Stockholm, August 22, 2024- Vicore Pharma Holding AB (STO: VICO) ("Vicore"), unlocking the potential of a new class of drug candidates, angiotensin II type 2 receptor agonists (ATRAGs), publishes the interim report for second quarter 2024.
"This quarter, we are excited to report promising results from our Phase 2a trial evaluating buloxibutid in patients with idiopathic pulmonary fibrosis (IPF). It marks a significant achievement for Vicore as the initiation of the Phase 2b ASPIRE trial is on track, having submitted materials to the regulatory authorities and ethics committees across the key countries that will be included. These results have further strengthened our conviction that buloxibutid has the potential to meaningfully improve the lives of patients suffering from IPF." Ahmed Mousa, CEO.
Significant events during the second quarter
- In May, Vicore strengthened and expanded its Board of Directors by electing Hans Schikan, PharmD, as the new Chair of the Board of Directors, and electing two new Board members, Ann Barbier, MD, PhD, and Yasir Al-Wakeel, BM, BCh.
- In May, Vicore presented final data from the Phase 2a AIR trial as a late-breaking abstract at the 2024 American Thoracic Society (ATS) International Conference, which showed that buloxibutid improved lung function over 36 weeks in patients with idiopathic pulmonary fibrosis (IPF).
- In May, also at the ATS International Conference, Vicore presented additional preclinical and translational data reflecting the potency of buloxibutid's upstream mechanism of action as well as the design of the upcoming Phase 2b ASPIRE trial.
Significant events after the period
- No significant events occurred after the period.
Financial overview for the period
April 1 - June 30, 2024
- Net revenues amounted to SEK 0.0 million and SEK 0.0 million for the three months ended June 30, 2024 and 2023, respectively.
- Operating loss amounted to SEK 63.1 million and SEK 69.8 million for the three months ended June 30, 2024 and 2023, respectively.
- Loss amounted to SEK 56.3 million and SEK 69.2 million for the three months ended June 30, 2024 and 2023, respectively.
- Loss per share, before and after dilution, amounted to SEK 0.50 and SEK 0.85 for the three months ended June 30, 2024 and 2023, respectively.
- On June 30, 2024, cash, cash equivalents, and short-term investments amounted to SEK 466.4 million, equivalent to USD 44.0 million (SEK 482.8 million as of December 31, 2023).
January 1 - June 30, 2024
- Net revenues amounted to SEK 104.2 million and SEK 0.0 million for the six months ended June 30, 2024 and 2023, respectively.
- Operating loss amounted to SEK 40.0 million and SEK 135.9 million for the six months ended June 30, 2024 and 2023, respectively.
- Loss amounted to SEK 24.6 million and SEK 135.5 million for the six months ended June 30, 2024 and 2023, respectively.
- Loss per share, before and after dilution, amounted to SEK 0.22 and SEK 1.64 for the six months ended June 30, 2024 and 2023, respectively.
Financial summary of the group
| Amounts in SEK million | 2024 Apr-Jun | 2023 Apr-Jun | 2024 Jan-Jun | 2023 Jan-Jun | 2023 Jan-Dec |
| Net revenues (licensing income) | 0 | 0 | 104.2 | 0 | 0 |
| Operating profit/(loss) | (63.1) | (69.8) | (40.0) | (135.9) | (321.5) |
| Profit/(loss) for the period | (56.3) | (69.2) | (24.6) | (135.5) | (310.9) |
| Profit/(loss) per share, before/after dilution (SEK)1 | (0.50) | (0.85) | (0.22) | (1.64) | (3.22) |
| Research and development costs/ operating costs (%)2 | 79.1 | 85.9 | 81.8 | 85.7 | 85.4 |
| Equity at the end of the period | 435.0 | 302.1 | 435.0 | 302.1 | 455.4 |
| Cash flow from operating activities | (49.6) | (69.1) | (26.5) | (146.8) | (249.6) |
| Cash and cash equivalents and short-term investments at the end of the period | 466.4 | 259.6 | 466.4 | 259.6 | 482.8 |
1. No dilutive effect arises for potential common shares for periods when the result is negative or when the exercise price for options or share awards exceeds the average market price.
2. Alternative performance measure (APM). Defined on page 17 in the interim report.
CEO Comments
"This quarter, we are excited to report promising results from our Phase 2a trial evaluating buloxibutid in patients with idiopathic pulmonary fibrosis (IPF). It marks a significant achievement for Vicore as the initiation of the Phase 2b ASPIRE trial is on track, having submitted materials to the regulatory authorities and ethics committees across the key countries that will be included. These results have further strengthened our conviction that buloxibutid has the potential to meaningfully improve the lives of patients suffering from IPF."
During the second quarter, Vicore achieved an important clinical milestone in the development of buloxibutid for patients with IPF, announcing final results from the Phase 2a AIR trial. Buloxibutid demonstrated excellent safety and tolerability as well as unprecedented efficacy, meaningfully improving lung function as measured by forced vital capacity (FVC) over 36 weeks. Professor Toby Maher, Keck School of Medicine at University of Southern California, presented these results at the 2024 American Thoracic Society International Conference in May, where the results were positively received by key opinion leaders, patient advocacy organizations, and industry experts.
Buloxibutid, which modulates an upstream target in a safe and well-tolerated manner, was evaluated in 52 patients with IPF, a disease that affects approximately three million people globally and where current treatment options are limited. Buloxibutid improved FVC by an average of 216mL from baseline at week 36, which is a significant effect over the expected decline in untreated patients.
To confirm these striking results, we are now initiating the Phase 2b ASPIRE trial, a randomized, double-blind, placebo-controlled, parallel-group, multicenter trial, which will evaluate two doses of buloxibutid over 52 weeks. The ASPIRE trial will enroll 270 patients with IPF, either on stable nintedanib therapy or not treated with standard of care, with the primary endpoint being change from baseline FVC at 52 weeks. This robust trial was designed in collaboration with world leading pulmonologists and patient advocacy organizations. To support efficient recruitment and encourage patient participation in and adherence to the trial, we have also incorporated feedback from a patient and caregiver panel and are building a team of strong clinical science liaisons with IPF-specific expertise to work closely with clinical sites.
This quarter, we also strengthened and expanded our Board of Directors by electing Hans Schikan, PharmD, as the new Chair. Hans has more than 25 years of management experience in global pharmaceutical companies and an impressive background working with US Nasdaq-listed biopharmaceutical companies. He has been an integral part of Vicore's Board of Directors since 2018. We look forward to Hans' leadership as we move into late-stage clinical development. We have also welcomed two new members to our Board of Directors, Ann Barbier, MD, PhD, and Yasir Al-Wakeel, BM, BCh. Both seasoned biotech executives and board members, Ann brings experience in drug discovery and development from CMO roles at Translate Bio and CAMP4 Therapeutics and Yasir brings strategic finance and business development expertise stemming from his CEO, CFO, and Corporate Development roles at Addition Therapeutics, Kronos Bio, Neon Therapeutics, and Merrimack Pharmaceuticals. This expansion of our Board will support our continued growth, particularly as we advance buloxibutid into a robust Phase 2b trial. In addition to our board, we have filled several key positions to strengthen the Vicore team.
In parallel, Vicore continues to evaluate novel early-stage angiotensin II type 2 (AT2) receptor agonists for indications where this mechanism can have a transformative effect for patients. While we believe that AT2 receptor agonism can play a key role in serious respiratory diseases, including pulmonary arterial hypertension and pulmonary hypertension-interstitial lung disease, we are currently prioritizing our efforts and resources to ensure the success of the Phase 2b ASPIRE trial given our conviction in the potential of buloxibutid in IPF and our commitment to bringing this potentially disease-modifying therapy to IPF patients. We also continue to explore development paths for Almee, our digital therapeutic for the treatment of anxiety in pulmonary fibrosis, which received FDA Breakthrough Device Designation last quarter.
We are proud of our team's passion and dedication to advancing buloxibutid to late-stage clinical development for IPF and are executing on our strategy to conduct an efficient Phase 2b trial. I want to express my appreciation for Vicore's stakeholders supporting us in our efforts to bringing buloxibutid forward for patients in need of better therapies for IPF.
Ahmed Mousa
Interim report, Q2 2024; https://vicorepharma.com/investors/financial-reports/
For further information, please contact:
Ahmed Mousa, CEO, tel: +1 607 437-0235, ahmed.mousa@vicorepharma.com
Hans Jeppsson, CFO, tel: +46 70 553 14 65, hans.jeppsson@vicorepharma.com
Megan Richards, VP of IR, Communications, and Portfolio Strategy, tel: +1 978 269-4372, megan.richards@vicorepharma.com
About Vicore Pharma Holding AB (publ)
Vicore is an innovative clinical-stage pharmaceutical company unlocking the potential of a new class of drugs with disease-modifying potential. The company is establishing a portfolio in respiratory diseases, including idiopathic pulmonary fibrosis (IPF). Buloxibutid (C21) is a first-in-class orally available small molecule angiotensin II type 2 receptor agonist (ATRAG) recently completing a phase 2a study in IPF. Almee (an investigational medical device in clinical development) is a digital therapeutic based on cognitive behavioral therapy created to address the psychological impact of living with pulmonary fibrosis. Almee has received Breakthrough Device Designation from the FDA, reflecting its potential to have transformative impact. Using its unique expertise in ATRAG chemistry and biology, Vicore is further fueling its pipeline with several new therapies across additional potential indications.
The company's shares (VICO) are listed on Nasdaq Stockholm's main market. For more information, see www.vicorepharma.com
This information is information that Vicore Pharma Holding is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication, through the agency of the contact persons set out above, at 2024-08-22 08:00 CEST.
