SOURCE: Titan Pharmaceuticals, Inc.

Titan Pharmaceuticals, Inc.

August 13, 2015 16:30 ET

Titan Pharmaceuticals Reports Second Quarter 2015 Financial Results

Management Team to Host Conference Call August 17 at 1 p.m. EDT /10 a.m. PDT

SOUTH SAN FRANCISCO, CA--(Marketwired - Aug 13, 2015) - Titan Pharmaceuticals, Inc. (OTCQB: TTNP), a specialty pharmaceutical company developing proprietary therapeutics for the treatment of select chronic diseases utilizing its ProNeura™ long-term drug delivery technology, today reported financial results for the second quarter ended June 30, 2015.

Total revenue in the second quarter of 2015 was approximately $0.8 million compared with revenue of approximately $0.9 million in the second quarter of 2014. Second quarter 2015 and 2014 revenues consisted entirely of license revenue and reflect the amortization of the upfront license fee received from development and commercialization partner Braeburn Pharmaceuticals in December 2012.

Total operating expenses for the quarter ended June 30, 2015 were approximately $1.9 million, compared with approximately $1.5 million in the same quarter in 2014. The increase of approximately $0.4 million in total operating expenses during the second quarter was driven primarily by higher research and development (R&D) expenses totaling approximately $1.1 million, compared with approximately $0.7 million in the second quarter of 2014. This increase was associated with external and internal development expenses related to the support of Titan's Probuphine® and ProNeura-ropinirole product development programs and other R&D expenses. General and administrative (G&A) expenses for the second quarter of 2015 and 2014 were approximately $0.8 million and approximately $0.7 million, respectively.

Net other expenses for the second quarter of 2015 were approximately $1.2 million, compared with approximately $0.3 million for the same period in 2014. Net other expense consisted primarily of non-cash losses on changes in the fair value of warrants.

Net loss for the second quarter 2015 was approximately $2.3 million, or approximately $0.02 per share, compared with approximately $0.8 million, or approximately $0.01 per share in the same quarter in 2014.

At June 30, 2015, Titan had approximately $11.5 million in cash, which the Company believes is sufficient to fund planned operations into the fourth quarter of 2016.

"During the second quarter, Titan reported positive final Phase 3 results of Probuphine for the long-term maintenance treatment of opioid addiction, marking an important milestone for the company and our partner Braeburn Pharmaceuticals," said Titan President Sunil Bhonsle. "Preparation of the NDA is progressing rapidly and its resubmission to the FDA is expected during the third quarter. At the same time, we are also aggressively advancing our development plans for ProNeura-ropinirole for Parkinson's disease and are on target to submit briefing material to the FDA in the fourth quarter to support a pre-IND meeting. ProNeura's unique ability to deliver non-fluctuating, steady-state levels of medication in the blood holds the potential to significantly improve motor function in patients with Parkinson's disease. We have also made progress in evaluating additional compounds that can be delivered in the ProNeura implant, and expect to add another product to the development pipeline in the next few months."

Business highlights of the second quarter include:

  • In June, Titan and Braeburn reported positive topline results from PRO 814, the final Phase 3 double blind, double dummy clinical study of Probuphine, the company's subdermal implant containing buprenorphine HCl for the long-term maintenance treatment of opioid addiction. The study met the pre-specified primary endpoint of non-inferiority (Probuphine-sublingual buprenorphine/naloxone 95% confidence interval: 0.009, 0.167), as well as all secondary efficacy endpoints. Analyses conducted according to the pre-planned Statistical Analysis Plan indicated response rates of 96.4% for the Probuphine arm and 87.6% for the sublingual buprenorphine/naloxone arm. In order to further evaluate the observed numerical difference between the proportion of responders on the two treatment arms, a sequential superiority analysis was conducted that indicates a statistically significant difference in favor of Probuphine over the sublingual buprenorphine/naloxone treatment arm (p < 0.05). The overall safety and tolerability profiles for each treatment group were comparable. The implantation procedures were also generally well tolerated and comparable to observations from earlier studies with Probuphine.

  • In June, Titan presented nonclinical data at the 19th International Congress of Parkinson's Disease and Movement Disorders demonstrating the potential of ProNeura in the treatment of Parkinson's disease. The dose-escalating study in a Parkinsonian primate model showed that motor function could be significantly improved with no onset of dyskinesias (involuntary movements), following the continuous, non-fluctuating release of the dopamine agonist ropinirole contained in the ProNeura-based subdermal implants.

"The board is extremely pleased with the progress Titan is making in its product development programs, and we look forward to building a product pipeline with the ProNeura platform for the treatment of diseases that may benefit from non-fluctuating levels of medication in the blood over long periods of time," said Marc Rubin, M.D., executive chairman of Titan. "With both late- and early-stage programs utilizing our ProNeura platform under way, and the potential for FDA approval of Probuphine in the first half of 2016, Titan is very well positioned to deliver significant value to our shareholders."

Conference Call
Titan will host a live conference call at 1 p.m. EDT / 10 a.m. PDT on Monday, Aug. 17, 2015 to discuss the company's financial results as of June 30, 2015. The call will be hosted by Sunil Bhonsle, president; Kate Glassman Beebe, Ph.D., executive vice president and chief development officer; Brian Crowley, vice president of finance; and Marc Rubin, M.D., executive chairman.

The live webcast of the call may be accessed by visiting the Titan website at http://www.titanpharm.com. The call can also be accessed by dialing 888-417-8516, participant code 1862785, five minutes prior to the start time. A replay of the call will be available on the company website approximately two hours after completion of the call and will be archived for two weeks.

About the ProNeura Long-term Drug Delivery Platform
ProNeura is Titan's proprietary, long-term drug delivery platform utilized in the development of products for the treatment of select chronic conditions that may benefit from the delivery of continuous, non-fluctuating levels of certain medications over an extended period of six months to a year. ProNeura consists of a small, solid rod made from a mixture of ethylene-vinyl acetate ("EVA") and a drug substance. The resulting product is a solid matrix that is placed subdermally, normally in the inner part of the upper arm, during a simple office procedure, and is removed in a similar manner at the end of treatment. The drug substance is released continuously through the process of dissolution, resulting in a stable, non-fluctuating blood level similar to that seen with intravenous administration. These long-term, linear-release characteristics are medically desirable to avoid the peak and trough swings from oral dosing that pose problems in the current treatments for many diseases, especially diseases of the central nervous system. Titan has issued patents as well as patent applications covering the use of the ProNeura long-term drug delivery platform for the formulation of specific products for the treatment of certain chronic diseases, such as opioid dependence, Parkinson's disease, and others.

About Titan Pharmaceuticals
Titan Pharmaceuticals Inc. (OTCQB: TTNP), based in South San Francisco, CA, is a specialty pharmaceutical company developing proprietary therapeutics primarily for the treatment of serious medical disorders. The company's lead product candidate is Probuphine®, a novel and long-acting formulation of buprenorphine for the long-term maintenance treatment of opioid addiction. Probuphine employs Titan's proprietary drug delivery system ProNeura™, which is capable of delivering sustained, consistent levels of medication for six months or longer. Titan has granted North American commercial rights for Probuphine to Braeburn Pharmaceuticals. If approved, Probuphine would be the first and only commercialized maintenance treatment of opioid addiction to provide continuous, around-the-clock blood levels of buprenorphine for six months following a single procedure. The ProNeura technology has the potential to be used in developing products for treating other chronic conditions, such as Parkinson's disease, where maintaining consistent blood levels of a dopamine agonist may benefit the patient and improve medical outcomes. For more information about Titan, please visit www.titanpharm.com.

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 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.

   
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,
 
    2015     2014     2015     2014  
Revenue:                                
  License revenue   $ 760     $ 911     $ 1,671     $ 1,823  
    Total revenue     760       911       1,671       1,823  
                                 
Operating expense:                                
  Research and development     1,099       748       2,530       1,698  
  General and administrative     753       713       1,848       1,609  
    Total operating expense     1,852       1,461       4,378       3,307  
Loss from operations     (1,092 )     (550 )     (2,707 )     (1,484 )
                                 
    Other expense, net     (1,189 )     (292 )     (4,471 )     (1,162 )
                                 
Net loss and comprehensive loss   $ (2,281 )   $ (842 )   $ (7,178 )   $ (2,646 )
Basic net loss per share   $ (0.02 )   $ (0.01 )   $ (0.07 )   $ (0.03 )
Diluted net loss per share   $ (0.02 )   $ (0.01 )   $ (0.07 )   $ (0.03 )
Weighted average shares used in computing basic net loss per share     110,328       88,998       110,249       88,964  
Weighted average shares used in computing diluted net loss per share     110,401       88,998       110,305       88,964  
                                 
                                 
                                 
CONDENSED BALANCE SHEETS
(in thousands)
(unaudited)
         
    June 30,   December 31,
    2015   2014
             
Assets            
  Cash   $ 11,499   $ 15,470
  Receivables     4,476     3,968
  Prepaid expenses and other current assets     238     145
    Total current assets     16,213     19,583
  Furniture and equipment, net     1,100     1,268
    Total assets   $ 17,313   $ 20,851
Liabilities and Stockholders' Equity            
  Current liabilities   $ 5,285   $ 6,662
  Warrant liabilities     10,042     5,578
  Stockholders' equity     1,986     8,611
    Total liabilities and stockholders' equity   $ 17,313   $ 20,851
                 

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