TOKAI PHARMACEUTICALS, INC. (NASDAQ:TKAI) Files An 8-K Other Events
Item8.01. Other Events.
On April7, 2017, Tokai Pharmaceuticals, Inc. (Tokai or the
Company) filed a definitive proxy statement on Schedule 14A (the
Definitive Proxy Statement) with the Securities and Exchange
Commission (the SEC) with respect to the special meeting of
Tokais stockholders scheduled to be held on May9, 2017 in order
to, among other things, obtain the stockholder approvals
necessary to complete the purchase by Tokai of all of the
ordinary and preferred shares of Otic Pharma, Ltd., a private
limited company organized under the laws of the State of Israel
(Otic), in exchange for shares of Tokai common stock (the Otic
Transaction), on the terms and subject to the conditions set
forth in the Amended and Restated Share Purchase Agreement, dated
as of March2, 2017, among Tokai, Otic, and the shareholders of
Otic named therein (the Share Purchase Agreement).
With this filing, Tokai is hereby supplementing its disclosure in
the Definitive Proxy Statement in connection with litigation
brought by its stockholders, which is described below.Nothing in
this Current Report on Form8-K shall be deemed an admission of
the legal necessity or materiality under applicable laws of any
of the disclosures set forth herein. Tokai and the other named
defendants believe the claims asserted in the litigation to be
without merit, intend to defend against them vigorously, and deny
any wrongdoing alleged in the litigation.
Stockholder Litigation
In connection with the Otic Transaction, two putative securities
class actions have been filed in the U.S. District Court for the
District of Massachusetts against Tokai, Jodie P. Morrison, Seth
L. Harrison, Stephen Buckley, Jr., Cheryl L. Cohen, David A.
Kessler, and Joseph A. Yanchik, III. The two complaints are
captioned as follows: Bushansky v. Tokai Pharmaceuticals,
Inc., et al., No. 1:17-cv-10621-DPW (filed April11, 2017),
and Wilson v. Tokai Pharmaceuticals, Inc., et al., No.
1:17-cv-10645-DPW
(filed April14, 2017). Each lawsuit alleges that the Definitive
Proxy Statement made false and misleading statements and
omissions in connection with the Otic Transaction, in violation
of the Securities Exchange Act of 1934 and Rule 14a-9,
promulgated thereunder. Each plaintiff seeks to represent a class
of all persons and entities that own Tokai common stock. Each
lawsuit seeks, among other things, preliminary and permanent
injunctions of the Otic Transaction unless Tokai discloses
certain information requested by plaintiff, rescission and
unspecified damages if the Otic Transaction is consummated, and
attorneys fees. We refer to these two actions collectively as the
Stockholder Litigation.
The Company
believes that no supplemental disclosures are required under
applicable laws. However, to avoid the risk of the Stockholder
Litigation delaying or adversely affecting the closing of the
Share Purchase Agreement and to minimize the expense of defending
the Stockholder Litigation, and without admitting any liability
or wrongdoing, the Company is making certain disclosures below
that supplement and revise those contained in the Definitive
Proxy Statement, which we refer to as the litigation-related
supplemental disclosures. The litigation-related supplemental
disclosures contained below should be read in conjunction with
the Definitive Proxy Statement, which is available on the
Internet site maintained by the Securities and Exchange
Commission at http://www.sec.gov, along with periodic reports and
other information the Company files with the Securities and
Exchange Commission. The Company and the other named defendants
deny that they have committed or assisted others in committing
any violations of law or breaches of duty to Company
stockholders, and expressly maintain that they have complied with
their fiduciary and other legal duties and are providing the
litigation-related supplemental disclosures below solely to try
to eliminate the burden and expense of further litigation, to put
the claims that were or could have been asserted to rest, and to
avoid any possible delay to the closing of the Share Purchase
Agreement that might arise from further litigation. Nothing in
the litigation-related supplemental disclosures shall be deemed
an admission of the legal necessity or materiality under
applicable laws of any of the litigation-related supplemental
disclosures. To the extent that the information set forth herein
differs from or updates information contained in the Definitive
Proxy Statement, the information set forth herein shall supersede
or supplement the information in the Definitive Proxy Statement.
References to sections and subsections herein are references to
the corresponding sections or subsections in the Definitive Proxy
Statement, all page references are to pages in the Definitive
Proxy Statement, and terms used herein, unless otherwise defined,
have the meanings set forth in the Definitive Proxy
Statement.
SUPPLEMENT
TO DEFINITIVE PROXY STATEMENT
| 1. |
The section of the Definitive Proxy Statement entitled The Otic Transaction Background of the Otic Transaction is hereby supplemented as follows: |
| a. |
The second sentence of the last paragraph on page 75 (such paragraph beginning with During the process, Tokai sought ) of the Definitive Proxy Statement is hereby amended and restated as follows: |
However, all of
the parties which provided written non-binding indications of
interest to Tokai had only expressed an interest in pursuing a
reverse merger transaction, and none of these parties expressed
an interest in acquiring galeterone or the ARDA program or
entering into another kind of strategic transaction. For this
reason, and in light of the decision to discontinue enrollment in
ongoing galeterone clinical trials, including ARMOR3-SV, and not
to proceed with a planned study of galeterone and not invest any
further in the early stage ARDA program, the Tokai management and
the Tokai Board each ascribed minimal value to galeterone and the
ARDA program, projected no future revenue from galeterone or the
ARDA program, and therefore provided no projections regarding
galeterone or the ARDA program to Wedbush.
| b. |
The following paragraph is hereby inserted immediately after the fourth full paragraph on page 76 (such paragraph beginning with In conducting these evaluations, ) of the Definitive Proxy Statement: |
The
confidentiality agreement that Tokai entered into with each third
party prior to holding discussions with the third party regarding
a possible strategic transaction included a standstill provision
under which the third party agreed, for a specified period of
time, that it would not (i)effect or seek, offer or propose
(whether publicly or otherwise) to effect, or cause or
participate in or in any way advise, assist or encourage any
other person to effect or seek, offer or propose (whether
publicly or otherwise) to effect or participate in, (a)any
acquisition of any securities (or beneficial ownership thereof)
or assets of Tokai, or any rights to acquire any such securities
(including derivative securities representing the right to vote
or economic benefit of any such securities) or assets; (b)any
tender or exchange offer, merger or other business combination
involving Tokai; (c)any recapitalization, restructuring,
liquidation, dissolution or other extraordinary transaction with
respect to Tokai; or (d)any solicitation of proxies (as such
terms are used in the proxy rules of the Securities and Exchange
Commission) or consents to vote any voting securities of Tokai;
or (ii)otherwise act, alone or in concert with others, to seek to
control or influence the management, Board of Directors or
policies of Tokai. As part of this undertaking, the third party
agreed that it would not during such period request Tokai (or its
directors, officers, employees or agents), directly or
indirectly, to amend or waive any provision of the standstill.
Such standstill provisions under certain confidentiality
agreements, including those applicable to Company A, Company B
and Company C, are still in effect. Certain of the other
confidentiality agreements that Tokai entered into with third
parties provide for the termination of the standstill provisions
upon Tokais entry into, or the announcement of Tokais entry into,
a definitive agreement for the sale, transfer or disposition of
more than 50% of its assets or outstanding voting securities, or
in certain cases, the sale, transfer or disposition of
substantially all of its assets or outstanding voting securities,
and such standstill provisions are no longer in effect. In
addition, Tokai is not prohibited under the Share Purchase
Agreement from amending, or granting a waiver or release, under
any such standstill provision with respect to any capital stock
of such party with any qualified person, as defined below.
| c. |
The following paragraph is hereby inserted immediately after the third full paragraph on page 80 (such paragraph beginning with On November7, 2016, ) of the Definitive Proxy Statement: |
Following the
Transaction Committee meeting on November7, 2016, at the
direction of the Transaction Committee, Wedbush corresponded
between November7, 2016 and November22, 2016 with the six high
priority companies other than Otic and Company B with which Tokai
held in-person diligence meetings and either informed them that
the Transaction Committee had decided to not pursue a transaction
with them or received indication from the parties that they no
longer were interested in pursuing the transaction with Tokai.
Subsequent to this correspondence, neither Tokai nor Wedbush had
any further communications with those potential counterparties
regarding a transaction with Tokai.
| d. |
The following is hereby inserted immediately before the penultimate sentence in the first full paragraph on page 82 (such paragraph beginning with On November29, 2016, ) of the Definitive Proxy Statement: |
The
representatives of Otic discussed its development plans for the
OP-01 and OP-02. Representatives from Otic indicated an intent to
reformulate OP-01 with a second active pharmaceutical ingredient
and to continue the on-going development with respect to
OP-02.
| e. |
The following is hereby inserted immediately following the last sentence in the last paragraph on page 84 (such paragraph beginning with On December15, 2016, representatives of Company A ) of the Definitive Proxy Statement: |
Tokai did not
communicate with Company A regarding the revised draft of the
merger agreement. Instead, Tokai management continued to conduct
diligence regarding Company A and to communicate with Company A
in connection with such diligence.
| f. |
The following is hereby inserted immediately following the last sentence in the first paragraph on page 85 (such paragraph beginning with On December20, 2016, representatives of Company C ) of the Definitive Proxy Statement: |
Tokai did not
communicate with Company C regarding its final written
non-binding
indication of interest, which Company C termed its best and final
offer.
| 2. |
The section of the Definitive Proxy Statement entitled The Otic Transaction Opinion of Tokais Financial Advisor is hereby supplemented as follows: |
| a. |
The third full paragraph on page 92 (such paragraph beginning with Wedbush further relied on ) of the Definitive Proxy Statement is hereby amended and restated as follows: |
Wedbush further relied on the
assurances of Tokais management that they were unaware of any
facts that would make the information provided to Wedbush
incomplete or misleading. Except for certain estimates of
liabilities expected to be incurred by Tokai in connection with a
potential liquidation of Tokai prepared by management of Tokai
and estimated equity values of Tokai upon liquidation prepared by
management of Tokai, Wedbush did not make and was not provided
with any independent evaluations or appraisals of any of the
assets, properties, liabilities (including any contingent,
derivative or off-balance-sheet assets or
liabilities) or securities, nor did Wedbush make any physical
inspection of the properties or assets, of Tokai or Otic.
Further, as the Tokai board of directors was aware, Otics
management did not provide Wedbush with, and Wedbush did not
otherwise have access to, financial forecasts regarding Otics
business, and, accordingly, Wedbush did not perform either a
discounted cash flow analysis or any multiples-based analyses
with respect to Otic. Given Otics current lack of revenue and the
uncertain nature of any revenue forecasts, a discounted cash flow
analysis and multiples-based analyses were considered to be of
little value. Wedbush did provide the Tokai board of directors
with expense forecasts for Otic for the five years ending
December31, 2021 set forth below, which were derived from a model
provided to Wedbush by Otic:
| Year Ending December31, | ||||||||||||||||||||||||
|
($ in thousands) |
5 Year Total | |||||||||||||||||||||||
|
SGA |
$ | 4,464 | $ | 5,164 | $ | 5,481 | $ | 5,695 | $ | 5,936 | $ | 26,740 | ||||||||||||
|
RD |
$ | 5,592 | $ | 7,563 | $ | 19,936 | $ | 23,306 | $ | 12,339 | $ | 68,735 | ||||||||||||
|
Total |
$ | 10,055 | $ | 12,727 | $ | 25,417 | $ | 29,001 | $ | 18,275 | $ | 95,475 | ||||||||||||
This prospective financial
model was prepared assuming a closing of the Otic Transaction on
or about February28, 2017. Further, the financial model presented
by Wedbush excluded any expenses associated with Tokais continued
operations as a public company.
This prospective financial
information was not prepared with a view toward compliance with
published guidelines of the Securities and Exchange Commission or
the guidelines established by the American Institute of Certified
Public Accountants for preparation and presentation of
prospective financial information.
The prospective financial
information included in this proxy statement has been prepared
by, and is the responsibility of, Otics management. No
independent registered accounting firm has examined, compiled or
performed any procedures with respect to the accompanying
prospective financial information or expressed an opinion or any
other form of assurance with respect thereto. The independent
registered accounting firm reports included or incorporated into
this proxy statement relate to historical financial information
and do not extend to the prospective financial information and
should not be read to do so.
With respect to such operating
expense forecasts of Otic, upon the advice of Tokai and Otic,
Wedbush assumed that the projections on which Wedbush based the
information provided to the Tokai board of directors were
reasonably prepared on a basis reflecting the best currently
available estimates and judgments of the management of Otic as to
the future operating expenses of Otic and that Otic will perform
substantially in accordance with such projections. Wedbush
further assumed no responsibility for and expressed no view as to
any such projections or the assumptions on which they are based.
Wedbush did not evaluate the solvency or fair value of Tokai,
Otic, or any of their subsidiaries (or the impact of the
transactions contemplated by the Share Purchase Agreement
thereon) under any law relating to bankruptcy, insolvency or
similar matters. Further, the operating expenses forecasts of
Otic presented by Wedbush were based on projections prepared by
Otic as of December 2016 and assumed that the transaction would
close by February 2017. Accordingly, these forecasts are not
necessarily representative of current expense
projections.
| b. |
The penultimate sentence in the fourth full paragraph on page 93 (such paragraph beginning with Tokai paid Wedbush a ) of the Definitive Proxy Statement is hereby amended and restated to read as follows: |
In the two years prior to the
date of its opinion, Wedbush has not provided any services to
Tokai, Otic or Apple Tree Partners or its
affiliates.
| c. |
The following is hereby inserted immediately after the last sentence in the fifth full paragraph on page 94 (such paragraph beginning with Wedbush did not perform ) of the Definitive Proxy Statement: |
For those reasons, Wedbush
also did not perform any premiums- or multiples-based analyses
for any of the other market data described
below.
| d. |
The bulleted list immediately following the third full paragraph on page 95 (such paragraph beginning with Wedbush reviewed publicly available ) of the Definitive Proxy Statement is hereby amended and restated as follows: |
|
Issuer |
SharePrice as of Dec. 20, 2016 |
Fully Diluted Shares Outstanding (in millions) |
Market Capitalization ($ in millions) |
Total ($ in millions) | Enterprise Value ($inmillions) | |||||||||||||||||||
| Cash(1) | Debt(2) | |||||||||||||||||||||||
|
Regenxbio Inc. |
$ | 20.65 | 26.5 | $ | 546.4 | $ | 184.9 | $ | 0.0 | $ | 361.6 | |||||||||||||
|
Protagonist Therapeutics, Inc. |
$ | 22.84 | 18.0 | $ | 410.7 | $ | 98.5 | $ | 0.0 | $ | 312.1 | |||||||||||||
|
Voyager Therapeutics, Inc. |
$ | 13.31 | 27.2 | $ | 361.8 | $ | 193.6 | $ | 0.0 | $ | 168.2 | |||||||||||||
|
Ra Pharmaceuticals, Inc. |
$ | 14.44 | 22.5 | $ | 325.6 | $ | 31.2 | $ | 0.0 | $ | 294.4 | |||||||||||||
|
Proteostasis Therapeutics, Inc. |
$ | 12.10 | 25.0 | $ | 302.0 | $ | 100.2 | $ | 0.0 | $ | 201.8 | |||||||||||||
|
Madrigal Pharmaceuticals, Inc. |
$ | 15.89 | 11.6 | $ | 183.8 | $ | 39.6 | $ | 0.0 | $ | 144.3 | |||||||||||||
|
Applied Genetic Technologies Corporation |
$ | 9.60 | 18.1 | $ | 173.5 | $ | 133.3 | $ | 0.0 | $ | 40.1 | |||||||||||||
|
KalVista Pharmaceuticals, Inc. |
$ | 6.53 | 26.3 | $ | 172.0 | $ | 35.2 | $ | 0.0 | $ | 136.8 | |||||||||||||
|
Dimension Therapeutics, Inc. |
$ | 4.35 | 25.2 | $ | 109.4 | $ | 93.8 | $ | 0.0 | $ | 15.7 | |||||||||||||
|
Mean |
$ | 287.2 | $ | 101.1 | $ | 0.0 | $ | 186.1 | ||||||||||||||||
|
Median |
$ | 302.0 | $ | 98.5 | $ | 0.0 | $ | 168.2 |
| (1) |
Total cash includes cash, marketable securities and short term investments |
| (2) |
Total debt includes current and outstanding portion of long term debt obligation |
| e. |
The table immediately following the first full paragraph on page 97 (such paragraph beginning with Wedbush reviewed publicly available ) of the Definitive Proxy Statement is hereby amended and restated as follows: |
|
Announcement Date |
Target |
Acquiror |
Type |
Total Offer Valuation(1) ($inmillions) |
Upfront Payment ($inmillions) |
Future Contingent Payment(s) ($inmillions) |
||||||||||||
|
September6, 2016 |
RetroSenseTherapeutics |
Allergan plc | Private | $ | 555.0 | $ | 60.0 | $ | 495.0 | |||||||||
|
August1, 2016 |
Bamboo Therapeutics |
Pfizer | Private | $ | 688.0 | $ | 193.0 | $ | 495.0 | |||||||||
|
July5, 2016 |
CormorantPharmaceuticals |
Bristol-Myers Squibb | Private | $ | 520.0 | $ | 35.0 | $ | 485.0 | |||||||||
|
December23,2015 |
PhosImmune |
Agenus | Private | $ | 44.9 | $ | 9.9 | $ | 35.0 | |||||||||
|
October21, 2015 |
Admune Therapeutics |
Novartis AG | Private | $ | 258.0 | $ | 140.0 | $ | 118.0 | |||||||||
|
October9, 2015 |
Adheron Therapeutics |
RocheHolding AG | Private | $ | 580.0 | $ | 105.0 | $ | 475.0 | |||||||||
|
July28, 2015 |
cCAM Biotherapeutics |
MerckCo. | Private | $ | 605.0 | $ | 95.0 | $ | 510.0 | |||||||||
|
May1, 2014 |
Fibrotech Therapeutics Pty | Shire plc | Private | $ | 557.5 | $ | 75.0 | $ | 482.5 | |||||||||
|
Mean |
$ | 476.1 | $ | 89.1 | $ | 386.9 | ||||||||||||
|
Median |
$ | 556.3 | $ | 85.0 | $ | 483.8 |
| (1) |
Total offer value is the sum of upfront and future contingent payments at announcement, and does not reflect a view as to the probability of payment of contingent payments |
| f. |
The table immediately following the second full paragraph on page 98 (such paragraph beginning with Wedbush reviewed publicly available ) of the Definitive Proxy Statement is hereby amended and restated as follows: |
|
Pricing Date |
Issuer |
Initial Public Offering | Fully Diluted | |||||||||||||||||||||||
| Price Per Share | Net Proceeds ($inmillions) | Pre-Money Equity Value(1) ($inmillions) | Pre-Money Shares Outstanding (in millions) | Post-Money Equity Value(2,3) ($inmillions) | Post-Money Shares Outstanding (in million) | |||||||||||||||||||||
|
August10,2016 |
Protagonist Therapeutics, Inc. |
$ | 12.00 | $ | 90.0 | $ | 118.7 | 9.9 | $ | 208.7 | 17.4 | |||||||||||||||
|
October25,2016 |
Ra Pharmaceuticals, Inc. |
$ | 13.00 | $ | 105.4 | $ | 187.7 | 14.4 | $ | 293.1 | 22.5 | |||||||||||||||
|
March22, 2016 |
Corvus Pharmaceuticals, Inc. |
$ | 15.00 | $ | 70.5 | $ | 235.6 | 15.7 | $ | 306.1 | 20.4 | |||||||||||||||
|
February10,2016 |
Proteostasis Therapeutics, Inc. |
$ | 8.00 | $ | 50.0 | $ | 105.6 | 13.2 | $ | 155.6 | 19.4 | |||||||||||||||
|
November10,2015 |
Voyager Therapeutics, Inc. |
$ | 14.00 | $ | 80.5 | $ | 296.8 | 21.2 | $ | 377.3 | 26.9 | |||||||||||||||
|
October28, 2015 |
MyoKardia, Inc. |
$ | 10.00 | $ | 62.5 | $ | 218.2 | 21.8 | $ | 280.8 | 28.1 |
|
Pricing Date |
Issuer |
Initial Public Offering | Fully Diluted | |||||||||||||||||||||||
| Price Per Share | Net Proceeds ($inmillions) | Pre-Money Equity Value(1) ($inmillions) | Pre-Money Shares Outstanding (in millions) | Post-Money Equity Value(2,3) ($inmillions) | Post-Money Shares Outstanding (in million) | |||||||||||||||||||||
|
October21,2015 |
Dimension Therapeutics, Inc. |
$ | 13.00 | $ | 72.9 | $ | 283.1 | 21.8 | $ | 355.9 | 27.4 | |||||||||||||||
|
June16, 2015 |
Nivalis Therapeutics, Inc. |
$ | 14.00 | $ | 88.6 | $ | 127.8 | 9.1 | $ | 216.3 | 15.5 | |||||||||||||||
|
May6,2015 |
aTyr Pharma, Inc. |
$ | 14.00 | $ | 86.3 | $ | 254.9 | 18.2 | $ | 341.2 | 24.4 | |||||||||||||||
|
July31,2014 |
Loxo Oncology, Inc. |
$ | 13.00 | $ | 76.7 | $ | 150.2 | 11.6 | $ | 230.0 | 17.7 | |||||||||||||||
|
July23, 2014 |
Immune Design Corp. |
$ | 12.00 | $ | 64.9 | $ | 129.2 | 10.8 | $ | 194.2 | 16.2 | |||||||||||||||
|
Mean |
$ | 12.55 | $ | 77.1 | $ | 191.6 | 15.2 | $ | 246.6 | 21.4 | ||||||||||||||||
|
Median |
$ | 13.00 | $ | 76.7 | $ | 187.7 | 14.4 | $ | 255.4 | 20.4 |
| (1) |
Pre-Money value excludes net proceeds received by the issuer from the IPO |
| (2) |
Post-Money value includes net proceeds received by the issuer from the IPO |
| (3) |
Loxo Oncology post-money includes gross proceeds from a concurrent private placement |
| 3. |
The section of the Definitive Proxy Statement entitled UNAUDITED PRO FORMA COMBINED FINANCIAL INFORMATION is hereby supplemented as follows: |
| a. |
The second sentence of the second full paragraph under the heading 4. Pro Forma Adjustments on page 183 (such paragraph beginning with Based on Otics managements review ) of the Definitive Proxy Statement is hereby amended and restated as follows: |
Tokai does not anticipate
declaring and paying any cash dividends prior to the closing of
the Otic Transaction. Tokai previously estimated that its net
cash at the closing would be approximately $25.0million, based on
an assumption provided to potential acquirors that, depending on
the timing of closing, its net cash at closing would be between
approximately $20.0million and $25.0million. With the closing
date scheduled, Tokai now anticipates that its net cash at the
closing will be approximately
$20.0million.
ADDITIONAL INFORMATION
ABOUT THE TRANSACTION AND WHERE TO FIND
IT
In connection with the
proposed Otic Transaction, Tokai filed a Definitive Proxy
Statement with the SEC on April7, 2017. The Definitive Proxy
Statement was first mailed on or about April7, 2017 to the
Companys stockholders of record as of the close of business on
April3, 2017. Stockholders of Tokai are urged to read these
materials carefully because they contain important information
about Tokai, Otic, and the proposed Otic Transaction and related
transactions. The Definitive Proxy Statement and any amendments
or supplements thereto (when such amendments or supplements
become available) and other documents filed by Tokai with the SEC
may be obtained free of charge through the SEC web site
atwww.sec.gov. They may also be obtained for free by
directing a written request to: Tokai Pharmaceuticals, Inc., 255
State Street, 6th Floor,
Boston, Massachusetts, 02109, Attention: Chief Financial Officer
and Chief Operating Officer.
This communication shall not
constitute an offer to sell or the solicitation of an offer to
sell or the solicitation of an offer to buy any securities, nor
shall there be any sale of securities in any jurisdiction in
which such offer, solicitation or sale would be unlawful prior to
registration or qualification under or applicable exemption from
the securities laws of any such
jurisdiction.
PARTICIPANTS IN THE
SOLICITATION
Tokai, Otic and each of their
respective directors and executive officers may be deemed to be
participants in the solicitation of proxies from the stockholders
of Tokai in connection with the transactions contemplated by the
Share Purchase Agreement and the other transactions described in
the Definitive Proxy Statement. Information regarding the
interests of these directors and executive officers in the
proposed transaction is included in the Definitive Proxy
Statement. Additional information regarding the directors and
executive officers of Tokai is included in its Form 10-K/A, which
was filed with the SEC on April25, 2017.
CAUTIONARY STATEMENT
REGARDING FORWARD-LOOKING
INFORMATION
This Form 8-K may contain
predictions, projections, forecasts, estimates and other
information that may be considered forward-looking statements,
within the meaning of the Private Securities Litigation Reform
Act of 1995 (which is applicable to Tokai, but not Otic, because
Tokai, unlike Otic, is a public company subject to the reporting
requirements of the Securities Exchange Act of 1934, as amended
(the Exchange Act)). Such forward-looking statements include,
without limitation: statements regarding the structure, timing
and completion of the proposed transaction; expectations
regarding the capitalization, cash balances and working capital,
resources and ownership structure of the company after the
transaction; expectations regarding the sufficiency of the
companys resources to fund the advancement of any development
program or the completion of any clinical trial; projections
regarding Otics future expenditures and financial results; and
the expectations regarding voting by Tokai stockholders. You can
typically identify forward-looking statements by the use of
forward-looking terminology including believe, expect, may, will,
should, could, seek, intend, plan, pro forma, estimate, project,
continue, potential, forecast or anticipate or the negative of
these words and phrases or other variations of these words and
phrases or comparable terminology. Stockholders are cautioned
that any forward-looking statements are not guarantees of future
performance. Actual results may differ materially from those
indicated by such forward-looking statements as a result of
various important factors, including: risks and uncertainties
associated with stockholder approval of and the ability to
consummate the proposed transaction; whether the anticipated cash
resources will be sufficient to fund operations for the period
anticipated and to conduct the anticipated studies; whether the
necessary approvals to commence clinical trials of Otics product
candidates can be obtained on a timely basis or at all; and
whether the results of clinical trials will warrant submission
for regulatory approval, any such submission will receive
approval from the United States Food and Drug Administration or
equivalent foreign regulatory agencies and, if any of such
product candidates obtains such approval, it will be successfully
distributed and marketed.
For a further discussion of
the factors that may cause Tokai or the combined companys actual
results, performance or achievements to differ materially from
any future results, performance or achievements expressed or
implied in such forward-looking statements, or for a discussion
of risks associated with the ability of Tokai and Otic to
complete the Otic Transaction and the effect of the Otic
Transaction on the business of Tokai and the combined company,
see the section entitled Risk Factors, beginning on page 30 of
the Definitive Proxy Statement.
If any of these risks or
uncertainties materializes or any of these assumptions proves
incorrect, the results of Tokai, Otic or the combined company
could differ materially from the forward-looking statements. All
forward-looking statements in this Form 8-K and the Definitive
Proxy Statement are current only as of the date on which the
statements were made. Tokai and Otic expressly disclaim any
obligation to update any forward-looking statements, whether as a
result of new information, future events or
otherwise.
About TOKAI PHARMACEUTICALS, INC. (NASDAQ:TKAI)
Tokai Pharmaceuticals, Inc. is a United States-based biopharmaceutical company. The Company focuses on developing and commercializing therapies for prostate cancer and other hormonally-driven diseases. The Company’s lead drug candidate, galeterone, is an oral small molecule that utilizes the mechanistic pathways of second-generation androgen signaling inhibitors, while also introducing a mechanism called androgen receptor degradation, including impairing the function of androgen receptors. The Company is developing galeterone for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). Androgen Receptor Modulation Optimized for Response (ARMOR) is its clinical development program for the evaluation of galeterone in patients with prostate cancer. Its drug discovery platform, androgen receptor degradation agents (ARDA), enables the Company to identify and develop compounds with potent androgen receptor degradation activity. TOKAI PHARMACEUTICALS, INC. (NASDAQ:TKAI) Recent Trading Information
TOKAI PHARMACEUTICALS, INC. (NASDAQ:TKAI) closed its last trading session down -0.004 at 0.612 with 67,250 shares trading hands.