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
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.
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
|For the Three Months Ended
|For the Six Months Ended
|Operating costs and expenses:|
|Research and development||$||1,871,242||$||774,476||$||2,720,925||$||1,206,630|
|General and administrative||1,686,903||1,144,220||2,812,794||2,315,545|
|Total operating costs and expenses||3,606,408||1,969,357||5,645,070||3,650,538|
|Total other income||21,756||6,333||47,728||14,279|
|Net loss per common share – basic and diluted||$||(0.71||)||$||(1.41||)||$||(1.12||)||$||(2.84||)|
|Weighted average common shares outstanding – basic and diluted||5,064,805||1,395,330||5,005,116||1,278,625|
RITTER PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEETS
|June 30,||December 31,|
|Cash and cash equivalents||$||16,254,455||$||22,631,971|
|Total current assets||16,792,992||22,799,371|
|Property and equipment, net||23,087||23,873|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Total current liabilities||1,910,340||2,707,588|
|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
|Common stock, $0.001 par value; 225,000,000 shares authorized, 5,334,639 and 4,940,652 shares issued and outstanding as of as of June 30, 2018 and
December 31, 2017, respectively
|Additional paid-in capital||69,597,523||68,323,939|
|Total stockholders’ equity||14,916,065||20,125,982|
|Total Liabilities and Stockholders’ Equity||$||16,826,405||$||22,833,570|
CONTACT: Contacts John Beck 310-203-1000 John@ritterpharma.com