CalciMedica Reports Second Quarter 2023 Financial Results and Provides Clinical & Corporate Updates
August 10 2023 - 3:05PM
CalciMedica Inc. (“CalciMedica”) (Nasdaq: CALC), a clinical-stage
biopharmaceutical company focused on developing novel calcium
release-activated calcium (CRAC) channel inhibition therapies for
acute and chronic inflammatory and immunologic illnesses, today
reported financial results for the second quarter ended June 30,
2023.
“Following the completion of our reverse merger
in March 2023, CalciMedica has taken critical steps to accelerate
clinical activities with our lead compound, Auxora,” said Rachel
Leheny, Ph.D., Chief Executive Officer of CalciMedica. “We
undertook the international expansion of our Phase 2b CARPO study
in acute pancreatitis with systemic inflammatory response syndrome
and enrolled our first patient in India. Also, our collaborators at
St. Jude Children’s Research Hospital are expanding our Phase 1/2
CRSPA study in asparaginase-induced pancreatic toxicity to
additional sites. Further, we expect to file our IND application
for Auxora in acute kidney injury by year-end.”
Dr. Leheny continued, “On the corporate side, we
appointed a new Chief Regulatory Officer, Raven Jaeger, M.S., as
well as a Senior Vice President of Clinical Development, Andrew
Cunningham, M.D., MRCPI. Raven and Andrew have proved to be
wonderful additions to our team and are providing leadership in the
execution of our clinical and regulatory plans. Finally, due to the
diligent work of our entire team, we were able to relist our common
stock on the Nasdaq Capital Market in June, and we are pleased to
be trading on that exchange.”
Clinical and Pre-Clinical Updates and
Anticipated Milestones:
- In April 2023, CalciMedica initiated the international
expansion of CARPO, a Phase 2b clinical trial of its lead
candidate, Auxora, in AP patients with accompanying SIRS, in India
and began enrolling patients there during the third quarter of
2023. CARPO enrollment is expected to be complete by the first
quarter of 2024, with topline data available in the first half of
2024.
- In May 2023, the Independent Data Monitoring Committee for
CARPO met to review data from the first 90 patients enrolled in the
trial and determined that the trial should continue without
modifications.
- Collaborators at St. Jude Children’s Research Hospital are
expanding the Phase 1/2 CRSPA trial of Auxora in pediatric patients
with asparaginase-induced pancreatic toxicity (AIPT), which has
been a single-center study to date. Patient enrollment from
additional sites is expected to begin in the fourth quarter of
2023.
- CalciMedica expects to file an IND
application for Auxora in AKI by year-end 2023. If allowed,
CalciMedica will then be in a position to initiate clinical trials
in this indication in the first half of 2024, pending additional
funding.
- In May 2023, preclinical data from studies in animal models of
recurrent acute pancreatitis (RAP) and early chronic pancreatitis
(CP) conducted at University of Szeged were published in The
Journal of Clinical Investigation Insight. The data showed that
inhibiting Orai1-mediated store-operated Ca2+ entry with a
selective CRAC channel inhibitor prevented the progression of RAP
and early CP into established CP, thus supporting the initiation of
clinical studies assessing Orai1 inhibition in patients with RAP
and early CP.
Financial Results for the Three and Six
Months Ended June 30, 2023:
- Cash, Cash Equivalents and
Marketable Securities: As of June 30, 2023, CalciMedica had $19.1
million in cash and cash equivalents, which the Company expects to
be sufficient to fund operations for at least the next twelve
months.
- Total Operating Expenses: Total
operating expenses were $6.6 million for the three months ended
June 30, 2023. Total operating expenses were $28.9 million for the
six months ended June 30, 2023, which included $16.2 million of
one-time charges related to accelerated vesting and severance for
employees of Graybug Vision, Inc. at the time of the reverse merger
with Graybug. The majority of costs stemming from the reverse
merger have been expensed including the payment of accrued
transaction expenses in the second quarter.
- Net Loss: Net loss was $6.3
million, or $1.11 per share (basic and diluted), and $25.6 million,
or $7.86 per share (basic and diluted), for the three and six
months ended June 30, 2023, respectively.
Corporate Updates
- In May 2023, CalciMedica announced the appointments of Raven
Jaeger, M.S. as Chief Regulatory Officer and Andrew Cunningham,
M.D., MRCPI as Senior Vice President of Clinical Development.
- In June 2023, CalciMedica’s common stock was relisted on the
Nasdaq Capital Market. CalciMedica trades on the Nasdaq Capital
Market under the ticker symbol “CALC”.
About Auxora™CalciMedica’s lead
clinical compound, Auxora™, is a potent and selective small
molecule inhibitor of Orai1-containing CRAC channels that is being
developed for use in patients with acute inflammatory and
immunologic illnesses. CRAC channels are found on many cell types,
including pancreatic acinar cells, lung endothelium cells and
immune system cells, where aberrant activation of these channels
may play a key role in the pathobiology of acute and chronic
inflammatory syndromes. Auxora is currently being evaluated in: (i)
a Phase 2b trial for AP with accompanying SIRS, called CARPO, (ii)
an investigator-sponsored Phase 1/2 trial called CRSPA being
conducted in pediatric patients with AIPT as a side effect of
pediatric acute lymphoblastic leukemia treatment with asparaginase,
and (iii) a Phase 2 dose-ranging pharmacodynamic study in critical
COVID-19 patients. There are currently no approved therapies to
treat either AP or AIPT. In previous trials, patients responded
well to Auxora regardless of severity or cause of disease.
CalciMedica is also exploring the potential of Auxora treatment for
other acute indications including acute kidney injury and acute
respiratory distress syndrome.
About CARPOCARPO is an
international, randomized, double-blind, placebo-controlled,
dose-ranging trial intended to establish efficacy in AP with
accompanying SIRS. It is expected to enroll 216 patients. AP can be
a life-threatening condition where the pancreas becomes inflamed,
sometimes leading to pancreatic cell death or necrosis, systemic
inflammation, organ failure and death. There are an estimated
275,000 hospitalizations for AP annually in the United States, of
which approximately 40% present with SIRS, which can compromise the
function of other tissues or organs, especially the lungs. Organ
failure is responsible for much of the mortality seen in AP. There
is currently no approved therapy for AP. Details of the CARPO trial
are available on clinicaltrials.gov (NCT04681066).
About CRSPACRSPA is an
investigator-sponsored Phase 1/2 trial being conducted in pediatric
acute lymphoblastic leukemia (ALL) patients with AIPT, which is
acute pancreatitis toxicity caused by the administration of
asparaginase and for which there is no approved therapy. Treatment
with asparaginase triggers the development of AIPT in 7-10% of
these patients, with approximately half developing pancreatic
necrosis and/or pseudocysts. CalciMedica believes that the CRSPA
trial has defined an optimal pediatric dose for Auxora in this
setting and the trial is currently being expanded to additional
sites. Details of the CRSPA trial are available on
clinicaltrials.gov (NCT04195347).
About CalciMedicaCalciMedica is
a clinical-stage biopharmaceutical company focused on developing
novel CRAC channel inhibition therapies for inflammatory and
immunologic diseases. CalciMedica’s proprietary technology targets
the inhibition of CRAC channels designed to modulate the immune
response and protect against tissue cell injury, with the potential
to provide therapeutic benefits in life-threatening inflammatory
and immunologic diseases for which there are currently no approved
therapies. CalciMedica’s lead product candidate Auxora™, a
proprietary, intravenous-formulated CRAC channel inhibitor, has
demonstrated positive and consistent clinical results in multiple
completed efficacy clinical trials. Auxora is in development for AP
with SIRS and AIPT. CalciMedica was founded by scientists from
Torrey Pines Therapeutics and the Harvard CBR Institute for
Biomedical Research, and is headquartered in La Jolla, CA. For more
information, please visit www.calcimedica.com.
Forward-Looking StatementsThis
communication contains forward-looking statements which include,
but are not limited to, statements regarding CalciMedica’s expected
cash runway; CalciMedica’s business strategy; the design and
potential benefits of Auxora; CalciMedica’s plans and expected
timing for developing its product candidates and potential benefits
of its product candidates; CalciMedica’s ongoing and planned
clinical trials; the development and outcomes of CARPO and CRSPA
trial programs, including the milestones, data announcements,
expected enrollment and any other potential results related
thereto. These forward-looking statements are subject to the safe
harbor provisions under the Private Securities Litigation Reform
Act of 1995. CalciMedica’s expectations and beliefs regarding these
matters may not materialize. Actual outcomes and results may differ
materially from those contemplated by these forward-looking
statements as a result of uncertainties, risks, and changes in
circumstances, including but not limited to risks and uncertainties
related to: the impact of fluctuations in global financial markets
on CalciMedica’s business and the actions it may take in response
thereto; CalciMedica’s ability to execute its plans and strategies;
the ability to obtain and maintain regulatory approval for Auxora;
results from clinical trials may not be indicative of results that
may be observed in the future; potential safety and other
complications from Auxora; the scope progress and expansion of
developing and commercializing Auxora; the size and growth of the
market therefor and the rate and degree of market acceptance
thereof; economic, business, competitive, and/or regulatory factors
affecting the business of CalciMedica generally;
CalciMedica’s ability to protect its intellectual property
position; and the impact of government laws and regulations.
Additional risks and uncertainties that could cause actual outcomes
and results to differ materially from those contemplated by the
forward-looking statements are included under the caption “Risk
Factors” in CalciMedica’s Quarterly Report on Form 10-Q for the
quarter ended March 31, 2023 and elsewhere in
CalciMedica’s subsequent reports on Form 10-K, Form 10-Q or Form
8-K filed with the SEC from time to time and available
at www.sec.gov. These documents can be accessed on
CalciMedica’s web page
at ir.calcimedica.com/financials-filings/sec-filings.
CalciMedica Contact:
Investors and MediaArgot
Partners Sarah Sutton/Kevin
Murphycalcimedica@argotpartners.com(212) 600-1902
|
Selected Financial InformationCondensed
Consolidated Balance Sheets(In thousands, except
par value and share amounts) |
|
|
|
June 30,2023 |
|
December 31,2022 |
|
|
(unaudited) |
|
|
Assets |
|
|
|
|
Current assets |
|
|
|
|
Cash and cash equivalents |
|
$ |
19,084 |
|
|
$ |
1,476 |
|
Prepaid expenses and other current assets |
|
|
961 |
|
|
|
254 |
|
Total current assets |
|
|
20,045 |
|
|
|
1,730 |
|
Property and equipment, net |
|
|
199 |
|
|
|
147 |
|
Right-of-use asset, net |
|
|
— |
|
|
|
48 |
|
Other assets |
|
|
1 |
|
|
|
1,424 |
|
Total assets |
|
$ |
20,245 |
|
|
$ |
3,349 |
|
Liabilities and Stockholders’ Equity
(Deficit) |
|
|
|
|
Current liabilities |
|
|
|
|
Accounts payable |
|
$ |
1,743 |
|
|
$ |
2,866 |
|
Accrued clinical trial costs |
|
$ |
1,207 |
|
|
$ |
1,143 |
|
Accrued other |
|
|
1,074 |
|
|
|
572 |
|
Other current liabilities |
|
|
— |
|
|
|
199 |
|
Total current liabilities |
|
|
4,024 |
|
|
|
4,780 |
|
Long-term liabilities |
|
|
|
|
Warrant liability |
|
|
— |
|
|
|
2,645 |
|
Convertible promissory notes |
|
|
— |
|
|
|
5,157 |
|
Total liabilities |
|
|
4,024 |
|
|
|
12,582 |
|
Commitments and contingencies (Note 8) |
|
|
|
|
Preferred stock |
|
|
— |
|
|
|
62,071 |
|
Stockholders’ equity (deficit) |
|
|
|
|
Common stock |
|
|
1 |
|
|
|
3 |
|
Additional paid-in capital |
|
|
153,519 |
|
|
|
40,400 |
|
Accumulated deficit |
|
|
(137,299 |
) |
|
|
(111,707 |
) |
Total stockholders’ equity (deficit) |
|
|
16,221 |
|
|
|
(71,304 |
) |
Total liabilities and stockholders’ equity |
|
$ |
20,245 |
|
|
$ |
3,349 |
|
|
|
|
|
|
|
|
|
|
Selected Financial InformationCondensed
Statements of Operations and Comprehensive Loss(In
thousands, except share and per share
amounts)(Unaudited) |
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
3,814 |
|
|
$ |
2,259 |
|
|
$ |
10,305 |
|
|
$ |
5,184 |
|
General and administrative |
|
|
2,769 |
|
|
|
1,330 |
|
|
|
18,618 |
|
|
|
2,616 |
|
Total operating expenses |
|
|
6,583 |
|
|
|
3,589 |
|
|
|
28,923 |
|
|
|
7,800 |
|
Loss from operations |
|
|
(6,583 |
) |
|
|
(3,589 |
) |
|
|
(28,923 |
) |
|
|
(7,800 |
) |
Other income (expense) |
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense), net |
|
|
279 |
|
|
|
(29 |
) |
|
|
163 |
|
|
|
(29 |
) |
Change in fair value of financial instruments |
|
|
— |
|
|
|
588 |
|
|
|
3,168 |
|
|
|
1,169 |
|
Total other income (expense),
net |
|
|
279 |
|
|
|
559 |
|
|
|
3,331 |
|
|
|
1,140 |
|
Net loss and comprehensive
loss |
|
$ |
(6,304 |
) |
|
$ |
(3,030 |
) |
|
$ |
(25,592 |
) |
|
$ |
(6,660 |
) |
Net loss per share—basic and
diluted |
|
$ |
(1.11 |
) |
|
$ |
(36.55 |
) |
|
$ |
(7.86 |
) |
|
$ |
(82.42 |
) |
Weighted-average number of shares
outstanding used in computing net loss per share—basic and
diluted |
|
|
5,661,933 |
|
|
|
82,923 |
|
|
|
3,255,868 |
|
|
|
80,812 |
|
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