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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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