Rani Therapeutics Holdings, Inc. (“Rani Therapeutics” or “Rani”) (Nasdaq: RANI), a clinical stage biotherapeutics company focused on the oral delivery of biologics, today reported financial results for the fourth quarter and full year ended December 31, 2021 and provided a corporate update.
“The year 2021 and the subsequent months that have passed have been a productive period for Rani. We refined and progressed our development pipeline; made strides on RaniPill HC, the high capacity version of our RaniPill platform; bolstered our balance sheet through a successful IPO; and strengthened our board and management with the addition of key personnel,” said Talat Imran, Chief Executive Officer of Rani Therapeutics. “Looking ahead to the rest of 2022, we expect to announce topline results from our Phase 1 trial of RT-102 and initiate an additional Phase 1 trial – the company’s third – in the second half of the year. We also expect to make progress with the RaniPill HC, which adds over 50 potential biologic drug candidates as opportunities for internal development or partnership.”
Fourth Quarter and Subsequent Highlights
Expected Near-Term Milestones
Full Year 2021 Financial Results
Conference Call
Rani will host a corresponding conference call and live webcast at 1:30 p.m. PT / 4:30 p.m. ET on March 29, 2022 to discuss the results and provide a business update. Individuals interested in listening to the live conference call may do so by dialing (844) 605-7369 for domestic callers, or (929) 517-0917 for international callers and reference conference ID: 7192045; or from the webcast link in the investor relations section of the company's website at: www.ranitherapeutics.com.
A webcast replay will be available in the investor relations section on the company's website for 90 days following the completion of the call.
Rani Therapeutics
Rani Therapeutics is a clinical stage biotherapeutics company focused on advancing technologies to enable the development of orally administered biologics. Rani has developed the RaniPill™ capsule, which is a novel, proprietary and patented platform technology, intended to replace subcutaneous injection of biologics with oral dosing. Rani has successfully conducted several preclinical and clinical studies to evaluate safety, tolerability and bioavailability using the RaniPill™ capsule. For more information, visit www.ranitherapeutics.com.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the timing of topline results from Rani’s Phase 1 trial of RT-102, the expected initiation of an additional Phase 1 trial of another product candidate in the second half of 2022, expected progress with the RaniPill HC platform, and potential expansion of Rani’s prospective opportunity, alone or in partnership, to an additional 50 biologics across multiple new indications, Rani’s development and advancement of its RaniPill capsule technology, the impact of its technology on medical treatment, Rani’s advancement of its preclinical and clinical programs and timing of results, customer acceptance of the RaniPill capsule technology, the potential benefits of the RaniPill capsule technology, Rani’s ability to attract and retain talent, Rani’s prospects for entering into strategic partnerships or transactions, and Rani’s growth as a company. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “may,” “could,” “prospective,” “look forward,” “progress,” “advance” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Rani’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Rani’s business in general, the impact of the COVID-19 pandemic, and the other risks described in Rani’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Rani undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
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Source: Rani Therapeutics
Rani Therapeutics Holdings, Inc.
Consolidated Balance Sheets
(In Thousands, Except Par Value)
| Year End December 31, | ||||||||
| 2021 | 2020 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 117,453 | $ | 73,058 | ||||
| Related party note receivable | — | 1,720 | ||||||
| Prepaid expenses | 2,142 | 167 | ||||||
| Total current assets | 119,595 | 74,945 | ||||||
| Property and equipment, net | 4,612 | 4,470 | ||||||
| Total assets | $ | 124,207 | $ | 79,415 | ||||
| Liabilities, Convertible Preferred Units and Stockholders' Equity / Members’ Deficit | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,080 | $ | 537 | ||||
| Related party payable | 126 | 145 | ||||||
| Accrued expenses | 1,434 | 550 | ||||||
| Deferred revenue | — | 2,717 | ||||||
| Current portion of long-term debt | — | 1,359 | ||||||
| Total current liabilities | 2,640 | 5,308 | ||||||
| Preferred unit warrant liability | — | 320 | ||||||
| Long-term debt, less current portion | — | 2,412 | ||||||
| Total liabilities | 2,640 | 8,040 | ||||||
| Commitments and contingencies | ||||||||
| Convertible preferred units | — | 184,714 | ||||||
| Stockholders' equity / (members’ deficit): | ||||||||
| Common units | — | 664 | ||||||
| Preferred stock, $0.0001 par value - 20,000 shares authorized; none issued and outstanding as of December 31, 2021 | — | — | ||||||
| Class A common stock, $0.0001 par value - 800,000 shares authorized; 19,712 issued and outstanding as of December 31, 2021 | 2 | — | ||||||
| Class B common stock, $0.0001 par value - 40,000 shares authorized; 29,290 issued and outstanding as of December 31, 2021 | 3 | — | ||||||
| Class C common stock, $0.0001 par value - 20,000 shares authorized; none issued and outstanding as of December 31, 2021 | — | — | ||||||
| Additional paid-in capital | 55,737 | — | ||||||
| Accumulated deficit | (8,331 | ) | (114,003 | ) | ||||
| Total stockholders' equity attributable to Rani Therapeutics Holdings, Inc. / (members' deficit) | 47,411 | (113,339 | ) | |||||
| Non-controlling interest | 74,156 | — | ||||||
| Total stockholders' equity / (members' deficit) | 121,567 | (113,339 | ) | |||||
| Total liabilities, convertible preferred units and stockholders' equity / (members' deficit) | $ | 124,207 | $ | 79,415 | ||||
Rani Therapeutics Holdings, Inc.
Consolidated Statements of Operations and Comprehensive Loss
(In Thousands, Except Per Share Amounts)
| Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Contract revenue | $ | — | $ | 210 | $ | 2,717 | $ | 462 | ||||||||
| Operating expenses | ||||||||||||||||
| Research and development | 7,417 | 3,336 | 26,482 | 12,044 | ||||||||||||
| General and administrative | 5,945 | 1,818 | 27,834 | 4,962 | ||||||||||||
| Total operating expenses | $ | 13,362 | $ | 5,154 | $ | 54,316 | $ | 17,006 | ||||||||
| Loss from operations | (13,362 | ) | (4,944 | ) | (51,599 | ) | (16,544 | ) | ||||||||
| Other income (expense), net | ||||||||||||||||
| Interest income | 16 | (24 | ) | 89 | 63 | |||||||||||
| Loss on extinguishment of debt | — | — | (700 | ) | — | |||||||||||
| Interest expense and other, net | 1 | (58 | ) | (466 | ) | (124 | ) | |||||||||
| Change in estimated fair value of preferred unit warrant | — | (718 | ) | (371 | ) | (63 | ) | |||||||||
| Loss before income taxes | (13,345 | ) | (5,744 | ) | (53,047 | ) | (16,668 | ) | ||||||||
| Income tax expense | 40 | (12 | ) | (41 | ) | (35 | ) | |||||||||
| Net loss and comprehensive loss | $ | (13,305 | ) | $ | (5,756 | ) | $ | (53,088 | ) | $ | (16,703 | ) | ||||
| Net loss attributable to non-controlling interest | (8,116 | ) | (5,756 | ) | (44,757 | ) | (16,703 | ) | ||||||||
| Net loss attributable to Rani Therapeutics Holdings, Inc. | $ | (5,189 | ) | $ | — | $ | (8,331 | ) | $ | — | ||||||
| Net loss per Class A common share attributable to Rani Therapeutics Holdings, Inc., basic and diluted | $ | (0.27 | ) | $ | (0.43 | ) | ||||||||||
| Weighted-average Class A common shares outstanding—basic and diluted | 19,439 | 19,534 | ||||||||||||||
| Last Trade: | US$1.40 |
| Daily Change: | 0.10 7.69 |
| Daily Volume: | 462,920 |
| Market Cap: | US$46.630M |
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