SOUTH SAN FRANCISCO - 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.
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.
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
Tel: (650) 989-2215
Email: skilmer@titanpharm.com
TITAN PHARMACEUTICALS, INC. 
