Rani Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results; Provides Corporate Update
March 22 2023 - 4:05PM
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 and full year ended December 31, 2022 and
provided a corporate update.
“The past year has proven transformative for Rani, highlighted
by the positive topline Phase 1 results for RT-102 in osteoporosis
and the unveiling of our high-capacity capsule, the RaniPill HC. We
also announced the preclinical development of our oral ustekinumab
program, RT-111, and earlier this year partnered with Celltrion to
support the advancement of that program. These achievements mark
significant milestones for the Company and are a testament to the
hard work and dedication of the entire Rani team,” said Talat
Imran, Chief Executive Officer of Rani. “In 2023, we anticipate
continuing this momentum with the initiation of the Company’s first
Phase 2 study in RT-102 as well as the initiation of Phase 1
studies with three additional pipeline assets. I look forward to
providing updates throughout the year as we work to further
solidify our commitment to developing orally delivered biologics
and drugs.”
Fourth Quarter 2022 and Subsequent
Highlights:
- Announced topline results from
Phase 1 study of RT-102. In December 2022, Rani announced
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.
- Preliminary feedback received
from the U.S. Food and Drug Administration (“FDA”) on future
development of RT-102. Following feedback from a pre-IND
meeting with 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 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.
- Announced partnership with
Celltrion on development of an ustekinumab biosimilar for
RT-111. In October 2022, Rani announced the preclinical
development of RT-111, a RaniPill GO capsule containing a
biosimilar of STELARA® (ustekinumab) for the potential treatment of
psoriatic arthritis, ulcerative colitis, Crohn’s disease and
psoriasis, all of which have large unmet medical needs for oral
treatment. In January 2023, Rani announced a partnership with
Celltrion for the development of RT-111. Rani was granted an
exclusive license to use Celltrion’s ustekinumab biosimilar,
CT-P43, in the development and commercialization of RT-111, and
Celltrion was granted a right of first negotiation to acquire
worldwide rights to RT-111 following a Phase 1 clinical trial.
Near-Term Milestone Expectations:
- Initiation of Phase 2 study of RT-102
expected in the second half of 2023
- Initiation of three additional Phase 1
studies expected in 2023 with pipeline molecules:
- RT-105 containing an adalimumab
biosimilar
- RT-110 containing PTH for
hypo-parathyroidism
- RT-111 containing an ustekinumab
biosimilar
Full Year 2022 Financial Results:
- Cash, cash equivalents, and
marketable securities as of December 31, 2022 totaled
$98.5 million, compared to cash and cash equivalents of $117.5
million for the year ended December 31, 2021. There were no
marketable securities in the prior comparative period. Rani expects
its cash, cash equivalents and marketable securities to be
sufficient to fund its operations to mid-2024.
- Research and development
expenses for the three and twelve months ended December
31, 2022 were $10.4 million and $36.6 million, respectively,
compared to $7.4 million and $26.5 million for the same periods in
2021, respectively. The difference was primarily attributed to
higher compensation costs of $6.6 million due to headcount growth,
third-party services expense of $3.3 million and facilities,
materials and supplies expense of $2.1 million due to increased
preclinical and clinical development activities, partially offset
by a decrease of $1.9 million in equity-based compensation due to
our non-recurring initial public offering (IPO) and organizational
transactions for the year ended December 31, 2021.
- General and administrative
expenses for the three and twelve months ended December
31, 2022 were $7.1 million and $26.8 million, respectively,
compared to $5.9 million and $27.8 million for the same periods in
2021, respectively. The difference was primarily attributed to
higher compensation costs of $2.0 million due to headcount growth,
third-party services of $1.6 million due to public company related
costs, and travel expenses of $1.0 million, partially offset by a
decrease of $4.9 million in equity-based compensation due to our
non-recurring IPO and organizational transactions for the year
ended December 31, 2021 and facility, material and supplies
expenses of $0.6 million.
- Net loss for the three
and twelve months ended December 31, 2022 was $17.3 million and
$63.3 million, respectively, compared to $13.3 million and $53.1
million for the same periods in 2021, respectively, including
non-cash charges primarily attributable to equity-based
compensation expense of $4.0 million for the three months ended
December 31, 2022 and $15.5 million for the full year 2022,
compared to $3.3 million and $24.3 million for the same periods in
2021, respectively.
Conference Call
Rani will host a corresponding conference call and live webcast
at 1:30 p.m. PT / 4:30 p.m. ET on March 22, 2023 to discuss the
results and provide a business update. Individuals interested in
listening to the live conference call may do so by using the
webcast link in the “Investors” section of the company’s website at
www.ranitherapeutics.com. A webcast replay will be available in the
investor relations section on the company’s website for 90 days
following the completion of the call.
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, the ability of
the data from the Phase 1 study of RT-102 to support progressing to
a Phase 2 trial of RT-102, 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 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:investors@ranitherapeutics.com
Media
Contact:media@ranitherapeutics.com
|
RANI THERAPEUTICS HOLDINGS,
INCConsolidated Balance Sheets(In
thousands, except par value) |
|
|
|
|
|
|
December 31, |
|
|
|
2022 |
|
|
2021 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
27,007 |
|
|
$ |
117,453 |
|
Restricted cash equivalents |
|
|
500 |
|
|
|
— |
|
Marketable securities |
|
|
71,475 |
|
|
|
— |
|
Prepaid expenses and other current assets |
|
|
1,942 |
|
|
|
2,142 |
|
Total current assets |
|
|
100,924 |
|
|
|
119,595 |
|
Property and equipment, net |
|
|
6,038 |
|
|
|
4,612 |
|
Operating lease right-of-use asset |
|
|
1,065 |
|
|
|
— |
|
Total assets |
|
$ |
108,027 |
|
|
$ |
124,207 |
|
Liabilities and
Stockholders' Equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
1,460 |
|
|
$ |
1,080 |
|
Related party payable |
|
|
53 |
|
|
|
126 |
|
Accrued expenses |
|
|
2,296 |
|
|
|
1,434 |
|
Operating lease liability, current portion |
|
|
1,006 |
|
|
|
— |
|
Total current liabilities |
|
|
4,815 |
|
|
|
2,640 |
|
Operating lease liability, less current portion |
|
|
59 |
|
|
|
— |
|
Long-term debt |
|
|
29,149 |
|
|
|
— |
|
Total liabilities |
|
|
34,023 |
|
|
|
2,640 |
|
Commitments and
contingencies |
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
|
Preferred stock, $0.0001 par
value - 20,000 shares authorized; none issued and outstanding as of
December 31, 2022 and December 31, 2021 |
|
|
— |
|
|
|
— |
|
Class A common stock, $0.0001 par
value - 800,000 shares authorized; 25,295 and 19,712 issued and
outstanding as of December 31, 2022 and December 31, 2021,
respectively |
|
|
3 |
|
|
|
2 |
|
Class B common stock, $0.0001 par
value - 40,000 shares authorized; 24,116 and 29,290 issued and
outstanding as of December 31, 2022 and December 31, 2021,
respectively |
|
|
2 |
|
|
|
3 |
|
Class C common stock, $0.0001 par
value - 20,000 shares authorized; none issued and outstanding as of
December 31, 2022 and December 31, 2021 |
|
|
— |
|
|
|
— |
|
Additional paid-in capital |
|
|
75,842 |
|
|
|
55,737 |
|
Accumulated other comprehensive loss |
|
|
(73 |
) |
|
|
— |
|
Accumulated deficit |
|
|
(38,919 |
) |
|
|
(8,331 |
) |
Total stockholders' equity attributable to Rani Therapeutics
Holdings, Inc. |
|
|
36,855 |
|
|
|
47,411 |
|
Non-controlling interest |
|
|
37,149 |
|
|
|
74,156 |
|
Total stockholders' equity |
|
|
74,004 |
|
|
|
121,567 |
|
Total liabilities and stockholders' equity |
|
$ |
108,027 |
|
|
$ |
124,207 |
|
|
|
|
|
|
|
|
|
|
|
RANI THERAPEUTICS HOLDINGS,
INCConsolidated Statements of
Operations(In thousands, except per share
amounts) |
|
|
|
|
|
|
|
|
|
For the Three Months Ended December 31, |
|
|
Year Ended December 31, |
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
Contract revenue |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
2,717 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
10,386 |
|
|
|
7,417 |
|
|
|
36,607 |
|
|
|
26,482 |
|
General and administrative |
|
|
7,097 |
|
|
|
5,945 |
|
|
|
26,844 |
|
|
|
27,834 |
|
Total operating expenses |
|
$ |
17,483 |
|
|
$ |
13,362 |
|
|
$ |
63,451 |
|
|
$ |
54,316 |
|
Loss from operations |
|
|
(17,483 |
) |
|
|
(13,362 |
) |
|
|
(63,451 |
) |
|
|
(51,599 |
) |
Other income (expense), net |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income and other, net |
|
|
818 |
|
|
|
16 |
|
|
|
1,248 |
|
|
|
89 |
|
Loss on extinguishment of debt |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(700 |
) |
Interest expense and other, net |
|
|
(719 |
) |
|
|
1 |
|
|
|
(1,071 |
) |
|
|
(466 |
) |
Change in estimated fair value of preferred unit warrant |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(371 |
) |
Loss before income taxes |
|
|
(17,384 |
) |
|
|
(13,345 |
) |
|
|
(63,274 |
) |
|
|
(53,047 |
) |
Income tax expense |
|
|
41 |
|
|
|
40 |
|
|
|
(70 |
) |
|
|
(41 |
) |
Net loss |
|
$ |
(17,343 |
) |
|
$ |
(13,305 |
) |
|
$ |
(63,344 |
) |
|
$ |
(53,088 |
) |
Net loss attributable to non-controlling interest |
|
|
(8,556 |
) |
|
|
(8,116 |
) |
|
|
(32,756 |
) |
|
|
(44,757 |
) |
Net loss attributable to Rani
Therapeutics Holdings, Inc. |
|
$ |
(8,787 |
) |
|
$ |
(5,189 |
) |
|
$ |
(30,588 |
) |
|
$ |
(8,331 |
) |
Net loss per Class A common share attributable to Rani Therapeutics
Holdings, Inc., basic and diluted |
|
$ |
(0.35 |
) |
|
$ |
(0.27 |
) |
|
$ |
(1.28 |
) |
|
$ |
(0.43 |
) |
Weighted-average Class A common
shares outstanding—basic and diluted |
|
|
24,910 |
|
|
|
19,439 |
|
|
|
23,817 |
|
|
|
19,534 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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