- Support from existing investors Redmile Group, Invus and
Sofinnova Partners
- Participation from leading US Healthcare Specialists funds
including Aquilo Capital, as well as two large investment
management firms
- Financing will enable the Company to extend its cash runway
through the end of Q2 2025
Regulatory News:
Sensorion (FR0012596468 – ALSEN) a pioneering
clinical-stage biotechnology company which specializes in the
development of novel therapies to restore, treat and prevent
hearing loss disorders, today announced a €50.5 million offering
reserved to specific categories of investors (the “Reserved
Offering”) through the issuance of 88,594,737 new ordinary
shares of the Company (the “New Shares”) at a price per New
Share of €0.57 (the “Subscription Price”) to the benefit of
Redmile Group, Invus and Sofinnova Partners, existing shareholders,
and leading US Healthcare Specialists funds including Aquilo
Capital, as well as two large investment management firms. The
settlement-delivery of the Reserved Offering is expected to take
place around February 13, 2024, subject to customary
conditions.
Nawal Ouzren, Chief Executive Officer of Sensorion, said:
“We are delighted to announce today’s successful capital raise of
EUR 50.5 million. We are very thankful to the top tier new
investors who joined us and express our gratitude to our existing
shareholders who have reaffirmed their support in this transaction,
Redmile Group, Invus and Sofinnova Partners. This strengthened
shareholder base reinforces Sensorion’s ambition to advance its
pipeline of innovative therapies intended to improve the quality of
life of patients suffering from hearing disorders. The capital
increase will enable the Company to pursue its relentless efforts
in moving forward its gene therapy programs developed in the
framework of the renewed collaboration with the Institut Pasteur.
Firstly, SENS-501, our lead program, which has recently received
approval from competent authorities to initiate its Phase 1/2
clinical study, Audiogene, in some European countries with France
as first country. We are now entirely focused on the patients
recruitment. The proceeds will also benefit our second gene therapy
program, GJB2-GT, allowing us to complete the preclinical IND/CTA
enabling activities in order to target Clinical Trial Applications
submission in H1 2025.”
Khalil Barrage, ad interim Chair, Sensorion, said: “We
extend a warm welcome to the new investors who joined us. Their
arrival in Sensorion’s capital not only strengthens our financial
foundation but also propels us forward on our path to innovation
and scientific breakthrough for patients suffering from hearing
disorders. We are excited about the opportunities that lie ahead
and look forward to achieving new heights together.”
Expected next clinical milestones:
- H1 2024 – SENS-401 in combination with cochlear implantation:
Primary endpoint readout
- H2 2024, World Congress of Audiology – SENS-401 in
Cisplatin-Induced Ototoxicity: Preliminary safety and efficacy
data
- H2 2024 – SENS-501: First patient communication
- H1 2025 – SENS-501: Enrollment of the first two cohorts of
Phase 1/2 Audiogene trial completed
- H1 2025 – GJB2-GT: Clinical Trial Applications Submission
Impact on cash flow and use of
proceeds
The Company intends to use the net proceeds from the Reserved
Offering, which amount to circa €47 million (based on the aggregate
Subscription Price), to fund the company’s R&D activities
through the end of Q2 2025, covering GJB2 CTA submission and the
first two cohorts of the Audiogene Phase 1/2 clinical trial, which
was approved in Europe in January 2024 as well as for other R&D
and corporate overhead expenses.
Based on its forecasted expenses, cash balance as of December
31st, 2023, which amounts to c. €36.5 million (unaudited), as well
as the net proceeds from the Reserved Offering, the Company
believes that it will be able to finance its operations through the
end of Q2 2025. The company continues to pursue non-dilutive
financing for the other assets.
Main terms of the Reserved
Offering
Sensorion’s board of directors and Chief Executive Officer using
the delegation of powers granted by the 8th resolution of the
extraordinary shareholders’ general meeting held on December 20th,
2023 (capital increase with cancellation of preferential
subscription rights in favor of categories of persons with specific
characteristics) and in accordance with article L. 225-138 et seq.
of the French Commercial Code (Code de commerce), have decided on
February 8, 2024, to complete the issuance of the New Shares. The
New Shares were issued at a price of €0.57, which represents a 0,96
% discount to the weighted average share price on the five days
preceding the date on which the issuance price is set, in
accordance with the 8th resolution of the extraordinary
shareholders’ meeting of the Company held on December 20th,
2023.
The issuance of the 88,594,737 New Shares will result in an
immediate capital increase of €50,499,000.09 (i.e., a nominal
amount of €8,859,473.70 and a total issuance premium of
€41,639,526.39 and corresponding to a nominal value of 10 cents
(€0.10) plus an issuance premium of €0.47 per New Share),
representing approximately 47% of the Company’s share capital and
voting rights outstanding before the Reserved Offering.
Redmile Group, Invus and Sofinnova Partners who are existing
shareholders and are also represented on the Board of Directors of
the Company, will participate in the Reserved Offering for
subscription amounts of €9.6 million, €9.2 million and €7.0
million, respectively, representing 19%, 18% and 14% of the
aggregate gross amount of the Reserved Offering, respectively. It
is specified that Redmile Group, Invus and Sofinnova Partners, who
are also members of Sensorion’s Board of Directors, did not take
part in the vote of the Reserved Offering at the Board of
Directors’ meeting held on February 8, 2024.
Following the settlement-delivery expected to occur on February
13, 2024, the Company's total share capital will be €27,567,553.10
divided into 275,675,531 ordinary shares, each with a par value of
€0.10. The New Shares will be fungible with the existing ordinary
shares of the Company and will be admitted to trading on Euronext
Growth in Paris under the ISIN FR0012596468.
Leerink Partners LLC (“Leerink Partners”) and
Stifel Europe AG (“Stifel”) are acting as lead agents in
connection with the Reserved Offering. Chardan Capital Markets LLC
(“Chardan”) is acting as placement agent in connection with
the Reserved Offering (Leerink Partners together with Stifel and
Chardan, the “Placing Agents”). Stifel is acting as
Centralizing Agent. Namsen Capital is acting as equity capital
markets advisor.
Shareholding Structure after the
Reserved Offering
On an illustrative basis, a shareholder holding 1% of the
Company's share capital before the Reserved Offering and who did
not participate in the Reserved Offering will hold 0.68% of the
Company's share capital after the issuance of the New Shares.
To the Company's knowledge, the shareholding structure, on a
non-diluted base, before and after the Reserved Offering, breaks
down as follows:
Shareholding Structure as of
February 1st, 2024 (non diluted)
Shareholding Structure POST
FINANCING (non diluted)
Shareholding Structure POST
FINANCING (fully diluted)
Number of shares
Number of shares (%)
Number of Voting Rights
Number of Voting Rights (%)
Number of shares
Number of shares (%)
Number of Voting Rights
Number of Voting Rights (%)
Number of shares
Number of shares (%)
Number of Voting Rights
Number of Voting Rights (%)
Redmile Group LLC
46 428 571
24,82%
46 428 571
24,84%
63 270 676
23,0%
63 270 676
23,0%
81 127 819
26,9%
81 127 819
26,9%
Invus / Artal Group
62 204 700
33,25%
62 204 700
33,28%
78 345 050
28,4%
78 345 050
28,4%
78 345 050
26,0%
78 345 050
26,0%
Sofinnova Partners
40 469 458
21,63%
40 469 458
21,65%
52 750 159
19,1%
52 750 159
19,1%
52 750 159
17,5%
52 750 159
17,5%
WuXi App Tec
5 249 608
2,81%
5 249 608
2,81%
5 249 608
1,9%
5 249 608
1,9%
5 249 608
1,7%
5 249 608
1,7%
3SBio
4 055 150
2,17%
4 055 150
2,17%
4 055 150
1,5%
4 055 150
1,5%
4 055 150
1,3%
4 055 150
1,3%
Innobio
3 499 874
1,87%
3 499 874
1,87%
3 499 874
1,3%
3 499 874
1,3%
3 499 874
1,2%
3 499 874
1,2%
SONOVA AG
2 941 176
1,57%
2 941 176
1,57%
2 941 176
1,1%
2 941 176
1,1%
2 941 176
1,0%
2 941 176
1,0%
Cochlear
533 755
0,29%
533 755
0,29%
533 755
0,2%
533 755
0,2%
533 755
0,2%
533 755
0,2%
New investors
0
0,00%
0
0,00%
43 331 581
15,7%
43 331 581
15,7%
43 331 581
14,4%
43 331 581
14,4%
Sub Total Institutional
Shareholders
165 382 292
88,40%
165 382 292
88,47%
253 977 029
92,1%
253 977 029
92,2%
271 834 172
90,2%
271 834 172
90,2%
Officers
160 000
0,09%
160 000
0,09%
160 000
0,1%
160 000
0%
4 010 355
1,3%
4 010 355
1,3%
Directors
-
-
-
-
-
0,0%
-
0%
1 365 290
0,5%
1 365 290
0,5%
Employees &
consulting
-
-
-
-
-
0,0%
-
0%
2 352 020
0,8%
2 352 020
0,8%
Treasury shares
151 162
0,08%
151 162
0,1%
-
0,0%
151 162
0,1%
-
0,0%
Free Float
21 387 340
11,43%
21 387 340
11,44%
21 387 340
7,8%
21 387 340
7,8%
21 683 340
7,2%
21 683 340
7,2%
TOTAL
187 080 794
186 929 632
100,00%
275 675 531
100,0%
275 524 369
100,0%
301 396 339
100,0%
301 245 177
100,0%
Lock-up agreements
In connection with the Reserved Offering, the Company has
entered into a lock-up agreement restricting the issuance of
additional ordinary shares for a period ending 90 days following
the execution of the securities purchase agreement entered into
with the investors, subject to customary exceptions. The Company’s
management, Board members and shareholders represented at the Board
of Directors who hold ordinary shares of the Company are also
subject to a lock-up for a period of 90 days following the
execution of the securities purchase agreement entered into with
the investors, subject to customary exceptions.
Settlement-delivery of the Reserved
Offering
The admission of the New Shares to trading on the Euronext
Growth market in Paris is scheduled for the time of settlement and
delivery, which is expected to take place on February 13, 2024.
The New Shares will be immediately assimilated to the Company's
existing shares already traded on Euronext Growth in Paris, and
will be able to be traded, from their issuance, on the same listing
line (ISIN code: FR0012596468).
The Reserved Offering has not given rise to a prospectus
submitted for approval by the AMF.
Risk Factors
The Company draws the public’s attention to the risk factors
related to the Company and its activities presented in section I.3
of the Rapport financier annuel for the year ended December 31st,
2022, which is available free of charge on the website of the
Company (www.sensorion.com).
In addition, investors are invited to consider the following
risks: (i) shareholders stake in the Company will be diluted
further to the issuance of the New Shares for the shareholders who
did not participate to the Reserved Offering, (ii) the market price
for the Company's shares may fluctuate and fall below the
subscription price of the shares issued pursuant to the Reserved
Offering, (iii) the volatility and liquidity of the Company's
shares may fluctuate significantly, (iv) sales of the Company’s
shares may occur on the market and have a negative impact on the
market price of the shares, and (v) the Company’s shareholders
could undergo a potentially material dilution resulting from any
future capital increases that are needed to finance the
Company.
About Sensorion
Sensorion is a pioneering clinical-stage biotech company, which
specializes in the development of novel therapies to restore, treat
and prevent hearing loss disorders, a significant global unmet
medical need. Sensorion has built a unique R&D technology
platform to expand its understanding of the pathophysiology and
etiology of inner ear related diseases, enabling it to select the
best targets and mechanisms of action for drug candidates. It has
two gene therapy programs aimed at correcting hereditary monogenic
forms of deafness, developed in the framework of its broad
strategic collaboration focused on the genetics of hearing with the
Institut Pasteur. SENS-501 (OTOF-GT) targets deafness caused by
mutations of the gene encoding for otoferlin and is currently
developed in a Phase 1/2 clinical study, and GJB2-GT targets
hearing loss related to mutations in GJB2 gene to potentially
address important hearing loss segments in adults and children. The
Company is also working on the identification of biomarkers to
improve diagnosis of these underserved illnesses. Sensorion’s
portfolio also comprises clinical-stage small molecule programs for
the treatment and prevention of hearing loss disorders. Sensorion’s
clinical-stage portfolio includes one Phase 2 product: SENS-401
(Arazasetron) progressing in a Phase 2 proof of concept clinical
study of SENS-401 in Cisplatin-Induced Ototoxicity (CIO) and, with
partner Cochlear Limited, in a study of SENS-401 in patients
scheduled for cochlear implantation. A Phase 2 study of SENS-401
was also completed in Sudden Sensorineural Hearing Loss (SSNHL) in
January 2022.
www.sensorion.com
Label: SENSORION ISIN: FR0012596468 Mnemonic:
ALSEN
Forward-looking statements
This press release contains certain forward-looking statements
concerning Sensorion and its business. Such forward looking
statements are based on assumptions that Sensorion considers to be
reasonable. However, there can be no assurance that such
forward-looking statements will be verified, which statements are
subject to numerous risks, including the risks set forth in the
2022 full year financial report published on March 30, 2023, and
available on Sensorion's website and to the development of economic
conditions, financial markets and the markets in which Sensorion
operates. The forward-looking statements contained in this press
release are also subject to risks not yet known to Sensorion or not
currently considered material by Sensorion. The occurrence of all
or part of such risks could cause actual results, financial
conditions, performance or achievements of Sensorion to be
materially different from such forward-looking statements. This
press release and the information that it contains do not
constitute an offer to sell or subscribe for, or a solicitation of
an offer to purchase or subscribe for, Sensorion shares in any
country. The communication of this press release in certain
countries may constitute a violation of local laws and regulations.
Any recipient of this press release must inform oneself of any such
local restrictions and comply therewith.
Disclaimer
This press release does not constitute an offer to sell or the
solicitation of an offer to buy ordinary shares of the Company, and
shall not constitute an offer, solicitation or sale in any
jurisdiction in which such offer, solicitation or sale would be
unlawful prior to registration or qualification under the
securities laws of that jurisdiction.
This announcement is an advertisement and not a prospectus
within the meaning of Regulation (EU) 2017/1129 of the European
Parliament and of the Council of 14 June 2017, as amended (the
“Prospectus Regulation”).
In France, the Reserved Offering described above is exclusively
carried out in the form of a placement to a category of
institutional investors, in accordance with Article L. 225-138 of
the Code de commerce and applicable regulations.
With respect to Member States of the European Economic Area
(including France), no action has been taken or will be taken to
permit a public offering of the securities referred to in this
press release which would require the publication of a prospectus
(pursuant to article 3 of the Prospectus Regulation) in any Member
State.
This press release and the information it contains is not an
offer to sell, nor the solicitation of an offer to subscribe for or
buy the New Shares in the United States or any other jurisdiction
where restrictions may apply including notably Canada, Australia or
Japan. Securities may not be offered or sold in the United States
absent registration under the Securities Act or an exemption from
registration thereunder. Sensorion does not intend to register the
New Shares under the Securities Act or conduct a public offering of
the New Shares in France, the United States, or in any other
jurisdiction.
This communication is being distributed only to, and is directed
only at (a) persons outside the United Kingdom, (b) persons who
have professional experience in matters relating to investments
falling within Article 19(5) of the Financial Services and Markets
Act 2000 (Financial Promotion) Order 2005 (the "Order"), and (c)
high net worth entities, and other persons to whom it may otherwise
lawfully be communicated, falling within Article 49(2) of the Order
(all such persons together being referred to as "relevant
persons"). Any investment or investment activity to which this
communication relates is available only to relevant persons and
will be engaged in only with relevant persons. Any person who is
not a relevant person should not act or rely on this communication
or any of its contents.
This distribution of this press release may be subject to legal
or regulatory restrictions in certain jurisdictions. Any person who
comes into possession of this press release must inform him or
herself of and comply with any such restrictions.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240208595169/en/
Investor Relations Noémie Djokovic, Investor Relations
and Communications Associate ir.contact@sensorion-pharma.com
Press Relations Ulysse Communication Pierre-Louis Germain
/ 00 33 (0)6 64 79 97 51 plgermain@ulysse-communication.com Bruno
Arabian / 00 00(0)6 87 88 47 26
barabian@ulysse-communication.com
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