SOURCE: Ritter Pharmaceuticals, Inc.

August 08, 2016 08:30 ET

Ritter Pharmaceuticals Reports Second Quarter 2016 Financial Results and Provides Business Update

LOS ANGELES, CA--(Marketwired - Aug 8, 2016) - Ritter Pharmaceuticals, Inc. (NASDAQ: RTTR) ("Ritter Pharmaceuticals" or the "Company"), a pharmaceutical company developing novel therapeutic products that modulate the human gut microbiome to treat gastrointestinal diseases, today reported financial results and a business update for the second quarter ended June 30, 2016.

Quarter Highlights

  • RP-G28 received method of use patent which covers methods for treating symptoms associated with lactose intolerance and for overall improvement in gastrointestinal health expiring in 2030
  • Enrollment of Phase 2b/3 clinical trial continues to progress very well, keeping the company within its stated timeframe of top-line data in early 2017

"We are pleased with the execution of our Phase 2b/3 trial of RP-G28 in patients suffering from lactose intolerance. Enrollment in this 372 patient study has progressed well, demonstrating strong operational effort by our team and CRO. Interest by patients to enroll in the trial continues to show a clear need for a safe, effective, and durable treatment for lactose intolerance," said Michael D. Step, Chief Executive Officer of Ritter Pharmaceuticals. "While our trial is ongoing, we continue our efforts to position the company for long-term value. As previously announced, we were awarded a method of use patent during the quarter. In total, we are now protected with 9 patents, providing protection for RP-G28 through 2030. Additionally we continue to evaluate RP-G28 for additional medical uses and evaluate preclinical and clinical programs which could offer insight to RP-G28 use in adapting the microbiome. Lastly, we continue to operate the company in a financially sound fashion with the ability to fund the company through our clinical trial results."

Andrew Ritter, President of Ritter Pharmaceuticals, added, "While there is still work to be done, we are confident in our ability to complete this trial and report data by early 2017. This trial consists of a 30-day course of treatment, followed by a 30-day post-treatment evaluation, and therefore can be run in a relatively short period of time. We are excited to be moving toward data in this study and look forward to providing results once available."

Second Quarter 2016 Financial Results

For the second quarter of 2016, Ritter Pharmaceuticals reported a net loss attributable to common stockholders of approximately $4.1 million compared to a net loss of approximately $2.3 million for the second quarter of 2015. Basic and diluted net loss per share was $0.48 for the three months ended June 30, 2016 compared to basic and diluted net loss per share of $4.18 for the same period in 2015.

Research and development expenses totaled approximately $2.9 million for the quarter ended June 30, 2016 versus approximately $48,000 for comparable period of 2015. This increase was primarily attributable to the execution of our Phase2b/3 clinical trial.

General and administrative expenses for the second quarter of 2016 were approximately $1.2 million, compared to approximately $2.0 million for the second quarter of 2015. This decrease was primarily due to non-recurring expenses related to our IPO in Q2 2015, stock-based compensation expense associated with the IPO, offset partially by higher employment expense associated with the clinical trial efforts.

Total operating expenses for the second quarter of 2016 were approximately $4.2 million, compared to approximately $2.1 for the previous year period.

As of June 30, 2016, Ritter Pharmaceuticals had cash and cash equivalents of approximately $10.8 million.

About Ritter Pharmaceuticals

Ritter Pharmaceuticals, Inc. develops novel therapeutic products that modulate the human gut microbiome to treat gastrointestinal diseases. The Company is advancing human gut health research by exploring the metabolic capacity of gut microbiota, and translating the functionality of these microbiome modulators into safe and effective applications. Their lead drug candidate, RP-G28, has the potential to become the first FDA-approved drug for lactose intolerance, a condition that affects more than one billion people worldwide.

Forward-Looking Statements

This release may contain forward-looking statements, which express the current beliefs and expectations of Ritter Pharmaceuticals' management. Such statements involve a number of known and unknown risks and uncertainties that could cause the Company's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Any statements contained herein that do not describe historical facts are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. These forward-looking statements are made only as of the date hereof, and the Company undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise.

   
RITTER PHARMACEUTICALS, INC.  
CONDENSED STATEMENTS OF OPERATIONS  
(Unaudited)  
   
    Three Months Ended
June 30,
    Six Months Ended
June 30,
 
    2016     2015     2016     2015  
Operating costs and expenses:                        
  Research and development   $ 2,880,574     $ 47,977     $ 4,763,422     $ 79,555  
  Patent costs     68,616       50,148       100,980       112,423  
  General and administrative     1,206,943       2,001,706       2,441,961       3,304,152  
    Total operating costs and expenses     4,156,133       2,099,831       7,306,363       3,496,130  
Operating loss     (4,156,133 )     (2,099,831 )     (7,306,363 )     (3,496,130 )
                                 
Other income:                                
  Interest income     16,661       2,101       37,227       4,305  
  Other income     --       --       1,214       7,091  
    Total other income     16,661       2,101       38,441       11,396  
Net loss   $ (4,139,472 )   $ (2,097,730 )   $ (7,267,922 )   $ (3,484,734 )
Cumulative preferred stock dividends     --       (178,286 )     --       (327,569 )
Accretion of discount on Series C preferred stock     --       (31,465 )     --       (63,283 )
Net loss applicable to common shareholders   $ (4,139,472 )   $ (2,307,481 )   $ (7,267,922 )   $ (3,875,586 )
Net loss per common share -- basic and diluted   $ (0.48 )   $ (4.18 )   $ (0.85 )   $ (7.62 )
Weighted-average common shares outstanding -- basic and diluted     8,584,661       551,912       8,583,259       508,645  
                                 
   
RITTER PHARMACEUTICALS, INC.  
CONDENSED BALANCE SHEETS  
   
    June 30, 2016     December 31, 2015  
    (unaudited)        
ASSETS            
Current assets            
  Cash and cash equivalents   $ 10,771,639     $ 15,819,566  
  Prepaid expenses     65,905       189,136  
    Total current assets     10,837,544       16,008,702  
                 
Other assets     10,326       10,326  
Property and equipment, net     26,172       20,688  
    Total Assets   $ 10,874,042     $ 16,039,716  
                 
LIABILITIES AND STOCKHOLDERS' EQUITY                
Current liabilities                
  Accounts payable   $ 1,802,655     $ 739,357  
  Accrued expenses     932,028       614,141  
  Other liabilities     12,842       1,223  
    Total current liabilities     2,747,525       1,354,721  
                 
Stockholders' equity                
Preferred stock, $0.001 par value; 5,000,000 shares authorized; 0 shares issued and outstanding as of June 30, 2016 and December 31, 2015     --       --  
Common stock, $0.001 par value; 25,000,000 shares authorized; 8,584,661 and 8,582,004 shares issued and outstanding as of June 30, 2016 and December 31, 2015, respectively     8,585       8,582  
Additional paid-in capital     42,468,796       41,759,355  
Accumulated deficit     (34,350,864 )     (27,082,942 )
    Total stockholders' equity     8,126,517       14,684,995  
                 
    Total Liabilities and Stockholders' Equity   $ 10,874,042     $ 16,039,716  
                 

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