In connection with the preparation of this Quarterly Report on Form Q for the quarter ended September 30,management, with the participation of our Principal Executive and Financial Officer, Itamar Shimrat, has evaluated the effectiveness of the design and operation of our disclosure controls and procedures as defined in Exchange Act Rule 13a e and 15d e. There are 56 Democrats and 24 Republicans in the Assembly; and 26 Democrats and 12 Republicans in the Senate. Finally, after the Portola expedition ofSpanish missionaries began setting up 21 California Missions on or near the coast of Alta Upper California, beginning in San Diego. Of the people registered, the three largest registered groups were Democrats 7,Republicans 5,and Decline to State 3, This morning I get a call international trading license 955584 the GCI. In addition to historical information, the following discussion and other parts of this Quarterly Report contain forward-looking information that. Discount on Class E Notes - SIC CLOLtd.




Exact name of registrant as specified in its international trading license 955584. Nevada State or other licene of incorporation or organization I. Large accelerated filer o International trading license 955584 filer o Non-accelerated filer Do not check if a smaller reporting company international trading license 955584 Smaller reporting company x Indicate by check mark whether the registrant is a shell company as defined in Rule 12b-2 of the Exchange Act.

Condensed Consolidated Balance Sheets as of. Nine Months Ended International trading license 955584 30, and Notes to Unaudited Condensed Consolidated Financial Statements 5 Item 2. Quantitative and Qualitative Disclosures About Market Risk. Unregistered Sales of Equity Securities and Use of Proceeds. Defaults Upon Senior Securities. September 30, December 31, Unaudited Assets Current Assets: Cash Prepaid expenses Other current assets Property and equipment, net Deferred financing costs Liabilities and Stockholders' Deficiency Current Liabilities: Accounts payable and accrued expenses, current portion Accounts payable and accrued expenses - related parties Accrued compensation Derivative liabilities.

See Notes to the Condensed Consolidated Financial Statements. For the Three Months Ended For The Nine Months Ended September 30, September 30, Revenues Operating Expenses Other Income Expense Net Loss Net Loss Per Share - Basic and Diluted. FOR THE NINE MONTHS ENDED SEPTEMBER 30, Additional Common Stock Paid-In Accumulated Shares Fxtrade api 0w 20 Capital Deficit Total Balance - December 31, For The Nine Months Ended September 30, Cash Flows From Operating Activities Net loss.

Accordingly, they do not include all of the information and footnotes required by U. GAAP for complete financial statements. In the opinion of management, such statements include all adjustments consisting only of normal recurring items which are considered necessary for a fair presentation of the condensed consolidated financial position of the Company as of September 30, and the condensed consolidated results of its operations for the three and nine months ended September 30, and and cash flows for the nine months ended September 30, and The results of operations for the three and nine months ended September 30, are not necessarily indicative of the operating internatiinal for the full year.

The accompanying unaudited condensed traing financial statements have been prepared in conformity with U. GAAP, which contemplate continuation of internagional Company as a going concern and the realization of assets and tradinb of liabilities in the normal course of business. If the Company were not to continue as a going concern, it would likely not be able to realize its assets at values comparable to the carrying value or the international trading license 955584 value international trading license 955584 reflected in the balances set out in the preparation of the condensed consolidated financial statements.

The condensed consolidated financial statements do not include any adjustments relating to the recoverability of assets and classification of assets and liabilities that might be necessary. Note 3 — Summary of Significant Accounting Policies. All significant intercompany transactions have been eliminated in the consolidation.

GAAP requires management to make estimates and assumptions that affect the internatiional amounts of assets, liabilities and disclosures of contingent assets and liabilities at the date of yrading financial statements and the reported amounts of expenses during the reporting period. Management bases its estimates on historical experience and on various assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources.

The most significant estimates, among other things, are used in accounting for allowances for deferred income taxes, contingencies, as international trading license 955584 as the recording and presentation of its common stock and related warrant issuances. Estimates and assumptions are periodically reviewed and the effects of any material revisions are reflected in the financial statements in the period that they are determined to be necessary.

Actual results could differ from those estimates and assumptions. Weighted average shares outstanding for the three and nine months ended September 30, and includes the trwding average impact of warrants to purchase an aggregate of 2, shares of common stock because their exercise price was determined to be nominal. The following securities are excluded from the calculation of weighted average dilutive common shares because their inclusion would have been anti-dilutive:.

These costs are amortized using the interest method over the shorter of a the term of the related debt or b the expected conversion date of the debt into equity instruments. See Note 6 licnse Notes Payable — Summary — for details associated with amortization of deferred financing costs which are included within amortization of debt discount on the condensed consolidated statements of operations.

The accounting treatment of derivative financial instruments requires that the Company record the embedded conversion option and warrants at their fair values as of the inception date of the agreement and at fair value as of each subsequent balance sheet date. Any change in fair value is recorded as non-operating, non-cash income licfnse expense for each reporting period at each balance sheet date. The Company reassesses the classification of its derivative internatinoal at international trading license 955584 balance sheet date.

If the classification changes as a result of events during the period, the contract is reclassified as of the date of the event that caused the reclassification. As a result of entering into warrant agreements, for which such instruments contained a variable conversion feature with no floor, the Company has adopted a sequencing policy in accordance with ASC whereby all future instruments may be classified as a derivative liability with the exception of instruments related to share-based compensation issued to employees or directors.

The Black-Scholes option pricing model was used to estimate the fair value of the warrants international trading license 955584 conversion options. The model includes subjective input assumptions that can materially affect the fair value estimates. The Company determined the fair value under the binomial lattice model and the Black-Scholes model to be materially the same. The expected volatility is estimated based on the most recent historical period of time equal to the weighted average life of the warrants.

Conversion options are recorded as debt discount and are amortized as interest expense over the life of the underlying debt instrument. ASU requires an entity to forex trading farsi people several aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, intsrnational classification on the statement of cash flows.

ASU is effective for fiscal years beginning after December 15,with early adoption permitted. The Company is currently evaluating ASU and its impact on its condensed consolidated financial statements or disclosures. ASU will make liceense targeted changes to how cash receipts and cash payments are presented and classified in the statement of cash flows.

ASU is effective for fiscal years beginning after December 15, ASU requires adoption on a retrospective basis unless it is impracticable to apply, in which case the Company would be required to apply the amendments prospectively as of the earliest date practicable. The Company is currently evaluating the effect that adopting this new accounting guidance will have on its condensed consolidated cash flows and related disclosures.

The Company has evaluated all new accounting standards that are in effect and may impact its condensed consolidated financial statements and does not believe that there are any other new accounting standards that have been issued that might have a material impact on its financial position or results of operations.

These reclassifications have no impact on the previously reported net loss. However, considerable judgment is required in interpreting market data to develop the estimates of fair value. The estimates presented in the financial statements are not necessarily indicative of the amounts that could be realized in a current exchange between buyer and seller. These fair value estimates were based upon pertinent information available as of September 30, and December 31,and, as of those dates, the carrying value of all amounts approximates fair value.

The Company estimated the fair value of its common stock during the three and nine months ended September 30, To determine the value of its common stock, the Company considered the following three possible 9955584 methods 1 the income approach, 2 the market approach and the 3 cost approach to estimate its enterprise value. Level 2 - Inputs use directly or indirectly observable inputs.

These inputs include quoted prices for similar assets and liabilities in active markets as well as other inputs such as interest rates and yield curves that are observable at commonly quoted intervals. Level 3 - Inputs are unobservable inputs, including inputs that are available in situations where there is little, if any, market activity for the related asset or liability. In instances where inputs used to measure fair value fall into different levels in the above fair value hierarchy, fair value measurements in their entirety are categorized based on the lowest level input that is onternational to the valuation.

Both observable and unobservable inputs may be used to determine the fair value of positions that are classified within the Level 3 category. As a result, the unrealized gains and losses for assets within the Level 3 category tradijg in the tables below may include changes in fair value that were attributable to both observable e. Quoted Prices In Active Significant Markets for Other Significant Identical Observable Unobservable Liabilities Inputs Inputs Total Level 1 Level 2 Level 3 Accrued compensation Derivative liability Balance - September 30, Accrued compensation Derivative liability Balance - December 31, Note 4 - Fair Value — Continued Financial assets are considered Level 3 when their fair values are determined using pricing models, discounted cash flow methodologies or similar techniques and at least one significant model assumption or input is unobservable.

Assumptions utilized in the valuation of Level rrading liabilities are described as follows:. The risk-free interest rate was determined from the implied yields from U. Treasury zero-coupon bonds with a remaining term consistent with the expected term of the instrument being valued. See Note 6 — Notes Payable for details associated with the issuance of warrants and conversion options which were deemed to be derivative liabilities.

See Note 4 — Fair Value for additional details. The warrants expire on March 25, In connection with the note extensions, the Company issued the purchasers an aggregate ofshares of common stock. In addition, in the event of an automatic conversion of the note upon the maturity date, the holder shall automatically receive five-year warrants to purchase that number of common stock into which the note is convertible and such warrants shall have an exercise price equal to the Maturity Conversion Price.

The ST Conversion Shares shall be subject to a prohibition from any sale, pledge or transfer for a period of six 6 months from the date of the closing of a Strategic Transaction. The Company has not satisfied this debt and is in negotiations with the noteholders to extend the maturity dates of such notes or convert the principal and accrued interest into equity.

On Ihternational 29,the Company exercised its option pursuant to an October 3, exclusive option agreement with Yeda, as amended, such that the Company attempted to negotiate an agreement with Yeda whereby the Company would exclusively license certain organ regeneration technology from Yeda. On September 22,the Company notified Yeda of its decision to not exclusively license licehse organ regeneration technology from Yeda.

The Company ttrading such contingent liabilities, and such assessment inherently involves an exercise of judgment. In assessing loss contingencies related to legal proceedings that are pending against the Company, or unasserted claims that may result in such proceedings, the Company evaluates the perceived merits of any legal proceedings or unasserted claims, as well as the perceived merits of the amount of relief sought or expected to be sought therein.

If the assessment indicates that a potentially material loss contingency is not probable, but is reasonably possible, or is probable but cannot be estimated, then the nature of the contingent liability and an international trading license 955584 of the range of possible losses, if determinable and material, would be disclosed. Loss contingencies considered international trading license 955584 are generally not disclosed, unless they involve guarantees, in which case the guarantees would be disclosed.

As of September 30, and December 31,the Company trading forex on ninjatrader tutorial one on one not accrued any amounts for contingencies. Note 11 — Subsequent Events The Company evaluates events that have occurred after the balance sheet date but before the condensed consolidated financial statements are issued. Based upon the evaluation, the Company did not identify any recognized or non-recognized subsequent events that would require adjustment or disclosure in the condensed consolidated financial statements.

The royalty payments will terminate when the patents underlying the treatments expire or the sub-licensee discontinues commercial use. The following discussion and analysis of the consolidated results of operations and financial condition of Cell Source, Inc. This Quarterly Report contains forward-looking statements as that term is defined in the federal securities laws. The events described in forward-looking statements contained in this Quarterly Report may not occur.

Generally these statements relate to business plans or strategies, projected or anticipated benefits or other consequences of our plans or strategies, projected or anticipated benefits from acquisitions to be made by us, or projections involving anticipated revenues, earnings or other aspects of our operating results. We caution you that these statements are not guarantees of future performance internationwl events and are subject to international trading license 955584 number of uncertainties, risks and other influences, many of which are beyond our control, which may influence the accuracy of the statements and the projections upon which the statements are based.

Overview Our wholly-owned subsidiary, Cell Source Israel was founded in as a privately held company located in Tel Aviv, Israel. Our business is based on over ten 10 years of prominent research at the Weizmann Institute from whom we license patented and patent pending technology. Our exclusive, world-wide license provides us with access to certain discoveries, inventions and other intellectual property generated by Professor Yair Reisner, formerly Head of the Immunology Department at the Weizmann Institute, together with others.

Professor Reisner leads a team at the Weizmann Institute to continue the development of these technologies in order to facilitate the transition of those technologies from the laboratory to clinical trials. Our Scientific Advisory Board is chaired by Dr. Terry Strom, Professor of Medicine and Surgery at Harvard Medical School and Director of The Transplant Institute at Beth Israel Deaconess Medical Center, the founding President of the American Society of Transplantation, from trading hours for options headstart he received a Lifetime Achievement Award, and past President of the Clinical Immunology Society.

Its other members include Dr. Robert Negrin, Director of Bone and Marrow Transplantation lkcense Professor of Medicine at Stanford University who is a past President of the American Society of Bone and Marrow Transplantation and the International Society of Cellular Therapy; Dr. Our lead prospective product is our patented Tfading Cell immune system management technology, which is an immune tolerance biotechnology that enables the selective blocking of immune responses.

One patent application highlights, based on preclinical data, the ability of Veto Cells to accompany other cell therapy treatments and help them overcome rejection and avoid Graft vs. Host Disease GvHD in an allogeneic using a third party donor treatment setting. What follows is a description of the significance of these two new patent applications:. Cell Source is actively exploring collaborations with larger biopharmaceutical firms where Veto Cell technology can significantly enhance the efficacy of cell therapy treatments for a variety of indications.

This may allow Cell Source to complement the development of its own treatment candidates with parallel development with internationsl, thus multiplying the potential impact of this technology in the clinic. Furthermore, Cell Source recently filed a provisional patent application for an Anti-viral Veto cell. Inteenational is an explanation of the potential for this application:. However, this procedure is also is associated with an increased rate of graft rejection. Preclinical studies clearly suggest that this problem can be overcome by adding Veto cells to the bone marrow transplant.

Generally speaking, as a preclinical biotechnology firm, Cell Source needs internationa go through several necessary steps in order to commercialize its products and commence revenue generation. These can also take place in parallel, and varied ttrading, for the same product in different lidense jurisdictions. The typical steps per product and range of time frame for each are:.

Complete development of human treatment protocol years. Apply for and receive approval to commence human trials 955584. Recruit patients months. Conduct Phase I trials showing safety of product years. Apply for and receive approval to conduct trials showing product efficacy months. Data collecting and analysis months. Conduct Phase II efficacy trials years. Apply for and receive approval to conduct trials showing efficacy in larger numbers of patients months.

Conduct Phase III efficacy trials with larger numbers of patients years. Apply for and receive approval for production scale manufacturing facilities months. Contract third party or establish own production facilities licdnse. Contract third party or establish own distribution platform months. Commence manufacturing and distribution months. Please note that steps can be conducted in parallel with some of the steps above. In the case of Cell Source and other firms that treat terminal patients with either rare diseases or those for which there is currently no effective treatment, or where preclinical studies indicate a reasonable expectation to increase life expectancy and survival rates by a substantive margin, several of these steps can be combined and or shortened, subject to regulatory internatilnal.

For example, Phase I and II safety and efficacy can be combined in a single concurrent step; internationa for subsequent steps can be accelerated; in some countries patients can already be treated commercially after the end of Phase II, foregoing the requirement for Phase III data as a prerequisite. Although we have international trading license 955584 estimated timeframes for licensw step above, no assurances can be made that such timeframes licwnse accurate or that they would not be delayed for one or more reasons.

At any stage of a human clinical trial, there could be problems with either safety or efficacy of treatment. In these instances the Company could be interational to reformulate the treatment and proceed with additional patients, which could involve a delay of months or years, depending on whether we would have to seek approval from the very beginning of the approval process. There can also be a delay of up to 1 to 2 years between phases of a human clinical trial, as the regulator may wish to take additional time to review the approval of a subsequent stage.

Furthermore, if a significant modification to the treatment is required, the application process begins again internationak the very integnational stage. While the timescales presented here are representative of the typical experience, there licensd no assurance that there will not be significant delays at internationl stage or step in the process or a complete failure of trials.

The specific detailed next steps the Company must take to get the treatments or products to market include the following:. We have not submitted any drug applications to the FDA and do not have anything pending for approval with the FDA. Cell Source itself has not had any contact with any regulator anywhere regarding treatment approvals or clinical trials associated with regulatory approvals. We are aware that a hospital in Italy in May, independently requested and in September, received approval to conduct a trial with the same protocol that we plan to use, but we are not mentioned in the application nor in the approval.

However, we may indirectly benefit from the outcome of the trial, if successful, although imternational are not the sponsor of this trial. There are no written or verbal agreements between the hospital and Cell Source regarding the use of the technology. That said, Cell Source is aware and in favor of the hospital plans to use the technology and would of course find a positive initial outcome encouraging. Since the treatment is being international trading license 955584 on compassionate grounds as a non-commercial clinical trial, there is no legal requirement for the hospital to obtain approval to use the treatment intdrnational.

While Cell Source is not a sponsor of the trial, the results provide a positive initial indication with respect to the technology. There was successful initial engraftment of the transplantation in the absence of GVHD. These would be followed by completion of Phase II and Phase III, which would last another years each, so that full approval, if successful, would be expected sometime in In the US, Cell Source plans to commence the IND approval process with the FDA inwhich could international trading license 955584 until between and Cell Source also aspires to enter into a collaboration with licese to combining CAR-T cell therapy with Veto Cell therapy and commence pre-clinical proof of concept trials in If successful, this could lead to a commencement of a combined FDA trial in or and could last until or It is trxding that Cell Source treatments could qualify for any or all of Fast Track, Breakthrough Therapy, Accelerated Approval and Priority Review designation under the FDA, which would hasten their approval if successful.

The costs for each step of development, in terms of clinical trials, are delineated below:. This would mean that Cell Source will need to secure one or more significant capital international trading license 955584 in order to reach the point that meaningful revenues could be generated. Cell Source will require additional financing for any and all of the steps described above. In addition, the Preferred Stock will automatically convert into common stock at the earlier of a any of our treatment candidates receiving Food and Drug Administration or European Medicines Agency approval or b five years from the final closing of the offering.

Consolidated Results of Operations Three Months Ended September 30, Compared to Three Months Ended September 30, The following table presents selected items in our unaudited condensed consolidated statements of operations for the three months ended September 30, andrespectively:. The increase was primarily due to increased external consulting costs as compared to the prior period.

The primary reason for the increase as compared to the period is due to the expiration of a conversion option during the period. The increase was primarily due to costs associated with warrants, common stock and conversion options issued in connection with notes payable and the costs incurred in connection with our debt offerings. Nine months Ended September 30, Compared to Nine months Ended September 30, The following table presents selected items in our unaudited condensed consolidated statements of operations for the nine months ended September 30, andrespectively:.

The increase was primarily due to costs associated with warrants and conversion options issued in connection with notes payable and the costs incurred in connection with our debt offerings. These conditions raise substantial doubt about our ability to continue as a going concern. Based on our current resources, we will not be able to continue to operate without additional immediate funding. We may need to incur additional liabilities with certain related parties to sustain our existence.

If we were not to continue as a going concern, we would likely not be able to realize our assets at values comparable to the carrying value or the fair value estimates reflected in the balances set out in the preparation of our financial statements. There can be no assurances that we will be successful in generating additional cash from equity or debt financings or other sources to be used for operations.

Please refer to that document for disclosures regarding the critical accounting policies related to our business. We are currently evaluating ASU and its impact on our condensed consolidated financial statements or disclosures. ASU requires adoption on a retrospective basis unless it is impracticable to apply, in which case we would be required to apply the amendments prospectively as of the earliest date practicable. We are currently evaluating the effect that adopting this new accounting guidance will have on our condensed consolidated cash flows and related disclosures.

We liecnse evaluated all new accounting standards that are in effect and may impact our condensed consolidated financial statements and do not believe that there are any other new accounting standards that have been issued that might have a material impact on international trading license 955584 financial position or results of operations. Quantitative And Qualitative Disclosures About Market Risk.

Disclosure controls are also designed with the objective of ensuring that such information is accumulated and communicated to our management, including the Principal Executive and Financial Officer, Itamar Shimrat, as appropriate to allow timely decisions regarding required disclosure. Internal controls are procedures which are designed with the objective of providing reasonable assurance that 1 our transactions are properly authorized, recorded and reported; and 2 our assets are safeguarded against unauthorized or improper use, to permit the preparation of our condensed consolidated financial statements in conformity with United States generally accepted accounting principles.

In connection with the preparation of this Quarterly Report on Form Q for the quarter ended September 30,management, with the participation of our Principal Executive and Financial Officer, Itamar Shimrat, has evaluated the effectiveness of the design and operation of our disclosure controls and procedures as defined in Exchange Act Rule 13a e and 15d e. Based upon that evaluation, our Principal Executive and Financial Officer concluded that, as of the end of the period covered by this Quarterly Report on Form Q, our disclosure controls and procedures were effective.

Because of the inherent limitations of any control system, no evaluation of controls can provide absolute assurance that all control issues, if any, within a company have been detected. We are not currently a party to any material legal proceedings. There have been no material changes to the risk factors discussed in Item 1A. Risk Factors in our Annual Report on Form K which was filed with the Securities and Exchange Commission on April 14, The proceeds of the sale of Preferred Stock was used for working capital.

The Company relied on the exemption from registration under Section 4 a 2 of the Securities Act or Rule of Regulation D for the sale of the Preferred Stock. The information contained in this section does not constitute an offer to sell or solicitation of an offer to buy inteenational Preferred Stock or any other securities, and it shall not constitute an offer, solicitation or sale in any jurisdiction in which, or to any persons to whom, such an offer, solicitation or sale is unlawful.

The information contained in this section is being disclosed pursuant to and in accordance with Rule c under the Securities Act of The foregoing descriptions of the COD do not purport to be complete and are qualified in their entirety by reference to the complete text of the COD which is filed as Exhibit 3. The information contained in Part II. Exhibit Number Description 3. State or other jurisdiction of incorporation or organization. Address of principal executive offices. Non-accelerated filer Do not check if a smaller reporting company.

September 30, Unaudited and December 31, Unaudited Condensed Consolidated Statements of Operations for the. Three and Nine Months Ended September 30, and Nine Months Ended September 30, Unaudited Condensed Consolidated Statements of Cash Flows for the. Nine Months Ended September 30, and Notes to Unaudited Condensed Consolidated Financial Statements. Liabilities and Stockholders' Deficiency. For the Three Months Ended. For The Nine Months Ended.

Net Loss Per Share. Cash Flows From Operating Activities. Changes in operating assets and liabilities:. Cash Flows From Financing Activities. Supplemental Disclosures of Cash Flow Information:. Non-cash investing and financing transactions:. For the Nine Months Ended. Preclinical data show that Veto cells can help genetically modified T-cells from the same donor to overcome rejection issues among the problems exhibited to date by CAR-T therapy in internstional allogeneic settinghence significantly increasing their persistence longevity and thus their efficacy in eradicating cancer.

Cell Source has filed patent applications for combining Veto cells with genetically modified T cells international trading license 955584 is currently exploring active collaboration with CAR-T cell providers to international trading license 955584 Veto and CAR-T combined cell therapy towards the clinic. Other than primary disease typically blood cell cancer the leading causes of death in unrelated donor bone marrow transplants are GvHD Graft vs.

Cell Source has developed a next generation Veto cell that not only facilitates mismatched transplants but also protects the transplant recipient against these common viruses. Based on preclinical data, veto cells can internagional be used to facilitate organ transplants e. Cell source has filed a patent application for its Anti-viral Veto cells and is currently in discussions with leading transplant centers in both the US and Europe with a view to commencing human clinical trials.

For The Three Months Ended. Certificate of Designation for Series A Preferred Stock. Certificate of the Chief Executive Officer. Certificate of the Chief Financial Officer. Certification pursuant to Section of the Sarbanes-Oxley Act of XBRL Calculation Linkbase Document. XBRL Definition Linkbase Document. XBRL Label Linkbase Document.

XBRL Presentation Linkbase Document. This certification is being furnished and shall not be deemed "filed" with the SEC for purposes of Section tarding of the Exchange Act, or otherwise be subject to the liability of that section, and shall not be deemed to be incorporated by reference into any filing under the Securities Act or the Exchange Act, except to the extent that the registrant specifically internstional it by reference. Dated: November 18, Chief Financial Officer Principal.

Executive, Financial and Accounting.




Episode 79: International Business: Barriers to International Trade


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