CalciMedica Reports First Quarter 2023 Financial Results and Provides Clinical & Corporate Updates
May 15 2023 - 8:55AM
CalciMedica Inc. (“CalciMedica”) (OTCQB: CALC), a clinical-stage
biopharmaceutical company focused on developing therapies for
life-threatening inflammatory diseases with high unmet need, today
reported financial results for the first quarter ended March 31,
2023.
“We ended our first quarter as a public company
in a strong position, with a cash runway that will last into the
second half of 2024,” said Rachel Leheny, Ph.D., Chief Executive
Officer of CalciMedica. “We are pleased to have entered the second
quarter of 2023 with forward momentum, continuing the work towards
our near-term clinical milestones with Auxora in acute pancreatitis
and asparaginase-associated pancreatitis for critically ill patient
populations whose needs are currently unmet.”
Financial Results for the Three Months
Ended March 31, 2023:
- Cash, Cash Equivalents and
Marketable Securities: As of March 31, 2023, CalciMedica had $34.2
million in cash, cash equivalents and short-term investments.
- Total Operating Expenses: Total
operating expenses were $22.3 million, which included $16.2 million
of one-time charges related to accelerated vesting and severance
for employees of Graybug Vision, Inc. (Graybug) at the time of the
merger with Graybug.
- Net Loss: Net loss was $19.3
million, or $23.43 per share (basic and diluted), for the three
months ended March 31, 2023.
Clinical Updates and Anticipated
Milestones:
- In April, 2023, CalciMedica initiated the ex-US expansion of
its Phase 2b clinical trial in acute pancreatitis patients (CARPO)
in India with an investigator meeting and expects to begin
enrolling patients in India in the second quarter of 2023.
- On May 9, 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.
- CalciMedica anticipates results from the first cohort of the
investigator-sponsored Phase 1/2 CRSPA study of lead candidate
Auxora in patients with Asparaginase-Associated Pancreatitis (AAP)
and trial expansion in the second half of 2023.
- The Company also expects to
complete enrollment in the ongoing Phase 2b CARPO clinical trial of
Auxora in Acute Pancreatitis (AP) patients with systemic
inflammatory response syndrome (SIRS) by year-end 2023, with
topline results expected in the first quarter of 2024.
- The Company expects to file an IND
for Auxora in acute kidney injury in the second half of 2023 and,
if accepted, will then be in a position to initiate clinical trials
in this indication pending additional funding.
Corporate Updates
- On March 20, 2023, CalciMedica closed a merger with Graybug.
Immediately following the closing of the merger, CalciMedica
equityholders owned approximately 72% of the combined company and
Graybug equityholders owned approximately 28%.
- On March 30, 2023, the Company’s common stock was suspended
from trading on Nasdaq due to non-compliance with Nasdaq listing
requirements. The Company’s common stock is currently trading on
the OTCQB and the Company is working diligently towards relisting
its common stock on Nasdaq.
About AuxoraCalciMedica’s lead
clinical compound, Auxora, is a potent and selective small molecule
inhibitor of Orai1-containing calcium release-activated calcium
(CRAC) channels that is being developed for use in patients with
inflammatory 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 a
Phase 2b trial for acute pancreatitis (AP) with accompanying
systemic inflammatory response syndrome (SIRS) called CARPO, an
investigator-sponsored Phase 1/2 trial being conducted in pediatric
patients with asparaginase-associated pancreatitis (AAP) called
CRSPA and a Phase 2 dose escalation study in critical COVID-19
patients. There are currently no approved therapies to treat either
AP or AAP. In previous trials patients responded well to Auxora
regardless of severity or cause of disease. CalciMedica is also
exploring potential Auxora treatment for other acute indications
including acute kidney injury, acute respiratory distress syndrome
and acute lung injury.
About CARPOCARPO is a
randomized, double-blind, placebo-controlled, dose-ranging trial
intended to establish efficacy in acute pancreatitis (AP). 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 AAP, 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 AAP 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
therapies for life-threatening inflammatory diseases with high
unmet need. 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
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 four completed efficacy
clinical trials. Auxora is in development for acute AP with SIRS
and AAP. 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; and CalciMedica’s ability to relist on Nasdaq. 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)
|
|
March 31,2023 |
|
December 31,2022 |
|
|
(unaudited) |
|
(as restated) |
Assets |
|
|
|
|
Current
assets |
|
|
|
|
Cash and cash equivalents |
|
$ |
24,386 |
|
|
$ |
1,476 |
|
Short-term investments |
|
|
9,776 |
|
|
|
— |
|
Prepaid expenses and other current assets |
|
|
336 |
|
|
|
254 |
|
Total current assets |
|
|
34,498 |
|
|
|
1,730 |
|
Property
and equipment, net |
|
|
134 |
|
|
|
147 |
|
Right-of-use asset, net |
|
|
10 |
|
|
|
48 |
|
Other
assets |
|
|
27 |
|
|
|
1,424 |
|
Total assets |
|
$ |
34,669 |
|
|
$ |
3,349 |
|
Liabilities and Stockholders’ Equity
(Deficit) |
|
|
|
|
Current
liabilities |
|
|
|
|
Accounts payable |
|
$ |
2,055 |
|
|
$ |
2,866 |
|
Accrued other |
|
|
10,482 |
|
|
|
1,715 |
|
Other current liabilities |
|
|
113 |
|
|
|
199 |
|
Total current liabilities |
|
|
12,650 |
|
|
|
4,780 |
|
Long-term liabilities |
|
|
|
|
Warrant liability |
|
|
— |
|
|
|
2,645 |
|
Convertible promissory notes |
|
|
— |
|
|
|
5,157 |
|
Total liabilities |
|
|
12,650 |
|
|
|
12,582 |
|
Commitments and contingencies (Note 8) |
|
|
|
|
Preferred stock |
|
|
— |
|
|
|
62,071 |
|
Stockholders’ equity (deficit) |
|
|
|
|
Common stock |
|
|
1 |
|
|
|
3 |
|
Additional paid-in capital |
|
|
153,013 |
|
|
|
40,400 |
|
Accumulated deficit |
|
|
(130,995 |
) |
|
|
(111,707 |
) |
Total stockholders’ equity (deficit) |
|
|
22,019 |
|
|
|
(71,304 |
) |
Total liabilities and stockholders’ equity |
|
$ |
34,669 |
|
|
$ |
3,349 |
|
Selected Financial
InformationCondensed Statements of
Operations(In thousands, except share and per
share data)
|
|
Three Months Ended March 31, |
|
|
|
2023 |
|
|
|
2022 |
|
Operating expenses: |
|
|
|
|
Research and development |
|
$ |
6,491 |
|
|
$ |
2,925 |
|
General and administrative |
|
|
15,849 |
|
|
|
1,286 |
|
Total operating expenses |
|
|
22,340 |
|
|
|
4,211 |
|
Loss
from operations |
|
|
(22,340 |
) |
|
|
(4,211 |
) |
Other
income (expense) |
|
|
|
|
Other income (expense), net |
|
|
(116 |
) |
|
|
— |
|
Change in fair value of financial instruments |
|
|
3,168 |
|
|
|
581 |
|
Total
other income (expense), net |
|
|
3,052 |
|
|
|
581 |
|
Net loss
and comprehensive loss |
|
$ |
(19,288 |
) |
|
$ |
(3,630 |
) |
Net loss
per share—basic and diluted |
|
$ |
(23.43 |
) |
|
$ |
(46.13 |
) |
Weighted-average number of shares outstanding used in
computing net loss per share—basic and diluted |
|
|
823,069 |
|
|
|
78,678 |
|
CalciMedica (NASDAQ:CALC)
Historical Stock Chart
From Jun 2024 to Jul 2024
CalciMedica (NASDAQ:CALC)
Historical Stock Chart
From Jul 2023 to Jul 2024