Recent Updates
Recently added Catalysts
CALC

OPERATOR]: Ladies and gentlemen, thank you for standing by and welcome to the Graybug and CalciMedica Merger Announcement call. I would now like to turn the call over to Fred Guerard, Chief Executive Officer of Graybug.

Key Takeaway: [OPERATOR]: Ladies and gentlemen, thank you for standing by and welcome to the Graybug and CalciMedica Merger Announcement call. I would now like to turn the call over to Fred Guerard, Chief Executive [FRED GUERARD]: Thank you for joining us today. I m Fred Guerard, Chief Exec

Full Press Release Details

[OPERATOR]: Ladies and gentlemen, thank you for
standing by and welcome to the Graybug and CalciMedica Merger Announcement call.
I would now like to turn the call over to Fred Guerard, Chief Executive
[FRED GUERARD]: Thank you for joining us today. I m Fred Guerard, Chief Executive Officer of Graybug Vision, and I am
joined by Rachel Leheny, Chief Executive Officer of CalciMedica. Yesterday, after market close, we announced the proposed merger between our two companies. Today, we are pleased to discuss our plans with you, share our excitement about this
important and transformative business combination, and describe the value proposition for current and future shareholders.
[FRED GUERARD]: Please note that in
this presentation, we will be making forward-looking statements. Please refer to this slide for purposes of the safe harbor provision under the Private Securities Litigation Reform Act of 1995. These statements reflect management s intentions,
beliefs and expectations about the proposed merger with CalciMedica, the strategy, competition, products, operating plans and performance of the combined company. All forward-looking statements included in this presentation are made as of the date
hereof based on information currently available to Graybug and CalciMedica, are subject to various risks and uncertainties, and actual results could differ materially from those anticipated in the forward-looking statements. Except as required by
law, we assume no obligation to update any such forward looking statements after the date of this presentation or to conform these forward-looking statements to actual results.
[FRED GUERARD]: After an extensive review of
strategic alternatives, Graybug s Board of Directors and leadership team believe the proposed merger with CalciMedica represents the best potential value creation opportunity for Graybug shareholders. CalciMedica is a clinical-stage
biopharmaceutical company focused on the development of first-in-class therapies for life-threatening inflammatory diseases. The company s lead product candidate
Auxora expects clinical milestones in the next 12 months, including a Phase 2b readout in the second half of next year in its lead indication, acute pancreatitis. There are currently no approved therapies for any of the indications being pursued by
[FRED GUERARD]: Moving to an overview of the
transaction, the ownership split of the combined company at closing will be approximately 71% for CalciMedica shareholders and 29% for Graybug s shareholders, subject to adjustments based on Graybug s net cash at closing. The
combined company anticipates having a net cash balance of approximately $35M. This cash balance will provide a runway into the second half of 2024, which is expected to be 9 to 12 months beyond the anticipated Phase 2b trial read-out in acute pancreatitis. The combined company will be led by Rachel Leheny as CEO and existing members of CalciMedica s leadership team. The board composition of the combined company will consist of
seven board members five selected by CalciMedica and two selected by Graybug. We expect the closing to happen in the first quarter of 2023, subject to approval from the respective shareholders.
[FRED GUERARD]: CalciMedica s
differentiated platform targets calcium release-activated calcium channel inhibition, or CRAC channel inhibition. The lead product candidate, Auxora, is an intravenously administered, small molecule, CRAC channel inhibitor that was
discovered and formulated in-house by CalciMedica and has since been studied in four completed efficacy trials in more than 300 patients, demonstrating positive and consistent clinical results and a favorable
safety profile. CalciMedica s IP protection is robust with composition of matter protected to 2036, formulation protected until 2038, and methods of use protected to 2041.
Auxora s lead indication is Acute Pancreatitis, or AP. The target population for Auxora are patients with predicted severe AP and persistent systemic
inflammatory response syndrome, or AP with SIRS, which has the potential to be a billion-dollar market opportunity in the U.S. alone. There are currently no approved therapies for AP.
Auxora is also being developed for asparaginase-associated pancreatitis, or AAP, a pediatric indication that impacts 7 to 10% of all patients being treated
for acute lymphoblastic leukemia that develop AAP as a result of asparaginase treatment. There are currently no approved therapies for the approximately 300 children a year with AAP in the U.S., and it is estimated that 50% of these children will
develop pancreatic necrosis.
CalciMedica anticipates a Phase 2b readout in the lead acute pancreatitis indication in the second half of 2023, and a Phase
1/2 readout in AAP for the first cohort in the first half of 2023.
These highlights form the basis of our excitement for the proposed merger, and
it s why we believe this combination represents a unique value creating opportunity for our shareholders. The focus to develop CalciMedica s pipeline to make meaningful improvements in the standard of care for patients with high unmet need
also aligns with Graybug s own values and mission.
With that, I will turn the call over to Rachel.
[RACHEL LEHENY]: Thanks, Fred. Again, welcome
everyone. I m Rachel Leheny, CEO of CalciMedica.
I d like to begin by talking about why we re so excited about CRAC channels as a target
for a new class of therapies for immuno-inflammatory diseases of high unmet need.
CRAC channels maintain calcium homeostasis in certain cells. They are
found both in the immune system and in a number of organs, like the pancreas, lung, kidney, and brain. They were originally identified in T-cells, where they play a key role in the adaptive immune response.
In a disease state where there is an infection, toxin overload, or trauma, CRAC channels in the organ tissue cells become hyperactivated and allow excess
calcium to enter the cell causing apoptosis and tissue damage.
Shutting down activated CRAC channels results in a
two-pronged benefit by acting on both the immune system and in the organs directly. First, the inhibition reduces the pro inflammatory response of the immune system. And second, it directly protects organ
tissues from injury. It s this two-pronged effect that we believe is one of the key drivers of the efficacy data we ve seen in the clinic to date.
[RACHEL LEHENY]: We have already studied Auxora
in a number of clinical trials, including four completed Phase 2 trials in acute indications with two of those trials in our lead indication, acute pancreatitis. Across all four trials, we have included over 300 patients, and Auxora has consistently
shown clinical activity and a favorable safety profile, which gives us the confidence in the promise of Auxora and our technology.
Phase 2a data in acute pancreatitis, we are also encouraged by the preliminary observations of an ongoing Phase 1/2 asparaginase-associated pancreatitis, or AAP, trial, in pediatric leukemia patients.
Our largest Phase 2 trial to date was conducted in respiratory failure where we enrolled over 280 patients with
COVID-19 pneumonia. The positive results from this trial not only validate the clinical effect of Auxora in life-threatening inflammatory conditions but also further
de-risk our platform.
I will go over the compelling data we ve generated to date in a few moments. But
first, I ll turn to our pipeline.
[RACHEL LEHENY]: As Fred mentioned, Auxora is
being evaluated in multiple clinical trials.
Acute pancreatitis is our lead indication. We have an ongoing Phase 2b study called CARPO. We expect a read-out of the data from our CARPO trial in late 2023.
In addition, we have finished enrolling the first cohort of our
Phase 1/2 open-label CRSPA trial in pediatric AAP patients. We expect to report initial results in the first half of next year. We also expect to expand this trial to multiple centers, and to talk to the FDA to determine the path forward for a
potential accelerated approval of Auxora in this indication.
We are further exploring other indications for Auxora, including acute kidney injury. We
intend to treat patients who already have acute kidney injury, which will be a differentiated approach.
Finally, we are completing a Phase 2 biomarker
and mechanism of action trial with Auxora in COVID-19 ventilated patients. This trial is designed to provide evidence of the immunomodulatory and tissue protective effects of Auxora. Data is expected to be
published in early 2023.
[RACHEL LEHENY]: Auxora has the potential to
address high unmet medical needs in large markets with no currently approved therapies. In each case, the current standard of care for patients is supportive or palliative treatment. Disease progression puts stress on hospitals and the medical
system with long hospital stays, often weeks and months, long-term complications, and even mortality.
We will discuss the patient journey and target
population for each of these indications in more detail in a bit. We are excited about the market opportunity for our pipeline, as Auxora has the potential to become a much-needed therapy for significant patient populations.
[RACHEL LEHENY]: Before we discuss our clinical
results to-date, we want to tell you a bit more about acute pancreatitis.
[RACHEL LEHENY]: There are roughly 275,000
patients hospitalized for acute pancreatitis each year in the United States alone. Our target market is about 40% of these patients, or roughly 100,000 per year, who are diagnosed with SIRS, or systemic inflammation. These patients are the most
likely to progress to severe pancreatitis, which can lead to infection and life-threatening organ failure.
[RACHEL LEHENY]: On this slide, we show you the
journey for a patient with acute pancreatitis.
Patients present to the emergency room with stomach pain so severe that they often cannot stand up
straight. They cannot eat without pain or vomiting. Upon hospital admission, patients receive supportive therapy, including fluids, IV or liquid nutrition, and antibiotics to avoid infection. In certain cases, minimally invasive therapy may be
needed for local complications.
Upon admission, patients are also screened for SIRS, and again, roughly 40% of these patients are likely to suffer from
SIRS. As mentioned earlier, these patients are the most likely to develop severe disease, and for some of these patients, the disease may become life-threatening.
Auxora is designed to be used as a once-daily, four-hour infusion in the first three days of hospital admittance and it is being studied to stop the
progression to severe pancreatitis.
One key treatment goal is to get patients to tolerate solid food more rapidly. Eating solid food is an indication
that the pancreas is functioning and that the patient may be ready for discharge. This translates into fewer days in the hospital or ICU, which provides a strong pharmaco-economic argument for Auxora. Adoption of Auxora may be further driven by
reductions in organ failure and reductions in pancreatic necrosis.
[RACHEL LEHENY]: This slide illustrates the
trial design of our Phase 2a trial for Auxora in acute pancreatitis. In this trial we evaluated 21 patients, of which 14 were treated with Auxora and 7 were treated with standard of care.
We assessed these patients over 90 days. Importantly, we did a CT scan both at entry and when the patients were discharged from the hospital to determine if
there was an improvement in the condition of the pancreas over the course of treatment.
[RACHEL LEHENY]: In the trial, we saw positive results on all primary endpoints. The most striking observation was
that after treatment with Auxora, patients tolerated solid food more rapidly than those on standard of care.
At enrollment, there was only one patient in
the treated group and one patient in the standard-of-care group who were eating. Over time, we observed a divergence. At 72 hours, about half the patients in the treated
group were eating, compared to only one in the standard of care group. At discharge, nearly all the patients in the treated group were eating, as compared to about half the patients in the standard of care group. Importantly, patients who are not
eating at discharge are at particular risk of re-admission, and with the more rapid recovery of food tolerance, we also observed a decrease in hospital stay of over two days for patients treated with Auxora.
As I mentioned, CT scans were performed on all patients to evaluate improvement in the CT Severity Index score, or CTSI. This is a measure of the
severity of pancreatic inflammation and necrosis. Over the course of the hospital stay, none of the standard of care patients with elevated CTSI scores improved. However, over only 3 to 5 days, three out of the eight Auxora patients with elevated
scores saw improvement.
Last updated: Nov 22, 2022