Form 8-K Rani Therapeutics Holdin For: Dec 06

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December 6, 2022 4:07 PM EST

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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): 
December 06, 2022

Rani Therapeutics Holdings, Inc.

(Exact name of Registrant as Specified in Its Charter)


Delaware	001-40672	86-3114789
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer 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

N/A

(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:


Title of each class	Trading Symbol(s)	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 7.01 Regulation FD Disclosure.

On December 6, 2022, Rani Therapeutics Holdings, Inc. (the “Company” or “Rani”) issued a press release to announce topline results from Part 2 of the RT-102 Phase 1 study. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference. The Company is also furnishing a copy of a presentation (the “Presentation”) that the Company intends to use, in whole or in part, during discussions with.external parties A copy of the Presentation is furnished as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated by reference herein.

All of the information furnished in this Item 7.01 and Item 9.01 (including Exhibit 99.1 and Exhibit 99.2) shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (“Exchange Act”), and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Item 8.01 Other Events.

On December 6, 2022, Rani announced topline results from Part 2 of the RT-102 Phase 1 study.

Study Design

Part 2 is a continuation of Rani’s single-center, open-label Phase 1 study of RT-102, a RaniPill™ GO capsule containing parathyroid hormone (1-34) analog (PTH), conducted in Australia. The study evaluated the safety and tolerability of once-daily administration of RT-102 containing 20μg of PTH given repeatedly for seven consecutive days in 10 healthy female volunteers (5 of whom were post-menopausal). Complete pharmacokinetic profiles of PTH were obtained for each subject on Day 7.

Topline Results

Safety and Tolerability

•

RT-102 was generally well tolerated, with no serious adverse events (SAEs) noted during the study

None of the participants withdrew from the repeat-dose study due to any adverse event related to the RaniPill™ capsule or due to difficulty swallowing the capsule

Two subjects had transient, mild-to-moderate adverse events which resolved without any intervention

•

Device remnants were excreted without sequelae in all subjects

Device Performance

•

In all 10 participants who completed seven days of daily, consecutive dosing, the RaniPill™ GO capsule demonstrated an overall drug delivery success rate of 91% over the seven days (drug sampling was done at three, six and nine hours after capsule swallowing on Days 1-6)

•

On Day 7, with more frequent, serial drug sampling after capsule swallowing on that day, the drug delivery success rate was 100%

•

On Days 1 through 6, participants ate food three hours after administration of the RaniPill™ GO capsule. The number of successful deployments was comparable before and after food was consumed

Pharmacokinetics

•

RT-102 delivered 20µg of PTH with high bioavailability (relative to 20µg subcutaneous Forteo® (teriparatide) in Part 1 of the study), confirming the high bioavailability of PTH delivered via the RaniPill™ capsule observed during Part 1 of the Phase 1 study

This report contains "forward-looking" statements, including statements regarding topline results from Part 2 of the RT-102 Phase 1 study. Actual results may differ materially from those set forth in this report due to the risks and uncertainties inherent in research and development, including the risk that initial (or topline) clinical results do not report on all data from a clinical trial that may be important for development or regulatory approval, the risk that results from earlier clinical trials may not be indicative of future clinical results, as well as other risks detailed in the "Risk Factors" section of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 as well as discussions of potential risks, uncertainties and other important factors in the Company’s other filings with the U.S. Securities and Exchange Commission. The Company undertakes no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits


Exhibit Number		Exhibit Description
99.1		Press Release of Rani Therapeutics Holdings, Inc. dated December 6, 2022
99.2		Presentation dated December 2022
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.