Rain Therapeutics Inc., (NasdaqGS: RAIN),. (“Rain”), a late-stage
company developing precision oncology therapeutics, today reports
financial results for the second quarter and six months ended June
30, 2021, along with an update on the company's key developments,
business operations and upcoming milestones.
“Rain has made strong progress in the second quarter and six
months ended 2021,” said Avanish Vellanki, co-founder and chief
executive officer of Rain. “Patients with dedifferentiated
liposarcoma are in desperate need of new therapies, and we are
proud to have been able to dose the first patient in a pivotal
Phase 3 trial in under 12 months from acquiring the program. As we
move forward with the milademetan clinical strategy, we look to
commence our second trial, MANTRA-2, in patients with
MDM2-amplified solid tumors, in the second half of 2021.”
Key Developments and Operational Updates
- First Patient Dosed in Phase 3 MANTRA Clinical Trial of
Milademetan (RAIN-32) for DD LPS
- In July 2021, Rain announced that the first patient was
randomized in the multicenter, open-label, Phase 3 registrational
trial (MANTRA) evaluating milademetan, an oral mouse double minute
2 (“MDM2”) inhibitor, for the treatment of DD LPS.
- Rain anticipates data from this trial in 2023.
- MDM2-Amplified Phase 2 Basket Trial (MANTRA-2) to
commence shortly
- Rain anticipates enrolling the first patient in its basket
study of patients with MDM2-amplified advanced solid tumors
(MANTRA-2) in the second half of 2021. These patients will exhibit
a degree of MDM2 amplification that Rain believes is oncogenic and
sensitive to MDM2 inhibition.
- Rain anticipates interim data in 2H 2022.
- Collaborations with Tempus and Caris Life Sciences for
the Milademetan MDM2-Amplified Phase 2 Basket Trial
(MANTRA-2)
- In June 2021, Rain announced an agreement with Tempus, an
artificial intelligence and precision medicine company, to use
their comprehensive genomic profiling testing platform for the
Phase 2, MANTRA-2 basket trial for milademetan. Under the terms of
the agreement, Tempus will provide both centralized tumor testing
and patient matching services using their Connect & TIME Trial®
Network.
- In June 2021, Rain also announced a patient referral
partnership with Caris Life Sciences (“Caris”). Under the terms of
the partnership, Caris will provide patient referral services using
their molecular intelligence trials platform for MANTRA-2.
- Milademetan Non-Clinical Data Abstracts Submitted to
Upcoming Conferences
- Rain, in collaboration with several research partners, intends
to present non-clinical data at upcoming conferences relating to
additional clinical opportunities for milademetan in the second
half of 2021. Presentations for milademetan have been submitted and
accepted to the 2021 World Conference of Lung Cancer (Sept. 8-14,
2021) and the 2021 EORTC-NCI-AACR International Conference on
Molecular Targets and Cancer Therapeutics virtual conference (Oct.
7-10, 2021).
Anticipated Near-term Milestones
- Milademetan MDM2-Amplified Phase 2 Basket Study
(MANTRA-2)
- Phase 2 trial expected to commence in the second half of
2021
- Rain anticipates interim data in 2H 2022
- Milademetan Intimal Sarcoma Phase 2 Study
- Phase 2 trial expected to commence by early 2022
- Rain anticipates interim data in late 2022
- Milademetan DD LPS Phase 3 Study (MANTRA)
- Rain anticipates data from this trial in 2023
- RAD52 Research Program
- Lead candidate selection expected in 2022
Second Quarter Financial ResultsFor the three
and six months ended June 30, 2021, Rain reported a net loss of
$8.2 million and $15.0 million, respectively, as compared to a net
loss of $2.6 million and $5.2 million for the same periods in 2020,
respectively. Net loss per share for the three and six months ended
June 30, 2021, were $0.39 and $1.23, respectively, as compared to a
net loss per share of $0.78 and $1.60 for the same periods in 2020,
respectively.
Research and development ("R&D") expenses were $5.5 million
and $10.8 million for the three and six months ended June 30, 2021,
respectively, as compared to $1.5 million and $3.2 million for the
same periods in 2020, respectively. The increases were primarily
driven by the clinical costs for Rain’s lead product candidate,
milademetan, as Rain prepared to launch its Phase 3 pivotal trial
in DD LPS in July 2021, as well as personnel costs. Non-cash
stock-based compensation expenses included in R&D expenses were
approximately $0.6 million and $0.8 million in the three and six
months ended June 30, 2021, respectively, as compared to $0.1
million and $0.2 million in the same periods in 2020,
respectively.
General and administrative ("G&A") expenses were $2.7
million and $4.2 million for the three and six months ended June
30, 2021, respectively, as compared to $1.1 million and $1.8
million for the same periods in 2020, respectively. The increases
were primarily due to increases in various third-party G&A
costs, including legal, outside consulting, as well as accounting
and audit fees. Non-cash stock-based compensation expense included
in G&A expenses were approximately $0.2 million in each of the
three and six months ended June 30, 2021, as compared to $0.1
million and $0.2 million for the same periods in 2020,
respectively.
Total non-cash stock-based compensation expenses were
approximately $0.8 million and $1.0 million in the three and six
months ended June 30, 2021, respectively, as compared to $0.2
million and $0.4 million for the same periods in 2020,
respectively.
As of June 30, 2021, Rain had $164.6 million in cash, cash
equivalents and short-term investments. This included the $121.5
million in net proceeds from Rain’s initial public offering in
April 2021. Rain’s quarter-end cash position adequately
provides runway through late-2024.
As of June 30, 2021, Rain had approximately 26.5 million shares
of common stock outstanding.
The Company continues to expect its full year 2021 net cash used
in operating activities to be approximately $50.0 million to $60.0
million and a projected year end cash balance of approximately
$137.0 million to $147.0 million in cash, cash equivalents and
short-term investments.
Second Quarter 2021 Results Conference Call and Webcast
DetailsThe management of Rain Therapeutics will host a
conference call and webcast for the investment community today,
August 10, 2021, at 1:30 p.m. PT (4:30 p.m. ET). The conference
call can be accessed by dialing 1 (800) 708-4539 (U.S. Toll Free) /
1 (847) 619-6396 (U.S. Toll). The passcode for the conference call
is 50202648. A live webcast may be accessed by visiting the
“Investors” section of the Rain Therapeutics’ website at
www.rainthera.com. The call will be recorded and available for
replay on the Company’s website for approximately 30 days after the
call.
About Well-Differentiated/Dedifferentiated
LiposarcomaLiposarcoma (“LPS”) is a rare cancer
originating from fat cells located in the soft tissues of the body.
It is a malignant cancer that can spread to other parts of the
body. Well-differentiated (“WD”) LPS is less aggressive and tends
to present as a large painless mass found in deeper tissues.
Dedifferentiated (“DD”) LPS is more aggressive, arising from WD
LPS, and is usually found in tissue behind the abdominal area
(retroperitoneal) or the extremities. WD/DD LPS are the most
frequent subtypes of LPS and share common genomic abnormalities,
predominately MDM2 gene amplification. The incidence of LPS is
estimated at approximately 3,000 patients annually in the U.S., of
which two-thirds are of the DD and WD type, and for which there are
few effective treatment options.
About MANTRA TrialThe MANTRA trial is a
randomized, multicenter, open-label, Phase 3 registrational trial
evaluating milademetan, an oral MDM2 inhibitor, for the treatment
of DD LPS. The MANTRA trial is designed to evaluate the safety and
efficacy of milademetan compared to trabectedin, a current standard
of care, in patients with unresectable or metastatic DD LPS that
progressed on one or more prior systemic therapies, including at
least one anthracycline-based therapy. Approximately 160 patients
will be randomly assigned in a 1:1 ratio to receive milademetan or
trabectedin. The primary objective of the MANTRA trial is to
compare progression-free survival as determined by blinded
independent review between the milademetan treatment arm and
trabectedin control arm, in patients with unresectable or
metastatic DD LPS, with or without a well-differentiated LPS
component. Overall survival, disease control rate, objective
response rate, duration of response, safety and patient reported
outcomes will also be evaluated.
About Rain Therapeutics Inc.Rain Therapeutics
Inc. is a late-stage precision oncology company developing
therapies that target oncogenic drivers for which it is able to
genetically select patients it believes will most likely benefit.
This approach includes using a tumor-agnostic strategy to select
patients based on their tumors’ underlying genetics rather than
histology. Rain’s lead product candidate, milademetan (RAIN-32), is
a small molecule, oral inhibitor of MDM2, which is oncogenic in
numerous cancers. In addition to milademetan, Rain is also
developing a preclinical program that is focused on inducing
synthetic lethality in cancer cells by inhibiting RAD52.
Forward Looking StatementsStatements 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 results, conduct, progress and timing of Rain’s
ongoing and planned trials for milademetan (RAIN-32), the
tolerability and safety profile of milademetan, the timing for
selection of a lead candidate for RAD52 and the expect net cash
used in operation activities and year end cash balance for full
year 2021. 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 “plans,” “will,” “anticipates,” “goal,” “potential” and similar
expressions are intended to identify forward-looking statements.
These forward-looking statements are based upon Rain’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 Rain’s business
in general, our substantial dependence on the success of our lead
product candidate, lack of success in our clinical trials,
difficulties in enrolling patients, competition from competing
products, the impact of the COVID-19 pandemic, and the other risks
and uncertainties described in Rain’s Quarterly Report on Form 10-Q
for the quarter ended March 31, 2021 and subsequent 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. Rain 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.
Media Contact:Jordyn TemperatoLifeSci
Communications +1.646.876.5196
jtemperato@lifescicomms.com
RAIN
THERAPEUTICS INC. |
|
|
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CONDENSED
STATEMENTS OF OPERATIONS |
|
|
|
(in
thousands, except share and per share amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended June 30, |
|
Six Months
Ended June 30, |
|
|
|
|
|
2021 |
|
|
2020 |
|
|
|
2021 |
|
|
2020 |
|
|
|
|
|
|
(unaudited) |
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research and
development |
|
5,489 |
|
|
1,473 |
|
|
|
10,817 |
|
|
3,235 |
|
|
|
|
|
Selling,
general and administrative |
|
2,700 |
|
|
1,119 |
|
|
|
4,180 |
|
|
1,787 |
|
|
|
|
|
Total costs and expenses |
|
8,189 |
|
|
2,592 |
|
|
|
14,997 |
|
|
5,022 |
|
|
|
|
Loss from operations |
|
(8,189 |
) |
|
(2,592 |
) |
|
|
(14,997 |
) |
|
(5,022 |
) |
|
|
|
Other income (expense) |
|
|
|
|
|
|
|
|
|
Interest
income |
|
6 |
|
|
6 |
|
|
|
14 |
|
|
26 |
|
|
|
|
|
Interest
expense, related party |
|
— |
|
|
(33 |
) |
|
|
- |
|
|
(64 |
) |
|
|
|
|
Change in
fair value of convertible promissory notes, related party |
|
— |
|
|
(5 |
) |
|
|
- |
|
|
(133 |
) |
|
|
|
Total other income (expense), net |
|
6 |
|
|
(32 |
) |
|
|
14 |
|
|
(171 |
) |
|
|
|
Net loss |
$ |
(8,183 |
) |
$ |
(2,624 |
) |
|
$ |
(14,983 |
) |
$ |
(5,193 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic and diluted |
$ |
(0.39 |
) |
$ |
(0.78 |
) |
|
$ |
(1.23 |
) |
$ |
(1.60 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares used in computing net loss per share, |
|
|
|
|
|
|
|
|
|
basic and
diluted |
|
20,825,334 |
|
|
3,360,388 |
|
|
|
12,225,929 |
|
|
3,250,039 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SUMMARY
BALANCE SHEET DATA |
|
|
|
|
|
|
|
(in
thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June
30 |
December
31, |
|
|
|
|
|
|
|
|
|
2021 |
|
2020 (1) |
|
|
|
|
|
|
|
|
(unaudited) |
|
|
|
|
|
|
|
|
Cash, cash
equivalents and short-term investments |
$ |
164,647 |
|
$ |
58,863 |
|
|
|
|
|
|
|
|
Total
assets |
|
174,553 |
|
|
61,080 |
|
|
|
|
|
|
|
|
Stockholders' equity (deficit) |
|
164,834 |
|
|
(37,417 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1 |
) |
Derived from
audited financial statements |
|
|
|
|
|
|
|
|
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|
|
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|
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|
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