SEC Company Response from CALLISTO PHARMACEUTICALS INC (CIK 0001142380) — Jun 6, 2005
CALLISTO PHARMACEUTICALS INC (CIK 0001142380)
Date: June 6, 2005 · CIK: 0001142380 · Accession: 0000930413-05-004162
AI Filing Summary & Sentiment
File numbers found in text: 333-123863
Referenced dates: April 29, 2005, April 29, 2005
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June 6, 2005
Securities and Exchange Commission
Division of Corporation Finance
450 Fifth Street, N.W.
Washington, D.C. 20549
Attention: Jeffrey Riedler, Esq.
Re: Callisto Pharmaceuticals, Inc.
Form S-3 filed April 5, 2005
File No. 333-123863
Dear Mr. Riedler:
This letter sets forth the responses of Callisto Pharmaceuticals, Inc., a
Delaware corporation (the "Company" or "we"), to the comments received from the
Staff (the "Staff") of the Securities and Exchange Commission (the "Commission")
by letter dated April 29, 2005 concerning the Company's Registration Statement
on Form S-3 (File No. 333-123863) filed with the Commission on April 5, 2005
(the "Registration Statement"). We are authorized by the Company to provide the
responses contained in this letter on behalf of the Company.
The numbers of the responses in this letter correspond to the numbers of
the Staff's comments as set forth in its letter to the Company dated April 29,
2005. References in the text of the responses herein to captions and page
numbers are to Amendment No. 1 to Form S-3 or to Form 10-K/A for the year ended
December 31, 2004, as applicable, both of which are being filed herewith. For
your convenience, we set forth each comment from your comment letter in bold
type-face and include the Company's response below it.
GENERAL
1. PLEASE NOTE THAT WHERE WE PROVIDE EXAMPLES TO ILLUSTRATE WHAT WE MEAN BY
OUR COMMENTS, THEY ARE EXAMPLES AND NOT EXHAUSTIVE LISTS. IF OUR COMMENTS
ARE APPLICABLE TO PORTIONS OF THE FILING THAT WE HAVE NOT CITED AS
EXAMPLES, MAKE THE APPROPRIATE CHANGES IN ACCORDANCE WITH OUR COMMENTS.
Where applicable, we have made changes in accordance with your comments
throughout Amendment No. 1 to Form S-3 and Form 10-K/A.
2. WE NOTE THAT YOUR 10-KSB INDICATES THAT YOUR PUBLIC FLOAT EXCEEDS $40
MILLION. PLEASE PROVIDE US WITH AN ANALYSIS SUPPORTING THE COMPANY'S
DECISION TO FILE A FORM 10-KSB INSTEAD OF A 10-K. WE NOTE THAT THE FLOAT
DISCLOSED ON THE PRIOR 10-K WAS NEARLY $70 MILLION.
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We have converted the Form 10-KSB to a Form 10-K for the year ended
December 31, 2004.
3. PLEASE INCLUDE PAGE NUMBERS ON THE FILING.
We have included page numbers on Amendment No. 1 to Form S-3.
FORM S-3
SUMMARY
4. PLEASE CONSIDER PRESENTING THIS INFORMATION USING MORE SIMPLE LANGUAGE THAT
INVESTORS WILL UNDERSTAND. AS A FEW EXAMPLES ONLY, TERMS SUCH AS
"OSTEOLYTIC BONE DISEASE," "ANTHRACYCLINE," "REFRACTORY," AND SIMILARLY
COMPLEX TERMS SHOULD BE REPLACED WITH MORE SIMPLE TERMS OR DEFINED THE
FIRST TIME THEY ARE USED SO THAT INVESTORS CAN EASILY UNDERSTAND YOUR
DISCLOSURE. PLEASE REVIEW THE SECTION AND THE RISK FACTORS AND REVISE THE
SECTION ACCORDINGLY.
Throughout the Summary section of Amendment No. 1 to Form S-3 and Form
10-K/A we have replaced or defined complex terms.
5. WE NOTE YOUR USE OF THE TERM "PHASE I/II" REGARDING YOUR RECENTLY COMPLETED
AND CURRENTLY ONGOING CLINICAL TRIALS REGARDING YOUR TWO RESPECTIVE
PRODUCTS. THE USE OF THE TERM "PHASE I/II" SHOULD ONLY BE USED IF YOUR
TRIAL MET ALL THE FDA REQUIREMENTS FOR A PHASE II STUDY. PLEASE TELL US
WHETHER OR NOT YOUR PHASE I/II TRIAL MET ALL OF THE REQUIREMENTS OF PHASE
II CLINICAL TRIALS. WE NOTE THAT PHASE II TRIALS TYPICALLY INVOLVE
ADMINISTERING THE PRODUCT UNDER DEVELOPMENT TO 100-300 PARTICIPANTS,
ALLOWING FOR THE EVALUATION OF THE EFFECTIVENESS OF THE DRUG AND
DETERMINING THE SHORT-TERM SIDE EFFECTS AND RISKS. HAS THE FDA AGREED THAT
YOUR RESPECTIVE STUDIES WERE DESIGNED TO MEET THE REQUIREMENTS OF PHASE II
TRIALS? FOR ANY OF YOUR STUDIES NOT DESIGNED TO MEET ALL REQUIREMENTS OF
FDA APPROVED PHASE II CLINICAL TRIALS, PLEASE DELETE THE REFERENCES TO
"PHASE I/II," REPLACE THE REFERENCES WITH THE TERM "PHASE I" AND EXPLAIN
THAT THE TRIALS ARE DESIGNATED TO PROVIDE INFORMATION RELATED TO THE
EFFICACY, NOT THE EFFECTIVENESS, OF THE PRODUCT CANDIDATE. THIS COMMENT
ALSO APPLIES TO YOUR REFERENCES TO "PHASE II/III" THROUGHOUT THE
PROSPECTUS.
The use of the term "Phase I/IIa" is unique to cancer trials where an
experimental drug entering the clinic is immediately evaluated in cancer
patients rather than in healthy volunteers which is the case for other
disease indications. Consequently, in cancer trials, the term "Phase I/IIa"
is used rather than "Phase I" which is the designation for an initial
safety trial in the clinic. A Phase I/IIa cancer trial has the potential to
pick up an early indication of a drug effect which is something that is
normally assessed in a Phase II trial in other diseases. The ongoing
Atiprimod clinical trial in relapsed multiple myeloma patients qualifies as
a Phase I/IIa trial, by these criteria. The protocol was reviewed by the
FDA and by the institutional review boards of the clinical institutions
where the
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clinical trial is being held. As stated on page 5 of Form 10-K/A under
"Development Strategy" the primary objective of the clinical study is to
assess the safety of the drug and the secondary objective is to measure the
pharmacokinetics, evaluate the response in patients with refractory disease
and to identify possible surrogate responses to the drug to better
determine the mechanism of drug action. Therefore, the Atiprimod clinical
trial's objectives are to assess the safety as well as some efficacy of the
drug which is why it is a Phase I/IIa clinical trial.
The earlier trial of Annamycin also qualifies as a Phase I/IIa trial as it
was conducted in relapsed leukemia patients, and in fact, data were
reported on complete remissions in this study, which is an effect that
exemplifies the Phase IIa portion of the Phase I/IIa trial.
We do not refer to a Phase II/III trial designation in Amendment No. 1 to
Form S-3 or in Form 10-K/A since no such designation exists in clinical
development.
RECENT DEVELOPMENTS
6. PLEASE EXPLAIN WHAT YOU MEAN BY "IRB APPROVAL."
In Recent Developments in Amendment No. 1 to Form S-3 on page 6, we have
defined IRB approval as Institutional Review Board approval.
RISK FACTORS
7. WHEN DISCLOSING A RISK FACTOR, YOU SHOULD CUSTOMIZE IT WITH SPECIFIC
REASONS WHY YOU MAY BE EXPOSED TO A PARTICULAR RISK SO AS TO MAKE THE
DISCLOSURE MORE MEANINGFUL. AS ONE EXAMPLE ONLY, THE DISCLOSURE IN "IF OUR
AGREEMENTS WITH ANORMED oR THE UNIVERSITY OF TEXAS.. .," YOU SHOULD EXPAND
AND CUSTOMIZE THE RISK FACTOR TO DISCLOSE WHETHER THERE ARE ANY FACTS OR
CIRCUMSTANCES THAT COULD CAUSE YOU TO MISS A PAYMENT OR OTHERWISE HAVE
EITHER OF THESE AGREEMENTS TERMINATED, RATHER THAN GENERICALLY REFERRING TO
THEIR POSSIBLE TERMINATION BECAUSE OF A MISSED PAYMENT.
PLEASE REVIEW ALL OF YOUR RISK FACTORS TO ENSURE THAT YOUR DISCLOSURE IS
CUSTOMIZED FOR THE COMPANY AND IS AS SPECIFIC AS POSSIBLE. IN YOUR RESPONSE
LETTER, PLEASE IDENTIFY ALL PLACES WHERE REVISIONS ARE MADE IN RESPONSE TO
THIS COMMENT.
We have reviewed all of our risk factors to ensure that our disclosure is
customized and is as specific as possible. The following risk factors have
been modified in response to this comment.
"If our agreements with AnorMED Inc. or the University of Texas .....".
"Delays in clinical testing .....".
"If our product candidates are unable to compete effectively ......".
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"If our relationships with our contract manufacturer for Annamycin .....".
"We will need to increase the size of our organization .....".
"It is difficult and costly to protect our proprietary rights ......".
8. IN YOUR HEADING, PLEASE ELIMINATE THE SENTENCE "THE RISKS DESCRIBED BELOW
ARE NOT THE ONLY ONES AFFECTING US." ALL MATERIAL RISK FACTORS SHOULD BE
DISCLOSED.
In the heading to Risk Factors in Amendment No. 1 to Form S-3 on page 7 we
have deleted the sentence "the risks described below are not the only ones
affecting us."
"WE HAVE INCURRED SIGNIFICANT LOSSES..."
9. PLEASE UPDATE YOUR FINANCIAL DATA IN THIS RISK FACTOR TO INCLUDE NUMBERS
FOR THE FIRST QUARTER OF THIS YEAR.
Such risk factor in Amendment No. 1 to Form S-3 on page 7 has been updated
to include financial data for the quarter ended March 31, 2005.
"WE WILL NEED TO RAISE SUBSTANTIAL ADDITIONAL CAPITAL.."
10. PLEASE DISCLOSE THE AMOUNT OF CASH YOU EXPEND ON A MONTHLY BASIS. IF THERE
IS A SIGNIFICANT VARIABILITY, PLEASE INCLUDE A RANGE.
Such risk factor in Amendment No. 1 to Form S-3 and Form 10-K/A on page 8
and 10, respectively, has been modified to disclose the amount of cash
expended in 2004 and on a monthly basis during 2004 which is an average.
"DELAYS IN CLINICAL TESTING. . ."
11. PLEASE DISCLOSE ANY DELAYS YOU HAVE EXPERIENCED IN CLINICAL TRIALS TO THIS
POINT.
Such risk factor has been modified in Amendment No. 1 to Form S-3 and Form
10-K/A on page 9 and 11, respectively.
"THE COMMERCIAL SUCCESS OF OUR PRODUCTS..."
12. TO THE EXTENT THAT THERE ARE FACTS OR CIRCUMSTANCES THAT WOULD SUPPORT THE
CONCERNS SET FORTH IN THE BULLET POINTS IN THIS SECTION, PLEASE DISCLOSE
THOSE FACTS IN THIS RISK FACTOR.
We have removed this risk factor because our lead drug candidates are
targeting cancers that have no "standard of care." In the event our lead
drug candidates are approved we anticipate the concerns set forth in this
risk factor will not be a material risk to the Company.
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"IF OUR PRODUCT CANDIDATES ARE UNABLE TO COMPETE EFFECTIVELY.."
13. IF THERE ARE ANY PRODUCTS ON THE MARKET OR IN DEVELOPMENT THAT WOULD BE
COMPETITIVE WITH YOUR PRODUCTS, PLEASE DESCRIBE THOSE PRODUCTS AND DISCLOSE
ANY ADVANTAGES THAT THOSE PRODUCTS MIGHT HAVE RELATIVE TO YOUR PRODUCTS.
Such risk factor has been modified in Amendment No. 1 to Form S-3 and Form
10-K/A on page 10 and page 11, respectively.
"WE MAY NEED OTHERS TO MARKET AND COMMERCIALIZE OUR PRODUCT CANDIDATES..
14. PLEASE DISCLOSE IF YOU HAVE ANY CURRENT PLANS TO ENTER INTERNATIONAL
MARKETS.
Such risk factor has been modified in Amendment No. 1 to Form S-3 and Form
10-K/A on page 11 and page 12, respectively, to state that we have no
current plans to enter international markets.
"IF THE FDA DOES NOT APPROVE OUR CONTRACT MANUFACTURERS' FACILITIES. . ." "WE
RELY UPON THIRD PARTIES TO CONDUCT CLINICAL TRIALS..."
15. CURRENTLY, THIS RISK FACTOR DESCRIBES THE POTENTIAL PROBLEMS ASSOCIATED
WITH COLLABORATIONS. HOWEVER, IF THE COMPANY IS CURRENTLY DEPENDENT UPON
COLLABORATORS IN A MATERIAL WAY (SUCH AS THE THIRD PARTY MANUFACTURERS AND
CLINICAL TRIAL PROVIDERS YOU DESCRIBE IN A SUBSEQUENT RISK FACTOR), THIS
RISK FACTOR SHOULD ALSO DISCUSS THE RISKS ASSOCIATED WITH THAT DEPENDENCE.
YOU SHOULD DESCRIBE THE SPECIFIC COLLABORATION UPON WHICH YOU ARE DEPENDENT
SO THAT INVESTORS CAN UNDERSTAND THE DEPENDENCE AND THE RISKS ASSOCIATED
WITH LOSING THE COLLABORATION. YOU SHOULD ALSO DESCRIBE THE ALTERNATIVES
THE COMPANY WOULD FACE IF THE COLLABORATION WERE LOST.
In Amendment No. 1 to Form S-3 and Form 10-K/A on page 12 and 13,
respectively, we have added a risk factor regarding our dependence on the
manufacturer of Annamycin which discusses the risks associated with that
dependence as well as the alternatives we would face if the collaboration
was lost.
"IF WE FAIL TO ATTRACT AND KEEP SENIOR MANAGEMENT.."
16. TO THE EXTENT THAT YOU HAVE EXPERIENCED PROBLEMS ATTRACTING AND RETAINING
KEY PERSONNEL IN THE RECENT PAST, PLEASE REVISE TO DESCRIBE THESE PROBLEMS.
ADDITIONALLY, IF ANY KEY EMPLOYEE HAS PLANS TO RETIRE OR LEAVE YOUR COMPANY
IN THE NEAR FUTURE, PLEASE REVISE THE DISCUSSION TO DISCLOSE THIS
INFORMATION.
To date we have not experienced problems attracting and retaining key
personnel. We are not aware of any key employee planning to retire or leave
our company in the near future.
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"IF WE FAIL TO ACQUIRE AND DEVELOP.."
17. PLEASE DISCLOSE WHETHER ACQUISITIONS ARE A MATERIAL COMPONENT OF YOUR
BUSINESS MODEL OR BUSINESS STRATEGY AND ALSO DISCLOSE WHETHER THE COMPANY
HAS ANY CURRENT INTENTIONS TO ACQUIRE ANOTHER COMPANY.
Such risk factor has been modified in Amendment No. 1 to Form S-3 and Form
10-K/A on page 13 and 14_, respectively, to state that as part of our
growth strategy in addition to developing our product candidates, we intend
to license or acquire additional products and product candidates. We also
state that we have no current intentions to acquire another company.
"WE WILL NEED TO INCREASE THE SIZE OF OUR ORGANIZATION.."
18. PLEASE DISCLOSE THE NUMBER OF NEW EMPLOYEES THAT THE COMPANY PLANS TO HIRE
TO FULFILL ITS STRATEGY FOR THE NEXT TWO YEARS.
Such risk factor has been modified in Amendment No. 1 to Form S-3 and Form
10-K/A on page 14 and 15, respectively, to disclose the approximate number
of employees the Company plans to hire over the next year. The Company was
uncomfortable forecasting a number beyond one year since the determination
is dependent on the progress of the Company's development activities and
clinical trials as well as financing of the Company.
19. IN ADDITION, YOU INDICATE THAT YOU WILL BROADEN EXPERTISE AND EXTEND
MANUFACTURING CAPABILITIES. PLEASE EXPAND THIS DISCUSSION TO DISCLOSE
SPECIFICALLY WHAT YOUR P1ANS ARE IN THESE REGARDS.
We do not have any plans to broaden expertise and develop or extend
manufacturing capabilities.
"RISKS RELATED TO OUR INTELLECTUAL PROPERTY"
20. WITH RESPECT TO YOUR CONCERNS REGARDING INTELLECTUAL PROPERTY, PLEASE
DISCLOSE WHAT INTELLECTUAL PROPERTY THAT YOU POSSESS AND ANY SPECIFIC
CONCERNS THAT YOU MAY HAVE, EITHER WITH REGARD TO INVALIDATION OR CLAIMS
THAT YOU HAVE INFRINGED UPON THE RIGHTS OF OTHERS.
Such risk factor in Amendment No. 1 to Form S-3 and Form 10-K/A on page 15
and 16, respectively, has been modified to disclose our intellectual
property. We currently do not have any specific concerns either with regard
to invalidation or claims the we have infringed upon the rights of others.
21. PLEASE DISCLOSE WHEN YOUR MATERIAL PATENTS WILL EXPIRE.
Such risk factor in Amendment No. 1 to Form S-3 and Form 10-K/A on page 15
and 16, respectively, has been modified to state when our material patents
will expire.
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RISKS ASSOCIATED WITH OUR COMMON STOCK
"WE ARE AT RISK OF SECURITIES CLASS ACTION LITIGATION"
22. TO THE EXTENT THAT THERE ARE ANY FACTS OR CIRCUMSTANCES THAT MIGHT INDICATE
THAT A PARTY IS CONSIDERING BRINGING A CLASS ACTION SUIT AGAINST THE
COMPANY OR IF ONE HAS BEEN FILED, DISCLOSE THOSE FACTS IN THIS RISK FACTOR.
We are not aware of any facts or circumstances that might indicate that a
party is considering bringing a class action suit against the Company.
SELLING SECURITYHOLDERS
23. WE CALL TO YOUR ATTENTION THE REQUIREMENTS OF FORM S-3 WITH RESPECT TO THE
INFORMATION REQUIRED BY ITEM 507 (SELLING SHAREHOLDERS). WE NOTE THAT
CERTAIN ENTITIES LISTED AS SELLING SHAREHOLDERS IN THE SELLING
SECURITYHOLDER TABLE MAY BE BROKER-DEALERS THAT HAVE OBTAINED THE SHARES
OTHER THAN AS COMPENSATION FOR SERVICES. IN THAT EVENT, SUCH SELLING
SHAREHOLDERS ARE DEEMED UNDERWRITERS UNDER THE SECURITIES ACT OF 1933. IN
THAT CASE, PLEASE REVISE YOUR REGISTRATION