Form 8-K - Current report
27 Juni 2024 - 2:45PM
Edgar (US Regulatory)
NASDAQ false 0001534133 0001534133 2024-06-27 2024-06-27
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
June 27, 2024
Date of Report (Date of earliest event reported)
CalciMedica, Inc.
(Exact name of registrant as specified in its charter)
|
|
|
|
|
Delaware |
|
001-39538 |
|
45-2120079 |
(State or other jurisdiction of incorporation) |
|
(Commission File Number) |
|
(IRS Employer Identification No.) |
|
|
|
505 Coast Boulevard South, Suite 307 La Jolla, California |
|
92037 |
(Address of principal executive offices) |
|
(Zip Code) |
Registrant’s telephone number, including area code: (858) 952-5500
Not Applicable
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:
☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
|
|
|
|
|
Title of each class |
|
Trading Symbol(s) |
|
Name of each exchange on which registered |
Common Stock, $0.0001 par value per share |
|
CALC |
|
The Nasdaq Capital Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 7.01. |
Regulation FD Disclosure. |
On June 27, 2024, CalciMedica, Inc. (the “Company”) issued a press release announcing topline data from the Phase 2b CARPO trial of Auxora in acute pancreatitis (“AP”). A copy of the press release is attached hereto as Exhibit 99.1.
Included as Exhibit 99.2 to this Form 8-K is a slide presentation titled Developing Novel Therapies for Acute Inflammatory and Immunologic Diseases: CARPO Trial Topline Results dated June 27, 2024, that is incorporated herein by reference. The Company intends to utilize this presentation and its contents in various meetings with securities analysts, investors and others, including during a conference call and live webcast with the investment community on June 27, 2024, at 8:30 a.m. Eastern Time.
The information in this Item 7.01, including the attached Exhibits 99.1 and 99.2, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act.
On January 27, 2024, the Company announced positive topline data from CARPO, the Company’s international, randomized, double-blind, placebo-controlled, dose-ranging Phase 2b trial evaluating Auxora for the treatment of AP with accompanying systemic inflammatory response syndrome (“SIRS”).
The Phase 2b CARPO trial intended to establish Auxora’s dose-response and efficacy in AP with accompanying SIRS. The trial reached its target enrollment of 216. Patients were randomized into four groups to receive either high 2.0 mg/kg dose (n=53), medium 1.0 mg/kg dose (n=56) or low 0.5 mg/kg dose (n=52) of Auxora or a matched dose of placebo (n=53) intravenously every 24 hours for a total of three doses. Treatment and observation of patients continued for 30 days. Patients were stratified by baseline hematocrit, a biomarker for inflammation severity, so that efficacy in a pre-specified hyper-inflamed sub-group of patients could be evaluated. These patients represented approximately 43% of the patients enrolled (2.0 mg/kg, n=23; 1.0 mg/kg, n=25; 0.5 mg/kg, n=24; and placebo, n=20). Patients were well-matched for all baseline characteristics with the exception that the placebo group had approximately 12% lower proportion of hyper-inflamed patients than the study overall.
Summary Efficacy Data
The Phase 2b CARPO trial met its study objective by showing a dose response for time to solid food tolerance as well as other clinical endpoints. The primary endpoint of median time to solid food tolerance in the pre-specified subgroup of patients with hyper-inflammatory AP showed a statistically significant dose response with placebo patients requiring 4.7 days to tolerate solid food and patients in the high dose group showing a 1.9 day improvement (41.0% relative risk reduction) when compared to placebo, the medium dose group showing a 2.1 day improvement (43.6% relative risk reduction) and the low dose group showing a 1.5 day improvement (31.0% relative risk reduction). In patients without hyper-inflammatory AP, Auxora did not show a measurable benefit due to the patients tolerating solid food relatively quickly in all treatment groups.
Additionally, Auxora demonstrated a statistically significant dose response in reduction of severe organ failure which was defined as respiratory failure requiring invasive mechanical ventilation or 48 hours or more of high-flow nasal canula therapy, renal failure requiring renal replacement therapy, or cardiovascular failure requiring the use of vasopressor or inotropic support for greater than 48 hours. Severe organ failure occurred in 3.8% of high dose patients, 3.6% of medium dose patients, 9.6% of low dose patients, and 9.4% of placebo patients, representing a 59.6% relative risk reduction for the high dose patients when compared to placebo and 61.7% risk reduction for the medium dose patients when compared to placebo.
The median length of hospital stay was 5.0 days for the placebo group while the high dose group showed a reduction in the length of stay of 1.0 day. The mean length of hospital stay was 7.1 days for the placebo group while both the high dose and medium dose patients showed a reduction in the length of stay of 1.2 days and the hyperinflammatory AP subgroup showed a reduction in the length of stay of 1.5 days for the hyper-inflamed high dose patients and 1.9 days for the hyper-inflamed medium dose patients.
The proportion of patients who remained in the hospital for longer than 21 days was 0% for high dose patients, 1.8% for medium dose patients, 5.8% for low dose patients, and 5.7% for placebo patients. Comparing the combined placebo and low dose patients to the combined high and medium dose patients, this represents an 84.3% relative risk for a prolonged hospital stay.
Summary of Safety Data
Auxora was well-tolerated with 20 treatment-emergent serious adverse events (“TESAEs”) reported in the placebo group, 14 in the high dose group, 21 in the medium dose group, and 23 in the low dose group. None of the TESAEs in the high and medium dose groups and only 1 in the low dose group were deemed to be drug-related. There were no related TESAEs in the placebo group. Treatment-emergent adverse events (“TEAEs”) led to drug discontinuation in 3 patients in the placebo group, 2 in the high dose group, 2 in the medium dose group, and 2 in the low dose group. TEAEs led to death in 1 patient in the placebo group and 1 patient in the medium dose group. There were no deaths in the high dose or low dose group.
The Company intends to present additional data from the Phase 2b CARPO trial, including results from the analysis of CTs taken at baseline and 30-days post enrollment, at a medical meeting later this year.
Cautionary Statement Regarding Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements which include, but are not limited to, statements related to the Company’s business strategy; the potential benefits of Auxora for treatment of AP patients and the healthcare system; the dose response for Auxora across multiple endpoints, the target patient population and the likely drug dose for a pivotal trial; the Company’s planned and ongoing clinical trials and the timing, design, expected patient enrollment thereof and the expected timing for the release of data from those trials, including its plans to present additional data from the Phase 2b CARPO trial of Auxora for AP with accompanying SIRS at a future medical meeting later this year; plans to move forward rapidly with a pivotal trial of Auxora for AP; plans regarding its ongoing Phase 1/2 CRSPA trial of Auxora in pediatric patients with asparaginase-induced pancreatic toxicity (“AIPT”) and its planned Phase 2 KOURAGE trial of Auxora in acute kidney injury (“AKI”) with associated acute hypoxemic respiratory failure; the potential benefits of Auxora for the treatment of AIPT and AKI; and the potential of the Company’s proprietary technology to provide therapeutic benefits in life-threatening inflammatory and immunologic diseases. These forward-looking statements are subject to the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. The Company’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 the Company’s business and the actions it may take in response thereto; the Company’s ability to execute its plans and strategies; the ability to obtain and maintain regulatory approval for Auxora; results from clinical trials or preclinical studies, including preliminary results, 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 the Company generally; the Company’s ability to protect its intellectual property position; the impact of government laws and regulations; and the Company’s need for additional capital. 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 the Company’s most recent filings with the U.S. Securities and Exchange Commission (“SEC”), including its Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 and any subsequent reports on Form 10-K, Form 10-Q or Form 8-K filed with the SEC from time to time.
The forward-looking statements included in this Current Report on Form 8-K are made only as of the date hereof. The Company assumes no obligation and does not intend to update these forward-looking statements, except as required by law.
Item 9.01. |
Financial Statements and Exhibits. |
(d) Exhibits
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
|
|
|
|
|
|
Date: June 27, 2024 |
|
CalciMedica, Inc. |
|
|
|
|
|
|
|
|
By: |
|
/s/ A. Rachel Leheny, Ph.D. |
|
|
|
|
Name: |
|
A. Rachel Leheny, Ph.D. |
|
|
|
|
Title: |
|
Chief Executive Officer |
Exhibit 99.1
CalciMedica Announces Positive Topline Data from Phase 2b CARPO Trial of Auxora
in Acute Pancreatitis (AP)
Primary objective of the trial met with statistically significant dose response with up to 43.6% relative
reduction (2.1 day improvement) in median time to solid food tolerance versus placebo in hyper-inflamed patients
Statistically
significant dose response with up to 61.7% reduction in severe organ failure in all patients versus placebo
Up to 100% reduction in
hospital stays longer than 21 days
Planning
End-of-Phase 2 meeting with the FDA in preparation for a pivotal trial
Conference call to discuss the CARPO topline results scheduled for 8:30 a.m. ET today
LA JOLLA, Calif., June 27, 2024 /PRNewswire/ 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 announced positive topline data from CARPO, the Companys randomized,
double-blind, placebo-controlled Phase 2b trial evaluating Auxora for the treatment of acute pancreatitis (AP) with accompanying systemic inflammatory response syndrome (SIRS). The trial
established a dose response for Auxora across multiple endpoints, identified both the target patient population and the likely drug dose for a pivotal trial, and re-affirmed Auxoras safety profile and
tolerability as seen in prior clinical trials.
With these results, CARPO has added significantly to the body of evidence showing Auxoras
potential as an effective treatment for critically ill patients with acute inflammatory disease and warrants advancing our drug in both AP and acute kidney injury, said Rachel Leheny, Ph.D., Chief Executive Officer of CalciMedica. We
plan to move quickly towards initiating our Phase 3 trial in AP and are eager to engage with the FDA to discuss our trial plans once we have all the data from CARPO. We look forward to unlocking Auxoras potential to treat these patients who
have few treatment options.
There are currently no drugs for the treatment of AP and the CARPO data show a benefit in multiple endpoints,
supporting the need for Auxora, said Joseph Miller, M.D., Clinical Associate Professor of Emergency Medicine at Henry Ford Health and Michigan State University and Associate Director Emergency Care Research at Henry Ford Health and a principal
investigator in the CARPO trial. AP is one of the costliest gastrointestinal diseases for hospitals due to prolonged lengths of stay for severe patients. By reducing the occurrence of severe organ failure and extended hospital stays, Auxora
may provide significant benefits to patients with AP and to the health care system and should be welcomed by clinicians and hospitals.
The CARPO
Trial Topline Results:
The Phase 2b CARPO trial was an international, randomized, double-blind, placebo-controlled, dose-ranging trial intended to
establish Auxoras dose-response and efficacy in AP with accompanying SIRS. The trial reached its target enrollment of 216. Patients were randomized into four groups to receive either high 2.0 mg/kg dose (n=53), medium 1.0 mg/kg dose (n=56) or
low 0.5 mg/kg dose (n=52) of Auxora or a matched dose of placebo (n=53) intravenously every 24 hours for a total of three doses. Treatment and observation of patients continued for 30 days. Patients were stratified by baseline hematocrit, a
biomarker for inflammation severity, so that efficacy in a pre-specified hyper-inflamed sub-group of patients could be evaluated. These patients represented
approximately 43% of the patients enrolled (2.0 mg/kg, n=23; 1.0 mg/kg, n=25; 0.5 mg/kg, n=24; and placebo, n=20). Patients were well-matched for all baseline characteristics with the exception that the placebo group had approximately 12% lower
proportion of hyper-inflamed patients than the study overall.
Summary of Efficacy Data:
CARPO met its study objective by showing a dose response for time to solid food tolerance as well as other clinical endpoints. The primary endpoint of median
time to solid food tolerance in the pre-specified subgroup of patients with hyper-inflammatory acute pancreatitis showed a statistically significant dose response with placebo patients requiring 4.7 days to
tolerate solid food and patients in the high dose group showing a 1.9 day improvement (41.0% relative risk reduction) when compared to placebo, the medium dose group a 2.1 day improvement (43.6% relative risk reduction) and the low dose group a 1.5
day improvement (31.0% relative risk reduction). In patients without hyper-inflammatory AP, Auxora did not show a measurable benefit due to the patients tolerating solid food relatively quickly in all treatment groups.
Additionally, Auxora demonstrated a statistically significant dose response in reduction of severe organ failure which was defined as respiratory failure
requiring invasive mechanical ventilation or 48 hours or more of high-flow nasal canula therapy, renal failure requiring renal replacement therapy, or cardiovascular failure requiring the use of vasopressor or inotropic support for greater than 48
hours. Severe organ failure occurred in 3.8% of high dose patients, 3.6% of medium dose patients, 9.6% of low dose patients, and 9.4% of placebo patients, representing a 59.6% relative risk reduction for the high dose patients when compared to
placebo and 61.7% risk reduction for the medium dose patients when compared to placebo.
The median length of hospital stay was 5.0 days for the placebo group while the high dose group showed a
reduction in the length of stay of 1.0 day. The mean length of stay showed a greater benefit: the placebo patients had a mean stay of 7.1 days and both the high dose and medium dose patients had a reduction of 1.2 days. In the patients with
hyperinflammatory acute pancreatitis, the reduction was even greater, 1.5 days for the hyper-inflamed high dose patients and 1.9 days for the hyper-inflamed medium dose patients.
The proportion of patients who remained in the hospital for longer than 21 days was 0% for high dose patients, 1.8% for medium dose patients, 5.8% for low
dose patients, and 5.7% for placebo patients. Comparing the combined placebo and low dose patients to the combined high and medium dose patients, this represents a 84.3% relative risk for a prolonged hospital stay.
Summary of Safety Data:
Auxora was well-tolerated with
20 treatment-emergent serious adverse events (TESAEs) reported in the placebo group, 14 in the high dose group, 21 in the medium dose group, and 23 in the low dose group. None of the TESAEs in the high and medium dose groups and only 1 in the low
dose group were deemed to be drug-related. There were no related TESAEs in the placebo group. Treatment-emergent adverse events (TEAEs) led to drug discontinuation in 3 patients in the placebo group, 2 in the high dose group, 2 in the medium dose
group, and 2 in the low dose group. TEAEs led to death in 1 patient in the placebo group and 1 in the medium dose group. There were no deaths in the high dose or low dose group.
Consistent with our prior Phase 2b CARDEA trial in severe and critical COVID pneumonia patients and with our Phase 2a trial in AP patients with SIRS and
hypoxemia, CARPO has demonstrated Auxoras potential to treat some of the more severely ill patients with acute inflammatory diseases, said Sudarshan Hebbar, M.D., Chief Medical Officer of CalciMedica. Importantly, we found that
Auxora provided patients with clinically meaningful improvements in key outcome measures, while also being well-tolerated. We have identified the target population of patients most likely to benefit from Auxora and determined the likely dose for a
pivotal trial. With this information we are more confident in proceeding with a pivotal program in AP. I want to thank the patients who enrolled in the trial as well as the investigators and their study teams for their hard work and contributions to
the success of this trial. CARPO has advanced our understanding of AP and brought us closer to a solution for this potentially life-threatening condition for which currently no approved therapy exists.
CARPO has demonstrated that patients with hyper-inflammation benefit most from Auxora. This is encouraging as we initiate KOURAGE where we have
established enrollment criteria that select the acute kidney injury patients who are most likely to be suffering from severe inflammation and where reduction of organ failure is a key metric of efficacy, said Lakhmir Chawla, M.D., Clinical
Professor of Medicine at University of California San Diego, Chief Medical Officer at ExThera Medical, Scientific Advisor to CalciMedica, and Chair of the KOURAGE Steering Committee.
CalciMedica intends to present additional data from CARPO, including results from the analysis of CTs taken at baseline and
30-days post enrollment, at a medical meeting later this year.
Conference Call and Webcast Details
Stockholders and other interested parties may participate in the call by following the instructions below. A live webcast of the event can also be accessed in
the Upcoming Events section of CalciMedicas IR website at https://ir.calcimedica.com/. A replay of the webcast will be available following the completion of the event.
Participant Webcast Link: https://app.webinar.net/jDbvg4E9yPn
Participant Dial-in Numbers: 1-800-836-8184 (US) and 1-646-357-8785 (international)
About Auxora
CalciMedicas 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 immune system cells, endothelium cells and pancreatic
acinar 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 acute pancreatitis (AP) with
accompanying systemic inflammatory response syndrome (SIRS), called CARPO, (ii) a Phase 2 trial in acute kidney injury (AKI) with associated acute hypoxemic respiratory failure (AHRF), called KOURAGE, and (iii) an investigator-sponsored
Phase 1/2 trial, called CRSPA, being conducted in pediatric patients with asparaginase-induced pancreatic toxicity (AIPT) as a side effect of pediatric acute lymphoblastic leukemia treatment with asparaginase. There are currently no approved
therapies to treat either AP, AKI 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
respiratory distress syndrome.
About AP
AP, or
inflammation of the pancreas, can be a life-threatening condition. Moderate or severe AP sometimes leads 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, a predictor of moderate and severe disease 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 KOURAGE and AKI
KOURAGE is a randomized,
double-blind, placebo-controlled study that will evaluate 150 patients with Stage 2 and 3 AKI who have AHRF and are receiving oxygen by non-invasive mechanical ventilation, high flow nasal cannula or
intermittent mandatory ventilation (IMV). AKI denotes a sudden reduction in kidney function, the organs ability to clean and filter the blood. AKI can result as a complication of other serious illnesses such as sepsis, respiratory infections
and failure, acute pancreatitis, trauma, surgery and burns. There are approximately 3.7 million patients hospitalized with AKI in the United States each year with approximately 1.1 million advancing to Stage 2 and Stage 3 AKI,
over half of whom have associated AHRF. The risk of serious morbidities and mortality is significant for advanced Stage 2 and Stage 3 AKI patients. There are currently no approved therapies for AKI.
About CalciMedica
CalciMedica is a clinical-stage
biopharmaceutical company focused on developing novel CRAC channel inhibition therapies for inflammatory and immunologic diseases. CalciMedicas proprietary technology targets the inhibition of CRAC channels 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. CalciMedicas lead product candidate Auxora, has demonstrated positive and consistent clinical results in multiple completed efficacy clinical trials. CalciMedica has completed a Phase 2b trial (called CARPO NCT04681066) in
AP with SIRS and a Phase 2b trial (called CARDEA NCT04345614) in COVID pneumonia patients, continues to support the ongoing Phase 1/2 AIPT study (called CRSPA NCT04195347), with data expected in 2025, and has initiated its Phase 2
study (called KOURAGE NCT06374797) in AKI with associated AHRF with data expected in 2025. 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 Statements
This communication contains forward-looking statements which include, but are not limited to, statements related to: CalciMedicas business strategy;
the potential benefits of Auxora for treatment of AP patients and the healthcare system; the dose response for Auxora across multiple endpoints, the target patient population and the likely drug dose for a pivotal trial; CalciMedicas planned
and ongoing clinical trials and the timing, design, expected patient enrollment thereof and the expected timing for the release of data from those trials, including its plans to present additional data from the Phase 2b CARPO trial of Auxora for AP
with accompanying SIRS at future medical meeting later this year; plans to move forward rapidly with a pivotal trial of Auxora for AP; plans regarding its ongoing Phase 1/2 CRSPA trial of Auxora in pediatric patients with AIPT and its planned Phase
2 KOURAGE trial of Auxora in AKI with associated AHRF; the potential benefits of Auxora for the treatment of AIPT and AKI; and the potential of CalciMedicas proprietary technology to provide therapeutic benefits in life-threatening
inflammatory and immunologic diseases. These forward-looking statements are subject to the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. CalciMedicas 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 CalciMedicas business and the actions it may take in response thereto; CalciMedicas ability to execute its plans and strategies; the ability to obtain and maintain
regulatory approval for Auxora; results from clinical trials or preclinical studies 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;
CalciMedicas 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 CalciMedicas Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, and elsewhere in
CalciMedicas subsequent reports on Form 10-K, Form 10-Q or Form 8-K filed with the Securities and Exchange Commission (SEC)
from time to time and available at www.sec.gov. These documents can be accessed on CalciMedicas web page at ir.calcimedica.com/financials-filings/sec-filings. The forward-looking statements contained
herein are made as of the date hereof, and CalciMedica undertakes no obligation to update them after this date, except as required by law.
CalciMedica Contact:
Investors and Media
Argot Partners
Sarah Sutton/Kevin Murphy
calcimedica@argotpartners.com
(212) 600-1902
Exhibit 99.2 Developing Novel Therapies for Acute Inflammatory and
Immunologic Diseases CARPO Trial Topline Results June 27, 2024 1 Confidential
Forward-Looking Statements This presentation contains forward-looking
statements which include, but are not limited to, statements regarding CalciMedica’s business strategy and clinical development plans; the design and potential benefits of CalciMedica’s product candidates; CalciMedica’s ongoing and
planned clinical trials, including its planned Phase 3 trial of Auxora for acute pancreatitis (AP), pending discussions with the U.S. Food and Drug Administration (FDA), and Auxora being ready for such Phase 3 trial; the timing for
CalciMedica’s receipt and announcement of data from its clinical trials, including plans to release final data from the Phase 2b CARPO trial later this year; CalciMedica’s planned regulatory filings and the timing thereof; and results
from the Phase 2b CARPO trial increasing confidence in the KOURAGE trial of Auxora in acute kidney injury (AKI). 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 CalciMedica’s product candidates; results from clinical trials, including preliminary results, may not be indicative of results that may be observed
in the future; potential safety and other complications from CalciMedica’s product candidates; economic, business, competitive, and/or regulatory factors affecting the business of CalciMedica generally; CalciMedica’s ability to protect
its intellectual property position; the impact of government laws and regulations; and CalciMedica’s need for additional capital. 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 most recently filed periodic report, and subsequent periodic reports filed by CalciMedica, under the Securities Exchange
Act of 1934, as amended, from time to time and available at www.sec.gov. These documents can be accessed on CalciMedica’s web page at calcimedica.com. These forward-looking statements are based on information available to, and expectations of,
CalciMedica of the date of this presentation. CalciMedica disclaims any obligation to update these forward-looking statements, except as may be required by law. 2
CARPO Topline Takeaways • Primary objective was met with a dose
response for multiple endpoints • Statistically significant for time to solid food tolerance in high hematocrit patients • Statistically significant for severe organ failure in the entire population • Auxora was well-tolerated
• Auxora is ready for Phase 3 clinical development • Pending discussions with FDA following final data • Final data, including CT scan (baseline and 30-day) data, expected to presented at a medical meeting later this year •
Reduction in severe organ failure increases confidence in our KOURAGE AKI trial • Magnitude in reduction similar to what was seen in CARDEA and Phase 2a AP trials 3
Auxora Clinically Active and Well-Tolerated in Multiple Phase 2 Trials
Population Trial Size Results Pancreas • Topline results show: Ø Improvement in clinically significant endpoints Acute Pancreatitis Ø Statistically significant dose response for time to solid food tolerance in patients with hyper-
N=216 With SIRS (CARPO) inflammation Ø Statistically significant dose response in severe organ failure Acute Pancreatitis • Rapid increase in patients tolerating solid diet (potential trial pivotal endpoint) Accompanied by SIRS and N=21
• >2-day reduction in hospital stay and 50% reduction SIRS Hypoxemia Asparaginase-Induced Pancreatic • Trial ongoing, preliminary results show rapid resolution of pain and food tolerance N=9 Toxicity (CRSPA) Lung • 56%
statistically significant decrease in mortality at Day 30 N=284 COVID-19 with Respiratory Failure • 33% reduction in ventilation (Part 2) • >2-day shorter hospital stay (CARDEA) N=30 1 2 • ~40% reduction in reported acute kidney
injury On LFO or HFNC 2 (Part 1) • Mortality benefit in patients with compromised kidney function (low GFR) COVID-19 with Respiratory Failure • Open-label trial with varying doses showing pharmacodynamic response N=9 3 On IMV 1) LFO :
Low Flow Oxygen; 2) HFNC: High-Flow Nasal Cannula; 3) IMV: Invasive Mechanical Ventilation 2 4
Differentiated Pipeline in Acute and Chronic Inflammatory and
Immunologic Diseases Phase of Development 1 Indication Anticipated Milestones Program Preclinical Phase 1 Phase 2 Phase 3 Acute Disease (IV) CARPO Phase 2b trial topline data released; Auxora Acute Pancreatitis Final data expected in 2H2024
Asparaginase-Induced Pancreatic CRSPA Phase 1/2 trial ongoing; Auxora Data expected in 2025 Toxicity in Pediatric Patients KOURAGE Phase 2 trial first patient expected 2Q24; Auxora Acute Kidney Injury Data expected in 2025 Chronic Disease (Oral)
CM6336 Chronic Pancreatitis IND submission expected in 2025 IND submission expected in 2025 CM6336 Rheumatoid Arthritis With CARPO results, Auxora is Phase 3 ready pending End-of-Phase 2 Discussion with FDA 1) All Auxora programs are IV for rapid
onset in the acute care setting. CM6336 is intended for chronic oral dosing. 5
CARPO Phase 2b Clinical Trial in AP Primary End Point Secondary
Endpoints • Length of hospital stay • Time to solid food tolerance • Time to medically indicated discharged • Severe organ failure • Re-hospitalizations • Necrosis as determined by CT MEDIUM DOSE (n=54) Primary
Objective: Dose Response on Primary and Secondary Endpoints 6
Defining Who to Treat: Patients with Acute Critical Illnesses Vincent,
J. L., Opal, S. M., & Marshall, J. C. (2010). Ten reasons why we should NOT use severity scores as entry criteria for clinical trials or in our treatment 7 decisions. Critical care medicine, 38(1), 283-287.
Enrich CARPO for Patients with Hyperinflammatory Acute Pancreatitis
• CARPO added inclusion criteria to enroll pre-specified subgroup of patients with an elevated hematocrit • Inclusion criteria in addition to SIRS – Hematocrit ≥44% for men or ≥40% for women, established biomarker for
inflammation – HCT biomarker supported by Phase 2a AP trial results HCT at #Patients Initial NLR Max D-dimer Max CRP Max IL-6 ICU admission Baseline ng/mL mg/L pg/mL HCT ≤44% 13 8.41 (5.2, 13.2) 3996(1205, 13235) 195 (86, 343) 108 (41,
442) 2/13 (15%) HCT >44% 8 19.9 (13.2, 46.7) 4245 (3685, 6205) 380 (248, 395) 391 (245, 849) 6/8 (75%) – A peripancreatic fluid collection or a pleural effusion on a CECT performed in the 24 hours before Consent or after Consent and before
Randomization – Abdominal examination documenting either abdominal guarding or rebound tenderness 8
CARPO Baseline Characteristics Note: mITT was 214 patients as 2 enrolled
patients did not receive study drug 9
Time to Solid Food Tolerance Statistical significance achieved on dose
response in patients with hyperinflammatory AP *One hematocrit missing at baseline Determination of solid food tolerance • Patient offered a low fat, ≥500-calorie solid meal • Patient consumes ≥50% of the meal without
vomiting or an increase in abdominal pain in the two hours after the meal (as confirmed by clinical trial nurse) 10
Length of Hospital Stay Placebo 2.0 mg/kg 1.0 mg/kg 0.5 mg/kg N=53 N=53
N=56 N=52 LOS mITT Median days 5.0 4.0 5.0 5.5 LOS mITT Mean days 7.1 5.9 5.9 7.6 LOS High Mean days 7.8 6.3 5.7 7.9 Hematocrit 22-30 days n subjects (%) 3 (5.7) 0 (0.0) 1 (1.8) 3 (5.8) 11
Severe Organ Failure Statistical significance achieved on dose response
Placebo 2.0 mg/kg 1.0 mg/kg 0.5 mg/kg N=53 N=53 N=56 N=52 Severe Respiratory (%) 4/53 (7.5) 2/53 (3.8) 2/56 (3.6) 5/52 (9.6) Severe Renal (%) 1/53 (1.9) 0/53 (0.0) 1/56 (1.8) 2/52 (3.8) Severe Cardiovascular (%) 1/53 (1.9) 1/53 (1.9) 1/56 (1.8) 3/52
(5.8) Any severe organ failure (%) 5/53 (9.4) 2/53 (3.8) 2/56 (3.6) 5/52 (9.6) Definition of severe organ failure • Severe respiratory failure defined as those patients receiving invasive mechanical ventilation (IMV) or those receiving for
≥ 48 hours use of either high flow nasal cannula (HFNC) or non-invasive mechanical ventilation (NIMV) (Use of NIMV for the treatment of obstructive sleep apnea not considered as meeting the definition of severe respiratory failure) •
Severe renal failure defined as the initiation of renal replacement therapy • Severe cardiovascular failure defined as the use of vasopressor or inotropic support for ≥48 hours 12
Serious Adverse Event Summary Placebo 2.0 mg/kg 1.0 mg/kg 0.5 mg/kg
Total Auxora N=53 N=53 N=56 N=52 N=161 Number of TESAEs 20 14 21 23 58 Patients discontinuing study 3 2 2 2 6 drug due to TESAEs Patients with TEAEs leading 1 0 1 0 1 to death TESAE=treatment emergent serious adverse event TEAE=treatment emergent
adverse event 13
Conclusions and Next Steps • Auxora is ready for Phase 3 clinical
development pending FDA discussion • Primary objective met with a dose response for multiple endpoints • Auxora well-tolerated • Reduction in severe organ failure increases confidence in KOURAGE AKI trial • Next steps:
further analysis of additional data and End-of-Phase 2 meeting with FDA 14
v3.24.1.1.u2
X |
- DefinitionBoolean flag that is true when the XBRL content amends previously-filed or accepted submission.
+ References
+ Details
Name: |
dei_AmendmentFlag |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionFor the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period. The format of the date is YYYY-MM-DD.
+ References
+ Details
Name: |
dei_DocumentPeriodEndDate |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:dateItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'.
+ References
+ Details
Name: |
dei_DocumentType |
Namespace Prefix: |
dei_ |
Data Type: |
dei:submissionTypeItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionAddress Line 1 such as Attn, Building Name, Street Name
+ References
+ Details
Name: |
dei_EntityAddressAddressLine1 |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionAddress Line 2 such as Street or Suite number
+ References
+ Details
Name: |
dei_EntityAddressAddressLine2 |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- Definition
+ References
+ Details
Name: |
dei_EntityAddressCityOrTown |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionCode for the postal or zip code
+ References
+ Details
Name: |
dei_EntityAddressPostalZipCode |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionName of the state or province.
+ References
+ Details
Name: |
dei_EntityAddressStateOrProvince |
Namespace Prefix: |
dei_ |
Data Type: |
dei:stateOrProvinceItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionA unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityCentralIndexKey |
Namespace Prefix: |
dei_ |
Data Type: |
dei:centralIndexKeyItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionIndicate if registrant meets the emerging growth company criteria.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityEmergingGrowthCompany |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionCommission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.
+ References
+ Details
Name: |
dei_EntityFileNumber |
Namespace Prefix: |
dei_ |
Data Type: |
dei:fileNumberItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionTwo-character EDGAR code representing the state or country of incorporation.
+ References
+ Details
Name: |
dei_EntityIncorporationStateCountryCode |
Namespace Prefix: |
dei_ |
Data Type: |
dei:edgarStateCountryItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityRegistrantName |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityTaxIdentificationNumber |
Namespace Prefix: |
dei_ |
Data Type: |
dei:employerIdItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionLocal phone number for entity.
+ References
+ Details
Name: |
dei_LocalPhoneNumber |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 13e -Subsection 4c
+ Details
Name: |
dei_PreCommencementIssuerTenderOffer |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 14d -Subsection 2b
+ Details
Name: |
dei_PreCommencementTenderOffer |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionTitle of a 12(b) registered security.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b
+ Details
Name: |
dei_Security12bTitle |
Namespace Prefix: |
dei_ |
Data Type: |
dei:securityTitleItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionName of the Exchange on which a security is registered.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection d1-1
+ Details
Name: |
dei_SecurityExchangeName |
Namespace Prefix: |
dei_ |
Data Type: |
dei:edgarExchangeCodeItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Section 14a -Number 240 -Subsection 12
+ Details
Name: |
dei_SolicitingMaterial |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionTrading symbol of an instrument as listed on an exchange.
+ References
+ Details
Name: |
dei_TradingSymbol |
Namespace Prefix: |
dei_ |
Data Type: |
dei:tradingSymbolItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Securities Act -Number 230 -Section 425
+ Details
Name: |
dei_WrittenCommunications |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
Graybug Vision (NASDAQ:GRAY)
Historical Stock Chart
Von Dez 2024 bis Jan 2025
Graybug Vision (NASDAQ:GRAY)
Historical Stock Chart
Von Jan 2024 bis Jan 2025