AmpliPhi will continue this trend of positive momentum to help meet our near and long-term goals.”

 

The Company is planning to provide a mid-year corporate update via live conference call and webcast during its upcoming Annual Shareholder’s Meeting on June 30, 2015 in Washington, D.C.

 

###

 

About AmpliPhi BioSciences

AmpliPhi BioSciences Corporation (OTCQB: APHB) is a biotechnology company focused on the development and commercialization of novel bacteriophage-based antibacterial therapeutics. The Company's product development programs target infections that are often resistant to existing antibiotic treatments. AmpliPhi is collaborating with a number of leading organizations, including Intrexon Corporation (NYSE: XON), the U.S. Army, The Royal Brompton Clinic in London, UK and UK-based University of Leicester, to rapidly advance bacteriophage-based therapies.

For more information, visit www.ampliphibio.com.

 

About Bacteriophage

Bacteriophage are naturally occurring viruses that are highly specific for the bacterial hosts they infect. They can rapidly kill their host, amplifying themselves in the process. Bacteriophage are unaffected by antibiotic resistance and are able to disrupt bacterial biofilms. Such biofilms are a major line of defence for bacteria, contributing to antibiotic resistance.

Bacteriophage are able to penetrate biofilms and replicate locally to high levels, to produce strong local therapeutic effects.

 

 

 

2 | P a g e

 
 

 

AmpliPhi BioSciences Corporation
800 East Leigh Street
Richmond, VA 23219

 

Press Release

 

 

Forward Looking Statements

Statements in this press release about AmpliPhi’s manufacturing capabilities and ability to manufacture pure, reproducible, high quality, cost effective human preparations, the potential use of bacteriophages to treat bacterial infections, including infections in biofilms and infections that do not respond to antibiotics, and the development of bacteriophage-based therapies are forward looking statements subject to risks and uncertainties, including without limitation the risk that the Company will not be able to successfully manufacture sufficient quantities of products to conduct clinical trials or commercialize products in a timely manner or at all, that AmpliPhi may not commence clinical trials or complete IND- enabling studies as expected, that the clinical trials will not be successful, that further development of the Company's products will require extensive and expensive nonclinical and clinical testing, may not be safe or efficacious, and may not be approved for marketing by the United States Food and Drug Administration or any foreign regulatory agency. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to AmpliPhi's business in general, see AmpliPhi's Annual Report on Form 10-K for the fiscal year ended December 31, 2014, as amended, filed with the Securities and Exchange Commission (SEC) on April 15, 2015.

 

For further information please contact
Company and Investor relations: Media relations (USA) Media Relations (Europe and ROW)

Baxter Phillips III Chief Business Officer

+1-804-754-5442

bfp@ampliphibio.com

Danielle Lewis/Fern Lazar

Lazar Partners

+ 1 212-867-1762

ampliphi@lazarpartners.com

Gemma Howe/Sue Charles (Europe) Instinctif Partners

+44 (0)20 7457 2020

Dr Douglas Pretsell/Sue Charles (Australia)

+61 (0)3 9657 0706

ampliphi@instinctif.com

 

 

 

3 | P a g e

 

GRAPHIC 3 image_001.jpg GRAPHIC begin 644 image_001.jpg M_]C_X``02D9)1@`!`0```0`!``#_VP!#``@&!@<&!0@'!P<)"0@*#!0-#`L+ M#!D2$P\4'1H?'AT:'!P@)"XG("(L(QP<*#7J#A(6&AXB)BI*3E)66EYB9FJ*CI*6FIZBIJK*SM+6VM[BYNL+#Q,7& MQ\C)RM+3U-76U]C9VN'BX^3EYN?HZ>KQ\O/T]?;W^/GZ_\0`'P$``P$!`0$! M`0$!`0````````$"`P0%!@<("0H+_\0`M1$``@$"!`0#!`<%!`0``0)W``$" M`Q$$!2$Q!A)!40=A<1,B,H$(%$*1H;'!"2,S4O`58G+1"A8D-.$E\1<8&1HF M)R@I*C4V-S@Y.D-$149'2$E*4U155E=865IC9&5F9VAI:G-T=79W>'EZ@H.$ MA8:'B(F*DI.4E9:7F)F:HJ.DI::GJ*FJLK.TM;:WN+FZPL/$Q<;'R,G*TM/4 MU=;7V-G:XN/DY>;GZ.GJ\O/T]?;W^/GZ_]H`#`,!``(1`Q$`/P#W^BBB@`HH MK%\0>(HM"MU8P23229"`#"Y]V_IUII.3LB9245=FO++'!&TDKK'&HR68X`_& MN-UOQ[%`6@TM1,_0S-]T'V'?_/6N.U?7]0UF0&ZE^0?=B3A1^%9==<,.EK(X M*N+;TAH>I>![NXOM+NKBYE:65KDY9C_LK^5=17(_#S_D!7'_`%\'_P!!6NNK MGJ_&SLH.]-!116-HWBG1]?O+VTTV[$TUD^R9=I&.2,C/49!Y%19FUF;-%%%( M04444`%%%%`!1110`4444`%%%8,GC'1(I7C>Z8,A*D>4W4?A346]B92C'XG8 MWJ*S]/US3=48I9W:2.!DI@JV/H:T*&FMQIIJZ"BBBD,****`"LW5M=L-&BW7 M4OSD96)>7;\*Y?Q-XOO[25[.UM9+4\CS95^9AZKV_'G\*X*662>0R2NSN>K, MLCCJXI1TCN=%K7C*_P!49HH&-M:GC8A^9A[FN*\7>*=5\.^/;];* M<&WDBMS+:S*'BD_[S_KE!_Z)2NCDBFDD;9:W4J2 MY]=#J]-UO0?$[K':N-*U%O\`EUN'S%(WI')V^C8^M275I<64[07,+Q2KU5A@ MUY%78>'/'&I6:QZ9>6YUBQ8[4MY"3*A/_/-^2/IR/:GJC;$99&7O4M'V/<_A MY_R`KC_KX/\`Z"M==7.^#;1+71-Z)/$)W\WR+E0LL.0!M8`]>,]NO2NBKAJ. M\VT9THN,%%]#G/'>O#PYX.U"^#E9S&8H,=?,;@8^G7\*\1\!SW7@WQ?H=[?, M8[/6(2"<\%&8JI;Z,%/T-;GQMUV.[U^PT,2.8+0>;<"/D[F_J%_]"K(\>^-- M`\3Z%I]GIVG7UK/I[!86E5`HCVX*\,3V7\JWIQ?+:VYZ%*#4$K;GT97F/CSX MEW_@_P`66VGQV=O/9-"DLI8-YF"Q!`.<=!QQ74^`=='B+P9I]ZTF^=8_)G/? MS%X.?KP?QKS3XDV,&J?%_1;"Y!,%S%#$X!P<,[#BLJ<5SVD8THKG:EYGL]A? MVVIZ?!?6;+\59K[XCV^@Z9#;2::\X@:=@=['G<5.<8STXKB M9=1\2>!8=5\"I$\[7KA;*920=KG!*#_:''L%/BMX:TPOOG`BDG;MY MC;L@>PZ?A5JG%7O\C2-**NWKV/>M:O9-.T/4+Z)5:2VMI)4#="54D9]N*\AL MOBQXTNM,EU:/P]:7&G6[;9I8D?Y2`"<_,<<$&[[PYX4==1C,-Q=S&;R6^\BX``/H>,XKG=2_Y.+T[_KB/_134 M*,>:26PE&//)+;4]?KA/B!XUU#PIJ.BV]E!;2I?2%)#,&)&&4<8(_O&N[KR# MXS_\AOPK_P!=V_\`0HZBFDY69%))RLSU^O-O"]C:W_BK4([NWCF0+(P5UR`= MXYKTFO*M'.K#Q'??V.$,_P`^[?C&WK+J>NW*R M.I#+$ISG'0'L!["MSQ/_`,BSJ'_7(T2:;C'<(1<5.5K7V$\-:K-K.D"[G1%< MNRX0$#`^M4?$'B&ZTG6+*TACB:.?;N+@Y&6QQS7->'=0\1V^E"/3-/CGM]Y( M=ER<]_XA5?5KK5KK7]-;5K5;>0.@0*,9&[ZFJ5)<[[$.N_9JU[Z'J$C%(W8= M0":\V;XB:H#C[-:?]\M_C7I$W^HD_P!T_P`J\'?[YHP\(RO=#Q=24+Y7 MVGVNI6Y@NX5EC/J.1[@]C7!:WX#GM\S:6S3Q]XF^^/IZUZ-16,*DH;&]2C"I MN>$/&\4ICD1D=3@JPP17)_$S_D>[S_KE!_Z)2OH[5O#VGZRA^T0A9L8$R<,/ M\?QKB?$GA"ST_59M?.FG4[F58P'G`:*W"*%!V#J3MSEL@5TQK*37<6%7U64I MRU5CR+0?`NI:M''>7973M,;G[5<#!B`^@Y]Z;>7MU?SF6ZF>5^F6/0>@'857K;EON<^(S"I5TCHCTWX?, M7T6Y=B2S7)))ZD[5KJY&*1.X4N5!(4=3[5R?P\_Y`5Q_U\'_`-!6NM=@B,QZ M*,UPU?C9TT/X<3R;X?>$=9D\:ZEXF\2V3P3L6:%),'+.3DCKPJ\?C[5Z??:; M::A87%E<0HT-Q&T;C`Z$8-8&G>/=-U'1=1U1+:[2*P@%Q(K*I+(02,88C/RG M@D$5:U#Q;;65W-;16-]>/;0+W%G!+=6V?)F=`6CSUP>U>;^(/#NKW7QGTG5X-/FDT^(1>9<`#:N-V? MYUUUYXVL+.VNIOLUS(;?41II4;%W2D`Y!9@`O/4D5+-XOT^UUO3-)NDE@N=1 MA$L1;:4!/`4L"1DG@8R#Z\TH\R)CS1Z%[Q%!+=>&=5MX(S)-+9RHB#JS%"`/ MSKC_`(/Z)J>A>&;RWU2REM9GO"ZI)C)78@S^8-;\?C*RGT[3+FUM+NXFU+>; M:U15\PA/O$Y.%`XY)[BI;WQ1'8WNG64EA<_:;Z,R",O&OE@%0=Q9@,@L.!FD MKVY07,HN-C>KQWQCI?BBU^*O2K;Q%;WGB"Z MT>"WF>2T(6>7Y0J$KN'!.XC!ZXQFI]8UFWT6WBDFCEFDGE$,$$*[GEP0;@]CF?"&O^,M4U:2#Q!X?BT^T$)9954@E\C`Y8]B?RK)^* MF@:MK.K>'9=-L);E+>9FF:/'R#;IMX+Z\D:.&R`0R$ MJ"22=VT``9SGN*IR^.;"/2XKQ+2\DD>]-@UL%421SC.5;+`#IUSW%--\W,D- M-J7,D=/7%^%M(O['Q+?7-S;/'#(CA7.,'+@BK5[X]TNSTG3=3%O>36]_%)-' MY:`,B1KO=F!(Z`$\9Z5:N_%MK!P0H7E>,A5'4FL>_\`'VE6-M970ANKBVNK M4W@EB5?DB!4$D,0>KC@9-:.J^)K#1[W2[6Y\W=J,FR)E7Y4Z`%CV!+*/J:E) MIIV*E!M6[D/@^RN;#05@NHFBD$C':W7'%9OBK2[V]U_39[:V>2*+;O91P/GS M6I)XD*>)DT/^RKUI73S1,/+\ORP0"_WLX!(&,9]J1_%ED+,31P7,LLE[)8PV MZ*-\LJ%@<YU"YM[R,VETMI']16SFAO+C? M"DR2VZJ496&002P[55*4X[(*N%=:QWM%%%8&@4=:**`.9UOP78ZGF6VQ:W'J MJ_(WU']17GFJZ)?:/-Y=W"0/X9%Y5OH:]IJ.:"*YA:&>-9(W&&5AD&MH5Y1T M>J.:KAHSU6C.5^'G_("N/^O@_P#H*UUCKOC9,XW`BL;P[:PV9U.WMTV1)=D* MN239K17+!(XO3/AU:Z=HVHZ=_:$T@O;7[(7$2)L3YN<*!N;YC M\QR>E7M2\(M=WL]U9:O=6#7=NMM=B)%;S47(!&X?*P!(R/6NFHI5[G M+:IX)MM1M=-L$O)+?3[`1A($C0M\A!!60C:4'6"["*Q97^\K*>"#Q^0J?4/"LFH7NEWLFIEKJQB,9DEM M8Y/-R5);!&%.5'(Z5TE%',PYF<^_A<3>+8=?GOG=K<,(85B1,!EP0S@;F7J0 M#T)JWKNB)K=M`HN9;2YMIEGM[F(`M$XR,X/!!!((/4&M6BE=BYF<_=>'+J\M M["2369QJEE(TD5ZL*#(8$,I3&"I&!CKP.:IOX"T^;2X+*YGEN`+\ZA=/*JDW M,A!#;AT`.>W3`KK**?,Q\S.73P3:R0:'!?W+W\6D>8(UGC4B567:H<=#M&/K MBI]4\+O=ZF^H:?JEQIEQ-;BVG,**PDC!)7AA\K#)P1ZUT-%',PYF M05.[>`."2V&YR/E%=/11S,.>7] M9\GA"/[$D<%_/!=0W\M];W*JI:-W9BRX/!7#%<'M7244KL7,SEU\%P&TV37L MTMU)J,6HW%RRKF61""!@\BU&ZM8Y&W"!%5EC]0N>@ 2SDX[9KTZBJ4Y+9E*I):IG__9 ` end