Spexis provides business update and announces financial results for the full-year 2021

Spexis AG / Key word(s): Annual Results

24-March-2022 / 07:15 CET/CEST
Release of an ad hoc announcement pursuant to Art. 53 LR
The issuer is solely responsible for the content of this announcement.

Ad hoc announcement pursuant to Art. 53 LR

Allschwil, Switzerland, March 24, 2022

Spexis provides business update and announces financial results for the full-year 2021

- 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

Spexis AG (SIX: SPEX), a clinical-stage biopharmaceutical company, focused on rare diseases and oncology with an initial focus on chronic respiratory diseases, today announced its financial results for the full-year of 2021 and provided a strategic business update.

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."

Pipeline development

Spexis is initially focusing on rare, chronic respiratory diseases and plans to become an important player in cystic fibrosis ("CF"). Although CFTR modulators introduced over the last few years have resulted in significant improvement in the lung health of CF patients, the number of CF patients with moderate-to-severe lung dysfunction is projected to actually increase over the next 20-30 years as a result. And these patients are precisely those who would benefit most from the company's two clinical program candidates ColiFin(R) and inhaled murepavadin.

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.

Financial Results

In the full year of 2021, our total loss was CHF 11.9 million, primarily driven by financial expenses as a result of the fair value changes of derivatives triggered by the reverse merger and other operating expenses. R&D expenditures are expected to increase in 2022 as we prepare and launch our Phase 3 trial for ColiFin(R). Spexis has completed a pre-merger financing of USD 12.8 million. This brings our total cash position to CHF 14.4 million (cash and cash equivalents) as of December 31, 2021, which we expect to finance our operations into Q3 2022.

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

Jeff Wager, M.D. (Chairman & CEO), Stephan Wehselau (COO), Juergen Froehlich, M.D. (CMDO) and Hernan Levett (CFO) will provide a business and financial update, followed by a Q&A session.

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

France: +33 (0)1 70 730 3 39
Germany: +49 (0)69 22222 5197
Italy: +39 02 3602 6066
Switzerland +41 (0)44 580 7279
United Kingdom +44 (0)330 165 4012
United States +1 646-828-8073

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
Link for participants of the conference call (only slides, no audio, no delay): https://www.webcast-eqs.com/spexis20220324/no-audio

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

Key figures¹

CHF million

¹⁾ based on the consolidated IFRS financial statements
²⁾ represents the average monthly cash used in operating and investing activities

The annual report 2021 is available for download on our website: https://www.spexisbio.com/investor-relations/reporting/

Next Events
April 7, 2022 - Annual General Meeting Information call
April 26, 2022 - Annual General Meeting

For further information please contact:

About Spexis
Spexis is a clinical-stage biopharmaceutical company based in Allschwil, Switzerland, focused on rare diseases and oncology. The current pipeline of the company is a combination of two legacy companies, Polyphor AG and EnBiotix, Inc. (Boston, MA, USA) which merged in December 2021. The combined company has been renamed to Spexis AG and is trading on the SIX Swiss Exchange under the symbol SIX:SPEX. 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.