- Preliminary feedback from FDA on RT-102 development plans; 505(b)(2) pathway for RT-102 could be suitable -
- Multiple anticipated clinical milestones expected in 2023, including initiation of Phase 2 study of RT-102 in osteoporosis -
Pipeline Updates:
- Preliminary feedback received from the FDA on future development of RT-102. Following feedback from a pre-IND meeting with the FDA, Rani believes that a 505(b)(2) pathway is suitable for the development of RT-102 in the
U.S. In addition, Rani obtained guidance from the FDA on its preclinical and clinical development plans for RT-102, including the Phase 2 clinical trial which is expected to initiate in the second half of 2023. - Announced topline results from Phase 1 study of RT-102. In
December 2022 , Rani announced positive topline results from Part 2 (repeat-dose portion) of the Phase 1 study of RT-102. RT-102 is being developed for the treatment of osteoporosis. The study achieved all of its endpoints, with repeat doses of RT-102 being generally well tolerated and delivering drug with high reliability to participants via the RaniPill™ GO.
“We thank FDA for its feedback and helping us chart the path forward for RT-102. As we enter 2023, Rani has multiple upcoming clinical milestones that we believe could be transformative for the company, including the initiation of a Phase 2 trial for RT-102 - our first Phase 2 trial - and the initiation of three additional Phase 1 studies, including two antibody programs,” said
Near-Term Milestone Expectations:
- RT-102 – Phase 2 initiation in the second half of 2023
- Initiation of three additional Phase 1 studies in 2023 with pipeline molecules:
- RT-105 containing an adalimumab biosimilar
- RT-110 containing PTH for hypo-parathyroidism
- RT-111 containing an ustekinumab biosimilar for psoriatic arthritis, ulcerative colitis, Crohn’s disease and psoriasis
Preliminary Unaudited Cash Position:
- Rani has approximately
$99 million in cash, cash equivalents, restricted cash equivalents and marketable securities as ofDecember 31, 2022 . This estimate of the Company’s cash, cash equivalents, restricted cash equivalents and marketable securities as ofDecember 31, 2022 is preliminary, unaudited and is subject to change upon completion of the Company’s financial statement closing procedures and the audit of the Company’s consolidated financial statements.
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 expected initiation of a Phase 2 trial of RT-102 in 2023, the expected initiation of additional Phase 1 trials of other product candidates in 2023, the impact achievement of upcoming clinical milestones could have on the business of the Company, the potential suitability of the 505(b)(2) pathway for RT-102 or other Rani programs, the ability of the data from the Phase 1 study of RT-102 to support progressing to a Phase 2 trial of RT-102, and the preliminary cash position of the 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,” “anticipate,” “believe,” “look forward,” “progress,” “advance,” “potential”, “be able to” 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
Investor Contact:
investors@ranitherapeutics.com
Media Contact:
media@ranitherapeutics.com
Source:
2023 GlobeNewswire, Inc., source