CalciMedica Reports 2023 Financial Results and Provides Clinical & Corporate Updates
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Insights
The financial results and clinical trial updates of CalciMedica Inc. indicate a strategic positioning for the company within the biopharmaceutical sector. The reported $11.2 million in cash reserves at the end of 2023, bolstered by a subsequent private placement of approximately $54 million, demonstrates a robust funding strategy. This is anticipated to extend the company's operational runway into the second half of 2025, which is a positive signal for investors focused on the company's liquidity and short-term financial health.
However, the reported net loss of $34.4 million, or $7.66 per share, raises questions about the company's long-term profitability, especially considering the one-time charges related to the reverse merger with Graybug Vision, Inc. It is essential to scrutinize the non-recurring expenses to assess the company's core operational efficiency. Investors should also consider the potential dilutive effect of the accompanying warrants included in the private placement, which could impact share value if exercised.
The progression of CalciMedica's clinical trials, particularly the CARPO Phase 2b trial and the upcoming KOURAGE Phase 2 trial, are critical milestones that could significantly influence the company's valuation and future prospects. The successful enrollment and anticipated topline data for CARPO in acute pancreatitis by 2Q 2024, along with the IND clearance for the AKI trial, are indicative of the company's ability to advance its pipeline in line with regulatory timelines.
Furthermore, the expansion of the CRSPA Phase 1/2 trial and the promising initial cohort results presented at ASH 2023 suggest a potential for Auxora in reducing hospital and ICU days. These developments could lead to increased interest from healthcare providers and payers, pending further positive outcomes. The implications for stakeholders hinge on the trial results, which could either catalyze a surge in investor confidence or necessitate a reassessment of the drug's viability.
The biopharmaceutical industry is highly competitive and CalciMedica's focus on CRAC channel inhibition therapies for inflammatory and immunologic illnesses places it in a niche but growing segment of the market. The company's strategic move to present preclinical data at the AKI & CRRT conference demonstrates an understanding of the importance of scientific community engagement for gaining credibility and potentially attracting research collaborations.
Investors should be aware of the competitive landscape, including how CalciMedica's pipeline compares to alternative treatments for acute pancreatitis and AKI. The potential market size, reimbursement challenges and the commercialization pathway for Auxora, if approved, are important factors that will determine the long-term impact on the company's stock performance.
Enrollment in CARPO, Phase 2b trial of Auxora™ in acute pancreatitis (AP), on track with topline data expected in 2Q 2024
Auxora granted Investigational New Drug clearance by the FDA for Phase 2 trial in severe acute kidney injury (AKI); KOURAGE initiating in 2Q 2024
CRSPA Phase 1/2 trial of Auxora in asparaginase-induced pancreatic toxicity (AIPT) expanded and progressing to Phase 2 following initial patient cohort results presented at ASH 2023
Following a private placement financing in January, Company's cash position is expected to fund operations into 2H 2025
"Over the course of 2023 and into this year, we have continued to build upon CalciMedica's clinical and financial strength, which has culminated in several recent achievements and has positioned us to execute on key milestones in 2024 including presenting topline data from our ongoing CARPO trial in acute pancreatitis in the second quarter," said Rachel Leheny, Ph.D., Chief Executive Officer of CalciMedica. "Importantly, the support from leading life science investors in our recent private placement financing allows us to initiate KOURAGE, our Phase 2 trial of Auxora in severe AKI patients, and to continue to progress other key programs in our pipeline."
Recent Clinical and Preclinical Updates and Anticipated Milestones:
- Phase 2b CARPO enrollment on track and topline data expected in 2Q: Enrollment in CARPO, CalciMedica's randomized, double-blind, placebo-controlled Phase 2b trial of Auxora™ in AP patients, is expected to be complete and topline data from the trial to be announced in the second quarter of 2024.
- IND application for Auxora in AKI approved and Phase 2 KOURAGE trial initiation underway: In February 2024, CalciMedica received clearance of its Investigational New Drug (IND) application by the
U.S. Food and Drug Administration (FDA) for Auxora to be evaluated in a Phase 2 trial in AKI with associated acute hypoxemic respiratory failure (AHRF) which has been named KOURAGE. CalciMedica expects to enroll the first patient in KOURAGE in the second quarter of 2024, with data expected in 2025. - Data from initial cohort of Phase 1/2 CRSPA study with St. Jude presented at ASH: In December 2023, CalciMedica's collaborators at St. Jude Children's Research Hospital presented data from the initial cohort of the Phase 1/2 CRSPA study of Auxora in AIPT at the 65th Annual American Society of Hematology Meeting & Exposition (ASH) in
San Diego, CA. The data from the initial cohort compared to a historical matched control group showed fewer hospital and ICU days for treated patients. No patients in the CRSPA study required total parenteral nutrition, compared to68.8% in the historical matched control group, who required 27 days of nutritional support on average.27% of patients in the matched control group had greater than30% pancreatic necrosis at 30 days compared to none of the Auxora-treated patients. - CRSPA study expanded and continuing to enroll in Phase 2 portion of trial: The CRSPA study has been expanded to additional sites, the dose used in the initial cohort has been established as the recommended Phase 2 dose and a target total trial enrollment has been set at 24. Data is expected in 2025.
- Preclinical data presented at AKI & CRRT: In March 2024, CalciMedica presented data from preclinical studies of Auxora in AKI at the 29th International Acute Kidney Injury and Continuous Renal Replacement Therapy Conference (AKI & CRRT) in
San Diego, CA. The results of the studies indicate that Auxora has the ability to hasten the recovery of kidney function and improve survival in rat models of AKI through inhibiting the Orai1 channels on Th17 and endothelial cells.
2023 Financial Results and Corporate Updates:
- As of December 31, 2023, CalciMedica had
$11.2 million - In January 2024, CalciMedica completed a private placement of securities to new and existing investors for up to approximately
$54 million $20.4 million $33.1 million - As of the end of the first quarter of 2024, the Company expects its cash, cash equivalents and short-term investments to be approximately
$25.5 million - Total operating expenses were
$38.1 million $16.2 million $10.5 million - Net loss was
$34.4 million $7.66
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 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, expected to initiate in the second quarter of 2024 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 CARPO and AP
CARPO is an international, randomized, double-blind, placebo-controlled, dose-ranging trial intended to establish Auxora's dose-response and 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
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, or the organ's 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 hospitalized with AKI in
About CRSPA and AIPT
CRSPA 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 (such as Oncaspar and Rylaze). 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 and is expected to enroll 24 patients. Approximately 3,000 pediatric patients are treated for ALL in
About CalciMedica
CalciMedica 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 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. CalciMedica is currently conducting a Phase 2b trial (called CARPO – NCT04681066) for AP with SIRS, with topline data expected in the second quarter of 2024, as well as supporting the ongoing Phase 1/2 AIPT study (called CRSPA – NCT04195347), with data expected in 2025. CalciMedica plans to initiate its Phase 2 study (called KOURAGE) in AKI with associated AHRF in the second quarter of 2024 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
Forward-Looking Statements
This communication contains forward-looking statements which include, but are not limited to, statements regarding CalciMedica's expected cash, cash equivalents and short-term investments as of the end of the first quarter of 2024; CalciMedica's expected use of proceeds from the private placement; CalciMedica's expected cash runway; CalciMedica's business strategy; CalciMedica'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 planned Phase 2 KOURAGE trial of Auxora in AKI with associated AHRF, its ongoing Phase 2b CARPO trial of Auxora for AP with accompanying SIRS and its ongoing Phase 1/2 CRSPA trial of Auxora in pediatric patients with AIPT; the potential benefits of Auxora for the treatment of AKI, AP and AIPT; the estimated patient populations in
CalciMedica Contact:
Investors and Media
Argot Partners
Sarah Sutton/Kevin Murphy
calcimedica@argotpartners.com
(212) 600-1902
CALCIMEDICA, INC. | ||||||||
December 31, | December 31, | |||||||
Assets | ||||||||
Current assets | ||||||||
Cash and cash equivalents | $ | 5,530 | $ | 1,327 | ||||
Restricted cash | — | 149 | ||||||
Short-term investments | 5,708 | — | ||||||
Prepaid expenses and other current assets | 367 | 254 | ||||||
Total current assets | 11,605 | 1,730 | ||||||
Property and equipment, net | 167 | 147 | ||||||
Right-of-use asset, net | — | 48 | ||||||
Other assets | 413 | 1,424 | ||||||
Total assets | $ | 12,185 | $ | 3,349 | ||||
Liabilities and Stockholders' Equity (Deficit) | ||||||||
Current liabilities | ||||||||
Accounts payable | $ | 1,419 | $ | 2,866 | ||||
Accrued clinical trial costs | 1,141 | 1,143 | ||||||
Accrued other | 1,468 | 572 | ||||||
Other current liabilities | — | 199 | ||||||
Total current liabilities | 4,028 | 4,780 | ||||||
Long-term liabilities | ||||||||
Warrant liability | — | 2,645 | ||||||
Convertible promissory notes | — | 5,157 | ||||||
Total liabilities | 4,028 | 12,582 | ||||||
Commitments and contingencies (Note 9) | ||||||||
Convertible preferred stock | ||||||||
Series A convertible preferred stock, | — | 19,107 | ||||||
Series B convertible preferred stock, | — | 8,224 | ||||||
Series C-1 convertible preferred stock, | — | 5,683 | ||||||
Series C-2 convertible preferred stock, | — | 9,563 | ||||||
Series D convertible preferred stock, | — | 19,494 | ||||||
Stockholders' equity (deficit) | ||||||||
Preferred stock, | — | — | ||||||
Common stock, | 1 | 1 | ||||||
Additional paid-in capital | 154,218 | 40,402 | ||||||
Accumulated deficit | (146,064) | (111,707) | ||||||
Accumulated other comprehensive income (loss) | 2 | |||||||
Total stockholders' equity (deficit) | 8,157 | (71,304) | ||||||
Total liabilities, convertible preferred stock and stockholders' equity (deficit) | $ | 12,185 | $ | 3,349 | ||||
CALCIMEDICA, INC. Consolidated Statements of Operations (in thousands, except share and per share amounts) | ||||||||
Year Ended December 31, | ||||||||
2023 | 2022 | |||||||
Operating expenses: | ||||||||
Research and development | $ | 15,859 | $ | 8,350 | ||||
General and administrative | 22,216 | 5,843 | ||||||
Total operating expenses | 38,075 | 14,193 | ||||||
Loss from operations | (38,075) | (14,193) | ||||||
Other income (expense) | ||||||||
Change in fair value of warrant liability | 1,146 | 3,784 | ||||||
Change in fair value of convertible promissory notes | 2,022 | 2,745 | ||||||
Interest on convertible promissory notes payable | (110) | (132) | ||||||
Other income (expense), net | 660 | (28) | ||||||
Total other income (expense), net | 3,718 | 6,369 | ||||||
Net loss | (34,357) | (7,824) | ||||||
Deemed distribution to convertible promissory note holders | — | (1,318) | ||||||
Net loss attributable to common stockholders | $ | (34,357) | $ | (9,142) | ||||
Net loss per share—basic and diluted | $ | (7.66) | $ | (111.16) | ||||
Weighted-average number of shares outstanding used in | 4,486,258 | 82,245 | ||||||
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SOURCE CalciMedica, Inc.
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