Rani Therapeutics Reports Second Quarter 2023 Financial Results; Provides Corporate Update
- Expansion of partnership with Celltrion for development of RT-105 to complement existing partnership for RT-111
- Appointment of Kate McKinley as Chief Business Officer
- Presentation of three abstracts on RT-102 and RT-112 at the Endocrine Society Annual Conference and selection as winner of Presidential Poster Competition in its category for exceptional scientific work on RT-102
- Presentation of late-breaking abstract on oral delivery of GLP-1 agonist at American Diabetes Association’s Scientific Sessions
- Plan to initiate Phase 2 study for RT-102 and Phase 1 study for RT-111 in 2H of 2023
SAN JOSE, Calif., Aug. 11, 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 and drugs, today reported financial results for the quarter ended June 30, 2023, and provided a corporate update.
“We are thrilled to have the opportunity to build upon our existing partnership with Celltrion,” said Talat Imran, Chief Executive Officer of Rani. “The partnership to develop RT-105 is our first involving the RaniPill®HC, a high-capacity device that is designed to deliver up to a
Second Quarter or Subsequent Highlights:
- Announced expansion of partnership with Celltrion to include adalimumab biosimilar for RT-105. This is the second deal announced between Rani and Celltrion, building upon a previously announced partnership for ustekinumab biosimilar for RT-111. Under the terms of the new license and supply agreement announced in June 2023, Celltrion will exclusively supply to Rani the adalimumab biosimilar drug substance (CT-P17) required for RT-105. Rani is granted an exclusive license to use CT-P17 in the development and commercialization of RT-105, and Celltrion is granted a right of first negotiation to acquire worldwide rights to RT-105 following a Phase 1 study.
- Appointed Kate McKinley as Chief Business Officer. In May 2023, Ms. McKinley joined Rani’s executive leadership team bringing with her 20 years of biopharmaceutical industry experience. She has proven success in securing global partnerships and executing regulatory and commercial strategies with respect to biologics, cell therapies and small molecules across multiple therapeutic areas.
- Presented three abstracts at Endocrine Society Annual Conference (ENDO). Rani presented two abstracts on RT-102, an orally administered version of human parathyroid hormone analog teriparatide, which is being developed as an osteoanabolic therapy for osteoporosis. Both abstracts were nominated for ENDO’s Presidential Poster Competition and one of which was named the winner of the competition in the area of Bone and Mineral Metabolism. The Endocrine Society committee recognized Rani for its exceptional scientific work on RT-102. Rani presented a third abstract on an orally administered, follicle-stimulating hormone biosimilar and patient preference which reported that a vast majority (
91% ) of patients surveyed preferred an oral pill over parenteral injection. - Presented late-breaking abstract on the oral delivery of GLP-1 agonist at the American Diabetes Association Annual Conference (ADA). The abstract focused on the oral delivery of a GLP-1 agonist with high bioavailability in dogs and humans.
Near-Term Milestone Expectations:
- Initiation of Phase 2 study of RT-102 for osteoporosis expected in the second half of 2023
- Initiation of Phase 1 study of RT-111 containing an ustekinumab biosimilar in the second half of 2023
Second Quarter Financial Results:
- Cash, cash equivalents and marketable securities as of June 30, 2023, totaled
$74.6 million , compared to cash, cash equivalents and marketable securities of$98.5 million for the year ended December 31, 2022. Rani expects its cash, cash equivalents and marketable securities to be sufficient to fund its operations through at least the next twelve months. - Research and development expenses for the three months ended June 30, 2023, were
$11.1 million , compared to$9.5 million for the same period in 2022. The increase was primarily attributed to higher compensation costs of$1.4 million , which includes an increase of$0.2 million in stock-based compensation, due to headcount growth. - General and administrative expenses for the three months ended June 30, 2023, were
$7.2 million , compared to$6.3 million for the same period in 2022. The increase was primarily attributed to higher compensation costs of$1.2 million , which includes an increase of$0.9 million in stock-based compensation, due to headcount growth, partially offset by a decrease in third-party services of$0.3 million due to non-recurring public company-related costs. - Net loss for the three months ended June 30, 2023, was
$18.7 million , compared to$16.0 million for the same period in 2022, including non-cash charges primarily attributed to stock-based compensation expense of$4.8 million for the three months ended June 30, 2023, compared to$4.1 million for the same period in 2022.
About Rani Therapeutics
Rani Therapeutics is a clinical-stage biotherapeutics company focused on advancing technologies to enable the development of orally administered biologics and drugs. Rani has developed the RaniPill® capsule, which is a novel, proprietary and patented platform technology, intended to replace subcutaneous injection or intravenous infusion of biologics and drugs with oral dosing. Rani is progressing two RaniPill® capsules, the RaniPill®GO and the RaniPill®HC. Rani has successfully conducted several preclinical and clinical studies to evaluate safety, tolerability and bioavailability using RaniPill capsule technology. For more information, visit 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 potential for the partnerships with Celltrion to deliver value, the advancement of Rani’s pipeline and RaniPill® platform technology including the RaniPill®HC, the potential of the RaniPill®HC to deliver
Investor Contact:
investors@ranitherapeutics.com
Media Contact:
| RANI THERAPEUTICS HOLDINGS, INC Condensed Consolidated Balance Sheets (In thousands, except par value) | ||||||||
| June 30, | December 31, | |||||||
| 2023 | 2022 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 7,552 | $ | 27,007 | ||||
| Marketable securities | 67,054 | 71,475 | ||||||
| Prepaid expenses and other current assets | 1,768 | 2,442 | ||||||
| Total current assets | 76,374 | 100,924 | ||||||
| Property and equipment, net | 5,939 | 6,038 | ||||||
| Operating lease right-of-use asset | 1,194 | 1,065 | ||||||
| Total assets | $ | 83,507 | $ | 108,027 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,037 | $ | 1,460 | ||||
| Accrued expenses and other current liabilities | 3,842 | 2,349 | ||||||
| Operating lease liability, current portion | 856 | 1,006 | ||||||
| Total current liabilities | 5,735 | 4,815 | ||||||
| Operating lease liability, less current portion | 338 | 59 | ||||||
| Long-term debt | 29,265 | 29,149 | ||||||
| Total liabilities | 35,338 | 34,023 | ||||||
| Stockholders' equity: | ||||||||
| Preferred stock, | — | — | ||||||
| Class A common stock, | 3 | 3 | ||||||
| Class B common stock, | 2 | 2 | ||||||
| Class C common stock, | — | — | ||||||
| Additional paid-in capital | 80,746 | 75,842 | ||||||
| Accumulated other comprehensive loss | (63 | ) | (73 | ) | ||||
| Accumulated deficit | (56,594 | ) | (38,919 | ) | ||||
| Total stockholders' equity attributable to Rani Therapeutics Holdings, Inc. | 24,094 | 36,855 | ||||||
| Non-controlling interest | 24,075 | 37,149 | ||||||
| Total stockholders' equity | 48,169 | 74,004 | ||||||
| Total liabilities and stockholders' equity | $ | 83,507 | $ | 108,027 | ||||
| RANI THERAPEUTICS HOLDINGS, INC Condensed Consolidated Statements of Operations (In thousands, except per share amounts) (Unaudited) | ||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Operating expenses | ||||||||||||||||
| Research and development | 11,086 | 9,528 | $ | 20,798 | $ | 17,118 | ||||||||||
| General and administrative | 7,208 | 6,319 | 14,012 | 12,509 | ||||||||||||
| Total operating expenses | $ | 18,294 | $ | 15,847 | $ | 34,810 | $ | 29,627 | ||||||||
| Loss from operations | (18,294 | ) | (15,847 | ) | (34,810 | ) | (29,627 | ) | ||||||||
| Other income (expense), net | ||||||||||||||||
| Interest income and other, net | 896 | 35 | 1,787 | 50 | ||||||||||||
| Interest expense and other, net | (1,266 | ) | — | (2,473 | ) | — | ||||||||||
| Loss before income taxes | (18,664 | ) | (15,812 | ) | (35,496 | ) | (29,577 | ) | ||||||||
| Income tax expense | — | (154 | ) | — | (217 | ) | ||||||||||
| Net loss | $ | (18,664 | ) | $ | (15,966 | ) | $ | (35,496 | ) | $ | (29,794 | ) | ||||
| Net loss attributable to non-controlling interest | (9,361 | ) | (8,342 | ) | (17,821 | ) | (15,947 | ) | ||||||||
| Net loss attributable to Rani Therapeutics Holdings, Inc. | $ | (9,303 | ) | $ | (7,624 | ) | $ | (17,675 | ) | $ | (13,847 | ) | ||||
| Net loss per Class A common share attributable to Rani Therapeutics Holdings, Inc., basic and diluted | $ | (0.37 | ) | $ | (0.31 | ) | $ | (0.70 | ) | $ | (0.60 | ) | ||||
| Weighted-average Class A common shares outstanding—basic and diluted | 25,345 | 24,371 | 25,293 | 22,930 | ||||||||||||
