Rani Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results; Provides Corporate Update

Rhea-AI Summary

Rani Therapeutics reported positive topline results from Phase 1 study of RT-111, an oral anti-Interleukin 12/23 antibody, and preclinical data on GLP-1 Incretin Triagonist. Cash runway extended to 2025. Financial results show a decrease in cash and an increase in R&D and G&A expenses. Key milestones include RaniPill HC Phase 1 trials and Phase 2 trial of RT-102 in 2024.

Positive

• Positive topline results from Phase 1 study of RT-111
• Successful oral delivery of Humira® in preclinical study
• Expansion of manufacturing and strategic program prioritization
• Upcoming milestones for RaniPill HC and RT-102 in 2024

Negative

• Decrease in cash, cash equivalents, and marketable securities
• Increase in research and development expenses
• Increase in net loss for the year ended December 31, 2023

Medical Research Analyst

The recent announcement by Rani Therapeutics regarding the successful Phase 1 study of RT-111, an oral Anti-Interleukin 12/23 antibody, is a significant milestone in the field of drug delivery systems. The ability to transform injectable large molecules into oral pills could revolutionize the administration of biologics, potentially improving patient compliance and accessibility. The reported high bioavailability and safety profile underscore the potential of the RaniPill technology to disrupt the market, particularly for chronic conditions where long-term treatment adherence is essential.

Furthermore, the preclinical pharmacodynamic data showing rapid weight loss in animal studies through the transenteric delivery of a GLP-1 incretin triagonist indicates the platform's versatility. This could open up new avenues for oral therapies in the treatment of obesity, a condition with a high prevalence and significant market demand for effective and convenient treatments.

From a financial perspective, the strategic prioritization of key development programs and expansion of manufacturing capabilities, coupled with cost reduction initiatives, suggest a focused approach to managing resources. The extended cash runway into 2025 provides Rani Therapeutics with a buffer to continue their research and development efforts without the immediate pressure of fundraising. However, investors should monitor the progress of the RaniPill HC towards Phase 1 clinical trials and the initiation of the Phase 2 clinical trial of RT-102 for osteoporosis, as these milestones will be critical in determining the company's future trajectory and market potential.

Financial Analyst

Examining Rani Therapeutics' financial results, the decrease in cash reserves from $98.5 million to $48.5 million year-over-year raises questions about the company's burn rate and the sustainability of its operations. However, the anticipated cost savings and strategic program prioritization appear to be a proactive measure to extend the company's financial runway. The increase in research and development expenses aligns with the company's continued investment in its pipeline, which is essential for future growth.

It is also noteworthy that the net loss has increased compared to the previous year, which is not uncommon for clinical-stage biotech companies focused on research and development. The stock-based compensation expense, a non-cash item, has also risen, which could be indicative of efforts to retain key personnel during this critical phase. Investors should consider the balance between the company's spending on development and the potential for these investments to yield approved products and generate revenue in the long-term.

Pharmaceutical Market Analyst

The oral delivery of biologics represents a significant unmet need in the pharmaceutical industry. Rani Therapeutics' progress in this area, particularly with the RaniPill platform, positions the company in a potentially lucrative segment of the market. The oral delivery of drugs like Humira® through the RaniPill HC in preclinical studies suggests that the technology could be applied to a range of high-value biologics currently limited to injectable forms.

The company's focus on diseases with large patient populations, such as obesity and osteoporosis, indicates a strategic targeting of markets with substantial growth opportunities. The successful translation of these technologies from preclinical to clinical stages and ultimately to market approval could capture significant market share. However, the competitive landscape, including the emergence of biosimilars and alternative drug delivery systems, should be carefully monitored as they may impact the company's positioning and pricing power.

- Announced Positive Topline Results from Phase 1 Study of an Oral Anti-Interleukin 12/23 Antibody (RT-111) -

- Announced Preclinical Pharmacodynamic Data on Transenteric Delivery of GLP-1 Incretin Triagonist -

- Cash runway extended into 2025 -

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

SAN JOSE, Calif., March 20, 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 and full year ended December 31, 2023 and provided a corporate update.

“We have kicked off 2024 with positive momentum announcing positive topline results from our Phase 1 study for RT-111, which serves as our third successfully completed Phase 1 trial using RaniPill technology,” said Talat Imran, Chief Executive Officer of Rani. “The results of our Phase 1 study for RT-111 provide validation that our platform can transform injectable large molecules into convenient, oral pills. We are committed to our vision of making oral biologics a reality across a wide variety of indications. Looking ahead, we continue development of the RaniPill HC to be ready for potential Phase 1 clinical trials in the second half of the year.”

Fourth Quarter 2023 and Subsequent Highlights:

• Announced 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.
• Announced Preclinical Pharmacodynamic Data on Transenteric Delivery of GLP-1 Incretin Triagonist. In December 2023, Rani announced preclinical data demonstrating the transenteric delivery of an incretin triagonist of GLP-1, GIP, glucagon receptors elicits rapid weight loss in animal study. Preclinical data support the potential for the RaniPill platform to enable oral delivery of multiple obesity treatments.
• Announced Strategic Program Prioritization, Expansion of Manufacturing and Plans to Streamline Business Operations to Support Near-Term Value Drivers and Long-Term Growth of the RaniPill Technology Platform. In November 2023, Rani announced strategic prioritization of its key development programs, RT-102, RT-111 and the RaniPill HC and expansion of its manufacturing footprint to support increased scale and partnerships, and cost reduction initiatives that align with Rani’s near-term goals. Development of RT-101 was discontinued, while the development of RT-105 and RT-110 programs were paused. In addition, Rani reduced its workforce. Anticipated cost savings are expected to support Rani’s operating plans into 2025.
• Completed 60-Day, Repeat Oral-Administration GLP Safety Study. In October 2023, Rani announced preclinical data from a 60-day, repeat oral-administration GLP safety study of the RaniPill capsule in healthy animals. The RaniPill capsule was well-tolerated with no treatment-related adverse events and all animals remained clinically healthy throughout the study.
• Announced Successful Oral Delivery of Humira® (adalimumab) via High-Capacity Pill in Preclinical Study. In October 2023, Rani announced the successful oral delivery of a monoclonal antibody, Humira® (adalimumab), via its high-capacity capsule, the RaniPill HC, in a preclinical study. The preclinical study tracked the serum concentrations of adalimumab, following the oral administration of the enteric-coated, RaniPill HC capsule containing 11mg of Humira® (adalimumab) to four canine models. The RaniPill HC successfully delivered adalimumab in all of the subjects.
• Presented an Abstract on RT-102 at the 2023 Annual Meeting of the American Society for Bone and Mineral Research. The abstract, presented in October 2023, focused on the safe and reliable delivery of teriparatide with high bioavailability through daily administration of an oral robotic pill (RT-102) in female volunteers.

Near-Term Milestone Expectations:

• Development of RaniPill HC to be ready for potential Phase 1 clinical trials in the second half of 2024.
• Initiation of Phase 2 clinical trial of RT-102, a RaniPill capsule containing teriparatide for osteoporosis, in 2024.

Full Year 2023 Financial Results:

• Cash, cash equivalents and marketable securities as of December 31, 2023 totaled $48.5 million, compared to $98.5 million for the year ended December 31, 2022.
• Research and development expenses for the three and twelve months ended December 31, 2023 were $7.6 million and $39.6 million, respectively, compared to $10.4 million and $36.6 million for the same periods in 2022, respectively. The year over year increase of $3.0 million was primarily attributed to higher compensation costs of $1.4 million, an increase of $1.2 million in third-party services and an increase of $0.6 million in facilities, materials and supplies expense related to preclinical and clinical development activities, offset by a decrease in other costs of $0.2 million.
• General and administrative expenses for the three and twelve months ended December 31, 2023 were $5.8 million and $26.5 million, respectively, compared to $7.1 million and $26.8 million for the same periods in 2022, respectively. The year over year decrease of $0.3 million was primarily attributed to lower third-party services of $1.8 million related to support for compliance with public company requirements and lower facilities, material and supplies and other costs of $0.3 million, offset by higher compensation costs of $1.8 million.
• Net loss for the three and twelve months ended December 31, 2023 was $14.1 million and $67.9 million, respectively, compared to $17.3 million and $63.3 million for the same periods in 2022, respectively, including stock-based compensation expense of $4.5 million for the three months ended December 31, 2023 and $19.0 million for the full year 2023, compared to $4.5 million and $15.8 million for the same periods in 2022, respectively.

Conference Call

Rani will host a corresponding conference call and live webcast at 4:30 p.m. ET / 1:30 p.m. PT on March 20, 2024 to discuss the results and provide a business update. Individuals interested in listening to the live conference call may do so by using the webcast 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 for 90 days 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 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 2 trial of RT-102 in 2024, the expected readiness of the RaniPill HC for clinical development in the second half of 2024, the ability of expanded manufacturing footprint to support scaling of manufacturing and partnering, the ability to streamline its business operations and to realize the cost-savings contemplated by such streamlining of business operations, reduction in workforce and other initiatives announced by Rani, Rani’s development and advancement of its RaniPill capsule technology, including RaniPill HC, Rani’s advancement of its preclinical and clinical programs and timing of results, the sufficiency of Rani’s cash reserves to support operations into 2025,  the timing and extent of its expenses, future financial performance, and Rani’s growth as a company. 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 “expect,” “could,” “anticipate,” “look forward,” “potential,” “intend” 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.

Trademarks

Trade names, trademarks and service marks of other companies appearing in this press release are the property of their respective owners. Solely for convenience, the trademarks and trade names referred to in this press release appear without the ® and ™ symbols, but those references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights, or the right of the applicable licensor to these trademarks and tradenames.

Investor Contact:

investors@ranitherapeutics.com

Media Contact:

media@ranitherapeutics.com

RANI THERAPEUTICS HOLDINGS, INC Consolidated Balance Sheets  (In thousands, except par value)
	December 31,
	2023				2022
Assets
Current assets:
Cash and cash equivalents	$	5,864			$	27,007
Marketable securities		42,675				71,475
Prepaid expenses and other current assets		2,308				2,442
Total current assets		50,847				100,924
Property and equipment, net		6,105				6,038
Operating lease right-of-use asset		718				1,065
Other assets		246				—
Total assets	$	57,916			$	108,027
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable	$	648			$	1,460
Accrued expenses and other current liabilities		1,726				2,349
Current portion of long-term debt		4,897				—
Current portion of operating lease liability		718				1,006
Total current liabilities		7,989				4,815
Long-term debt, less current portion		24,484				29,149
Operating lease liability, less current portion		—				59
Total liabilities		32,473				34,023
Stockholders' equity:
Preferred stock, $0.0001 par value - 20,000 shares authorized; none issued and outstanding as of December 31, 2023 and December 31, 2022		—				—
Class A common stock, $0.0001 par value - 800,000 shares authorized; 26,036 and 25,295 issued and outstanding as of December 31, 2023 and December 31, 2022, respectively		3				3
Class B common stock, $0.0001 par value - 40,000 shares authorized; 24,116 issued and outstanding as of December 31, 2023 and December 31, 2022		2				2
Class C common stock, $0.0001 par value - 20,000 shares authorized; none issued and outstanding as of December 31, 2023 and December 31, 2022		—				—
Additional paid-in capital		85,762				75,842
Accumulated other comprehensive loss		(12	)			(73	)
Accumulated deficit		(72,889	)			(38,919	)
Total stockholders' equity attributable to Rani Therapeutics Holdings, Inc.		12,866				36,855
Non-controlling interest		12,577				37,149
Total stockholders' equity		25,443				74,004
Total liabilities and stockholders' equity	$	57,916			$	108,027

RANI THERAPEUTICS HOLDINGS, INC Consolidated Statements of Operations (In thousands, except per share amounts)
	Three Months Ended December 31,								Year Ended December 31,
	2023				2022				2023				2022
Operating expenses
Research and development	$	7,606			$	10,386			$	39,624			$	36,607
General and administrative		5,829				7,097				26,475				26,844
Total operating expenses	$	13,435			$	17,483			$	66,099			$	63,451
Loss from operations		(13,435	)			(17,483	)			(66,099	)			(63,451	)
Other income (expense), net
Interest income and other, net		676				818				3,301				1,248
Interest expense and other, net		(1,296	)			(719	)			(5,085	)			(1,071	)
Loss before income taxes		(14,055	)			(17,384	)			(67,883	)			(63,274	)
Income tax expense		—				41				—				(70	)
Net loss	$	(14,055	)		$	(17,343	)		$	(67,883	)		$	(63,344	)
Net loss attributable to non-controlling interest		(6,956	)			(8,556	)			(33,913	)			(32,756	)
Net loss attributable to Rani Therapeutics Holdings, Inc.	$	(7,099	)		$	(8,787	)		$	(33,970	)		$	(30,588	)
Net loss per Class A common share attributable to Rani Therapeutics Holdings, Inc., basic and diluted	$	(0.27	)		$	(0.35	)		$	(1.33	)		$	(1.28	)
Weighted-average Class A common shares outstanding—basic and diluted		25,874				24,910				25,505				23,817

FAQ

What were the key highlights of Rani Therapeutics' recent Phase 1 study results for RT-111?

Rani Therapeutics announced positive topline results from the Phase 1 study of RT-111, showing high bioavailability and good tolerance with no serious adverse events in humans.

What did the preclinical pharmacodynamic data on GLP-1 Incretin Triagonist reveal?

The data demonstrated that the transenteric delivery of GLP-1 Incretin Triagonist elicits rapid weight loss in animal studies, supporting the potential for oral delivery of obesity treatments.

What was the financial status of Rani Therapeutics as of December 31, 2023?

As of December 31, 2023, Rani had cash, cash equivalents, and marketable securities totaling $48.5 million, compared to $98.5 million in 2022.

What are some upcoming milestones for Rani Therapeutics in 2024?

Rani plans to develop RaniPill HC for potential Phase 1 trials and initiate a Phase 2 clinical trial of RT-102, a RaniPill capsule containing teriparatide for osteoporosis, in 2024.

What were some cost-related changes for Rani Therapeutics in 2023 compared to 2022?

Research and development expenses increased in 2023, attributed to higher compensation costs, third-party services, and facilities expenses. General and administrative expenses decreased due to lower third-party services.

Where can individuals find a webcast replay of Rani Therapeutics' conference call?

A webcast replay will be available in the investor relations section on Rani Therapeutics' website for 90 days following the completion of the call.