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 November 8, 2023, Rani Therapeutics Holdings, Inc. (the “Company”) issued a press release providing a corporate update and announcing its financial results for the third quarter ended September 30, 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 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On November 7, 2023, the Board of Directors of the Company (the “Board”) approved a reduction in the annual salary of Talat Imran, the Company’s Chief Executive Officer, from his current annual salary of $520,000 to $100,000, effective November 1, 2023 through December 31, 2024 or until such earlier time as the Company receives gross proceeds of $50,000,000 or more, in the aggregate, from equity financing and/or one or more non-dilutive strategic, licensing or partnering transactions. The decreased base salary amends the Amended and Restated Employment Agreement, dated August 31, 2022, by and between Rani Therapeutics, LLC and Mr. Imran, previously filed with the SEC as Exhibit 10.19 to the Company’s Annual Report on Form 10-K for the year ended December 2022.
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 November 8, 2023 |
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: |
November 8, 2023 |
By: |
/s/ Svai Sanford |
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Svai Sanford |
Exhibit 99.1
Rani Therapeutics Reports Third Quarter 2023 Financial Results; Provides Corporate Update
- Cash runway extended into 2025 -
- Announced strategic program prioritization, expansion of manufacturing and plans to streamline business operations -
- Initiated Phase 1 clinical trial of RT-111, a RaniPill GO containing ustekinumab biosimilar CT-P43, with topline results expected in 1Q 2024 -
- Initiation of Phase 2 clinical trial of RT-102, a RaniPill GO containing teriparatide for osteoporosis, expected by the year-end 2023 -
- Announced RaniPill capsule was well-tolerated in 60-day, repeat oral-administration GLP safety study -
- Announced successful drug delivery with RaniPill HC high-capacity capsule in multiple preclinical studies with cumulative >90% success rate -
SAN JOSE, Calif., November 8, 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 third quarter ended September 30, 2023, and provided a corporate update.
“In the third quarter, we made important decisions to drive forward our key programs to create long-term value for our shareholders and extend our cash runway into 2025. We announced a strategic prioritization of our RT-102 and RT-111 programs, as well as development of the RaniPill HC to be Phase 1 ready,” said Talat Imran, Chief Executive Officer of Rani Therapeutics. “We are highly encouraged by the continued development of the RaniPill HC, a novel high-capacity capsule capable of delivering up to a 500%-plus higher drug payload than Rani’s existing oral biologics capsule. We have completed multiple preclinical studies of the RaniPill HC with antibodies and other molecules. Our goal is to get this capsule ready for Phase 1 studies in the clinic and we look forward to potential partnering opportunities involving the RaniPill HC.”
Third Quarter or Subsequent Highlights:
Development Update
Adalimumab 11mg via RaniPill HC vs Adalimumab Biosimilar 5mg via Subcutaneous Injection
All Data are Means ± SE
Pharmacokinetics of Interleukin (16.5mg) Delivered Orally via RaniPill HC Capsules to Awake Canines (N=6)
All Data are Means ± SE
Preliminary preclinical testing supports the potential for the RaniPill HC to have high reliability and initial analysis of drug delivery via the RaniPill HC shows a potential for mimicking parenteral (subcutaneous) administration. Rani expects to continue preclinical testing of RaniPill HC to confirm the preliminary reliability rate and optimize device performance with a goal for the RaniPill HC to be ready to advance into the clinic in the second half of 2024.
Near-Term Milestone Expectations:
Third Quarter 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 is progressing two RaniPill capsules, the RaniPill GO and the RaniPill HC. 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 advancement of Rani’s pipeline and RaniPill platform technology including the RaniPill HC, the potential of the RaniPill HC to deliver 500%-plus higher drug payload than Rani’s existing oral biologics capsule, the expected initiation of a Phase 2 clinical trial of RT-102 in 2023, the ability to confirm preliminary reliability and optimize performance of the RaniPill HC, the expected timing of topline results from the RT-111 Phase 1 clinical trial in the first quarter of 2024, the expected readiness of the RaniPill HC for clinical development in the second half of 2024, the ability of expanded manufacturing footpoint 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, the potential for the RaniPill HC to have high reliability and mimic parenteral (subcutaneous) administration, the potential for partner opportunities with the RaniPill HC, customer acceptance of the RaniPill capsule technology, the potential benefits of the RaniPill capsule technology, cash sufficiency forecast, 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 “capable of,” “potential,” “expects,” “with a goal for,” “anticipate” 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
Condensed Consolidated Balance Sheets
(In thousands, except par value)
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September 30, |
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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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$ |
4,972 |
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$ |
27,007 |
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Marketable securities |
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55,554 |
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71,475 |
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Prepaid expenses and other current assets |
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2,696 |
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2,442 |
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Total current assets |
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63,222 |
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100,924 |
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Property and equipment, net |
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6,255 |
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6,038 |
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Operating lease right-of-use asset |
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959 |
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1,065 |
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Total assets |
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$ |
70,436 |
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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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$ |
1,405 |
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$ |
1,460 |
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Accrued expenses and other current liabilities |
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3,930 |
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2,349 |
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Current portion of long-term debt |
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1,222 |
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— |
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Current portion of operating lease liability |
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788 |
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1,006 |
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Total current liabilities |
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7,345 |
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4,815 |
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Long-term debt, less current portion |
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28,101 |
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29,149 |
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Operating lease liability, less current portion |
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171 |
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59 |
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Total liabilities |
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35,617 |
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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 September 30, 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; 25,876 and 25,295 issued and outstanding as of September 30, 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 September 30, 2023 and December 31, 2022 |
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2 |
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2 |
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Class C common stock, $0.0001 par value - 20,000 shares authorized; none issued and outstanding as of September 30, 2023 and December 31, 2022 |
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— |
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— |
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Additional paid-in capital |
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83,380 |
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75,842 |
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Accumulated other comprehensive loss |
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(41 |
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(73 |
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Accumulated deficit |
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(65,791 |
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(38,919 |
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Total stockholders' equity attributable to Rani Therapeutics Holdings, Inc. |
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17,553 |
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36,855 |
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Non-controlling interest |
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17,266 |
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37,149 |
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Total stockholders' equity |
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34,819 |
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74,004 |
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Total liabilities and stockholders' equity |
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$ |
70,436 |
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$ |
108,027 |
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RANI THERAPEUTICS HOLDINGS, INC
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
(Unaudited)
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2023 |
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2022 |
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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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$ |
11,220 |
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$ |
9,103 |
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$ |
32,018 |
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$ |
26,221 |
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General and administrative |
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6,635 |
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7,239 |
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20,647 |
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19,748 |
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Total operating expenses |
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$ |
17,855 |
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$ |
16,342 |
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$ |
52,665 |
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$ |
45,969 |
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Loss from operations |
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(17,855 |
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(16,342 |
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(52,665 |
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(45,969 |
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Other income (expense), net |
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Interest income and other, net |
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839 |
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379 |
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2,626 |
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430 |
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Interest expense and other, net |
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(1,316 |
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(352 |
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(3,789 |
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(352 |
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Loss before income taxes |
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(18,332 |
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(16,315 |
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(53,828 |
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(45,891 |
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Income tax expense |
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— |
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107 |
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— |
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(111 |
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Net loss |
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$ |
(18,332 |
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$ |
(16,208 |
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$ |
(53,828 |
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$ |
(46,002 |
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Net loss attributable to non-controlling interest |
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(9,135 |
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(8,253 |
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(26,956 |
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(24,200 |
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Net loss attributable to Rani Therapeutics Holdings, Inc. |
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$ |
(9,197 |
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$ |
(7,955 |
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$ |
(26,872 |
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$ |
(21,802 |
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Net loss per Class A common share attributable to Rani Therapeutics Holdings, Inc., basic and diluted |
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$ |
(0.36 |
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$ |
(0.33 |
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$ |
(1.06 |
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$ |
(0.93 |
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Weighted-average Class A common shares outstanding—basic and diluted |
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25,552 |
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24,468 |
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25,380 |
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23,449 |
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