Actionable news
0
All posts from Actionable news
Actionable news in KTOV: KITOV PHARAMCEUTICALS HOLDINGS Ltd. AMERICAN DEPOSITARY SHARES,

Kitov Pharmaceuticals Holdings Ltd.

Amendment No. 4

One Azrieli Center, Round Building,

Tel Aviv, 6701101

Israel

+972-2-6254124
(Address, including zip code, and telephone number, including area code, of Registrant’s principal executive offices)

Puglisi & Associates
850 Library Avenue, Suite 204
Newark, DE 19715
(302) 738-6680
(Name, address, including zip code, and telephone number, including area code, of agent for service)

Perry Wildes, Adv. Rick A. Werner, Esq. Robert F. Charron, Esq. Ronen Kantor, Adv.
Gross, Kleinhendler, Haynes and Boone, LLP Ellenoff Grossman Doron Tikotzky Kantor
Hodak, Halevy, 30 Rockefeller Plaza, & Schole LLP Gutman Cederboum

Greenberg & Co.

One Azrieli Center

Tel Aviv 67021, Israel

Tel: +972 (3) 607-4444

26th Floor

New York, New York 10112
(212) 659-7300

1345 Avenue of the Americas

New York, NY 10105

Tel: (212) 370-1300

12 Abba Hillel Silver Street

Ramat Gan 52506, Israel Tel: +972 (3) 613 3371

Approximate date of commencement of proposed sale to the public: As soon as practicable after effectiveness of this registration statement.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box. x

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. o

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. o

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. o
CALCULATION OF REGISTRATION FEE
Title of Each Class of Securities to be Registered Proposed
Maximum
Aggregate
Offering Price (1)(2)(3)
Amount of
Registration
Fee (6)
Ordinary shares, no par value per share, represented by American Depositary Shares US$ 13,411,875 US$ 1,350.58
Warrants to purchase American Depositary Shares 14,375 1.45
Ordinary shares underlying the American Depositary Shares issuable upon exercise of warrants 13,411,875 1,350.58
Underwriter’s warrants to purchase American Depositary Shares(4)
Ordinary shares underlying the American Depositary Shares issuable upon exercise of underwriter’s warrants (5) 670,594 67.53
Total US$ 27,508,719 US$ 2,770.14

(1) Estimated solely for the purpose of calculating the registration fee pursuant to Rule 457(o) under the Securities Act of 1933.

(2) American Depositary Shares, or ADSs, issuable upon deposit of ordinary shares registered hereby are registered under a separate registration statement on Form F-6 (Registration No. 333-207858) . Each ADS represents twenty (20) ordinary shares.

(3) Includes shares granted pursuant to the underwriters’ over-allotment option.

(4) In accordance with Rule 457(g) under the Securities Act, because the ordinary shares of the Registrant underlying the Underwriter’s warrants are registered hereby, no separate registration fee is required with respect to the warrants registered hereby.

(5) Estimated solely for the purpose of calculating the registration fee pursuant to Rule 457(g) under the Securities Act. The warrants are exercisable at a per share exercise price equal to 100% of the public offering price. As estimated solely for the purpose of recalculating the registration fee pursuant to Rule 457(g) under the Securities Act, the proposed maximum aggregate offering price of the underwriter’s warrants is $670,594 (which is equal to 5% of $13,411,875).

(6) Previously paid.

The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the registration statement shall become effective on such date as the Commission acting pursuant to said Section 8(a), may determine.

The information in this prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell these securities and is not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.

Per ADS Per
Warrant
Total
Initial public offering price $ $ $
Underwriting discounts and commissions (1) $ $ $
Proceeds to us (before expenses) (2) $ $ $
Prospectus Summary 1
The Offering 4
Summary Consolidated Financial and Other Data 6
Risk Factors 7
Special Note Regarding Forward-Looking Statements 28
Price Range of our Ordinary Shares 29
Use of Proceeds 30
Dividend Policy 31
Capitalization 32
Dilution 33
Selected Consolidated Financial and Other Data 34
Management’s Discussion and Analysis of Financial Condition and Results of Operations 35
Business 43
Management 62
Principal Shareholders 81
Certain Relationships and Related Party Transactions 83
Description of Share Capital 84
Description of Securities 89
Shares Eligible for Future Sale 97
Taxation and Government Programs 99
Expenses Related to Offering 107
Underwriting 108
Legal Matters 115
Experts 115
Enforceability of Civil Liabilities 115
Where You Can Find Additional Information 117
· purchasing one drug as opposed to purchasing two separate drugs may lead to financial savings for patients in the U.S. by requiring payment of just one co-payment and prescription fee as opposed to a double co-payment and prescription fee. In addition, the use of one combination drug reduces the patient’s discretion with respect to whether to purchase and use only one of the drugs and provides a comprehensive dual medical treatment in one combined drug; and
· using calcium channel blockers in our therapeutic candidates as an antihypertensive. Calcium channel blockers are not included in the FDA Safety Information Release for NSAIDs co-administered with ACE inhibitors or with angiotensin II receptor antagonists.
· develop combination products with clinical and commercial advantages in the treatment of hypertension and pain caused by osteoarthritis, based on a combination of existing drugs and obtain approval thereof from the FDA and other foreign regulatory authorities;
· expand our line of therapeutic candidates through the acquisition or in-licensing of technologies, products and drugs intended to meet clinical needs, thereby utilizing the skills, knowledge and experience of our personnel to develop and enhance the value of additional products, and bring them to market efficiently;
· capitalize on the FDA’s 505(b)(2) regulatory pathway to obtain more timely and efficient approval of our formulations of previously approved products, when applicable; and
· cooperate with third parties to both develop and commercialize therapeutic candidates in order to share costs and leverage the expertise of others.
· we have a history of operating losses. We expect to incur additional losses in the future and may never be profitable;
· our limited operating history as a pharmaceutical research and development company makes it difficult to evaluate our business and prospects;
· our current working capital is not sufficient to complete our research and development with respect to each of our therapeutic candidates. Our failure to raise sufficient capital would significantly impair our ability to fund our operations, develop our therapeutic candidates, attract development or commercial partners and retain key personnel;
· if we and/or our potential commercialization partners are unable to obtain FDA or other foreign regulatory authority approval for our therapeutic candidates, we and/or our potential commercialization partners will be unable to commercialize our therapeutic candidates;
· clinical trials may involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results. We and/or our potential commercialization partners will not be able to commercialize our therapeutic candidates without completing such trials;
· we rely on third parties to conduct our clinical trials, and those third parties may not perform satisfactorily, including, but not limited to, failing to meet established deadlines for the completion of such clinical trials;
· even if our therapeutic candidates receive regulatory approval or do not require regulatory approval, they may not become commercially viable products; and
· the market for our therapeutic candidates is rapidly changing and competitive, and new drug delivery mechanisms, drug delivery technologies, new drugs and new treatments which may be developed by others could impair our ability to maintain and grow our business and remain competitive.
·

one of the active pharmaceutical ingredients we use in KIT-302, celecoxib, enjoys patent protection in the United States until December 2015. If the patent on this active pharmaceutical ingredient is further extended, it would delay the commercialization of our leading therapeutic candidate.

ADSs we are offering

1,250,000 ADSs representing 25,000,000 ordinary shares (or 1,437,500 ADSs representing 28,750,000 ordinary shares if the underwriters exercise their over-allotment option to purchase additional ADSs in full).

Warrants we are offering Warrants to purchase 1,250,000 ADSs. Each warrant will have a per ADS exercise price of 100% of the per ADS public offering price, will be exercisable upon issuance and will expire in five years from the date of issuance. The ADSs issuable upon exercise of the warrants will be subject to anti-dilution in certain circumstances. See the “Description of Securities” section of this prospectus.
The ADSs and warrants will be separately issued, but the ADSs and warrants will be issued and sold to purchasers in equal proportion.
Option to purchase
additional ADSs and warrants

We have granted to the underwriters an option, exercisable within 45 days from the date of this prospectus, to purchase up to an aggregate of 187,500 additional ADSs and/or additional warrants to purchase up to an aggregate amount of 187,500 ADSs solely to cover over-allotments, if any.

Ordinary shares to be outstanding after this offering 37,958,560 ordinary shares, or 62,958,560 ordinary shares if the warrants offered in this offering are exercised in full. If the underwriters exercise their over-allotment option in full, the ordinary shares outstanding immediately after this offering will be 41,708,560 ordinary shares, or 70,458,560 ordinary shares if the warrants offered in this offering are exercised in full.
Offering Price

The offering price will be determined by reference to the closing price of our ordinary shares on the TASE, on the pricing date after taking into account prevailing market conditions and through negotiations between us and the underwriters. Among the factors to be considered in these negotiations will be prevailing market conditions, our financial information, market valuations of other companies that we and the underwriters believe to be comparable to us, estimates of our business potential, the present state of our development and other factors deemed relevant. On November 16, 2015, the last reported sale price of our ordinary shares was New Israeli Shekel, or NIS 1.815, or $0.466, per share (based on the exchange rate reported by the Bank of Israel for such date).

Use of proceeds

We estimate that we will receive net proceeds from this offering of approximately $10,123,603, or approximately $11,874,850 if the underwriters exercise their over-allotment option to purchase additional ADSs and warrants in full, assuming an initial public offering price of $9.33 per ADS, based on last reported sale price of our ordinary shares on the TASE on November 16, 2015 (based on the exchange rate reported by the Bank of Israel on that date) and $0.01 per warrant, after deducting underwriting discounts and commissions and estimated offering expenses payable by us.

We expect to use the net proceeds from this offering as follows:
(i) approximately $1.5 million to expand our clinical development program, specifically with respect to the Phase III clinical trial for our leading therapeutic candidate, KIT-302;
(ii) approximately $1.0 million to finance the CMC activities required for submitting a New Drug Application (NDA) for KIT-302 to the FDA;
(iii) approximately $0.5 million to perform the final PK (pharmacokinetic) trial for the selected formulation of KIT-302;
(iv) approximately $0.5 million to finance our business development activities to enable out-licensing of our leading therapeutic candidate, KIT-302;
(v) up to approximately $0.6 million to repay outstanding loans entered into on August 12, 2015, or the August Loans, See "Business – August Loan Agreement" on page of this prospectus;
(vi) approximately $1 to $3 million to expand our clinical development pipeline for additional drug products; and
(vii) the balance of the net proceeds for general corporate purposes, including working capital requirements. See “Use of Proceeds” on page 30 of this prospectus.
Depositary The Bank of New York Mellon, Depositary
The ADSs Each ADS represents 20 ordinary shares. The depositary will hold the ordinary shares underlying your ADSs. You will have rights as provided in the deposit agreement. To better understand the terms of the ADSs and warrants, you should carefully read the “Description of Securities” section of this prospectus. You should also read the deposit agreement and warrant agent agreement, which are filed as exhibits to the registration statement that includes this prospectus.
Risk factors See “Risk Factors” and other information included in this prospectus for a discussion of factors you should carefully consider before deciding to invest in our ordinary shares.
Proposed NASDAQ Capital Market symbol We have applied to list our ADSs and our warrants on The NASDAQ Capital Market under the symbols “KTOV” and “KTOVW”, respectively. Our ordinary shares are currently traded on the TASE under the symbol “KTOV.”
Year Ended
December 31,

Six Months ended

June 30,

2014 2013 2015 2014
(U.S. Dollars in thousands, except per share and
weighted average shares data)
Statement of Operations:
Research and development expenses 3,192 109 919 1,928
General and administrative expenses 1,269 1,061 708 476
Trade listing expenses and other expenses 720 1,383 - 720
Operating loss 5,181 2,553 1,627 3,124
Financing expense, net 71 75 55 85
Loss for the period 5,252 2,628 1,682 3,209
Loss per ordinary share: (1)
Basic and diluted *(1.17 ) 1.60 (0.18 ) *(0.91 )
Weighted average number of ordinary shares used in computing basic and diluted loss per share (in thousands): *4,482 *1,641 9,338 *3,529
As of December 31,
2014 2013 As of June 30, 2015
Actual As Adjusted (2)
(U.S. Dollars, in thousands) (U.S. Dollars, in thousands)
Balance Sheet Data:
Cash and cash equivalents 1,313 193 1,652

11,776

Working capital (*) 773 (946 ) 1,216

11,340

Total assets 1,759 311 2,009

12,133

Total liabilities (986 ) (1,257 ) (877 ) (877)
Accumulated deficit (9,852 ) (4,600 ) (11,534 ) (11,534)
Total equity (deficit) 773 (946 ) 1,132

11,256

(2) As adjusted gives effect to the sale of ADSs and warrants by us in this offering assuming an initial public offering price of $9.33 per ADS, based on the last reported sale price of our ordinary shares on the TASE on November 16, 2015 (based on the exchange rate reported by the Bank of Israel on that date) and $0.01 per warrant, after deducting underwriting discounts and commissions and estimated offering expenses payable by us. A $1.00 increase (decrease) in the initial public offering prices would increase (decrease) each of cash and cash equivalents, total current assets and total shareholders’ equity by approximately $1,150,000 million, assuming that the number of ADSs and warrants offered by us, as set forth on the cover page of this prospectus, remains the same, and after deducting the underwriting discounts and commissions. The as adjusted information presented in the summary statement of financial position data is illustrative only and will change based on the actual initial public offering price and other terms of this offering determined at pricing.
· the federal Anti-Inducement Law (also known as the Civil Monetary Penalties Law)...

More