1. SOUTH SAN FRANCISCO, Calif., Feb. 1, 2021 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) today announced that studies of its kappa opioid agonist peptide, JT-09, has demonstrated high potency and specificity for the human kappa-opioid receptor ("KOR"). JT-09 is being developed for use in combination with Titan's ProNeura® long-term, continuous drug delivery technology for the treatment of moderate-to-severe chronic pruritus (itch).

    The KOR potency studies used the cAMP Hunter™ assay with cloned human mu, delta and kappa opioid receptors. In addition, in studies conducted in collaboration with Charles Chavkin, Ph.D., Allan and Phyllis Treuer Endowed Chair of Pain Research and Professor, Department of Pharmacology, at the University of Washington Health Sciences Center, Seattle, WA, pretreatment with JT-09 or with difelikefalin (which is being developed as Korsuva™ by Cara Therapeutics, Inc.) were observed to be equally potent in reducing scratching and grooming bouts when injected subcutaneously (0.3 mg/kg) in a 5'-guanidinonaltrindole (5'-GNTI) itch-induced mouse model.

    "Pilot pharmacokinetic studies in rats previously indicated that subcutaneous placement of ProNeura implants containing JT-09 could deliver potentially therapeutic concentrations of this KOR agonist for up to six months or longer," said Kate Beebe DeVarney, Ph.D., President and Chief Operating Officer of Titan.

    Dr. Beebe DeVarney continued, "These additional early positive data provide strong support for us to move forward with our planned non-clinical proof-of-concept study of JT-09 ProNeura implants in this animal itch model. This is an important next step for Titan towards developing a new treatment modality for moderate-to-severe chronic pruritus that is effective, patient-friendly and convenient."

    About Chronic Pruritus

    Chronic pruritus is an unpleasant sensation resulting in a need to scratch that lasts more than 6 weeks. It is a prevalent and bothersome symptom associated with both cutaneous and systemic conditions. Due to its complex pathogenesis and numerous contributing factors, effective treatment of chronic pruritus therapy remains challenging.

    About Titan Pharmaceuticals

    Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) is a development-stage biotechnology company developing proprietary therapeutics using its clinically proven ProNeura® long-term, continuous drug delivery technology. The ProNeura technology has the potential to be used in developing products for treating  a number of chronic conditions where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. For more information about Titan, please visit www.titanpharm.com.

    Forward-Looking Statements

    This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to our ability to raise capital, the winding down of U.S. commercial activities related to Probuphine, the regulatory approval process, the development, testing, production and marketing of our drug candidates, patent and intellectual property matters and strategic agreements and relationships. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

    Korsuva is a trademark of Cara Therapeutics, Inc.

    CONTACT:

    Stephen Kilmer

    Investor Relations

    (650) 989-2215

     

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  2. SOUTH SAN FRANCISCO, Calif., Jan. 15, 2021 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) today announced it has entered into a securities purchase agreement with certain accredited institutional investors to purchase approximately $9.7 million of its common stock in a registered direct offering and warrants to purchase common stock in a concurrent private placement. The combined purchase price for one share of common stock and each warrant will be $3.55.

    Under the terms of the purchase agreement, Titan has agreed to sell 2,725,000 shares of its common stock and warrants to purchase up to an aggregate of 2,725,000 shares of common stock. The warrants will be immediately exercisable, will expire on the five year and six-month anniversary of the issuance date and will have an exercise price of $3.55 per share.

    Titan expects the net proceeds from the registered direct offering and concurrent private placement to be approximately $8.9 million after deducting the placement agent's fees and other estimated offering expenses. The offering is expected to close on or about January 20, 2021, subject to the satisfaction of customary closing conditions.

    Maxim Group LLC is acting as the sole placement agent in connection with the offering.

    The shares of common stock are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-230742), which was declared effective by the United States Securities and Exchange Commission ("SEC") on April 24, 2019. The warrants issued in the concurrent private placement and shares issuable upon exercise of such warrants were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and have not been registered under the Act or applicable state securities laws.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. A prospectus supplement relating to the shares of common stock and warrants will be filed by Titan with the SEC. When available, copies of the prospectus supplement relating to the registered direct offering, together with the accompanying prospectus, can be obtained at the SEC's website at www.sec.gov or from Maxim Group LLC, 405 Lexington Avenue, New York, NY 10174, Attention: Syndicate Department, or via email at or telephone at (212) 895-3745.

    About Titan Pharmaceuticals

    Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is a development stage company developing proprietary therapeutics with its ProNeura® long-term, continuous drug delivery technology. The ProNeura technology has the potential to be used in developing products for treating a number of chronic conditions, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. For more information about Titan, please visit www.titanpharm.com.

    Forward-Looking Statements

    This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to our ability to raise capital, the winding down of U.S. commercial activities related to Probuphine, the regulatory approval process, the development, testing, production and marketing of our drug candidates, patent and intellectual property matters and strategic agreements and relationships. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

    CONTACTS:

    Stephen Kilmer

    Investor Relations

    (650) 989-2215

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    SOURCE Titan Pharmaceuticals, Inc.

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  3. SOUTH SAN FRANCISCO, Calif., Dec. 16, 2020 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) ("the "Company") today announced that on December 15, 2020, it received a notification letter from The Nasdaq Stock Market LLC ("Nasdaq") confirming that the Company has regained compliance with Nasdaq's minimum bid price requirement and is in compliance with all applicable listing standards. Therefore, the scheduled hearing before the Nasdaq Hearings Panel has been cancelled and the Company's common stock will continue to trade on the Nasdaq Capital Market. 

    About Titan Pharmaceuticals

    Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is a development stage company developing proprietary therapeutics with its ProNeura® long-term, continuous drug delivery technology. The ProNeura technology has the potential to be used in developing products for treating a number of chronic conditions, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. For more information about Titan, please visit www.titanpharm.com.

    Forward-Looking Statements

    This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to our ability to raise capital, the winding down of U.S. commercial activities related to Probuphine, the regulatory approval process, the development, testing, production and marketing of our drug candidates, patent and intellectual property matters and strategic agreements and relationships. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

    CONTACTS:

    Stephen Kilmer

    Investor Relations

    (650) 989-2215

       

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    SOURCE Titan Pharmaceuticals, Inc.

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  4. SOUTH SAN FRANCISCO, Calif., Nov. 30, 2020 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) ("Titan" or the "Company") today announced that its Board of Directors has approved a 1-for-30 reverse stock split of the Company's common stock, which will be effective at 5:00 p.m. Eastern Time on Monday, November 30, 2020. The Company's stockholders approved the reverse stock split at a Special Meeting of Stockholders on November 30, 2020. The Company's shares will begin trading on a split-adjusted basis on the Nasdaq Capital Market commencing upon market open on December 1, 2020. 

    As a result of the reverse split, each 30 shares of the Company's issued and outstanding common stock will be automatically combined and converted into one issued and outstanding share of common stock, par value $0.001 per share. The Company will not issue any fractional shares in connection with the reverse stock split. Instead, the number of shares will be rounded up to the next whole number. The reverse stock split will not modify the rights or preferences of the common stock.

    Immediately after the reverse split becomes effective, there will be approximately 6.6 million shares of common stock issued and outstanding. The common shares will trade under a new CUSIP number, 888314606, effective December 1, 2020, and continue to trade under the symbol "TTNP." All stock options and warrants of the Company outstanding immediately prior to the reverse stock split have been proportionally adjusted.

    The Company has appointed its transfer agent, Continental Stock Transfer & Trust Company ("Continental"), to act as exchange agent for the reverse stock split. Stockholders owning shares via a bank, broker or other nominee will have their positions automatically adjusted to reflect the reverse stock split and will not be required to take further action in connection with the reverse stock split, subject to brokers' particular processes. Continental can be reached at (917) 262-2378.

    About Titan Pharmaceuticals

    Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is a development stage company developing proprietary therapeutics with its ProNeura® long-term, continuous drug delivery technology. The ProNeura technology has the potential to be used in developing products for treating a number of chronic conditions, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. For more information about Titan, please visit www.titanpharm.com.

    Forward-Looking Statements

    This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to our ability to raise capital, the winding down of U.S. commercial activities related to Probuphine, the regulatory approval process, the development, testing, production and marketing of our drug candidates, patent and intellectual property matters and strategic agreements and relationships. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

    CONTACTS:

    Stephen Kilmer

    Investor Relations

    (650) 989-2215

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  5. SOUTH SAN FRANCISCO, Calif., Nov. 16, 2020 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) ("Titan" or the "Company") today reported financial results for the third quarter ended September 30, 2020 and provided an update on its business.

    Third Quarter 2020 and Recent Highlights

    • In September 2020, the Company completed a registered direct offering, resulting in net cash proceeds of approximately $2.4 million.
    • In October 2020, Titan announced a strategic restructuring, where it will focus on ProNeura®-based product development; and discontinue its U.S. Probuphine implant sales and wind down Probuphine commercialization activities.
    • In October 2020, Kate DeVarney, Ph.D., was promoted from the position of Executive Vice President and Chief Scientific Officer to President and Chief Operating Officer. In addition, Sunil Bhonsle stepped down from his executive role. Dr. Marc Rubin, Titan's Executive Chairman, together with Dr. DeVarney, will oversee the Company's product development activities.
    • In October 2020, Titan completed a public offering resulting in net cash proceeds of approximately $5.7 million.
    • In October 2020, the Company settled all of its debt obligations with Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A and Horizon Credit LLC II.
    • In October 2020, Titan acquired JT Pharmaceuticals, Inc.'s kappa opioid agonist peptide, JT-09, for use in combination with Titan's ProNeura® long-term, continuous drug delivery technology, for the treatment of chronic pruritus.

    "Subsequent to the end of the third quarter, Titan began an important, focused restructuring to position the Company for future growth," said Dr. DeVarney. "We believe that our ProNeura platform, which has the potential to provide continuous drug delivery over extended periods of up to six to 12 months, offers potential key value-generating opportunities. These include the platform's application to the recently-acquired JT-09, for which we plan to establish proof-of-concept as a treatment of chronic pruritus in the first half of next year. In addition, we remain committed to helping individuals impacted by the opioid epidemic through our ongoing, National Institute on Drug Abuse-funded nalmefene implant development program, with plans to file an investigational New Drug Application with the U.S. Food and Drug Administration in the first half of 2021."

    "In addition to refocusing our efforts on the ProNeura platform, our recent restructuring significantly reduced operating expenses, while our debt settlements restored our ability to fully capitalize on our IP," said Dr. Rubin. "These, combined with the recent completion of two financings, positions Titan to execute on our new strategy."

    Third Quarter 2020 Financial Results 

    For the three months ended September 30, 2020, Titan reported approximately $1.1 million in revenue, which reflects approximately $0.1 million in product sales and approximately $1.0 million related to the Company's National Institute on Drug Abuse ("NIDA") grant. This compared with revenues of approximately $0.9 million in the same period in 2019, which was comprised of $0.2 million in product sales and $0.8 million related to the NIDA grant. Product revenue during the three month period ended September 30, 2020 declined from the comparable periods in 2019 due to a substantial decrease in unit sales volumes; increased utilization of patient assistance programs; and the effects of the COVID-19 pandemic and the related shelter-in-place restrictions and clinic closures. 

    Total operating expenses for the third quarter of 2020 were approximately $5.8 million, compared with approximately $4.8 million from the same quarter in 2019, and consisted primarily of research and development ("R&D") and selling, general and administrative ("SG&A") expenses and costs of goods sold, inclusive of distribution expenses. R&D expenses for the quarter ended September 30, 2020 were approximately $1.6 million, consistent with the same three month period in 2019. SG&A expenses for the 2020 third quarter were approximately $3.5 million, compared with approximately $3.0 million in the same quarter a year ago. Costs of goods sold for the third quarter of 2020 were approximately $0.7 million, compared with approximately $0.2 million the 2019 third quarter.

    Net other expense, consisting primarily of interest expense, was approximately $0.3 million in the third quarter of 2020, compared with net other income of approximately $1.1 million in the third quarter of 2019. The increase in other expense, net for the three months ended September 30, 2020 was primarily due to an approximately $1.0 million non-cash gain on changes in the fair value of warrants issued in connection with Titan's August 2019 offering and an approximately $0.3 million non-cash gain on debt extinguishment related to the modification of Titan's loan from Molteni.

    Net loss applicable to common stockholders in the third quarter of 2020 was approximately $4.9 million, or approximately $0.05 per share, compared with a net loss applicable to common stockholders of approximately $2.8 million, or approximately $0.18 per share, in the same quarter in 2019.

    As of September 30, 2020, Titan had cash and cash equivalents of approximately $4.1 million, which the Company believes, along with the proceeds of public offering, is sufficient to fund planned operations into the third quarter of 2021.

    Conference Call Details

    Titan management will host a conference call today at 12:00 p.m. ET / 9:00 a.m. PT to discuss business developments in the period. The conference call will be hosted by Marc Rubin, M.D., Executive Chairman, and Kate DeVarney, Ph.D., President and Chief Operating Officer.

    The live conference call may be accessed by dialing 1-888-317-6003 (U.S.) or 1-412-317-6061 (international) and providing passcode 9502574. The call will also be broadcast live at https://www.webcaster4.com/Webcast/Page/1655/38848, and archived on Titan's website at www.titanpharm.com/news/events.    

    About Titan Pharmaceuticals

    Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is a development stage company developing proprietary therapeutics with its ProNeura® long-term, continuous drug delivery technology. The ProNeura technology has the potential to be used in developing products for treating a number of chronic conditions, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. For more information about Titan, please visit www.titanpharm.com.

    Forward-Looking Statements

    This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to our ability to raise capital, the winding down of U.S. commercial activities related to Probuphine, the regulatory approval process, the development, testing, production and marketing of our drug candidates, patent and intellectual property matters and strategic agreements and relationships. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

    CONTACT:

    Stephen Kilmer

    Investor Relations

    (650) 989-2215

     

    TITAN PHARMACEUTICALS, INC.

    CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

    (in thousands, except per share amount)

    (unaudited)













    Three Months Ended

    September 30,



    Nine Months Ended

    September 30,











    2020



    2019



    2020



    2019

    Revenue:





















    License revenue





    $            -



    $             -



    $              6



    $          313



    Product revenue





    102



    190



    427



    811



    Grant revenue





    1,018



    757



    3,348



    1,270





    Total revenue





    1,120



    947



    3,781



    2,394

























    Operating expense:





















    Cost of goods sold





    683



    188



    1,081



    738



    Research and development





    1,562



    1,619



    5,846



    5,370



    Selling, general and administrative





    3,549



    3,023



    10,137



    9,336





    Total operating expense





    5,794



    4,830



    17,064



    15,444

    Loss from operations





    (4,674)



    (3,883)



    (13,283)



    (13,050)





























    Other income (expense), net





    (258)



    1,080



    (1,874)



    533

























    Net loss and comprehensive loss





    $     (4,932)



    $      (2,803)



    $   (15,157)



    $   (12,517)

















































    Basic and diluted net loss per common share





    $       (0.05)



    $        (0.18)



    $       (0.17)



    $       (0.89)

























    Weighted average shares used in computing 





















    basic and diluted net loss per share





    97,906



    15,517



    91,848



    14,112



















































    CONDENSED BALANCE SHEETS

    (in thousands)

    (unaudited)







































    September 30,







    December 31,















    2020







    2019

























    Assets





















    Cash and cash equivalents









    $       4,073







    $       5,223



    Receivables









    423







    993



    Inventory









    1,073







    998



    Prepaid expenses and other current assets









    1,080







    1,094





    Total current assets









    6,649







    8,308



    Property and equipment, net









    1,161







    817



    Operating lease right-of-use asset









    208







    397





    Total assets









    $       8,018







    $       9,522

    Liabilities and Stockholders' Equity (Deficit)





















    Current liabilities









    $       5,877







    $       3,600



    Operating lease liability, non-current









    -







    150



    Long-term debt, non-current









    3,038







    4,019



    Warrant liability









    -







    320



    Stockholders' equity (deficit)









    (897)







    1,433





    Total liabilities and stockholders' equity (deficit)



    $       8,018







    $       9,522

     

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  6. SOUTH SAN FRANCISCO, Calif., Nov. 2, 2020 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) today announced the completion of its agreement to settle all of its debt obligations with Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A ("Molteni") and Horizon Credit LLC II ("Horizon"), as well as its agreement to acquire JT Pharmaceuticals, Inc.'s  ("JT Pharma") kappa opioid agonist peptide, JT-09, for use in combination with Titan's ProNeura® long-term, continuous drug delivery technology, for the treatment of chronic pruritus.

    The completion of both transactions had been subject to Titan's closing of its previously announced underwritten public offering, which occurred on October 30, 2020.

    "As a result of the debt settlement with Molteni and Horizon, there are no liens remaining on any of Titan's assets, including all the ProNeura intellectual property," commented Titan's Executive Chairman, Dr. Marc Rubin. "With the net proceeds from our recent public offering, a significant reduction in operating expenses, and full ability to capitalize on our IP, we are well positioned to progress preclinical development of our ProNeura-based product candidate pipeline, including establishing proof of concept with JT-09 in the first half of 2021."

    About Titan Pharmaceuticals

    Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is a development stage company developing proprietary therapeutics with its ProNeura® long-term, continuous drug delivery technology.  The ProNeura technology has the potential to be used in developing products for treating a number of chronic conditions, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. For more information about Titan, please visit www.titanpharm.com.

    Forward-Looking Statements

    This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to our ability to raise capital, the winding down of U.S. commercial activities related to Probuphine, the regulatory approval process, the development, testing, production and marketing of our drug candidates, patent and intellectual property matters and strategic agreements and relationships. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

    CONTACT:

    Stephen Kilmer

    Investor Relations

    (650) 989-2215

     

     

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  7. SOUTH SAN FRANCISCO, Calif., Oct. 28, 2020 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) today announced the pricing of an underwritten public offering of 80,000,000 units at a price of $0.10 per unit.  Each unit issued in the offering consists of one share of common stock and one warrant to purchase one share of common stock.  Gross proceeds, before underwriting discounts and commissions and estimated offering expenses, are expected to be $8.0 million.

    The warrants will have an exercise price of $0.10, will be exercisable commencing on the effective date of an increase in our authorized shares of common stock or a reverse split in an amount sufficient to permit the exercise in full of the warrants and will expire on the fifth anniversary of the initial exercise date. The shares of common stock and the accompanying warrants are immediately separable from the units, and can only be purchased together in the offering.  The offering is expected to close on or about October 30, 2020.

    Maxim Group LLC is acting as the sole book-running manager for the offering.

    The Securities and Exchange Commission (the "SEC") declared effective a registration statement on Form S-1 (File No. 333-249550) relating to these securities on October 28, 2020.  A final prospectus relating to the offering will be filed with the SEC and will be available on the SEC's website at http://www.sec.gov. The offering is being made only by means of a prospectus forming part of the effective registration statement.  Electronic copies of the prospectus relating to this offering, when available, may be obtained from Maxim Group LLC, 405 Lexington Avenue, 2nd Floor, New York, NY 10174, at (212) 895-3745.

    This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor may there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Titan Pharmaceuticals

    Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is a development stage company developing proprietary therapeutics with its ProNeura® long-term, continuous drug delivery technology. The ProNeura technology has the potential to be used in developing products for treating a number of chronic conditions, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. For more information about Titan, please visit www.titanpharm.com.

    Forward-Looking Statements

    This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to our ability to raise capital, the winding down of U.S. commercial activities related to Probuphine, the regulatory approval process, the development, testing, production and marketing of our drug candidates, patent and intellectual property matters and strategic agreements and relationships. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

    CONTACTS:

    Stephen Kilmer

    Investor Relations

    (650) 989-2215

     

     

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  8. SOUTH SAN FRANCISCO, Calif., Oct. 28, 2020 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) today announced that it has entered into a definitive asset purchase agreement (the "Agreement") with JT Pharmaceuticals, Inc. ("JT Pharma"), a peptide drug development company, to acquire JT Pharma's kappa opioid agonist peptide, JT-09, for use in combination with Titan's ProNeura® long-term, continuous drug delivery technology, for the treatment of chronic pruritus.

    Under the terms of the Agreement, JT Pharma is entitled to receive from Titan future milestone payments based on the achievement of regulatory milestones, including potential regulatory approval for commercialization, plus single-digit percentage earn-out payments on net sales of the product.

    "Current treatments for moderate to severe chronic pruritus, a debilitating condition characterized by itching of the skin lasting longer than six weeks, are relatively ineffective and are associated with undesirable side-effects," said Dr. Kate DeVarney, President and Chief Operating Officer of Titan. "Our early non-clinical data suggest that subcutaneous implantation of JT-09 ProNeura implants could potentially deliver therapeutic concentrations of JT-09 for six months or longer, and we are looking forward to conducting additional preclinical studies to establish proof-of-concept with data available in the first half of 2021."

    The closing of the agreement is subject to customary closing conditions and Titan's completion of a financing with gross proceeds of at least $8,000,000.

    About Titan Pharmaceuticals

    Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is a commercial stage company developing proprietary therapeutics with its ProNeura® long-term, continuous drug delivery technology. The ProNeura technology has the potential to be used in developing products for treating a number of chronic conditions, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. For more information about Titan, please visit www.titanpharm.com.

    Forward-Looking Statements

    This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to our ability to raise capital, the winding down of U.S. commercial activities related to Probuphine, the regulatory approval process, the development, testing, production and marketing of our drug candidates, patent and intellectual property matters and strategic agreements and relationships. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

    CONTACT:

    Stephen Kilmer

    Investor Relations

    (650) 989-2215

     

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    SOURCE Titan Pharmaceuticals, Inc.

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  9. SOUTH SAN FRANCISCO, Calif., Oct. 26, 2020 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), a company developing proprietary therapeutics for the treatment of select chronic diseases utilizing its ProNeura® long-term, continuous drug delivery technology, today announced its entry into an agreement to settle all of its debt obligations with Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A ("Molteni) and Horizon Credit LLC II ("Horizon"). The debt was secured with a lien on all assets of Titan.

    Under the terms of the agreement, Molteni and Horizon agreed to settle the approximately $5.2 million of outstanding indebtedness in exchange for the payment by Titan of a total of $1.6 million in cash to Horizon and Molteni, the transfer of certain Probuphine® assets to Molteni, including certain equipment, inventory and non-U.S. Probuphine intellectual property, and the termination of Titan's rights to future payments under its asset purchase, supply and support agreement with Molteni.

    "Reaching agreement on the settlement of the outstanding debt is a major step in the restructuring of Titan, and we appreciate the timely action and cooperation of Molteni and Horizon in accomplishing this goal," said Dr. DeVarney, President and Chief Operating Officer of Titan. "We are making good progress in closing down the U.S. commercial activities for Probuphine, and except for the required pharmacovigilance and REMS support to health care providers who have patients in treatment, we will have completed this task during the quarter."

    The closing of the agreement is subject to customary closing conditions and Titan's completion of a financing that will enable it to make the cash payments thereunder. Upon closing, there will be no liens on Titan's remaining assets, including all the ProNeura® intellectual property.

    About Titan Pharmaceuticals

    Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is a commercial stage company developing proprietary therapeutics with its ProNeura® long-term, continuous drug delivery technology. The ProNeura technology has the potential to be used in developing products for treating a number of chronic conditions, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. For more information about Titan, please visit www.titanpharm.com.

    Forward-Looking Statements

    This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to our ability to raise capital, the winding down of U.S. commercial activities related to Probuphine, the development, testing, production and regulatory approval process relating to our drug candidates, patent and intellectual property matters and strategic agreements and relationships. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

    CONTACT:

    Stephen Kilmer

    Investor Relations

    (650) 989-2215

     

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    SOURCE Titan Pharmaceuticals, Inc.

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  10. SOUTH SAN FRANCISCO, Calif., Oct. 15, 2020 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) ("Titan" or the "Company") today announced a strategic restructuring designed to position it for future growth. Specifically, the Company plans to:

    • Restructure the Company to focus on ProNeura®-based product development, specifically a kappa opioid receptor agonist and nalmefene;
    • Discontinue its U.S. Probuphine® (buprenorphine) implant sales and wind down Probuphine commercialization activities;
    • Make strategic senior management changes;
    • Substantially reduce its operating costs; and
    • Complete negotiations with its lenders to eliminate outstanding debt.

    Probuphine

    Probuphine is the first product based on Titan's ProNeura technology approved in the U.S., Canada and the European Union ("EU") for the maintenance treatment of opioid use disorder ("OUD") in clinically stable patients taking 8 mg or less a day of oral buprenorphine.

    Commercializing Probuphine with the requirements of the current product label, as well as 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 exacerbated these issues. As a result, sales of Probuphine have been, and would likely continue for the foreseeable future to be, extremely limited.

    Accordingly, Titan's Board has determined to wind down its U.S. Probuphine business and redirect its focus and resources on its ProNeura-based product development efforts. 

    Key ProNeura-Based Product Development Programs

    Kappa Opioid Receptor Agonist Peptide Implant

    In October 2020, Titan entered into a non-binding term sheet with JT Pharma for the acquisition and development of JT-09 for use in combination with Titan's ProNeura technology. James McNab, a member of our board of directors, is a principal of JT Pharma. Several years ago, we began limited laboratory work in collaboration with JT Pharma to assess the feasibility of delivering JT-09 through ProNeura implants in animal models. Our initial work focused on JT-09's ability to activate peripheral kappa opioid receptors, with the JT-09 ProNeura implants potentially providing a non-addictive treatment for certain types of pain. Recently, we have begun exploring the feasibility of using JT-09 ProNeura implants in the treatment of pruritus. We believe, based on our early animal data, that subcutaneous administration of the JT-09 ProNeura implants could potentially deliver therapeutic concentrations of JT-09 for up to one year.

    Cara Therapeutics Inc. (NASDAQ:CARA) has recently demonstrated in phase 2 and phase 3 clinical trials the efficacy of a selective kappa opioid receptor agonist peptide, CR845, in the treatment of pruritus associated with end-stage kidney disease.

    Nalmefene Implant

    In September 2019, the National Institute for Drug Addiction ("NIDA") awarded Titan approximately $8.7 million in a two-year grant for its nalmefene implant development program for the prevention of opioid relapse following detoxification. This grant provides funds for the completion of implant formulation development, cGMP manufacturing and non-clinical studies required for filing an Investigation New Drug ("IND") application.

    During the first quarter of 2020, the Company met with the U.S. Food and Drug Administration ("FDA") to review Titan's non-clinical development plans and obtain guidance regarding filing an IND.

    Titan has been making good progress with the IND-enabling non-clinical studies, which it expects to complete in mid-2021, followed by filing of the IND.

    Strategic Management Changes

    As disclosed in August 2020, Titan's President & CEO, Sunil Bhonsle, has expressed his desire to retire. Accordingly, the current Executive Chairman, Marc Rubin, M.D., will assume the position of Chairman and CEO, and its current Executive Vice President and Chief Scientific Officer, Kate Beebe DeVarney, Ph.D., will be appointed President and Chief Operating Officer.

    Significant Reduction in Operating Costs and Negotiations to Eliminate Debt

    While there will be costs in the near term associated with the wind down of commercial operations and Titan's transition back to a development stage company, the change is expected to result in a lower operating cash burn moving forward. Also, in support of its efforts to continue as a research and development company, Titan is in negotiations to eliminate its outstanding debt, which is secured by a lien on all of its assets. There can be no assurance regarding the timing or outcome of these efforts, all of which will depend on the Company's ability to raise additional capital. 

    Comments from Management

    "Marketing of Probuphine in the U.S. has used considerable resources over the past two years and would continue to require additional investments for meaningful growth," commented Dr. Rubin. "After careful review of the recent sales and marketing results, we recognize the improbability of near-term indicators of material revenue growth for Probuphine. Accordingly, we have decided to discontinue sales and wind down commercialization activities for Probuphine. Our plan is to focus on our ProNeura-based product development programs. Of course, we are also open to evaluating reasonable offers, if any, that we receive from interested third-parties to continue making Probuphine commercially available in the U.S."

    Commenting on the management changes announced today, Dr. Rubin said, "On behalf of everyone at Titan, I would like to thank Sunil for his many contributions over the years and wish him well in his retirement. At the same time, I am excited that Kate has agreed to take on an expanded role as President and Chief Operating Officer. Kate's long-standing leadership across multiple functional areas of the company has been greatly valued, and I believe she is exceptionally well qualified to lead Titan's overall operations."

    "While I am deeply disappointed that we can no longer support the commercialization of Probuphine, I look forward to working with Marc and the Titan team to strategically advance the ProNeura delivery platform across key development programs, specifically our NIDA-funded nalmefene implant program for OUD and our newly acquired kappa opioid agonist peptide for the treatment of pruritus," said Dr. DeVarney. "I have greatly enjoyed working with Sunil over the past 14 years and wish him all the best in his well-earned retirement."

    About Probuphine

    Probuphine is the only subdermal implant designed to deliver buprenorphine continuously for six months following insertion.

    Probuphine was developed using ProNeura®, the continuous drug delivery system developed by Titan that consists of a small, solid implant made from a mixture of ethylene-vinyl acetate and a drug substance. The resulting construct is a solid matrix that is placed subdermally, normally in the upper inner arm in an outpatient office procedure and removed in a similar manner at the end of the treatment period. The U.S. Food and Drug Administration ("FDA") approved Probuphine in May 2016, and it is the first and only buprenorphine implant available for the maintenance treatment of opioid addiction in eligible patients.

    IMPORTANT SAFETY INFORMATION INCLUDING INDICATION AND BOXED WARNING

    INDICATION

    PROBUPHINE is an implant that contains the medicine buprenorphine. PROBUPHINE is used to treat certain adults who are addicted to (dependent on) opioid drugs (either prescription or illegal). PROBUPHINE is indicated for the maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses (doses no more than 8 mg per day) of a buprenorphine-containing product.

    PROBUPHINE is part of a complete treatment program that also includes counseling and behavioral therapy.

    It is not known if PROBUPHINE is safe or effective in children less than 16 years of age.

    IMPORTANT SAFETY INFORMATION

    WARNING: COMPLICATIONS FROM INSERTION AND REMOVAL OF PROBUPHINE

    See Full Prescribing Information for complete Boxed Warning

     

    Serious complications may happen from insertion and removal of PROBUPHINE, including:

    • Nerve or blood vessel injury in your arm
    • Movement of implant (migration). PROBUPHINE or pieces of it can move into blood vessels, possibly to your lung, and could lead to death
    • Implant sticks out of the skin (protrusion)
    • Implant comes out by itself (expulsion) 

    Call your healthcare provider right away if: 

    • PROBUPHINE sticks out of the skin or comes out by itself
    • You have bleeding or symptoms of infection at the site after insertion or removal, including excessive or worsening itching, pain, irritation, redness, or swelling
    • You have numbness or weakness in your arm after the insertion or removal procedure
    • You have weakness or numbness in your arm, or shortness of breath

    If the implant comes out by itself, keep it away from others, especially children, as it may cause severe difficulty in breathing and possibly death.

    Because of the risk of complications of, migration, protrusion, expulsion and nerve injury with insertion and removal of PROBUPHINE, it is only available through a restricted program called the PROBUPHINE REMS Program. Healthcare providers who prescribe and/or insert PROBUPHINE must be certified with the program by enrolling and completing live training.

    • PROBUPHINE is not available in retail pharmacies
    • PROBUPHINE must be inserted or removed only in the facility of the certified prescriber

    Implants may be difficult to locate if inserted too deeply, if you manipulate them, or if you gain significant weight after insertion.  Your healthcare provider may do special procedures or tests, or refer you to a surgical specialist to remove the implants if they are difficult to locate.

    The medicine in PROBUPHINE can cause serious and life-threatening problems, especially if you take or use certain other medicines or drugs.  Call your healthcare provider right away or get emergency help if you:

    Feel faint or dizzy, have mental changes such as confusion, slower breathing than you normally have, severe sleepiness, blurred vision, problems with coordination, slurred speech, cannot think well or clearly, high body temperature, slowed reflexes, feel agitated, stiff muscles or have trouble walking.

    These can be signs of an overdose or other serious problems. 

    Coma or death can happen if you take anxiety medicines or benzodiazepines, sleeping pills, tranquilizers, or sedatives, antidepressants, or antihistamines, or drink alcohol during treatment with PROBUPHINE. Tell your healthcare provider if you are taking any of these medicines or if you drink alcohol.

    Who should not use PROBUPHINE?

    Do not use PROBUPHINE if you are allergic to buprenorphine or any of its ingredients, this includes buprenorphine hydrochloride and the inactive ingredient ethylene vinyl acetate or EVA.

    PROBUPHINE may not be right for you. Before starting PROBUPHINE tell your doctor about all of your medical conditions, including:

    Trouble breathing or lung problems, an enlarged prostate gland (men), a head injury or brain problem, problems urinating, a curve in your spine that affects your breathing, liver problems, gallbladder or adrenal gland problems, Addison's disease, low thyroid hormone levels (hypothyroidism), a history of alcoholism, a history of keloid formation, connective tissue disease (such as scleroderma), or history of MRSA infections, mental problems such as hallucinations, an allergy to numbing medicines or medicines used to clean your skin, are pregnant or plan to become pregnant or are breastfeeding or plan to breastfeed.

    Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

    What should I avoid while being treated with PROBUPHINE?

    • Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how this medication affects you
    • You should not drink alcohol during treatment. You should not take anxiety medicines or benzodiazepines, sleeping pills, tranquilizers, or sedatives that are not prescribed to you during treatment with PROBUPHINE, as this can lead to slowed breathing, drowsiness, delayed reaction time, loss of consciousness or even death

    What are the possible side effects of PROBUPHINE?

    PROBUPHINE can cause serious side effects, including:

    • Infection at the insertion or removal site. Infection may happen at the implant site during insertion or removal. Do not try to remove PROBUPHINE implants yourself 
    • Opioid withdrawal. If PROBUPHINE comes out of your arm or if you stop treatment, tell your doctor right away as you can have symptoms of shaking, sweating more than normal, feeling hot or cold more than normal, runny nose, watery eyes, goose bumps, diarrhea, vomiting and muscle aches
    • Physical dependency
    • Liver problems. Call your doctor right away if you notice signs of liver problems that may include your skin or the white part of your eyes turning yellow (jaundice)
    • Allergic reaction. If you get a rash, hives, itching, swelling of your face, or wheezing, low blood pressure, dizziness or decrease in consciousness
    • Decrease in blood pressure. You may feel dizzy when you get up from sitting or lying down
    • Sleep Apnea. Call your doctor right away if you or someone close to you notices:  Observed episodes of stopped breathing or abnormal breathing patterns during sleep

    Tell your healthcare provider if you develop any of the symptoms listed.

    Common side effects of PROBUPHINE include: Headache, nausea, toothache, constipation, depression, vomiting, back pain, mouth and throat pain.

    Common risks with the minor surgical procedure:  Itching, pain, irritation, redness, swelling, bleeding, or bruising at the insertion or removal site. Scarring around the insertion site. 

    Please read Full Prescribing Information, including BOXED WARNING regarding IMPLANT MIGRATION, PROTRUSION, EXPULSION and NERVE DAMAGE ASSOCIATED WITH INSERTION AND REMOVAL.

    Titan encourages you to report negative side effects of prescription drugs to the FDA. You can visit www.fda.gov/safety/medwatch/ or call 1-800-FDA-1088.

    About Titan Pharmaceuticals

    Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is a commercial stage company developing proprietary therapeutics with its ProNeura® long-term, continuous drug delivery technology. The ProNeura technology has the potential to be used in developing products for treating a number of chronic conditions, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. For more information about Titan, please visit www.titanpharm.com.

    Forward-Looking Statements

    This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to the commercialization of Probuphine, the regulatory approval process, the development, testing, production and marketing of our drug candidates, patent and intellectual property matters and strategic agreements and relationships. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

    CONTACT:

    Stephen Kilmer

    Investor Relations

    (650) 989-2215

     

     

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  11. SOUTH SAN FRANCISCO, Calif., Sept. 24, 2020 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) today announced it has entered into a share purchase agreement with certain accredited institutional investors to purchase 19,440,000 shares of its common stock in a registered direct offering at a purchase price of $0.14 per share.

    Titan expects the net proceeds from the offering to be approximately $2.5 million after deducting the placement agent's fees and other estimated offering expenses. The offering is expected to close on or about September 28, 2020, subject to the satisfaction of customary closing conditions.

    Maxim Group LLC is acting as the sole placement agent in connection with the offering

    The shares of common stock are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-230742), which was declared effective by the United States Securities and Exchange Commission ("SEC") on April 24, 2019.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. A prospectus supplement relating to the shares of common stock will be filed by Titan with the SEC. When available, copies of the prospectus supplement relating to the registered direct offering, together with the accompanying prospectus, can be obtained at the SEC's website at www.sec.gov or from Maxim Group LLC, 405 Lexington Avenue, New York, NY 10174, Attention: Syndicate Department, or via email at or telephone at (212) 895-3745.

    About Titan Pharmaceuticals

    Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is a commercial stage company developing proprietary therapeutics with its ProNeura™ long-term, continuous drug delivery technology. The company's lead product is Probuphine® (buprenorphine) implant, a novel and long-acting formulation of buprenorphine for the long-term maintenance treatment of opioid use disorder ("OUD"). Approved by the U.S. Food and Drug Administration in May 2016, Probuphine is the first and only commercialized treatment for eligible patients with OUD to provide continuous, around-the-clock blood levels of buprenorphine for six months following a single procedure. The ProNeura technology also has the potential to be used in developing products for treating other chronic conditions, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. For more information about Titan, please visit www.titanpharm.com.

    Forward-Looking Statements

    This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to the commercialization of Probuphine, the regulatory approval process, the development, testing, production and marketing of our drug candidates, patent and intellectual property matters and strategic agreements and relationships. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

    CONTACTS:

    Stephen Kilmer

    Investor Relations

    (650) 989-2215

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    SOURCE Titan Pharmaceuticals, Inc.

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  12. SOUTH SAN FRANCISCO, Calif., Sept. 18, 2020 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) ("Titan" or the "Company") announced that, at today's special meeting, its stockholders approved the proposal to amend Titan's certificate of incorporation to increase the number of authorized shares of common stock from 125 million to 225 million (the "Amendment").

    The voting results are available in our Current Report on Form 8-K filed with the SEC today.

    "On behalf of the Board and management team, I would like to thank our stockholders for their continued support and we look forward to updating you on our progress," said Titan's Executive Chairman, Dr. Marc Rubin.

    About Titan Pharmaceuticals

    Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is a commercial stage company developing proprietary therapeutics with its ProNeura® long-term, continuous drug delivery technology. The Company's lead product is Probuphine® (buprenorphine) implant, a novel and long-acting formulation of buprenorphine for the long-term maintenance treatment of opioid dependence. Approved by the U.S. Food and Drug Administration in May 2016, Probuphine is the first and only commercialized treatment of opioid dependence to provide continuous, around-the-clock blood levels of buprenorphine for six months following a single procedure. The ProNeura technology also has the potential to be used in developing products for treating other chronic conditions such as Parkinson's disease and hypothyroidism, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. For more information about Titan, please visit www.titanpharm.com.

    Forward-Looking Statements

    This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to the commercialization of Probuphine; the regulatory approval process; Titan's ability to access capital; the development, testing, production and marketing of our drug candidates; patent and intellectual property matters; and strategic agreements and relationships.  We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

    CONTACTS:

    Sunil Bhonsle

    President & CEO

    (650) 244-4990

    Stephen Kilmer

    Investor Relations

    (650) 989-2215

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  13. SOUTH SAN FRANCISCO, Calif., Sept. 15, 2020 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) ("Titan" or the "Company") today announced that its partner, Molteni Farmaceutici ("Molteni"), has entered into an exclusive distribution agreement with Accord Healthcare Europe ("Accord") for the commercialization of Sixmo®-(6-months buprenorphine implant), the brand name for Probuphine® in the European Union ("EU").

    This distribution agreement brings together the expertise and heritage of Molteni in the specialty opioid addiction market with the extensive commercial reach of Accord, one of the fastest growing pharmaceutical companies in Europe.

    "Accord is a global pharmaceutical company with a strong presence across Europe; the decision to enter the addiction treatments' space with Sixmo confirms the attractiveness of our novel product as well as the potential of our proprietary technology to contribute to the fight against the global opioid epidemic. We are preparing to ship to Molteni the product supply for the European launch," said Titan's President and CEO, Sunil Bhonsle. "Pursuant to our asset purchase, supply and support agreement with Molteni, we are entitled to approximately $1.1 million in future milestone payments and royalty payments on net sales of Sixmo, commencing in the second half of 2021."

    About Titan Pharmaceuticals

    Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is a commercial stage company developing proprietary therapeutics with its ProNeura® long-term, continuous drug delivery technology. The Company's lead product is Probuphine® (buprenorphine) implant, a novel and long-acting formulation of buprenorphine for the long-term maintenance treatment of opioid dependence. Approved by the U.S. Food and Drug Administration in May 2016, Probuphine is the first and only commercialized treatment of opioid dependence to provide continuous, around-the-clock blood levels of buprenorphine for six months following a single procedure. The ProNeura technology also has the potential to be used in developing products for treating other chronic conditions such as Parkinson's disease and hypothyroidism, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. For more information about Titan, please visit www.titanpharm.com.

    Forward-Looking Statements

    This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to the commercialization of Probuphine; the regulatory approval process; Titan's ability to access capital; the development, testing, production and marketing of our drug candidates; patent and intellectual property matters; and strategic agreements and relationships.  We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

    CONTACTS:

    Sunil Bhonsle

    President & CEO

    (650) 244-4990

    Stephen Kilmer

    Investor Relations

    (650) 989-2215

     

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    SOURCE Titan Pharmaceuticals, Inc.

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  14. SOUTH SAN FRANCISCO, Calif., Sept. 14, 2020 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) ("Titan" or the "Company") today provided an update on the upcoming special meeting of stockholders (the "Meeting") in response to recent stockholder inquiries regarding the number of meeting adjournments. The sole purpose of the Meeting is to seek approval of a proposal to amend Titan's certificate of incorporation to increase the number of authorized shares of common stock.

    Without approval of the share increase, the several strategic alternatives management has been exploring with the Company's bankers will not be possible. The failure to obtain stockholder approval will almost certainly result in the cessation of Titan's operations and likely a total loss of value to stockholders, given the pledge of all of the Company's assets as security for its outstanding debt.

    The goal of Titan's Board of Directors is to enable as many stockholders as possible to exercise their right to vote. In contrast to many other types of proposals, the amendment to effect the share increase requires a higher hurdle – the affirmative votes from a majority of the outstanding shares entitled to vote.  Since Titan has a large retail stockholder base, this task poses greater challenges than in the past. Importantly, some of the newer, popular brokerage firms do not exercise their permitted discretion to vote shares held in their accounts without explicit direction from the beneficial holder, and companies such as Titan are finding it quite difficult and time consuming to reach individual investors who hold shares in street name.

    Prior to each meeting adjournment, the Board examined the voting data and determined, in light of the fact that a substantial majority of votes received to date have been in favor of the proposal, that it would be in the best interest of stockholders to extend the date of the meeting, particularly in light of the stakes involved. As of the close of business on September 11, 2020, approximately 30.7 million shares (28.3% of the record date shares) had not yet been voted. Of those shares that were voted, approximately 72% were in favor of the amendment proposal. The affirmative vote of holders of only 1,251,207 shares (less than 1.5% of the record date shares) are now needed to file the amendment and effect the authorized share increase.

    "I and my fellow Board members would like to thank those stockholders who have already voted in favor of the proposal, which if approved should enable the continuation of Titan's operations by facilitating the raising of capital as well as the pursuit of strategic alternatives," said Titan's Executive Chairman, Dr. Marc Rubin. "And, to those who have not yet voted, we implore you to do so now."

    About Titan Pharmaceuticals

    Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is a commercial stage company developing proprietary therapeutics with its ProNeura® long-term, continuous drug delivery technology. The Company's lead product is Probuphine® (buprenorphine) implant, a novel and long-acting formulation of buprenorphine for the long-term maintenance treatment of opioid dependence. Approved by the U.S. Food and Drug Administration in May 2016, Probuphine is the first and only commercialized treatment of opioid dependence to provide continuous, around-the-clock blood levels of buprenorphine for six months following a single procedure. The ProNeura technology also has the potential to be used in developing products for treating other chronic conditions such as Parkinson's disease and hypothyroidism, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. For more information about Titan, please visit www.titanpharm.com.

    Forward-Looking Statements

    This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to the commercialization of Probuphine; the regulatory approval process; Titan's ability to access capital; the development, testing, production and marketing of our drug candidates; patent and intellectual property matters; and strategic agreements and relationships.  We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

    CONTACTS:

    Sunil Bhonsle

    President & CEO

    (650) 244-4990

    Stephen Kilmer

    Investor Relations

    (650) 989-2215

     

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    SOURCE Titan Pharmaceuticals, Inc.

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  15. SOUTH SAN FRANCISCO, Calif., Aug. 14, 2020 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) ("Titan" or the "Company") today reported financial results for the second quarter ended June 30, 2020 and provided an update on its business.

    Second Quarter 2020 Highlights

    • In June 2020, Titan initiated a fully-virtual Probuphine® (buprenorphine) implant Risk Evaluation and Mitigation Strategy ("REMS") training and certification program for qualified health care providers ("HCPs") who treat patients with Opioid Use Disorder ("OUD").
    • In June 2020, the Company entered into a co-promotion partnership with Indegene, Inc., a leading healthcare solutions company, to establish multichannel digital marketing programs throughout the United States to increase awareness of Probuphine as a long-term maintenance treatment for OUD, and expand the capabilities for the engagement of HCPs who can be certified to prescribe Probuphine to eligible patients.
    • Since January 1, 2020, Titan received proceeds of approximately $7.0 million as a result of the exercise of previously issued common stock purchase warrants.

    COVID-19 Impact and Adjusted Probuphine Commercial Strategy

    Early this year, Titan implemented its staffing plans for expanded commercial operations with additions to its sales and medical liaison teams, including support from additional marketing and medical access staff to enable improved coverage across all 50 states and Puerto Rico. Unfortunately, the COVID-19 pandemic-related shelter in place and social distancing restrictions and minimized personal physician/patient interaction have hindered the full effectiveness of the commercial team. In order to try and mitigate the impact of the ongoing public health crisis, Titan has undertaken a number of key activities during this period, including:

    • Training the commercial team in utilizing digital communication techniques to establish relationships with existing and new HCPs and their staff;
    • Providing Probuphine information in electronic format for ease of virtual communication for HCPs to use with their patients and to highlight the potential benefits of Probuphine as a treatment modality in the increasing telemedicine environment;
    • Establishing a social media presence in select geographies to increase awareness of Probuphine and enhance its share of voice in the OUD medication assisted treatment space;
    • Rapidly developing and obtaining FDA approval to implement a virtual REMS training program to certify HCPs during this period; and
    • Seeking partnering opportunities to increase the commercial capabilities in support of Probuphine.

    "We continue to adapt to this ever-changing pandemic environment, and thanks to our dedicated staff, we are making progress," said Titan's President and CEO, Sunil Bhonsle. "We are pleased with the FDA's prompt approval of our fully-virtual REMS training program, which enables us to continue to certify HCPs to prescribe and administer Probuphine, facilitating access to our six-month maintenance treatment option for eligible patients with OUD. Our commercial team continues to focus on digital outreach to establish relationships with the medical community and to inform HCPs, their staff and their patients of the potential benefits of Probuphine, particularly at a time when patient/physician interactions are limited. Following a substantial decline in the number of patient enrollments for Probuphine treatment during the first two months of the quarter, clinics in certain regions began to see an increase in enrollments in June, which has continued. We believe this is an early indication that the efforts of our commercial team are working and we look forward to continued progress in the coming months."

    Probuphine is indicated for the maintenance treatment of OUD in eligible patients.

    Please see Full Indication and Important Safety Information below, and link below to Full Prescribing Information.

    "Our goal is to increase the use of Probuphine for the maintenance treatment of OUD, and in the current environment, our recently established co-promotion partnership with Indegene is timely," said Titan's Executive Chairman, Dr. Marc Rubin. "With the support of our commercial team, Indegene's capabilities provide Titan with sophisticated multichannel marketing tools, predictive analytics and social media campaigns that will be critical to expanding our outreach to the medical community and patients. The first virtual nationwide outreach campaign commenced last week, and the Titan-Indegene team is looking forward to continuing the implementation of a comprehensive program over the next few months. During the third quarter we will also implement a three-month program to seek and assist patients who may be suitable for treatment with Probuphine and connect them with REMS-certified HCPs. I want to emphasize that our progress can be sustained only if our stockholders approve the proposal to increase the authorized shares at our special stockholder meeting scheduled for August 31, 2020.

    "In addition, Sunil has expressed his desire to retire, hopefully by the end of the year. To prepare for this transition, and contingent on our ability to raise additional capital, we will look for a successor with experience in the commercial space, as we continue our transition to a commercial-stage company."

    Second Quarter 2020 Financial Results

    For the three months ended June 30, 2020, Titan reported approximately $1.3 million in revenue, which reflects approximately $0.1 million in product sales and approximately $1.2 million related to the Company's National Institute on Drug Abuse ("NIDA") grant. This compared with revenues of approximately $0.5 million in the same period in 2019, which was comprised of $0.3 million in product sales and $0.2 million related to the NIDA grant. Product revenue during the quarter ended June 30, 2020 declined substantially from the comparable period in 2019 due to substantial decreases in unit sales volumes, increased utilization of our patient assistance programs and the COVID-19 pandemic and the related shelter in place restrictions and clinic closures. Also, the second quarter of 2019 unit sales volume included initial purchases by a specialty pharmacy. 

    Total operating expenses for the second quarter of 2020 were approximately $5.7 million, compared with approximately $5.4 million from the same quarter in 2019, and consisted primarily of research and development ("R&D") and selling, general and administrative ("SG&A") expenses and costs of goods sold, inclusive of distribution expenses. R&D expenses for the quarter ended June 30, 2020 were approximately $2.0 million, compared to approximately $1.9 million in the same three month period in 2019. SG&A expenses for the 2020 second quarter were approximately $3.5 million, compared with approximately $3.2 million in the same quarter a year ago. Costs of goods sold for the second quarter of 2020 were approximately $0.2 million, consistent with the 2019 second quarter.

    Net other expense, consisting primarily of interest expense, was approximately $0.3 million in the second quarter of 2020, consistent with the second quarter of 2019.

    Net loss applicable to common stockholders in the second quarter of 2020 was approximately $4.6 million, or approximately $0.05 per share, compared with a net loss applicable to common stockholders of approximately $5.2 million, or approximately $0.38 per share, in the same quarter in 2019.

    As of June 30, 2020, Titan had cash and cash equivalents of approximately $5.5 million, which the Company believes are sufficient to fund planned operations through the third quarter of 2020.

    Conference Call Details

    Titan management will host a conference call today at 12:00 p.m. ET / 9:00 a.m. PT to review these financial results and discuss business developments in the period. The conference call will be hosted by Sunil Bhonsle, President and CEO; Kate Beebe DeVarney, Ph.D., Executive Vice President and Chief Scientific Officer; Brian Crowley, Vice President of Finance; Joe Schrei, Executive Director, Commercial Operations; Mike Fritz, National Sales Director; and Marc Rubin, M.D., Executive Chairman.

    The live conference call may be accessed by dialing 1-888-317-6003 (U.S.) or 1-412-317-6061 (international) and providing passcode 8493149. The call will also be broadcast live and archived on Titan's website at www.titanpharm.com/news/events.    

    About Probuphine

    Probuphine is the only subdermal implant designed to deliver buprenorphine continuously for six months following insertion.

    Probuphine was developed using ProNeura®, the continuous drug delivery system developed by Titan that consists of a small, solid implant made from a mixture of ethylene-vinyl acetate and a drug substance. The resulting construct is a solid matrix that is placed subdermally, normally in the upper inner arm in an outpatient office procedure and removed in a similar manner at the end of the treatment period. The U.S. Food and Drug Administration ("FDA") approved Probuphine in May 2016, and it is the first and only buprenorphine implant available for the maintenance treatment of opioid addiction in eligible patients.

    IMPORTANT SAFETY INFORMATION INCLUDING INDICATION AND BOXED WARNING

    INDICATION

    PROBUPHINE is an implant that contains the medicine buprenorphine. PROBUPHINE is used to treat certain adults who are addicted to (dependent on) opioid drugs (either prescription or illegal). PROBUPHINE is indicated for the maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses (doses no more than 8 mg per day) of a buprenorphine-containing product.

    PROBUPHINE is part of a complete treatment program that also includes counseling and behavioral therapy.

    It is not known if PROBUPHINE is safe or effective in children less than 16 years of age.

    IMPORTANT SAFETY INFORMATION











    WARNING: COMPLICATIONS FROM INSERTION AND REMOVAL OF PROBUPHINE



    See Full Prescribing Information for complete Boxed Warning







    Serious complications may happen from insertion and removal of PROBUPHINE, including:





    Nerve or blood vessel injury in your arm





    Movement of implant (migration). PROBUPHINE or pieces of it can move into blood vessels, possibly to your lung, and could lead to death





    Implant sticks out of the skin (protrusion)





    Implant comes out by itself (expulsion)





    Call your healthcare provider right away if: 

    • PROBUPHINE sticks out of the skin or comes out by itself
    • You have bleeding or symptoms of infection at the site after insertion or removal, including excessive or worsening itching, pain, irritation, redness, or swelling
    • You have numbness or weakness in your arm after the insertion or removal procedure
    • You have weakness or numbness in your arm, or shortness of breath

    If the implant comes out by itself, keep it away from others, especially children, as it may cause severe difficulty in breathing and possibly death.

    Because of the risk of complications of, migration, protrusion, expulsion and nerve injury with insertion and removal of PROBUPHINE, it is only available through a restricted program called the PROBUPHINE REMS Program. Healthcare providers who prescribe and/or insert PROBUPHINE must be certified with the program by enrolling and completing live training.

    • PROBUPHINE is not available in retail pharmacies
    • PROBUPHINE must be inserted or removed only in the facility of the certified prescriber

    Implants may be difficult to locate if inserted too deeply, if you manipulate them, or if you gain significant weight after insertion.  Your healthcare provider may do special procedures or tests, or refer you to a surgical specialist to remove the implants if they are difficult to locate.

    The medicine in PROBUPHINE can cause serious and life-threatening problems, especially if you take or use certain other medicines or drugs.  Call your healthcare provider right away or get emergency help if you:

    Feel faint or dizzy, have mental changes such as confusion, slower breathing than you normally have, severe sleepiness, blurred vision, problems with coordination, slurred speech, cannot think well or clearly, high body temperature, slowed reflexes, feel agitated, stiff muscles or have trouble walking.

    These can be signs of an overdose or other serious problems. 

    Coma or death can happen if you take anxiety medicines or benzodiazepines, sleeping pills, tranquilizers, or sedatives, antidepressants, or antihistamines, or drink alcohol during treatment with PROBUPHINE. Tell your healthcare provider if you are taking any of these medicines or if you drink alcohol.

    Who should not use PROBUPHINE?

    Do not use PROBUPHINE if you are allergic to buprenorphine or any of its ingredients, this includes buprenorphine hydrochloride and the inactive ingredient ethylene vinyl acetate or EVA.

    PROBUPHINE may not be right for you. Before starting PROBUPHINE tell your doctor about all of your medical conditions, including:

    Trouble breathing or lung problems, an enlarged prostate gland (men), a head injury or brain problem, problems urinating, a curve in your spine that affects your breathing, liver problems, gallbladder or adrenal gland problems, Addison's disease, low thyroid hormone levels (hypothyroidism), a history of alcoholism, a history of keloid formation, connective tissue disease (such as scleroderma), or history of MRSA infections, mental problems such as hallucinations, an allergy to numbing medicines or medicines used to clean your skin, are pregnant or plan to become pregnant or are breastfeeding or plan to breastfeed.

    Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

     What should I avoid while being treated with PROBUPHINE?

    • Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how this medication affects you
    • You should not drink alcohol during treatment. You should not take anxiety medicines or benzodiazepines, sleeping pills, tranquilizers, or sedatives that are not prescribed to you during treatment with PROBUPHINE, as this can lead to slowed breathing, drowsiness, delayed reaction time, loss of consciousness or even death

    What are the possible side effects of PROBUPHINE?

    PROBUPHINE can cause serious side effects, including:

    • Infection at the insertion or removal site. Infection may happen at the implant site during insertion or removal. Do not try to remove PROBUPHINE implants yourself 
    • Opioid withdrawal. If PROBUPHINE comes out of your arm or if you stop treatment, tell your doctor right away as you can have symptoms of shaking, sweating more than normal, feeling hot or cold more than normal, runny nose, watery eyes, goose bumps, diarrhea, vomiting and muscle aches
    • Physical dependency
    • Liver problems. Call your doctor right away if you notice signs of liver problems that may include your skin or the white part of your eyes turning yellow (jaundice)
    • Allergic reaction. If you get a rash, hives, itching, swelling of your face, or wheezing, low blood pressure, dizziness or decrease in consciousness
    • Decrease in blood pressure. You may feel dizzy when you get up from sitting or lying down
    • Sleep Apnea. Call your doctor right away if you or someone close to you notices:  Observed episodes of stopped breathing or abnormal breathing patterns during sleep

    Tell your healthcare provider if you develop any of the symptoms listed.

    Common side effects of PROBUPHINE include: Headache, nausea, toothache, constipation, depression, vomiting, back pain, mouth and throat pain.

    Common risks with the minor surgical procedure:  Itching, pain, irritation, redness, swelling, bleeding, or bruising at the insertion or removal site. Scarring around the insertion site. 

    Please read Full Prescribing Information, including BOXED WARNING regarding IMPLANT MIGRATION, PROTRUSION, EXPULSION and NERVE DAMAGE ASSOCIATED WITH INSERTION AND REMOVAL.

    Titan encourages you to report negative side effects of prescription drugs to the FDA. You can visit www.fda.gov/safety/medwatch/ or call 1-800-FDA-1088.

    About Titan Pharmaceuticals

    Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is a commercial stage company developing proprietary therapeutics with its ProNeura® long-term, continuous drug delivery technology. The Company's lead product is Probuphine® (buprenorphine) implant, a novel and long-acting formulation of buprenorphine for the long-term maintenance treatment of opioid dependence. Approved by the U.S. Food and Drug Administration in May 2016, Probuphine is the first and only commercialized treatment of opioid dependence to provide continuous, around-the-clock blood levels of buprenorphine for six months following a single procedure. The ProNeura technology also has the potential to be used in developing products for treating other chronic conditions such as Parkinson's disease and hypothyroidism, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. For more information about Titan, please visit www.titanpharm.com.

    Forward-Looking Statements

    This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to the commercialization of Probuphine; the regulatory approval process; Titan's ability to access capital; the development, testing, production and marketing of our drug candidates; patent and intellectual property matters; and strategic agreements and relationships.  We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

    CONTACTS:

    Sunil Bhonsle

    President & CEO

    (650) 244-4990

    Stephen Kilmer

    Investor Relations

    (650) 989-2215



    TITAN PHARMACEUTICALS, INC.

    CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

    (in thousands, except per share amount)

    (unaudited)









    Three Months Ended

    June 30,



    Six Months Ended

    June 30,







    2020



    2019



    2020



    2019

    Revenue:

















    License revenue

    $              6



    $            -



    $              6



    $          313



    Product revenue

    115



    304



    325



    621



    Grant revenue

    1,204



    198



    2,330



    513





    Total revenue

    1,325



    502



    2,661



    1,447





















    Operating expense:

















    Cost of goods sold

    228



    246



    399



    550



    Research and development

    2,007



    1,907



    4,284



    3,751



    Selling, general and administrative

    3,474



    3,231



    6,589



    6,313





    Total operating expense

    5,709



    5,384



    11,272



    10,614

    Loss from operations

    (4,384)



    (4,882)



    (8,611)



    (9,167)

























    Other expense, net

    (257)



    (315)



    (1,614)



    (547)





































    Net loss and comprehensive loss

    $     (4,641)



    $     (5,197)



    $   (10,225)



    $     (9,714)





















    Basic and diluted net loss per common share

    $       (0.05)



    $       (0.38)



    $       (0.12)



    $       (0.73)









































    Weighted average shares used in computing 

















    basic and diluted net loss per share

    94,930



    13,576



    88,785



    13,397

























    CONDENSED BALANCE SHEETS

    (in thousands)

    (unaudited)



















    June 30,



    December 31,







    2020



    2019













    Assets









    Cash and cash equivalents

    $       5,498



    $       5,223



    Receivables

    1,061



    993



    Inventory

    969



    998



    Prepaid expenses and other current assets

    1,162



    1,094





    Total current assets

    8,690



    8,308



    Property and equipment, net

    799



    817



    Operating lease right-of-use asset

    273



    397





    Total assets

    $       9,762



    $       9,522

    Liabilities and Stockholders' Equity









    Current liabilities

    $       4,857



    $       3,600



    Operating lease liability, non-current

    -



    150



    Long-term debt, non-current

    3,345



    4,019



    Warrant liability

    -



    320



    Stockholders' equity 

    1,560



    1,433





    Total liabilities and stockholders' equity 

    $       9,762



    $       9,522

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/titan-pharmaceuticals-reports-second-quarter-2020-financial-results-301112386.html

    SOURCE Titan Pharmaceuticals, Inc.

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  16. SOUTH SAN FRANCISCO, Calif., Aug. 10, 2020 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) today announced that its second quarter 2020 financial results will be released on Friday, August 14, 2020.

    Titan will host a live conference call to discuss the financial results and provide a general business review the same day, August 14, 2020, at 9:00 a.m. PT / 12:00 p.m. ET. The call will be hosted by Sunil Bhonsle, president and CEO; Kate Beebe DeVarney, Ph.D., executive vice president and chief scientific officer; Brian Crowley, vice president of finance; Joe Schrei, executive director, commercial operations; Mike Fritz, national sales director; and Marc Rubin, M.D., executive chairman. A summary of the second quarter financial results and other highlights will be included in a press release to be issued prior to the call.

    The live webcast and a replay of the call may be accessed by visiting http://www.titanpharm.com/news/events. The call can also be accessed by dialing 1-888-317-6003 (or 1-412-317-6061 from outside the U.S.) ten minutes prior to the start time, and providing passcode 8493149.

    About Titan Pharmaceuticals

    Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is a commercial stage company developing proprietary therapeutics with its ProNeura® long-term, continuous drug delivery technology. The company's lead product is Probuphine® (buprenorphine) implant, a novel and long-acting formulation of buprenorphine for the long-term maintenance treatment of opioid dependence. Approved by the U.S. Food and Drug Administration in May 2016, Probuphine is the first and only commercialized treatment of opioid dependence to provide continuous, around-the-clock blood levels of buprenorphine for six months following a single procedure. The ProNeura technology also has the potential to be used in developing products for treating other chronic conditions such as Parkinson's disease and hypothyroidism, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. For more information about Titan, please visit www.titanpharm.com.

    Forward-Looking Statements

    This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to the commercialization of Probuphine; the regulatory approval process; Titan's ability to access capital; the development, testing, production and marketing of our drug candidates; patent and intellectual property matters; and strategic agreements and relationships. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

    CONTACTS:

    Sunil Bhonsle

    President & CEO

    (650) 244-4990

    Stephen Kilmer

    Investor Relations

    (650) 989-2215

    harm.com

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/titan-pharmaceuticals-to-report-second-quarter-2020-financial-results-on-august-14-2020-301109397.html

    SOURCE Titan Pharmaceuticals, Inc.

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  17. SOUTH SAN FRANCISCO, Calif., July 8, 2020 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) ("Titan" or the "Company") today urged its stockholders to vote "FOR" an amendment to its certificate of incorporation that will provide additional shares for potential financings as and when needed to support efforts to expand the use of Probuphine® (buprenorphine) implant and fund other product development efforts, as well as to pursue potential strategic corporate opportunities that may become available to it.

    The majority of Titan stockholders who have submitted their votes have voted in favor of the amendment proposal; however, more votes are needed to meet the required threshold for approval under Delaware law.

    "We recently announced a co-promotion partnership with Indegene for commercialization of Probuphine that focuses on countrywide, multichannel digital marketing programs to rapidly expand product awareness and help increase the use of Probuphine for the treatment of Opioid Use Disorder in eligible patients," said Titan's Executive Chairman, Dr. Marc Rubin. "The implementation of this partnership has already begun and we expect to see positive results over the next six to nine months."

    "However, as previously disclosed, our current cash resources are only sufficient to fund our operations through the third quarter of this year and with only 5,000,000 authorized shares remaining, approval of the proposed amendment is critical to continue operations beyond the next three months. Importantly, we will need to use some of the newly authorized shares to provide us with the cash runway required to make our co-promotion program with Indegene a success," added Dr. Rubin.

    Titan stockholders – Please vote Today!

    How to Vote

    The Meeting can be attended using the access information that was set forth in the Definitive Proxy Statement filed with the U.S. Securities and Exchange Commission on May 22, 2020. The fastest and easiest way to vote is to call 866-619-4651 and speak with a proxy voting specialist Monday through Friday 9:00 a.m. to 10:00 p.m. Eastern Time.

    Please see Probuphine Full Indication and Important Safety Information and Boxed Warning below, and link below to Full Prescribing Information.

    About Probuphine

    Probuphine is the only subdermal implant designed to deliver buprenorphine continuously for six months following insertion.

    Probuphine was developed using ProNeura®, the continuous drug delivery system developed by Titan that consists of a small, solid implant made from a mixture of ethylene-vinyl acetate and a drug substance. The resulting construct is a solid matrix that is placed subdermally, normally in the upper inner arm in an outpatient office procedure and removed in a similar manner at the end of the treatment period. The U.S. Food and Drug Administration ("FDA") approved Probuphine in May 2016, and it is the first and only buprenorphine implant available for the maintenance treatment of opioid addiction in eligible patients.

    IMPORTANT SAFETY INFORMATION INCLUDING INDICATION AND BOXED WARNING

    INDICATION

    PROBUPHINE is an implant that contains the medicine buprenorphine. PROBUPHINE is used to treat certain adults who are addicted to (dependent on) opioid drugs (either prescription or illegal). PROBUPHINE is indicated for the maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses (doses no more than 8 mg per day) of a buprenorphine-containing product.

    PROBUPHINE is part of a complete treatment program that also includes counseling and behavioral therapy.

    It is not known if PROBUPHINE is safe or effective in children less than 16 years of age.

     

    WARNING: COMPLICATIONS FROM INSERTION AND REMOVAL OF PROBUPHINE

    See Full Prescribing Information for complete Boxed Warning

     

    Serious complications may happen from insertion and removal of PROBUPHINE, including:

    • Nerve or blood vessel injury in your arm

    • Movement of implant (migration). PROBUPHINE or pieces of it can move into blood vessels, possibly to your lung, and could lead to death

    • Implant sticks out of the skin (protrusion)

    • Implant comes out by itself (expulsion)

     

    Call your healthcare provider right away if: 

    • PROBUPHINE sticks out of the skin or comes out by itself
    • You have bleeding or symptoms of infection at the site after insertion or removal, including excessive or worsening itching, pain, irritation, redness, or swelling
    • You have numbness or weakness in your arm after the insertion or removal procedure
    • You have weakness or numbness in your arm, or shortness of breath

    If the implant comes out by itself, keep it away from others, especially children, as it may cause severe difficulty in breathing and possibly death.

    Because of the risk of complications of, migration, protrusion, expulsion and nerve injury with insertion and removal of PROBUPHINE, it is only available through a restricted program called the PROBUPHINE REMS Program. Healthcare providers who prescribe and/or insert PROBUPHINE must be certified with the program by enrolling and completing live training.

    • PROBUPHINE is not available in retail pharmacies
    • PROBUPHINE must be inserted or removed only in the facility of the certified prescriber

    Implants may be difficult to locate if inserted too deeply, if you manipulate them, or if you gain significant weight after insertion.  Your healthcare provider may do special procedures or tests, or refer you to a surgical specialist to remove the implants if they are difficult to locate.

    The medicine in PROBUPHINE can cause serious and life-threatening problems, especially if you take or use certain other medicines or drugs.  Call your healthcare provider right away or get emergency help if you:

    Feel faint or dizzy, have mental changes such as confusion, slower breathing than you normally have, severe sleepiness, blurred vision, problems with coordination, slurred speech, cannot think well or clearly, high body temperature, slowed reflexes, feel agitated, stiff muscles or have trouble walking.

    These can be signs of an overdose or other serious problems. 

    Coma or death can happen if you take anxiety medicines or benzodiazepines, sleeping pills, tranquilizers, or sedatives, antidepressants, or antihistamines, or drink alcohol during treatment with PROBUPHINE. Tell your healthcare provider if you are taking any of these medicines or if you drink alcohol.

    Who should not use PROBUPHINE?

    Do not use PROBUPHINE if you are allergic to buprenorphine or any of its ingredients, this includes buprenorphine hydrochloride and the inactive ingredient ethylene vinyl acetate or EVA.

    PROBUPHINE may not be right for you. Before starting PROBUPHINE tell your doctor about all of your medical conditions, including:

    Trouble breathing or lung problems, an enlarged prostate gland (men), a head injury or brain problem, problems urinating, a curve in your spine that affects your breathing, liver problems, gallbladder or adrenal gland problems, Addison's disease, low thyroid hormone levels (hypothyroidism), a history of alcoholism, a history of keloid formation, connective tissue disease (such as scleroderma), or history of MRSA infections, mental problems such as hallucinations, an allergy to numbing medicines or medicines used to clean your skin, are pregnant or plan to become pregnant or are breastfeeding or plan to breastfeed.

    Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

     What should I avoid while being treated with PROBUPHINE?

    • Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how this medication affects you
    • You should not drink alcohol during treatment. You should not take anxiety medicines or benzodiazepines, sleeping pills, tranquilizers, or sedatives that are not prescribed to you during treatment with PROBUPHINE, as this can lead to slowed breathing, drowsiness, delayed reaction time, loss of consciousness or even death

    What are the possible side effects of PROBUPHINE?

    PROBUPHINE can cause serious side effects, including:

    • Infection at the insertion or removal site. Infection may happen at the implant site during insertion or removal. Do not try to remove PROBUPHINE implants yourself 
    • Opioid withdrawal. If PROBUPHINE comes out of your arm or if you stop treatment, tell your doctor right away as you can have symptoms of shaking, sweating more than normal, feeling hot or cold more than normal, runny nose, watery eyes, goose bumps, diarrhea, vomiting and muscle aches
    • Physical dependency
    • Liver problems. Call your doctor right away if you notice signs of liver problems that may include your skin or the white part of your eyes turning yellow (jaundice)
    • Allergic reaction. If you get a rash, hives, itching, swelling of your face, or wheezing, low blood pressure, dizziness or decrease in consciousness
    • Decrease in blood pressure. You may feel dizzy when you get up from sitting or lying down
    • Sleep Apnea. Call your doctor right away if you or someone close to you notices:  Observed episodes of stopped breathing or abnormal breathing patterns during sleep

    Tell your healthcare provider if you develop any of the symptoms listed.

    Common side effects of PROBUPHINE include: Headache, nausea, toothache, constipation, depression, vomiting, back pain, mouth and throat pain.

    Common risks with the minor surgical procedure:  Itching, pain, irritation, redness, swelling, bleeding, or bruising at the insertion or removal site. Scarring around the insertion site. 

    Please read Full Prescribing Information, including BOXED WARNING regarding IMPLANT MIGRATION, PROTRUSION, EXPULSION and NERVE DAMAGE ASSOCIATED WITH INSERTION AND REMOVAL.

    Titan encourages you to report negative side effects of prescription drugs to the FDA. You can visit www.fda.gov/safety/medwatch/ or call 1-800-FDA-1088.

    About Indegene, Inc.

    Indegene is a leading global healthcare solutions company that enables healthcare organizations address complex challenges to improve health and business outcomes. Indegene helps drive effectiveness and efficiency while bringing pharma products to market through modern commercial and medical operations by combining deep medical understanding, modern technology, and flexible engagement models.  Indegene has a global footprint with offices in North America, Europe, China and India.

    About Titan Pharmaceuticals

    Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is a commercial stage company developing proprietary therapeutics with its ProNeura® long-term, continuous drug delivery technology. The Company's lead product is Probuphine® (buprenorphine) implant, a novel and long-acting formulation of buprenorphine for the long-term maintenance treatment of opioid dependence. Approved by the U.S. Food and Drug Administration in May 2016, Probuphine is the first and only commercialized treatment of opioid dependence to provide continuous, around-the-clock blood levels of buprenorphine for six months following a single procedure. The ProNeura technology also has the potential to be used in developing products for treating other chronic conditions such as Parkinson's disease and hypothyroidism, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. For more information about Titan, please visit www.titanpharm.com.

    Forward-Looking Statements

    This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to the commercialization of Probuphine; the regulatory approval process; Titan's ability to access capital; the development, testing, production and marketing of our drug candidates; patent and intellectual property matters; and strategic agreements and relationships.  We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

    CONTACTS:

    Sunil Bhonsle

    President & CEO

    (650) 244-4990

    Stephen Kilmer

    Investor Relations

    (650) 989-2215

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/titan-pharmaceuticals-urges-stockholders-to-vote-for-proposal-to-amend-its-certificate-of-incorporation-301089792.html

    SOURCE Titan Pharmaceuticals, Inc.

    View Full Article Hide Full Article
  18. SAN FRANCISCO, June 24, 2020 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) ("Titan" or the "Company") today announced that it has entered into a co-promotion partnership with Indegene Inc. to establish multichannel digital marketing programs throughout the United States and expand the capabilities for the engagement of health care providers ("HCPs") who are eligible to prescribe Titan's Probuphine® (buprenorphine) implant.

    Indegene is a leading healthcare solutions company with a unique blend of life sciences domain expertise and state-of-the-art technology capabilities that will complement and help accelerate the build out of the current commercial operations at Titan. Under the terms of the renewable four-year agreement, Indegene's sophisticated multichannel marketing tools, predictive analytics, webinars and social media campaigns will be used along with its dedicated tele-representatives to help expand the universe of Probuphine Risk Evaluation and Mitigation Strategy ("REMS")-certified HCPs and enable further expansion of maintenance treatment with Probuphine for eligible Opioid Use Disorder ("OUD") patients. Titan will continue its ongoing commercial efforts with its field sales and medical liaison personnel who will also provide support to Indegene as needed. Titan will be responsible for all training of HCPs, administration of the REMS program and regulatory affairs.

    "This partnership with Indegene further strengthens and expands our Probuphine commercial operations, especially with the COVID-19-related restrictions that have limited in-person HCP outreach capabilities," said Titan's President and CEO, Sunil Bhonsle. "Indegene brings a wealth of business expertise and experience in the digital arena working globally with large and small pharmaceutical companies that is invaluable in today's changing environment. This partnership accelerates the expansion of our capabilities to potentially achieve our goals and enable access to Probuphine for eligible patients suffering from OUD, especially at a time when a six-month maintenance treatment option could be very important in minimizing frequent direct contact."

    Please see Probuphine Full Indication and Important Safety Information and Boxed Warning below, and link below to Full Prescribing Information.

    "We are looking forward to partnering with Titan using our proven AI-driven Next Generation Commercialization Platform," said Gaurav Kapoor, Executive Vice President of Indegene Inc. "This partnership comes at a meaningful time, when the COVID-19 pandemic is exacerbating the opioid crisis while limiting direct engagement with the HCPs that treat OUD patients. I believe the 'new normal' model in pharma commercial operations will start relying just as much on digital programs with remote representatives, as field representatives providing face-to-face interaction. We at Indegene are making significant investments to be at the forefront of this transition and are excited to see Titan embrace this innovative approach."

    About Probuphine

    Probuphine is the only subdermal implant designed to deliver buprenorphine continuously for six months following insertion.

    Probuphine was developed using ProNeura®, the continuous drug delivery system developed by Titan that consists of a small, solid implant made from a mixture of ethylene-vinyl acetate and a drug substance. The resulting construct is a solid matrix that is placed subdermally, normally in the upper inner arm in an outpatient office procedure and removed in a similar manner at the end of the treatment period. The U.S. Food and Drug Administration ("FDA") approved Probuphine in May 2016, and it is the first and only buprenorphine implant available for the maintenance treatment of opioid addiction in eligible patients.

    IMPORTANT SAFETY INFORMATION INCLUDING INDICATION AND BOXED WARNING

    INDICATION

    PROBUPHINE is an implant that contains the medicine buprenorphine. PROBUPHINE is used to treat certain adults who are addicted to (dependent on) opioid drugs (either prescription or illegal). PROBUPHINE is indicated for the maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses (doses no more than 8 mg per day) of a buprenorphine-containing product.

    PROBUPHINE is part of a complete treatment program that also includes counseling and behavioral therapy.

    It is not known if PROBUPHINE is safe or effective in children less than 16 years of age.

    WARNING: COMPLICATIONS FROM INSERTION AND REMOVAL OF PROBUPHINE

    See Full Prescribing Information for complete Boxed Warning

     Serious complications may happen from insertion and removal of PROBUPHINE, including:

    • Nerve or blood vessel injury in your arm
    • Movement of implant (migration). PROBUPHINE or pieces of it can move into blood vessels, possibly to your lung, and could lead to death
    • Implant sticks out of the skin (protrusion)
    • Implant comes out by itself (expulsion)

    Call your healthcare provider right away if: 

    • PROBUPHINE sticks out of the skin or comes out by itself
    • You have bleeding or symptoms of infection at the site after insertion or removal, including excessive or worsening itching, pain, irritation, redness, or swelling
    • You have numbness or weakness in your arm after the insertion or removal procedure
    • You have weakness or numbness in your arm, or shortness of breath

    If the implant comes out by itself, keep it away from others, especially children, as it may cause severe difficulty in breathing and possibly death.

    Because of the risk of complications of, migration, protrusion, expulsion and nerve injury with insertion and removal of PROBUPHINE, it is only available through a restricted program called the PROBUPHINE REMS Program. Healthcare providers who prescribe and/or insert PROBUPHINE must be certified with the program by enrolling and completing live training.

    • PROBUPHINE is not available in retail pharmacies
    • PROBUPHINE must be inserted or removed only in the facility of the certified prescriber

    Implants may be difficult to locate if inserted too deeply, if you manipulate them, or if you gain significant weight after insertion.  Your healthcare provider may do special procedures or tests, or refer you to a surgical specialist to remove the implants if they are difficult to locate.

    The medicine in PROBUPHINE can cause serious and life-threatening problems, especially if you take or use certain other medicines or drugs.  Call your healthcare provider right away or get emergency help if you:

    Feel faint or dizzy, have mental changes such as confusion, slower breathing than you normally have, severe sleepiness, blurred vision, problems with coordination, slurred speech, cannot think well or clearly, high body temperature, slowed reflexes, feel agitated, stiff muscles or have trouble walking.

    These can be signs of an overdose or other serious problems. 

    Coma or death can happen if you take anxiety medicines or benzodiazepines, sleeping pills, tranquilizers, or sedatives, antidepressants, or antihistamines, or drink alcohol during treatment with PROBUPHINE. Tell your healthcare provider if you are taking any of these medicines or if you drink alcohol.

    Who should not use PROBUPHINE?

    Do not use PROBUPHINE if you are allergic to buprenorphine or any of its ingredients, this includes buprenorphine hydrochloride and the inactive ingredient ethylene vinyl acetate or EVA.

    PROBUPHINE may not be right for you. Before starting PROBUPHINE tell your doctor about all of your medical conditions, including:

    Trouble breathing or lung problems, an enlarged prostate gland (men), a head injury or brain problem, problems urinating, a curve in your spine that affects your breathing, liver problems, gallbladder or adrenal gland problems, Addison's disease, low thyroid hormone levels (hypothyroidism), a history of alcoholism, a history of keloid formation, connective tissue disease (such as scleroderma), or history of MRSA infections, mental problems such as hallucinations, an allergy to numbing medicines or medicines used to clean your skin, are pregnant or plan to become pregnant or are breastfeeding or plan to breastfeed.

    Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

     What should I avoid while being treated with PROBUPHINE?

    • Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how this medication affects you
    • You should not drink alcohol during treatment. You should not take anxiety medicines or benzodiazepines, sleeping pills, tranquilizers, or sedatives that are not prescribed to you during treatment with PROBUPHINE, as this can lead to slowed breathing, drowsiness, delayed reaction time, loss of consciousness or even death

    What are the possible side effects of PROBUPHINE?

    PROBUPHINE can cause serious side effects, including:

    • Infection at the insertion or removal site. Infection may happen at the implant site during insertion or removal. Do not try to remove PROBUPHINE implants yourself 
    • Opioid withdrawal. If PROBUPHINE comes out of your arm or if you stop treatment, tell your doctor right away as you can have symptoms of shaking, sweating more than normal, feeling hot or cold more than normal, runny nose, watery eyes, goose bumps, diarrhea, vomiting and muscle aches
    • Physical dependency
    • Liver problems. Call your doctor right away if you notice signs of liver problems that may include your skin or the white part of your eyes turning yellow (jaundice)
    • Allergic reaction. If you get a rash, hives, itching, swelling of your face, or wheezing, low blood pressure, dizziness or decrease in consciousness
    • Decrease in blood pressure. You may feel dizzy when you get up from sitting or lying down
    • Sleep Apnea. Call your doctor right away if you or someone close to you notices:  Observed episodes of stopped breathing or abnormal breathing patterns during sleep

    Tell your healthcare provider if you develop any of the symptoms listed.

    Common side effects of PROBUPHINE include: Headache, nausea, toothache, constipation, depression, vomiting, back pain, mouth and throat pain.

    Common risks with the minor surgical procedure:  Itching, pain, irritation, redness, swelling, bleeding, or bruising at the insertion or removal site. Scarring around the insertion site. 

    Please read Full Prescribing Information, including BOXED WARNING regarding IMPLANT MIGRATION, PROTRUSION, EXPULSION and NERVE DAMAGE ASSOCIATED WITH INSERTION AND REMOVAL.

    Titan encourages you to report negative side effects of prescription drugs to the FDA. You can visit www.fda.gov/safety/medwatch/ or call 1-800-FDA-1088.

    About Indegene, Inc.

    Indegene is a leading global healthcare solutions company that enables healthcare organizations address complex challenges to improve health and business outcomes. Indegene helps drive effectiveness and efficiency while bringing pharma products to market through modern commercial and medical operations by combining deep medical understanding, modern technology, and flexible engagement models.  Indegene has a global footprint with offices in North America, Europe, China and India.

    About Titan Pharmaceuticals

    Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is a commercial stage company developing proprietary therapeutics with its ProNeura® long-term, continuous drug delivery technology. The Company's lead product is Probuphine® (buprenorphine) implant, a novel and long-acting formulation of buprenorphine for the long-term maintenance treatment of opioid dependence. Approved by the U.S. Food and Drug Administration in May 2016, Probuphine is the first and only commercialized treatment of opioid dependence to provide continuous, around-the-clock blood levels of buprenorphine for six months following a single procedure. The ProNeura technology also has the potential to be used in developing products for treating other chronic conditions such as Parkinson's disease and hypothyroidism, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. For more information about Titan, please visit www.titanpharm.com.

    Forward-Looking Statements

    This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to the commercialization of Probuphine; the regulatory approval process; Titan's ability to access capital; the development, testing, production and marketing of our drug candidates; patent and intellectual property matters; and strategic agreements and relationships.  We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

    CONTACTS:

    Sunil Bhonsle

    President & CEO

    (650) 244-4990

    Stephen Kilmer

    Investor Relations

    (650) 989-2215

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/titan-pharmaceuticals-and-indegene-enter-into-probuphine-co-promotion-partnership-301082645.html

    SOURCE Titan Pharmaceuticals, Inc.

    View Full Article Hide Full Article
  19. SOUTH SAN FRANCISCO, Calif., June 16, 2020 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) ("Titan" or the "Company") today announced that it has initiated a fully-virtual Probuphine® (buprenorphine) implant Risk Evaluation and Mitigation Strategy ("REMS") training and certification program for qualified health care providers ("HCPs") who treat patients with Opioid Use Disorder ("OUD").

    The U.S. Food and Drug Administration ("FDA") has approved the virtual REMS training program for use during the COVID-19 pandemic to support the safety of HCPs, their staff and the training personnel. The program is now available to qualified HCPs at treatment centers across the U.S.

    "We are grateful for the FDA's expeditious review and approval of our fully-virtual REMS training program, which enables us to continue to certify HCPs to prescribe and administer Probuphine during this critical time when rates of opioid-related morbidity and mortality are significantly increasing," said Titan's Executive Vice President and Chief Scientific Officer, Dr. Kate Beebe DeVarney. "We believe that the ability to continue certifying HCPs amidst the pandemic will facilitate access to our six-month maintenance treatment option for eligible patients with OUD who are now at increased risk for infection, relapse, and overdose due to the COVID-19 health crisis."

    Please see Probuphine Full Indication and Important Safety Information and Boxed Warning below, and link below to Full Prescribing Information.

    "A few days ago, I had the honor of becoming Titan's first HCP to receive fully-virtual training on prescribing, inserting, and removing Probuphine," said Dr. Christopher Ray, of Phoenix, Arizona. "Titan's virtual, REMS training is so well-planned, organized and thorough in every detail that I feel comfortable prescribing Probuphine treatment to eligible OUD patients receiving buprenorphine maintenance therapy, particularly given the COVID-19 pandemic-related restrictions that limit the frequency of face-to-face interaction with patients. I would recommend this virtual Probuphine REMS training to any qualified HCP providing long-term buprenorphine maintenance treatment for OUD."

    About Probuphine

    Probuphine is the only subdermal implant designed to deliver buprenorphine continuously for six months following insertion.

    Probuphine was developed using ProNeura®, the continuous drug delivery system developed by Titan that consists of a small, solid implant made from a mixture of ethylene-vinyl acetate and a drug substance. The resulting construct is a solid matrix that is placed subdermally, normally in the upper inner arm in an outpatient office procedure and removed in a similar manner at the end of the treatment period. The U.S. Food and Drug Administration ("FDA") approved Probuphine in May 2016, and it is the first and only buprenorphine implant available for the maintenance treatment of opioid addiction in eligible patients.

    IMPORTANT SAFETY INFORMATION INCLUDING INDICATION AND BOXED WARNING

    INDICATION

    PROBUPHINE is an implant that contains the medicine buprenorphine. PROBUPHINE is used to treat certain adults who are addicted to (dependent on) opioid drugs (either prescription or illegal). PROBUPHINE is indicated for the maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses (doses no more than 8 mg per day) of a buprenorphine-containing product.

    PROBUPHINE is part of a complete treatment program that also includes counseling and behavioral therapy.

    It is not known if PROBUPHINE is safe or effective in children less than 16 years of age.

    WARNING: COMPLICATIONS FROM INSERTION AND REMOVAL OF PROBUPHINE 

    See Full Prescribing Information for complete Boxed Warning 

     

    Serious complications may happen from insertion and removal of PROBUPHINE, including:

    • Nerve or blood vessel injury in your arm
    • Movement of implant (migration). PROBUPHINE or pieces of it can move into blood vessels, possibly to your lung, and could lead to death
    • Implant sticks out of the skin (protrusion)
    • Implant comes out by itself (expulsion)

    Call your healthcare provider right away if: 

    • PROBUPHINE sticks out of the skin or comes out by itself
    • You have bleeding or symptoms of infection at the site after insertion or removal, including excessive or worsening itching, pain, irritation, redness, or swelling
    • You have numbness or weakness in your arm after the insertion or removal procedure
    • You have weakness or numbness in your arm, or shortness of breath

    If the implant comes out by itself, keep it away from others, especially children, as it may cause severe difficulty in breathing and possibly death.

    Because of the risk of complications of, migration, protrusion, expulsion and nerve injury with insertion and removal of PROBUPHINE, it is only available through a restricted program called the PROBUPHINE REMS Program. Healthcare providers who prescribe and/or insert PROBUPHINE must be certified with the program by enrolling and completing live training.

    • PROBUPHINE is not available in retail pharmacies
    • PROBUPHINE must be inserted or removed only in the facility of the certified prescriber

    Implants may be difficult to locate if inserted too deeply, if you manipulate them, or if you gain significant weight after insertion.  Your healthcare provider may do special procedures or tests, or refer you to a surgical specialist to remove the implants if they are difficult to locate.

    The medicine in PROBUPHINE can cause serious and life-threatening problems, especially if you take or use certain other medicines or drugs.  Call your healthcare provider right away or get emergency help if you:

    Feel faint or dizzy, have mental changes such as confusion, slower breathing than you normally have, severe sleepiness, blurred vision, problems with coordination, slurred speech, cannot think well or clearly, high body temperature, slowed reflexes, feel agitated, stiff muscles or have trouble walking.

    These can be signs of an overdose or other serious problems. 

    Coma or death can happen if you take anxiety medicines or benzodiazepines, sleeping pills, tranquilizers, or sedatives, antidepressants, or antihistamines, or drink alcohol during treatment with PROBUPHINE. Tell your healthcare provider if you are taking any of these medicines or if you drink alcohol.

    Who should not use PROBUPHINE?

    Do not use PROBUPHINE if you are allergic to buprenorphine or any of its ingredients, this includes buprenorphine hydrochloride and the inactive ingredient ethylene vinyl acetate or EVA.

    PROBUPHINE may not be right for you. Before starting PROBUPHINE tell your doctor about all of your medical conditions, including:

    Trouble breathing or lung problems, an enlarged prostate gland (men), a head injury or brain problem, problems urinating, a curve in your spine that affects your breathing, liver problems, gallbladder or adrenal gland problems, Addison's disease, low thyroid hormone levels (hypothyroidism), a history of alcoholism, a history of keloid formation, connective tissue disease (such as scleroderma), or history of MRSA infections, mental problems such as hallucinations, an allergy to numbing medicines or medicines used to clean your skin, are pregnant or plan to become pregnant or are breastfeeding or plan to breastfeed.

    Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

     What should I avoid while being treated with PROBUPHINE?

    • Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how this medication affects you
    • You should not drink alcohol during treatment. You should not take anxiety medicines or benzodiazepines, sleeping pills, tranquilizers, or sedatives that are not prescribed to you during treatment with PROBUPHINE, as this can lead to slowed breathing, drowsiness, delayed reaction time, loss of consciousness or even death

    What are the possible side effects of PROBUPHINE?

    PROBUPHINE can cause serious side effects, including:

    • Infection at the insertion or removal site. Infection may happen at the implant site during insertion or removal. Do not try to remove PROBUPHINE implants yourself 
    • Opioid withdrawal. If PROBUPHINE comes out of your arm or if you stop treatment, tell your doctor right away as you can have symptoms of shaking, sweating more than normal, feeling hot or cold more than normal, runny nose, watery eyes, goose bumps, diarrhea, vomiting and muscle aches
    • Physical dependency
    • Liver problems. Call your doctor right away if you notice signs of liver problems that may include your skin or the white part of your eyes turning yellow (jaundice)
    • Allergic reaction. If you get a rash, hives, itching, swelling of your face, or wheezing, low blood pressure, dizziness or decrease in consciousness
    • Decrease in blood pressure. You may feel dizzy when you get up from sitting or lying down
    • Sleep Apnea. Call your doctor right away if you or someone close to you notices:  Observed episodes of stopped breathing or abnormal breathing patterns during sleep

    Tell your healthcare provider if you develop any of the symptoms listed.

    Common side effects of PROBUPHINE include: Headache, nausea, toothache, constipation, depression, vomiting, back pain, mouth and throat pain.

    Common risks with the minor surgical procedure:  Itching, pain, irritation, redness, swelling, bleeding, or bruising at the insertion or removal site. Scarring around the insertion site. 

    Please read Full Prescribing Information, including BOXED WARNING regarding IMPLANT MIGRATION, PROTRUSION, EXPULSION and NERVE DAMAGE ASSOCIATED WITH INSERTION AND REMOVAL.

    Titan encourages you to report negative side effects of prescription drugs to the FDA. You can visit www.fda.gov/safety/medwatch/ or call 1-800-FDA-1088.

    About Titan Pharmaceuticals

    Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is a commercial stage company developing proprietary therapeutics with its ProNeura® long-term, continuous drug delivery technology. The Company's lead product is Probuphine® (buprenorphine) implant, a novel and long-acting formulation of buprenorphine for the long-term maintenance treatment of opioid dependence. Approved by the U.S. Food and Drug Administration in May 2016, Probuphine is the first and only commercialized treatment of opioid dependence to provide continuous, around-the-clock blood levels of buprenorphine for six months following a single procedure. The ProNeura technology also has the potential to be used in developing products for treating other chronic conditions such as Parkinson's disease and hypothyroidism, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. For more information about Titan, please visit www.titanpharm.com.

    Forward-Looking Statements

    This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to the commercialization of Probuphine; the regulatory approval process; Titan's ability to access capital; the development, testing, production and marketing of our drug candidates; patent and intellectual property matters; and strategic agreements and relationships.  We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

    CONTACTS:

    Sunil Bhonsle

    President & CEO

    (650) 244-4990

    Stephen Kilmer

    Investor Relations

    (650) 989-2215

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/titan-pharmaceuticals-launches-virtual-rems-training-for-probuphine-health-care-providers-301077482.html

    SOURCE Titan Pharmaceuticals, Inc.

    View Full Article Hide Full Article
  20. SOUTH SAN FRANCISCO, Calif., May 15, 2020 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) ("Titan" or the "Company") today reported financial results for the first quarter ended March 31, 2020 and provided an update on its business.

    First Quarter 2020 Highlights

    • In January 2020, Titan completed an offering resulting in net cash proceeds of approximately $1.9 million.
    • Since January 1, 2020, the Company received proceeds of approximately $6.7 million as a result of the exercise of previously issued common stock purchase warrants.

    COVID-19 Impact and Adjusted Probuphine Commercial Strategy

    Titan's commercial operations expansion has continued throughout the past several months, with additions to its sales and medical liaison teams, including support from additional marketing and medical access staff, that now provide coverage for all 50 states and Puerto Rico. Unfortunately, the emergence of the COVID-19 pandemic during the latter half of the first quarter and the resulting restrictions on travel and social distancing rules that have minimized personal physician/patient interaction, except in emergencies, has hindered the effectiveness of the commercial team. In order to try and mitigate the impact of the ongoing public heath crisis, Titan has undertaken a number of key activities during this period, including:

    • Preparatory work using digital communication techniques to establish relationships with new health care providers ("HCPs") and their staff;
    • Providing virtual communication tools for HCPs to use with their patients and to highlight the potential benefits of Probuphine as a treatment modality in the increasing telemedicine environment; and
    • Establishing a social media presence in select geographies to increase awareness of Probuphine and enhance its share of voice in the medication assisted treatment space.

    "Our first quarter of 2020 financial results were affected by the COVID-19 pandemic, and we have had to make several adjustments to our commercial tactics to best position Titan in the current environment," said Titan's President and CEO, Sunil Bhonsle. "We have been working in a virtual environment and have focused our efforts on using digital communication tools to establish strong relationships with the medical community as well as inform patients of Probuphine's long acting treatment option, which may be well-suited for telemedicine. In addition, our Medical Affairs team continues to develop a virtual process for providing training to health care providers, which, if approved by the FDA, could be a very valuable tool for Titan and health care providers alike."

    Probuphine is indicated for the maintenance treatment of OUD in eligible patients.

    Please see Full Indication and Important Safety Information below, and link below to Full Prescribing Information.

    "The board has been very supportive of the team's initiative in the face of these new challenges, and I am very pleased with our progress," said Titan's Executive Chairman, Dr. Marc Rubin. "The unfortunate reality is that patients suffering from OUD are now facing more challenges to getting proper treatment during this pandemic, and we are working hard to ensure we can support their needs, as well as the needs of their health care providers."

    First Quarter 2020 Financial Results

    For the three months ended March 31, 2020, Titan reported approximately $1.3 million in revenue, which reflects approximately $0.2 million in product sales and approximately $1.1 million related to the Company's National Institute on Drug Abuse ("NIDA") grant. This compared with revenues of approximately $0.9 million in the same period in 2019, which was comprised of $0.3 million in product sales, $0.3 million related to the amortization of deferred revenue related to the sale to Molteni of the European intellectual property rights to Probuphine and $0.3 million related to the NIDA grant.

    Total operating expenses for the first quarter of 2020 were approximately $5.6 million, compared with approximately $5.2 million from the same quarter in 2019, and consisted primarily of research and development ("R&D") and selling, general and administrative ("SG&A") expenses and costs of goods sold, inclusive of distribution expenses. R&D expenses for the quarter ended March 31, 2020 were approximately $2.3 million, compared with approximately $1.8 million for the same three month period in 2019. SG&A expenses for the 2020 first quarter were approximately $3.1 million, essentially unchanged from the same quarter a year ago. Costs of goods sold for the first quarter of 2020 were approximately $0.2 million, compared with approximately $0.3 million in the 2019 first quarter.

    Net other expense, consisting primarily of interest expense, non-cash losses on changes in the fair value of warrants and costs attributable to the issuance of warrants was approximately $1.4 million in the first quarter of 2020, compared with net other expense of approximately $0.2 million in the first quarter of 2019.

    Net loss applicable to common stockholders in the first quarter of 2020 was approximately $5.6 million, or approximately $0.07 per share, compared with a net loss applicable to common stockholders of approximately $4.5 million, or approximately $0.34 per share, in the same quarter in 2019.

    As of March 31, 2020, Titan had cash and cash equivalents of approximately $8.0 million, which the Company believes, together with proceeds from a Paycheck Protection Program loan and the subsequent exercise of warrants, are sufficient to fund planned operations through the third quarter of 2020.

    Conference Call Details

    Titan management will host a conference call today at 12:00 p.m. ET / 9:00 a.m. PT to review these financial results and discuss business developments in the period. The conference call will be hosted by Sunil Bhonsle, President and CEO; Kate Beebe DeVarney, Ph.D., Executive Vice President and Chief Scientific Officer; Brian Crowley, Vice President of Finance; and Marc Rubin, M.D., Executive Chairman.

    The live conference call may be accessed by dialing 1-888-317-6003 (U.S.) or 1-412-317-6061 (international) and providing passcode 3367973. The call will also be broadcast live and archived on Titan's website at www.titanpharm.com/news/events.    

    About Probuphine

    Probuphine is the only subdermal implant designed to deliver buprenorphine continuously for six months following insertion.

    Probuphine was developed using ProNeura®, the continuous drug delivery system developed by Titan that consists of a small, solid implant made from a mixture of ethylene-vinyl acetate and a drug substance. The resulting construct is a solid matrix that is placed subdermally, normally in the upper inner arm in an outpatient office procedure and removed in a similar manner at the end of the treatment period. The U.S. Food and Drug Administration ("FDA") approved Probuphine in May 2016, and it is the first and only buprenorphine implant available for the maintenance treatment of opioid addiction in eligible patients.

    IMPORTANT SAFETY INFORMATION INCLUDING INDICATION AND BOXED WARNING INDICATION

    PROBUPHINE is an implant that contains the medicine buprenorphine. PROBUPHINE is used to treat certain adults who are addicted to (dependent on) opioid drugs (either prescription or illegal). PROBUPHINE is indicated for the maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses (doses no more than 8 mg per day) of a buprenorphine-containing product.

    PROBUPHINE is part of a complete treatment program that also includes counseling and behavioral therapy.

    It is not known if PROBUPHINE is safe or effective in children less than 16 years of age.

    IMPORTANT SAFETY INFORMATION


    WARNING: COMPLICATIONS FROM INSERTION AND REMOVAL OF PROBUPHINE

    See Full Prescribing Information for complete Boxed Warning




    Serious complications may happen from insertion and removal of PROBUPHINE, including:


    Nerve or blood vessel injury in your arm


    Movement of implant (migration). PROBUPHINE or pieces of it can move into blood vessels, possibly to your lung, and could lead to death


    Implant sticks out of the skin (protrusion)


    Implant comes out by itself (expulsion)




    Call your healthcare provider right away if: 

    • PROBUPHINE sticks out of the skin or comes out by itself
    • You have bleeding or symptoms of infection at the site after insertion or removal, including excessive or worsening itching, pain, irritation, redness, or swelling
    • You have numbness or weakness in your arm after the insertion or removal procedure
    • You have weakness or numbness in your arm, or shortness of breath

    If the implant comes out by itself, keep it away from others, especially children, as it may cause severe difficulty in breathing and possibly death.

    Because of the risk of complications of, migration, protrusion, expulsion and nerve injury with insertion and removal of PROBUPHINE, it is only available through a restricted program called the PROBUPHINE REMS Program. Healthcare providers who prescribe and/or insert PROBUPHINE must be certified with the program by enrolling and completing live training.

    • PROBUPHINE is not available in retail pharmacies
    • PROBUPHINE must be inserted or removed only in the facility of the certified prescriber

    Implants may be difficult to locate if inserted too deeply, if you manipulate them, or if you gain significant weight after insertion.  Your healthcare provider may do special procedures or tests, or refer you to a surgical specialist to remove the implants if they are difficult to locate.

    The medicine in PROBUPHINE can cause serious and life-threatening problems, especially if you take or use certain other medicines or drugs.  Call your healthcare provider right away or get emergency help if you:

    Feel faint or dizzy, have mental changes such as confusion, slower breathing than you normally have, severe sleepiness, blurred vision, problems with coordination, slurred speech, cannot think well or clearly, high body temperature, slowed reflexes, feel agitated, stiff muscles or have trouble walking.

    These can be signs of an overdose or other serious problems. 

    Coma or death can happen if you take anxiety medicines or benzodiazepines, sleeping pills, tranquilizers, or sedatives, antidepressants, or antihistamines, or drink alcohol during treatment with PROBUPHINE. Tell your healthcare provider if you are taking any of these medicines or if you drink alcohol.

    Who should not use PROBUPHINE?

    Do not use PROBUPHINE if you are allergic to buprenorphine or any of its ingredients, this includes buprenorphine hydrochloride and the inactive ingredient ethylene vinyl acetate or EVA.

    PROBUPHINE may not be right for you. Before starting PROBUPHINE tell your doctor about all of your medical conditions, including:

    Trouble breathing or lung problems, an enlarged prostate gland (men), a head injury or brain problem, problems urinating, a curve in your spine that affects your breathing, liver problems, gallbladder or adrenal gland problems, Addison's disease, low thyroid hormone levels (hypothyroidism), a history of alcoholism, a history of keloid formation, connective tissue disease (such as scleroderma), or history of MRSA infections, mental problems such as hallucinations, an allergy to numbing medicines or medicines used to clean your skin, are pregnant or plan to become pregnant or are breastfeeding or plan to breastfeed.

    Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

     What should I avoid while being treated with PROBUPHINE?

    • Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how this medication affects you
    • You should not drink alcohol during treatment. You should not take anxiety medicines or benzodiazepines, sleeping pills, tranquilizers, or sedatives that are not prescribed to you during treatment with PROBUPHINE, as this can lead to slowed breathing, drowsiness, delayed reaction time, loss of consciousness or even death

    What are the possible side effects of PROBUPHINE?

    PROBUPHINE can cause serious side effects, including:

    • Infection at the insertion or removal site. Infection may happen at the implant site during insertion or removal. Do not try to remove PROBUPHINE implants yourself 
    • Opioid withdrawal. If PROBUPHINE comes out of your arm or if you stop treatment, tell your doctor right away as you can have symptoms of shaking, sweating more than normal, feeling hot or cold more than normal, runny nose, watery eyes, goose bumps, diarrhea, vomiting and muscle aches
    • Physical dependency
    • Liver problems. Call your doctor right away if you notice signs of liver problems that may include your skin or the white part of your eyes turning yellow (jaundice)
    • Allergic reaction. If you get a rash, hives, itching, swelling of your face, or wheezing, low blood pressure, dizziness or decrease in consciousness
    • Decrease in blood pressure. You may feel dizzy when you get up from sitting or lying down
    • Sleep Apnea. Call your doctor right away if you or someone close to you notices:  Observed episodes of stopped breathing or abnormal breathing patterns during sleep

    Tell your healthcare provider if you develop any of the symptoms listed.

    Common side effects of PROBUPHINE include: Headache, nausea, toothache, constipation, depression, vomiting, back pain, mouth and throat pain.

    Common risks with the minor surgical procedure:  Itching, pain, irritation, redness, swelling, bleeding, or bruising at the insertion or removal site. Scarring around the insertion site. 

    Please read Full Prescribing Information, including BOXED WARNING regarding IMPLANT MIGRATION, PROTRUSION, EXPULSION and NERVE DAMAGE ASSOCIATED WITH INSERTION AND REMOVAL.

    Titan encourages you to report negative side effects of prescription drugs to the FDA. You can visit www.fda.gov/safety/medwatch/ or call 1-800-FDA-1088.

    About Titan Pharmaceuticals

    Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is a commercial stage company developing proprietary therapeutics with its ProNeura® long-term, continuous drug delivery technology. The Company's lead product is Probuphine® (buprenorphine) implant, a novel and long-acting formulation of buprenorphine for the long-term maintenance treatment of opioid dependence. Approved by the U.S. Food and Drug Administration in May 2016, Probuphine is the first and only commercialized treatment of opioid dependence to provide continuous, around-the-clock blood levels of buprenorphine for six months following a single procedure. The ProNeura technology also has the potential to be used in developing products for treating other chronic conditions such as Parkinson's disease and hypothyroidism, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. For more information about Titan, please visit www.titanpharm.com.

    Forward-Looking Statements

    This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to the commercialization of Probuphine; the regulatory approval process; Titan's ability to access capital; the development, testing, production and marketing of our drug candidates; patent and intellectual property matters; and strategic agreements and relationships.  We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

    CONTACTS:

    Sunil Bhonsle
    President & CEO
    (650) 244-4990

    Stephen Kilmer
    Investor Relations
    (650) 989-2215

    TITAN PHARMACEUTICALS, INC.

    CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

    (in thousands, except per share amount)

    (unaudited)





    Three Months Ended





    March 31,





    2020


    2019

    Revenue:






    License revenue


    $                        -


    $                      313


    Product revenue


    210


    317


    Grant revenue


    1,126


    315



    Total revenue


    1,336


    945








    Operating expense:






    Cost of goods sold


    171


    304


    Research and development


    2,277


    1,844


    Selling, general and administrative


    3,114


    3,082



    Total operating expense


    5,562


    5,230

    Loss from operations


    (4,226)


    (4,285)










    Other expense, net


    (1,358)


    (232)








    Net loss and comprehensive loss


    $                 (5,584)


    $                 (4,517)








    Basic and diluted net loss per common share


    $                   (0.07)


    $                   (0.34)








    Weighted average shares used in computing basic and diluted net loss per common share


    82,641


    13,217

     

    CONDENSED BALANCE SHEETS

    (in thousands)

    (unaudited)












    March 31,


    December 31,





    2020


    2019

    Assets






    Cash and cash equivalents


    $                   8,038


    $                   5,223


    Receivables


    1,551


    993


    Inventory


    1,064


    998


    Prepaid expenses and other current assets


    1,493


    1,094



    Total current assets


    12,146


    8,308


    Furniture and equipment, net


    780


    817


    Operating lease right-of-use asset


    336


    397



    Total assets


    $                 13,262


    $                   9,522

    Liabilities and Stockholders' Equity 






    Current liabilities


    $                   4,410


    $                   3,600


    Operating lease liability, non-current


    76


    150


    Long-term debt


    3,500


    4,019


    Warrant liability


    -


    320


    Stockholders' equity 


    5,276


    1,433



    Total liabilities and stockholders' equity

    $                 13,262


    $                   9,522

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/titan-pharmaceuticals-reports-first-quarter-2020-financial-results-301059905.html

    SOURCE Titan Pharmaceuticals, Inc.

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  21. SOUTH SAN FRANCISCO, Calif., May 11, 2020 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) today announced that its first quarter 2020 financial results will be released on Friday, May 15, 2020.

    Titan will host a live conference call to discuss the financial results and provide a general business review the same day, May 15, 2020, at 9:00 a.m. PT / 12:00 p.m. ET. The call will be hosted by Sunil Bhonsle, president and CEO; Kate Beebe DeVarney, Ph.D., executive vice president and chief scientific officer; Brian Crowley, vice president of finance; and Marc Rubin, M.D., executive chairman. A summary of the first quarter financial results and other highlights will be included in a press release to be issued prior to the call.

    The live webcast and a replay of the call may be accessed by visiting http://www.titanpharm.com/news/events. The call can also be accessed by dialing 1-888-317-6003 (or 1-412-317-6061 from outside the U.S.) ten minutes prior to the start time, and providing passcode 3367973.

    About Titan Pharmaceuticals

    Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is a commercial stage company developing proprietary therapeutics with its ProNeura® long-term, continuous drug delivery technology. The company's lead product is Probuphine® (buprenorphine) implant, a novel and long-acting formulation of buprenorphine for the long-term maintenance treatment of opioid dependence. Approved by the U.S. Food and Drug Administration in May 2016, Probuphine is the first and only commercialized treatment of opioid dependence to provide continuous, around-the-clock blood levels of buprenorphine for six months following a single procedure. The ProNeura technology also has the potential to be used in developing products for treating other chronic conditions such as Parkinson's disease and hypothyroidism, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. For more information about Titan, please visit www.titanpharm.com.

    Forward-Looking Statements

    This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to the commercialization of Probuphine; the regulatory approval process; Titan's ability to access capital; the development, testing, production and marketing of our drug candidates; patent and intellectual property matters; and strategic agreements and relationships. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

    CONTACTS:

    Sunil Bhonsle
    President & CEO
    (650) 244-4990

    Stephen Kilmer
    Investor Relations
    (650) 989-2215

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/titan-pharmaceuticals-to-report-first-quarter-2020-financial-results-on-may-15-2020-301056815.html

    SOURCE Titan Pharmaceuticals, Inc.

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  22. SOUTH SAN FRANCISCO, Calif., March 30, 2020 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) ("Titan" or the "Company") today reported financial results for the fourth quarter and full year ended December 31, 2019 and provided an update on its business.

    Full Year 2019 Business Highlights

    • In early 2019, Titan reported completion of the initial activities planned for the reacquisition of Probuphine® (buprenorphine) implant, Titan's novel six-month maintenance treatment for opioid use disorder ("OUD") in eligible patients, from its former licensee. This included the recruitment and onboarding of a small number of highly qualified commercial and medical affairs personnel to reengage with health care providers who had previously treated patients with Probuphine, providing retraining and medical liaison assistance where needed, and assuring the medical community of the continued supply of the product with the goal to stabilize Probuphine usage.
    • A key objective for Titan in the first half of 2019 was to improve the overall commercial services provided to the health care providers and patients through streamlining the product distribution and third party payor reimbursement process. This was accomplished through the following steps that were completed by August 2019:
      • Entering into an agreement with AppianRx to establish a new 'hub' that provides a full suite of patient and healthcare provider support services related to Probuphine, including an improved product ordering system and performing REMS required verification steps, and initial assessment of third party payor benefits available to the patient.
      • Establishing specialty pharmacy distribution and services agreements for Probuphine with a number of well recognized companies, including AllianceRx Walgreens Prime, Accredo® specialty pharmacy (a subsidiary of Express Scripts), CVS Caremark (a subsidiary of CVS Health) and Southside Specialty Pharmacy, with the goal to improve third party payor access and improve product distribution.
    • Also in the first half of 2019, Titan and Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A. ("Molteni"), Titan's Probuphine partner for Europe and certain other territories, worked closely to meet with the Committee for Medicinal Products for Human Use of the European Medicines Agency and address all their questions regarding Sixmo®-buprenorphine (the brand name for Probuphine implant in the European Union) which led to the adoption of a positive opinion recommending the granting of a marketing authorization. Those efforts culminated in the European Commission approving Sixmo in June 2019 for substitution treatment for opioid dependence in clinically stable adult patients who require no more than 8 mg/day of sublingual buprenorphine, within a framework of medical, social and psychological treatment.
    • While Titan successfully established the infrastructure to support Probuphine and began to stabilize revenues, it became clear that it was also necessary to expand the sales outreach to grow the business. Accordingly, in the second half of 2019 Titan completed two financing transactions (August and October 2019) that provided total net proceeds of approximately $9.9 million, after which the Company began the process to expand the sales and commercial team.
    • Also, in the second half of 2019, the National Institutes of Health's National Institute on Drug Abuse ("NIDA") approved approximately $6.1 million in second-year funding for Titan's non-clinical development of a ProNeura™ based six-month implantable formulation of Nalmefene, an opioid antagonist, intended for the prevention of relapse to opioid addiction, following opioid detoxification.

    Year-to-Date 2020 Business Highlights

    • In January 2020, Titan completed an offering resulting in net cash proceeds of approximately $1.9 million.
    • In January 2020, Titan signed an agreement for Probuphine to be included on the Federal Supply Schedule, providing U.S. veterans and other federal government agencies with access to Titan's novel six-month maintenance treatment for OUD in eligible patients.
    • Since January 1, 2020, the Company has received proceeds of approximately $6.2 million as a result of the exercise of previously issued common stock purchase warrants.

    "Throughout 2019, we focused on initiatives to successfully transition to a commercial-stage company," said Titan's President and CEO, Sunil Bhonsle. "I am very pleased with our team's progress during 2019, which, among other things, includes executing arrangements with multiple top tier specialty pharmacy companies, establishing a new patient services 'hub,' and obtaining insurance coverage from a broad range of third party payors – all of which served to broaden product access for healthcare providers and patients. While we primarily focused on stabilizing our product revenue during the transition, our goal during the remainder of 2020 is to focus on executing our sales growth initiatives in the U.S. and extending the commercial reach of Probuphine to eligible patients suffering from OUD."

    Probuphine is indicated for the maintenance treatment of OUD in eligible patients. Please see Full Prescribing Information including Boxed Warning below.

    "An important 2019 milestone for Titan was the European Commission's approval of Sixmo, Probuphine's brand name in the EU," said Titan's Executive Chairman, Dr. Marc Rubin. "Our EU commercialization partner, Molteni, is located in Italy, one of the countries hit hardest by the global COVID-19 pandemic. While the launch of Sixmo may be delayed as a result, we are confident that Molteni is poised to aggressively roll-out the product across Europe once the situation allows."

    Dr. Rubin continued, "As the developments involving the COVID-19 pandemic continue to evolve, we are monitoring and implementing recommendations from local, national and global health organizations. Titan's top priorities are the health and safety of our employees, customers and the communities in which we live and work. To that end, we have put proactive, precautionary measures in place, such as sheltering in place and working from home, freezing all non-essential travel, and we have pivoted to virtual sales and business meetings only, with the goal of keeping everyone safe. At the same time, we remain deeply committed to continuing to execute additional components of our growth plan throughout 2020. These include initiatives to increase awareness and adoption of Probuphine, advance our Nalmefene program toward the clinic, and explore opportunities for the use of our ProNeura platform technology in additional important medical applications. Everyone at Titan is working remotely and being productive. We sincerely hope that all of our stakeholders will be safe and healthy as well."

    Fourth Quarter 2019 Financial Results

    For the three months ended December 31, 2019, Titan reported approximately $1.2 million in revenue, which reflect approximately $0.2 million in product sales and approximately $1.0 million related to the Company's NIDA grant. This compared with revenues of approximately $1.2 million in the same period in 2018, which was comprised of $0.2 million in product sales, $0.3 million related to the amortization of deferred revenue related to the sale to Molteni of the European intellectual property rights to Probuphine and $0.7 million related to the NIDA grant.

    Total operating expenses for the fourth quarter of 2019 were approximately $5.0 million, compared with approximately $4.5 million from the same quarter in 2018, and consisted primarily of research and development ("R&D") and selling, general and administrative ("SG&A") expenses and costs of goods sold, inclusive of distribution expenses. R&D expenses for both the quarter ended December 31, 2019 and the same quarter in 2018 were approximately $1.9 million. SG&A expenses for the 2019 fourth quarter were approximately $2.6 million, compared with approximately $2.4 million in the same quarter a year ago. Costs of goods sold for the fourth quarter of 2019 were approximately $0.6 million, compared with approximately $0.3 million in the 2018 fourth quarter.

    Net other expense, consisting primarily of interest expense, was approximately $0.1 million in the fourth quarter of 2019, compared with net other expense of approximately $0.2 million in the fourth quarter of 2018.

    Net loss applicable to common stockholders in the fourth quarter of 2019 was approximately $4.0 million, or approximately $0.08 per share, compared with a net loss applicable to common stockholders of approximately $3.5 million, or approximately $0.29 per share, in the same quarter in 2018.

    Full Year 2019 Financial Results

    Total revenues for the full year ended December 31, 2019 were approximately $3.6 million, reflecting approximately $0.3 million in license revenue, approximately $1.0 million from sales of Probuphine and approximately $2.3 million related to Titan's NIDA grant. This compares to total revenues of approximately $6.6 million in 2018 which included approximately $5.4 million in license revenue, approximately $0.5 million from sales of Probuphine and approximately $0.7 million related to Titan's NIDA grant. The approximately $3.0 million decrease resulted primarily from non-recurring license revenue in 2018  of approximately $3.2 million in upfront and milestone payments from Molteni, and approximately $2.1 million related to reacquiring the rights to Probuphine from our former licensee which was partially offset by increases in  product revenue of approximately $0.5 million, and grant revenues of approximately $1.6 million in 2019 and approximately $0.3 million of license revenue which represented the remaining amortization of the Molteni upfront payment in 2019.

    Total operating expenses in 2019 were approximately $20.5 million, compared with approximately $14.9 million in 2018, and consisted primarily of R&D and SG&A expenses. R&D expenses for the year ended December 31, 2019 were approximately $7.3 million compared to approximately $7.5 million in 2018. The decrease in R&D costs was primarily associated with decreases in employee-related expenses and other research and development expenses, partially offset by increased activities related to the NIDA grant and an increase in our contract manufacturing costs. SG&A expenses for 2019 were approximately $11.9 million, compared to approximately $6.9 million in 2018. The increase in SG&A expenses was primarily due to higher sales and marketing expenses related to establishing the infrastructure to streamline the Probuphine ordering and distribution network and the increased expenses associated with expanding Titan's Probuphine commercial activities.

    Net other income for the year ended December 31, 2019 was approximately $0.4 million, compared to net other expense of approximately $0.8 million in 2018. Net other income in 2019 was primarily due to non-cash gain on changes in the fair value of warrants. Net other expense in 2018 was primarily due to interest expense on the Company's debt.

    Net loss applicable to common stockholders for 2019 was approximately $16.5 million, or $0.72 per share, compared with net loss applicable to common stockholders of approximately $9.3 million, or $1.64 per share, for 2018.

    As at December 31, 2019, Titan had cash and cash equivalents of approximately $5.2 million, which the Company believes, together with the net cash proceeds of approximately $8.0 million received from the January 2020 offering and exercises of warrants in the first quarter of 2020, are sufficient to fund planned operations into the fourth quarter of 2020.

    Conference Call Details

    Titan management will host a conference call today at 4:30 p.m. ET / 1:30 p.m. PT to review these financial results and discuss business developments in the period. The conference call will be hosted by Sunil Bhonsle, President and CEO; Kate Beebe DeVarney, Ph.D., Executive Vice President and Chief Scientific Officer; Dane Hallberg, Executive Vice President and Chief Commercial Officer; Brian Crowley, Vice President of Finance; and Marc Rubin, M.D., Executive Chairman.

    The live conference call may be accessed by dialing 1-888-317-6003 (U.S.) or 1-412-317-6061 (international) and providing passcode 2248161. The call will also be broadcast live and archived on Titan's website at www.titanpharm.com/news/events.    

    About Probuphine

    Probuphine is the only subdermal implant designed to deliver buprenorphine continuously for six months following insertion.

    Probuphine was developed using ProNeura®, the continuous drug delivery system developed by Titan that consists of a small, solid implant made from a mixture of ethylene-vinyl acetate and a drug substance. The resulting construct is a solid matrix that is placed subdermally, normally in the upper inner arm in an outpatient office procedure and removed in a similar manner at the end of the treatment period. The U.S. Food and Drug Administration ("FDA") approved Probuphine in May 2016, and it is the first and only buprenorphine implant available for the maintenance treatment of opioid addiction in eligible patients.

    IMPORTANT SAFETY INFORMATION INCLUDING INDICATION AND BOXED WARNING

    INDICATION

    PROBUPHINE is an implant that contains the medicine buprenorphine. PROBUPHINE is used to treat certain adults who are addicted to (dependent on) opioid drugs (either prescription or illegal). PROBUPHINE is indicated for the maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses (doses no more than 8 mg per day) of a buprenorphine-containing product.

    PROBUPHINE is part of a complete treatment program that also includes counseling and behavioral therapy.

    It is not known if PROBUPHINE is safe or effective in children less than 16 years of age.

    IMPORTANT SAFETY INFORMATION


    WARNING: COMPLICATIONS FROM INSERTION AND REMOVAL OF PROBUPHINE

    See Full Prescribing Information for complete Boxed Warning



    Serious complications may happen from insertion and removal of PROBUPHINE, including:


    Nerve or blood vessel injury in your arm


    Movement of implant (migration). PROBUPHINE or pieces of it can move into blood vessels, possibly to your lung, and could lead to death


    Implant sticks out of the skin (protrusion)


    Implant comes out by itself (expulsion)



    Call your healthcare provider right away if: 

    • PROBUPHINE sticks out of the skin or comes out by itself
    • You have bleeding or symptoms of infection at the site after insertion or removal, including excessive or worsening itching, pain, irritation, redness, or swelling
    • You have numbness or weakness in your arm after the insertion or removal procedure
    • You have weakness or numbness in your arm, or shortness of breath

    If the implant comes out by itself, keep it away from others, especially children, as it may cause severe difficulty in breathing and possibly death.

    Because of the risk of complications of, migration, protrusion, expulsion and nerve injury with insertion and removal of PROBUPHINE, it is only available through a restricted program called the PROBUPHINE REMS Program. Healthcare providers who prescribe and/or insert PROBUPHINE must be certified with the program by enrolling and completing live training.

    • PROBUPHINE is not available in retail pharmacies
    • PROBUPHINE must be inserted or removed only in the facility of the certified prescriber

    Implants may be difficult to locate if inserted too deeply, if you manipulate them, or if you gain significant weight after insertion.  Your healthcare provider may do special procedures or tests, or refer you to a surgical specialist to remove the implants if they are difficult to locate.

    The medicine in PROBUPHINE can cause serious and life-threatening problems, especially if you take or use certain other medicines or drugs.  Call your healthcare provider right away or get emergency help if you:

    Feel faint or dizzy, have mental changes such as confusion, slower breathing than you normally have, severe sleepiness, blurred vision, problems with coordination, slurred speech, cannot think well or clearly, high body temperature, slowed reflexes, feel agitated, stiff muscles or have trouble walking.

    These can be signs of an overdose or other serious problems. 

    Coma or death can happen if you take anxiety medicines or benzodiazepines, sleeping pills, tranquilizers, or sedatives, antidepressants, or antihistamines, or drink alcohol during treatment with PROBUPHINE. Tell your healthcare provider if you are taking any of these medicines or if you drink alcohol.

    Who should not use PROBUPHINE?

    Do not use PROBUPHINE if you are allergic to buprenorphine or any of its ingredients, this includes buprenorphine hydrochloride and the inactive ingredient ethylene vinyl acetate or EVA.

    PROBUPHINE may not be right for you. Before starting PROBUPHINE tell your doctor about all of your medical conditions, including:

    Trouble breathing or lung problems, an enlarged prostate gland (men), a head injury or brain problem, problems urinating, a curve in your spine that affects your breathing, liver problems, gallbladder or adrenal gland problems, Addison's disease, low thyroid hormone levels (hypothyroidism), a history of alcoholism, a history of keloid formation, connective tissue disease (such as scleroderma), or history of MRSA infections, mental problems such as hallucinations, an allergy to numbing medicines or medicines used to clean your skin, are pregnant or plan to become pregnant or are breastfeeding or plan to breastfeed.

    Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

     What should I avoid while being treated with PROBUPHINE?

    • Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how this medication affects you
    • You should not drink alcohol during treatment. You should not take anxiety medicines or benzodiazepines, sleeping pills, tranquilizers, or sedatives that are not prescribed to you during treatment with PROBUPHINE, as this can lead to slowed breathing, drowsiness, delayed reaction time, loss of consciousness or even death

    What are the possible side effects of PROBUPHINE?

    PROBUPHINE can cause serious side effects, including:

    • Infection at the insertion or removal site. Infection may happen at the implant site during insertion or removal. Do not try to remove PROBUPHINE implants yourself 
    • Opioid withdrawal. If PROBUPHINE comes out of your arm or if you stop treatment, tell your doctor right away as you can have symptoms of shaking, sweating more than normal, feeling hot or cold more than normal, runny nose, watery eyes, goose bumps, diarrhea, vomiting and muscle aches
    • Physical dependency
    • Liver problems. Call your doctor right away if you notice signs of liver problems that may include your skin or the white part of your eyes turning yellow (jaundice)
    • Allergic reaction. If you get a rash, hives, itching, swelling of your face, or wheezing, low blood pressure, dizziness or decrease in consciousness
    • Decrease in blood pressure. You may feel dizzy when you get up from sitting or lying down
    • Sleep Apnea. Call your doctor right away if you or someone close to you notices:  Observed episodes of stopped breathing or abnormal breathing patterns during sleep

    Tell your healthcare provider if you develop any of the symptoms listed.

    Common side effects of PROBUPHINE include: Headache, nausea, toothache, constipation, depression, vomiting, back pain, mouth and throat pain.

    Common risks with the minor surgical procedure:  Itching, pain, irritation, redness, swelling, bleeding, or bruising at the insertion or removal site. Scarring around the insertion site. 

    Please read Full Prescribing Information, including BOXED WARNING regarding IMPLANT MIGRATION, PROTRUSION, EXPULSION and NERVE DAMAGE ASSOCIATED WITH INSERTION AND REMOVAL.

    Titan encourages you to report negative side effects of prescription drugs to the FDA. You can visit www.fda.gov/safety/medwatch/ or call 1-800-FDA-1088.

    About Titan Pharmaceuticals

    Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is a commercial stage company developing proprietary therapeutics with its ProNeura® long-term, continuous drug delivery technology. The Company's lead product is Probuphine® (buprenorphine) implant, a novel and long-acting formulation of buprenorphine for the long-term maintenance treatment of opioid dependence. Approved by the U.S. Food and Drug Administration in May 2016, Probuphine is the first and only commercialized treatment of opioid dependence to provide continuous, around-the-clock blood levels of buprenorphine for six months following a single procedure. The ProNeura technology also has the potential to be used in developing products for treating other chronic conditions such as Parkinson's disease and hypothyroidism, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. For more information about Titan, please visit www.titanpharm.com.

    Forward-Looking Statements

    This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to the commercialization of Probuphine; the regulatory approval process; Titan's ability to access capital; the development, testing, production and marketing of our drug candidates; patent and intellectual property matters; and strategic agreements and relationships.  We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

    CONTACTS:

    Sunil Bhonsle
    President & CEO
    (650) 244-4990

    Stephen Kilmer
    Investor Relations
    (650) 989-2215

    TITAN PHARMACEUTICALS, INC.

    CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

    (in thousands, except per share amount*)

    (unaudited)





    Three Months Ended
    December 31,


    Year Ended
    December 31,




    2019


    2018


    2019


    2018

    Revenue:









    License revenue

    $                  2


    $                313


    $                315


    $             5,376


    Product revenue

    195


    217


    1,006


    535


    Grant revenue

    1,020


    707


    2,290


    707



    Total revenue

    1,217


    1,237


    3,611


    6,618











    Operating expense:









    Cost of goods sold

    550


    290


    1,288


    538


    Research and development

    1,872


    1,855


    7,242


    7,478


    Selling, general and administrative

    2,589


    2,358


    11,925


    6,866



    Total operating expense

    5,011


    4,503


    20,455


    14,882

    Loss from operations

    (3,794)


    (3,266)


    (16,844)


    (8,264)













    Other income (expense), net

    (147)


    (238)


    386


    (759)











    Net loss and comprehensive loss

    $           (3,941)


    $           (3,504)


    $         (16,458)


    $           (9,023)

    Deemed dividend on trigger of down round provision

    -


    -


    -


    (285)

    Net loss attributable to common stockholders

    $           (3,941)


    $           (3,504)


    $         (16,458)


    $           (9,308)











    Basic net loss per share

    $             (0.08)


    $             (0.29)


    $             (0.72)


    $             (1.64)











    Diluted net loss per share

    $             (0.08)


    $             (0.29)


    $             (0.72)


    $             (1.66)











    Weighted average shares used in computing basic net loss per share

    49,206


    11,960


    22,957


    5,688











    Weighted average shares used in computing diluted net loss per share

    49,206


    11,960


    22,957


    5,688


    * Adjusted to reflect the impact of the 1:6 reverse split effective January 24, 2019.

     

    CONDENSED BALANCE SHEETS

    (in thousands)

    (unaudited)














    December 31,


    December 31,






    2019


    2018









    Assets







    Cash and cash equivalents



    $             5,223


    $             9,295


    Restricted cash



    -


    361


    Receivables



    993


    1,737


    Inventory



    998


    1,262


    Contract assets



    -


    99


    Prepaid expenses and other current assets



    1,094


    547



    Total current assets



    8,308


    13,301


    Property and equipment, net



    817


    794


    Operating lease right-of-use asset



    397


    -



    Total assets



    $             9,522


    $           14,095

    Liabilities and Stockholders' Equity 







    Current liabilities



    $             3,600


    $             3,452


    Long-term debt



    4,019


    3,787


    Warrant liability



    320


    -


    Derivative liability



    -


    25


    Operating lease liability, non-current



    150


    -


    Stockholders' equity 



    1,433


    6,831



    Total liabilities and stockholders' equity 



    $             9,522


    $           14,095

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/titan-pharmaceuticals-reports-fourth-quarter-and-full-year-2019-financial-results-301031956.html

    SOURCE Titan Pharmaceuticals, Inc.

    View Full Article Hide Full Article
  23. SOUTH SAN FRANCISCO, Calif., March 26, 2020 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) today announced that its fourth quarter and full year 2019 financial results will be released after market close on Monday, March 30, 2020.

    Titan will host a live conference call to discuss the financial results and provide a general business review the same day, March 30, 2020, at 4:30 p.m. ET / 1:30 p.m. PT. The call will be hosted by Sunil Bhonsle, president and CEO; Kate Beebe DeVarney, Ph.D., executive vice president and chief scientific officer; Dane Hallberg, executive vice president and chief commercial officer; Brian Crowley, vice president of finance; and Marc Rubin, M.D., executive chairman. A summary of the fourth quarter and full year financial results and other highlights will be included in a press release to be issued prior to the call.

    The live webcast and a replay of the call may be accessed by visiting http://www.titanpharm.com/news/events. The call can also be accessed by dialing 1-888-317-6003 (or 1-412-317-6061 from outside the U.S.) ten minutes prior to the start time, and providing passcode 2248161.

    About Titan Pharmaceuticals

    Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is a commercial stage company developing proprietary therapeutics with its ProNeura® long-term, continuous drug delivery technology. The company's lead product is Probuphine® (buprenorphine) implant, a novel and long-acting formulation of buprenorphine for the long-term maintenance treatment of opioid dependence. Approved by the U.S. Food and Drug Administration in May 2016, Probuphine is the first and only commercialized treatment of opioid dependence to provide continuous, around-the-clock blood levels of buprenorphine for six months following a single procedure. The ProNeura technology also has the potential to be used in developing products for treating other chronic conditions such as Parkinson's disease and hypothyroidism, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. For more information about Titan, please visit www.titanpharm.com.

    Forward-Looking Statements

    This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to the commercialization of Probuphine; the regulatory approval process; Titan's ability to access capital; the development, testing, production and marketing of our drug candidates; patent and intellectual property matters; and strategic agreements and relationships. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

    CONTACTS:

    Sunil Bhonsle
    President & CEO
    (650) 244-4990

    Stephen Kilmer
    Investor Relations
    (650) 989-2215

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/titan-pharmaceuticals-to-report-fourth-quarter-and-full-year-2019-financial-results-on-march-30-2020-301030140.html

    SOURCE Titan Pharmaceuticals, Inc.

    View Full Article Hide Full Article
  24. SOUTH SAN FRANCISCO, Calif., March 5, 2020 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) today announced that, since January 1, 2020, it has received proceeds of approximately $5.9 million as a result of the exercise of approximately 26.2 million previously issued Class B common share purchase warrants (the "Class B Warrants").

    The Class B Warrants were issued in connection with the Company's public offering completed in October 2019. The Class B Warrants have an exercise price of $0.225 and are set to expire in October 2024. Approximately 14.1 Class B Warrants remain outstanding.

    Sunil Bhonsle, Titan's President and CEO, commented, "We have been very pleased to see this level of warrant exercises and believe that the proceeds received year-to-date will extend our cash runway into the fourth quarter as we continue to drive our commercial activities."

    This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. The Class B Warrants and underlying common stock are registered on Form S-1 (File No. 333-233722) on file with the U.S. Securities and Exchange Commission ("SEC"). The registration statement was declared effective by the SEC on October 16, 2019. The registration statement is available on the SEC's web site at  http://www.sec.gov.

    About Titan Pharmaceuticals

    Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is a commercial stage company developing proprietary therapeutics with its ProNeura® long-term, continuous drug delivery technology. The company's lead product is Probuphine®  (buprenorphine) implant, a novel and long-acting formulation of buprenorphine for the long-term maintenance treatment of opioid dependence. Approved by the U.S. Food and Drug Administration in May 2016, Probuphine is the first and only commercialized treatment of opioid dependence to provide continuous, around-the-clock blood levels of buprenorphine for six months following a single procedure. The ProNeura technology also has the potential to be used in developing products for treating other chronic conditions such as Parkinson's disease and hypothyroidism, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. For more information about Titan, please visit www.titanpharm.com.

    Forward-Looking Statements

    This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to the commercialization of Probuphine; the regulatory approval process; Titan's ability to access capital; the development, testing, production and marketing of our drug candidates; patent and intellectual property matters; and strategic agreements and relationships.  We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

    CONTACTS:

    Sunil Bhonsle
    President & CEO
    (650) 244-4990

    Stephen Kilmer
    Investor Relations
    (650) 989-2215

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/titan-pharmaceuticals-receives-5-9-million-from-exercise-of-warrants-301017060.html

    SOURCE Titan Pharmaceuticals, Inc.

    View Full Article Hide Full Article
  25. SOUTH SAN FRANCISCO, Calif., Jan. 13, 2020 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) today announced that it has signed an agreement for Probuphine (buprenorphine) implant to be included on the Federal Supply Schedule ("FSS"), providing U.S. veterans and other federal government agencies with access to Titan's novel 6-month maintenance treatment for Opioid Use Disorder ("OUD") in eligible patients. The final FSS contract is effective January 15, 2020 and has a five-year term. The FSS contract will extend access to Probuphine to over nine million VA beneficiaries and others within the federal system.

    Titan Pharmaceuticals, Inc. (PRNewsfoto/Titan Pharmaceuticals, Inc.)

    "This agreement further extends the commercial reach of Probuphine to eligible patients suffering from OUD," said Dane Hallberg

    SOUTH SAN FRANCISCO, Calif., Jan. 13, 2020 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) today announced that it has signed an agreement for Probuphine (buprenorphine) implant to be included on the Federal Supply Schedule ("FSS"), providing U.S. veterans and other federal government agencies with access to Titan's novel 6-month maintenance treatment for Opioid Use Disorder ("OUD") in eligible patients. The final FSS contract is effective January 15, 2020 and has a five-year term. The FSS contract will extend access to Probuphine to over nine million VA beneficiaries and others within the federal system.

    Titan Pharmaceuticals, Inc. (PRNewsfoto/Titan Pharmaceuticals, Inc.)

    "This agreement further extends the commercial reach of Probuphine to eligible patients suffering from OUD," said Dane Hallberg, Titan's Executive Vice President and Chief Commercial Officer. "Titan is committed to helping those who serve and have served our country, and it is our hope that, through this agreement, we can make a positive impact on the lives of veterans affected by this epidemic."

    About Probuphine

    Probuphine is the only subdermal implant designed to deliver buprenorphine continuously for six months following insertion.

    Probuphine was developed using ProNeura®, the continuous drug delivery system developed by Titan that consists of a small, solid implant made from a mixture of ethylene-vinyl acetate and a drug substance. The resulting construct is a solid matrix that is placed subdermally, normally in the upper inner arm in an outpatient office procedure and removed in a similar manner at the end of the treatment period. The U.S. Food and Drug Administration ("FDA") approved Probuphine in May 2016, and it is the first and only buprenorphine implant available for the maintenance treatment of opioid addiction in eligible patients.

    IMPORTANT SAFETY INFORMATION INCLUDING INDICATION AND BOXED WARNING

    INDICATION

    PROBUPHINE is an implant that contains the medicine buprenorphine. PROBUPHINE is used to treat certain adults who are addicted to (dependent on) opioid drugs (either prescription or illegal). PROBUPHINE is indicated for the maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses (doses no more than 8 mg per day) of a buprenorphine-containing product.

    PROBUPHINE is part of a complete treatment program that also includes counseling and behavioral therapy.

    It is not known if PROBUPHINE is safe or effective in children less than 16 years of age.

    IMPORTANT SAFETY INFORMATION

     

    WARNING: COMPLICATIONS FROM INSERTION AND REMOVAL OF PROBUPHINE

    See Full Prescribing Information for complete Boxed Warning



    Serious complications may happen from insertion and removal of PROBUPHINE, including:

    • Nerve or blood vessel injury in your arm
    • Movement of implant (migration). PROBUPHINE or pieces of it can move into blood vessels, possibly to your lung, and could lead to death
    • Implant sticks out of the skin (protrusion)
    • Implant comes out by itself (expulsion)

    Call your healthcare provider right away if: 

    • PROBUPHINE sticks out of the skin or comes out by itself
    • You have bleeding or symptoms of infection at the site after insertion or removal, including excessive or worsening itching, pain, irritation, redness, or swelling
    • You have numbness or weakness in your arm after the insertion or removal procedure
    • You have weakness or numbness in your arm, or shortness of breath

    If the implant comes out by itself, keep it away from others, especially children, as it may cause severe difficulty in breathing and possibly death.

    Because of the risk of complications of, migration, protrusion, expulsion and nerve injury with insertion and removal of PROBUPHINE, it is only available through a restricted program called the PROBUPHINE REMS Program. Healthcare providers who prescribe and/or insert PROBUPHINE must be certified with the program by enrolling and completing live training.

    • PROBUPHINE is not available in retail pharmacies
    • PROBUPHINE must be inserted or removed only in the facility of the certified prescriber

    Implants may be difficult to locate if inserted too deeply, if you manipulate them, or if you gain significant weight after insertion. Your healthcare provider may do special procedures or tests, or refer you to a surgical specialist to remove the implants if they are difficult to locate.

    The medicine in PROBUPHINE can cause serious and life-threatening problems, especially if you take or use certain other medicines or drugs. Call your healthcare provider right away or get emergency help if you:

    Feel faint or dizzy, have mental changes such as confusion, slower breathing than you normally have, severe sleepiness, blurred vision, problems with coordination, slurred speech, cannot think well or clearly, high body temperature, slowed reflexes, feel agitated, stiff muscles or have trouble walking.

    These can be signs of an overdose or other serious problems. 

    Coma or death can happen if you take anxiety medicines or benzodiazepines, sleeping pills, tranquilizers, or sedatives, antidepressants, or antihistamines, or drink alcohol during treatment with PROBUPHINE. Tell your healthcare provider if you are taking any of these medicines or if you drink alcohol.

    Who should not use PROBUPHINE?

    Do not use PROBUPHINE if you are allergic to buprenorphine or any of its ingredients, this includes buprenorphine hydrochloride and the inactive ingredient ethylene vinyl acetate or EVA.

    PROBUPHINE may not be right for you. Before starting PROBUPHINE tell your doctor about all of your medical conditions, including:

    Trouble breathing or lung problems, an enlarged prostate gland (men), a head injury or brain problem, problems urinating, a curve in your spine that affects your breathing, liver problems, gallbladder or adrenal gland problems, Addison's disease, low thyroid hormone levels (hypothyroidism), a history of alcoholism, a history of keloid formation, connective tissue disease (such as scleroderma), or history of MRSA infections, mental problems such as hallucinations, an allergy to numbing medicines or medicines used to clean your skin, are pregnant or plan to become pregnant or are breastfeeding or plan to breastfeed.

    Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

     What should I avoid while being treated with PROBUPHINE?

    • Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how this medication affects you
    • You should not drink alcohol during treatment. You should not take anxiety medicines or benzodiazepines, sleeping pills, tranquilizers, or sedatives that are not prescribed to you during treatment with PROBUPHINE, as this can lead to slowed breathing, drowsiness, delayed reaction time, loss of consciousness or even death

    What are the possible side effects of PROBUPHINE?

    PROBUPHINE can cause serious side effects, including:

    • Infection at the insertion or removal site. Infection may happen at the implant site during insertion or removal. Do not try to remove PROBUPHINE implants yourself 
    • Opioid withdrawal. If PROBUPHINE comes out of your arm or if you stop treatment, tell your doctor right away as you can have symptoms of shaking, sweating more than normal, feeling hot or cold more than normal, runny nose, watery eyes, goose bumps, diarrhea, vomiting and muscle aches
    • Physical dependency
    • Liver problems. Call your doctor right away if you notice signs of liver problems that may include your skin or the white part of your eyes turning yellow (jaundice)
    • Allergic reaction. If you get a rash, hives, itching, swelling of your face, or wheezing, low blood pressure, dizziness or decrease in consciousness
    • Decrease in blood pressure. You may feel dizzy when you get up from sitting or lying down
    • Sleep Apnea. Call your doctor right away if you or someone close to you notices: Observed episodes of stopped breathing or abnormal breathing patterns during sleep

    Tell your healthcare provider if you develop any of the symptoms listed.

    Common side effects of PROBUPHINE include: Headache, nausea, toothache, constipation, depression, vomiting, back pain, mouth and throat pain.

    Common risks with the minor surgical procedure: Itching, pain, irritation, redness, swelling, bleeding, or bruising at the insertion or removal site. Scarring around the insertion site. 

    Please read Full Prescribing Information, including BOXED WARNING regarding IMPLANT MIGRATION, PROTRUSION, EXPULSION and NERVE DAMAGE ASSOCIATED WITH INSERTION AND REMOVAL.

    Titan encourages you to report negative side effects of prescription drugs to the FDA. You can visit www.fda.gov/safety/medwatch/ or call 1-800-FDA-1088.

    About Titan Pharmaceuticals

    Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is a commercial stage company developing proprietary therapeutics with its ProNeura® long-term, continuous drug delivery technology. The company's lead product is Probuphine® (buprenorphine) implant, a novel and long-acting formulation of buprenorphine for the long-term maintenance treatment of opioid dependence. Approved by the U.S. Food and Drug Administration in May 2016, Probuphine is the first and only commercialized treatment of opioid dependence to provide continuous, around-the-clock blood levels of buprenorphine for six months following a single procedure. The ProNeura technology also has the potential to be used in developing products for treating other chronic conditions such as Parkinson's disease and hypothyroidism, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. For more information about Titan, please visit www.titanpharm.com.

    Forward-Looking Statements

    This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to the commercialization of Probuphine; the regulatory approval process; Titan's ability to access capital; the development, testing, production and marketing of our drug candidates; patent and intellectual property matters; and strategic agreements and relationships.  We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

    CONTACTS:

    Sunil Bhonsle
    President & CEO
    (650) 244-4990

    Stephen Kilmer
    Investor Relations
    (650) 989-2215

     

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    SOURCE Titan Pharmaceuticals, Inc.

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  26. SOUTH SAN FRANCISCO, Calif., Jan. 7, 2020 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) today announced it has entered into a securities purchase agreement with certain accredited institutional investors to purchase approximately $2.2 million of its common stock in a registered direct offering and warrants to purchase shares of common stock in a concurrent private placement. The combined purchase price for one share of common stock and each warrant will be $0.25.

    Titan Pharmaceuticals, Inc. (PRNewsfoto/Titan Pharmaceuticals, Inc.)

    Under the terms of the purchase agreement, Titan has agreed to sell 8,700,000 shares of its common stock. In a concurrent private placement, Titan has agreed to issue warrants to purchase up to an aggregate of 8,700,000 shares of common stock.  The warrants will be exercisable…

    SOUTH SAN FRANCISCO, Calif., Jan. 7, 2020 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) today announced it has entered into a securities purchase agreement with certain accredited institutional investors to purchase approximately $2.2 million of its common stock in a registered direct offering and warrants to purchase shares of common stock in a concurrent private placement. The combined purchase price for one share of common stock and each warrant will be $0.25.

    Titan Pharmaceuticals, Inc. (PRNewsfoto/Titan Pharmaceuticals, Inc.)

    Under the terms of the purchase agreement, Titan has agreed to sell 8,700,000 shares of its common stock. In a concurrent private placement, Titan has agreed to issue warrants to purchase up to an aggregate of 8,700,000 shares of common stock.  The warrants will be exercisable commencing on the later of (i) six months from the date of issuance or (ii) the date that Titan's stockholders approve a reverse stock split in an amount sufficient to permit the exercise in full of all of the warrants, will expire on the five year and six month anniversary of the issuance date and will have an exercise price of $0.25 per share.

    Titan expects the gross proceeds from the registered direct offering and concurrent private placement to be approximately $1.9 million after deducting the placement agent's fees and other estimated offering expenses. The registered direct offering and concurrent private placement is expected to close on or about January 9, 2020, subject to the satisfaction of customary closing conditions.

    Maxim Group LLC is acting as the sole placement agent in connection with the offering

    The shares of common stock are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-230742), which was declared effective by the United States Securities and Exchange Commission ("SEC") on April 24, 2019. The warrants issued in the concurrent private placement and shares issuable upon exercise of such warrants are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and have not been registered under the Act or applicable state securities laws.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. A prospectus supplement relating to the shares of common stock will be filed by Titan with the SEC. When available, copies of the prospectus supplement relating to the registered direct offering, together with the accompanying prospectus, can be obtained at the SEC's website at www.sec.gov or from Maxim Group LLC, 405 Lexington Avenue, New York, NY 10174, Attention: Syndicate Department, or via email at or telephone at (212) 895-3745.

    About Titan Pharmaceuticals

    Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is a commercial stage company developing proprietary therapeutics with its ProNeura™ long-term, continuous drug delivery technology. The company's lead product is Probuphine® (buprenorphine) implant, a novel and long-acting formulation of buprenorphine for the long-term maintenance treatment of opioid dependence. Approved by the U.S. Food and Drug Administration in May 2016, Probuphine is the first and only commercialized treatment of opioid dependence to provide continuous, around-the-clock blood levels of buprenorphine for six months following a single procedure. The ProNeura technology also has the potential to be used in developing products for treating other chronic conditions such as Parkinson's disease and hypothyroidism, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. For more information about Titan, please visit www.titanpharm.com.

    Forward-Looking Statements

    This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to the commercialization of Probuphine, the regulatory approval process, the development, testing, production and marketing of our drug candidates, patent and intellectual property matters and strategic agreements and relationships. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

    CONTACTS:

    Stephen Kilmer
    Investor Relations
    (650) 989-2215

     

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    SOURCE Titan Pharmaceuticals, Inc.

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  27. SOUTH SAN FRANCISCO, Calif., Dec. 30, 2019 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) today announced that at its recent annual stockholders meeting, Kate DeVarney, Ph.D., its Executive Vice President and Chief Scientific Officer, was elected to the Company's Board of Directors.

    Titan Pharmaceuticals, Inc. (PRNewsfoto/Titan Pharmaceuticals, Inc.)

    Dr. DeVarney, a clinical neuropsychologist by training, joined Titan in January 2007 and spearheaded the development of Probuphine® (buprenorphine) implant, the first six-month long acting product approved in the United States, Canada and Europe for the treatment of opioid use disorder in eligible patients. Prior to joining Titan, she served as Senior Director at Corcept Therapeutics and as Senior Medical Director for Neurosciences within World Wide…

    SOUTH SAN FRANCISCO, Calif., Dec. 30, 2019 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) today announced that at its recent annual stockholders meeting, Kate DeVarney, Ph.D., its Executive Vice President and Chief Scientific Officer, was elected to the Company's Board of Directors.

    Titan Pharmaceuticals, Inc. (PRNewsfoto/Titan Pharmaceuticals, Inc.)

    Dr. DeVarney, a clinical neuropsychologist by training, joined Titan in January 2007 and spearheaded the development of Probuphine® (buprenorphine) implant, the first six-month long acting product approved in the United States, Canada and Europe for the treatment of opioid use disorder in eligible patients. Prior to joining Titan, she served as Senior Director at Corcept Therapeutics and as Senior Medical Director for Neurosciences within World Wide Human Health at Merck & Co. Dr. DeVarney also held positions within the Neurosciences research and development and medical affairs organizations of SmithKline Beecham and GlaxoSmithKline. Throughout her academic and industry careers, Dr. DeVarney's research has focused primarily on addiction; neurodegenerative disorders, including Alzheimer's disease and Parkinson's disease; mood and anxiety disorders; metabolic disorders and obesity.

    "Kate's leadership of the clinical development and medical affairs team at Titan is greatly valued by all, and we welcome her as a Board member and look forward to her future contributions to the growth of the company," said Titan's Executive Chairman, Dr. Marc Rubin. "I would like to take this opportunity to thank Dr. Rajinder Kumar, who retired from the Board in December, for his contributions to Titan over the past several years, and wish him the best in his future endeavors." 

    About Probuphine

    Probuphine is the only subdermal implant designed to deliver buprenorphine continuously for six months following insertion.

    Probuphine was developed using ProNeura®, the continuous drug delivery system developed by Titan that consists of a small, solid implant made from a mixture of ethylene-vinyl acetate and a drug substance. The resulting construct is a solid matrix that is placed subdermally, normally in the upper inner arm in an outpatient office procedure and removed in a similar manner at the end of the treatment period. The U.S. Food and Drug Administration ("FDA") approved Probuphine in May 2016, and it is the first and only buprenorphine implant available for the maintenance treatment of opioid addiction in eligible patients.

    IMPORTANT SAFETY INFORMATION INCLUDING INDICATION AND BOXED WARNING

    INDICATION

    PROBUPHINE is an implant that contains the medicine buprenorphine. PROBUPHINE is used to treat certain adults who are addicted to (dependent on) opioid drugs (either prescription or illegal). PROBUPHINE is indicated for the maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses (doses no more than 8 mg per day) of a buprenorphine-containing product.
    PROBUPHINE is part of a complete treatment program that also includes counseling and behavioral therapy.
    It is not known if PROBUPHINE is safe or effective in children less than 16 years of age.

    IMPORTANT SAFETY INFORMATION

    WARNING: COMPLICATIONS FROM INSERTION AND REMOVAL OF PROBUPHINE

    See Full Prescribing Information for complete Boxed Warning


    Serious complications may happen from insertion and removal of PROBUPHINE, including:

    • Nerve or blood vessel injury in your arm
    • Movement of implant (migration). PROBUPHINE or pieces of it can move into blood vessels, possibly to your lung, and could lead to death
    • Implant sticks out of the skin (protrusion)
    • Implant comes out by itself (expulsion)

    Call your healthcare provider right away if: 

    • PROBUPHINE sticks out of the skin or comes out by itself
    • You have bleeding or symptoms of infection at the site after insertion or removal, including excessive or worsening itching, pain, irritation, redness, or swelling
    • You have numbness or weakness in your arm after the insertion or removal procedure
    • You have weakness or numbness in your arm, or shortness of breath

    If the implant comes out by itself, keep it away from others, especially children, as it may cause severe difficulty in breathing and possibly death.

    Because of the risk of complications of, migration, protrusion, expulsion and nerve injury with insertion and removal of PROBUPHINE, it is only available through a restricted program called the PROBUPHINE REMS Program. Healthcare providers who prescribe and/or insert PROBUPHINE must be certified with the program by enrolling and completing live training.

    • PROBUPHINE is not available in retail pharmacies
    • PROBUPHINE must be inserted or removed only in the facility of the certified prescriber

    Implants may be difficult to locate if inserted too deeply, if you manipulate them, or if you gain significant weight after insertion.  Your healthcare provider may do special procedures or tests, or refer you to a surgical specialist to remove the implants if they are difficult to locate.

    The medicine in PROBUPHINE can cause serious and life-threatening problems, especially if you take or use certain other medicines or drugs.  Call your healthcare provider right away or get emergency help if you:

    Feel faint or dizzy, have mental changes such as confusion, slower breathing than you normally have, severe sleepiness, blurred vision, problems with coordination, slurred speech, cannot think well or clearly, high body temperature, slowed reflexes, feel agitated, stiff muscles or have trouble walking.

    These can be signs of an overdose or other serious problems. 

    Coma or death can happen if you take anxiety medicines or benzodiazepines, sleeping pills, tranquilizers, or sedatives, antidepressants, or antihistamines, or drink alcohol during treatment with PROBUPHINE. Tell your healthcare provider if you are taking any of these medicines or if you drink alcohol.

    Who should not use PROBUPHINE?

    Do not use PROBUPHINE if you are allergic to buprenorphine or any of its ingredients, this includes buprenorphine hydrochloride and the inactive ingredient ethylene vinyl acetate or EVA.

    PROBUPHINE may not be right for you. Before starting PROBUPHINE tell your doctor about all of your medical conditions, including:

    Trouble breathing or lung problems, an enlarged prostate gland (men), a head injury or brain problem, problems urinating, a curve in your spine that affects your breathing, liver problems, gallbladder or adrenal gland problems, Addison's disease, low thyroid hormone levels (hypothyroidism), a history of alcoholism, a history of keloid formation, connective tissue disease (such as scleroderma), or history of MRSA infections, mental problems such as hallucinations, an allergy to numbing medicines or medicines used to clean your skin, are pregnant or plan to become pregnant or are breastfeeding or plan to breastfeed.

    Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

     What should I avoid while being treated with PROBUPHINE?

    • Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how this medication affects you
    • You should not drink alcohol during treatment. You should not take anxiety medicines or benzodiazepines, sleeping pills, tranquilizers, or sedatives that are not prescribed to you during treatment with PROBUPHINE, as this can lead to slowed breathing, drowsiness, delayed reaction time, loss of consciousness or even death

    What are the possible side effects of PROBUPHINE?

    PROBUPHINE can cause serious side effects, including:

    • Infection at the insertion or removal site. Infection may happen at the implant site during insertion or removal. Do not try to remove PROBUPHINE implants yourself 
    • Opioid withdrawal. If PROBUPHINE comes out of your arm or if you stop treatment, tell your doctor right away as you can have symptoms of shaking, sweating more than normal, feeling hot or cold more than normal, runny nose, watery eyes, goose bumps, diarrhea, vomiting and muscle aches
    • Physical dependency
    • Liver problems. Call your doctor right away if you notice signs of liver problems that may include your skin or the white part of your eyes turning yellow (jaundice)
    • Allergic reaction. If you get a rash, hives, itching, swelling of your face, or wheezing, low blood pressure, dizziness or decrease in consciousness
    • Decrease in blood pressure. You may feel dizzy when you get up from sitting or lying down
    • Sleep Apnea. Call your doctor right away if you or someone close to you notices:  Observed episodes of stopped breathing or abnormal breathing patterns during sleep

    Tell your healthcare provider if you develop any of the symptoms listed.

    Common side effects of PROBUPHINE include: Headache, nausea, toothache, constipation, depression, vomiting, back pain, mouth and throat pain.

    Common risks with the minor surgical procedure:  Itching, pain, irritation, redness, swelling, bleeding, or bruising at the insertion or removal site. Scarring around the insertion site. 

    Please read Full Prescribing Information, including BOXED WARNING regarding IMPLANT MIGRATION, PROTRUSION, EXPULSION and NERVE DAMAGE ASSOCIATED WITH INSERTION AND REMOVAL.

    Titan encourages you to report negative side effects of prescription drugs to the FDA. You can visit www.fda.gov/safety/medwatch/ or call 1-800-FDA-1088.

    About Titan Pharmaceuticals

    Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is a commercial stage company developing proprietary therapeutics with its ProNeura® long-term, continuous drug delivery technology. The company's lead product is Probuphine® (buprenorphine) implant, a novel and long-acting formulation of buprenorphine for the long-term maintenance treatment of opioid dependence. Approved by the U.S. Food and Drug Administration in May 2016, Probuphine is the first and only commercialized treatment of opioid dependence to provide continuous, around-the-clock blood levels of buprenorphine for six months following a single procedure. The ProNeura technology also has the potential to be used in developing products for treating other chronic conditions such as Parkinson's disease and hypothyroidism, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. For more information about Titan, please visit www.titanpharm.com.

    Forward-Looking Statements

    This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to the commercialization of Probuphine; the regulatory approval process; Titan's ability to access capital; the development, testing, production and marketing of our drug candidates; patent and intellectual property matters; and strategic agreements and relationships.  We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

    CONTACTS:

    Sunil Bhonsle
    President & CEO
    (650) 244-4990

    Stephen Kilmer
    Investor Relations
    (650) 989-2215

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    SOURCE Titan Pharmaceuticals, Inc.

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  28. SOUTH SAN FRANCISCO, Calif., Dec. 3, 2019 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) today announced that management will present an update on the Company's business at the first annual BioTuesdays Pre-JPM Virtual Conference on Tuesday, December 10, 2019 at 3:00 p.m. EST / 12:00 p.m. PST.

    Titan Pharmaceuticals, Inc. (PRNewsfoto/Titan Pharmaceuticals, Inc.)

    The presentation will be broadcast live and archived on Titan's website at www.titanpharm.com/news/events.

    About Titan Pharmaceuticals

    Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is a commercial stage company developing proprietary therapeutics with its ProNeura™ long-term, continuous drug delivery technology. The company's lead product is Probuphine® (buprenorphine) implant, a novel and long-acting formulation…

    SOUTH SAN FRANCISCO, Calif., Dec. 3, 2019 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) today announced that management will present an update on the Company's business at the first annual BioTuesdays Pre-JPM Virtual Conference on Tuesday, December 10, 2019 at 3:00 p.m. EST / 12:00 p.m. PST.

    Titan Pharmaceuticals, Inc. (PRNewsfoto/Titan Pharmaceuticals, Inc.)

    The presentation will be broadcast live and archived on Titan's website at www.titanpharm.com/news/events.

    About Titan Pharmaceuticals

    Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is a commercial stage company developing proprietary therapeutics with its ProNeura™ long-term, continuous drug delivery technology. The company's lead product is Probuphine® (buprenorphine) implant, a novel and long-acting formulation of buprenorphine for the long-term maintenance treatment of opioid dependence. Approved by the U.S. Food and Drug Administration in May 2016, Probuphine is the first and only commercialized treatment of opioid dependence to provide continuous, around-the-clock blood levels of buprenorphine for six months following a single procedure. The ProNeura technology also has the potential to be used in developing products for treating other chronic conditions such as Parkinson's disease and hypothyroidism, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. For more information about Titan, please visit www.titanpharm.com.  

    Forward-Looking Statements
    This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to the commercialization of Probuphine; the regulatory approval process; Titan's ability to access capital; the development, testing, production and marketing of our drug candidates; patent and intellectual property matters; and strategic agreements and relationships.  We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

    CONTACTS:

    Sunil Bhonsle,
    President & CEO
    (650) 244-4990

    Stephen Kilmer
    Investor Relations
    (650) 989-2215

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/titan-pharmaceuticals-to-present-at-the-first-annual-biotuesdays-pre-jpm-virtual-conference-300968006.html

    SOURCE Titan Pharmaceuticals, Inc.

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  29. CAMBRIDGE, ON / ACCESSWIRE / December 3, 2019 / Kilmer Lucas, a healthcare-focused investor relations and capital markets advisory firm, today announced the agenda for its first annual BioTuesdays Pre-JPM Virtual Conference, beginning at 11:00 am ET on Tuesday, December 10, 2019.

    "Since 2009, BioTuesdays has featured interviews with senior representatives of more than 450 healthcare companies," said Kilmer Lucas' President, Stephen Kilmer. "BioTuesdays' mission is to increase small- and medium-sized healthcare companies' visibility across a broader and more diverse range of investors, and we do so at no cost to the companies, nor our subscribers. In keeping with this philosophy, we are proud to highlight nine innovative healthcare companies…

    CAMBRIDGE, ON / ACCESSWIRE / December 3, 2019 / Kilmer Lucas, a healthcare-focused investor relations and capital markets advisory firm, today announced the agenda for its first annual BioTuesdays Pre-JPM Virtual Conference, beginning at 11:00 am ET on Tuesday, December 10, 2019.

    "Since 2009, BioTuesdays has featured interviews with senior representatives of more than 450 healthcare companies," said Kilmer Lucas' President, Stephen Kilmer. "BioTuesdays' mission is to increase small- and medium-sized healthcare companies' visibility across a broader and more diverse range of investors, and we do so at no cost to the companies, nor our subscribers. In keeping with this philosophy, we are proud to highlight nine innovative healthcare companies via this no-cost virtual conference ahead of the industry's much anticipated gathering in San Francisco next month."

    11:00 am

    11:30 am

    12:00 pm

    12:30 pm

    1:00 pm

    1:30 pm

    2:00 pm

    2:30 pm

    3:00 pm

    Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA)

    iBio, Inc. (NYSE:IBIO)

    Imagin Medical (CSE:IME, OTCQB:IMEXF, Frankfurt &amp, Stuttgart Symbol:DPD2))

    IntelGenx Technologies Corp. (OTCQX:IGXT, TSXV:IGX)

    Profound Medical Corp. (NASDAQ:PROF, TSX:PRN)

    Soricimed Biopharma Inc. (Private)

    Kane Biotech Inc. (TSXV:KNE)

    Scientus Pharma (Private)

    Titan Pharmaceuticals, Inc. (NASDAQ:TTNP)

    Pre-JPM Virtual Conference Agenda (Eastern Time)

    To save time, it is recommended that participants pre-register for the live presentation webcasts here.

    Presentations will be available for on-demand replay following the conclusion of the virtual conference at www.biotuesdays.com/events.

    About BioTuesdays

    Published since 2009 by Kilmer Lucas, BioTuesdays covers small- and medium-sized healthcare company news often overlooked by traditional media. To-date, BioTuesdays has profiled more than 450 healthcare companies, providing invaluable exposure for innovative technologies and compelling investment stories that may have otherwise gone unnoticed. More information about BioTuesdays can be found at www.biotuesdays.com.

    About Kilmer Lucas

    Kilmer Lucas is a healthcare-focused investor relations and capital markets advisory firm. It takes a holistic approach to building a customized IR strategy, that begins with a deep understanding of a company's corporate and financial goals. Kilmer Lucas seeks to leverage its longstanding relationships and strong track record to positively influence investor perceptions, maximize stock valuations and lower the cost of capital needed to fund its clients' growth. More information about the firm can be found at www.kilmerlucas.com.

    For further information, please contact:

    Abby Hardy
    Vice President, Communications
    Kilmer Lucas Inc. & BioTuesdays Publishing Corporation
    Direct: 587.969.0445

    SOURCE: Kilmer Lucas Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/568834/Kilmer-Lucas-Announces-Agenda-for-BioTuesdays-Pre-JPM-Virtual-Conference-on-December-10th

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  30. SOUTH SAN FRANCISCO, Calif., Nov. 14, 2019 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) today reported financial results for the third quarter ended September 30, 2019 and provided an update on its business.

    Titan Pharmaceuticals, Inc. (PRNewsfoto/Titan Pharmaceuticals, Inc.)

    Third Quarter 2019 and Recent Business Highlights

    • In July 2019, Titan announced a specialty product distribution agreement for Probuphine® (buprenorphine) implants with CVS Caremark, a subsidiary of CVS Health.
    • In August 2019, Titan completed a $2.1 million offering resulting in net cash proceeds of approximately $1.8 million.
    • In September, 2019, the National Institutes of Health's National Institute on Drug Abuse ("NIDA") approved approximately $6.1 million in second-year funding for Titan's non-clinical development…

    SOUTH SAN FRANCISCO, Calif., Nov. 14, 2019 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) today reported financial results for the third quarter ended September 30, 2019 and provided an update on its business.

    Titan Pharmaceuticals, Inc. (PRNewsfoto/Titan Pharmaceuticals, Inc.)

    Third Quarter 2019 and Recent Business Highlights

    • In July 2019, Titan announced a specialty product distribution agreement for Probuphine® (buprenorphine) implants with CVS Caremark, a subsidiary of CVS Health.
    • In August 2019, Titan completed a $2.1 million offering resulting in net cash proceeds of approximately $1.8 million.
    • In September, 2019, the National Institutes of Health's National Institute on Drug Abuse ("NIDA") approved approximately $6.1 million in second-year funding for Titan's non-clinical development of a ProNeura™ based six-month implantable formulation of Nalmefene, an opioid antagonist, intended for the prevention of relapse to opioid addiction, following opioid detoxification.
    • In October 2019, Titan announced that Crossroads of Southern Nevada rehabilitation facility began offering Probuphine for use in eligible patients with Opioid Use Disorder ("OUD").
    • In October 2019, Titan completed a $9.1 million offering resulting in net cash proceeds of approximately $8.1 million.
    • In October 2019, Titan presented two posters on its Probuphine implant at the 10th American Conference on Pharmacometrics.

    "This quarter, we continued to make important progress on the commercial activities for Probuphine by expanding the specialty product distribution network and implementing the patient portal to enhance the capabilities of the product order processing hub," said Titan's President and CEO, Sunil Bhonsle. "We have also been engaged in addressing the company's capital needs and raised gross proceeds of approximately $11.2 million from two financings, which enables us to expand our commercial efforts in select market segments, including potential partnering with other companies if possible." 

    Probuphine is indicated for the maintenance treatment of opioid dependence in eligible patients. Please see full indication below.

    Titan's Executive Chairman, Dr. Marc Rubin, commented, "While our recent financing has provided the requisite resources to execute additional components of our growth plan, we are also continuing to opportunistically improve our overall cost structure in order to further extend our cash runway. The recent receipt of a second year of NIDA funding for our Nalmefene program was a very positive development, as it enables us to progress the program toward the clinic while continuing to focus our resources on the achievement of commercial success with Probuphine. Also, in collaboration with other companies or institutions, we are exploring opportunities for the use of our ProNeura platform technology in additional important medical applications, including chronic pain and malaria prophylaxis, and just starting a non-clinical feasibility study to evaluate the long-term delivery of CBD."

    Third Quarter 2019 Financial Results

    For the three months ended September 30, 2019, Titan reported approximately $0.9 million in total revenues, which reflect approximately $0.2 million in product revenues and approximately $0.8 million of grant revenues. This compared with total revenues of approximately $1.7 million in the same period in 2018. The decrease was primarily related to one-time payments in 2018 from license agreements associated with Probuphine, which were partially offset by 2019 grant revenue.

    Total operating expenses for the third quarter of 2019 were approximately $4.8 million, compared with approximately $3.6 million in the same quarter in 2018, and consisted primarily of research and development ("R&D") and selling, general and administrative ("SG&A") expenses and costs of goods sold, inclusive of distribution expenses.

    R&D expenses for the third quarter of 2019 were approximately $1.6 million, compared with approximately $1.9 million in the same quarter in 2018. The decrease was primarily due to approximately $0.6 million of lower R&D expenses related to Probuphine and approximately $0.2 million of lower expenses related to employee compensation; partially offset by approximately $0.5 million of higher R&D expenses related to the Nalmefene product development program, which were partially reimbursed under the NIDA grant.

    SG&A expenses for the 2019 third quarter were approximately $3.0 million, compared with approximately $1.5 million in the same quarter a year ago. The increase in SG&A expenses for the three months ended September 30, 2019 was primarily attributable to increases in employee-related expenses of approximately $0.5 million, expenses related to consulting, professional and outside services of approximately $0.8 million and expenses related to facilities and travel of approximately $0.2 million.

    Costs of goods sold, which reflects product costs and other distribution expenses associated with sales of Probuphine, were approximately $0.2 million for both quarters ended September 30, 2019 and 2018.

    Net other income was approximately $1.1 million for the three month period ended September 30, 2019, compared with net other expense of approximately $0.1 million in the same quarter a year ago. The increase was primarily attributable to an approximately $1.0 million non-cash gain on changes in the fair value of warrants issued in connection with the August 2019 offering and an approximately $0.3 million non-cash gain on debt extinguishment associated with the modification of the Molteni convertible loan.

    Net loss applicable to common shareholders in the third quarter of 2019 was approximately $2.8 million, or approximately $0.18 per share, compared with a net loss applicable to common shareholders of approximately $2.3 million, or approximately $0.64 per share, in the same quarter in 2018.

    As of September 30, 2019, Titan had cash and cash equivalents of approximately $0.9 million. Titan believes that its cash and cash equivalents as of September 30, 2019, along with the approximately $8.1 million of net cash proceeds from the public offering completed in October 2019, will be sufficient to fund its operations into the third quarter of 2020. 

    Conference Call Details

    Titan management will host a conference call today at 4:30 p.m. ET to review these financial results and discuss business developments in the period. The conference call will be hosted by Sunil Bhonsle, President and CEO; Kate Beebe DeVarney, Ph.D., Executive Vice President and Chief Scientific Officer; Dane Hallberg, Executive Vice President and Chief Commercial Officer; Brian Crowley, Vice President of Finance; and Marc Rubin, M.D., Executive Chairman.

    The live conference call may be accessed by dialing 1-888-317-6003 (U.S.) or 1-412-317-6061 (international) and providing passcode 9174896. The call will also be broadcast live and archived on Titan's website at www.titanpharm.com/news/events.   

    About Probuphine

    Probuphine is the only subdermal implant designed to deliver buprenorphine continuously for six months following insertion.

    Probuphine was developed using ProNeura®, the continuous drug delivery system developed by Titan that consists of a small, solid implant made from a mixture of ethylene-vinyl acetate and a drug substance. The resulting construct is a solid matrix that is placed subdermally, normally in the upper inner arm in an outpatient office procedure and removed in a similar manner at the end of the treatment period. The U.S. Food and Drug Administration ("FDA") approved Probuphine in May 2016, and it is the first and only buprenorphine implant available for the maintenance treatment of opioid addiction in eligible patients.

    IMPORTANT SAFETY INFORMATION INCLUDING INDICATION AND BOXED WARNING

    INDICATION

    PROBUPHINE is an implant that contains the medicine buprenorphine. PROBUPHINE is used to treat certain adults who are addicted to (dependent on) opioid drugs (either prescription or illegal). PROBUPHINE is indicated for the maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses (doses no more than 8 mg per day) of a buprenorphine-containing product.

    PROBUPHINE is part of a complete treatment program that also includes counseling and behavioral therapy.

    It is not known if PROBUPHINE is safe or effective in children less than 16 years of age.

    IMPORTANT SAFETY INFORMATION

    WARNING: COMPLICATIONS FROM INSERTION AND REMOVAL OF PROBUPHINE
    See Full Prescribing Information for complete Boxed Warning

     Serious complications may happen from insertion and removal of PROBUPHINE, including:

    • Nerve or blood vessel injury in your arm
    • Movement of implant (migration). PROBUPHINE or pieces of it can move into blood vessels, possibly to your lung, and could lead to death
    • Implant sticks out of the skin (protrusion)
    • Implant comes out by itself (expulsion)

    Call your healthcare provider right away if: 

    • PROBUPHINE sticks out of the skin or comes out by itself
    • You have bleeding or symptoms of infection at the site after insertion or removal, including excessive or worsening itching, pain, irritation, redness, or swelling
    • You have numbness or weakness in your arm after the insertion or removal procedure
    • You have weakness or numbness in your arm, or shortness of breath

    If the implant comes out by itself, keep it away from others, especially children, as it may cause severe difficulty in breathing and possibly death.

    Because of the risk of complications of, migration, protrusion, expulsion and nerve injury with insertion and removal of PROBUPHINE, it is only available through a restricted program called the PROBUPHINE REMS Program. Healthcare providers who prescribe and/or insert PROBUPHINE must be certified with the program by enrolling and completing live training.

    • PROBUPHINE is not available in retail pharmacies
    • PROBUPHINE must be inserted or removed only in the facility of the certified prescriber

    Implants may be difficult to locate if inserted too deeply, if you manipulate them, or if you gain significant weight after insertion.  Your healthcare provider may do special procedures or tests, or refer you to a surgical specialist to remove the implants if they are difficult to locate.

    The medicine in PROBUPHINE can cause serious and life-threatening problems, especially if you take or use certain other medicines or drugs.  Call your healthcare provider right away or get emergency help if you:

    Feel faint or dizzy, have mental changes such as confusion, slower breathing than you normally have, severe sleepiness, blurred vision, problems with coordination, slurred speech, cannot think well or clearly, high body temperature, slowed reflexes, feel agitated, stiff muscles or have trouble walking.

    These can be signs of an overdose or other serious problems. 

    Coma or death can happen if you take anxiety medicines or benzodiazepines, sleeping pills, tranquilizers, or sedatives, antidepressants, or antihistamines, or drink alcohol during treatment with PROBUPHINE. Tell your healthcare provider if you are taking any of these medicines or if you drink alcohol.

    Who should not use PROBUPHINE?

    Do not use PROBUPHINE if you are allergic to buprenorphine or any of its ingredients, this includes buprenorphine hydrochloride and the inactive ingredient ethylene vinyl acetate or EVA.

    PROBUPHINE may not be right for you. Before starting PROBUPHINE tell your doctor about all of your medical conditions, including:

    Trouble breathing or lung problems, an enlarged prostate gland (men), a head injury or brain problem, problems urinating, a curve in your spine that affects your breathing, liver problems, gallbladder or adrenal gland problems, Addison's disease, low thyroid hormone levels (hypothyroidism), a history of alcoholism, a history of keloid formation, connective tissue disease (such as scleroderma), or history of MRSA infections, mental problems such as hallucinations, an allergy to numbing medicines or medicines used to clean your skin, are pregnant or plan to become pregnant or are breastfeeding or plan to breastfeed.

    Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

     What should I avoid while being treated with PROBUPHINE?

    • Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how this medication affects you
    • You should not drink alcohol during treatment. You should not take anxiety medicines or benzodiazepines, sleeping pills, tranquilizers, or sedatives that are not prescribed to you during treatment with PROBUPHINE, as this can lead to slowed breathing, drowsiness, delayed reaction time, loss of consciousness or even death

    What are the possible side effects of PROBUPHINE?

    PROBUPHINE can cause serious side effects, including:

    • Infection at the insertion or removal site. Infection may happen at the implant site during insertion or removal. Do not try to remove PROBUPHINE implants yourself 
    • Opioid withdrawal. If PROBUPHINE comes out of your arm or if you stop treatment, tell your doctor right away as you can have symptoms of shaking, sweating more than normal, feeling hot or cold more than normal, runny nose, watery eyes, goose bumps, diarrhea, vomiting and muscle aches
    • Physical dependency
    • Liver problems. Call your doctor right away if you notice signs of liver problems that may include your skin or the white part of your eyes turning yellow (jaundice)
    • Allergic reaction. If you get a rash, hives, itching, swelling of your face, or wheezing, low blood pressure, dizziness or decrease in consciousness
    • Decrease in blood pressure. You may feel dizzy when you get up from sitting or lying down
    • Sleep Apnea. Call your doctor right away if you or someone close to you notices:  Observed episodes of stopped breathing or abnormal breathing patterns during sleep

    Tell your healthcare provider if you develop any of the symptoms listed.

    Common side effects of PROBUPHINE include: Headache, nausea, toothache, constipation, depression, vomiting, back pain, mouth and throat pain.

    Common risks with the minor surgical procedure:  Itching, pain, irritation, redness, swelling, bleeding, or bruising at the insertion or removal site. Scarring around the insertion site. 

    Please read Full Prescribing Information, including BOXED WARNING regarding IMPLANT MIGRATION, PROTRUSION, EXPULSION and NERVE DAMAGE ASSOCIATED WITH INSERTION AND REMOVAL.

    Titan encourages you to report negative side effects of prescription drugs to the FDA. You can visit www.fda.gov/safety/medwatch/ or call 1-800-FDA-1088.

    About Titan Pharmaceuticals

    Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is a commercial stage company developing proprietary therapeutics with its ProNeura® long-term, continuous drug delivery technology. The company's lead product is Probuphine® (buprenorphine) implant, a novel and long-acting formulation of buprenorphine for the long-term maintenance treatment of opioid dependence. Approved by the U.S. Food and Drug Administration in May 2016, Probuphine is the first and only commercialized treatment of opioid dependence to provide continuous, around-the-clock blood levels of buprenorphine for six months following a single procedure. The ProNeura technology also has the potential to be used in developing products for treating other chronic conditions such as Parkinson's disease and hypothyroidism, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. For more information about Titan, please visit www.titanpharm.com.

    Forward-Looking Statements

    This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to the commercialization of Probuphine; the regulatory approval process; Titan's ability to access capital; the development, testing, production and marketing of our drug candidates; patent and intellectual property matters; and strategic agreements and relationships.  We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

    CONTACTS:

    Sunil Bhonsle
    President & CEO
    (650) 244-4990

    Stephen Kilmer
    Investor Relations
    (650) 989-2215

    TITAN PHARMACEUTICALS, INC.

    CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

    (in thousands, except per share amount)

    (unaudited)





    Three Months Ended
    September 30,


    Nine Months Ended
    September 30,




    2019


    2018


    2019


    2018

    Revenue:









    License revenue

    $        -


    $  1,406


    $       313


    $  5,063


    Product revenue

    190


    244


    811


    318


    Grant revenue

    757


    -


    1,270


    -



    Total revenue

    947


    1,650


    2,394


    5,381











    Operating expense:









    Cost of goods sold

    188


    178


    738


    248


    Research and development

    1,619


    1,910


    5,370


    5,623


    Selling, general and administrative

    3,023


    1,514


    9,336


    4,508



    Total operating expense

    4,830


    3,602


    15,444


    10,379

    Loss from operations

    (3,883)


    (1,952)


    (13,050)


    (4,998)













    Other income (expense), net

    1,080


    (93)


    533


    (521)











    Net loss and comprehensive loss

    $ (2,803)


    $(2,045)


    $ (12,517)


    $ (5,519)











    Deemed dividend on trigger of down round provision

    -


    (285)


    -


    (285)











    Net loss attributable to common stockholders

    (2,803)


    (2,330)


    (12,517)


    (5,804)











    Basic net loss per common share

    $   (0.18)


    $  (0.64)


    $     (0.89)


    $   (1.62)











    Diluted net loss per common share

    $   (0.18)


    $  (0.68)


    $     (0.89)


    $   (1.66)











    Weighted average shares used in computing basic and diluted net loss per share

    15,517


    3,650


    14,112


    3,573

     

    CONDENSED BALANCE SHEETS

    (in thousands)

    (unaudited)










    September 30,


    December 31,




    2019


    2018







    Assets





    Cash and cash equivalents

    $     921


    $  9,295


    Restricted cash

    -


    361


    Receivables

    775


    1,737


    Inventory

    1,309


    1,262


    Contract assets

    -


    99


    Prepaid expenses and other current assets

    941


    547



    Total current assets

    3,946


    13,301


    Property and equipment, net

    752


    794


    Operating lease right-of-use asset

    456


    -


    Deferred offering costs

    150


    -



    Total assets

    $  5,304


    $14,095

    Liabilities and Stockholders' Equity (Deficit)





    Current liabilities

    $  3,482


    $  3,452


    Operating lease liability, non-current

    222


    -


    Long-term debt, non-current

    3,872


    3,787


    Warrant liability

    388


    -


    Derivative liability

    -


    25


    Stockholders' equity (deficit)

    (2,660)


    6,831



    Total liabilities and stockholders' equity (deficit)

    $  5,304


    $14,095

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/titan-pharmaceuticals-reports-third-quarter-2019-financial-results-300958782.html

    SOURCE Titan Pharmaceuticals, Inc.

    View Full Article Hide Full Article
  31. SOUTH SAN FRANCISCO, Calif., Nov. 7, 2019 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) will announce its third quarter 2019 financial results after market close on Thursday, November 14, 2019.  Following the release, Titan management will host a conference call at 4:30 p.m. EST / 1:30 p.m. PST to review the financial results and discuss business developments in the period.

    Titan Pharmaceuticals, Inc. (PRNewsfoto/Titan Pharmaceuticals, Inc.)

    The conference call will be hosted by Sunil Bhonsle, President and CEO; Kate Beebe DeVarney, Ph.D., Executive Vice President and Chief Scientific Officer; Dane Hallberg, Executive Vice President and Chief Commercial Officer; Brian Crowley, Vice President of Finance; and Marc Rubin, M.D., Executive Chairman.

    The live conference call may be accessed by dialing…

    SOUTH SAN FRANCISCO, Calif., Nov. 7, 2019 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) will announce its third quarter 2019 financial results after market close on Thursday, November 14, 2019.  Following the release, Titan management will host a conference call at 4:30 p.m. EST / 1:30 p.m. PST to review the financial results and discuss business developments in the period.

    Titan Pharmaceuticals, Inc. (PRNewsfoto/Titan Pharmaceuticals, Inc.)

    The conference call will be hosted by Sunil Bhonsle, President and CEO; Kate Beebe DeVarney, Ph.D., Executive Vice President and Chief Scientific Officer; Dane Hallberg, Executive Vice President and Chief Commercial Officer; Brian Crowley, Vice President of Finance; and Marc Rubin, M.D., Executive Chairman.

    The live conference call may be accessed by dialing 1-888-317-6003 (U.S.) or 1-412-317-6061 (international) and providing passcode 9174896. The call will also be broadcast live and archived on Titan's website at www.titanpharm.com/news/events.

    About Titan Pharmaceuticals
    Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is a commercial stage company developing proprietary therapeutics with its ProNeura™ long-term, continuous drug delivery technology. The company's lead product is Probuphine® (buprenorphine) implant, a novel and long-acting formulation of buprenorphine for the long-term maintenance treatment of opioid dependence. Approved by the U.S. Food and Drug Administration in May 2016, Probuphine is the first and only commercialized treatment of opioid dependence to provide continuous, around-the-clock blood levels of buprenorphine for six months following a single procedure. The ProNeura technology also has the potential to be used in developing products for treating other chronic conditions such as Parkinson's disease and hypothyroidism, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. For more information about Titan, please visit www.titanpharm.com.

    Forward-Looking Statements
    This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our product commercialization and development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to the commercialization of Probuphine, the regulatory approval process, the development, testing, production and marketing of our drug candidates, patent and intellectual property matters and strategic agreements and relationships. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

    CONTACTS:

    Sunil Bhonsle
    President & CEO
    (650) 244-4990

    Stephen Kilmer
    Investor Relations
    (650) 989-2215

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/titan-pharmaceuticals-to-release-third-quarter-2019-financial-results-on-november-14--conference-call-to-follow-300954308.html

    SOURCE Titan Pharmaceuticals, Inc.

    View Full Article Hide Full Article
  32. SOUTH SAN FRANCISCO, Calif., Oct. 1, 2019 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) and Crossroads of Southern Nevada ("Crossroads") rehabilitation facility today announced that Crossroads has healthcare providers who are specially trained in the insertion and removal of Probuphine® (buprenorphine) implants, and will now offer Probuphine for use in eligible patients with Opioid Use Disorder (OUD).

    Titan Pharmaceuticals, Inc. (PRNewsfoto/Titan Pharmaceuticals, Inc.)

    Based in Las Vegas, Crossroads is a drug and alcohol rehabilitation center licensed by the State of Nevada and its Substance Abuse Prevention and Treatment Agency (SAPTA).

    "We are excited that Crossroads is implementing Probuphine as part of their comprehensive OUD treatment program," said Titan's Executive Vice President and Chief…

    SOUTH SAN FRANCISCO, Calif., Oct. 1, 2019 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) and Crossroads of Southern Nevada ("Crossroads") rehabilitation facility today announced that Crossroads has healthcare providers who are specially trained in the insertion and removal of Probuphine® (buprenorphine) implants, and will now offer Probuphine for use in eligible patients with Opioid Use Disorder (OUD).

    Titan Pharmaceuticals, Inc. (PRNewsfoto/Titan Pharmaceuticals, Inc.)

    Based in Las Vegas, Crossroads is a drug and alcohol rehabilitation center licensed by the State of Nevada and its Substance Abuse Prevention and Treatment Agency (SAPTA).

    "We are excited that Crossroads is implementing Probuphine as part of their comprehensive OUD treatment program," said Titan's Executive Vice President and Chief Commercial Officer, Dane Hallberg. "Having already completed our Risk Evaluation and Mitigation Strategy, or REMS, training among the facility's healthcare providers, we believe Crossroads is well-positioned to offer Probuphine as an OUD treatment option."

    "At Crossroads, we use a multi-dimensional intervention approach that considers all aspects of a patient's needs, and we believe that offering Probuphine as a six-month maintenance treatment for OUD could positively impact our clients," said Kevin Morss, CEO of Crossroads. "Probuphine is now part of our armamentarium to treat OUD and our providers are well prepared to serve those who may need and want it."

    About Probuphine

    Probuphine is the only subdermal implant designed to deliver buprenorphine continuously for six months following insertion.

    Probuphine was developed using ProNeura™, the continuous drug delivery system developed by Titan that consists of a small, solid implant made from a mixture of ethylene-vinyl acetate and a drug substance. The resulting construct is a solid matrix that is placed subdermally, normally in the upper inner arm in an outpatient office procedure and removed in a similar manner at the end of the treatment period. The U.S. Food and Drug Administration ("FDA") approved Probuphine in May 2016, and it is the first and only buprenorphine implant available for the maintenance treatment of opioid addiction in eligible patients.

    IMPORTANT SAFETY INFORMATION INCLUDING INDICATION AND BOXED WARNING

    INDICATION

    PROBUPHINE is an implant that contains the medicine buprenorphine. PROBUPHINE is used to treat certain adults who are addicted to (dependent on) opioid drugs (either prescription or illegal). PROBUPHINE is indicated for the maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses (doses no more than 8 mg per day) of a buprenorphine-containing product.

    PROBUPHINE is part of a complete treatment program that also includes counseling and behavioral therapy.

    It is not known if PROBUPHINE is safe or effective in children less than 16 years of age.

    IMPORTANT SAFETY INFORMATION 

     

     

    WARNING: COMPLICATIONS FROM INSERTION AND REMOVAL OF PROBUPHINE
    See Full Prescribing Information for complete Boxed Warning

     

    Serious complications may happen from insertion and removal of PROBUPHINE, including:

    • Nerve or blood vessel injury in your arm
    • Movement of implant (migration). PROBUPHINE or pieces of it can move into blood vessels, possibly to your lung, and could lead to death
    • Implant sticks out of the skin (protrusion)
    • Implant comes out by itself (expulsion)

    Call your healthcare provider right away if: 

    • PROBUPHINE sticks out of the skin or comes out by itself
    • You have bleeding or symptoms of infection at the site after insertion or removal, including excessive or worsening itching, pain, irritation, redness, or swelling
    • You have numbness or weakness in your arm after the insertion or removal procedure
    • You have weakness or numbness in your arm, or shortness of breath

    If the implant comes out by itself, keep it away from others, especially children, as it may cause severe difficulty in breathing and possibly death.

    Because of the risk of complications of, migration, protrusion, expulsion and nerve injury with insertion and removal of PROBUPHINE, it is only available through a restricted program called the PROBUPHINE REMS Program. Healthcare providers who prescribe and/or insert PROBUPHINE must be certified with the program by enrolling and completing live training.

    • PROBUPHINE is not available in retail pharmacies
    • PROBUPHINE must be inserted or removed only in the facility of the certified prescriber

    Implants may be difficult to locate if inserted too deeply, if you manipulate them, or if you gain significant weight after insertion.  Your healthcare provider may do special procedures or tests, or refer you to a surgical specialist to remove the implants if they are difficult to locate.

    The medicine in PROBUPHINE can cause serious and life-threatening problems, especially if you take or use certain other medicines or drugs.  Call your healthcare provider right away or get emergency help if you:

    Feel faint or dizzy, have mental changes such as confusion, slower breathing than you normally have, severe sleepiness, blurred vision, problems with coordination, slurred speech, cannot think well or clearly, high body temperature, slowed reflexes, feel agitated, stiff muscles or have trouble walking.

    These can be signs of an overdose or other serious problems. 

    Coma or death can happen if you take anxiety medicines or benzodiazepines, sleeping pills, tranquilizers, or sedatives, antidepressants, or antihistamines, or drink alcohol during treatment with PROBUPHINE. Tell your healthcare provider if you are taking any of these medicines or if you drink alcohol.

    Who should not use PROBUPHINE?

    Do not use PROBUPHINE if you are allergic to buprenorphine or any of its ingredients, this includes buprenorphine hydrochloride and the inactive ingredient ethylene vinyl acetate or EVA.

    PROBUPHINE may not be right for you. Before starting PROBUPHINE tell your doctor about all of your medical conditions, including:

    Trouble breathing or lung problems, an enlarged prostate gland (men), a head injury or brain problem, problems urinating, a curve in your spine that affects your breathing, liver problems, gallbladder or adrenal gland problems, Addison's disease, low thyroid hormone levels (hypothyroidism), a history of alcoholism, a history of keloid formation, connective tissue disease (such as scleroderma), or history of MRSA infections, mental problems such as hallucinations, an allergy to numbing medicines or medicines used to clean your skin, are pregnant or plan to become pregnant or are breastfeeding or plan to breastfeed.

    Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

     What should I avoid while being treated with PROBUPHINE?

    • Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how this medication affects you
    • You should not drink alcohol during treatment. You should not take anxiety medicines or benzodiazepines, sleeping pills, tranquilizers, or sedatives that are not prescribed to you during treatment with PROBUPHINE, as this can lead to slowed breathing, drowsiness, delayed reaction time, loss of consciousness or even death

    What are the possible side effects of PROBUPHINE?

    PROBUPHINE can cause serious side effects, including:

    • Infection at the insertion or removal site. Infection may happen at the implant site during insertion or removal. Do not try to remove PROBUPHINE yourself 
    • Opioid withdrawal. If PROBUPHINE comes out of your arm or if you stop treatment, tell your doctor right away as you can have symptoms of shaking, sweating more than normal, feeling hot or cold more than normal, runny nose, watery eyes, goose bumps, diarrhea, vomiting and muscle aches
    • Physical dependency
    • Liver problems. Call your doctor right away if you notice signs of liver problems that may include your skin or the white part of your eyes turning yellow (jaundice)
    • Allergic reaction. If you get a rash, hives, itching, swelling of your face, or wheezing, low blood pressure, dizziness or decrease in consciousness
    • Decrease in blood pressure. You may feel dizzy when you get up from sitting or lying down

    Tell your healthcare provider if you develop any of the symptoms listed.

    Common side effects of PROBUPHINE include: Headache, nausea, toothache, constipation, depression, vomiting, back pain, mouth and throat pain.

    Common risks with the minor surgical procedure:  Itching, pain, irritation, redness, swelling, bleeding, or bruising at the insertion or removal site. Scarring around the insertion site. 

    Please read Full Prescribing Information, including BOXED WARNING regarding IMPLANT MIGRATION, PROTRUSION, EXPULSION and NERVE DAMAGE ASSOCIATED WITH INSERTION AND REMOVAL.

    Titan encourages you to report negative side effects of prescription drugs to the FDA. You can visit www.fda.gov/safety/medwatch/ or call 1-800-FDA-1088.

    About Crossroads

    Based in Las Vegas, Crossroads is a drug and alcohol rehabilitation center licensed by the State of Nevada and the Substance Abuse Prevention and Treatment Agency (SAPTA).  Crossroads is a person-centered organization that prioritizes the care of individuals above all other considerations. The company utilizes a multi-dimensional intervention approach focusing on socio-economic, physical and emotional needs, and is dedicated to providing hope to those who are overwhelmed and to restoring lives one journey at a time. Crossroads continually works to refine processes and create more effective ways to serve the community, and exercises the highest degrees of professionalism and compassion. We treat all individuals with respect, recognition and dignity.

    About Titan Pharmaceuticals

    Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is a commercial stage company developing proprietary therapeutics with its ProNeura™ long-term, continuous drug delivery technology. The company's lead product is Probuphine® (buprenorphine) implant, a novel and long-acting formulation of buprenorphine for the long-term maintenance treatment of opioid dependence. Approved by the U.S. Food and Drug Administration in May 2016, Probuphine is the first and only commercialized treatment of opioid dependence to provide continuous, around-the-clock blood levels of buprenorphine for six months following a single procedure. The ProNeura technology also has the potential to be used in developing products for treating other chronic conditions such as Parkinson's disease and hypothyroidism, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. For more information about Titan, please visit www.titanpharm.com.

    Forward-Looking Statements

    This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to the commercialization of Probuphine, the regulatory approval process, the development, testing, production and marketing of our drug candidates, patent and intellectual property matters and strategic agreements and relationships.  We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

    CONTACTS:

    Kevin Morss
    CEO
    Crossroads of Southern Nevada
    (702) 382-7746

    Sunil Bhonsle
    President & CEO
    Titan Pharmaceuticals, Inc.
    (650) 244-4990

    Stephen Kilmer
    Investor Relations
    Titan Pharmaceuticals, Inc.
    (650) 989-2215
     

    Krisina Antonio
    Media Relations
    (646) 599-8611
    kantonio 

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/titan-pharmaceuticals-and-crossroads-of-southern-nevada-announce-probuphine-availability-at-crossroads-rehabilitation-facilities-300928363.html

    SOURCE Titan Pharmaceuticals, Inc.

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  33. SOUTH SAN FRANCISCO, Calif., Sept. 18, 2019 /PRNewswire/ -- National Institutes of Health's National Institute on Drug Abuse (NIDA) has approved approximately $6.1 million in second-year funding for Titan's non-clinical development of a ProNeura™ based six-month implantable formulation of Nalmefene, an opioid antagonist, intended for the prevention of relapse to opioid addiction, following opioid detoxification.

    Titan Pharmaceuticals, Inc. (PRNewsfoto/Titan Pharmaceuticals, Inc.)

    NIDA awarded Titan a two-year grant in the amount of $6.7 million in September 2018 for the project, subject to satisfactory project progress, fund availability and certain other conditions. The award for the first year, which ended August 31, 2019, was approximately $2.7 million. As a result of a change in the grant award terms…

    SOUTH SAN FRANCISCO, Calif., Sept. 18, 2019 /PRNewswire/ -- National Institutes of Health's National Institute on Drug Abuse (NIDA) has approved approximately $6.1 million in second-year funding for Titan's non-clinical development of a ProNeura™ based six-month implantable formulation of Nalmefene, an opioid antagonist, intended for the prevention of relapse to opioid addiction, following opioid detoxification.

    Titan Pharmaceuticals, Inc. (PRNewsfoto/Titan Pharmaceuticals, Inc.)

    NIDA awarded Titan a two-year grant in the amount of $6.7 million in September 2018 for the project, subject to satisfactory project progress, fund availability and certain other conditions. The award for the first year, which ended August 31, 2019, was approximately $2.7 million. As a result of a change in the grant award terms regarding company matching funds, the second-year award covers both the Federal and company match amounts of the original year two award, thereby increasing the aggregate potential expense reimbursement to approximately $8.7 million.

    "We believe our ProNeura technology is well-suited to this approach to treating opioid addiction, so we are grateful for NIDA's ongoing support," said Titan's President and CEO, Sunil Bhonsle. "As we continue to execute on the program's development milestones, we are encouraged by the potential for additional NIDA grant funding for clinical development activities beyond the current grant's end date of September 2020."

    This second-year grant award provides funds for the completion of implant formulation development, cGMP manufacturing and non-clinical studies which, if successful, are expected to support the Company's submission of a Nalmefene six-month implant Investigational New Drug Application to the U.S. Food and Drug Administration. Titan retains full commercial rights to the Nalmefene implant product.

    About Titan Pharmaceuticals

    Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is a commercial stage company developing proprietary therapeutics with its ProNeura™ long-term, continuous drug delivery technology. The company's lead product is Probuphine® (buprenorphine) implant, a novel and long-acting formulation of buprenorphine for the long-term maintenance treatment of opioid dependence. Approved by the U.S. Food and Drug Administration in May 2016, Probuphine is the first and only commercialized treatment of opioid dependence to provide continuous, around-the-clock blood levels of buprenorphine for six months following a single procedure. The ProNeura technology also has the potential to be used in developing products for treating other chronic conditions such as Parkinson's disease and hypothyroidism, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. For more information about Titan, please visit www.titanpharm.com.

    About Probuphine

    Probuphine is the only subdermal implant designed to deliver buprenorphine continuously for six months following insertion.

    Probuphine was developed using ProNeura™, the continuous drug delivery system developed by Titan that consists of a small, solid implant made from a mixture of ethylene-vinyl acetate and a drug substance. The resulting construct is a solid matrix that is placed subdermally, normally in the upper arm, in an outpatient office procedure and removed in a similar manner at the end of the treatment period. The U.S. Food and Drug Administration ("FDA") approved Probuphine in May 2016, and it is the first and only buprenorphine implant available for the maintenance treatment of opioid addiction in eligible patients.

    IMPORTANT SAFETY INFORMATION INCLUDING INDICATION AND BOXED WARNING

    INDICATION

    PROBUPHINE is an implant that contains the medicine buprenorphine. PROBUPHINE is used to treat certain adults who are addicted to (dependent on) opioid drugs (either prescription or illegal). PROBUPHINE is indicated for the maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses (doses no more than 8 mg per day) of a buprenorphine-containing product.

    PROBUPHINE is part of a complete treatment program that also includes counseling and behavioral therapy.

    It is not known if PROBUPHINE is safe or effective in children less than 16 years of age.

    IMPORTANT SAFETY INFORMATION

    WARNING: COMPLICATIONS FROM INSERTION AND REMOVAL OF
    PROBUPHINE
    See Full Prescribing Information for complete Boxed Warning


    Serious complications may happen from insertion and removal of PROBUPHINE, including:

    • Nerve or blood vessel injury in your arm
    • Movement of implant (migration). PROBUPHINE or pieces of it can move into blood vessels, possibly to your lung, and could lead to death
    • Implant sticks out of the skin (protrusion)
    • Implant comes out by itself (expulsion)

    Call your healthcare provider right away if: 

    • PROBUPHINE sticks out of the skin or comes out by itself
    • You have bleeding or symptoms of infection at the site after insertion or removal, including excessive or worsening itching, pain, irritation, redness, or swelling
    • You have numbness or weakness in your arm after the insertion or removal procedure
    • You have weakness or numbness in your arm, or shortness of breath

    If the implant comes out by itself, keep it away from others, especially children, as it may cause severe difficulty in breathing and possibly death.

    Because of the risk of complications of, migration, protrusion, expulsion and nerve injury with insertion and removal of PROBUPHINE, it is only available through a restricted program called the PROBUPHINE REMS Program. Healthcare providers who prescribe and/or insert PROBUPHINE must be certified with the program by enrolling and completing live training.

    • PROBUPHINE is not available in retail pharmacies
    • PROBUPHINE must be inserted or removed only in the facility of the certified prescriber

    Implants may be difficult to locate if inserted too deeply, if you manipulate them, or if you gain significant weight after insertion.  Your healthcare provider may do special procedures or tests, or refer you to a surgical specialist to remove the implants if they are difficult to locate.

    The medicine in PROBUPHINE can cause serious and life-threatening problems, especially if you take or use certain other medicines or drugs.  Call your healthcare provider right away or get emergency help if you:

    Feel faint or dizzy, have mental changes such as confusion, slower breathing than you normally have, severe sleepiness, blurred vision, problems with coordination, slurred speech, cannot think well or clearly, high body temperature, slowed reflexes, feel agitated, stiff muscles or have trouble walking.

    These can be signs of an overdose or other serious problems. 

    Coma or death can happen if you take anxiety medicines or benzodiazepines, sleeping pills, tranquilizers, or sedatives, antidepressants, or antihistamines, or drink alcohol during treatment with PROBUPHINE. Tell your healthcare provider if you are taking any of these medicines or if you drink alcohol.

    Who should not use PROBUPHINE?

    Do not use PROBUPHINE if you are allergic to buprenorphine or any of its ingredients, this includes buprenorphine hydrochloride and the inactive ingredient ethylene vinyl acetate or EVA.

    PROBUPHINE may not be right for you. Before starting PROBUPHINE tell your doctor about all of your medical conditions, including:

    Trouble breathing or lung problems, an enlarged prostate gland (men), a head injury or brain problem, problems urinating, a curve in your spine that affects your breathing, liver problems, gallbladder or adrenal gland problems, Addison's disease, low thyroid hormone levels (hypothyroidism), a history of alcoholism, a history of keloid formation, connective tissue disease (such as scleroderma), or history of MRSA infections, mental problems such as hallucinations, an allergy to numbing medicines or medicines used to clean your skin, are pregnant or plan to become pregnant or are breastfeeding or plan to breastfeed.

    Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

     What should I avoid while being treated with PROBUPHINE?

    • Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how this medication affects you
    • You should not drink alcohol during treatment. You should not take anxiety medicines or benzodiazepines, sleeping pills, tranquilizers, or sedatives that are not prescribed to you during treatment with PROBUPHINE, as this can lead to slowed breathing, drowsiness, delayed reaction time, loss of consciousness or even death

    What are the possible side effects of PROBUPHINE?

    PROBUPHINE can cause serious side effects, including:

    • Infection at the insertion or removal site. Infection may happen at the implant site during insertion or removal. Do not try to remove PROBUPHINE yourself 
    • Opioid withdrawal. If PROBUPHINE comes out of your arm or if you stop treatment, tell your doctor right away as you can have symptoms of shaking, sweating more than normal, feeling hot or cold more than normal, runny nose, watery eyes, goose bumps, diarrhea, vomiting and muscle aches
    • Physical dependency
    • Liver problems. Call your doctor right away if you notice signs of liver problems that may include your skin or the white part of your eyes turning yellow (jaundice)
    • Allergic reaction. If you get a rash, hives, itching, swelling of your face, or wheezing, low blood pressure, dizziness or decrease in consciousness
    • Decrease in blood pressure. You may feel dizzy when you get up from sitting or lying down

    Tell your healthcare provider if you develop any of the symptoms listed.

    Common side effects of PROBUPHINE include: Headache, nausea, toothache, constipation, depression, vomiting, back pain, mouth and throat pain.

    Common risks with the minor surgical procedure:  Itching, pain, irritation, redness, swelling, bleeding, or bruising at the insertion or removal site. Scarring around the insertion site. 

    Please read Full Prescribing Information, including BOXED WARNING regarding IMPLANT MIGRATION, PROTRUSION, EXPULSION and NERVE DAMAGE ASSOCIATED WITH INSERTION AND REMOVAL.

    Titan encourages you to report negative side effects of prescription drugs to the FDA. You can visit www.fda.gov/safety/medwatch/ or call 1-800-FDA-1088.

    Forward-Looking Statements

    This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to the commercialization of Probuphine, the regulatory approval process, the development, testing, production and marketing of our drug candidates, patent and intellectual property matters and strategic agreements and relationships.  We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

    CONTACTS:

    Sunil Bhonsle,
    President & CEO
    (650) 244-4990

    Stephen Kilmer
    Investor Relations
    (650) 989-2215

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/titan-receives-approval-for-second-year-of-nida-grant-funding-for-development-of-a-nalmefene-implant-300920440.html

    SOURCE Titan Pharmaceuticals, Inc.

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