RCS - Spexis AG - Financial results for the full-year 2021

Spexis AGAnnouncement

24/03/2022 09:15

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RNS Number : 8863F  Spexis AG  24 March 2022

 Spexis AG / Key word(s): Annual Results

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

24-March-2022

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
 (https://che01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.webcast-eqs.com%2Fspexis20220324&data=04%7C01%7CHernan.Levett%40spexisbio.com%7Cc890ec0d7e13432ba6c508d9fdc5d491%7Cc13de0c0b4d3464c93a923fcbc19b97f%7C0%7C0%7C637819848427736353%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=XtkY0lfN%2BgGGKzb21D5awr4YULoKN0MKbe9Sq7fnSW4%3D&reserved=0)

 Link for participants of the conference call (only slides, no audio, no
 delay): https://www.webcast-eqs.com/spexis20220324/no-audio
 (https://che01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.webcast-eqs.com%2Fspexis20220324%2Fno-audio&data=04%7C01%7CHernan.Levett%40spexisbio.com%7Cc890ec0d7e13432ba6c508d9fdc5d491%7Cc13de0c0b4d3464c93a923fcbc19b97f%7C0%7C0%7C637819848427736353%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=nX%2Bss5DeS7tSoG5ATzbCwPzgsI%2BS2XgvkctsPtw7Ux0%3D&reserved=0)

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

 Key figures(1)

 CHF million

Income Statement                   2021   2020
 Total revenue                      0.0    0.0
 Research and development expenses  -0.9   -0.6
 Other operating expenses           -3.4   -0.7
 Net loss for the period            -11.9  -1.9
 Balance Sheet                      2021   2020
 Cash on hand                       14.4   0.3
 Total assets                       49.9   0.3
 Total equity                       30.2   -11.3
 Average net cash burn(2)           0.2    -0.1
 Number of FTE                      28     3
 Equity ratio in %                  61     -3'306

 

 (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/
 (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:

For Investors:                               For Media:

Hernan Levett
 Dr. Stephan Feldhaus

Chief Financial Officer
 Feldhaus & Partner

Spexis AG.
 +41 79 865 92 56

+41 61 567 16 00
 feldhaus@feldhaus-partner.ch (mailto:feldhaus@feldhaus-partner.ch)

IR@spexisbio.com (mailto:IR@spexisbio.com)

 

 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 (http://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.

 Additional features:

File: Spexis FY 2021 Results & Business update
 (http://eqs-cockpit.com/c/fncls.ssp?u=d4fd1af6ac1606b0f17a87cd18bf442d)

 End of ad hoc announcement

 

 

(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/
(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:

 For Investors:                               For Media:

Hernan Levett
Dr. Stephan Feldhaus

Chief Financial Officer
Feldhaus & Partner

Spexis AG.
+41 79 865 92 56

+41 61 567 16 00
feldhaus@feldhaus-partner.ch (mailto:feldhaus@feldhaus-partner.ch)

IR@spexisbio.com (mailto:IR@spexisbio.com)

 

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 (http://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.

Additional features:

File: Spexis FY 2021 Results & Business update
(http://eqs-cockpit.com/c/fncls.ssp?u=d4fd1af6ac1606b0f17a87cd18bf442d)

 

End of ad hoc announcement

 

 

 Language:     English
 Company:      Spexis AG
               Hegenheimermattweg 125
               4123 Allschwil
               Switzerland
 Phone:        +41 61 567 1600
 Fax:          +41 61 567 1601
 E-mail:       info@spexisbio.com
 Internet:     www.spexisbio.com
 ISIN:         CH0106213793
 Valor:        SPEX
 Listed:       SIX Swiss Exchange
 EQS News ID:  1310313

 

 

 End of Announcement  EQS News Service

 

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