SEC Company Response from Tonix Pharmaceuticals Holding Corp. (TNXP) (CIK 0001430306) (TNXP) — Dec 23, 2011
Tonix Pharmaceuticals Holding Corp. (TNXP) (CIK 0001430306)
Date: Dec. 23, 2011 · CIK: 0001430306 · Accession: 0001013762-11-003410
AI Filing Summary & Sentiment
Reasoning
File numbers found in text: 333-150149
Referenced dates: November 10, 2011
Letter
corresp.htm
Tonix Pharmaceuticals Holding Corp.
509 Madison Avenue, Suite 306
New York, New York 10022
December 27, 2011
VIA EDGAR
Securities and Exchange Commission
100 F Street, N.E.
Washington, DC 20549-7010
Attn:
John Reynolds, Assistant Director
Division of Corporation Finance
James Lopez, Branch Chief
Division of Corporation Finance
Ruairi Regan, Esq.
John Archfield
Joanna Lam
Re:
Tonix Pharmaceuticals Holding Corp.
Current Report on Form 8-K
Filed October 14, 2011
File No. 333-150149
Ladies and Gentlemen:
The following responses address the comments of the reviewing Staff of the Commission as set forth in a comment letter dated November 10, 2011 (the "Comment Letter") relating to the Current Report on Form 8-K filed on October 14, 2011 (the "Form 8-K") by Tonix Pharmaceuticals Holding Corp. (the Company”). The answers set forth herein refer to each of the Staff’s' comments by number.
We are filing herewith Amendment No. 1 to the Company's Form 8-K.
Description of our Business, page 4
1.
Your business description should address the general development of your business for the past three years. For example, your corporate overview should clearly explain your relationship to each of the persons and entities referenced in that description. Also, expand your disclosure in this section to describe clearly the activities you have undertaken to develop your products since inception, including, for example, the research and development activities described on pages 37 and 38, and why, for example, you do not appear to have undertaken further studies on TNX-102 since the Phase 2a study in 2001.
Securities and Exchange Commission
December 27, 2011
Page 2 of 13
Response
We have revised our business description to address the general development of our business for the past three years, including explaining our relationship to each person/entity referenced and further describing activities undertaken to develop our products since inception.
2.
Please revise to clarify if and how the development studies, research and other necessary activities you describe are being conducted by your employees, L&L Technologies, Lederman & Co, Pharmanet Canada or others. Please describe any arrangements to share responsibilities or designate certain tasks as the responsibility of one or a number of the participating groups of persons.
Response
We have revised our disclosure to clarify what activities are being conducted by employees, consultants or others. We have also clarified which persons/entities are responsible for what tasks.
3.
We note the statement on your subsidiary’s website that “[d]ue to the competitive nature of this business, Krele is not disclosing the assets it is developing or is considering adding to its portfolio.” With a view to clarifying disclosure, advise us of any such assets.
Response
Because of capital and personnel constraints we do not currently have active business activities within Krele. Earlier this year, we were evaluating generic products based on:
‐
Calcitriol;
‐
Ibuprofen (400mg, 600mg, 800mg);
‐
Naproxin (250mg, 375mg, 500mg);
‐
Nystatin powder; and
‐
Disulfiram.
As both funds and time permit, Krele will continue to review additional generic product opportunities. Because Gerald Price resigned from Krele and because Krele’s activities have been slowed down, we have moved the Krele disclosure to a later point in the business description.
4.
Please clarify when you intend to undertake the proposed studies you outline in this section, and disclose in approximate quantitative terms the material costs, if any, associated with each of those studies.
Response
We have revised our disclosure to discuss the intended timeline for the proposed studies mentioned, along with anticipated costs of such studies.
Securities and Exchange Commission
December 27, 2011
Page 3 of 13
5.
Please revise to provide an overview, in quantitative and qualitative terms, summarizing the approximate amount of time to reach commercialization for each of your principal product candidates taking into account material factors such as research and regulatory approval. Also, given the state of development of your products, revise your disclosure that appears to suggest you already create marketable products, such as your disclosure that “We create new dose formulations” on page 4.
Response
We have revised our disclosure to provide an overview as to the anticipated timeline and costs for each of our principal product candidates to reach commercialization. With regards to the disclosure that “We create new dose formulations,” this is accurate because we do create new dose formulations as part of our research and development, with such dosage formulations adjusted to achieve our targeted results. We have revised our disclosure to state that we do not market any of these new formulations.
6.
Please clarify the purpose of the licenses disclosed at the bottom of the second paragraph in this section.
Response
We have revised our disclosure to state that such licenses are required in order to manufacture, distribute and market prescription medications.
7.
Please tell us why your business description does not appear to address the rights relating to isometheptene mucate that you acquired from Lederman & Co. LLC pursuant to Exhibit 10.7.
Response
We have revised our disclosure to include the rights relating to isometheptene mucate that we acquired from Lederman & Co. LLC.
8.
Please revise to reconcile the statement on page six that “the therapeutic uses we target are new uses for these active ingredients” with the disclosure that cyclobenzaprine is widely used off-label to treat FM.
Response
We have revised the disclosure to indicate that when our patents were initially filed, the therapeutic uses we target were novel and unexpected, and that since our patents were filed, the use of cyclobenzaprine off-label to treat FM has apparently become widely used.
Securities and Exchange Commission
December 27, 2011
Page 4 of 13
9.
We note the statement on page seven that “TNX-102, our most advanced product candidate, is a bedtime pill.” Your disclosure suggests that you currently have a manufactured pill. Please revise to clarify. Also, it is unclear what you mean by “advanced” and in what way TNX-102 is closer to commercialization than TNX-105.
Response
We have revised our disclosure to indicate that the TNX-102 pill has been manufactured in small quantities for use in human clinical trials. As disclosed in the Form 8-K, we have conducted a clinical trial with bedtime very low dose cyclobenzaprine on fibromyalgia patients, whereas no clinical trials have been conducted with regards to TNX-105. As such, TNX-102 is closer to commercialization than TNX-105.
Emerging Market Opportunity, page 10
10.
Please revise to further clarify the nature of the studies and findings you identify in the two bullet points on page 10. For example, it is unclear what material elements made up the study conducted by Caliper Life Sciences and when it was undertaken. It is also unclear what your basis is for the “findings” in the first bullet point. Please disclose what activities were undertaken, the nature of any analyses conducted on those results, and the background of the individuals who conducted the activities and analyses.
Response
We have revised the disclosure to indicate the material elements of the study conducted by Caliper Life Sciences on the interactions of active pharmaceutical ingredients with receptors and when they were conducted. We also have revised the disclosure to indicate the basis for the findings, the activities undertaken, and analyses and the background of the individual involved. With regards to our “findings” in the first bullet point, we have changed findings to clinical studies. As disclosed throughout the business section, a low dose cyclobenzaprine has had therapeutic effects on FM symptoms. TNX-102 is a new formulation of low dose cyclobenzaprine.
11.
Similarly, we note the statement that “[o]ther compounds that bind this receptor have been shown to have effects in treating PTSD.” It is unclear why you do not describe what effects the compound had and what studies or institutions were the source of the observations that “have been shown.” Please revise accordingly.
Response
We have revised our disclosure to provide greater clarity about the rationale for studying the effects of cyclobenzaprine in PTSD. Specifically, our study from Caliper Life Sciences determined that cyclobenzaprine interacted with a receptor on brain cells called the serotonin type 2a receptor. Furthermore, it is a scientific fact that other compounds that bind this receptor have been shown to have effects in treating PTSD. Both of these statements, that (i) other compounds bind to the serotonin type 2a receptor and (ii) those other compounds have been shown to have effects in treating PTSD, are supported by numerous peer-reviewed scientific publications. We believe it would be unnecessary and confusing to the reader to provide cites to these publications, but for the Commission’s review, the following are approximately two dozen supporting articles:
Securities and Exchange Commission
December 27, 2011
Page 5 of 13
Anttila, S. A. and E. V. Leinonen (2001). "A review of the pharmacological and clinical profile of mirtazapine." CNS Drug Rev 7(3): 249-64.
Bahk, W. M., C. U. Pae, et al. (2002). "Effects of mirtazapine in patients with post-traumatic stress disorder in Korea: a pilot study." Hum Psychopharmacol 17(7): 341-4.
Bartzokis, G., P. H. Lu, et al. (2005). "Adjunctive risperidone in the treatment of chronic combat-related posttraumatic stress disorder." Biol Psychiatry 57(5): 474-9.
Brophy, M. H. (1991). "Cyproheptadine for combat nightmares in post-traumatic stress disorder and dream anxiety disorder." Mil Med 156(2): 100-1.
Chung, M. Y., K. H. Min, et al. (2004). "Efficacy and tolerability of mirtazapine and sertraline in Korean veterans with posttraumatic stress disorder: a randomized open label trial." Hum Psychopharmacol 19(7): 489-94.
Connor, K. M., J. R. Davidson, et al. (1999). "A pilot study of mirtazapine in post-traumatic stress disorder." Int Clin Psychopharmacol 14(1): 29-31.
Cusack, B., A. Nelson, et al. (1994). "Binding of antidepressants to human brain receptors: focus on newer generation compounds." Psychopharmacology (Berl) 114(4): 559-65.
Davidson, J. R., R. H. Weisler, et al. (2003). "Mirtazapine vs. placebo in posttraumatic stress disorder: a pilot trial." Biol Psychiatry 53(2): 188-91.
Davidson, J. R., R. H. Weisler, et al. (1998). "Treatment of posttraumatic stress disorder with nefazodone." Int Clin Psychopharmacol 13(3): 111-3.
Davis, L. L., M. E. Jewell, et al. (2004). "A placebo-controlled study of nefazodone for the treatment of chronic posttraumatic stress disorder: a preliminary study." J Clin Psychopharmacol 24(3): 291-7.
Hamner, M. B., R. A. Faldowski, et al. (2003). "Adjunctive risperidone treatment in post-traumatic stress disorder: a preliminary controlled trial of effects on comorbid psychotic symptoms." Int Clin Psychopharmacol 18(1): 1-8.
Harsch, H. H. (1986). "Cyproheptadine for recurrent nightmares." Am J Psychiatry 143(11): 1491-2.
Hertzberg, M. A., M. E. Feldman, et al. (1996). "Trial of trazodone for posttraumatic stress disorder using a multiple baseline group design." J Clin Psychopharmacol 16(4): 294-8.
Hertzberg, M. A., M. E. Feldman, et al. (1998). "Open trial of nefazodone for combat-related posttraumatic stress disorder." J Clin Psychiatry 59(9): 460-4.
Hidalgo, R., M. A. Hertzberg, et al. (1999). "Nefazodone in post-traumatic stress disorder: results from six open-label trials." Int Clin Psychopharmacol 14(2): 61-8.
Honda, M., T. Nishida, et al. (2003). "Tricyclic analogs cyclobenzaprine, amitriptyline and cyproheptadine inhibit the spinal reflex transmission through 5-HT(2) receptors." Eur J Pharmacol 458(1-2): 91-9.
Kim, W., C. U. Pae, et al. (2005). "The effectiveness of mirtazapine in the treatment of post-traumatic stress disorder: a 24-week continuation therapy." Psychiatry Clin Neurosci 59(6): 743-7.
Lewis, J. D. (2002). "Mirtazapine for PTSD nightmares." Am J Psychiatry 159(11): 1948-9.
Owens, M. J., W. N. Morgan, et al. (1997). "Neurotransmitter receptor and transporter binding profile of antidepressants and their metabolites." J Pharmacol Exp Ther 283(3): 1305-22.
Rijnders, R. J. P., D. D. M. Laman, et al. (2000). "Cyproheptadine for Posttraumatic Nightmares." Am J Psychiatry 157(9): 1524-a-1525.
Stein, M. B., N. A. Kline, et al. (2002). "Adjunctive olanzapine for SSRI-resistant combat-related PTSD: a double-blind, placebo-controlled study." Am J Psychiatry 159(10): 1777-9.
Warner, M. D., M. R. Dorn, et al. (2001). "Survey on the usefulness of trazodone in patients with PTSD with insomnia or nightmares." Pharmacopsychiatry 34(4): 128-31.
Securities and Exchange Commission
December 27, 2011
Page 6 of 13
Drug Delivery Technology, page 11
12.
Please describe the material terms of your agreement with Lipocine, Inc. referenced in the first paragraph. Also, describe the reformulation work being undertaken by Lipocine on your behalf.
Response
We have revised the disclosure to indicate the material terms of the agreement with Lipocine and the reformulation work being undertaken by Lipocine. As the payment terms of our agreement with Lipocine are subject to a pending request for confidential treatment, they have not been disclosed in the amended Form 8-K.
13.
Please provide an expanded description of the study referenced in the second paragraph, including the extent of the study, how the results were measured and when it was undertaken.
Response
We have revised the disclosure to expand the description of the study including the extent of the study and how the results were measured and when it was undertaken.
Intellectual Property, page 14
14.
With a view to disclosure, please tell us which intellectual property disclosed on page 14 relates to TNX-201 that you disclose on page 37 was received from Lederman & Co. in exchange for $295,500. Please disclose the duration of material patents. Also, given your disclosure in the fourth paragraph on page 23 regarding licenses, please describe your material patent licenses and file material license agreements as exhibits.
Response
We have revised the disclosure in our MD&A section to state that Tonix incurred an expense of $295,500 in June 2010 related to the technical transfer of intellectual property associated with Isometheptene Mucate (“ICA IP”), which included all patentable subject matter, all resulting patent applications and patents and other intellectual property and data relating to the ICA IP. In addition, we have disclosed the duration of our material patents. Currently, we have no licensed patents. Pursuant to our agreement with Lipocine, which is filed as an exhibit to the Form 8-K, we have the option to purchase exclusive licenses to certain patents held by Lipocine. As a result, we have revised our disclosure accordingly.
Securities and Exchange Commission
December 27, 2011
Page 7 of 13
Risk Factors, page 20
15.
Please revise page 20 or where appropriate to further address “potential side effects.” We note, for example, the reference to adverse effects of cyclobenzaprine on slide 42 of Exhibit 99.02.
Response
We have revised the disclosure to describe the two most significant potential side effects of cyclobenzaprine.
16.
Consider revising here or where appropriate to address any material risk related to the assumption that there will be a significant market-wide increase in the use of all muscle relaxants for the treatment of FM. We note slide 23 of Exhibit 99.02.
Response
The significant market-wide increase is directly related to the anticipated sales
Show Raw Text
CORRESP
1
filename1.htm
corresp.htm
Tonix Pharmaceuticals Holding Corp.
509 Madison Avenue, Suite 306
New York, New York 10022
December 27, 2011
VIA EDGAR
Securities and Exchange Commission
100 F Street, N.E.
Washington, DC 20549-7010
Attn:
John Reynolds, Assistant Director
Division of Corporation Finance
James Lopez, Branch Chief
Division of Corporation Finance
Ruairi Regan, Esq.
John Archfield
Joanna Lam
Re:
Tonix Pharmaceuticals Holding Corp.
Current Report on Form 8-K
Filed October 14, 2011
File No. 333-150149
Ladies and Gentlemen:
The following responses address the comments of the reviewing Staff of the Commission as set forth in a comment letter dated November 10, 2011 (the "Comment Letter") relating to the Current Report on Form 8-K filed on October 14, 2011 (the "Form 8-K") by Tonix Pharmaceuticals Holding Corp. (the Company”). The answers set forth herein refer to each of the Staff’s' comments by number.
We are filing herewith Amendment No. 1 to the Company's Form 8-K.
Description of our Business, page 4
1.
Your business description should address the general development of your business for the past three years. For example, your corporate overview should clearly explain your relationship to each of the persons and entities referenced in that description. Also, expand your disclosure in this section to describe clearly the activities you have undertaken to develop your products since inception, including, for example, the research and development activities described on pages 37 and 38, and why, for example, you do not appear to have undertaken further studies on TNX-102 since the Phase 2a study in 2001.
Securities and Exchange Commission
December 27, 2011
Page 2 of 13
Response
We have revised our business description to address the general development of our business for the past three years, including explaining our relationship to each person/entity referenced and further describing activities undertaken to develop our products since inception.
2.
Please revise to clarify if and how the development studies, research and other necessary activities you describe are being conducted by your employees, L&L Technologies, Lederman & Co, Pharmanet Canada or others. Please describe any arrangements to share responsibilities or designate certain tasks as the responsibility of one or a number of the participating groups of persons.
Response
We have revised our disclosure to clarify what activities are being conducted by employees, consultants or others. We have also clarified which persons/entities are responsible for what tasks.
3.
We note the statement on your subsidiary’s website that “[d]ue to the competitive nature of this business, Krele is not disclosing the assets it is developing or is considering adding to its portfolio.” With a view to clarifying disclosure, advise us of any such assets.
Response
Because of capital and personnel constraints we do not currently have active business activities within Krele. Earlier this year, we were evaluating generic products based on:
‐
Calcitriol;
‐
Ibuprofen (400mg, 600mg, 800mg);
‐
Naproxin (250mg, 375mg, 500mg);
‐
Nystatin powder; and
‐
Disulfiram.
As both funds and time permit, Krele will continue to review additional generic product opportunities. Because Gerald Price resigned from Krele and because Krele’s activities have been slowed down, we have moved the Krele disclosure to a later point in the business description.
4.
Please clarify when you intend to undertake the proposed studies you outline in this section, and disclose in approximate quantitative terms the material costs, if any, associated with each of those studies.
Response
We have revised our disclosure to discuss the intended timeline for the proposed studies mentioned, along with anticipated costs of such studies.
Securities and Exchange Commission
December 27, 2011
Page 3 of 13
5.
Please revise to provide an overview, in quantitative and qualitative terms, summarizing the approximate amount of time to reach commercialization for each of your principal product candidates taking into account material factors such as research and regulatory approval. Also, given the state of development of your products, revise your disclosure that appears to suggest you already create marketable products, such as your disclosure that “We create new dose formulations” on page 4.
Response
We have revised our disclosure to provide an overview as to the anticipated timeline and costs for each of our principal product candidates to reach commercialization. With regards to the disclosure that “We create new dose formulations,” this is accurate because we do create new dose formulations as part of our research and development, with such dosage formulations adjusted to achieve our targeted results. We have revised our disclosure to state that we do not market any of these new formulations.
6.
Please clarify the purpose of the licenses disclosed at the bottom of the second paragraph in this section.
Response
We have revised our disclosure to state that such licenses are required in order to manufacture, distribute and market prescription medications.
7.
Please tell us why your business description does not appear to address the rights relating to isometheptene mucate that you acquired from Lederman & Co. LLC pursuant to Exhibit 10.7.
Response
We have revised our disclosure to include the rights relating to isometheptene mucate that we acquired from Lederman & Co. LLC.
8.
Please revise to reconcile the statement on page six that “the therapeutic uses we target are new uses for these active ingredients” with the disclosure that cyclobenzaprine is widely used off-label to treat FM.
Response
We have revised the disclosure to indicate that when our patents were initially filed, the therapeutic uses we target were novel and unexpected, and that since our patents were filed, the use of cyclobenzaprine off-label to treat FM has apparently become widely used.
Securities and Exchange Commission
December 27, 2011
Page 4 of 13
9.
We note the statement on page seven that “TNX-102, our most advanced product candidate, is a bedtime pill.” Your disclosure suggests that you currently have a manufactured pill. Please revise to clarify. Also, it is unclear what you mean by “advanced” and in what way TNX-102 is closer to commercialization than TNX-105.
Response
We have revised our disclosure to indicate that the TNX-102 pill has been manufactured in small quantities for use in human clinical trials. As disclosed in the Form 8-K, we have conducted a clinical trial with bedtime very low dose cyclobenzaprine on fibromyalgia patients, whereas no clinical trials have been conducted with regards to TNX-105. As such, TNX-102 is closer to commercialization than TNX-105.
Emerging Market Opportunity, page 10
10.
Please revise to further clarify the nature of the studies and findings you identify in the two bullet points on page 10. For example, it is unclear what material elements made up the study conducted by Caliper Life Sciences and when it was undertaken. It is also unclear what your basis is for the “findings” in the first bullet point. Please disclose what activities were undertaken, the nature of any analyses conducted on those results, and the background of the individuals who conducted the activities and analyses.
Response
We have revised the disclosure to indicate the material elements of the study conducted by Caliper Life Sciences on the interactions of active pharmaceutical ingredients with receptors and when they were conducted. We also have revised the disclosure to indicate the basis for the findings, the activities undertaken, and analyses and the background of the individual involved. With regards to our “findings” in the first bullet point, we have changed findings to clinical studies. As disclosed throughout the business section, a low dose cyclobenzaprine has had therapeutic effects on FM symptoms. TNX-102 is a new formulation of low dose cyclobenzaprine.
11.
Similarly, we note the statement that “[o]ther compounds that bind this receptor have been shown to have effects in treating PTSD.” It is unclear why you do not describe what effects the compound had and what studies or institutions were the source of the observations that “have been shown.” Please revise accordingly.
Response
We have revised our disclosure to provide greater clarity about the rationale for studying the effects of cyclobenzaprine in PTSD. Specifically, our study from Caliper Life Sciences determined that cyclobenzaprine interacted with a receptor on brain cells called the serotonin type 2a receptor. Furthermore, it is a scientific fact that other compounds that bind this receptor have been shown to have effects in treating PTSD. Both of these statements, that (i) other compounds bind to the serotonin type 2a receptor and (ii) those other compounds have been shown to have effects in treating PTSD, are supported by numerous peer-reviewed scientific publications. We believe it would be unnecessary and confusing to the reader to provide cites to these publications, but for the Commission’s review, the following are approximately two dozen supporting articles:
Securities and Exchange Commission
December 27, 2011
Page 5 of 13
Anttila, S. A. and E. V. Leinonen (2001). "A review of the pharmacological and clinical profile of mirtazapine." CNS Drug Rev 7(3): 249-64.
Bahk, W. M., C. U. Pae, et al. (2002). "Effects of mirtazapine in patients with post-traumatic stress disorder in Korea: a pilot study." Hum Psychopharmacol 17(7): 341-4.
Bartzokis, G., P. H. Lu, et al. (2005). "Adjunctive risperidone in the treatment of chronic combat-related posttraumatic stress disorder." Biol Psychiatry 57(5): 474-9.
Brophy, M. H. (1991). "Cyproheptadine for combat nightmares in post-traumatic stress disorder and dream anxiety disorder." Mil Med 156(2): 100-1.
Chung, M. Y., K. H. Min, et al. (2004). "Efficacy and tolerability of mirtazapine and sertraline in Korean veterans with posttraumatic stress disorder: a randomized open label trial." Hum Psychopharmacol 19(7): 489-94.
Connor, K. M., J. R. Davidson, et al. (1999). "A pilot study of mirtazapine in post-traumatic stress disorder." Int Clin Psychopharmacol 14(1): 29-31.
Cusack, B., A. Nelson, et al. (1994). "Binding of antidepressants to human brain receptors: focus on newer generation compounds." Psychopharmacology (Berl) 114(4): 559-65.
Davidson, J. R., R. H. Weisler, et al. (2003). "Mirtazapine vs. placebo in posttraumatic stress disorder: a pilot trial." Biol Psychiatry 53(2): 188-91.
Davidson, J. R., R. H. Weisler, et al. (1998). "Treatment of posttraumatic stress disorder with nefazodone." Int Clin Psychopharmacol 13(3): 111-3.
Davis, L. L., M. E. Jewell, et al. (2004). "A placebo-controlled study of nefazodone for the treatment of chronic posttraumatic stress disorder: a preliminary study." J Clin Psychopharmacol 24(3): 291-7.
Hamner, M. B., R. A. Faldowski, et al. (2003). "Adjunctive risperidone treatment in post-traumatic stress disorder: a preliminary controlled trial of effects on comorbid psychotic symptoms." Int Clin Psychopharmacol 18(1): 1-8.
Harsch, H. H. (1986). "Cyproheptadine for recurrent nightmares." Am J Psychiatry 143(11): 1491-2.
Hertzberg, M. A., M. E. Feldman, et al. (1996). "Trial of trazodone for posttraumatic stress disorder using a multiple baseline group design." J Clin Psychopharmacol 16(4): 294-8.
Hertzberg, M. A., M. E. Feldman, et al. (1998). "Open trial of nefazodone for combat-related posttraumatic stress disorder." J Clin Psychiatry 59(9): 460-4.
Hidalgo, R., M. A. Hertzberg, et al. (1999). "Nefazodone in post-traumatic stress disorder: results from six open-label trials." Int Clin Psychopharmacol 14(2): 61-8.
Honda, M., T. Nishida, et al. (2003). "Tricyclic analogs cyclobenzaprine, amitriptyline and cyproheptadine inhibit the spinal reflex transmission through 5-HT(2) receptors." Eur J Pharmacol 458(1-2): 91-9.
Kim, W., C. U. Pae, et al. (2005). "The effectiveness of mirtazapine in the treatment of post-traumatic stress disorder: a 24-week continuation therapy." Psychiatry Clin Neurosci 59(6): 743-7.
Lewis, J. D. (2002). "Mirtazapine for PTSD nightmares." Am J Psychiatry 159(11): 1948-9.
Owens, M. J., W. N. Morgan, et al. (1997). "Neurotransmitter receptor and transporter binding profile of antidepressants and their metabolites." J Pharmacol Exp Ther 283(3): 1305-22.
Rijnders, R. J. P., D. D. M. Laman, et al. (2000). "Cyproheptadine for Posttraumatic Nightmares." Am J Psychiatry 157(9): 1524-a-1525.
Stein, M. B., N. A. Kline, et al. (2002). "Adjunctive olanzapine for SSRI-resistant combat-related PTSD: a double-blind, placebo-controlled study." Am J Psychiatry 159(10): 1777-9.
Warner, M. D., M. R. Dorn, et al. (2001). "Survey on the usefulness of trazodone in patients with PTSD with insomnia or nightmares." Pharmacopsychiatry 34(4): 128-31.
Securities and Exchange Commission
December 27, 2011
Page 6 of 13
Drug Delivery Technology, page 11
12.
Please describe the material terms of your agreement with Lipocine, Inc. referenced in the first paragraph. Also, describe the reformulation work being undertaken by Lipocine on your behalf.
Response
We have revised the disclosure to indicate the material terms of the agreement with Lipocine and the reformulation work being undertaken by Lipocine. As the payment terms of our agreement with Lipocine are subject to a pending request for confidential treatment, they have not been disclosed in the amended Form 8-K.
13.
Please provide an expanded description of the study referenced in the second paragraph, including the extent of the study, how the results were measured and when it was undertaken.
Response
We have revised the disclosure to expand the description of the study including the extent of the study and how the results were measured and when it was undertaken.
Intellectual Property, page 14
14.
With a view to disclosure, please tell us which intellectual property disclosed on page 14 relates to TNX-201 that you disclose on page 37 was received from Lederman & Co. in exchange for $295,500. Please disclose the duration of material patents. Also, given your disclosure in the fourth paragraph on page 23 regarding licenses, please describe your material patent licenses and file material license agreements as exhibits.
Response
We have revised the disclosure in our MD&A section to state that Tonix incurred an expense of $295,500 in June 2010 related to the technical transfer of intellectual property associated with Isometheptene Mucate (“ICA IP”), which included all patentable subject matter, all resulting patent applications and patents and other intellectual property and data relating to the ICA IP. In addition, we have disclosed the duration of our material patents. Currently, we have no licensed patents. Pursuant to our agreement with Lipocine, which is filed as an exhibit to the Form 8-K, we have the option to purchase exclusive licenses to certain patents held by Lipocine. As a result, we have revised our disclosure accordingly.
Securities and Exchange Commission
December 27, 2011
Page 7 of 13
Risk Factors, page 20
15.
Please revise page 20 or where appropriate to further address “potential side effects.” We note, for example, the reference to adverse effects of cyclobenzaprine on slide 42 of Exhibit 99.02.
Response
We have revised the disclosure to describe the two most significant potential side effects of cyclobenzaprine.
16.
Consider revising here or where appropriate to address any material risk related to the assumption that there will be a significant market-wide increase in the use of all muscle relaxants for the treatment of FM. We note slide 23 of Exhibit 99.02.
Response
The significant market-wide increase is directly related to the anticipated sales