Spexis provides business update and announces financial results for the first half of 2022

Ad hoc announcement pursuant to Art. 53 LR

• Study start-up activities nearly complete for COPILOT, the first part of the Phase 3 ColiFin® program, including regulatory and ethics committee approvals of trial sites
• Enrollment of Phase 1 trial of inhaled murepavadin in healthy volunteers continues with top-line results expected by year-end 2022
• Analysis of balixafortide PK/safety clinical trial in renally impaired subjects completed; results expected to be announced this fall
• Good progress in earlier-stage pipeline derived from macrocycle platform
• Variety of partnering and funding options continue to be vigorously explored
• Cash and cash equivalents of CHF 7.0 million as of June 30, 2022 expected to finance operations through January 2023
• Renewal of the IRIS equity-linked financing facility for up to CHF 15m completed, which may extend cash runway as needed to achieve additional corporate partnering and financing milestones
• Conference call scheduled for today, Tuesday, September 6, 2022, at 8 AM EDT / 2 PM CET

ALLSCHWIL, Switzerland, Sept. 06, 2022 (GLOBE NEWSWIRE) — Spexis AG (SIX: SPEX), a clinical-stage biopharmaceutical company focused on rare diseases and oncology, today announced its financial results for the first half of 2022 and provided a strategic business update.

“Despite the ongoing very challenging financial markets, we continue to make steady progress with Spexis,” said Jeff Wager, M.D., Chairman & CEO of Spexis. “Our two cystic fibrosis programs are proceeding as smoothly and as quickly as possible given market conditions, with inhaled murepavadin expected to generate top-line results by the end of 2022 and ColiFin® to begin Phase 3 testing in the first half of 2023, assuming sufficient funding.” He continued: “In addition, we continue to vigorously pursue a variety of financing, corporate partnering and strategic transaction possibilities to advance our portfolio and our macrocycle platform as a leader in this space.”

Pipeline status and plans

The plans outlined below regarding the further development of various programs are subject to Spexis raising additional funds and/or entering into partnering agreements.

Lead program, ColiFin^®: The Company continues to focus its resources on its lead program ColiFin^®, which is being developed for the treatment of chronic lung infections in cystic fibrosis (CF) patients. While the introduction of CFTR modulators in recent years has improved and extended the lives of CF patients, progressive lung function decline due to chronic lung infections remains a major problem and is projected to rise as patients live longer, further increasing the need for safe and effective therapies. ColiFin® is believed to also have strong therapeutic potential in non-CF bronchiectasis (nCFBE) and chronic obstructive pulmonary disease (COPD). A significant number of these patients suffer from chronic Pseudomonas aeruginosa (PA) lung infections, representing far larger markets than that of CF.

Spexis has worldwide rights to ColiFin^® ex-Europe and is focused on developing the product first for the U.S. market. Spexis is preparing a Phase 3 program in adult and adolescent CF patients with moderate to severe lung function impairment and chronic PA lung infection. The Phase 3 program includes the COPILOT safety and tolerability pilot clinical trial. Its objective is to evaluate and confirm the use of once or twice daily dosing for COPA, the planned single efficacy and safety Phase 3 trial. PA infection accounts for two-thirds of CF chronic lung infections and is the leading cause of lung function decline and mortality in CF patients.

Prior to starting the COPILOT pilot trial or COPA Phase 3 trial with ColiFin®, Spexis needs to secure additional funding but is continuing to advance clinical trial readiness through a variety of internal and externally contracted clinical operations activities. In addition, as reported in July, the Company had originally planned to engage clinical trial sites in Ukraine and Russia. In view of the ongoing Ukraine war, the trial was expanded to sites in other countries. The process of site initiation is proceeding well, and the COPILOT trial is now planned to start in H1 of 2023, and aims to provide dosing data for COPA, which is now expected to initiate in H2 2023.

Balixafortide, discovered from Spexis’ macrocycle platform, is a potent, specific and highly selective inhibitor of CXCR4, which plays a role in a number of tumor types as well as non-oncology indications. As reported in the Company’s July 28, 2022 update, Spexis is analyzing existing clinical and preclinical data with balixafortide to help determine the appropriate path forward for this program, including potential new indications, and recently published data demonstrating synergistic efficacy in combination with docetaxel in metastatic prostate cancer. These data and others in development will inform future decisions on the program. In addition, this fall, the Company expects to report the results of its recently completed safety/PK study of balixafortide in human subjects with renal impairment. This clinical trial was initiated pursuant to interactions with the FDA as a condition to potentially include such patients in any future labeling claim. The Company also expects to share additional data and more details on its development plan for balixafortide later in 2022.

Inhaled murepavadin (iMPV), a novel inhaled therapeutic specifically targeting PA and discovered from Spexis’ macrocycle platform, is currently in a Phase 1 study in healthy volunteers to evaluate safety and tolerability of single and multiple ascending doses (SAD/MAD). The study is ongoing and top-line data are expected by the end of this year. Potential indications that could be eventually targeted with iMPV include CF, nCFBE and COPD in patients with chronic PA infection.  

OMPTA is another class of products derived from application of its macrocycle platform. Spexis was previously awarded funding from CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator), a global non-profit partnership accelerating antibacterial products to address drug-resistant bacteria. This funding is to support the development of thanatin derivatives belonging to Spexis’ novel Outer Membrane Protein Targeting Antibiotic (OMPTA) class of therapeutics to potentially treat life-threatening infections caused by difficult-to-treat Gram-negative bacteria.   This work is almost entirely funded by CARB-X, continues to move forward as planned, and was recently presented at the Gordon Research Conference New Antibacterial Discovery and Development event.

Macrocycle platform

Macrocycles are a proven chemical class of pharmaceutical therapeutics occupying the chemical space between small molecules and biologics. With a unique conformational balance of flexibility and rigidity, macrocycles can act on both extracellular and intracellular targets that are not easily accessible by other chemical classes. Indeed, since 2014, some 19 distinct macrocycle compounds have been approved by various drug regulatory authorities worldwide, involving a wide range of diseases and indications. More recently, with the emergence of the field of molecular glues and protein-protein interactions/degraders, macrocycles are increasingly recognized as possessing significant potential to target unique molecular targets and be combined with complementary technologies. Spexis possesses two distinct, highly diverse and very well characterized macrocycle libraries, together with deep data on same: PEMfinder®, which is comprised of peptidomimetic macrocycles, and MACROfinder®, which are small molecule macrocycles. Each library has distinct applications depending on the targets in question. In addition, Spexis has several pre-clinical leads for various indications which have already been considerably characterized. Spexis is looking to partner either these pre-clinical leads or the entire platform itself, potentially in combination with complementary technologies.

Financial results
In the first half of 2022, total loss was CHF 10.0 million, primarily driven by R&D expenses related to preparation of the ColiFin® Phase 3 program and other operating expenses. Total cash position was CHF 7.0 million (cash and cash equivalents) as of June 30, 2022, which is expected to finance operations through January 2023.

On July 28, 2022, Spexis announced that it had renewed an equity-linked financing arrangement with the French company IRIS. The remaining CHF 13.6 million of the original agreement was replaced with a new equity-linked financing agreement which may raise, as needed, a gross amount of up to CHF 15.0 million over the period of two years.

Key figures¹

CHF million

¹⁾ based on the consolidated IFRS financial statements
²⁾ represents the average monthly cash used in operating and investing activities
³⁾ Restated as a result of measurement period adjustments, refer to note 2.4 Business combinations of the half year report 2022, and correction of the presentation of Additional paid-in capital and Accumulated deficit, please refer to note 2.3 of the half year report 2022
  
The half year report 2022 is available for download on our website: https://www.spexisbio.com/investor-relations/reporting/

Spexis H1 2022 financial results and business update call on September 6, 2022 at 14:00 CET/8:00 AM EDT

Management will provide a business and financial update, followed by a Q&A session.

To access the earnings call, please use the following details:

The presentation will also be available via webcast: https://www.webcast-eqs.com/spexis20220906

Link for participants of the conference call (only slides, no audio, no delay): https://www.webcast-eqs.com/spexis20220906/ no-audio

After the call, the presentation will be available via the above link.

For further information please contact:

About Spexis
Spexis (SIX: SPEX) is a clinical-stage biopharmaceutical company based in Allschwil, Switzerland, focused on rare diseases and oncology. For further information please visit: www.spexisbio.com.

Disclaimer

This press release contains forward-looking statements which are based on current assumptions and forecasts of Spexis management. Known and unknown risks, uncertainties, and other factors could lead to material differences between the forward-looking statements made here and the actual development, in particular Spexis’ results, financial situation, and performance. Readers are cautioned not to put undue reliance on forward-looking statements, which speak only of the date of this communication. Spexis disclaims any intention or obligation to update and revise any forward-looking statements, whether as a result of new information, future events or otherwise.