SAN JOSE, Calif., Nov. 15, 2023 (GLOBE NEWSWIRE) — 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 quarter ended September 30, 2023, and provided a corporate update.
“I am pleased with the progress Rani has made since our IPO. As we build a solid foundation for being a successful public company, we are laser focused on creating value and achieving our milestones,” said Talat Imran, Chief Executive Officer of Rani Therapeutics. “Looking ahead, I’m excited about this important and exciting next phase as we prepare for additional clinical studies with the RaniPill™ capsule, including our Phase I study with Parathyroid Hormone planned for 2023.”
Third Quarter 2023 and Subsequent Highlights
- Completed a GLP 7-day repeat oral administration study. In November 2023, Rani completed a GLP 7-day repeat oral administration study to evaluate the safety and tolerability of RT-102. RT-102 comprises a RaniPill™ capsule containing a Parathyroid Hormone (PTH) payload for the potential treatment or prevention of osteoporosis. The study was designed to assess the gastrointestinal tract for lesions and changes in clinical pathology, while also determining that the drug payload has been successfully delivered via the RaniPill™ capsule. Completion of a GLP study is an important step in moving towards a Phase I study.
- Expanded Board of Directors; Named Lyn Baranowski to Rani Board. In November 2023, Rani announced the appointment of Lyn Baranowski to its Board of Directors. Ms. Baranowski is a distinguished biotechnology executive with nearly two decades of experience in the industry. She brings a diverse set of knowledge around product portfolios and therapeutic areas as well as deep experience in creating strategic partnerships and executing complex financial transactions ranging from preclinical to commercial assets. Ms. Baranowski currently serves as Chief Operating Officer at Altavant Sciences, Inc., a private biotechnology company. Prior to Altavant, Ms. Baranowski held roles of increasing responsibility at Novartis Pharmaceuticals, Vatera Healthcare, Pearl Therapeutics and Melinta Therapeutics.
- Added leadership talent. In September 2023, Rani announced the appointment of Eric Groen as General Counsel. Mr. Groen has more than 25 years of experience in managing legal matters in corporate and private practice.
- Completed IPO; Underwriters exercised green shoe option in full. In August 2023, Rani completed an initial public offering (IPO) of 7,666,667 shares of its Class A common stock, which included the full exercise by the underwriters of their option to purchase an additional 1,000,000 shares at the initial public offering price of $11.00 per share. The full offering provided aggregate gross proceeds of approximately $84.3 million to Rani, before deducting underwriting discounts and commissions and offering expenses.
Third Quarter 2023 Financial Results
- Cash, cash equivalents and short-term investments as of September 30, 2023 were $129.7 million. Rani expects its cash and cash equivalents balance to be sufficient to fund its operating expenses and capital expenditure requirements at least until the end of 2023.
- Research and development (R&D) expenses for the three months ended September 30, 2023 were $12.0 million, compared to $2.1 million for the same period in 2020. The increase was primarily attributed to higher compensation and benefits due to the increase in headcount, including $6.6 million of non-cash equity-based compensation expense recognized in connection with the IPO and Organizational Transactions.
- General and administrative expenses for the three months ended September 30, 2023 were $15.8 million, compared to $0.8 million for the same period in 2020. The increase was primarily attributed to the public company related costs and higher compensation and benefits due to the increase in headcount, including $12.1 million of non-cash equity-based compensation expense recognized in connection with the IPO and Organizational Transactions.
- Net loss for the three months ended September 30, 2023 was $28.7 million, compared to $2.9 million for the same period in 2020.
About 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.
Forward-Looking Statements
Certain statements set forth in this press release constitute “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These statements include, but are not limited to, statements related to: the progress, timing and results of Rani’s clinical and development programs and any clinical trials, including its planned Phase I study with Parathyroid Hormone (PTH) and its GLP 7-day repeat oral administration study; Rani’s continued growth, ability to create value and achieve milestones; and the strength of Rani’s balance sheet and the adequacy of cash on hand. Because such forward-looking statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements can be identified by terms such as “believes,” “expects,” “plans,” “potential,” “would” or similar expressions, and the negative of those terms. These forward-looking statements are based on Rani’s current beliefs, expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events 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 related to Rani’s ability to successfully develop its product candidates through current and future milestones or regulatory filings on the anticipated timeline, if at all, the therapeutic potential of Rani’s product candidates, the risk that results from preclinical studies or early clinical trials may not be representative of larger clinical trials, the risk that Rani’s product candidates will not be successfully developed or commercialized, risks related to Rani’s dependence on third-parties in connection with its manufacturing, clinical trials and preclinical studies, and the potential impact of COVID-19 on Rani’s clinical and preclinical development timelines and results of operations. For a further list and description of the risks and uncertainties Rani faces, please refer to Rani’s periodic and other filings with the Securities and Exchange Commission (SEC), which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Rani assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Investor Contact
Media Relations Contact
RANI THERAPEUTICS HOLDINGS, INC
Condensed Consolidated Balance Sheets
(In thousands, except par value)
| September 30, 2021 |
December 31, 2020 |
|||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 129,743 | $ | 73,058 | ||||
| Related party note receivable | — | 1,720 | ||||||
| Prepaid expenses | 2,622 | 167 | ||||||
| Total current assets | 132,365 | 74,945 | ||||||
| Property and equipment, net | 4,593 | 4,470 | ||||||
| Total assets | $ | 136,958 | $ | 79,415 | ||||
| Liabilities, Convertible Preferred Units and Stockholders’ Equity / Members’ Deficit | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,311 | $ | 537 | ||||
| Related party payable | 290 | 145 | ||||||
| Accrued expenses | 3,649 | 550 | ||||||
| Deferred revenue | — | 2,717 | ||||||
| Current portion of long-term debt | — | 1,359 | ||||||
| Total current liabilities | 5,250 | 5,308 | ||||||
| Preferred unit warrant liability | — | 320 | ||||||
| Long-term debt, less current portion | — | 2,412 | ||||||
| Total liabilities | 5,250 | 8,040 | ||||||
| Commitments and contingencies (Note 10) | ||||||||
| 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 September 30, 2023 | — | — | ||||||
| Class A common stock, $0.0001 par value – 800,000 shares authorized; 19,712 issued and outstanding as of September 30, 2023 | 2 | — | ||||||
| Class B common stock, $0.0001 par value – 40,000 shares authorized; 29,290 issued and outstanding as of September 30, 2023 | 3 | — | ||||||
| Class C common stock, $0.0001 par value – 20,000 shares authorized; none issued and outstanding as of September 30, 2023 | — | — | ||||||
| Additional paid-in capital | 54,503 | — | ||||||
| Accumulated deficit | (3,142 | ) | (114,003 | ) | ||||
| Total stockholders’ equity attributable to Rani Therapeutics Holdings, Inc. / (members’ deficit) | 51,366 | (113,339 | ) | |||||
| Non-controlling interest | 80,342 | — | ||||||
| Total stockholders’ equity / (members’ deficit) | 131,708 | (113,339 | ) | |||||
| Total liabilities, convertible preferred units and stockholders’ equity / (members’ deficit) | $ | 136,958 | $ | 79,415 | ||||
RANI THERAPEUTICS HOLDINGS, INC
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except per share amounts)
(Unaudited)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Contract revenue | $ | — | $ | 108 | $ | 2,717 | $ | 252 | ||||||||
| Operating expenses | ||||||||||||||||
| Research and development | 11,959 | 2,090 | 19,065 | 8,708 | ||||||||||||
| General and administrative | 15,822 | 845 | 21,889 | 3,144 | ||||||||||||
| Total operating expenses | $ | 27,781 | $ | 2,935 | $ | 40,954 | $ | 11,852 | ||||||||
| Loss from operations | (27,781 | ) | (2,827 | ) | (38,237 | ) | (11,600 | ) | ||||||||
| Other income (expense), net | ||||||||||||||||
| Interest income | 13 | 13 | 73 | 87 | ||||||||||||
| Loss on extinguishment of debt | (700 | ) | — | (700 | ) | — | ||||||||||
| Interest expense and other, net | (110 | ) | (64 | ) | (467 | ) | (66 | ) | ||||||||
| Change in estimated fair value of preferred unit warrant | (85 | ) | — | (371 | ) | 655 | ||||||||||
| Loss before income taxes | (28,663 | ) | (2,878 | ) | (39,702 | ) | (10,924 | ) | ||||||||
| Income tax expense | (37 | ) | (5 | ) | (81 | ) | (23 | ) | ||||||||
| Net loss and comprehensive loss | $ | (28,700 | ) | $ | (2,883 | ) | $ | (39,783 | ) | $ | (10,947 | ) | ||||
| Net loss attributable to non-controlling interest | (25,558 | ) | (2,883 | ) | (36,641 | ) | (10,947 | ) | ||||||||
| Net loss attributable to Rani Therapeutics Holdings, Inc. | $ | (3,142 | ) | $ | — | $ | (3,142 | ) | $ | — | ||||||
| Net loss per Class A common share attributable to Rani Therapeutics Holdings, Inc., basic and diluted | $ | (0.16 | ) | $ | (0.16 | ) | ||||||||||
| Weighted-average Class A common shares outstanding—basic and diluted | 19,437 | 19,437 | ||||||||||||||
