Press Release: Rani Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results; Provides Corporate Update

Dow Jones
01 Apr

Rani Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results; Provides Corporate Update

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

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

- Preclinical data of four incretin-based molecules underscores the RaniPill(R) platform's potential to facilitate the oral delivery of a diverse array of obesity treatments -

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

- Conference call today at 4:30 p.m. ET / 1:30 p.m. PT -

SAN JOSE, Calif., March 31, 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 quarter and full year ended December 31, 2024 and provided a corporate update.

"We entered 2025 with strong momentum, delivering compelling preclinical data demonstrating the successful delivery of multiple obesity treatments. Our preclinical studies show that RT-114, the RaniPill(R) capsule containing a GLP-1/GLP-2 dual agonist (PG-102), delivered pharmacokinetics, weight loss, and bioavailability comparable to PG-102 administered via subcutaneous injection. Additionally, last month, we shared preclinical data confirming that semaglutide delivered via the RaniPill(R) capsule exhibits similar bioavailability, pharmacokinetics, and weight loss as subcutaneous administration," said Talat Imran, Chief Executive Officer of Rani Therapeutics. "Overall, we are encouraged by our robust preclinical data package across four incretin-based molecules, which highlights the RaniPill(R) platform's potential to effectively enable the oral delivery of multiple obesity treatments, paving the way for more convenient and accessible therapeutic options. Moreover, we are confident that RT-114 has the potential to become a first-in-class, orally administered GLP-1/GLP-2 dual agonist for the treatment of obesity, addressing a crucial gap in the current treatment landscape. As we look ahead, we intend to initiate a Phase 1 study of RT-114 later this year."

Fourth Quarter and Full Year 2024 Highlights:

   -- Positive topline results from phase 1 study of an oral anti-interleukin 
      12/23 antibody (RT-111). In February 2024, Rani announced RT-111 achieved 
      high bioavailability and was well tolerated, with no serious adverse 
      events in humans in a Phase 1 study. 
 
   -- Presentation of clinical and preclinical data on oral delivery of an 
      ustekinumab biosimilar via the RaniPill(R) capsule at Digestive Disease 
      Week 2024. In May 2024, Rani presented preclinical and clinical data 
      demonstrating the delivery of RT-111 with comparable bioavailability 
      relative to subcutaneous (SC) injection of ustekinumab in canines and 
      healthy human participants, respectively. 
 
   -- Partnership with ProGen on development of oral obesity treatment. In June 
      2024, Rani announced that it had entered into a definitive agreement with 
      ProGen Co., Ltd., a South Korean clinical-stage biotech company 
      developing next generation long-acting, multi-specific fusion protein 
      therapeutics, for the co-development and commercialization of RT-114, an 
      oral RaniPill(R) capsule containing ProGen's PG-102, a GLP-1/GLP-2 dual 
      agonist, for the treatment of obesity. 
 
   -- Completed two equity offerings for total gross proceeds of approximately 
      $20.0 million. In July and October 2024, Rani completed the sale and 
      issuance of Class A common stock, pre-funded warrants to purchase Class A 
      common stock, and warrants to purchase Class A common stock, to an 
      institutional investor for total gross proceeds of approximately $20.0 
      million, excluding any potential proceeds from the exercise of warrants, 
      if any. 
 
   -- Preclinical pharmacokinetic data supporting transenteric delivery of 
      GLP-1 incretin triagonist. In October 2024, Rani announced new 
      pharmacokinetic data from a preclinical study evaluating a GLP-1, GIP and 
      glucagon receptors incretin triagonist with a delivery method mimicking 
      the RaniPill(R) route of administration. The data demonstrated that 
      transenteric delivery of incretin triagonist GLP-1, GIP, glucagon 
      receptors elicited rapid weight loss and bioavailability comparable to 
      subcutaneous injection. 
 
   -- Preclinical data demonstrating successful oral delivery of semaglutide 
      via RaniPill(R) HC. In February 2025, Rani released preclinical data that 
      demonstrated semaglutide administered orally via the RaniPill(R) HC 
      (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. 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 bioequivalence of RT-114, a GLP-1/GLP-2 
      dual 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. 

Near-Term Milestone Expectations:

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

Fourth Quarter and Full Year 2024 Financial Results:

   -- Cash, cash equivalents and marketable securities as of December 31, 2024 
      totaled $27.6 million, compared to $48.5 million for the year ended 
      December 31, 2023. Rani expects its cash, cash equivalents and marketable 
      securities to be sufficient to fund its operations into the third quarter 
      of 2025 without additional funding. 
 
   -- Contract Revenue for the three and twelve months ended December 31, 2024 
      were $1.0 million and was attributable to evaluation services performed 
      for a customer. There was no contract revenue for the same periods in 
      2023. 
 
   -- Research and development expenses for the three and twelve months ended 
      December 31, 2024 were $6.8 million and $26.7 million, respectively, 
      compared to $7.6 million and $39.6 million for the same periods in 2023, 
      respectively. The year over year decrease of $12.9 million was primarily 
      attributable to lower compensation costs of $6.3 million due to reduction 
      in workforce, $5.6 million reduction in third-party services and $0.9 
      million reduction in materials and supplies due to the timing of certain 
      preclinical and clinical studies. 
 
   -- General and administrative expenses for the three and twelve months ended 
      December 31, 2024 were $5.5 million and $23.9 million, respectively, 
      compared to $5.8 million and $26.5 million for the same periods in 2023, 
      respectively. The year over year decrease of $2.5 million was primarily 
      attributable to lower compensation costs of $2.0 million due to reduction 
      in workforce, $1.2 million reduction in third-party services and other 
      costs primarily due to lower insurance premiums, offset by an increase in 
      facility costs of $0.7 million due to the lease in Fremont, California. 
 
   -- Impairment Loss for the three and twelve months ended December 31, 2024 
      were $3.7 million and was attributable to construction-in-progress 
      property and equipment. Rani considers many factors in evaluating whether 
      the value of its construction-in-progress property and equipment may not 
      be recoverable, including, but not limited to, alternative use, 
      cost-savings and strategic considerations. As a result, it was determined 
      that the carrying amount of the construction-in-progress property and 
      equipment exceeded its fair value and was written down to its salvage 
      value. There was no impairment loss for the same periods in 2023. 
 
   -- Net loss for the three and twelve months ended December 31, 2024 were 
      $15.7 million and $56.6 million, respectively, compared to $14.1 million 
      and $67.9 million for the same period in 2023, respectively, including 
      non-cash stock-based compensation expense of $4.0 million for the three 
      months ended December 31, 2024 and $16.0 million for the full year 2024, 
      compared to $4.5 million and $19.0 million for the same periods in 2023, 
      respectively. The net loss for the three and twelve months ended December 
      31, 2024 also includes the non-cash impairment loss of $3.7 million, as 
      described above. 

Conference Call

Rani will host a corresponding conference call today at 4:30 p.m. ET / 1:30 p.m. PT to discuss the results and provide a business update. Individuals interested in listening to the live conference call may do so by using the link in the "Investors" 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 following the completion of the call.

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. 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 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 RaniPill(R) platform to offer more convenient and accessible therapeutic options, the potential for RT-114 to become a first-in-class, orally administered GLP-1/GLP-2 dual agonist for the treatment of obesity, 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 "confident, " "intend," "potential," "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. 
                      CONSOLIDATED BALANCE SHEETS 
                   (In thousands, except par value) 
 
                                                   December 31, 
                                               -------------------- 
                                                 2024        2023 
                                               ---------   -------- 
Assets 
Current assets: 
   Cash and cash equivalents                   $   3,762   $  5,864 
   Contract asset                                    428         -- 
   Marketable securities                          23,877     42,675 
   Prepaid expenses and other current assets       1,677      2,308 
                                                --------    ------- 
     Total current assets                         29,744     50,847 
   Property and equipment, net                     1,548      6,105 
   Operating lease right-of-use asset              5,096        718 
   Other assets                                      246        246 
                                                --------    ------- 
     Total assets                              $  36,634   $ 57,916 
                                                ========    ======= 
Liabilities and Stockholders' Equity 
Current liabilities: 
   Accounts payable                            $   1,359   $    648 
   Accrued expenses and other current 
    liabilities                                    2,073      1,726 
   Current portion of long-term debt              15,000      4,897 
   Current portion of operating lease 
    liability                                      1,459        718 
                                                --------    ------- 
     Total current liabilities                    19,891      7,989 
   Long-term debt, less current portion            9,613     24,484 
   Operating lease liability, less current 
   portion                                         3,637         -- 
                                                --------    ------- 
     Total liabilities                            33,141     32,473 
                                                --------    ------- 
Stockholders' equity: 
Preferred stock, $0.0001 par value - 20,000 
shares authorized; none issued and 
outstanding as of December 31, 2024 and 
December 31, 2023                                     --         -- 
Class A common stock, $0.0001 par value - 
 800,000 shares authorized; 33,430 and 26,036 
 issued and outstanding as of December 31, 
 2024 and December 31, 2023, respectively              3          3 
Class B common stock, $0.0001 par value - 
 40,000 shares authorized; 23,972 and 24,116 
 issued and outstanding as of December 31, 
 2024 and December 31, 2023, respectively              2          2 
Class C common stock, $0.0001 par value - 
20,000 shares authorized; none issued and 
outstanding as of December 31, 2024 and 
December 31, 2023                                     --         -- 
   Additional paid-in capital                    104,889     85,762 
   Accumulated other comprehensive gain 
    (loss)                                             5        (12) 
   Accumulated deficit                          (102,907)   (72,889) 
                                                --------    ------- 
   Total stockholders' equity attributable to 
    Rani Therapeutics Holdings, Inc.               1,992     12,866 
   Non-controlling interest                        1,501     12,577 
                                                --------    ------- 
     Total stockholders' equity                    3,493     25,443 
                                                --------    ------- 
     Total liabilities and stockholders' 
      equity                                   $  36,634   $ 57,916 
                                                ========    ======= 
 
 
                 RANI THERAPEUTICS HOLDINGS, INC. 
               CONSOLIDATED STATEMENTS OF OPERATIONS 
              (In thousands, except per share amounts) 
 
                      Three Months Ended    Year Ended December 
                         December 31,               31, 
                     --------------------   -------------------- 
                       2024       2023        2024       2023 
                     --------   ---------   --------   --------- 
Contract revenue     $  1,028   $      --   $  1,028   $      -- 
Operating expenses 
   Research and 
    development         6,810       7,606     26,682      39,624 
   General and 
    administrative      5,462       5,829     23,946      26,475 
   Impairment loss      3,714          --      3,714          -- 
                      -------    --------    -------    -------- 
     Total 
      operating 
      expenses       $ 15,986   $  13,435   $ 54,342   $  66,099 
                      -------    --------    -------    -------- 
      Loss from 
       operations     (14,958)    (13,435)   (53,314)    (66,099) 
Other income 
(expense), net 
   Interest income 
    and other, net        361         676      1,763       3,301 
   Interest expense 
    and other, net     (1,124)     (1,296)    (5,033)     (5,085) 
                      -------    --------    -------    -------- 
Net loss             $(15,721)  $ (14,055)  $(56,584)  $ (67,883) 
  Net loss 
   attributable to 
   non-controlling 
   interest            (6,775)     (6,956)   (26,566)    (33,913) 
                      -------    --------    -------    -------- 
Net loss 
 attributable to 
 Rani Therapeutics 
 Holdings, Inc.      $ (8,946)  $  (7,099)  $(30,018)  $ (33,970) 
                      =======    ========    =======    ======== 
  Net loss per 
   Class A common 
   share 
   attributable to 
   Rani 
   Therapeutics 
   Holdings, Inc., 
   basic and 
   diluted           $  (0.27)  $   (0.27)  $  (1.05)  $   (1.33) 
                      =======    ========    =======    ======== 
Weighted-average 
 Class A common 
 shares 
 outstanding--basic 
 and diluted           32,660      25,874     28,476      25,505 
                      =======    ========    =======    ======== 
 

(END) Dow Jones Newswires

March 31, 2025 16:05 ET (20:05 GMT)

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