CalciMedica Inc. (CalciMedica) (Nasdaq: CALC), a clinical-stage
biopharmaceutical company focused on developing therapies for
life-threatening inflammatory diseases with high unmet need, today
announced the closing of its previously announced merger with
Graybug Vision, Inc. CalciMedica’s stock will commence trading on
March 21, 2023 on the Nasdaq Global Market under the trading symbol
“CALC”.
The combined company will focus on further
developing its lead product candidate Auxora™ (zegocractin), a
proprietary, intravenous-formulated, small molecule calcium
release-activated calcium (CRAC) channel inhibitor, to treat
life-threatening inflammatory diseases, such as acute pancreatitis
(AP), asparaginase-associated pancreatitis (AAP) which is a
toxicity caused by asparaginase treatment for pediatric acute
lymphoblastic leukemia (ALL), acute kidney injury (AKI), acute lung
injury (ALI) and acute respiratory distress syndrome (ARDS) for
which there are no currently approved therapies.
Immediately prior to the closing of the merger,
CalciMedica completed the previously announced private placement of
$10.3 million. With the closing of the merger, CalciMedica
has approximately $34 million in cash and cash equivalents, which
is expected to provide the company a cash runway into the second
half of 2024 and fund the advancement of Auxora through clinical
milestones in 2023, including:
- Topline results from the ongoing
Phase 2b clinical trial (CARPO) in AP patients with systemic
inflammatory response syndrome (SIRS) expected in Q4 2023,
and;
- Results from the ongoing
investigator-sponsored Phase 1/2 clinical trial (CRSPA) in
pediatric patients who develop AAP due to toxicity from treatment
with asparaginase for their underlying ALL expected later this
year.
“With the closing of this merger, CalciMedica
enters into a pivotal new phase of its future development, and we
are extremely thankful to have partnered with Graybug for this
transformational deal,” said Rachel Leheny, Ph.D., Chief Executive
Officer of CalciMedica. “With an extended cash runway, we are
poised to deliver on near-term clinical milestones of our lead
candidate, Auxora, in AP and AAP, while setting our company up to
deliver on our broader mission of developing novel therapies for
life-threatening inflammatory diseases affecting the pancreas,
kidney, and lung, for which there are currently no approved
therapies.”
On March 17, 2023, and in connection with but
prior to the closing of the merger, Graybug effected a 14:1 reverse
split of its common stock. Immediately following the merger,
CalciMedica had approximately 5.5 million shares of common stock
outstanding. The prior equityholders of CalciMedica collectively
own approximately 72% of the combined company and the prior
equityholders of Graybug collectively own approximately 28% of the
combined company, on a fully-diluted basis. In connection with the
merger, the parties waived the condition that the shares of Graybug
Vision, Inc. common stock to be issued to CalciMedica stockholders
in the merger be approved for listing on Nasdaq as of the closing
of the merger.
CalciMedica is headquartered in La Jolla, CA,
and its management team will continue to lead the combined company
following this transaction, with Rachel Leheny, Ph.D., as Chief
Executive Officer. The combined company’s board of directors is
composed of seven members, five selected by CalciMedica, Robert
Wilson, Fred Middleton, Allan Shaw, Eric Roberts and Rachel Leheny,
Ph.D.; and two selected by Graybug, Fred Guerard, PharmD, and Eric
Bjerkholt.
Piper Sandler served as financial advisor and
Fenwick & West LLP served as legal counsel to Graybug.
Oppenheimer & Co. Inc. served as financial advisor and Cooley
LLP served as legal counsel to CalciMedica.
Research and Development Event
InformationCalciMedica will host a Research and
Development Event focused on Auxora’s potential benefit in AP on
April 27, 2023, at 10:30 am ET. A separate invitation will be sent
out within the next few weeks.
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 lung injury, acute respiratory distress syndrome
and acute kidney 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
plans to meet with the U.S. Food and Drug Administration (FDA) in
2023 to determine the path forward to bring this therapy to
patients as quickly as possible. 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 through the second half of 2024, and its ability to
fund the advancement of Auxora through clinical milestones in 2023
and its estimated cash and cash equivalents balance at closing;
plans to host Research and Development Event and the timing
thereof; 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, including its plans
to meet with the FDA in 2023 and determine a path forward to bring
Auxora for the treatment of pediatric ALL patients with AAP;
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; CalciMedica’s belief that CRSPA
defined an optimal pediatric dose for Auxora; and CalciMedica’s
ability to continue trading on the Nasdaq Global Market. 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 ability of CalciMedica to timely and successfully
achieve the anticipated benefits of the merger; 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” and elsewhere in CalciMedica’s most
recent filings with the Securities and exchange commission (“SEC”),
including its definitive proxy statement filed with the SEC on
February 9, 2023 and its Annual Report on Form 10-K for the quarter
ended December 31, 2022 and any 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
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