Rani Therapeutics Reports First Quarter 2023 Financial Results; Provides Corporate Update
11 5월 2023 - 5:05AM
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:
- Announced partnership with Celltrion on development of
an ustekinumab biosimilar for RT-111. In January 2023,
Rani announced a partnership with Celltrion for the development of
RT-111, a RaniPill GO capsule containing Celltrion’s ustekinumab
biosimilar (CT-P43) for the potential treatment of psoriatic
arthritis, ulcerative colitis, Crohn’s disease and psoriasis. Rani
was granted an exclusive license to use 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.
- Preliminary feedback received from the U.S. Food and
Drug Administration (“FDA”) on future development of
RT-102. Following feedback from a pre-Investigational New
Drug 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.
Near-Term Milestone Expectations:
- Initiation of Phase 2 study of RT-102 for osteoporosis expected
in the second half of 2023
- Initiation of three additional Phase 1 studies expected in 2023
with pipeline molecules:
- RT-111 containing an ustekinumab biosimilar
- RT-105 containing an adalimumab biosimilar
- RT-110 containing parathyroid hormone for
hypo-parathyroidism
First Quarter Financial Results:
- Cash, cash equivalents and marketable
securities as of March 31, 2023 totaled $86.8 million,
compared to cash, cash equivalents and marketable securities of
$98.5 million for the year ended December 31, 2022. 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 months ended March 31, 2023 were $9.7 million, compared to
$7.6 million for the same period in 2022. The difference was
primarily attributed to higher compensation costs of $1.9 million,
which includes an increase of $0.4 million in stock-based
compensation, due to headcount growth, and an increase of $0.4
million in facilities, materials and supplies expense related to
preclinical and clinical development activities.
- General and administrative expenses for the
three months ended March 31, 2023 were $6.8 million, compared to
$6.2 million for the same period in 2022. The difference was
primarily attributed to an increase in stock-based compensation of
$1.1 million due to headcount growth, partially offset by a
decrease in third-party services of $0.5 million due to
non-recurring public company related costs.
- Net loss for the three months ended March 31,
2023 was $16.8 million, compared to $13.8 million for the same
period in 2022, including non-cash charges primarily attributable
to stock-based compensation expense of $4.0 million for the three
months ended March 31, 2023, compared to $3.0 million for the same
period in 2022.
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:
investors@ranitherapeutics.com
Media Contact:
media@ranitherapeutics.com
RANI THERAPEUTICS HOLDINGS, INC
Consolidated Balance Sheets (In
thousands, except par value)
|
|
March 31, |
|
|
December 31, |
|
|
|
2023 |
|
|
2022 |
|
|
|
(Unaudited) |
|
|
|
|
Assets |
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
18,984 |
|
|
$ |
27,007 |
|
Restricted cash equivalents |
|
|
500 |
|
|
|
500 |
|
Marketable securities |
|
|
67,803 |
|
|
|
71,475 |
|
Prepaid expenses and other current assets |
|
|
1,751 |
|
|
|
1,942 |
|
Total current assets |
|
|
89,038 |
|
|
|
100,924 |
|
Property and equipment, net |
|
|
5,985 |
|
|
|
6,038 |
|
Operating lease right-of-use asset |
|
|
1,423 |
|
|
|
1,065 |
|
Total assets |
|
$ |
96,446 |
|
|
$ |
108,027 |
|
Liabilities and Stockholders' Equity |
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
1,511 |
|
|
$ |
1,460 |
|
Accrued expenses and other current liabilities |
|
|
2,716 |
|
|
|
2,349 |
|
Operating lease liability, current portion |
|
|
923 |
|
|
|
1,006 |
|
Total current liabilities |
|
|
5,150 |
|
|
|
4,815 |
|
Operating lease liability, less current portion |
|
|
500 |
|
|
|
59 |
|
Long-term debt |
|
|
29,207 |
|
|
|
29,149 |
|
Total liabilities |
|
|
34,857 |
|
|
|
34,023 |
|
Stockholders' equity: |
|
|
|
|
|
|
Preferred stock, $0.0001 par value - 20,000 shares authorized; none
issued and outstanding as of March 31, 2023 and December 31,
2022 |
|
|
— |
|
|
|
— |
|
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 |
|
|
3 |
|
|
|
3 |
|
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 |
|
|
2 |
|
|
|
2 |
|
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 |
|
|
— |
|
|
|
— |
|
Additional paid-in capital |
|
|
78,018 |
|
|
|
75,842 |
|
Accumulated other comprehensive loss |
|
|
(10 |
) |
|
|
(73 |
) |
Accumulated deficit |
|
|
(47,291 |
) |
|
|
(38,919 |
) |
Total stockholders' equity attributable to Rani Therapeutics
Holdings, Inc. |
|
|
30,722 |
|
|
|
36,855 |
|
Non-controlling interest |
|
|
30,867 |
|
|
|
37,149 |
|
Total stockholders' equity |
|
|
61,589 |
|
|
|
74,004 |
|
Total liabilities and stockholders' equity |
|
$ |
96,446 |
|
|
$ |
108,027 |
|
RANI THERAPEUTICS HOLDINGS, INC
Consolidated Statements of Operations(In
thousands, except per share
amounts) (Unaudited)
|
|
Three Months Ended March 31, |
|
|
|
2023 |
|
|
2022 |
|
Operating expenses |
|
|
|
|
|
|
Research and development |
|
$ |
9,712 |
|
|
$ |
7,591 |
|
General and administrative |
|
|
6,804 |
|
|
|
6,189 |
|
Total operating expenses |
|
$ |
16,516 |
|
|
$ |
13,780 |
|
Loss from operations |
|
|
(16,516 |
) |
|
|
(13,780 |
) |
Other
income (expense), net |
|
|
|
|
|
|
Interest income and other, net |
|
|
891 |
|
|
|
15 |
|
Interest expense and other, net |
|
|
(1,207 |
) |
|
|
— |
|
Loss before income taxes |
|
|
(16,832 |
) |
|
|
(13,765 |
) |
Income tax expense |
|
|
— |
|
|
|
(63 |
) |
Net
loss |
|
$ |
(16,832 |
) |
|
$ |
(13,828 |
) |
Net loss attributable to non-controlling interest |
|
|
(8,460 |
) |
|
|
(7,605 |
) |
Net loss
attributable to Rani Therapeutics Holdings, Inc. |
|
$ |
(8,372 |
) |
|
$ |
(6,223 |
) |
Net loss per Class A common share attributable to Rani Therapeutics
Holdings, Inc., basic and diluted |
|
$ |
(0.33 |
) |
|
$ |
(0.29 |
) |
Weighted-average Class A common shares outstanding—basic and
diluted |
|
|
25,240 |
|
|
|
21,409 |
|
Rani Therapeutics (NASDAQ:RANI)
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Rani Therapeutics (NASDAQ:RANI)
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부터 5월(5) 2023 으로 5월(5) 2024