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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Trading |
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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 May 10, 2023, Rani Therapeutics Holdings, Inc. (the “Company”) issued a press release providing a corporate update and announcing its financial results for the three months ended March 31, 2023. 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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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: |
May 10, 2023 |
By: |
/s/ Svai Sanford |
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Svai Sanford |
Exhibit 99.1
Rani Therapeutics Reports First Quarter 2023 Financial Results; Provides Corporate Update
- Announced partnership with Celltrion on development of RT-111, a RaniPill GO capsule containing a biosimilar for the monoclonal antibody ustekinumab -
- Received preliminary feedback from FDA on RT-102 development plans; 505(b)(2) pathway for RT-102 could be suitable -
- Initiation of Phase 2 clinical trial for RT-102 for the treatment of osteoporosis expected in 2H of 2023 -
SAN JOSE, Calif., May 10, 2023 -- 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 March 31, 2023 and provided a corporate update.
“We started 2023 with great momentum when we announced a partnership with Celltrion on the development of our ustekinumab biosimilar for RT-111, a partnership that we believe validates RaniPill’s oral drug delivery technology,” said Talat Imran, Chief Executive Officer of Rani. “In addition, we received preliminary feedback from the FDA with respect to our RT-102 development plans, including the Phase 2 clinical trial that we intend to initiate in the second half of the year. Further, 2023 will be a crucial year for Rani as we commence three Phase 1 studies for RT-111, RT-105 and RT-110.”
First Quarter Highlights:
Near-Term Milestone Expectations:
First Quarter Financial Results:
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 the second half of 2023, the expected initiation of three Phase 1 trials of other product candidates in 2023, the impact achievement of upcoming clinical milestones could have on the business of the Company, the potential suitability of the 505(b)(2) pathway for RT-102 or other Rani programs, Rani’s advancement of its preclinical and clinical programs and timing of results, the sufficiency of Rani’s cash reserves for future operations, 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 “may,” “expect,” “could,” “anticipate,” “look forward,” “progress,” “advance,” “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, 2022 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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March 31, |
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December 31, |
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2023 |
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2022 |
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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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$ |
18,984 |
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$ |
27,007 |
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Restricted cash equivalents |
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500 |
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500 |
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Marketable securities |
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67,803 |
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71,475 |
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Prepaid expenses and other current assets |
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1,751 |
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1,942 |
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Total current assets |
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89,038 |
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100,924 |
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Property and equipment, net |
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5,985 |
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6,038 |
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Operating lease right-of-use asset |
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1,423 |
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1,065 |
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Total assets |
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$ |
96,446 |
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$ |
108,027 |
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Liabilities and Stockholders' Equity |
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Current liabilities: |
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Accounts payable |
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$ |
1,511 |
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$ |
1,460 |
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Accrued expenses and other current liabilities |
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2,716 |
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2,349 |
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Operating lease liability, current portion |
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923 |
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1,006 |
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Total current liabilities |
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5,150 |
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4,815 |
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Operating lease liability, less current portion |
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500 |
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59 |
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Long-term debt |
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29,207 |
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29,149 |
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Total liabilities |
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34,857 |
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34,023 |
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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 March 31, 2023 and December 31, 2022 |
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— |
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— |
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Class A common stock, $0.0001 par value - 800,000 shares authorized; 25,376 and 25,295 issued and outstanding as of March 31, 2023 and December 31, 2022, 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 March 31, 2023 and December 31, 2022 |
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2 |
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2 |
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Class C common stock, $0.0001 par value - 20,000 shares authorized; none issued and outstanding as of March 31, 2023 and December 31, 2022 |
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— |
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— |
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Additional paid-in capital |
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78,018 |
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75,842 |
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Accumulated other comprehensive loss |
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(10 |
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(73 |
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Accumulated deficit |
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(47,291 |
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(38,919 |
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Total stockholders' equity attributable to Rani Therapeutics Holdings, Inc. |
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30,722 |
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36,855 |
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Non-controlling interest |
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30,867 |
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37,149 |
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Total stockholders' equity |
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61,589 |
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74,004 |
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Total liabilities and stockholders' equity |
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$ |
96,446 |
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$ |
108,027 |
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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 March 31, |
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2023 |
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2022 |
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Operating expenses |
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Research and development |
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$ |
9,712 |
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$ |
7,591 |
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General and administrative |
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6,804 |
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6,189 |
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Total operating expenses |
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$ |
16,516 |
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$ |
13,780 |
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Loss from operations |
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(16,516 |
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(13,780 |
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Other income (expense), net |
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Interest income and other, net |
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891 |
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15 |
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Interest expense and other, net |
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(1,207 |
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— |
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Loss before income taxes |
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(16,832 |
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(13,765 |
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Income tax expense |
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— |
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(63 |
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Net loss |
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$ |
(16,832 |
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$ |
(13,828 |
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Net loss attributable to non-controlling interest |
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(8,460 |
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(7,605 |
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Net loss attributable to Rani Therapeutics Holdings, Inc. |
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$ |
(8,372 |
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$ |
(6,223 |
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Net loss per Class A common share attributable to Rani Therapeutics Holdings, Inc., basic and diluted |
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$ |
(0.33 |
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$ |
(0.29 |
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Weighted-average Class A common shares outstanding—basic and diluted |
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25,240 |
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21,409 |
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