CalciMedica Reports First Quarter 2023 Financial Results and Provides Clinical & Corporate Updates
“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
Financial Results for the Three Months Ended
Cash Equivalents and Marketable Securities: As of March 31, 2023, CalciMedicahad $34.2 millionin cash, cash equivalents and short-term investments.
- Total Operating Expenses: Total operating expenses were
$22.3 million, which included $16.2 millionof 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 $23.43per share (basic and diluted), for the three months ended March 31, 2023.
Clinical Updates and Anticipated Milestones:
- In April, 2023,
CalciMedicainitiated the ex-US expansion of its Phase 2b clinical trial in acute pancreatitis patients (CARPO) in Indiawith an investigator meeting and expects to begin enrolling patients in Indiain the second quarter of 2023.
May 9, 2023, the Independent Data Monitoring Committee for CARPOmet to review data from the first 90 patients enrolled in the trial and determined that the trial should continue without modifications. CalciMedicaanticipates 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.
March 20, 2023, CalciMedicaclosed a merger with Graybug. Immediately following the closing of the merger, CalciMedicaequityholders owned approximately 72% of the combined company and Graybugequityholders owned approximately 28%.
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.
CalciMedica’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.
CARPO 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
CRSPA 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.
This 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
Investors and Media
Selected Financial Information
Condensed Consolidated Balance Sheets
|Cash and cash equivalents||$||24,386||$||1,476|
|Prepaid expenses and other current assets||336||254|
|Total current assets||34,498||1,730|
|Property and equipment, net||134||147|
|Right-of-use asset, net||10||48|
|Liabilities and Stockholders’ Equity (Deficit)|
|Other current liabilities||113||199|
|Total current liabilities||12,650||4,780|
|Convertible promissory notes||—||5,157|
|Commitments and contingencies (Note 8)|
|Stockholders’ equity (deficit)|
|Additional paid-in capital||153,013||40,400|
|Total stockholders’ equity (deficit)||22,019||(71,304||)|
|Total liabilities and stockholders’ equity||$||34,669||$||3,349|
Selected Financial Information
Condensed Statements of Operations
(In thousands, except share and per share data)
|Three Months Ended
|Research and development||$||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|