UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 29, 2019
RITTER PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-37428 | 26-3474527 | ||
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
1880 Century Park East, Suite 1000 Los Angeles, California |
90067 | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code: (310) 203-1000
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| [ ] | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |
| [ ] | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |
| [ ] | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |
| [ ] | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company [X]
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [ ]
Item 2.02. Results of Operation and Financial Condition
On March 29, 2019, Ritter Pharmaceuticals, Inc. (the “Company”), issued a press release announcing the financial results for the year ending December 31, 2018, entitled “Ritter Pharmaceuticals Reports Year End 2018 Financial Results and Provides Business Update” (the “Press Release”). A copy of the Press Release is furnished as Exhibit 99.1 hereto and is incorporated herein by reference.
The information contained in this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed filed for the purposes of Section 18 of the United State Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of Section 18. Furthermore, the information shall not be deemed incorporated by reference into any registration statement or any other filing under the United States Securities Act of 1933, as amended, except as shall be expressly set forth by specific references in such filings.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | Press Release dated March 29, 2019, entitled “Ritter Pharmaceuticals Reports Year End 2018 Financial Results and Provides Business Update” |
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| RITTER PHARMACEUTICALS, INC. | ||
| By: | /s/ Andrew J. Ritter | |
| Name: | Andrew J. Ritter | |
| Title: | President and Chief Executive Officer | |
Date: March 29, 2019
Exhibit 99.1
Ritter Pharmaceuticals Reports Year End 2018 Financial Results and Provides Business Update
LOS ANGELES (March 29, 2019) – Ritter Pharmaceuticals, Inc. (Nasdaq: RTTR) (“Ritter Pharmaceuticals” or the “Company”), a developer of therapeutic products that modulate the gut microbiome to treat digestive disorders and 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 year ended December 31, 2018 and provided a business update.
Recent Highlights
| ● | Recently enrolled the last of approximately 557 patients in our ongoing Phase 3 clinical trial of RP-G28, known as “Liberatus”. The trial was fully-enrolled ahead of schedule and the pace of enrollment exceeded expectations. Top line data is expected to be released early in the fourth quarter of 2019. | |
| ● | Hosted a call with Dr. William Chey, a leading gastrointestinal disease expert to highlight the unmet medical need in LI and the potential of RP-G28 in LI. | |
| ● | Presented additional data from its previously completed Phase 2b clinical trial of RP-G28 exhibiting colonic microbiome adaptation and improved lactose tolerance in LI patients at the American College of Gastroenterology annual scientific meeting. |
“Our ability to fully enroll all patients in the Liberatus clinical trial in approximately eight months highlights both the operational improvements we have made as well as the intense patient interest there is in new pharmaceutical approaches to treat this affliction,” said Andrew J. Ritter, Chief Executive Officer of Ritter Pharmaceuticals. “Our focus in 2019 will be on the successful completion of this study, exploration of potential commercial partners for RP-G28 and pipeline growth by evaluating RP-G28 in other indications.”
Year ended December 31, 2018 Financial Results
As of December 31, 2018, we had $14.8 million in cash, cash equivalents and short-term investments in marketable debt securities, compared to $22.6 million in cash, cash equivalents and short-term investments in marketable debt securities as of December 31, 2017. The net decrease in cash, cash equivalents and short-term investments in marketable debt securities in 2018 was due to our use of cash to fund our Phase 3 clinical study of RP-G28, increased personnel costs and for other general corporate purposes offset by proceeds from our November 2018 private placement.
Operating expenses increased to $17.0 million for the year ended December 31, 2018 from $7.9 million for the year ended December 31, 2017. The increase in total operating expense in 2018 was primarily a result of an increase in development expenses due to the progression of RP-G28 into the Liberatus Phase 3 clinical study, as well as an increase in consulting and professional outside services and personnel and related costs to support these increased development activities, offset by reductions in non-cash stock-based compensation.
For the year ended December 31, 2018, net loss applicable to common stockholders increased to $19.4 million, or $3.66 per share, from $11.0 million, or $4.95 per share, for the year ended December 31, 2017. Net loss applicable to common stockholders included non-cash, deemed dividends of $2.5 million, or $0.48 per share, and stock-based compensation charges of $0.6 million, or $0.12 per share, as compared to deemed dividends of $3.1 million, or $1.40 per share, and stock-based compensation of $0.9 million, or $0.40 per share, for the years ended December 31, 2018 and 2017, respectively. The non-cash deemed dividend charges resulted from our November 2018, $6.0 million private placement and our October 2017, $23.0 million public offering.
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.
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. 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, our release of data from the study and the funding and timing of future clinical studies. 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.
Contacts
Investor Contact:
John Beck
310-203-1000
john@ritterpharma.com
RITTER PHARMACEUTICALS, INC.
STATEMENTS OF OPERATIONS
| For the Year Ended | ||||||||
| December 31, | ||||||||
| 2018 | 2017 | |||||||
| Operating costs and expenses: | ||||||||
| Research and development | $ | 11,366,117 | $ | 2,874,184 | ||||
| Patent costs | 204,396 | 250,372 | ||||||
| General and administrative | 5,425,033 | 4,777,902 | ||||||
| Total operating costs and expenses | 16,995,546 | 7,902,458 | ||||||
| Operating loss | $ | (16,995,546 | ) | $ | (7,902,458 | ) | ||
| Other income (expense): | ||||||||
| Interest income | 126,835 | 40,227 | ||||||
| Other expense | ― | (1,627 | ) | |||||
| Total other income | 126,835 | 38,600 | ||||||
| Net loss | $ | (16,868,711 | ) | $ | (7,863,858 | ) | ||
| Deemed dividend of preferred stock | (2,537,844 | ) | (3,111,020 | ) | ||||
| Net loss applicable to common stockholders | $ | (19,406,555 | ) | $ | (10,974,878 | ) | ||
| Net loss per common share – basic and diluted | $ | (3.66 | ) | $ | (4.95 | ) | ||
| Weighted average common shares outstanding – basic and diluted | 5,304,667 | 2,214,951 | ||||||
RITTER PHARMACEUTICALS, INC.
BALANCE SHEETS
| December 31, 2018 | December 31, 2017 | |||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 7,812,259 | $ | 22,631,971 | ||||
| Accrued interest receivable | 54,456 | ― | ||||||
| Investment in marketable securities | 6,988,780 | ― | ||||||
| Prepaid expenses | 421,522 | 167,400 | ||||||
| Total current assets | 15,277,017 | 22,799,371 | ||||||
| Other assets | 22,725 | 10,326 | ||||||
| Property and equipment, net | 20,160 | 23,873 | ||||||
| Total Assets | $ | 15,319,902 | $ | 22,833,570 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 4,512,316 | $ | 2,237,579 | ||||
| Accrued expenses | 1,407,843 | 454,252 | ||||||
| Other liabilities | 13,359 | 15,757 | ||||||
| Total current liabilities | 5,933,518 | 2,707,588 | ||||||
| Stockholders’ equity | ||||||||
| Series A preferred stock, $0.001 par value; 15,000,000 shares authorized; 4,080 and 9,140 shares issued and outstanding as of December 31, 2018 and 2017, respectively | 2,289,324 | 5,128,536 | ||||||
| Series B preferred stock, $0.001 par value; 6,000 shares authorized; 5,608 and 0 shares issued and outstanding as of December 31, 2018 and 2017, respectively | 3,906,931 | ― | ||||||
| Series C preferred stock, $0.001 par value; 1,880 shares authorized; 1,880 and 0 shares issued and outstanding as of December 31, 2018 and 2017, respectively | 1,880,000 | ― | ||||||
| Common stock, $0.001 par value; 225,000,000 and 25,000,000 shares authorized; 6,036,562 and 4,940,652 shares issued and outstanding as of December 31, 2018 and 2017, respectively | 6,037 | 4,940 | ||||||
| Additional paid-in capital | 71,505,160 | 68,323,940 | ||||||
| Accumulated other comprehensive loss | (923 | ) | ― | |||||
| Accumulated deficit | (70,200,145 | ) | (53,331,434 | ) | ||||
| Total stockholders’ equity | 9,386,384 | 20,125,982 | ||||||
| Total Liabilities and Stockholders’ Equity | $ | 15,319,902 | $ | 22,833,570 | ||||