Current Report Filing (8-k)

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934

Date of Report (Date of Earliest Event Reported): December 4, 2014

Titan Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

Delaware

(State or other jurisdiction of incorporation)

0-27436	94-3171940
(Commission File Number)	(IRS Employer Identification No.)

400 Oyster Point Blvd., Suite 505, South San Francisco, CA 94080

(Address of principal executive offices and zip code)

650-244-4990

(Registrant's telephone number including area code)

(Registrant's former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of registrant under any of the following provisions:

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12(b) under the Exchange Act (17 CFR 240.14a-12(b))

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 7.01. Regulation FD Disclosure.

On December 4, 2014, Titan Pharmaceuticals, Inc. (the “Company”) will present at a conference and post on its website a corporate presentation, a copy of which is attached hereto as Exhibit 99.1, and incorporated herein by reference.

The foregoing information, including the presentation attached hereto as Exhibit 99.1, is being furnished pursuant to Item 7.01 of this Current Report and shall not be deemed "filed" for the purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section. This information shall not be incorporated by reference into any registration statement pursuant to the Securities Act of 1933, as amended.

Item 9.01. Financial Statement and Exhibits.

(d) Exhibits.

Exhibit No.		Description

99.1		Corporate Presentation

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.  

	TITAN PHARMACEUTICALS, INC.


	By:	/s/ Sunil Bhonsle
	Name:	Sunil Bhonsle
	Title:	President

Dated: December 4, 2014

Corporate Presentation Sunil Bhonsle Dec. 2014

Safe Harbor The presentation 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. Reference is made in particular to the description of our plans and objectives for future operations, assumptions underlying such plans and objectives and other forward - looking terminology such as “may,” “expects,” “believes,” “anticipates,” “intends,” “projects,” or similar terms, variations of such terms or the negative of such terms. Forward - looking statements are based on management’s current expectations. Actual results could differ materially from those currently anticipated and such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to availability of financing, difficulties or delays in development, testing, regulatory approval, production and marketing of the Company's drug candidates, adverse side effects or inadequate therapeutic efficacy of the Company's drug candidates that could slow or prevent product development or commercialization and the uncertainty of patent protection for the Company's intellectual property or trade secrets. Titan Pharmaceuticals Company Overview | Proprietary & Confidential | ©2014 Titan Pharmaceutical, Inc. 2

Company Overview Titan Pharmaceuticals specializes in the development of treatments for select chronic diseases utilizing its proprietary ProNeura ™ technology platform • ProNeura : Proprietary Long - Term Drug Delivery Platform ▫ Provides non - fluctuating medication levels over periods of six months to a year ▫ Ideal for use in the treatment of chronic diseases for which maintenance of non - fluctuating medication levels may offer advantages over oral administration • Probuphine ® for the Treatment of Opioid Dependence ▫ Long - acting formulation of buprenorphine providing steady - state levels ▫ FDA requested Phase 3 clinical study fully enrolled with results expected by mid 2015 ▫ Resubmission of NDA expected in the second half of 2015 with potential approval in first half of 2016 • ProNeura for Parkinson’s Disease ( r opinirole ) ▫ Ideal application for Parkinson’s Disease ▫ Demonstrated proof of concept in non - clinical study ▫ Planned non - clinical studies in 2015 in support of IND with the goal to commence clinical testing in 2016 Titan Pharmaceuticals Company Overview | Proprietary & Confidential | ©2014 Titan Pharmaceutical, Inc. 3

Probuphine: The First of its Kind Expected to be the first long - acting buprenorphine product on the market for the treatment of opioid dependence • Six month sustained release of buprenorphine • Peak sales potential: $300 - $500 million • U.S. and Canadian partnership with Braeburn Pharmaceuticals ▫ Upfront: $15.75 mil; Approval: $15 mil; Sales Milestones: $165 mil; Tiered Royalties: mid teens - low 20s • U.S. patent to 2024 • Regulatory Status: ▫ NDA accepted for Priority Review in January 2013 ▫ Positive advisory committee vote in March 2013 ▫ Receipt of CRL in April 2013 requesting additional clinical testing ▫ Phase 3 study fully enrolled with results expected by mid 2015; potential resubmission of NDA later in the year • Pursuing ex - U.S. opportunities for approval and commercialization • Potential application in treating chronic pain 4 Titan Pharmaceuticals Company Overview | Proprietary & Confidential | ©2014 Titan Pharmaceutical, Inc.

The Epidemic of Opioid Dependence • Increasingly recognized as a global epidemic by world health authorities • Addiction - a primary, chronic disease of brain reward, motivation, memory and neurobiological circuitry ▫ Cravings, accompanied by lack of impulse control ▫ Abstinence is rarely a successful therapeutic approach ▫ Cycles of relapse and remission ▫ Progressive, and often results in disability or premature death if untreated Source: American Society of Addiction Medicine, Inc., 2011 ER Visits Due to Opioid Misuse 0.05 0.10 0.15 0.20 0.25 0.30 0.35 0.40 0.45 2004 2005 2006 2007 2008 2009 MM of Patient Visits 240% increase in 6 years Titan Pharmaceuticals Company Overview | Proprietary & Confidential | ©2014 Titan Pharmaceutical, Inc. 5

Opioid Dependence: Treatment Overview Buprenorphine is the Gold Standard in the U.S., Replacing Methadone • Buprenorphine pharmacology makes it an effective, safer and more convenient treatment option ▫ Controls withdrawal symptoms and cravings without inducing opioid euphoria in patients ▫ Convenient outpatient treatment allowing take home medication, unlike methadone ▫ Low risk of respiratory depression compared to other opiates * American Society of Addiction Medicine, Inc., 2011 Titan Pharmaceuticals Company Overview | Proprietary & Confidential | ©2014 Titan Pharmaceutical, Inc. 6

Sources: IMS Health Treatment of Opioid Dependence: Expanding the Market • Daily buprenorphine dominates the current market ▫ U.S. sales of daily oral formulations of buprenorphine estimated at $1.5B in 2013 ▫ U.S. buprenorphine prescriptions have exceeded those of methadone since 2006 • Challenges with oral buprenorphine ▫ Compliance ▫ Sublingual dosing results in variable levels of medication in blood ▫ Diversion and abuse associated with current daily dosed formulations 0 200 400 600 800 1000 1200 1400 1600 2008 2009 2010 2011 2012 Suboxone Brand Gross Sales Titan Pharmaceuticals Company Overview | Proprietary & Confidential | ©2014 Titan Pharmaceutical, Inc. 7

EVA polymer Buprenorphine Blended & Extruded Probuphine Proprietary ProNeura Technology: Probuphine Implant • Implant contains 80 mg of buprenorphine HCl , uniformly distributed throughout the ethylene vinyl acetate co - polymer (EVA) matrix • No reservoir, therefore no risk of drug dumping • Following sub - dermal placement Probuphine implant delivers non - fluctuating, stable blood levels of buprenorphine for 6 months; expected to enhance patient compliance and retention 8 Titan Pharmaceuticals Company Overview | Proprietary & Confidential | ©2014 Titan Pharmaceutical, Inc. 26 mm long ,2.5mm diameter

Probuphine Clinical Summary • Six clinical studies completed to date with final Phase 3 study under way ▫ Initial small dose finding study ▫ Two well - controlled Phase 3 safety and efficacy studies showing clinical and statistical superiority over placebo and non - inferiority to Suboxone published in Journal of American Medical Association and in the journal Addiction ▫ Two open label long - term treatment safety studies ▫ Relative bioavailability study • Mild - to - moderate adverse events typical of the safety profile of buprenorphine; low number of serious adverse events similar to placebo • Well - tolerated implant procedure • No evidence of implant diversion or misuse Titan Pharmaceuticals Company Overview | Proprietary & Confidential | ©2014 Titan Pharmaceutical, Inc. 9

Phase 3 Clinical Study in Progress (Pro - 814) The clinical study is a randomized, double blind and double dummy design that will provide information for a non - inferiority comparison of a six - month treatment with a dose of four Probuphine implants to treatment with 8 mg or less of an approved daily dosed sublingual formulation of buprenorphine . Patient enrollment completed in November 2014 and study results expected by mid year 2015. 10 Titan Pharmaceuticals Company Overview | Proprietary & Confidential | ©2014 Titan Pharmaceutical, Inc. R FOLLOW - UP 24 Weeks (Weeks 1 to 24 ) Monthly Visits Group A : Daily SL BPN ≤ 8 mg 4 placebo implants SCREENING Clinically stable, Daily ≤ 8 mg SL BPN for at least 90 days Opioid - negative urine toxicology for last 90 days MAINTENANCE PHASE 2 Weeks (25 to 26) 24 Weeks (6 months) on Treatment Urine Toxicology & Other Study Assesments Group B : 4 Probuphine implants Daily SL placebo Randomization takes place on Day 1 (day of implant ) SL BPN = sublingual buprenorphine or sublingual buprenorphine/naloxone R

Probuphine Value Proposition Probuphine is the first and only potential treatment for opioid dependence that provides non - fluctuating blood levels of buprenorphine around - the - clock for a period of six months 11 Titan Pharmaceuticals Company Overview | Proprietary & Confidential | ©2014 Titan Pharmaceutical, Inc. Efficacy Effective in reducing illicit opioid use Safety Non - fluctuating drug exposure over six months may provide superior safety and tolerability Compliance Treatment with implant expected to enhance compliance Ease of Use Patients dosed once every six months in an outpatient setting Diversion Limited access to implants

Titan: Adding Value Beyond Probuphine Proprietary ProNeura Technology Platform • Long - term drug delivery technology validated through the Probuphine program • Potential for the treatment of select chronic diseases for which low dose long - term delivery and stable drug levels may offer advantages over oral administration • Product development program in Parkinson’s disease (PD) in progress • Evaluation of additional compounds in other chronic disease settings under way 12 Titan Pharmaceuticals Company Overview | Proprietary & Confidential | ©2014 Titan Pharmaceutical, Inc.

Definition Characterized by the loss of dopaminergic neurons which alters activity in the brain region impacting movement and motor function Treatment Treated with drugs designed to replace or mimic dopamine in the brain Following several years of chronic treatment, these drugs lose their benefit and trigger serious side effects Research Pulsatile dopaminergic stimulation from current oral treatment may cause motor side effects Continuous dopaminergic stimulation (CDS) by subcutaneous infusion of dopamine agonists may palliate these motor complications and also delay or prevent the onset of dyskinesias Product Opportunity Titan’s ProNeura drug delivery technology has the potential to deliver continuous non - fluctuating levels of dopamine agonists and provide CDS for six months or longer from a single treatment Parkinson’s Disease Overview . Titan Pharmaceuticals Company Overview | Proprietary & Confidential | ©2014 Titan Pharmaceutical, Inc. 13

Treated Population Increasing Worldwide 14 Based on information from Titan and other sources believed to be reliable and prepared exclusively for Titan. Woodside Capita l P artners is not responsible for any use that Titan may make of this material.

Therapeutics Market • As many as one million people in the US affected by Parkinson’s disease • The number expected to almost double by 2030 because of the aging population • About 60,000 newly diagnosed for Parkinson’s disease annually • More than 23,000 die from Parkinson’s disease each year 15 Titan Pharmaceuticals Company Overview | Proprietary & Confidential | ©2014 Titan Pharmaceutical, Inc. SALES OF DOPAMINE AGONISTS, US* YEAR TOTAL SALES % DA $ DA 2012 $1.1 bil 26% $286 m. 2022 $2.3 bil 18% $414 m. Sources: * GlobalData ; **Parkinson’s Action Network, National Center for Health Statistics; “The Current and Projected Economic Burden of Parkinso n’s Disease in the United States” Movement Disorders, March 2013 Based on information from Titan and other sources believed to be reliable and prepared exclusively for Titan. Woodside Capita l P artners is not responsible for any use that Titan may make of this material. $14.4 billion annually COST TO AMERICAN SOCIETY** Treatment Costs $8.1 billion Indirect Costs $6.3 billion If costs continue to rise they double by 2040

ProNeura Parkinson’s Disease Program Non - clinical Proof of Concept • Ropinirole ( Requip ® ), a generic dopamine agonist marketed by GSK for PD, was evaluated in a Parkinsonian primate model using ProNeura technology • Results demonstrated: ▫ Sustained plasma ropinirole levels for several months following implantation ▫ No local skin irritation at implant site ▫ Controlled PD symptoms without triggering dyskinesias 16 Titan Pharmaceuticals Company Overview | Proprietary & Confidential | ©2014 Titan Pharmaceutical, Inc.

ProNeura Parkinson’s Disease Program Next Steps In consultation with the Scientific Advisory Board: • Optimize implant formulation of ropinirole • Develop non - clinical study plan to support Investigational New Drug (IND) application • Design a proof of concept clinical study • Conduct a pre - IND meeting with the FDA • Complete non - clinical studies to enable timely submission of IND and commence ‘proof of concept’ clinical study in 2016 17 Titan Pharmaceuticals Company Overview | Proprietary & Confidential | ©2014 Titan Pharmaceutical, Inc.

Titan Pharmaceuticals Summary • Titan Pharmaceuticals specializes in the development of treatments for select chronic diseases, utilizing its innovative ProNeura technology platform • Probuphine , a long - acting controlled - release buprenorphine product for opioid dependence; Patient enrolment in Phase 3 study completed in November 2014 with study results expected by mid 2015; resubmission of NDA expected later in 2015 with potential product approval in the first half of 2016 ▫ U.S. and Canadian partnership with Braeburn Pharmaceuticals − Upfront: $15.75 mil; Approval: $15 mil; Sales milestones: $165 mil; Tiered - royalties: mid - teens – low - 20s ▫ Pursuing ex - U.S. opportunities for approval and commercialization ▫ Potential for treatment of chronic pain • ProNeura for Parkinson’s ( ropinirole ) has potential to significantly enhance Titan value ▫ Goal is to commence ‘proof of concept’ clinical study in 2016 • Active evaluation of ProNeura long - term drug delivery for other chronic diseases 18 Titan Pharmaceuticals Company Overview | Proprietary & Confidential | ©2014 Titan Pharmaceutical, Inc.

• Marc Rubin, M.D, Executive Chairman and Director ▫ Seven years with Titan Pharmaceuticals. Former Head of Global Research & Development and member of the Board of Management at Bayer Pharma. Executive R&D and commercial responsibilities at GSK for 13 years. Twenty - four years in the pharmaceutical industry following seven years at NIH. • Sunil Bhonsle , M.B.A., President and Director ▫ Eighteen years with Titan Pharmaceuticals. Twenty years with Bayer Corporation in Biological and Pharmaceutical operations management. • Kate Glassman Beebe, Ph.D., Executive Vice President, Chief Development Officer ▫ Seven years with Titan Pharmaceuticals. Eighteen years in pharmaceutical industry, with senior positions in clinical development and medical affairs at GSK and Merck. Ten years in academic medicine. Titan Executive Management