Rani Therapeutics Reports First Quarter 2025 Financial Results; Provides Corporate Update

- Announced preclinical data demonstrating the bioequivalence of RT-114, a bispecific GLP-1/GLP-2 receptor agonist (PG-102), delivered orally via the RaniPill$(R)$ capsule, to subcutaneous administration of PG-102 -

- Phase 1 study for RT-114 for the treatment of obesity expected to initiate in mid-2025 -

- Announced preclinical data demonstrating successful oral delivery of semaglutide via RaniPill(R) capsule -

SAN JOSE, Calif., May 13, 2025 (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 first quarter ended March 31, 2025 and provided a corporate update.

"We are encouraged by our progress this quarter, highlighted by promising preclinical data supporting the development of multiple incretin-based therapies using the RaniPill(R) platform. These data serve as preclinical proof of concept for the treatment of obesity bringing us one step closer to our vision of making oral biologics a reality for patients living with obesity," said Talat Imran, Chief Executive Officer of Rani Therapeutics. "In our preclinical study, oral delivery of RT-114 demonstrated pharmacokinetics, bioavailability, and weight loss comparable to subcutaneous injection. Further, our target product profile for RT-114 requires less frequent dosing than current oral options providing a potentially more convenient dosing regimen for patients. Overall, we believe RT-114 has the potential to fill the current gap in the obesity treatment landscape as a first-in-class oral bispecific GLP-1/GLP-2 receptor agonist. Our Phase 1 study of RT-114 is expected to begin later this year."

First Quarter 2025 Highlights:

   -- Preclinical data demonstrating bioequivalence of RT-114, a bispecific 
      GLP-1/GLP-2 receptor agonist (PG-102) delivered orally via the 
      RaniPill(R) capsule, to subcutaneously administered PG-102. In March 
      2025, Rani released new preclinical data, where RT-114 yielded a relative 
      bioavailability of 111% compared to PG-102 delivered subcutaneously with 
      comparable pharmacokinetic profiles demonstrating bioequivalence. Data 
      adds to growing body of evidence of the RaniPill(R) platform's potential 
      to enable oral delivery of multiple obesity treatments. 
 
   -- Preclinical data demonstrating successful oral delivery of semaglutide 
      via RaniPill(R) capsule. In February 2025, Rani released preclinical data 
      that demonstrated semaglutide administered orally via the RaniPill(R) 
      capsule (RT-116) resulted in comparable bioavailability, pharmacokinetics 
      and weight loss to subcutaneous administration of semaglutide. RT-116 was 
      well tolerated with no serious adverse events. 

Near-Term Milestone Expectations:

   -- Initiation of Phase 1 clinical trial of RT-114 for the treatment of 
      obesity expected in mid-2025. 

First Quarter 2025 Financial Results:

   -- Cash, cash equivalents and marketable securities as of March 31, 2025 
      totaled $15.9 million, compared to $27.6 million for the year ended 
      December 31, 2024. 
 
   -- Contract Revenue for the three months ended March 31, 2025 were $0.2 
      million and was attributable to evaluation services performed for a 
      customer. There was no contract revenue for the same period in 2024. 
 
   -- Research and development expenses for the three months ended March 31, 
      2025 were $6.6 million, compared to $7.6 million for the same period in 
      2024. The decrease of $1.0 million was primarily attributable to lower 
      compensation costs. 
 
   -- General and administrative expenses for the three months ended March 31, 
      2025 were $5.6 million, compared to $6.4 million for the same period in 
      2024. The decrease of $0.8 million was primarily attributable to lower 
      compensation costs of $0.4 million and $0.5 million reduction in 
      third-party services. 
 
   -- Net loss for the three months ended March 31, 2025 were $12.7 million, 
      compared to $14.8 million for the same period in 2024, including non-cash 
      stock-based compensation expense of $3.9 million for both comparative 
      periods. 

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(R) 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 has successfully conducted several preclinical and clinical studies to evaluate safety, tolerability and bioavailability using RaniPill(R) capsule technology.

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 1 trial of RT-114 in mid-2025, the potential of the RaniPill(R) platform to enable oral delivery of multiple obesity treatments and validation of such potential through preclinical data, the potential of the RT-114 to offer less frequent and more convenient dosing than current options, the potential for RT-114 to become a first-in-class, orally administered bispecific GLP-1/GLP-2 receptor agonist for the treatment of obesity, the potential for Rani to make oral biologics a reality, the current preclinical data being supportive of development of multiple incretin-based therapies using the RaniPill(R) capsule, the sufficiency of Rani's cash reserves, the timing and extent of its expenses, and future financial performance. 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 "promising," "believe," "potential," "target," "expect," 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 and the other risks described in Rani's filings with the Securities and Exchange Commission, including Rani's annual report on Form 10-K for the year ended December 31, 2024, and subsequent filings and reports by Rani. 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.

Investor Contact:

investors@ranitherapeutics.com

Media Contact:

media@ranitherapeutics.com

 
 
                  RANI THERAPEUTICS HOLDINGS, INC. 
                CONDENSED CONSOLIDATED BALANCE SHEETS 
                   (In thousands, except par value) 
 
                                         March 31,      December 31, 
                                       -------------   -------------- 
                                           2025             2024 
                                       -------------   -------------- 
                                        (Unaudited) 
Assets 
Current assets: 
   Cash and cash equivalents            $     10,111    $       3,762 
   Accounts receivable                           600               -- 
   Contract asset                                 --              428 
   Marketable securities                       5,742           23,877 
   Prepaid expenses and other current 
    assets                                     1,330            1,677 
                                           ---------       ---------- 
     Total current assets                     17,783           29,744 
   Property and equipment, net                 1,348            1,548 
   Operating lease right-of-use asset          4,748            5,096 
   Other assets                                  246              246 
                                           ---------       ---------- 
     Total assets                       $     24,125    $      36,634 
                                           =========       ========== 
Liabilities and Stockholders' Equity 
Current liabilities: 
   Accounts payable                     $      1,520    $       1,359 
   Accrued expenses and other current 
    liabilities                                2,285            2,073 
   Current portion of long-term debt          15,000           15,000 
   Current portion of operating lease 
    liability                                  1,325            1,459 
                                           ---------       ---------- 
     Total current liabilities                20,130           19,891 
   Long-term debt, less current 
    portion                                    5,921            9,613 
   Operating lease liability, less 
    current portion                            3,423            3,637 
                                           ---------       ---------- 
     Total liabilities                        29,474           33,141 
                                           ---------       ---------- 
Stockholders' equity: 
Preferred stock, $0.0001 par value - 
20,000 shares authorized; none 
issued and outstanding as of March 
31, 2025 and December 31, 2024                    --               -- 

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