Financial Performance Overview

Revenue and Profit Trends

Rani’s net loss for the three months ended March 31, 2024 was $14.8 million, compared to $16.8 million for the same period in 2023. The decreased net loss was primarily due to lower operating expenses.

The company currently does not generate any revenue and does not expect to do so until one of its product candidates receives regulatory approval.

Expenses

Total operating expenses for the three months ended March 31, 2024 were $14.0 million, a 15% decrease from $16.5 million for the same period in 2023.

Research and Development Expenses

Research and development expenses decreased by 22% to $7.6 million for the three months ended March 31, 2024, from $9.7 million for the same period in 2023. The decrease was primarily due to lower compensation costs from a reduction in workforce and reduced third-party services.

General and Administrative Expenses

General and administrative expenses decreased by 5% to $6.4 million for the three months ended March 31, 2024, from $6.8 million for the same period in 2023. The decrease was primarily due to lower compensation costs from a reduction in workforce.

Liquidity and Capital Resources

As of March 31, 2024, Rani had $39.6 million in cash, cash equivalents and marketable securities. The company expects continued losses for the foreseeable future and the existing capital resources will not be sufficient for Rani to initiate any pivotal clinical trials.

In November 2023, Rani conducted a restructuring to prioritize programs, expand manufacturing, and streamline operations. The restructuring included a 25% reduction in workforce.

Rani will need to raise substantial additional funds in the future through equity or debt financing. If unable to raise additional funds, Rani may have to delay, reduce or terminate some or all of its development programs and clinical trials.

RT-111 Phase 1 Results

In February 2024, Rani announced positive topline results from a Phase 1 study of RT-111 for inflammatory conditions. RT-111 met all study endpoints and was generally well tolerated.

Lease Agreement

In November 2023, Rani entered into a 63-month lease for approximately 33,000 square feet of space in Fremont, California to serve as additional manufacturing capacity.

Outlook

Rani is focusing its resources on developing its lead product candidate, RT-111. Continued funding needs pose substantial doubt about Rani’s ability to continue operations over the next year. The company’s success is dependent on progress in clinical and regulatory initiatives.

Strengths and Weaknesses

Strengths

• Novel and versatile oral biologics delivery technology with the RaniPill capsule
• Pipeline of product candidates for large market opportunities
• Strategic manufacturing capabilities and capacity

Weaknesses

• No approved products and early stages of clinical development
• History of operating losses and need to raise substantial additional funding
• Business highly dependent on success of lead product candidate RT-111

Tables

Financial Metric	March 31, 2024	December 31, 2023
Cash and cash equivalents	$6.9 million	$5.9 million
Marketable securities	$32.7 million	$42.7 million
Total cash, cash equivalents and marketable securities	$39.6 million	$48.5 million

Expense	Three Months Ended March 31, 2024	Three Months Ended March 31, 2023	Change
Research and development	$7.6 million	$9.7 million	Decreased by 22%
General and administrative	$6.4 million	$6.8 million	Decreased by 5%
Total operating expenses	$14.0 million	$16.5 million	Decreased by 15%