Rani Therapeutics Reports Second Quarter 2024 Financial Results; Provides Corporate Update
August 06 2024 - 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 ended June 30, 2024 and provided a
corporate update.
“This quarter has been transformative for Rani, highlighted by
the recent partnership with ProGen for the co-development and
commercialization of RT-114, an oral RaniPill® capsule containing
ProGen’s PG-102, a GLP-1/GLP-2 dual agonist, for the treatment of
obesity,” said Talat Imran, Chief Executive Officer of Rani.
“RT-114 has the potential to provide better lean muscle
preservation and nutritional health of patients compared to current
therapies due to the unique mechanism of action of GLP-2. We intend
to evaluate RT-114 as a convenient, weekly oral dose. We look
forward to initiating our Phase 1 study for RT-114 in 2025 with the
aim of advancing a truly differentiated oral anti-obesity treatment
option.”
Second Quarter 2024 and Subsequent
Highlights:
- Announced Partnership with
ProGen on Development of Oral Obesity Treatment. In June
2024, Rani announced that it has entered into a definitive
agreement with ProGen Co., Ltd., a South Korean clinical-stage
biotech company developing next generation long-acting,
multi-specific fusion protein therapeutics, for the co-development
and commercialization of RT-114, an oral RaniPill® capsule
containing ProGen’s PG-102, a GLP-1/GLP-2 dual agonist, for the
treatment of obesity. Under the terms of the collaboration
agreement, Rani and ProGen agree to share responsibilities for the
development and commercialization of RT-114 worldwide, including a
50/50 cost and revenue share arrangement. Rani has exclusive rights
to lead development and commercialization of RT-114 in the United
States, Europe, Canada and Australia, and ProGen has exclusive
rights to lead development and commercialization in the rest of the
world. Rani is designated to lead operationally in conducting
preclinical and development activities through the Phase 1 program,
which is expected to initiate in 2025.
- Completed equity offering for
total gross proceeds of approximately $10.0 million. In
July 2024, Rani completed the sale and issuance of Class A common
stock, pre-funded warrants to purchase Class A common stock, and
warrants to purchase Class A common stock, to an institutional
investor for total gross proceeds of approximately $10.0 million,
excluding any potential proceeds from the exercise of warrants, if
any.
- ProGen presented data from
Phase 1 single-ascending dose study of PG-102, a GLP-1/GLP-2 dual
agonist, at the 2024 American Diabetes Association
conference. PG-102 showed a favorable safety profile with
lower frequencies of gastrointestinal side effects compared to
competitors’ trials in similar settings.
- Presented Clinical and
Preclinical Data on Oral Delivery of an Ustekinumab Biosimilar via
the RaniPill® Capsule at Digestive Disease Week 2024. In
May 2024, Rani presented clinical and preclinical data on the
RaniPill® capsule, the company’s oral delivery platform, at
Digestive Disease Week® (DDW). The clinical data presentation
demonstrated that an orally administered robotic pill (RP) reliably
and safely delivered an ustekinumab biosimilar RT-111 with high
bioavailability relative to subcutaneous (SC) ustekinumab in
healthy human participants. The preclinical data presentation
demonstrated that an orally-administered ustekinumab biosimilar
RT-111 delivered via a robotic pill yielded bioavailability
comparable to subcutaneous injection in canines.
Near-Term Milestone Expectations:
- Initiation of Phase
1 clinical trial of RT-114 containing a GLP-1/GLP-2 dual agonist
for the treatment of obesity expected in 2025.
Second Quarter 2024 Financial Results:
- Cash, cash equivalents and
marketable securities as of June 30, 2024 totaled $30.9
million, compared to $48.5 million for the year ended December 31,
2023.
- Research and development
expenses for the three months ended June 30, 2024 were
$6.1 million, compared to $11.1 million for the same period in
2023. The decrease of $5.0 million was primarily attributed to
lower compensation costs of $2.9 million due to reduction in
workforce, $1.6 million reduction in third-party services and $0.4
million reduction in materials and supplies due to the timing of
certain preclinical and clinical studies.
- General and administrative
expenses for the three months ended June 30, 2024 were
$6.4 million, compared to $7.2 million for the same period in 2023.
The decrease of $0.8 million was primarily attributed to lower
compensation costs of $1.3 million due to reduction in workforce,
offset by an increase in facility costs of $0.4 million due to the
lease in Fremont, California.
- Net loss for the three
months ended June 30, 2024 was $13.4 million, compared to $18.7
million for the same period in 2023, including stock-based
compensation expense of $4.1 million for the three months ended
June 30, 2024, compared to $5.1 million for the same period in
2023.
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
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, RT-114 therapeutic potential, the
expected initiation of a Phase 1 trial of RT-114 in 2025, the
success of Rani’s collaboration with ProGen, 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, the
timing and extent of its expenses, and future financial
performance. 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 “expect,” “intend,” “look forward,” “potential,” 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, 2023 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) |
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2024 |
|
|
2023 |
|
|
|
(Unaudited) |
|
|
|
|
Assets |
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
4,514 |
|
|
$ |
5,864 |
|
Marketable securities |
|
|
26,387 |
|
|
|
42,675 |
|
Prepaid expenses and other current assets |
|
|
1,133 |
|
|
|
2,308 |
|
Total current assets |
|
|
32,034 |
|
|
|
50,847 |
|
Property and equipment, net |
|
|
5,695 |
|
|
|
6,105 |
|
Operating lease right-of-use asset |
|
|
5,751 |
|
|
|
718 |
|
Other assets |
|
|
246 |
|
|
|
246 |
|
Total assets |
|
$ |
43,726 |
|
|
$ |
57,916 |
|
Liabilities and Stockholders' Equity |
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
506 |
|
|
$ |
648 |
|
Accrued expenses and other current liabilities |
|
|
2,422 |
|
|
|
1,726 |
|
Current portion of long-term debt |
|
|
12,290 |
|
|
|
4,897 |
|
Current portion of operating lease liability |
|
|
1,363 |
|
|
|
718 |
|
Total current liabilities |
|
|
16,581 |
|
|
|
7,989 |
|
Long-term debt, less current portion |
|
|
17,207 |
|
|
|
24,484 |
|
Operating lease liability, less current portion |
|
|
4,388 |
|
|
|
— |
|
Total liabilities |
|
|
38,176 |
|
|
|
32,473 |
|
Stockholders' equity: |
|
|
|
|
|
|
Preferred stock, $0.0001 par value - 20,000 shares authorized; none
issued and outstanding as of June 30, 2024 and December 31,
2023 |
|
|
— |
|
|
|
— |
|
Class A
common stock, $0.0001 par value - 800,000 shares authorized; 26,489
and 26,036 issued and outstanding as of June 30, 2024 and December
31, 2023, respectively |
|
|
3 |
|
|
|
3 |
|
Class B
common stock, $0.0001 par value - 40,000 shares authorized; 24,116
issued and outstanding as of June 30, 2024 and December 31,
2023 |
|
|
2 |
|
|
|
2 |
|
Class C
common stock, $0.0001 par value - 20,000 shares authorized; none
issued and outstanding as of June 30, 2024 and December 31,
2023 |
|
|
— |
|
|
|
— |
|
Additional paid-in capital |
|
|
90,012 |
|
|
|
85,762 |
|
Accumulated other comprehensive loss |
|
|
(5 |
) |
|
|
(12 |
) |
Accumulated deficit |
|
|
(87,177 |
) |
|
|
(72,889 |
) |
Total stockholders' equity attributable to Rani Therapeutics
Holdings, Inc. |
|
|
2,835 |
|
|
|
12,866 |
|
Non-controlling interest |
|
|
2,715 |
|
|
|
12,577 |
|
Total stockholders' equity |
|
|
5,550 |
|
|
|
25,443 |
|
Total liabilities and stockholders' equity |
|
$ |
43,726 |
|
|
$ |
57,916 |
|
|
|
|
|
|
|
|
|
|
RANI THERAPEUTICS HOLDINGS, INC
Consolidated Statements of Operations(In
thousands, except per share
amounts) (Unaudited) |
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
6,115 |
|
|
$ |
11,086 |
|
|
$ |
13,700 |
|
|
$ |
20,798 |
|
General and administrative |
|
|
6,409 |
|
|
|
7,208 |
|
|
|
12,857 |
|
|
|
14,012 |
|
Total operating expenses |
|
$ |
12,524 |
|
|
$ |
18,294 |
|
|
$ |
26,557 |
|
|
$ |
34,810 |
|
Loss from operations |
|
|
(12,524 |
) |
|
|
(18,294 |
) |
|
|
(26,557 |
) |
|
|
(34,810 |
) |
Other
income (expense), net |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income and other, net |
|
|
439 |
|
|
|
896 |
|
|
|
988 |
|
|
|
1,787 |
|
Interest expense and other, net |
|
|
(1,276 |
) |
|
|
(1,266 |
) |
|
|
(2,571 |
) |
|
|
(2,473 |
) |
Net
loss |
|
$ |
(13,361 |
) |
|
$ |
(18,664 |
) |
|
$ |
(28,140 |
) |
|
$ |
(35,496 |
) |
Net loss attributable to non-controlling interest |
|
|
(6,556 |
) |
|
|
(9,361 |
) |
|
|
(13,852 |
) |
|
|
(17,821 |
) |
Net loss
attributable to Rani Therapeutics Holdings, Inc. |
|
$ |
(6,805 |
) |
|
$ |
(9,303 |
) |
|
$ |
(14,288 |
) |
|
$ |
(17,675 |
) |
Net loss per Class A common share attributable to Rani Therapeutics
Holdings, Inc., basic and diluted |
|
$ |
(0.26 |
) |
|
$ |
(0.37 |
) |
|
$ |
(0.55 |
) |
|
$ |
(0.70 |
) |
Weighted-average Class A common shares outstanding—basic and
diluted |
|
|
26,324 |
|
|
|
25,345 |
|
|
|
26,179 |
|
|
|
25,293 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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