Spexis provides business update

Ad hoc announcement pursuant to Art. 53 LR

• Cash position to finance operations extended into January 2023
• Resources focused on advancing lead program, Phase 3 ColiFin^®
• Assessment of balixafortide development options continues; balixafortide PK/safety clinical trial in renally impaired subjects completed; results expected to be reported this fall
• Progress in earlier-stage pipeline derived from macrocycle platform
• Variety of partnering and funding options being vigorously explored
• Company renews equity-linked financing with IRIS for up to CHF 15 million
• Conference call scheduled for today, Thursday, July 28, 2022, at 8 AM EDT / 2 PM CET

ALLSCHWIL, Switzerland, July 28, 2022 (GLOBE NEWSWIRE) — Spexis AG (SIX: SPEX), a clinical-stage biopharmaceutical company focused on rare diseases and oncology, today provides a business update, including development programs’ progress and its efforts to secure funding for these projects.

Financial update and fundraising

The Company has carefully evaluated its portfolio and is further focusing its resources and prioritizing programs. Through this effort, Spexis believes it will be able to extend its current cash position to finance operations into January 2023. This cash reach does not take into account the equity-linked financing the Company has just renewed with IRIS, the Paris-based equity-linked financing provider. Spexis has extended this arrangement to raise a gross amount of up to CHF 15 million through 2024. IRIS will receive Spexis shares, which will be created from the Company’s conditional capital, based on this interest-free mandatory convertible bonds program. It remains at the sole discretion of Spexis to suspend or terminate the staggered financing. The Company is also actively pursuing a variety of other avenues to secure funding. This includes partnering opportunities for various programs, including ColiFin^®, balixafortide and other product candidates derived from the macrocycle platform; traditional equity via current and new potential investors; as well as alternative financing strategies.

Jeff Wager, M.D., Chairman and CEO of Spexis AG, said: “Given the challenges in raising funds in this currently very difficult economic and geopolitical climate, it is imperative that we explore a wide variety of options to secure the funding we need to advance our programs as well as to prioritize our development work. With ColiFin^® ready to start Phase 3 testing for the important U.S. market, along with the feedback we have received from the medical community about the significant unmet need for new safe and effective options to treat chronic lung infections in cystic fibrosis patients, we are allocating the majority of our resources to moving this important program ahead.”

He continued: “In addition to ColiFin^®, we have a broad pipeline that we believe offers numerous opportunities for further partnering. This includes balixafortide and other programs derived from our macrocycle platform, the latter which we think has strong potential in the exciting space of molecular glues and protein degradation. Encouraged by both our fundraising and partnering efforts, we look forward to updating the markets as we make progress in these areas.”

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 is further focusing its resources on 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.

Spexis has worldwide rights to ColiFin^® ex-Europe and is focused on developing the product first for the U.S. market. Spexis is moving forward with a Phase 3 program in adult and adolescent CF patients with moderate to severe lung function impairment and chronic Pseudomonas aeruginosa (PA) lung infections. The Phase 3 program includes the COPILOT pilot study to evaluate once daily versus twice daily dosing, and a single Phase 3 study, COPA. PA infections account for two-thirds of CF chronic lung infections and are the leading cause of lung function decline and mortality in CF patients.

Prior to starting COPILOT or COPA, Spexis needs to secure additional funding, as discussed above. In addition, the Company had originally planned to use clinical trial sites in Ukraine and Russia; in view of the ongoing war, additional sites in other countries need to be brought on. Given this situation, the COPILOT study is now planned to start in H1 of 2023. The COPA Phase 3 trial will start once COPILOT is completed as this will determine if a once-daily or twice-daily regimen will be administered in the Phase 3 trial. With this, COPA is now expected to initiate in H2 2023.

Balixafortide 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. The Company is analyzing existing clinical and preclinical data with balixafortide to help determine the appropriate path forward for this program, including potential new indications, and has recently published data demonstrating synergistic efficacy in combination with docetaxel in metastatic prostate cancer.¹ No definitive decisions have yet been made and several areas for further development are being explored. In the fall of 2022, the Company expects to report the results of its recently completed safety/PK (pharmacokinetics) 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 technology 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 data are expected by the end of this year. Potential indications that could be eventually targeted with IMPV include CF, non-CF bronchiectasis (nCFBE) and bronchiectasis associated with chronic obstructive pulmonary disease (COPD-BE).

OMPTA: 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 and continues to move forward.

Conference call today, July 28, 2022 at 8 AM EDT/2 PM CET

As previously announced, a conference call will be held today. To participate, please use the following numbers:

Please dial in approximately 10 minutes prior to the start of the call. When asked, please provide the name of the event – “Spexis AG – Business and Strategy Update” – and the following confirmation code: 1507661.

The presentation will also be available via webcast:

• For participants of the conference call: https://www.webcast-eqs.com/spexis20220728/ no-audio (audio via phone, presentation on the web browser)
• Live stream: https://www.webcast-eqs.com/spexis20220728 (audio and presentation on the web browser; for passive participants)

A replay of the call will be available on the Company’s website in the Investor Relations – Calendar section here or 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.

References
__________________

¹https://www.globenewswire.com/news-release/2022/07/07/2475531/0/en/Spexis-CXCR4-inhibitor-balixafortide-demonstrates-synergistic-efficacy-in-combination-with-docetaxel-in-a-metastatic-prostate-cancer-preclinical-model.html