# EDGAR Filing Document

**Accession Number:** 0001856725
**File Stem:** 0000950170-23-000239
**Filing Date:** 2023-1
**Character Count:** 12704
**Document Hash:** 6053864be0fcb8ab32d3584c61a1a61b
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0000950170-23-000239.hdr.sgml**: 20230105

**ACCESSION NUMBER**: 0000950170-23-000239

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20230105

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230105

**DATE AS OF CHANGE**: 20230105

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Rani Therapeutics Holdings, Inc.
- **CENTRAL INDEX KEY:** 0001856725
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **IRS NUMBER:** 000000000
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-40672
- **FILM NUMBER:** 23511570

**BUSINESS ADDRESS:**
- **STREET 1:** 2051 RINGWOOD AVENUE
- **CITY:** SAN JOSE
- **STATE:** CA
- **ZIP:** 95131
- **BUSINESS PHONE:** (408) 457-3700

**MAIL ADDRESS:**
- **STREET 1:** 2051 RINGWOOD AVENUE
- **CITY:** SAN JOSE
- **STATE:** CA
- **ZIP:** 95131

?xml version="1.0" encoding="ASCII"? 8-K

**UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549**

------

**FORM** 8-K

------

**CURRENT REPORT**

**Pursuant to Section 13 or 15(d)** 

**of the Securities Exchange Act of 1934**

**Date of Report (Date of earliest event reported):** <br>January 05, 2023<br>

------

Rani Therapeutics Holdings, Inc.

**(Exact name of Registrant as Specified in Its Charter)**

------

---

| | | |
|:---|:---|:---|
| Delaware | 001-40672 | 86-3114789 |
| **(State or Other Jurisdiction<br>of Incorporation)** | **(Commission File Number)** | **(IRS Employer<br>Identification No.)** |
| 2051 Ringwood Avenue |  |  |
| San Jose**,** California |  | 95131 |
| **(Address of Principal Executive Offices)** |  | **(Zip Code)** |

---

**Registrant's Telephone Number, Including Area Code:** (408) 457-3700<br>

N/A<br>

**(Former Name or Former Address, if Changed Since Last Report)**

------

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:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

**Securities registered pursuant to Section 12(b) of the Act:**

---

| | | |
|:---|:---|:---|
| **<br>Title of each class** | **Trading<br>Symbol(s)** | **<br>Name of each exchange on which registered** |
| Class A common stock, par value $0.0001 per share | RANI | The NASDAQ Stock Market LLC |

---

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 January 5, 2023, Rani Therapeutics Holdings, Inc. (the "Company") issued a press release reporting that based on preliminary estimates, the Company had approximately $99 million in cash, cash equivalents, restricted cash equivalents and marketable securities as of December 31, 2022. The Company has not yet completed its financial close process for the quarter and year ended December 31, 2022. This estimate of the Company's cash, cash equivalents, restricted cash equivalents and marketable securities as of December 31, 2022 is preliminary, unaudited and is subject to change upon completion of the Company's financial statement closing procedures and the audit of the Company's consolidated financial statements.

The information furnished under this Item 2.02 shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or incorporated by reference in any filing under the Securities Act of 1933, as amended (the "Securities Act") or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

**Item 7.01 Regulation FD Disclosure.**

On January 5, 2023, the Company issued a press release announcing the receipt of feedback from a pre-Investigational New Drug meeting with the U.S. Food and Drug Administration and providing a pipeline update. The full text of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

All of the information furnished in this Form 8-K, including the accompanying Exhibit 99.1, shall not be deemed to be "filed" for purposes of Section 18 of the Exchange Act, and shall not be incorporated by reference in any filing under the Securities Act or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

**Item 9.01 Financial Statements and Exhibits.**

**(d) Exhibits**

---

| | |
|:---|:---|
| **Exhibit**<br>**Number** | **Exhibit Description** |
| 99.1 | [<u>Press Release dated January 5, 2023</u>](rani-ex99_1.htm) |
| 104 | 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.

---

| | | | |
|:---|:---|:---|:---|
|  |  |  | Rani Therapeutics Holdings, Inc. |
| Date: | January 5, 2023 | By:  | /s/ Svai Sanford |
|  |  |  | Svai Sanford<br>Chief Financial Officer |

---

------

## Exhibit 99.1

**Exhibit 99.1**

![img125106939_0.jpg](img125106939_0.jpg)

**Rani Therapeutics Receives Feedback from Pre-IND Meeting with FDA; Provides Pipeline Update**

- Preliminary feedback from FDA on RT-102 development plans; 505(b)(2) pathway for RT-102 could be suitable -

- Multiple anticipated clinical milestones expected in 2023, including initiation of Phase 2 study of RT-102 in osteoporosis -

**SAN JOSE, Calif., January 5, 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 announced that it completed a pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration ("FDA") with respect to RT-102, the RaniPill™ GO containing a proprietary formulation of human parathyroid hormone (1-34) analog (PTH) for the potential treatment of osteoporosis, and provided a corporate update.

**Pipeline Updates:**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**Preliminary feedback received from the FDA on future development of RT-102.** Following feedback from a pre-IND meeting with the FDA, Rani believes that a 505(b)(2) pathway is suitable for the development of RT-102 in the U.S. In addition, Rani obtained guidance from the FDA on its preclinical and clinical development plans for RT-102, including the Phase 2 clinical trial which is expected to initiate in the second half of 2023.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**Announced topline results from Phase 1 study of RT-102.** In December 2022, Rani announced positive topline results from Part 2 (repeat-dose portion) of the Phase 1 study of RT-102. RT-102 is being developed for the treatment of osteoporosis. The study achieved all of its endpoints, with repeat doses of RT-102 being generally well tolerated and delivering drug with high reliability to participants via the RaniPill™ GO.

"We thank FDA for its feedback and helping us chart the path forward for RT-102. As we enter 2023, Rani has multiple upcoming clinical milestones that we believe could be transformative for the company, including the initiation of a Phase 2 trial for RT-102 – our first Phase 2 trial - and the initiation of three additional Phase 1 studies, including two antibody programs," said Talat Imran, Chief Executive Officer of Rani. "We are delighted by the recent results from our RT-102 program, with positive Phase 1 single and repeat-dose data reinforcing the potential of the RaniPill platform as an oral delivery solution for biologics. We plan to carry this momentum forward, and I look forward to providing further updates in coming months."

**Near-Term Milestone Expectations:**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•RT-102 – Phase 2 initiation in the second half of 2023

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Initiation of three additional Phase 1 studies in 2023 with pipeline molecules:

oRT-105 containing an adalimumab biosimilar

oRT-110 containing PTH for hypo-parathyroidism

oRT-111 containing an ustekinumab biosimilar for psoriatic arthritis, ulcerative colitis, Crohn's disease and psoriasis

------

**Preliminary Unaudited Cash Position:**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Rani has approximately $99 million in cash, cash equivalents, restricted cash equivalents and marketable securities as of December 31, 2022. This estimate of the Company's cash, cash equivalents, restricted cash equivalents and marketable securities as of December 31, 2022 is preliminary, unaudited and is subject to change upon completion of the Company's financial statement closing procedures and the audit of the Company's consolidated financial statements.

**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™ capsules, which are 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™ capsules. 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 2023, the expected initiation of additional 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, the ability of the data from the Phase 1 study of RT-102 to support progressing to a Phase 2 trial of RT-102, and the preliminary cash position of the 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," "could," "anticipate," "believe," "look forward," "progress," "advance," "potential", "be able to" 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, the impact of the COVID-19 pandemic, and the other risks described in Rani's filings with the Securities and Exchange Commission. 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.

**Investor Contact:**

<u>investors@ranitherapeutics.com</u>

**Media Contact:**

<u>media@ranitherapeutics.com</u>

------