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SEC Company Response from SOLIGENIX, INC. (SNGX) (CIK 0000812796) (SNGX) — Dec 18, 2006

SOLIGENIX, INC. (SNGX) (CIK 0000812796)
Date: Dec. 18, 2006 · CIK: 0000812796 · Accession: 0000812796-06-000073

AI Filing Summary & Sentiment

Sentiment
Urgency
Document Type
Confidence
SEC Posture
Company Posture

Summary

Reasoning

Referenced dates: December 5, 2006

Date
Dec. 18, 2006
Author
Not clearly detected
Form
CORRESP
Company
SOLIGENIX, INC. (SNGX) (CIK 0000812796)

Letter

Division of Corporation Finance United States Securities and Exchange Commission F Street, NE Washington, D.C. 20549 RE: Review of Filings and comments related to Form 10KSB for the Fiscal Year Ended December 31, 2005 and Form 10QSB for the Fiscal Quarter Ended June 30, 2006.

Dear Ms. Buckner:

Thank you for the opportunity to work with you and discuss the disclosure requirements. This letter is in response to your letter dated December 5, 2006. Below please find our responses to your inquiries and comments.

Form 10-KSB for the Fiscal Year Ended December 31,

Management’s Discussion and Analysis or Plan of Operation

Material Changes in Results of Operations

1. We acknowledge your response to comment 2. Please provide us with additional information, in a disclosure-type format, that reconciles the total research and development expense presented in your proposed disclosure for each project to the total research and development expense on the face of your statement of operations for the year ended December 31, 2005. More specifically, the aggregate 2005 expense per proposed disclosure appears to be $5,766,478, which does not reconcile to the face of your 2005 statement of operations. Please either reconcile the individual project information to the aggregate 2005 expense or tell us why the amounts per your proposed disclosure do not reconcile to the 2005 statement.

RESPONSE for 1.:

We hereby supplement the information previously supplied to you for comment 2..

The table below details our costs for 2005 and 2006 by project.

Projects-Research & Development Expenses

orBec®

$ 2,209,770

RiVax™

480,120

BT-VACC™

979,247

Oraprine™

8,100

LPMTM-Leuprolide

3,900

Research & Development Expense

$ 3,681,137

Projects-Reimbursed under Grant

orBec®

$ 124,958

RiVax™

1,942,076

BT-VACC™

-

Oraprine™

-

LPMTM-Leuprolide

-

Reimbursed under Grant

$ 2,067,034

TOTAL

$ 5,748,171

In addition, from previous response to 2.A, that read:

“Since 2000, we have incurred expenses of $13,925,498 in the development of orBec®. Research and development costs for orBec® totaled $2,209,770 in 2005 and $1,940,052 in the second quarter of 2006. Since June 30th 2006, we anticipate that the remaining R&D costs for orBec® will approximate $2 million. If orBec® is approved by the FDA in the first quarter of 2007, we expect orBec® to begin generating revenues by the third quarter of 2007. If the FDA rejects the NDA or does not approve orBec® in a timely manner, our financial condition, liquidity, and ability to raise additional equity financing could be impaired.”

Correction to read:

Since 2000, we have incurred expenses of $13,925,498 in the development of orBec®. Research and development costs for orBec® totaled $2,209,770 in 2005 of which $124,958 are for costs reimbursed under the FDA orphan products grant and $1,940,052 in the second quarter of 2006. Since June 30th 2006, we anticipate that the remaining R&D costs for orBec® will approximate $2 million. If orBec® is approved by the FDA in the third quarter of 2007, we expect orBec® to begin generating revenues by the fourth quarter of 2007. If the FDA rejects the NDA or does not approve orBec® in a timely manner (or in accordance with anticipated and established timelines), our financial condition, liquidity, and ability to raise additional equity financing could be impaired.

In addition, from previous response to 2.B, that read:

“The costs that we have incurred to develop RiVax™ since 2002 to date total $6,360,523. R&D costs for RiVax™ totaled $2,565,461 in 2005 and $2,130,516 in the second quarter of 2006”

Correction to read:

The costs that we have incurred to develop RiVax™ since 2002 to date total $6,360,523. R&D costs for RiVax™ totaled $2,422,196 in 2005 of which $1,942,076 are for costs reimbursed under the NIH grant, and $2,130,516 in the second quarter of 2006, of which $1,128,257 are for costs reimbursed under this grant.

Notes to Consolidated Financial Statements

Note 2. Summary of Significant Accounting Policies

Intangible Asset

2.

We acknowledge your response to comment 4. Please provide us with further detail regarding the “alternative future use” associated with both the UTSW RiVax vaccine license ($425k) and the SRI Brookwood license fee ($600k), as contemplated under paragraph 11c. of SFAS No. 2. Specifically, please tell us whether you could have used the RiVax vaccine and the SRI/Brookwood platform technology, in their current condition at the time of purchase, in other identifiable research and development projects that you had identified to be commenced at a future date and whether you could reasonably believe that any such future projects would generate economic benefit for your company. Finally, please clarify for us the financial reporting period during which you capitalized each of these license fees and tell us what the unamortized balance was related to each as of December 31, 2005.

RESPONSE for 2.:

We hereby supplement the information previously supplied to you for comment 4. As explained most of our intangible assets have alternative future uses; this is common in the pharmaceutical development industry. Of the intangible asset balance, $1,025,000 is for up-front license costs. We purchased a license from the University of Texas Southwestern (“UTSW”), for the license to the RiVaxTM vaccine for $425,000. We also purchased a license from a “pharmaceutical company” namely Southern Research Institute/Brookwood Pharmaceuticals, for a license of microsphere technology for $600,000. We capitalize license costs because they have alternative future use as referred to in paragraph 11 c. of SFAS No.2. We believe that both of these intangible assets purchased have alternative future uses. With respect to UTSW, we believe that arising out of the development of the vaccine RiVaxTM, our vaccine against ricin toxin, could potentially be a therapeutic antibody product to treat patients exposed to ricin toxin; this product would be purified antibodies from the serum of vaccinated animals or humans. In addition, the technology addresses specific methods to create vaccines from toxins that have similar structure, so that it is possible that a series of related vaccines can be developed. The technology is also applicable to distinctly different forms of vaccines which can be utilized by different patient populations based on route of delivery. Specifically, we envision future uses of the ricin vaccine for oral and nasal administration. Such uses also demand the introduction of complementary technology. With respect to SRI/Brookwood, at the time we purchased the license in 1998, we were aware that this technology was a platform technology for oral and nasal delivery of vaccines. This technology was also a key element of the business model of Innovaccines Corporation, a joint venture that we formed with Elan Corporation. In 2002, we and Elan dissolved Innovaccines, but we purchased the Elan rights to the microsphere technology, with a view toward developing its applications in biodefense and emerging infectious disease vaccines. This included the application to anthrax, plague, ricin, and other biowarfare toxins and pathogens. The value to us at the time was certainly in the knowledge that it could be applied to the development of any and all subunit vaccines that could be administered orally, as well as specific biodefense applications. Specifically, we engaged in product development for an orally administered ricin vaccine based on the SRI/Brookwood microspheres, but found that the technology did not have sufficient potency for commercial development. Consequently, due to its cost and reduced development prospects we decided to terminate the SRI/Brookwood agreement and have subsequently impaired the asset in the second quarter of 2006.

3.

We acknowledge your response to comment 5. It remains unclear, based on your response, how you concluded that it is appropriate to capitalize costs related to the protection/maintenance of your patent rights. Please tell us the basis for future accounting policy, referring to applicable authoritative accounting literature. Please also quantify for us the amount of such costs that you capitalized for the financial statement periods presented in your 2005 Form 10-KSB and tell us where you classified those cost on the related balance sheets

RESPONSE for 3.:

We hereby supplement the information previously supplied to you for comment 5. We capitalize legal costs associated with the protection and maintenance of our patents. For a development stage company with drug and vaccine products in an often lengthy basic and clinical research process, we believe that patent rights form one of our most valuable assets. Patents and patent applications are a key currency of intellectual property, especially in the early stage of product development, as their purchase and maintenance gives us access to key product development rights from our academic and industrial partners. These rights can also be sold or sub-licensed as part of our strategy to partner our products at each stage of development. The legal costs incurred for these patents consist of work designed to protect, preserve, maintain and perhaps extend the lives of the patents. Therefore, our policy is to capitalize these costs and amortize them over the remaining useful life of the patents. We maintain that we capitalize this based on intangible assets and the alternative future use as referred to in SFAS No.142 and in paragraph 11 c. of SFAS No. 2 as well as in the response to 2.

During 2005, we capitalized $250,570 in patent related costs. This amount is represented in the Cash Flow statement, in the section for investing activities presented in the 2005 10-KSB financial statements. On the balance sheet this amount is presented on the line intangible assets, net in the amount of $1,803,020. We also explain this amount in note 5 of the 2005 10-KSB. Attached is the excerpt from note 5.

5. Intangible Assets

The following is a summary of intangible assets which consists of licenses and patents:

Weighted Average Amortization period (years)

Cost

Accumulated

Amortization

Net Book Value

December 31, 2005

10.2

$ 2,605,472

$ 802,452

$ 1,803,020

December 31, 2004

10.6

$ 2,611,195

$ 728,741

$ 1,882,454

Amortization expense was $168,841 and $302,449 for 2005 and 2004, respectively.

Revenue Recognition

4.

We acknowledge your response to comment 6. Please confirm that you will include the expanded disclosure provided in your September 8, 2006 response letter in your next periodic report to be filed with the Commission, presumably your December 31, 2006 Form 10-KSB.

RESPONSE for 4.:

We will include the following disclosure in future filings:

All of our revenues are from government grants which are based upon subcontractor costs and internal costs covered by the grant, plus a facilities and administrative rate that provides funding for overhead expenses. Revenues are recognized when expenses have been incurred by subcontractors or when we incur internal expenses that are related to the grant.

Note 7. Shareholders’ Equity

Common Stock

Stock Compensation to Non-Employees

5. We acknowledge your response to comment 8. Pursuant to Question 18 of FIN 44, it does not appear that a “grant date” existed for the 2004 employee/director options in question until your board/shareholders approved your 2005 Equity Incentive Plan. As a result, it remains unclear why you believe variable accounting was appropriate for these stock options in December 2004. Giving consideration to Question 18 of FIN 44, please clarify your accounting position for us. Additionally, please provide us with a materiality analysis under provisions of SAB No. 99 with respect to the $285,000 that you recorded as expense in fiscal 2004 and subsequently reversed to income in fiscal 2005.

RESPONSE for 5.:

We believe that the answer provided in our previous response is adequate notwithstanding question 18 of FIN 44, that concludes that if a grant is not approved a measurement date does not exist and that in December of 2004, our authorized number of options under the then current 1995 stock option plan was insufficient to grant the options described above. The options were 1,764,339 in excess of the authorized number. Therefore, determination of a measurement date was not possible until the new plan was approved by the shareholders. According to FIN28, Footnote 1, “Plans for which the number of shares of stock that may be acquired by or awarded to an employee or the price or both are not specified or determinable until after the date of grant

Show Raw Text
CORRESP
1
filename1.htm

      DOR SEC Comment Letter 2nd Response for Letter of 12-5-06

    DOR
      BioPharma, Inc.

    1101
      Brickell Avenue

    701-S

    Miami,
      FL
      33131

    December
      18, 2006

    SENT
      VIA EDGAR

    Amy
      C. Buckner

    Staff
      Accountant

    Division
      of Corporation Finance

    United
      States Securities and Exchange Commission

    100
      F
      Street, NE

    Washington,
      D.C. 20549

    RE:
      Review of Filings and comments related to Form 10KSB for the Fiscal Year Ended
      December 31, 2005 and Form 10QSB for the Fiscal Quarter Ended June 30, 2006.

    Dear
      Ms.
      Buckner:

    Thank
      you
      for the opportunity to work with you and discuss the disclosure requirements.
      This letter is in response to your letter dated December 5, 2006. Below please
      find our responses to your inquiries and comments.

    Form
      10-KSB for the Fiscal Year Ended December 31,
      2005

    Management’s
      Discussion and Analysis or Plan of Operation

    Material
      Changes in Results of Operations

    1.
      We
      acknowledge your response to comment 2. Please provide us with additional
      information, in a disclosure-type format, that reconciles the total research
      and
      development expense presented in your proposed disclosure for each project
      to
      the total research and development expense on the face of your statement of
      operations for the year ended December 31, 2005. More specifically, the
      aggregate 2005 expense per proposed disclosure appears to be $5,766,478, which
      does not reconcile to the face of your 2005 statement of operations. Please
      either reconcile the individual project information to the aggregate 2005
      expense or tell us why the amounts per your proposed disclosure do not reconcile
      to the 2005 statement.

    RESPONSE
      for 1.:

    We
      hereby
      supplement the information previously supplied to you for comment 2..

    The
      table
      below details our costs for 2005 and 2006 by project.

              2005

              Projects-Research
                & Development Expenses

              orBec®

              $
                2,209,770

              RiVax™

              480,120

              BT-VACC™

              979,247

              Oraprine™

              8,100

              LPMTM-Leuprolide

              3,900

              Research
                & Development Expense

              $
                3,681,137

              Projects-Reimbursed
                under Grant

              orBec®

              $
                124,958

              RiVax™

              1,942,076

              BT-VACC™

              -

              Oraprine™

              -

              LPMTM-Leuprolide

              -

              Reimbursed
                under Grant

              $
                2,067,034

              TOTAL

              $
                5,748,171

    In
      addition, from previous response to 2.A, that read:

    “Since
      2000, we have incurred expenses of $13,925,498 in the development of
      orBec®.
      Research and development costs for orBec®
      totaled $2,209,770 in 2005 and $1,940,052 in the second quarter of 2006. Since
      June 30th
      2006, we anticipate that the remaining R&D costs for orBec®
      will
      approximate $2 million. If orBec®
      is
      approved by the FDA in the first quarter of 2007, we expect
      orBec®
      to
      begin generating revenues by the third quarter of 2007. If the FDA rejects
      the
      NDA or does not approve orBec®
      in a
      timely manner, our financial condition, liquidity, and ability to raise
      additional equity financing could be impaired.”

    Correction
      to read:

    Since
      2000, we have incurred expenses of $13,925,498 in the development of
      orBec®.
      Research and development costs for orBec®
      totaled
      $2,209,770 in 2005 of which $124,958 are for costs reimbursed under the FDA
      orphan products grant and $1,940,052 in the second quarter of 2006. Since June
      30th
      2006, we
      anticipate that the remaining R&D costs for orBec®
      will
      approximate $2 million. If orBec®
      is
      approved by the FDA in the third quarter of 2007, we expect orBec®
      to begin
      generating revenues by the fourth quarter of 2007. If the FDA rejects the NDA
      or
      does not approve orBec®
      in a
      timely manner (or in accordance with anticipated and established timelines),
      our
      financial condition, liquidity, and ability to raise additional equity financing
      could be impaired.

    In
      addition, from previous response to 2.B, that read:

    “The
      costs that we have incurred to develop RiVax™
      since
      2002 to date total $6,360,523. R&D costs for RiVax™
      totaled $2,565,461 in 2005 and $2,130,516 in the second quarter of 2006”

    Correction
      to read:

    The
      costs
      that we have incurred to develop RiVax™ since 2002 to date total $6,360,523.
      R&D costs for RiVax™ totaled $2,422,196 in 2005 of which $1,942,076 are for
      costs reimbursed under the NIH grant, and $2,130,516 in the second quarter
      of
      2006, of which $1,128,257 are for costs reimbursed under this grant.

    Notes
      to Consolidated Financial Statements

    Note
      2. Summary of Significant Accounting Policies

    Intangible
      Asset

          2.

            We
              acknowledge your response to comment 4. Please provide us with further
              detail regarding the “alternative future use” associated with both the
              UTSW RiVax vaccine license ($425k) and the SRI Brookwood license fee
              ($600k), as contemplated under paragraph 11c. of SFAS No. 2. Specifically,
              please tell us whether you could have used the RiVax vaccine and the
              SRI/Brookwood platform technology, in their current condition at the
              time
              of purchase, in other identifiable research and development projects
              that
              you had identified to be commenced at a future date and whether you
              could
              reasonably believe that any such future projects would generate economic
              benefit for your company. Finally, please clarify for us the financial
              reporting period during which you capitalized each of these license
              fees
              and tell us what the unamortized balance was related to each as of
              December 31, 2005.

    RESPONSE
      for 2.:

    We
      hereby
      supplement the information previously supplied to you for comment 4. As
      explained most of our intangible assets have alternative future uses; this
      is
      common in the pharmaceutical development industry. Of the intangible asset
      balance, $1,025,000 is for up-front license costs. We purchased a license from
      the University of Texas Southwestern (“UTSW”), for the license to the
      RiVaxTM
      vaccine
      for $425,000. We also purchased a license from a “pharmaceutical company” namely
      Southern Research Institute/Brookwood Pharmaceuticals, for a license of
      microsphere technology for $600,000. We capitalize license costs because they
      have alternative future use as referred to in paragraph
      11 c. of SFAS No.2.
      We
      believe that both of these intangible assets purchased have alternative future
      uses. With respect to UTSW, we believe that arising out of the development
      of
      the vaccine RiVaxTM,
      our
      vaccine against ricin toxin, could potentially be a therapeutic antibody product
      to treat patients exposed to ricin toxin; this product would be purified
      antibodies from the serum of vaccinated animals or humans. In addition, the
      technology addresses specific methods to create vaccines from toxins that have
      similar structure, so that it is possible that a series of related vaccines
      can
      be developed. The technology is also applicable to distinctly different forms
      of
      vaccines which can be utilized by different patient populations based on route
      of delivery. Specifically, we envision future uses of the ricin vaccine for
      oral
      and nasal administration. Such uses also demand the introduction of
      complementary technology. With respect to SRI/Brookwood, at the time we
      purchased the license in 1998, we were aware that this technology was a platform
      technology for oral and nasal delivery of vaccines. This technology was also
      a
      key element of the business model of Innovaccines Corporation, a joint venture
      that we formed with Elan Corporation. In 2002, we and Elan dissolved
      Innovaccines, but we purchased the Elan rights to the microsphere technology,
      with a view toward developing its applications in biodefense and emerging
      infectious disease vaccines. This included the application to anthrax, plague,
      ricin, and other biowarfare toxins and pathogens. The value to us at the time
      was certainly in the knowledge that it could be applied to the development
      of
      any and all subunit vaccines that could be administered orally, as well as
      specific biodefense applications. Specifically, we engaged in product
      development for an orally administered ricin vaccine based on the SRI/Brookwood
      microspheres, but found that the technology did not have sufficient potency
      for
      commercial development. Consequently, due to its cost and reduced development
      prospects we decided to terminate the SRI/Brookwood agreement and have
      subsequently impaired the asset in the second quarter of 2006.

          3.

            We
              acknowledge your response to comment 5. It remains unclear, based on
              your
              response, how you concluded that it is appropriate to capitalize costs
              related to the protection/maintenance of your patent rights. Please
              tell
              us the basis for future accounting policy, referring to applicable
              authoritative accounting literature. Please also quantify for us the
              amount of such costs that you capitalized for the financial statement
              periods presented in your 2005 Form 10-KSB and tell us where you
              classified those cost on the related balance
              sheets

    RESPONSE
      for 3.:

    We
      hereby
      supplement the information previously supplied to you for comment 5. We
      capitalize legal costs associated with the protection and maintenance of our
      patents. For a development stage company with drug and vaccine products in
      an
      often lengthy basic and clinical research process, we believe that patent rights
      form one of our most valuable assets. Patents and patent applications are a
      key
      currency of intellectual property, especially in the early stage of product
      development, as their purchase and maintenance gives us access to key product
      development rights from our academic and industrial partners. These rights
      can
      also be sold or sub-licensed as part of our strategy to partner our products
      at
      each stage of development. The legal costs incurred for these patents consist
      of
      work designed to protect, preserve, maintain and perhaps extend the lives of
      the
      patents. Therefore, our policy is to capitalize these costs and amortize them
      over the remaining useful life of the patents. We
      maintain that we capitalize this based on intangible assets and the alternative
      future use as referred to in SFAS
      No.142 and
      in
      paragraph 11 c. of SFAS No. 2 as
      well
      as in the response to 2.

    During
      2005, we capitalized $250,570 in patent related costs. This amount is
      represented in the Cash Flow statement, in the section for investing activities
      presented in the 2005 10-KSB financial statements. On the balance sheet this
      amount is presented on the line intangible
      assets, net
      in the
      amount of $1,803,020. We also explain this amount in note 5 of the 2005 10-KSB.
      Attached is the excerpt from note 5.

    5.
      Intangible Assets

    The
      following is a summary of intangible assets which consists of licenses and
      patents:

              Weighted
                Average Amortization period
                (years)

              Cost

              Accumulated

              Amortization

              Net
                Book Value

              December
                31, 2005

              10.2

              $
                2,605,472

              $
                802,452

              $
                1,803,020

              December
                31, 2004

              10.6

              $
                2,611,195

              $
                728,741

              $
                1,882,454

    Amortization
      expense was $168,841 and $302,449 for 2005 and 2004, respectively.

    Revenue
      Recognition

          4.

            We
              acknowledge your response to comment 6. Please confirm that you will
              include the expanded disclosure provided in your September 8, 2006
              response letter in your next periodic report to be filed with the
              Commission, presumably your December 31, 2006 Form 10-KSB.

    RESPONSE
      for 4.:

    We
      will
      include the following disclosure in future filings:

    All
      of
      our revenues are from government grants which are based upon subcontractor
      costs
      and internal costs covered by the grant, plus a facilities and administrative
      rate that provides funding for overhead expenses. Revenues are recognized when
      expenses have been incurred by subcontractors or when we incur internal expenses
      that are related to the grant.

    Note
      7. Shareholders’ Equity

    Common
      Stock

    Stock
      Compensation to
      Non-Employees

    5.
      We
      acknowledge your response to comment 8. Pursuant to Question 18 of FIN 44, it
      does not appear that a “grant date” existed for the 2004 employee/director
      options in question until your board/shareholders approved your 2005 Equity
      Incentive Plan. As a result, it remains unclear why you believe variable
      accounting was appropriate for these stock options in December 2004. Giving
      consideration to Question 18 of FIN 44, please clarify your accounting position
      for us. Additionally, please provide us with a materiality analysis under
      provisions of SAB No. 99 with respect to the $285,000 that you recorded as
      expense in fiscal 2004 and subsequently reversed to income in fiscal
      2005.

    RESPONSE
      for 5.:

    We
      believe that the answer provided in our previous response is adequate
      notwithstanding question 18 of FIN 44, that concludes that if a grant is not
      approved a measurement date does not exist and that in December of 2004, our
      authorized number of options under the then current 1995 stock option plan
      was
      insufficient to grant the options described above. The options were 1,764,339
      in
      excess of the authorized number. Therefore, determination of a measurement
      date
      was not possible until the new plan was approved by the shareholders. According
      to FIN28, Footnote 1, “Plans for which the number of shares of stock that may be
      acquired by or awarded to an employee or the price or both are not specified
      or
      determinable until after the date of grant