Current Report Filing (8-k)
October 15 2020 - 3:56PM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of The
Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported):
October 12, 2020
Titan
Pharmaceuticals, Inc.
(Exact name of registrant as specified in
its charter)
Delaware
(State or other jurisdiction of incorporation)
001-13341
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94-3171940
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(Commission File Number)
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(IRS Employer Identification No.)
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400 Oyster Point Blvd., Suite 505, South
San Francisco, CA 94080
(Address of principal executive offices
and zip code)
650-244-4990
(Registrant's telephone
number including area code)
(Registrant's former name or former address,
if changed since last report)
Securities registered pursuant to
Section 12(b) of the Act:
Title of each class
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Trading Symbol
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Name of each exchange on which registered
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Common Stock, $0.001 par value
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TTNP
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Nasdaq Capital Market
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Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of registrant under any of the following provisions:
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¨
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Written communications
pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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¨
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Soliciting material pursuant
to Rule 14a-12(b) under the Exchange Act (17 CFR 240.14a-12(b))
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¨
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Pre-commencement communications
pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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¨
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Pre-commencement communications
pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Indicate by check mark whether the registrant is an emerging
growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities
Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards
provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 1.01. Entry into Material Definitive
Agreement
Item 5.02. Departure of Directors or
Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
The information set forth in the third
paragraph of Item 8.01 is incorporated by reference herein.
Item 8.01. Other Events
On October 15, 2020, Titan Pharmaceuticals,
Inc. (the “Company” or “Titan”) issued a press release announcing its decision to discontinue selling Probuphine®
(buprenorphine) implant and wind down the Company’s commercialization activities and pursue a plan that will enable it to
focus on the Company’s ProNeura-based product development efforts. The Company based its decision on several factors, most
notably that commercializing Probuphine with the requirements of the current product label and the Risk Evaluation and Mitigation
Strategy, or REMS, program has proven to be onerous. Other factors that have negatively impacted Titan’s ability to effectively
commercialize Probuphine include the financial constraints that have limited our sales and marketing capabilities; suboptimal reimbursement
rates; and the complexity of the distribution channel. The complexity of the changing environment due to the COVID-19 pandemic
has further exacerbated these issues. As a result, sales of Probuphine have been, and would likely continue for the foreseeable
future to be, extremely limited. After careful review of the recent sales and marketing results, the hurdles that Titan has and
will continue to face, and the substantial additional expenditures and resources that would be required, the board of directors
determined to advise the U.S. Food and Drug Administration (“FDA”) of its decision to cease commercialization of Probuphine.
A wind-down plan taking into considerations FDA and state regulatory requirements, as well as business considerations is underway.
The Company also announced that it is in
negotiations with L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A. (“Molteni”) and Horizon Credit
II LLC, the holders of Titan’s outstanding secured debt ($4.0 million principal amount and approximately $1.2 million in
payoff amounts) to eliminate such obligations. The Company is seeking to settle the debt for cash payments, the transfer of certain
Probuphine assets to Molteni and the termination of the Company’s rights to future payments under the asset purchase and
supply agreement with Molteni in exchange for the release to Titan of the remaining collateral. This would allow the Company to
continue operating as a product development company, initially focused on its nalmefene implant for the prevention of opioid relapse
following detoxification and a kappa opioid receptor agonist peptide implant for the treatment of pruritus.
Consummation of a debt settlement agreement
and the continuation of any product development programs, however, are contingent upon Titan’s ability to raise sufficient
capital during the next few weeks and there can be no assurance that the required financing will be available on acceptable terms,
if at all. If the Company is unable to complete a financing, it will not have sufficient funds to continue its operations.
As previously disclosed, Sunil Bhonsle,
Titan’s Chief Executive Officer, expressed his desire to retire prior to the end of the year. Accordingly, Mr. Bhonsle will
retire from his position and Marc Rubin, the Company’s Executive Chairman, and Kate DeVarney, the Company’s Executive
Vice President and Chief Scientific Officer and a member of the board of directors, will assume the roles of Chairman and Chief
Executive Officer and President and Chief Operating Officer, respectively.
A copy of the press release issued on October
15, 2020 is attached hereto as Exhibit 99.1 and incorporated herein by reference.
Item 9.01. Financial Statements and
Exhibits.
(d) Exhibits
The following exhibit is filed herewith:
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act
of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Dated: October 15, 2020
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TITAN PHARMACEUTICALS, INC.
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By:
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/s/ Sunil Bhonsle
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Name:
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Sunil Bhonsle
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Title:
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President and Chief Executive Officer
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