CinCor Pharma, Inc. (NASDAQ: CINC) today announced financial
results for the second quarter ended June 30, 2022 and provided a
corporate update.
“We were very pleased to announce earlier today the positive
topline data for baxdrostat in treatment-resistant hypertension.
The CinCor team has continued strong execution across our clinical
milestones this quarter, also announcing the completion of
randomization in the Phase 2 HALO trial, initiation of a long-term
extension trial in patients with uncontrolled hypertension and
dosing the first patient in the Phase 2 figHTN-CKD trial,” said
Marc de Garidel, Chief Executive Officer. “We look forward to
continuing the clinical momentum with topline data for HALO
expected to read out in the second half of 2022.”
Recent Corporate and Clinical Highlights
- Positive
Topline Phase 2 BrigHtn Trial Data. Earlier
today, we reported positive topline data for the Phase 2 BrigHtn
trial of baxdrostat for the treatment of patients with
treatment-resistant hypertension (rHTN)
- Successfully met the
primary endpoint in the BrigHtn trial, delivering a 20.3 mmHg
reduction in systolic blood pressure (SBP), or an 11 mmHg SBP
(p-value < 0.0001) decline on a placebo-adjusted basis, at the 2
mg dose
- Dose-dependent reductions observed
in SBP
- Compelling safety and tolerability profile with no drug related
serious adverse events (SAEs) or major safety concerns reported
across all three dose levels tested after 12 weeks of
treatment
- Phase 2 HALO
Trial Completed Randomization. In July 2022, CinCor
completed enrollment in the Phase 2 HALO trial with 249 patients
randomized. HALO is a clinical trial designed to evaluate the
safety and efficacy of baxdrostat in patients with blood pressure
that is not controlled despite treatment with up to two
antihypertensive agents, referred to as uncontrolled hypertension
(uHTN), and remains on track to report topline study results in the
second half of 2022.
- Phase 2 Open
label extension (OLE) trial initiated, evaluating
baxdrostat for up to 52-weeks in patients that previously
participated in the Phase 2 HALO trial. Topline data from this
trial is expected in the second half of 2023.
- Dosed First
Patient in the Phase 2 figHTN-CKD Trial. In June 2022, the
first patient was dosed in the Phase 2 trial for baxdrostat in
patients with uncontrolled hypertension and chronic kidney disease
(CKD). Topline date from this trial is expected in the second half
of 2023.
Key Anticipated Upcoming Milestones
Spark-PA: Phase 2 trial designed to evaluate
the safety and efficacy of baxdrostat in patients with primary
aldosteronism (PA)
- Dosing of first patient expected in
the third quarter of 2022
- Topline data expected in the second
half of 2023
HALO: Phase 2 trial designed to evaluate the
safety and efficacy of baxdrostat in patients with uHTN
- Topline data expected in the second
half of 2022
figHTN-CKD: Phase 2 trial designed to evaluate
the safety and efficacy of baxdrostat in patients with uHTN and
CKD
- Topline data expected in the second
half of 2023
Second Quarter 2022 Financial Highlights
Cash Position: Cash, cash equivalents and
marketable securities totaled $294.3 million as of June 30, 2022,
as compared to $136.6 million as of December 31, 2021. The increase
in cash, cash equivalents and marketable securities of $157.7
million was driven primarily by the Company’s January 2022 initial
public offering (IPO) net proceeds of $193.6 million, partially
offset by operating cash outflows of $37.3 million.
Research and Development (R&D) Expenses:
R&D expenses for the three months ended June 30, 2022, were
$17.2 million, compared to $4.0 million for the three months ended
June 30, 2021. R&D expenses for the six months ended June 30,
2022, were $26.9 million, compared to $7.5 million for the six
months ended June 30, 2021. The increase for the three and six
month periods were primarily due to the progress of several Phase 2
clinical trials, including the full enrollment in our HALO trial,
the initiation of our figHTN CKD and Open Label Extension trials,
increased chemistry, manufacturing, and controls spending, and the
addition of several important full-time R&D resources.
General and Administrative (G&A) Expenses:
G&A expenses were $4.2 million for the three months ended June
30, 2022, compared to $1.2 million for the three months ended June
30, 2021. G&A expenses were $8.2 million for the six months
ended June 30, 2022, compared to $2.1 million for the six months
ended June 30, 2021. The increases for three and six month periods
were primarily attributable to increased personnel costs as we
continued to build out our in-house team primarily based in
Waltham, MA (reaching 21 employees by June 30, 2022), as well as
increased legal and professional fees and other costs associated
with operating as a public company.
Other Expenses: For the three months ended June
30, 2022 and 2021, CinCor incurred a non-cash expense of $0.0
million and $1.2 million, respectively, and $3.0 million and $2.4
million for the six months ended June 30, 2022 and 2021,
respectively. The non-cash expense was related to the change in
fair value of the Roche Warrants driven by an increase in the fair
value of the underlying common stock. The Roche Warrants were
automatically net exercised into common stock upon the completion
of the IPO in January 2022.
Net Loss: For the three months ended June 30,
2022, CinCor reported a net loss of $21.1 million, compared to a
net loss of $6.4 million for the three months ended June 30, 2021.
Net loss for the six months ended June 30, 2022, was $37.8 million
compared to a net loss of $12.0 million for the six months ended
June 30, 2021.
About CinCorCinCor, founded in 2018, is a
clinical-stage biopharmaceutical company with a mission to bring
innovation to the pharmaceutical treatment of cardio-renal
diseases. Its lead asset, baxdrostat, a highly selective, oral
small molecule inhibitor of aldosterone synthase, is in clinical
development for the treatment of hypertension and primary
aldosteronism.
About Baxdrostat (CIN-107)Baxdrostat (CIN-107)
is a highly selective, oral small molecule inhibitor of aldosterone
synthase, the enzyme responsible for the synthesis of aldosterone
in the adrenal gland, in development for patient populations with
significant unmet medical needs, including treatment-resistant
hypertension and primary aldosteronism. Hypertension, which is
defined by the American College of Cardiology and the American
Heart Association as resting blood pressure above 130/80 mm Hg, is
generally acknowledged to be one of the most common preventable
risk factors for premature death worldwide. Though often
asymptomatic, hypertension significantly increases the risk of
heart disease, stroke, and kidney disease, amongst other diseases.
It is estimated that as much as 20% of the global population
suffers from hypertension, including nearly one-half of the adult
population in the U.S., or 116 million hypertensive patients.
Forward-Looking Statements
This press release contains certain forward-looking statements,
including, but not limited to, statements related to CinCor’s
business in general; the results and timing of CinCor’s ongoing and
planned clinical trials; the anticipated timing of disclosure of
results of clinical trials; the progress of CinCor’s research and
development programs and clinical trials and studies, including
enrollment and retention in clinical trials; plans for initiating
future clinical trials and studies; the therapeutic potential of
baxdrostat (CIN-107); CinCor’s clinical milestones and pipeline;
expectations with respect to regulatory matters; expectations with
respect to potential market size; expectations relating to and the
sufficiency of CinCor’s cash resources; and other statements that
are not historical facts. Because such statements are
subject to risks and uncertainties, actual results may differ from
those expressed or implied by such forward-looking
statements. Words such as “anticipates,” “believes,”
“expected,” “intends,” “plan,” “may”, “will,” “project”,
“estimate”, “continue,” “advance” and “future” or similar
expressions are intended to identify forward-looking statements.
These forward-looking statements are based on CinCor’s current
plans, objectives, estimates, expectations and intentions, involve
assumptions that may never materialize or may prove to be incorrect
and inherently involve significant risks and uncertainties,
including factors beyond CinCor’s control, that could cause actual
results, performance, or achievement to differ materially and
adversely from those anticipated or implied in the statements,
including, without limitation, CinCor has incurred significant
operating losses since its inception; CinCor has a limited
operating history and no history of commercializing products;
CinCor will require substantial additional funding to finance its
operations; CinCor’s business is entirely dependent at this time on
the success of one drug, baxdrostat (CIN-107); interim, “top-line”
and preliminary data from clinical trials announced or published
from time to time may change; CinCor may not be successful in its
efforts to expand its pipeline beyond baxdrostat (CIN-107); success
in preclinical studies or earlier clinical trials may not be
indicative of results in future clinical trials; enrollment and
retention of patients in clinical trials could be delayed; CinCor
relies and will rely on third parties to conduct, supervise and
monitor existing clinical trials and potential future clinical
trials; developments from the company’s competitors and the
marketplace for the company’s products; and CinCor’s business,
operations and clinical development timelines and plans may be
adversely affected by the evolving and ongoing COVID-19 pandemic,
geopolitical events, including the ongoing military conflict
between Russia and Ukraine and related sanctions, and macroeconomic
conditions, including rising inflation and uncertain credit and
financial markets, and matters related thereto; and other risks and
uncertainties affecting the company, including those described
under the caption “Risk Factors” and elsewhere in CinCor’s Annual
Report on Form 10-K for the year ended December 31, 2021 filed with
the Securities and Exchange Commission (SEC) on March 22, 2022,
CinCor’s Quarterly Report on Form 10-Q for the three months ended
March 31, 2022 filed with the SEC on May 10, 2022, and other
filings and reports that CinCor may file from time to time with the
SEC, including its quarterly report on Form 10-Q for the three
months ended June 30, 2022. Other risks and uncertainties of which
CinCor is not currently aware may also affect the company’s
forward-looking statements and may cause actual results and the
timing of events to differ materially from those anticipated. 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. CinCor
undertakes no obligation to publicly update or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise, except as may be required by law.
Contacts: |
Investors: |
Terry Coelho |
Bob Yedid |
CinCor Pharma, Inc. |
LifeSci Advisors |
EVP, CFO and CBDO |
ir@CinCor.com |
CinCor Pharma,
Inc.Condensed Statements of Operations
(In thousands, except share and per share
amounts)(Unaudited)
|
Three MonthsEnded June 30 |
|
Six MonthsEnded June 30 |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Operating
expenses |
|
|
|
|
|
|
|
|
|
Research and development |
$ |
17,161 |
|
|
$ |
3,998 |
|
|
$ |
26,852 |
|
|
$ |
7,488 |
|
General and
administrative |
|
4,192 |
|
|
|
1,176 |
|
|
|
8,205 |
|
|
|
2,099 |
|
Total operating
expenses |
|
21,353 |
|
|
|
5,174 |
|
|
|
35,057 |
|
|
|
9,587 |
|
Loss from
operations |
|
(21,353 |
) |
|
|
(5,174 |
) |
|
|
(35,057 |
) |
|
|
(9,587 |
) |
|
|
|
|
|
|
|
|
Other (income) expense: |
|
|
|
|
|
|
|
Interest income |
|
(277 |
) |
|
|
(2 |
) |
|
|
(329 |
) |
|
|
(6 |
) |
Change in fair value of
warrant derivative liabilities |
|
— |
|
|
|
1,210 |
|
|
|
3,044 |
|
|
|
2,420 |
|
Total other (income) expense,
net |
|
(277 |
) |
|
|
1,208 |
|
|
|
2,715 |
|
|
|
2,414 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(21,075 |
) |
|
$ |
(6,383 |
) |
|
$ |
(37,772 |
) |
|
$ |
(12,001 |
) |
|
|
|
|
|
|
|
|
Net loss per common share,
basic and diluted |
$ |
(0.56 |
) |
|
$ |
(4.81 |
) |
|
$ |
(1.06 |
) |
|
$ |
(9.31 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares
outstanding, basic and diluted |
|
37,709,912 |
|
|
|
1,327.852 |
|
|
|
35,583,567 |
|
|
|
1,289,141 |
|
CinCor Pharma,
Inc.Condensed Balance Sheet
Data(In
thousands)(Unaudited)
|
June 30, |
|
December 31, |
|
2022 |
|
2021 |
Cash, cash equivalents & marketable securities |
$ |
294,312 |
|
$ |
136,606 |
|
Working capital |
|
295,693 |
|
|
124,557 |
|
Total assets |
|
303,016 |
|
|
141,107 |
|
Total stockholders’ equity
(deficit) |
|
295,734 |
|
|
(63,717 |
) |
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