SOURCE: Ritter Pharmaceuticals, Inc.

March 21, 2016 08:00 ET

Ritter Pharmaceuticals Reports Fourth Quarter and Full Year 2015 Financial Results and Provides Business Update

Initiates Phase 2b/3 Clinical Trial of RP-G28 and Doses First Patient[s]

LOS ANGELES, CA--(Marketwired - Mar 21, 2016) - Ritter Pharmaceuticals, Inc. (NASDAQ: RTTR) ("Ritter Pharmaceuticals" or the "Company"), a leading developer of novel therapeutics that modulate the human gut microbiome to treat gastrointestinal diseases, today reported financial results and a business update for the fourth quarter and full year ended December 31, 2015.

2015 and Recent Operational Highlights

  • Initiated Phase 2b/3 clinical trial of lead product candidate, RP-G28 in patients with lactose intolerance
  • Entered into a $10 million common stock purchase agreement with Aspire Capital Fund
  • Closed initial public offering in June 2015, generating gross proceeds of $20 million
  • Bolstered leadership team with appointment of AnnKatrin Petersen-Jappelli, M.D., M.SC. as Chief Medical Officer and addition of William J. Sandborn, M.D. to Medical Advisory Board
  • Strengthened intellectual property portfolio with patents covering manufacturing process for RP-G28 and composition for ameliorating symptoms of lactose intolerance, respectively

"2015 was a significant year for Ritter Pharmaceuticals with financing and building activities preparing us for the first quarter 2016 commencement of our Phase 2b/3 trial of RP-G28 and dosing of our first patient today, March 21, 2016. With 6 trial sites currently screening subjects, we expect to have 20 sites recruiting by mid-year, and are on-track to report top-line data in early 2017. We have effectively utilized our assets to reach this important milestone, and have further established a solid foundation for long-term growth and success by strengthening our executive and advisory teams with key appointments, as well as adding important patents to our portfolio," said Michael D. Step, Chief Executive Officer of Ritter Pharmaceuticals.

Andrew Ritter, President of Ritter Pharmaceuticals, added, "RP-G28 has the potential to become the first FDA approved product to treat lactose intolerance. This therapeutic represents a possible breakthrough in the treatment of lactose intolerance and a viable alternative to lactase supplements. We are proud of the progress we have made and look forward to updating our shareholders as we continue to advance our Phase 2b/3 clinical trial."

Fourth Quarter and Full Year 2015 Financial Results

For the fourth quarter of 2015, Ritter Pharmaceuticals reported a net loss attributable to common stockholders of approximately $2.2 million compared to a net loss of approximately $1.7 million for the fourth quarter of 2014. Basic and diluted net loss per share was $0.27 for the three months ended December 31, 2015 compared to basic and diluted net loss per share of $3.70 for the same period in 2014.

For the year ended December 31, 2015, Ritter Pharmaceuticals reported a net loss attributable to common stockholders of approximately $9.2 million compared to a net loss of approximately $3.1 million for the year ended December 31, 2014. Basic and diluted net loss per share was approximately $3.11 for the year ended December 31, 2015 compared to basic and diluted net loss per share of approximately $6.79 for the same period in 2014.

Research and development expenses for the fourth quarter of 2015 totaled approximately $676,000 compared to approximately $45,000 for the fourth quarter of 2014. This increase was due to the initiation of the Phase 2b/3 clinical trial.

For the year ended December 31, 2015, research and development expenses totaled approximately $2.3 million compared to approximately $114,000 for the year ended December 31, 2014. This increase in research and development expenses was primarily attributable to increased manufacturing costs associated with the preparation of product for clinical trial.

General and administrative expenses for the fourth quarter of 2015 were approximately $1.5 million, compared to approximately $1.2 million for the fourth quarter of 2014. This increase was primarily due an increase in costs of being a public company and the appointment and hiring of key personnel during this period.

For the year ended December 31, 2015, general and administrative expenses were approximately $6.4 million, compared to approximately $2.0 million for the year ended December 31, 2014. The increase in general and administrative expenses was primarily due to an increase in stock based compensation expenses, increased headcount, and costs associated with the closing of the Company's initial public offering.

Total operating expenses for the fourth quarter of 2015 were approximately $2.3 million compared to approximately $1.4 million for the fourth quarter of 2014.

For the year ended December 31, 2015, total operating expenses were $8.9 million, compared to approximately $2.3 million for the year ended December 31, 2014.

As of December 31, 2015, Ritter Pharmaceuticals had cash and cash equivalents of approximately $15.8 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.

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