[LETTERHEAD OF ADVENTRX]
AUGUST 8, 2005
VIA EDGAR AND FACSIMILE ((202) 772-9217)
Jeffrey Riedler, Esq.
Assistant Director
Securities and Exchange Commission
100 F Street, N.E.
Washington, DC 20549
RE: ADVENTRX PHARMACEUTICALS, INC.
FORM 10-KSB FOR THE YEAR ENDED DECEMBER 31, 2004
PROXY STATEMENT FILED MAY 20, 2005
FILE NO. 1-32157
Dear Mr. Riedler:
We are responding to the staff's July 28, 2005 comment letter in the
above matter. Our responses are keyed to each comment with each comment IN BOLD
and our response in a bullet point after the comment. Also, we have attached
pages from our proposed Amendment No. 1 to the 10-KSB for 2004, marked to
reflect the changes we propose to make (subject to staff review) in response to
these comments. We will file Amendment No. 1 by Edgar once we hear that the
staff has no additional comments.
FORM 10-KSB
RISK FACTORS, page 19
1. MANY OF YOUR RISK FACTORS COULD APPLY TO ANY ISSUER. PLEASE ENSURE THAT
ALL RISK FACTORS IN YOUR FILING DESCRIBE YOUR COMPANY'S CIRCUMSTANCES
WITH SPECIFICITY. WE NOTE THE FOLLOWING EXAMPLES:
o IN "IT IS UNCERTAIN THAT WE WILL HAVE ACCESS TO FUTURE CAPITAL OR
GOVERNMENT GRANTS" ON PAGE 19, PLEASE DESCRIBE THE DIFFICULTIES
YOU WOULD NEED TO OVERCOME TO OBTAIN A GOVERNMENT GRANT.
> we will delete the reference to government grants which are
not a source of funding on which we rely or on which we
presently plan to rely in the future.
Securities and Exchange Commission
August 8, 2005
Page 2
o "WE ARE NOT CERTAIN THAT WE WILL BE SUCCESSFUL . . ." ON PAGE 19,
PLEASE DESCRIBE ANY MATERIAL DELAYS OR DIFFICULTIES YOUR PRODUCTS
HAVE EXPERIENCED IN THE DEVELOPMENT PROCESS.
> we will enhance the disclosure to include delays due to lack
of funding in the past and manufacturing delays. While we have
not yet experienced manufacturing delays of commercial volumes
of our product, we are faced with challenges relating to
developing the manufacturing process to produce sufficient
quantities of our drugs to be used in preclinical and clinical
trials.
o IN "WE WILL FACE INTENSE COMPETITION FROM OTHER COMPANIES IN THE
PHARMACEUTICAL INDUSTRY" ON PAGE 20, PLEASE IDENTIFY YOUR
PRINCIPAL COMPETITORS AND THEIR PRODUCTS THAT COMPETE WITH YOURS.
> we will identify principal competitors and the competing
product.
o IN "UNCERTAINTIES RELATED TO HEALTH CARE REFORM MEASURES MAY
AFFECT OUR SUCCESS" ON PAGE 21, PLEASE IDENTIFY ANY REFORM
PROPOSALS THAT WOULD MATERIALLY AFFECT ON YOUR BUSINESS, AND STATE
WHERE THESE PROPOSALS STAND IN THE ENACTMENT PROCESS.
> we know of no current such proposals. We have revised this
risk factor accordingly.
o IF YOU HAVE RECEIVED NOTICE OF ANOTHER COMPANY'S BELIEF THAT YOU
ARE INFRINGING THEIR PATENT, OR IF YOU HAVE NOTIFIED ANOTHER
COMPANY OF YOUR BELIEF THAT THEY ARE INFRINGING ON YOUR PATENTS,
PLEASE DESCRIBE THE SITUATION AND POTENTIAL CONSEQUENCES IN
"PROTECTING OUR PROPRIETARY RIGHTS IS DIFFICULT AND COSTLY" ON
PAGE 23.
> there are no such pending infringement matters. We have
modified the risk factor accordingly.
o PLEASE IDENTIFY THE KEY PERSONNEL YOU REFER TO IN "OUR SUCCESS IS
DEPENDENT ON OUR KEY PERSONNEL" AND "WE MAY BE UNABLE TO RETAIN
SKILLED PERSONNEL AND MAINTAIN KEY RELATIONSHIPS" ON PAGE 23, AND
STATE WHETHER YOU HAVE WRITTEN EMPLOYMENT AGREEMENTS WITH THESE
INDIVIDUALS.
> we will delete the risk factor "OUR SUCCESS IS DEPENDENT ON
OUR KEY PERSONNEL" as no single employee or group of employees
is incapable of being replaced, and we will revise the other
risk factor.
WITH THE ABOVE GUIDANCE IN MIND, PLEASE RE-EVALUATE ALL RISK FACTORS
AND TAILOR THEM MORE TO YOUR COMPANY.
Securities and Exchange Commission
August 8, 2005
Page 3
> we have re-evaluated all risk factors and made the following
changes in response to this comment:
o deleted the risk factor entitled "Insurance coverage is
increasingly more difficult to obtain or maintain" since
much the same subject matter is covered in the succeeding
risk factor.
o deleted the risk factor entitled "We are not paying
dividends on our Common Stock" since stockholders should
be aware they are not receiving dividends and our dividend
policy is already stated in Part II, Item 5 of the 10-KSB.
o deleted the risk factor entitled "The issuance of shares
of our Preferred Stock may adversely affect our Common
Stock" since this is a standard risk of all companies and
is not specific to us.
o deleted the risk factor entitled "Under provisions of our
certificate of incorporation, bylaws and Delaware law, our
management may be able to block or impede a change in
control," since that type of disclosure describes standard
provisions in the certificates of incorporation of many
Delaware companies and is not material to the other
disclosures in the 10-KSB.
o deleted the risk factor entitled "Officers' and directors'
liabilities are limited under Delaware law," since that
risk factor simply describes a provision of Delaware law
which is a standard provision in the certificates of
incorporation of many Delaware companies, and is not
material to the other disclosures in the 10-KSB.
POWER OF ATTORNEY, PAGE 35
2. WE NOTE THE FILING DOES NOT INCLUDE THE SIGNATURE OF YOUR CONTROLLER OR
PRINCIPAL ACCOUNTING OFFICER. PLEASE INCLUDE THIS SIGNATURE IN AN
AMENDED FORM 10-KSB. IF CARRIE CARLANDER, THE CFO, ALSO SERVES AS THE
CONTROLLER OR PRINCIPAL ACCOUNTING OFFICER, HER SIGNATURE SHOULD BE
CAPTIONED AS SUCH IN YOUR AMENDED FILING. SEE GENERAL INSTRUCTION C.2
OF FORM 10-KSB.
> At the time our 10-KSB was filed, Ms. Carlander was operating
as both our CFO and our principal accounting officer. We will
include a signature page in Amendment No. 1 to the Form 10-KSB
which will indicate her current status as CFO and her status
as CFO and principal accounting officer at the time of the
original filing of the 10-KSB.
Securities and Exchange Commission
August 8, 2005
Page 4
PROXY STATEMENT
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, PAGE 12
3. IT APPEARS YOU DID NOT FILE AS AN EXHIBIT YOUR AGREEMENT WITH BURNHAM
HILL PARTNERS. PLEASE FILE THIS AGREEMENT WITH YOUR AMENDED FORM
10-KSB. SEE ITEM 601(b)(10)(i)(A) OF REGULATION S-B.
> We will file the Burnham Hill Partners agreement as an exhibit
to Amendment No. 1
The Company acknowledges the following:
o the Company is responsible for the adequacy and accuracy of the
disclosure in the above-referenced filings;
o staff comments or changes to disclosure in response to staff comments
do not foreclose the Commission from taking any action with respect to
the filing; and
o the Company may not assert staff comments as a defense in any
proceeding initiated by the Commission or any person under the federal
securities laws of the United States.
Please call the undersigned at (858) 552-0866 or Henry D. Evans, Esq. of Bingham
McCutchen LLP at (415) 393-2503, or Venrice R. Palmer, Esq. of that office at
(415) 393-2036, the Company's outside counsel, if you have any questions
concerning this response.
Sincerely,
/s/ Evan Levine
Evan Levine
Chief Executive Officer
cc: Gregory S. Belliston, Esq. (by facsimile)
Division of Corporation Finance
Henry D. Evans, Esq. (by facsimile)
Bingham McCutchen LLP
Venrice R. Palmer, Esq. (by facsimile)
Bingham McCutchen LLP