Rani Therapeutics Reports Third Quarter 2024 Financial Results; Provides Corporate Update

- Completed two equity offerings with total gross proceeds of approximately $20.0 million; cash runway extended into 3Q 2025 -

- Announced new preclinical pharmacokinetic data supporting transenteric delivery of GLP-1 incretin triagonist -

- Phase 1 study for RT-114, an oral GLP-1/GLP-2 dual agonist for the treatment of obesity, expected to initiate in 2025 -

SAN JOSE, Calif., Nov. 14, 2024 (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 September 30, 2024 and provided a corporate update.

"We are pleased with the progress we have made this quarter headlined by new preclinical pharmacokinetic data supporting the transenteric delivery of a GLP-1 incretin triagonist. This data, combined with the previously announced pharmacodynamic data from the study, underscores the potential of the RaniPill$(R)$ to contribute to the GLP-1 receptor agonist space and the broader obesity therapeutics market," said Talat Imran, Chief Executive Officer of Rani. "Additionally, we raised $20 million in aggregate gross proceeds from financings in July and October, enabling us to extend our cash runway into the third quarter of 2025. Looking ahead, we are excited to start our Phase 1 trial of RT-114 containing a GLP-1/GLP-2 dual agonist for the treatment of obesity next year."

Third Quarter 2024 and Subsequent Highlights:

   -- Announced new 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 pharmacokinetic 
      data provides further evidence of the RaniPill(R) platform's potential to 
      enable oral delivery of multiple obesity treatments. 
 
   -- Completed two equity offerings for total gross proceeds of approximately 
      $20.0 million. In equity offerings 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. 

Near-Term Milestone Expectations:

   -- Initiation of Phase 1 clinical trial of RT-114 containing a GLP-1/GLP-2 
      dual agonist for the treatment of obesity expected in 2025. 

Third Quarter 2024 Financial Results:

   -- Cash, cash equivalents and marketable securities as of September 30, 2024 
      totaled $30.4 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. 
 
   -- Research and development expenses for the three months ended September 
      30, 2024 were $6.2 million, compared to $11.2 million for the same period 
      in 2023. The decrease of $5.0 million in research and development 
      expenses in the three months ended September 30, 2024, as compared to the 
      same period in 2023, was primarily attributed to lower compensation costs 
      of $1.9 million due to reduction in workforce, $2.7 million reduction in 
      third-party services and $0.4 million reduction in materials and supplies 
      due to the timing of certain preclinical and clinical studies. 
 
   -- General and administrative expenses for the three months ended September 
      30, 2024 were $5.6 million, compared to $6.6 million for the same period 
      in 2023. The decrease of $1.0 million in general and administrative 
      expenses in the three months ended September 30, 2024, as compared to the 
      same period in 2023, was primarily attributed to lower compensation costs 
      of $0.5 million due to reduction in workforce, $0.4 million reduction in 
      third-party services due to lower directors and officers insurance 
      premiums and $0.3 million reduction in other costs, offset by an increase 
      in facility costs of $0.2 million due to the lease in Fremont, 
      California. 
 
   -- Net loss for the three months ended September 30, 2024 was $12.7 million, 
      compared to $18.3 million for the same period in 2023, including 
      stock-based compensation expense of $4.1 million for the three months 
      ended September 30, 2024, compared to $5.0 million for the same period in 
      2023. 

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 2025, the potential of the RaniPill(R) platform to contribute to the GLP-1 receptor agonist space and broader obesity therapeutics market, the potential of the RaniPill(R) platform to enable oral delivery of multiple obesity treatments. 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 "intend," "looking ahead," "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, 2023, 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) 
 
                                      September 30,     December 31, 
                                     ---------------   -------------- 
                                          2024              2023 
                                     ---------------   -------------- 
                                       (Unaudited) 
Assets 
Current assets: 
   Cash and cash equivalents          $        4,277    $       5,864 
   Marketable securities                      26,127           42,675 
   Prepaid expenses and other 
    current assets                             1,967            2,308 
                                         -----------       ---------- 
     Total current assets                     32,371           50,847 
   Property and equipment, net                 5,496            6,105 
   Operating lease right-of-use 
    asset                                      5,427              718 
   Other assets                                  246              246 
                                         -----------       ---------- 
     Total assets                     $       43,540    $      57,916 
                                         ===========       ========== 
Liabilities and Stockholders' 
Equity 
Current liabilities: 
   Accounts payable                   $        1,566    $         648 
   Accrued expenses and other 
    current liabilities                        1,867            1,726 
   Deferred revenue                              600               -- 
   Current portion of long-term 
    debt                                      14,768            4,897 
   Current portion of operating 
    lease liability                            1,410              718 
                                         -----------       ---------- 
     Total current liabilities                20,211            7,989 
   Long-term debt, less current 
    portion                                   13,537           24,484 
   Operating lease liability, less 
   current portion                             4,017               -- 
                                         -----------       ---------- 
     Total liabilities                        37,765           32,473 
                                         -----------       ---------- 
Stockholders' equity: 

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