SEC Company Response from VOLITIONRX LTD (VNRX) (CIK 0000093314) (VNRX) — Feb 24, 2012
VOLITIONRX LTD (VNRX) (CIK 0000093314)
Date: Feb. 24, 2012 · CIK: 0000093314 · Accession: 0001078782-12-000539
AI Filing Summary & Sentiment
File numbers found in text: 000-30402
Referenced dates: January 27, 2012, November 23, 2011
Show Raw Text
CORRESP 1 filename1.htm SEC Response Letter February 24, 2012 Jay Williamson Securities and Exchange Commission Division of Corporation Finance 100 F Street N.E. Washington, DC 20549 Re: VolitionRX Limited Amendment to Form 8-K Filed January 11, 2012 File No. 000-30402 Dear Mr. Williamson: VolitionRX Limited, a Delaware corporation (the “Company”), has received and reviewed your letter of January 27, 2012, pertaining to the Company’s Form 8-K/A (the “Filing”) filed January 11, 2012 with the Securities & Exchange Commission (the “Commission”). Specific to your comments, our responses below are in addition to those filed via the Edgar system: FORM S-1 The following numbered responses correspond to those numbered comments as set forth in the comment letter dated January 27, 2012. Form 8-K/A, filed January 11, 2012 General 1. We note you have made changes to certain financial statement items between Amendment 1 to Form 8-K filed November 1, 2011 and Amendment 2 to Form 8-K filed January 11, 2012. Please revise disclosure to include a discussion of changes that have been made between each amendment. In this regard, we note changes to amounts in your statement of cash flows as well as changes in the per share price of shares issued during each period presented. RESPONSE: We have revised the Filing on Page 2 to include the following language: “EXPLANATORY NOTE This Amendment No. 3 to our Current Report on Form 8-K originally filed on October 13, 2011, (the “Original Filing’) is being made to respond to certain comments received from the Staff of the Securities and Exchange Commission, including, but not limited to, various changes made to certain financial statement items between Amendment No. 1 to the Form 8-K filed November 1, 2011 and Amendment No. 2 to the Form 8-K filed January 11, 2012. 150 Orchard Road Orchard Plaza 08-02 Singapore 238841 Specifically, the financial statements filed as Exhibit 99.02 to Amendment No. 2 as compared to the financial statements for the same period that were filed as Exhibit 99.01 to the Amendment No. 1 reflect the following changes: (i) The figure for non-cash financing activities at the foot of the Consolidated Statement of Cash Flows was amended from $900,000 to $1,000,000 in order to reflect the entire note payable that was entered into; (ii) Note 2(f) Foreign Currency Translation was amended to provide additional information about our functional currency and exchange rate; (iii) Note 4 Property and Equipment was amended to revise the depreciation expense of the Company during the period ended December 11, 2010; (iv) Note 10 Subsequent Events was amended to provide additional information about shares issued for services subsequent to December 31, 2010. In particular, the valuation per share of 350,000 shares issued to a related party was revised from $0.30 to $1.00 to reflect the most recent cash issuance prices relative to the date of grant, and the disclosure was revised as follows: Subsequent to the period end, the Company also issued 350,000 shares of common stock to a related party in advance for research and development and investment relation services to be performed over a five year period. The shares were valued at $1.00 per share based on the most recent cash issuance prices relative to the grant date as this was determined to be the most readily determinable value in accordance with ASC 718 and ASC 505. The Company will expense the shares monthly as services are provided. Because the shares are fully vested and non-forfeitable, the shares were valued based on the current market price on the grant date and will be amortized over the life of the agreement; and (v) Note 10 Subsequent Events was also amended to include further information about the share exchange agreement with Standard Capital Corporation as follows: Upon completion of the transaction, the former shareholders of the Company owned 6,906,852 shares of the Company’s common stock, representing approximately 85% of the outstanding common stock of the Company. As a result, the acquisition has been recorded as a reverse merger with the Company being treated as the accounting acquirer and SCC as the legal acquirer (accounting acquiree). For convenience and ease of reference, the Company is filing this Form 8-K/A in its entirety with all applicable changes and unless otherwise stated, all information contained in this amendment is as of October 13, 2011, the filing date of the Original Filing. Except as stated herein, this Form 8-K/A does not reflect events or transactions occurring after such filing date or modify or update those disclosures in the Original Filing that may have been affected by events or transactions occurring subsequent to such filing date.” Item 1.01 2. Please explain the reference to the cancellation of 40% of the 2.02 million shares issued and outstanding. Please clarify when this cancellation occurred, the terms of the cancellation and how this cancellation was affected. Did the shareholders enter into an agreement for the cancellation of their shares? If so, please file as an exhibit. RESPONSE: Pursuant to the terms and conditions of that certain Share Exchange Agreement by and between Standard Capital Corporation (“Standard”), Singapore Volition Pte Limited, and the respective shareholders thereof, as filed on Form 8-K with the Commission on September 29, 2011, Standard was to effectuate a 0.6-for-1 reverse split which would have reduced each shareholder’s shares by 40% and resulted in 1,212,000 shares of the Company’s common stock issued and outstanding. However, the Company and its shareholders determined that in lieu of effectuating the reverse stock split each shareholder would simply cancel 40% of their existing shares. We have contacted previous management of Standard to obtain all documentation related to this transaction. We will provide you with an updated response once we have received this documentation. 150 Orchard Road Orchard Plaza 08-02 Singapore 238841 2 Item 5.01 3. We reissue prior comment nine from our letter dated November 23, 2011. Please provide the information requested by Item 5.01(a)(6). RESPONSE: We have revised the Filing on Page 4 to include the following language: “On September 26, 2011, the Company, then under the name Standard Capital Corporation, and its controlling stockholders (the “Controlling Stockholders”) entered into a Share Exchange Agreement (the “Share Exchange Agreement”) with Singapore Volition Pte Limited, a Singapore registered company (“Singapore Volition”) and the shareholders of Singapore Volition (the “Volition Shareholders”), whereby the Company acquired 6,908,652 (100%) shares of common stock of Singapore Volition (the “Volition Stock”) from the Volition Shareholders. At the time the Share Exchange Agreement closed, none of the Controlling Stockholders of the Company beneficially owned more than 5% of the Company’s issued and outstanding shares of common stock; accordingly, the Volition Shareholders acquired control collectively from the Board of Directors of the Company and its Officers. Form 10 Disclosure 4. We partially reissue prior comment 11. We continue to note references to your products. For instance, on page nine you state “we currently have two blood tests in the NuQ-X family” and “generally, one of the Company’s tests is used as a frontline test….” Please revise to clearly reflect that you are in the development stage and that you have no products to date. RESPONSE: We have revised the Filing throughout to indicate that we are in the development stage and have no products to date. 5. We note your statement on page six that your “early pilot clinical studies have demonstrated a high rate of detecting cancer … [and while] these small pilot studies must be confirmed in larger clinical studies, [they] are promising findings.” You further state your belief that your tests “will be able to detect and characterize cancer and other disease states better than existing methods based on the outcomes [you] have received …” We note similar statements elsewhere in your document. Please note that statements about the efficacy of your proposed product should be substantiated or removed. Please revise throughout as appropriate. Similarly, we continue to note your statement that you believe your tests will be adopted quickly in the healthcare market because these are ELISA tests. Please provide the basis. We continue to note that you are a development stage company and have only conducted limited testing of these proposed products. In this regard your attention is directed to prior comments 12, 15, and 17 from our letter dated November 23, 2011 for further clarification of the types of statements which require substantiation and the methods for doing so. RESPONSE: We have revised the Filing throughout to remove promotional statements and to either substantiate or remove statements regarding the efficacy of our proposed products. 6. We note your response to prior comment 15 and the revised text on page nine. Please revise to further substantiate these statements or remove them. Where statements are based on the results of scientific studies, please clarify: · The nature and results of the studies performed, including the procedures followed in conducting the study and the confidence levels associated with the results; and, · Advise us which journals you have submitted your studies to and provide us with copies of your submissions. RESPONSE: We have revised the Filing on Page 10 to include the following language: “Early clinical studies of the NuQ-XTM test prototype for the presence of circulating nucleosomes in the blood have been carried out on blood samples from 19 cancer patients (including lung, colon and pancreatic cancers) and 20 healthy patient controls. In these studies, a result was deemed positive if the level of circulating nucleosomes detected in the blood of a patient was elevated above the maximum level of the normal range expected of healthy people as commonly defined (the mean ± 2 standard deviations of the mean which statistically includes 95% of normal people). All tests were performed in duplicate. The results are shown in the graph below (bars show the error of duplicate analysis). 150 Orchard Road Orchard Plaza 08-02 Singapore 238841 3 Figure 2 – Results of NuQ-XTM test prototype clinical study carried out internally by the Company’s scientists at its laboratory in Belgium. Figure 2 shows the Optical Density (colour) result produced in the NuQ-XTM test of serum samples taken from healthy volunteers and subjects diagnosed with lung, colon or pancreatic cancer (as well as positive and negative control samples). Blood samples were taken and the serum was separated in the usual way - approximately 10mL blood was drawn by venepuncture into a glass tube and allowed to clot. The tube was centrifuged for approximately 10 minutes at approximately 3000 x g. The serum was removed to a plastic tube and frozen until analysed by ELISA. 10µL (0.01 mL) of serum was tested using the Nucleosomics ELISA procedure. This was a typical ELISA analytical procedure using 2 antibodies that bind to nucleosomes. The first antibody is immobilised on a plastic surface and the second antibody is linked to a detectable enzyme to monitor antibody nucleosome binding. Uniformly low antibody-nucleosome binding was detected in samples from healthy subjects. Higher antibody-nucleosome binding was detected in samples from subjects diagnosed with cancer. In addition, 12 other disease patient controls (Inflammatory Bowel Disease) were tested using the NuQ-XTM test. Some patients were positive for nucleosomes, but these nucleosomes were found to contain different proportions of histone variants and histone modifications and were distinguishable from cancer nucleosomes using the prototype NuQTM panel. This involved a further four ELISA tests on the same samples to determine the relative proportions of four different types of nucleosomes in the samples. The studies were carried out internally by the Company’s scientists at its laboratory in Belgium using a small number of patient samples from two hospitals in Belgium and samples taken from healthy volunteers in the United Kingdom. The results of these studies have not been submitted to or published in any journals (peer reviewed or otherwise). The Company intends to conduct large scale clinical validations, both retrospective and prospective, of these test prototypes for colon, lung, and pancreatic cancers as well as additional cancer types.” 7. We reissue prior comment 17. We continue to note several promotional statements throughout your document, such as your statement on page 13 that “we believe this Hyper Genomics TM technology has the potential to be groundbreaking” and the statement on page 21 that you expect rapid growth, if and when your products gain acceptance. Please remove these and similar promotional statements or provide us with the basis for your conclusion that your products are groundbreaking. RESPONSE: We have revised the Filing to remove these statements and other promotional statements made throughout the Filing. 8. We note statements throughout your document, including on pages 11 and 12 about the proposed pricing of your products and the estimated costs to manufacture. With a view to disclosure, please advise us how you developed these estimates. RESPONSE: We have revised the Filing throughout to either substantiate or remove statements regarding the proposed pricing of our proposed products and the estimated costs to manufacture. 150 Orchard Road Orchard Plaza 08-02 Singapore 238841 4 9. Given the development stage of the company, you have no agreements or arrangements with diagnostic companies, and the limited testing of your proposed products to date, the statement on page 11 that you believe your future products will command the high end of the price range and the reference to the “accuracy” of your products appears promotional. Please remove. Similarly, the discussion of the estimated cost to manufacture and the estimated selling price of the disposable home use tests appear promotional at this point in time. We note that you will have to undergo regulatory approval to sell your products other than for research use. RESPONSE: We have revised the Filing throughout to remove any promotional statements and to remove the estimated manufacture and selling price of the disposable home tests. 10. Please reconcile the disclosure on page 20 that “the funding required to bring our current pipeline of products to the RUO market is in place” with the disclosure in the Liquidity and Capital Resources section on page 33 that “our cash reserves are only adequate to fund operations for a limited period of time” and that “in view of the potential lack of financing, Singapore Volition may be obliged to discontinue operations.” Provide a more detailed discussion in this section of what cash is currently available for which portions of your business plan and clearly discuss in greater detail the need for additional financing and the impact upon the company and your business plan if you are unable to obtain such additional financing. RESPONSE: We have revised the Filing to include the following language: Page 33: “As of September 30, 2011, Singapore Volition had cash of $959,090 and prepaid expenses of $353,500, and other current assets of $98,452. Singapore Volition had current liabilities of $1,511,480, including $1,110,000 due in respect of stock issuances. This translates into a working capital surplus, excluding prepayments of $353,500 and $1,110,000 due in respect of stock issuances, of $656,062, which means that our cash reserves are only adequate to fund operations for a limited period of time. We intend to use our cash reserves to fund further research and development activities.