LOS ANGELES, Oct. 31, 2017 (GLOBE NEWSWIRE) -- 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 with an initial focus on developing the first FDA approved treatment for lactose intolerance, today reported financial results and a business update for the third quarter ended September 30, 2017.
- Announced Phase 3 plans after its End-of-Phase 2 Meeting with the FDA regarding the path forward toward a New Drug Application submission for RP-G28 for the treatment of lactose intolerance
- Raised approximately $23 million in an underwritten public offering, before deducting underwriting discounts, commissions and other offering expenses, to fund the initiation of its Phase 3 clinical program of RP-G28
- Initiating the first of two Phase 3 clinical trials in the first half of 2018
“We are very much committed and focused on the clinical development of RP-G28 to NDA submission,” said Michael D. Step, Chief Executive Officer of Ritter Pharmaceuticals. “I’m proud of our clinical and regulatory team’s swift and diligent effort to get us Phase 3 ready and we look forward to initiating our first phase 3 trial in the first half of 2018.”
Andrew J. Ritter, President of Ritter Pharmaceuticals, added, “With Phase 3 guidance from the FDA from our End of Phase 2 Meeting and our recent successful capital raise behind us, we have a clear regulatory pathway and we have sufficient funding to execute the first pivotal Phase 3 clinical trial of RP-G28 through data readout.”
Third Quarter 2017 Financial Results
For the third quarter of 2017, Ritter Pharmaceuticals reported a net loss attributable to common stockholders of approximately $2.0 million compared to a net loss of approximately $3.5 million for the third quarter of 2016. Basic and diluted net loss per share was $0.14 for the three months ended September 30, 2017 compared to basic and diluted net loss per share of $0.41 for the same period in 2016.
Research and development expenses totaled approximately $0.9 million for the quarter ended September 30, 2017 versus $2.3 million for the comparable quarter ended September 30, 2016. The quarter over quarter decrease of approximately $1.4 million was primarily driven by a decrease in activity related to our Phase 2b/3 clinical trial which was initiated in March 2016 and completed in the fourth quarter of 2016. Research and development costs incurred in the quarter ended September 30, 2017 were primarily attributable to Phase 2b/3 extension study fees and Phase 3 program planning expenses.
General and administrative expenses were approximately $1.1 million for both the third quarter of 2017 and 2016.
Total operating expenses for the third quarter of 2017 were approximately $2.0 million compared to approximately $3.5 million for the third quarter of 2016. The decrease of approximately $1.5 million is primarily attributable to the decrease in research and development costs as described above.
As of September 30, 2017, Ritter Pharmaceuticals had cash and cash equivalents of approximately $3.6 million. In addition, the company raised approximately $21.0 million, net of fees, through an underwritten public offering that closed on October 3, 2017.
About Ritter Pharmaceuticals
Ritter Pharmaceuticals, Inc. (www.RitterPharma.com, @RitterPharma) develops novel therapeutic products that modulate the gut microbiome to treat gastrointestinal diseases. Its lead product, RP-G28, has the potential to become the first FDA-approved treatment for lactose intolerance, a condition that affects millions worldwide. The Company is further exploring the functionality and discovering the therapeutic potential gut microbiome changes may have on treating/preventing a variety of conditions including: gastrointestinal diseases, immuno-oncology, metabolic, and liver disease.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the timing of our two Phase 3 clinical trials. Management believes that these forward-looking statements are reasonable as and when made. However, 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. For a discussion of certain risks and uncertainties affecting Ritter Pharmaceuticals’ forward-looking statements, please review the Company’s reports filed with the Securities and Exchange Commission, including, but not limited to, its Annual Report on Form 10-K for the period ended December 31, 2016 and Quarterly Reports on Form 10-Q for the periods ended March 31, 2017, June 30, 2017 and September 30, 2017. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made. These statements are based on management’s current expectations and Ritter Pharmaceuticals does not undertake any responsibility to revise or update any forward-looking statements contained herein, except as expressly required by law.
|RITTER PHARMACEUTICALS, INC.|
|CONDENSED STATEMENTS OF OPERATIONS|
|Three Months Ended|
|Nine Months Ended |
|Operating costs and expenses:|
|Research and development||$||915,268||$||2,348,755||$||2,121,898||$||7,112,177|
|General and administrative||1,052,236||1,091,647||3,367,781||3,533,608|
|Total operating costs and expenses||2,014,935||3,539,310||5,665,473||10,845,673|
|Total other income||4,083||13,239||18,362||51,680|
|Net loss per common share ― basic and diluted||$||(0.14||)||$||(0.41||)||$||(0.42||)||$||(1.26||)|
|Weighted-average common shares outstanding — basic and diluted||14,756,521||8,585,406||13,443,007||8,584,442|
|RITTER PHARMACEUTICALS, INC.|
|CONDENSED BALANCE SHEETS|
|September 30, 2017||December 31, 2016|
|Cash and cash equivalents||$||3,558,874||$||7,046,282|
|Total current assets||3,819,471||7,203,034|
|Deferred offering costs||310,786||—|
|Property and equipment, net||19,606||23,542|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Total current liabilities||2,957,875||3,133,839|
|Preferred stock, $0.001 par value; 15,000,000 shares authorized; 0 shares issued and outstanding as of September 30, 2017 and December 31, 2016||—||—|
|Common stock, $0.001 par value; 225,000,000 shares authorized; 14,756,521 and 11,619,197 shares issued and outstanding as of September 30, 2017 and December 31, 2016, respectively||14,757||11,619|
|Additional paid-in capital||52,302,244||49,559,020|
|Total stockholders’ equity||1,202,314||4,103,063|
|Total Liabilities and Stockholders’ Equity||$||4,160,189||$||7,236,902|
Source:Ritter Pharmaceuticals, Inc.