LOS ANGELES, May 14, 2019 (GLOBE NEWSWIRE) -- Ritter Pharmaceuticals, Inc. (RTTR) (“Ritter Pharmaceuticals” or the “Company”), a developer of innovative 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 (“LI”), today reported financial results for the three months ended March 31, 2019.
“Primary efforts over the past quarter have been focused on ensuring quality and compliance in our 557 subject Phase 3 clinical trial, called Liberatus. All subjects have now completed the treatment phase of the study, with only the 90-day real-world observational period remaining.” said Andrew J. Ritter, Chief Executive Officer of Ritter Pharmaceuticals. “We remain on track and look forward to completing the study and reporting top-line results early in the fourth quarter of 2019.”
John Beck, Chief Financial Officer, added, “Cash burn for the first quarter of 2019 was in line with our expectations as we progressed through the costliest phase of the Liberatus study and, as we move towards study completion, is expected to subside considerably. We remain on target to reach data readout with cash reserves in line with previous projections.”
Quarter ended March 31, 2019 Financial Results
As of March 31, 2019, we had $8.3 million in cash, cash equivalents, interest income receivable and short-term investments in marketable securities, compared to $14.9 million in cash, cash equivalents, interest income receivable and short-term investments in marketable securities as of December 31, 2018. The net decrease in cash, cash equivalents, interest income receivable and short-term investments in marketable securities as of March 31, 2019 was due to our use of cash to fund our Phase 3 clinical study of RP-G28 and for other general corporate purposes.
Operating expenses increased to $4.8 million for the three months ended March 31, 2019 from $2.0 million for the three months ended March 31, 2018. The increase in total operating expenses was primarily a result of an increase in development expenses due to the continued progression of our ongoing Phase 3 clinical trial of RP-G28 through completion of enrollment in March 2019, as well as an increase in consulting and professional outside services and related costs to support these increased development activities, offset by reductions in non-cash stock-based compensation. Operating expenses during the three months ended March 31, 2018 primarily reflect the preparation for the Phase 3 clinical trial of RP-G28 and associated manufacturing costs offset by a reduction in management and monitoring costs associated with the favorable settlement of certain disputed payables related to our prior clinical research organization.
Net loss applicable to common stockholders increased to $4.7 million, or $0.58 per share, for the three months ended March 31, 2019, from $2.0 million, or $0.41 per share, for the three months ended March 31, 2018. Net loss applicable to common stockholders included non-cash, stock-based compensation charges of $146,000, or $0.02 per share, as compared to stock-based compensation of $213,000, or $0.04 per share, for the three months ended March 31, 2019 and 2018, respectively.
About Ritter Pharmaceuticals
Ritter Pharmaceuticals, Inc. (www.RitterPharma.com, @RitterPharma) develops innovative therapeutic products that modulate the gut microbiome to treat digestive disorders and 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 over one billion people worldwide. RP-G28 is in Phase 3 clinical development with its first Phase 3 clinical trial, known as “Liberatus,” currently underway. 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. Any statements contained herein that do not describe historical facts are forward-looking statements, including statements related to our anticipated timing for completion of the Liberatus study and our release of data from the study and our expectations with respect to our cash burn and cash reserves following completion of our Liberatus study. Forward-looking statements 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. Some of the factors that could affect our actual results are included in the periodic reports on Form 10-K and Form 10-Q that we file with the Securities and Exchange Commission. Ritter cautions readers not to place undue reliance on any forward-looking statements, which speak only as of the date they were made. The Company undertakes no obligation to update or revise 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 AND COMPREHENSIVE LOSS
|For the Three Months Ended March 31,|
|Operating costs and expenses:|
|Research and development||$||3,574,855||$||849,683|
|General and administrative||1,153,577||1,125,891|
|Total operating costs and expenses||4,777,057||2,038,662|
|Total other income||71,291||25,972|
|Net loss applicable to common stockholders||$||(4,705,766||)||$||(2,012,690||)|
|Other comprehensive loss:|
|Unrealized loss on debt securities||1,511||-|
|Net loss per common share – basic and diluted||$||(0.58||)||$||(0.41||)|
|Weighted average common shares outstanding – basic and diluted||8,055,921||4,944,763|
RITTER PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEETS
|March 31, 2019||December 31, 2018|
|Cash and cash equivalents||$||5,516,748||$||7,812,259|
|Accrued interest receivable||17,393||54,456|
|Investment in marketable securities||2,765,996||6,988,780|
|Total current assets||8,742,345||15,277,017|
|Total other assets||199,874||22,725|
|Property and equipment, net||18,797||20,160|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Total current liabilities||4,061,542||5,933,518|
|Lease liabilities, non-current||70,854||-|
|Series A preferred stock, $0.001 par value; 15,000,000 shares authorized, 4,080 shares issued and outstanding as of March 31, 2019 and December 31, 2018||2,289,324||2,289,324|
|Series B preferred stock, $0.001 par value; 1,000,000 shares authorized, 3,000 and 5,608 shares issued and outstanding as of March 31, 2019 and December 31, 2018, respectively||2,090,199||3,906,931|
|Series C preferred stock, $0.001 par value; 100,000 shares authorized, 240 and 1,880 shares issued and outstanding as of March 31, 2019 and December 31, 2018, respectively||240,000||1,880,000|
|Common stock, $0.001 par value; 225,000,000 shares authorized, 9,042,332 and 6,036,562 shares issued and outstanding as of March 31, 2019 and December 31, 2018, respectively||9,042||6,037|
|Additional paid-in capital||75,105,378||71,505,160|
|Accumulated other comprehensive income (loss)||1,511||(923||)|
|Total stockholders’ equity||4,828,620||9,386,384|
|Total Liabilities and Stockholders’ Equity||8,961,016||$||15,319,902|