Spexis AG / Key word(s): Annual Results
Ad hoc announcement pursuant to Art. 53 LR
Allschwil, Switzerland, March 24, 2022
- Successful launch of Spexis AG as a reverse merger of Polyphor AG with EnBiotix Inc.
- Successful closing of a USD 12.8 million pre-merger financing
- First patient enrollment and start of Phase 1 trial for inhaled murepavadin
- Start of COPILOT, the first part of the Phase 3 ColiFin(R) program, in Q2 2022
- Analysis of balixafortide development options continues
- Good progress in earlier programs
- Cash on hand of CHF 14.4 million as of December 31, 2021 is expected to finance operations into Q3 2022
On December 29, 2021, the company announced the closing of the pre-merger financing that preceded the announcement of the merger of EnBiotix, Inc. with Polyphor AG itself and the launch of Spexis AG, which began trading on the Swiss stock exchange under the symbol "SPEX" (SIX:SPEX) on January 3, 2022.
"I am very pleased that we are making good progress with Spexis as a unique rare disease and oncology company with an initial focus on chronic respiratory diseases, a field where new treatment options are urgently needed. With a strong proprietary position on our products and research platforms, we are collaborating with leading corporate partners, academic institutions and investigators around the world - particularly in the field of Cystic Fibrosis," says Jeff Wager, M.D., Chairman & CEO of Spexis. "Two clinical programs are already underway, and our plan is to advance our portfolio of clinical-stage product candidates both via internal resources as well as with additional external partnerships. In addition, we will continue to build and advance our innovative R&D pipeline through further clinical trials, in-house pre-clinical programs and additional corporate acquisitions."
ColiFin(R), which EnBiotix in-licensed from PARI Pharma GmbH (a global leader in nebulized therapies) for worldwide rights ex-Europe, is an inhaled cyclic polypeptide with particularly effective activity against gram-negative pathogens and which acts via a different mechanism of action compared to other approved inhaled antibiotics. Approved in Europe since 2010 as a front-line therapy for chronic lung infections in CF, ColiFin(R) has a proven safety, efficacy, and commercial track record which Spexis aims to leverage towards the U.S. and global markets - and both within and potentially outside the field of CF. The company has received a "Study May Proceed" letter from the FDA to initiate a single Phase 3 trial of ColiFin(R) in adult and adolescent subjects with CF and chronic Pseudomonas aeruginosa ("PA") lung infections that will support a future US New Drug Application ("NDA") submission. The company is currently finalizing plans for initiating this Phase 3 program, with start of COPILOT in the second quarter 2022, enrollment of the first patient expected in the fourth quarter of 2022 and trial completion projected for the third quarter 2024.
Inhaled murepavadin ("iMPV"), a novel inhaled therapeutic specifically targeting Pseudomonas aeruginosa ("PA") was discovered from the company's macrocyclic peptide technology platform. In contrast to most other antibiotics, murepavadin is pathogen-specific. This makes it a precision medicine by design, and is also highly potent against PA. The Phase 1 iMPV study is evaluating safety and tolerability of single and multiple ascending doses of iMPV in healthy volunteers. This study already started enrolling subjects in the fourth quarter of 2021, with results expected in the second half of 2022, which could lead to a Phase 1b/2 trial in 2023. In addition, there is significant potential to develop iMPV for moderate to severe non-CF bronchiectasis ("nCFBE"), which is also characterized by chronic PA infections and is a market far larger than the CF market.
Balixafortide is a potent, specific and highly selective antagonist of the chemokine receptor CXCR4, a G-protein coupled receptor that regulates the trafficking and homing of both cancer and immune system cells. CXCR4 is a promising target for therapy of both hematologic and solid tumors, as well as for other non-oncology indications. Following the termination of the Phase 3 FORTRESS study in advanced breast cancer in 2021, Spexis has begun to evaluate additional oncology and non-oncology indications for balixafortide and is doing so both alone and in collaboration with Fosun Pharma, who has licensed certain balixafortide rights from Spexis for the Chinese market. In addition, via the company's proprietary discovery platform, Spexis is discovering and developing a CXCR4/CXCR7 inhibitor pipeline focused on resistant hematologic malignancies, and for rare disease, anti-inflammatory & anti-viral indications as well.
On October 28, 2021, Polyphor's shareholders approved all proposals of the Board of Directors at Extraordinary General Meeting with a significant majority. This includes approval of the increase of authorized share capital, the increase of conditional share capital for bonds and similar debt instruments and the creation for of conditional share capital for employee benefit plans. All of the approved proposals were subject to completion of the merger which was announced on December 30, 2021.
Full-year 2021 results conference call and business update at 14.30 CET on March 24, 2022
To access the earnings call, please use the following details:
France: +33 (0)1 70 730 3 39
Event Title: Spexis AG - Strategy Update and 2021 Financial Results
Confirmation code: 4015509
The presentation will also be available via webcast: https://www.webcast-eqs.com/spexis20220324
After the call, the presentation will be available via the above link.
1) based on the consolidated IFRS financial statements
File: Spexis FY 2021 Results & Business update
End of ad hoc announcement
|Phone:||+41 61 567 1600|
|Fax:||+41 61 567 1601|
|Listed:||SIX Swiss Exchange|
|EQS News ID:||1310313|
|End of Announcement||EQS News Service|
1310313 24-March-2022 CET/CEST