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

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Rani Therapeutics (NASDAQ: RANI) reported Q3 2024 financial results and corporate updates. The company completed two equity offerings raising $20.0 million in gross proceeds, extending cash runway into Q3 2025. Cash position was $30.4 million as of September 30, 2024. Q3 net loss decreased to $12.7 million from $18.3 million year-over-year. R&D expenses decreased to $6.2 million from $11.2 million, while G&A expenses reduced to $5.6 million from $6.6 million. The company announced new preclinical data supporting transenteric delivery of GLP-1 incretin triagonist and plans to initiate Phase 1 trial of RT-114 for obesity treatment in 2025.

Rani Therapeutics (NASDAQ: RANI) ha riportato i risultati finanziari e le novità aziendali per il terzo trimestre del 2024. L'azienda ha completato due offerte di capitale raccogliendo 20,0 milioni di dollari in proventi lordi, estendendo così il proprio margine di liquidità fino al terzo trimestre del 2025. La posizione di liquidità era di 30,4 milioni di dollari al 30 settembre 2024. La perdita netta nel terzo trimestre è diminuita a 12,7 milioni di dollari rispetto ai 18,3 milioni di dollari dell'anno precedente. Le spese per la ricerca e sviluppo sono scese a 6,2 milioni di dollari dai 11,2 milioni di dollari, mentre le spese generali e amministrative si sono ridotte a 5,6 milioni di dollari dai 6,6 milioni di dollari. L'azienda ha annunciato nuovi dati preclinici a sostegno della somministrazione transenterica del triagonista GLP-1 e prevede di avviare una sperimentazione di Fase 1 del RT-114 per il trattamento dell'obesità nel 2025.

Rani Therapeutics (NASDAQ: RANI) informó los resultados financieros del tercer trimestre de 2024 y actualizaciones corporativas. La compañía completó dos ofertas de acciones, recaudando 20,0 millones de dólares en ingresos brutos, extendiendo así su tiempo de liquidez hasta el tercer trimestre de 2025. La posición de efectivo era de 30,4 millones de dólares al 30 de septiembre de 2024. La pérdida neta del tercer trimestre se redujo a 12,7 millones de dólares desde 18,3 millones de dólares en comparación con el año anterior. Los gastos de I+D disminuyeron a 6,2 millones de dólares desde 11,2 millones de dólares, mientras que los gastos generales y administrativos se redujeron a 5,6 millones de dólares desde 6,6 millones de dólares. La compañía anunció nuevos datos preclínicos que apoyan la entrega transentérica del triagonista de GLP-1 y planea iniciar un ensayo de Fase 1 del RT-114 para el tratamiento de la obesidad en 2025.

라니 테라퓨틱스 (NASDAQ: RANI)는 2024년 3분기 재무 결과 및 기업 업데이트를 발표했습니다. 이 회사는 2회의 주식 공모를 완료하여 2천만 달러의 순수익을 올리며 2025년 3분기까지 자금 여유를 확보했습니다. 2024년 9월 30일 기준으로 현금 보유액은 3천만 4백만 달러였습니다. 3분기 순손실은 전년 동기 대비 1천2백70만 달러로 1천8백30만 달러에서 감소했습니다. R&D 비용은 1천2백만 달러에서 620만 달러로 줄어들었고, 일반 관리비는 660만 달러에서 560만 달러로 감소했습니다. 이 회사는 GLP-1 인크레틴 트리아곤스트를 통한 장 중 투여를 지원하는 새로운 비임상 데이터와 2025년에 비만 치료를 위한 RT-114의 1상 시험을 시작할 계획을 발표했습니다.

Rani Therapeutics (NASDAQ: RANI) a annoncé les résultats financiers et les mises à jour de l'entreprise pour le troisième trimestre 2024. La société a complété deux offres d'actions, levant 20,0 millions de dollars de produits bruts, prolongeant ainsi sa trésorerie jusqu'au troisième trimestre 2025. La position de trésorerie s'élevait à 30,4 millions de dollars au 30 septembre 2024. La perte nette du troisième trimestre a diminué à 12,7 millions de dollars contre 18,3 millions de dollars l'année précédente. Les dépenses de R&D ont diminué à 6,2 millions de dollars contre 11,2 millions de dollars, tandis que les dépenses générales et administratives ont été réduites à 5,6 millions de dollars contre 6,6 millions de dollars. L'entreprise a annoncé de nouvelles données précliniques soutenant l'administration transentérique du triagoniste GLP-1 et prévoit de lancer un essai de Phase 1 de RT-114 pour le traitement de l'obésité en 2025.

Rani Therapeutics (NASDAQ: RANI) hat die finanziellen Ergebnisse und Unternehmensupdates für das dritte Quartal 2024 veröffentlicht. Das Unternehmen hat zwei Aktienangebote abgeschlossen und dabei 20,0 Millionen Dollar an Bruttoeinnahmen erzielt, wodurch die Liquidität bis zum dritten Quartal 2025 verlängert wurde. Die liquide Mittel lagen am 30. September 2024 bei 30,4 Millionen Dollar. Der Verlust im dritten Quartal verringerte sich auf 12,7 Millionen Dollar gegenüber 18,3 Millionen Dollar im Vorjahr. Die F&E-Ausgaben sanken auf 6,2 Millionen Dollar von 11,2 Millionen Dollar, während die allgemeinen und administrativen Kosten auf 5,6 Millionen Dollar von 6,6 Millionen Dollar reduziert wurden. Das Unternehmen gab neue präklinische Daten zur Unterstützung der transenterischen Abgabe des GLP-1-Incretin-Triagonisten bekannt und plant, 2025 eine Phase-1-Studie von RT-114 zur Behandlung von Fettleibigkeit zu starten.

Positive
  • Raised $20.0 million through equity offerings extending cash runway into Q3 2025
  • Net loss decreased by $5.6 million year-over-year to $12.7 million
  • R&D expenses reduced by $5.0 million to $6.2 million
  • G&A expenses decreased by $1.0 million to $5.6 million
Negative
  • Cash position declined from $48.5 million (Dec 2023) to $30.4 million (Sep 2024)
  • Potential shareholder dilution from equity offerings and warrants
  • Continued operating losses with $12.7 million net loss in Q3

Insights

The Q3 results reveal both challenges and strategic moves. The $20M raised through equity offerings provides important runway extension into Q3 2025, but comes at the cost of dilution through stock and warrant issuances. Operating expenses show significant cost-cutting efforts, with R&D expenses down $5M (44.6%) and G&A expenses reduced by $1M (15.2%) year-over-year. However, the substantial net loss of $12.7M, though improved from last year's $18.3M and cash position decline to $30.4M from $48.5M indicate ongoing financial pressure. The workforce reduction signals aggressive cost management but could impact development timelines. The company's focus on GLP-1 related therapeutics aligns with a hot market segment, but significant capital needs persist.

The preclinical pharmacokinetic data for the GLP-1 incretin triagonist delivery system represents a potentially significant advancement in oral biologics delivery. The RaniPill® platform's demonstration of transenteric delivery capability for multiple obesity treatments could be transformative in a market dominated by injectable GLP-1 drugs. The planned Phase 1 trial of RT-114, a GLP-1/GLP-2 dual agonist for obesity treatment, marks a important step toward clinical validation. However, the timeline push to 2025 for trial initiation suggests some development delays. The company's strategic focus on the booming obesity therapeutics market is well-timed, but success will depend on translating preclinical results into human clinical outcomes.

- 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® 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® route of administration. The pharmacokinetic data provides further evidence of the RaniPill® 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® 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® 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® platform to contribute to the GLP-1 receptor agonist space and broader obesity therapeutics market, the potential of the RaniPill® 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:      
Preferred stock, $0.0001 par value - 20,000 shares authorized; none issued and outstanding as of September 30, 2024 and December 31, 2023      
Class A common stock, $0.0001 par value - 800,000 shares authorized; 29,807 and 26,036 issued and outstanding as of September 30, 2024 and December 31, 2023, respectively  3   3 
Class B common stock, $0.0001 par value - 40,000 shares authorized; 24,116 issued and outstanding as of September 30, 2024 and December 31, 2023  2   2 
Class C common stock, $0.0001 par value - 20,000 shares authorized; none issued and outstanding as of September 30, 2024 and December 31, 2023      
Additional paid-in capital  97,067   85,762 
Accumulated other comprehensive gain (loss)  8   (12)
Accumulated deficit  (93,960)  (72,889)
Total stockholders' equity attributable to Rani Therapeutics Holdings, Inc.  3,120   12,866 
Non-controlling interest  2,655   12,577 
Total stockholders' equity  5,775   25,443 
Total liabilities and stockholders' equity $43,540  $57,916 


RANI THERAPEUTICS HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(Unaudited)
 
  Three Months Ended
September 30,
  Nine Months Ended
September 30,
 
  2024  2023  2024  2023 
Operating expenses            
Research and development $6,172  $11,220  $19,872  $32,018 
General and administrative  5,627   6,635   18,484   20,647 
Total operating expenses $11,799  $17,855  $38,356  $52,665 
Loss from operations  (11,799)  (17,855)  (38,356)  (52,665)
Other income (expense), net            
Interest income and other, net  414   839   1,403   2,626 
Interest expense and other, net  (1,337)  (1,316)  (3,909)  (3,789)
Net loss $(12,722) $(18,332) $(40,862) $(53,828)
Net loss attributable to non-controlling interest  (5,939)  (9,135)  (19,791)  (26,956)
Net loss attributable to Rani Therapeutics Holdings, Inc. $(6,783) $(9,197) $(21,071) $(26,872)
Net loss per Class A common share attributable to Rani Therapeutics Holdings, Inc., basic and diluted $(0.24) $(0.36) $(0.78) $(1.06)
Weighted-average Class A common shares outstanding—basic and diluted  28,836   25,552   27,071   25,380 

FAQ

What was Rani Therapeutics (RANI) net loss in Q3 2024?

Rani Therapeutics reported a net loss of $12.7 million for Q3 2024, compared to $18.3 million in Q3 2023.

How much cash does RANI have as of September 30, 2024?

Rani Therapeutics had $30.4 million in cash, cash equivalents and marketable securities as of September 30, 2024.

When will Rani Therapeutics start the Phase 1 trial for RT-114?

Rani Therapeutics expects to initiate the Phase 1 clinical trial of RT-114, a GLP-1/GLP-2 dual agonist for obesity treatment, in 2025.

How much did RANI raise in their 2024 equity offerings?

Rani Therapeutics raised approximately $20.0 million in gross proceeds through two equity offerings completed in July and October 2024.

Rani Therapeutics Holdings, Inc.

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