Immunic(US:IMUX)2023-08-03 10:48Product Development - Immunic is developing three main product candidates: vidofludimus calcium (IMU-838) for multiple sclerosis, IMU-856 for gastrointestinal diseases, and IMU-381 for gastrointestinal diseases, with ongoing clinical trials for each[119][120][124]. - The Phase 3 ENSURE program for vidofludimus calcium is currently enrolling patients, with interim analysis data expected in late 2024 and top-line data by the end of 2025[120]. - IMU-856 has shown positive results in a Phase 1 clinical trial for celiac disease, demonstrating improvements in gut architecture, patient symptoms, biomarker response, and nutrient absorption[123][131]. - Vidofludimus calcium has been tested in over 1,400 human subjects, showing a consistent pharmacokinetic, safety, and tolerability profile[121]. - Positive data from the maintenance phase of the Phase 2b CALDOSE-1 trial of vidofludimus calcium showed a 33.7% absolute improvement in clinical remission over placebo at week 50, with statistical significance (p=0.0358) for the 30 mg dose[136]. - A dose-linear increase in endoscopic healing was observed, with a 37.8% absolute improvement over placebo for the 30 mg dose, achieving statistical significance (p=0.0259)[136]. - Recent preclinical data indicates that vidofludimus calcium acts as a potent Nurr1 activator, which may enhance its neuroprotective effects in MS[129]. - The company is preparing for a Phase 2 clinical trial of IMU-856 in patients with ongoing active celiac disease[132]. - The company is conducting additional preclinical research to explore antiviral-directed development activities with new antiviral molecules[125]. Financial Performance - Research and development expenses increased by $4.6 million (28%) to $21.2 million for the three months ended June 30, 2023, compared to the same period in 2022[149]. - Total operating expenses for the three months ended June 30, 2023, were $25.0 million, a 21% increase from $20.6 million in the same period in 2022[149]. - The net loss for the three months ended June 30, 2023, was $24.0 million, a 10% increase from $21.9 million in the same period in 2022[149]. - Research and development expenses for the six months ended June 30, 2023, increased by $10.2 million (30%) to $44.1 million compared to the same period in 2022[153]. - The net loss for the six months ended June 30, 2023, was $49.3 million, a 15% increase from $42.7 million in the same period in 2022[153]. - The accumulated deficit reached approximately $366.6 million as of June 30, 2023, up from $317.3 million as of December 31, 2022[157]. - As of June 30, 2023, the company had cash and cash equivalents of approximately $77.3 million, expected to fund operations beyond twelve months[160]. - The company has raised approximately $355.6 million from private and public offerings since inception through June 30, 2023[159]. - During the six months ended June 30, 2023, operating activities used $39.5 million of cash, primarily due to a net loss of $49.3 million[170]. - The company anticipates needing substantial additional funding for ongoing operations, with no committed external source of funds available[168]. Operational Overview - Immunic has approximately 75 employees and is headquartered in New York City, with main operations in Gräfelfing, Germany[118]. - The company is exploring potential strategic collaborations to enhance the commercialization of its product candidates[132]. - Immunic is utilizing its Gräfelfing, Germany location for most R&D activities, aiming for timely and cost-effective execution of development programs[126]. - The company raised gross proceeds of $10.3 million in the three months ended June 30, 2022, through the December 2020 ATM by selling 1,300,000 shares at a weighted average price of $7.90 per share[165]. - As of July 28, 2023, $8.1 million in capacity remains under the December 2020 ATM, and $80.0 million in capacity remains under the May 2022 ATM[162][163]. - The company does not expect to generate any revenue from product sales until regulatory approval is obtained for its product candidates[166]. - The company incurred net cash used in investing activities of $40,000 during the six months ended June 30, 2022, related to the purchase of property and equipment[172]. - The company has non-cancelable contractual obligations totaling approximately $3.4 million related to development programs, expected to be paid in the next twelve months[176]. Currency and Cash Flow - A 10% adverse change in foreign currency exchange rates could result in a decrease of approximately $0.5 million in net current assets as of June 30, 2023[184]. - Net cash provided by financing activities was $147,000 during the six months ended June 30, 2023, primarily from the issuance of common stock[173].