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Ritter Pharmaceuticals Reports Financial Results for the Three and Six Months Ended June 30, 2018 and Recent Progress

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LOS ANGELES, Aug. 14, 2018 (GLOBE NEWSWIRE) -- Ritter Pharmaceuticals, Inc. (NASDAQ:RTTR) ("Ritter Pharmaceuticals" or the "Company"), a developer of novel therapeutic products that modulate the gut microbiome to treat gastrointestinal diseases with an initial focus on the development of RP-G28, a drug candidate with the potential to be the first FDA-approved treatment for lactose intolerance, today reports financial results for the three and six months ended June 30, 2018.

Recent Corporate Highlights

  • Initiated first pivotal Phase 3 trial ("Liberatus") of RP-G28 for the treatment of lactose intolerance
  • Presented Phase 2b clinical trial data on RP-G28 at Digestive Diseases Week 2018
  • Andrew J. Ritter named chief executive officer
  • John W. Beck appointed as chief financial officer

 "In the second quarter, we accomplished several key milestones including, most importantly, commencement of our first Phase 3 pivotal clinical trial for RP-G28 in the treatment of lactose intolerance," said Andrew J. Ritter, chief executive officer of Ritter Pharmaceuticals. "With encouraging results from our Phase 2b trial for RP-G28, we retained many key protocol design components from our prior trials, and developed enhanced controls based on lessons learned from those trials and incorporated guidance and recommendations from our End-of-Phase 2 meeting with the FDA to enhance the design of our Phase 3 program.  As a result, we are optimistic about the prospects for our Phase 3 clinical trial and the potential for RP-G28 to become the first FDA-approved treatment for lactose intolerance.  Meanwhile, we continue to focus on the clinical and regulatory advancement of RP-G28 and its eventual commercialization, including our development of a more robust strategic commercialization plan and pricing and reimbursement analysis. In addition, we have begun to explore additional indications for RP-G28 in order to expand and enhance our product pipeline."

Corporate Priorities for Second Half of 2018 include:

  • Continue to enroll Liberatus study participants and closely monitor the clinical sites in our Phase 3 clinical trial of RP-G28
  • Conduct a panel discussion with leading GI experts Bill Sandborn, M.D. & Bill Chey, M.D. to cover emerging trends in Gastroenterology and the need for new LI treatments
  • Present additional Phase 2b microbiome data at the American College of Gastroenterology Conference 2018
  • Explore additional indications for RP-G28

Financial Results

The Company's net loss for the three and six months ended June 30, 2018 was $3.6 million and $5.6 million, or $0.71 per share and $1.12 per share, respectively, compared to $2.0 million and $3.6 million, or $1.41 per share and $2.84 per share, for the same periods in 2017, respectively. Net loss for the three and six months ended June 30, 2018, included non-cash, stock-based compensation expense of $178,000 and $391,000, respectively, compared to $249,000 and $543,000, for the same periods in 2017, respectively.  As of June 30, 2018, the Company had cash and cash equivalents of approximately $16.3 million.

About Ritter Pharmaceuticals
Ritter Pharmaceuticals, Inc. (www.RitterPharma.com, @RitterPharma) develops novel therapeutic products that modulate the gut microbiome to treat gastrointestinal diseases. The Company's lead product candidate, RP-G28, has the potential to become the first FDA-approved treatment for lactose intolerance, a condition that affects millions of people worldwide. RP-G28 is currently in Phase 3 clinical development. The Company is further exploring the therapeutic potential that gut microbiome changes may have on treating/preventing a variety of diseases including: gastrointestinal diseases, cancer, metabolic, and liver disease.

Forward-Looking Statements
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that express the current beliefs and expectations of Ritter Pharmaceuticals' management, including statements regarding its Phase 3 pivotal clinical trial for RP-G28 in the treatment of lactose intolerance and other research and development initiatives of the Company. Any statements contained herein that do not describe historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results, performance and achievements to differ materially from those discussed in such forward-looking statements. Factors that could affect our actual results are included in the Company's most recently filed periodic reports on Form 10-K and Form 10-Q and subsequent filings that we make with the Securities and Exchange Commission. 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, except as otherwise required by law, whether as a result of new information, future events or otherwise.    

 RITTER PHARMACEUTICALS, INC.

CONDENSED STATEMENTS OF OPERATIONS

(Unaudited)

    For the Three Months Ended
June 30,
    For the Six Months Ended
June 30,
 
    2018     2017     2018     2017  
Operating costs and expenses:                                
Research and development   $ 1,871,242     $ 774,476     $ 2,720,925     $ 1,206,630  
Patent costs     48,263       50,661       111,351       128,363  
General and administrative     1,686,903       1,144,220       2,812,794       2,315,545  
Total operating costs and expenses     3,606,408       1,969,357       5,645,070       3,650,538  
                                 
Operating loss     (3,606,408 )     (1,969,357 )     (5,645,070 )     (3,650,538 )
                                 
Other income:                                
Interest income     21,756       6,333       47,728       14,279  
Total other income     21,756       6,333       47,728       14,279  
Net loss   $ (3,584,652 )   $ (1,963,024 )   $ (5,597,342 )   $ (3,636,259 )
                                 
Net loss per common share – basic and diluted   $ (0.71 )   $ (1.41 )   $ (1.12 )   $ (2.84 )
                                 
Weighted average common shares outstanding – basic and diluted     5,064,805       1,395,330       5,005,116       1,278,625  

RITTER PHARMACEUTICALS, INC.

CONDENSED BALANCE SHEETS
   

    June 30,     December 31,  
    2018     2017  
    (unaudited)        
ASSETS                
Current assets                
Cash and cash equivalents   $ 16,254,455     $ 22,631,971  
Prepaid expenses     538,537       167,400  
Total current assets     16,792,992       22,799,371  
Other assets     10,326       10,326  
Property and equipment, net     23,087       23,873  
Total Assets   $ 16,826,405     $ 22,833,570  
                 
LIABILITIES AND STOCKHOLDERS' EQUITY                
Current liabilities                
Accounts payable   $ 1,361,268     $ 2,237,579  
Accrued expenses     534,222       454,252  
Other liabilities     14,850       15,757  
Total current liabilities     1,910,340       2,707,588  
                 
Stockholders' equity                
Preferred stock, $0.001 par value; 15,000,000 shares authorized, 7,560 and 9,140 shares issued and outstanding as of June 30, 2018 and
December 31, 2017, respectively
    4,241,983       5,128,536  
Common stock, $0.001 par value; 225,000,000 shares authorized, 5,334,639 and 4,940,652 shares issued and outstanding as of as of June 30, 2018 and
December 31, 2017, respectively
    5,335       4,941  
Additional paid-in capital     69,597,523       68,323,939  
Accumulated deficit     (58,928,776 )     (53,331,434 )
Total stockholders' equity     14,916,065       20,125,982  
Total Liabilities and Stockholders' Equity   $ 16,826,405     $ 22,833,570  

Contacts
John Beck
310-203-1000
John@ritterpharma.com

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