UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02 Results of Operations and Financial Condition.
On August 6, 2024, Rani Therapeutics Holdings, Inc. (the “Company”) issued a press release providing a corporate update and announcing its financial results for the quarter ended June 30, 2024. The full text of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information in this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit Number |
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Exhibit Description |
99.1 |
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Press Release of Rani Therapeutics Holdings, Inc. dated August 6, 2024 |
104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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Rani Therapeutics Holdings, Inc. |
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Date: |
August 6, 2024 |
By: |
/s/ Svai Sanford |
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Svai Sanford |
Exhibit 99.1
Rani Therapeutics Reports Second Quarter 2024 Financial Results; Provides Corporate Update
- Announced partnership with ProGen on development of RT-114, an oral GLP-1/GLP-2 dual agonist for the treatment of obesity -
- Phase 1 study for RT-114 expected to initiate in 2025 -
- Completed equity offering with gross proceeds of approximately $10.0 million -
- Presented clinical and preclinical data on oral delivery of an ustekinumab biosimilar via the RaniPill® Capsule at Digestive Disease Week 2024 -
SAN JOSE, Calif., August 6, 2024 --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 June 30, 2024 and provided a corporate update.
“This quarter has been transformative for Rani, highlighted by the recent partnership with ProGen for the co-development and commercialization of RT-114, an oral RaniPill® capsule containing ProGen’s PG-102, a GLP-1/GLP-2 dual agonist, for the treatment of obesity,” said Talat Imran, Chief Executive Officer of Rani. “RT-114 has the potential to provide better lean muscle preservation and nutritional health of patients compared to current therapies due to the unique mechanism of action of GLP-2. We intend to evaluate RT-114 as a convenient, weekly oral dose. We look forward to initiating our Phase 1 study for RT-114 in 2025 with the aim of advancing a truly differentiated oral anti-obesity treatment option.”
Second Quarter 2024 and Subsequent Highlights:
Near-Term Milestone Expectations:
Second Quarter 2024 Financial Results:
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, RT-114 therapeutic potential, the expected initiation of a Phase 1 trial of RT-114 in 2025, the success of Rani’s collaboration with ProGen, 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, 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 “expect,” “intend,” “look forward,” “potential,” 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:
Media Contact:
RANI THERAPEUTICS HOLDINGS, INC
Consolidated Balance Sheets
(In thousands, except par value)
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June 30, |
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December 31, |
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2024 |
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2023 |
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(Unaudited) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
4,514 |
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$ |
5,864 |
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Marketable securities |
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26,387 |
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42,675 |
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Prepaid expenses and other current assets |
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1,133 |
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2,308 |
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Total current assets |
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32,034 |
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50,847 |
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Property and equipment, net |
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5,695 |
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6,105 |
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Operating lease right-of-use asset |
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5,751 |
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718 |
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Other assets |
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246 |
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246 |
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Total assets |
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$ |
43,726 |
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$ |
57,916 |
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Liabilities and Stockholders' Equity |
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Current liabilities: |
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Accounts payable |
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$ |
506 |
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$ |
648 |
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Accrued expenses and other current liabilities |
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2,422 |
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1,726 |
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Current portion of long-term debt |
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12,290 |
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4,897 |
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Current portion of operating lease liability |
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1,363 |
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718 |
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Total current liabilities |
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16,581 |
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7,989 |
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Long-term debt, less current portion |
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17,207 |
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24,484 |
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Operating lease liability, less current portion |
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4,388 |
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— |
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Total liabilities |
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38,176 |
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32,473 |
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Stockholders' equity: |
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Preferred stock, $0.0001 par value - 20,000 shares authorized; none issued and outstanding as of June 30, 2024 and December 31, 2023 |
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— |
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— |
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Class A common stock, $0.0001 par value - 800,000 shares authorized; 26,489 and 26,036 issued and outstanding as of June 30, 2024 and December 31, 2023, respectively |
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3 |
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3 |
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Class B common stock, $0.0001 par value - 40,000 shares authorized; 24,116 issued and outstanding as of June 30, 2024 and December 31, 2023 |
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2 |
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2 |
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Class C common stock, $0.0001 par value - 20,000 shares authorized; none issued and outstanding as of June 30, 2024 and December 31, 2023 |
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— |
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— |
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Additional paid-in capital |
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90,012 |
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85,762 |
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Accumulated other comprehensive loss |
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(5 |
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(12 |
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Accumulated deficit |
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(87,177 |
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(72,889 |
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Total stockholders' equity attributable to Rani Therapeutics Holdings, Inc. |
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2,835 |
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12,866 |
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Non-controlling interest |
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2,715 |
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12,577 |
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Total stockholders' equity |
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5,550 |
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25,443 |
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Total liabilities and stockholders' equity |
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$ |
43,726 |
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$ |
57,916 |
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RANI THERAPEUTICS HOLDINGS, INC
Consolidated Statements of Operations
(In thousands, except per share amounts)
(Unaudited)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2024 |
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2023 |
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2024 |
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2023 |
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Operating expenses |
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Research and development |
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$ |
6,115 |
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$ |
11,086 |
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$ |
13,700 |
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$ |
20,798 |
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General and administrative |
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6,409 |
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7,208 |
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12,857 |
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14,012 |
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Total operating expenses |
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$ |
12,524 |
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$ |
18,294 |
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$ |
26,557 |
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$ |
34,810 |
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Loss from operations |
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(12,524 |
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(18,294 |
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(26,557 |
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(34,810 |
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Other income (expense), net |
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Interest income and other, net |
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439 |
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896 |
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988 |
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1,787 |
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Interest expense and other, net |
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(1,276 |
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(1,266 |
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(2,571 |
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(2,473 |
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Net loss |
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$ |
(13,361 |
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$ |
(18,664 |
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$ |
(28,140 |
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$ |
(35,496 |
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Net loss attributable to non-controlling interest |
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(6,556 |
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(9,361 |
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(13,852 |
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(17,821 |
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Net loss attributable to Rani Therapeutics Holdings, Inc. |
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$ |
(6,805 |
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$ |
(9,303 |
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$ |
(14,288 |
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$ |
(17,675 |
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Net loss per Class A common share attributable to Rani Therapeutics Holdings, Inc., basic and diluted |
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$ |
(0.26 |
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$ |
(0.37 |
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$ |
(0.55 |
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$ |
(0.70 |
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Weighted-average Class A common shares outstanding—basic and diluted |
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26,324 |
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25,345 |
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26,179 |
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25,293 |
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