Per Unit
|
Total
|
|||||||
Public Offering Price
|
$
|
$
|
||||||
Underwriting Discounts and Commissions (1)
|
$
|
$
|
||||||
Proceeds to Pluristem, before expenses
|
$
|
$
|
(1) |
We have agreed to reimburse the underwriters for certain expenses with respect to this offering. See “Underwriting” for additional information regarding underwriter compensation.
|
PAGE
|
|
S - ii | |
S - iii | |
S - 1 | |
S - 3 | |
S - 5 | |
S - 7 | |
S - 8 | |
S - 9 | |
S - 10 | |
S - 12 | |
S - 15 | |
S - 16 | |
S - 20 | |
S - 24 | |
S - 24 | |
S - 24 | |
S - 25 |
PAGE | |
1
|
|
1
|
|
2
|
|
2
|
|
3
|
|
3
|
|
3
|
|
4
|
|
6
|
|
7
|
|
10
|
|
10
|
|
10
|
|
11
|
• |
the expected development and potential benefits from our product candidates in treating various medical conditions;
|
• |
the clinical trials to be conducted according to our license agreement with CHA Biotech Co. Ltd.;
|
• |
our plan to execute our strategy independently, using our own personnel, and through relationships with research and clinical institutions or in collaboration with other companies;
|
• |
the prospects of entering into additional license agreements, or other forms of cooperation with other companies and medical institutions;
|
• |
our pre-clinical and clinical trials plans, including timing of initiation, enrollment and conclusion of trials;
|
• |
achieving regulatory approvals, including under accelerated paths;
|
• |
the expected timing of the release of data from our various studies;
|
• |
receipt of future funding from the European Commission, the Israel Innovation Authority, the European Union’s Horizon 2020 program and grants from other independent third parties;
|
• |
our marketing plans, including timing of marketing our product candidates, PLX-PAD and PLX-R18;
|
• |
developing capabilities for new clinical indications of placenta expanded (PLX) cells and new products;
|
• |
the timing and development of our PLX-Immune product candidate;
|
• |
our estimations regarding the size of the global market for our product candidates;
|
• |
our expectations regarding our production capacity;
|
• |
our expectation to demonstrate a real-world impact and value from our pipeline, technology platform and commercial-scale manufacturing capacity;
|
• |
our expectations regarding our short- and long-term capital requirements;
|
• |
the proposed joint venture to be established with Sosei Corporate Venture Capital Ltd. for the clinical development and commercialization of Pluristem’s PLX-PAD cell therapy product in Japan and the plan to enter into definitive agreements;
|
• |
our outlook for the coming months and future periods, including but not limited to our expectations regarding future revenue and expenses; and
|
• |
information with respect to any other plans and strategies for our business.
|
• |
Patients treated with PLX-PAD at the optimal dosing regimen showed statistically significant improvement (effect size=42.0%, p=0.043) in maximum walking distance at 52 weeks across all sites (U.S., Europe, Israel and South Korea), nationalities, gender and ethnicity as compared to placebo. These patients also experienced no revascularization events at 65 weeks as compared to 12% occurrence in the placebo group.
|
• |
Patients also experienced a statistically significant relative reduction of 7.77 (mmol/mol) in Hemoglobin A1C, or HbA1c, at 65 weeks compared to placebo (p=0.0155). HbA1c measures the amount of blood sugar (glucose) attached to hemoglobin. A reduction in HbA1c indicates better glucose control in patients and is the most commonly used measurement to evaluate treatment efficacy in diabetics.
|
Common stock and warrants offered by us
|
shares and warrants to purchase up to shares of common stock. This prospectus supplement also covers up to shares of common stock issuable upon exercise of the warrants. The shares and warrants will be sold in units, with each unit consisting of one share of common stock and a warrant to purchase shares of common stock, with the shares of common stock and warrants immediately separable upon issuance.
|
|
Price per unit
|
$
|
|
Terms of warrants
|
An exercise price of $ per share exercisable beginning and expiring on , 20 , the anniversary of the date of the issuance.
|
|
|
|
|
Option to purchase additional shares
|
We have granted the underwriters an option for a period of 30 days from the date of this prospectus supplement, to purchase up to an additional shares of our common stock and/or additional warrants to purchase up to shares of common stock to cover over-allotments, if any, at a price of $ per share of common stock and/or $ per warrant, less the underwriting discounts and commissions.
|
|
Concurrent registered direct offering
|
Concurrently with this offering, we are offering shares of common stock to certain investors in a concurrent registered direct offering, at the same price per share as the public offering price, for aggregate gross proceeds of $ million, without giving effect to any discounts and commissions. The concurrent registered direct offering is being conducted by means of a separate prospectus supplement and Ladenburg Thalmann & Co. Inc. is acting as Placement Agent.
|
|
|
|
|
Common stock to be outstanding
immediately after this offering and the
concurrent registered direct offering
|
shares, or shares if all of the warrants are exercised (or shares if the underwriters’ option to purchase additional shares and warrants is exercised in full).
|
|
|
||
Use of proceeds
|
We intend to use the net proceeds from this offering and the concurrent registered direct offering for research and product development activities, clinical trial activities, investment in capital equipment and for working capital and other general corporate purposes. See “Use of Proceeds.”
|
|
|
||
Risk factors
|
An investment in our common stock involves a high degree of risk. See “Risk Factors” beginning on page S-5 of this prospectus supplement and on page S-2 of the accompanying prospectus, as well as those risk factors that are incorporated by reference in this prospectus supplement and the accompanying prospectus, for a discussion of factors to consider carefully before deciding to purchase shares of our common stock.
|
|
|
|
|
Listing on Nasdaq and TASE
|
Our common stock is listed on Nasdaq under the symbol “PSTI” and on TASE under the symbol “PLTR.”
|
|
No market for the units or warrants
|
The units will not be certificated, and the securities that are part of such units are immediately separable and will be issued separately in this offering. There is no established public trading market for the warrants to be issued in this offering, and we do not intend to apply to list such securities on any securities exchange or automated quotation system.
|
● |
985,800 shares of common stock issuable upon the exercise of outstanding stock options as of December 31, 2018 at a weighted-average exercise price of $0.00001 per share;
|
● |
3,833,998 shares of common stock reserved for future issuances under our equity compensation plan;
|
● |
11,700,278 shares of common stock issuable upon the exercise of outstanding warrants as of December 31, 2018 at a weighted-average exercise price of $1.91 per share;
|
● |
9,922,569 shares of common stock issuable upon the vesting of outstanding restricted stock and restricted stock units as of December 31, 2018;
|
● |
the shares of common stock issuable upon the exercise of warrants being issued in this offering; and
|
● |
the shares of common stock to be issued in the concurrent registered direct offering.
|
● |
on an actual basis; and
|
● |
on an as adjusted basis giving effect to (i) the issuance and sale of units in this offering at a public offering price of $ per unit (assuming no separate consideration was paid for the warrants issued in this offering), after deducting the estimated underwriting commission and discounts and other estimated offering expenses payable by us and (ii) the issuance and sale of shares of common stock in the concurrent registered direct offering.
|
As of December 31, 2018
|
||||||||
(Actual)
|
(As Adjusted)
|
|||||||
Stockholders’ equity:
|
U.S. dollars in thousands (unaudited)
|
|||||||
Common stock, par value $0.00001 per share – authorized 200,000,000 shares; issued and outstanding 116,809,444 shares (as of December 31, 2018); shares issued and outstanding on an as adjusted basis;
|
$
|
1
|
||||||
Preferred stock, par value $0.00001 per share – authorized 10,000,000 shares, none issued
|
—
|
$
|
||||||
Additional paid-in capital (through December 31, 2018)
|
248,359
|
|||||||
Accumulated deficit (through December 31, 2018)
|
(233,166
|
)
|
||||||
Total stockholders’ equity
|
$
|
15,194
|
$
|
• |
985,800 shares of common stock issuable upon the exercise of outstanding stock options as of December 31, 2018 at a weighted-average exercise price of $0.000001 per share;
|
• |
3,833,998 shares of common stock reserved for future issuances under our equity compensation plan;
|
• |
11,700,278 shares of common stock issuable upon the exercise of outstanding warrants as of December 31, 2018 at a weighted-average exercise price of $1.91 per share;
|
• |
9,922,569 shares of common stock issuable upon the vesting of outstanding restricted stock and restricted stock units as of December 31, 2018; and
|
• |
the shares of common stock issuable upon the exercise of warrants being issued in this offering.
|
Public offering price per unit
|
$
|
|||||||
Historical net tangible book value per share as of December 31, 2018
|
$
|
0.13
|
||||||
Increase in net tangible book value per share attributable to this offering and the concurrent registered direct offering
|
$ | |||||||
As adjusted net tangible book value per share after this offering and the concurrent registered direct offering
|
$
|
|||||||
Dilution per share to new investors in this offering
|
$
|
Public offering price per unit
|
$
|
|||||||
Historical net tangible book value per share as of December 31, 2018
|
$
|
0.13
|
||||||
Increase in net tangible book value per share attributable to this offering and the concurrent registered direct offering
|
$ | |||||||
As adjusted net tangible book value per share after this offering and the concurrent registered direct offering
|
$
|
|||||||
Dilution per share to new investors in this offering
|
$
|
• |
985,800 shares of common stock issuable upon the exercise of outstanding stock options as of December 31, 2018 at a weighted-average exercise price of $0.000001 per share;
|
• |
3,833,998 shares of common stock reserved for future issuances under our equity compensation plan;
|
• |
11,700,278 shares of common stock issuable upon the exercise of outstanding warrants as of December 31, 2018 at a weighted-average exercise price of $1.91 per share; and
|
• |
9,922,569 shares of common stock issuable upon the vesting of outstanding restricted stock and restricted stock units as of December 31, 2018.
|
• |
an individual citizen or resident of the United States;
|
• |
a corporation (or other entity treated as a corporation for U.S. federal income tax purposes) created or organized under the laws of the United States, any state thereof or the District of Columbia;
|
• |
an estate, the income of which is subject to U.S. federal income tax regardless of its source; or
|
• |
a trust (1) whose administration is subject to the primary supervision of a U.S. court and which has one or more U.S. persons who have the authority to control all substantial decisions of the trust, or (2) that has a valid election in effect under applicable Treasury Regulations to be treated as a U.S. person.
|
• |
the gain is effectively connected with the non-U.S. holder’s conduct of a trade or business in the United States, and if required by an applicable income tax treaty, is attributable to a permanent establishment maintained by the non-U.S. holder in the United States;
|
• |
the non-U.S. holder is a nonresident alien individual present in the United States for 183 days or more during the taxable year of the disposition, and certain other requirements are met; or
|
• |
we are, or have been, at any time during the five-year period preceding such sale or other disposition (or the non-U.S. holder’s holding period, if shorter) a “U.S. real property holding corporation,” unless our common stock is regularly traded on an established securities market and the non-U.S. holder holds no more than 5% of our outstanding common stock, directly or indirectly, during the shorter of the 5-year period ending on the date of the taxable disposition or the period that the non-U.S. holder held our common stock.
|
Underwriter
|
Number of
Units
|
|||
Ladenburg Thalmann & Co. Inc.
|
$
|
|||
Total
|
$
|
Per Unit
|
Total
|
|||||||||||||||
Without
Option to
Purchase
Additional
Shares/Warrants
|
With
Option to
Purchase
Additional
Shares/Warrants
|
Without
Option to
Purchase
Additional
Units
|
With
Option to
Purchase
Additional
Shares/Warrants
|
|||||||||||||
Public offering price
|
$
|
$
|
$
|
$
|
||||||||||||
Underwriting discounts and commissions paid by us
|
$
|
$
|
$
|
$
|
||||||||||||
Proceeds to us, before expenses(1)
|
$
|
$
|
$
|
$
|
(1) | We estimate that our total expenses of this offering, excluding the underwriting discount, will be approximately $255,000. This amount excludes an additional fee we may elect to pay the underwriters based on their efforts and results of the offering of up to 0.5% of the aggregate gross proceeds raised in the offering but only with respect to investments made by investors other than those investors identified by the Israeli financial advisors referenced below. Banks and brokers and certain other parties in non-U.S. jurisdictions who raise capital in connection with this offering in such non-U.S. jurisdictions may be paid up to 4.0% from amounts received due to their efforts. Such amounts will be deducted from the above total underwriting discounts and commissions. In addition to the underwriting discounts and commissions, we have agreed to pay up to $65,000 of the fees and expenses of the underwriters, which may include the fees and expenses of counsel to the underwriters. |
|
•
|
Over-allotment involves sales by the underwriters of shares and/or warrants in excess of the number of shares and warrants the underwriters are obligated to purchase from us in the offering, which creates a syndicate short position. The short position may be either a covered short position or a naked short position. In a covered short position, the number of shares over-allotted by the underwriters is not greater than the number of shares that they may purchase in the over-allotment option. In a naked short position, the number of shares involved is greater than the number of shares in the over-allotment option. The underwriters may close out any short position by exercising their over-allotment option, in whole or in part, or purchasing shares in the open market.
|
|
•
|
Syndicate covering transactions involve purchases of securities in the open market after the distribution has been completed in order to cover syndicate short positions. In determining the source of securities needed to close out the short position, the underwriters will consider, among other things, the price of the securities available for purchase in the open market as compared to the price at which they may purchase the securities through the over-allotment option. If the underwriters sell more securities than could be covered by the over-allotment option known as, a naked short position, the position can only be closed out by buying securities in the open market. A naked short position is more likely to be created if the underwriters are concerned that there could be downward pressure on the price of the securities in the open market after pricing that could adversely affect investors who purchase in the offering.
|
|
•
|
Stabilizing transactions permit bids to purchase the underlying security so long as the stabilizing bids do not exceed a specific maximum.
|
|
•
|
Penalty bids permit the underwriters to reclaim a selling concession from a syndicate member or other broker-dealer participating in the offering when the securities originally sold by that syndicate member or other broker-dealer are purchased in a stabilizing or syndicate covering transaction to cover syndicate short positions.
|
|
§
|
pay cash to the holder in an amount equal to the excess (if any) of the buy-in price over the product of (A) such number of shares of common stock, times (B) the price at which the sell order giving rise to holder’s purchase obligation was executed; and
|
|
§
|
at the election of holder, either (A) reinstate the portion of the warrant as to such number of shares of common stock, or (B) deliver to holder the number of shares of common stock that would have been issued had we timely complied with its exercise and delivery obligations under the warrant.
|
1
|
|
1
|
|
2
|
|
2
|
|
3
|
|
3
|
|
3
|
|
4
|
|
6
|
|
7
|
|
10
|
|
10
|
|
10
|
|
11
|
·
|
common stock;
|
·
|
preferred stock;
|
·
|
warrants to purchase common stock; and
|
·
|
units of two or more of the securities mentioned above.
|
·
|
the offering price and aggregate number of warrants offered;
|
·
|
the currency for which the warrants may be purchased or exercised;
|
·
|
if applicable, the terms of the common stock with which the warrants are issued and the number of warrants issued with such common stock;
|
·
|
if applicable, the date on and after which the warrants and the related common stock will be separately transferable;
|
·
|
the number of shares of common stock or other securities purchasable upon the exercise of one warrant and the price at which these shares may be purchased upon such exercise;
|
·
|
the manner in which the warrants may be exercised, which may include by cashless exercise;
|
·
|
the effect of any merger, consolidation, sale or other disposition of our business on the warrant agreement and the warrants;
|
·
|
the terms of any rights to redeem or call the warrants;
|
·
|
any provisions for changes to or adjustments in the exercise price or number of shares of common stock issuable upon exercise of the warrants;
|
·
|
the dates on which the right to exercise the warrants will commence and expire;
|
·
|
the manner in which the warrant agreement and warrants may be modified;
|
·
|
the material United States federal income tax consequences of holding or exercising the warrants;
|
·
|
the terms of the common stock issuable upon exercise of the warrants; and
|
·
|
any other specific terms, preferences, rights or limitations of or restrictions on the warrants.
|
·
|
the designation and terms of the units, including whether and under what circumstances the securities comprising the units may be held or transferred separately; and
|
·
|
any provisions for the issuance, payment, settlement, transfer or exchange of the units or the securities comprising the units.
|
·
|
through agents to the public or to investors;
|
·
|
to one or more underwriters or distributors for resale to the public or to investors;
|
·
|
in “at the market offerings,” within the meaning of Rule 415(a)(4) of the Securities Act, to or through a market maker or into an existing trading market, on an exchange or otherwise;
|
·
|
directly to investors in privately negotiated transactions;
|
·
|
directly to a purchaser pursuant to what is known as an “equity line of credit” as described below;
|
·
|
through a combination of these methods of sale; or
|
·
|
upon exercise of outstanding warrants.
|
·
|
a fixed price or prices, which may be changed;
|
·
|
market prices prevailing at the time of sale;
|
·
|
prices related to prevailing market prices; or
|
·
|
negotiated prices.
|
·
|
the name or names of any agents or underwriters;
|
·
|
any securities exchange or market on which the common stock may be listed;
|
·
|
the purchase price and commission, if any, to be paid in connection with the sale of the securities being offered and the proceeds we will receive from the sale;
|
·
|
any over-allotment options pursuant to which underwriters may purchase additional securities from us;
|
·
|
any underwriting discounts or agency fees and other items constituting underwriters’ or agents’ compensation;
|
·
|
any public offering price; and
|
·
|
any discounts or concessions allowed or reallowed or paid to dealers.
|
·
|
Stabilizing transactions — Underwriters may make bids or purchases for the purpose of pegging, fixing or maintaining the price of the shares, so long as stabilizing bids do not exceed a specified maximum.
|
·
|
Options to purchase additional stock and syndicate covering transactions — Underwriters may sell more shares of our common stock than the number of shares that they have committed to purchase in any underwritten offering. This creates a short position for the underwriters. This short position may involve either “covered” short sales or “naked” short sales. Covered short sales are short sales made in an amount not greater than the underwriters’ option to purchase additional shares in any underwritten offering. The underwriters may close out any covered short position either by exercising their option or by purchasing shares in the open market. To determine how they will close the covered short position, the underwriters will consider, among other things, the price of shares available for purchase in the open market, as compared to the price at which they may purchase shares through their option. Naked short sales are short sales in excess of the option. The underwriters must close out any naked position by purchasing shares in the open market. A naked short position is more likely to be created if the underwriters are concerned that, in the open market after pricing, there may be downward pressure on the price of the shares that could adversely affect investors who purchase shares in the offering.
|
·
|
Penalty bids — If underwriters purchase shares in the open market in a stabilizing transaction or syndicate covering transaction, they may reclaim a selling concession from other underwriters and selling group members who sold those shares as part of the offering.
|
PROSPECTUS SUPPLEMENT
|