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IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO
THE UNITED STATES, AUSTRALIA, CANADA, HONG
KONG, JAPAN, SINGAPORE, SWITZERLAND, NEW
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CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OR REGULATIONS OF THAT
JURISDICTION. THIS DOCUMENT DOES NOT CONSTITUTE AN OFFER OF OR THE
SOLICITATION OF AN OFFER TO BUY SECURITIES IN ANY JURISDICTION. FOR
MORE INFORMATION, SEE THE SECTION IMPORTANT INFORMATION
BELOW.
LUND,
Sweden, Feb. 20, 2023 /PRNewswire/ -- The
Board of Directors of Immunovia AB (publ) ("Immunovia" or the
"Company") has today, on 20 February
2023, resolved on a new issue of shares of approximately
SEK 202.2 million with preferential
right for existing shareholders (the "Rights Issue"). The Rights
Issue is subject to the approval of an Extraordinary General
Meeting (the "EGM"), which is scheduled to be held on 16 March 2023. Notice to the EGM will be
published through a separate press release. The Company has
received subscription commitments, subscription intentions and
guarantee commitments for a total of SEK
151.8 million, corresponding to approximately 75 percent of
the Rights Issue. The purpose of the Rights Issue is to accelerate
the commercial rollout of IMMray® PanCan-d, invest in research and
development and strengthen the ongoing business operations in
accordance with the Company's communicated strategy. Due to the
Rights Issue, the Board of Directors has resolved to postpone the
publication of the Company's quarterly report for the first quarter
of 2023 until 23 May 2023 and the
annual general meeting until 26 May
2023.
SUMMARY
- The purpose of the Rights Issue is to accelerate the commercial
rollout of IMMray® PanCan-d, invest in research and development and
strengthen the ongoing business operations in accordance with the
Company's communicated strategy.
- The Rights Issue comprises a maximum of 30,175,440 shares and
the subscription price is set at SEK
6.70 per new share which, assuming that the Rights Issue is
fully subscribed, will provide the Company with proceeds of
approximately SEK 202.2 million
before issue costs.
- Provided that the Rights issue is approved by the EGM, the
record date for the Rights Issue is expected to be 21 March 2023 and the subscription period will
run from and including 23 March 2023
to and including 6 April 2023.
- Existing shareholders in Immunovia as of the record date,
21 March 2023, will be assigned one
subscription right for each existing share. Three (3) subscription
rights entitle to subscription of four (4) shares in the Rights
Issue.
- The last day of trading in Immunovia's shares including a right
to participate in the Rights Issue is 17
March 2023.
- In connection with the Rights Issue, the Company has received
subscription commitments amounting to approximately SEK 18.8 million, corresponding to 9.3 percent of
the Rights Issue, from a number of the Company's major existing
shareholders, among others Coeli and Ranny Davidoff. In addition,
several members of the Company's Board of Directors and management,
among others the Company's CEO Philipp
Mathieu, have declared their intention to subscribe shares
in the Rights Issue, amounting to approximately SEK 0.2 million in total, corresponding to 0.1
percent of the Rights Issue. These investors, which as of the date
of this press release own approximately 11.9 percent of the votes
in the Company, have, subject to customary conditions, undertaken,
or declared their intention to undertake, to vote in favor of the
Rights Issue at the EGM.
- In addition, some of the Company's existing shareholders as
well as external investors have provided guarantee commitments in
accordance with customary terms for a total of approximately
SEK 133.0 million, corresponding to
approximately 65.8 percent of the Rights Issue. The Company has
thus obtained subscription commitments, subscription intentions and
guarantee commitments of up to a total of approximately 75 percent
of the Rights Issue.
- All board members and members of the management with holdings
in the Company have, in relation to Vator Securities, undertaken to
not, with certain exceptions, sell or otherwise transfer or dispose
of securities (excluding securities subscribed within the scope of
the Rights Issue or thereafter) in the Company. The lock-up
agreement applies for a period of 180 days from the announcement of
the Rights Issue, i.e. from 20 February
2023. In addition to same undertakings as the above, the
founders and major shareholders Carl Borrebaeck, Mats Ohlin and Sara
Andersson Ek have also undertaken towards Vator Securities
AB not to sell or otherwise transfer the subscription rights not
used for subscription in the Rights Issue.
- Notice to the EGM will be published through a separate press
release and the Company intends to publish the prospectus regarding
the Rights Issue on or around 17 March
2023.
- Due to the Rights Issue, the Board of Directors has resolved to
postpone the publication of the Company's quarterly report for the
first quarter of 2023 until 23 May
2023 and the annual general meeting until 26 May 2023.
PHILIPP MATHIEU, PRESIDENT AND
CEO OF IMMUNOVIA
"Immunovia has entered a new phase with a full focus on the
commercialization of IMMray PanCan-d in the US where we aim to
obtain reimbursement from the first insurers during 2023. The
recent payment determination by the Centers for Medicare &
Medicaid Services (CMS) at a highly attractive rate of USD 897 for Immunovia's IMMray PanCan-d test is
the latest milestone on that journey. Through the Rights Issue, we
will be able to further accelerate the commercial rollout of
IMMray® PanCan-d as well as execute on our communicated strategy.
We are highly confident that 2023 and this rights issue will lead
to increased adoption of our test through heightened awareness,
initial reimbursement successes and a broadening of the clinical
validation of our test for the current and additional risk groups
within pancreatic cancer."
BACKGROUND AND RATIONALE
Immunovia is a diagnostics company with the vision to
revolutionize blood-based diagnostics and increase the survival
rate for patients with cancer. Immunovia has launched the first
blood test in the world designed for the early detection of
pancreatic cancer, a serious form of cancer with a low survival
rate.1 The low survival rate is explained by the
fact that pancreatic cancer is usually detected at a late stage
when the tumor has metastasized.
Immunovia has developed IMMray® PanCan-d, which is the first
blood-based test specifically developed for the early diagnosis of
pancreatic ductal adenocarcinoma (PDAC).2 Since
2016, Immunovia has conducted several large-scale studies targeting
the main pancreatic cancer risk groups. Altogether, the studies
have been conducted at around 30 hospitals in the USA and Europe and included several thousand patients.
Based on the studies conducted, Immunovia's assessment is that
IMMray® PanCan-d has unmatched clinical performance for the early
detection of pancreatic cancer.
IMMray® PanCan-d is offered exclusively by Immunovia Inc.
(Immunovia's US subsidiary) as a laboratory-developed test (LDT).
During 2022, Immunovia has significantly strengthened its US
organization to drive market acceptance and has worked towards cost
reimbursement in the US market, which the Company considers to be
the largest and most lucrative market. The Company estimates that
the total addressable market for pancreatic cancer early detection
in the US includes over 1.8 million patients3.
Commercialization of IMMray® PanCan-d started in August 2021 in the
United States. In 2022, Immunovia took decisive steps in the
process towards reimbursement in the US. In June 2022, the Company received approval for a
Current Procedural Terminology Proprietary Laboratory Analyzes (CPT
PLA) code from the American Medical Association (AMA) for the
IMMray® PanCan-d test. The code became effective on 1 October 2022. Another important step was taken
in November 2022 when the Centers for
Medicare & Medicaid Services (CMS) set the pricing at
USD 897 for Immunovia's IMMray®
PanCan-d test. Payment for the IMMray® PanCan-d with this PLA code
has been included in the CMS Clinical Lab Fee Schedule 2023 and
established pricing became effective on 1
January 2023. The next step in the reimbursement process is
to obtain reimbursement from US insurers for IMMray® PanCan-d.
The Company intends to make a series of investments over the
next 24 months as part of scaling up operations and accelerating
the commercial rollout of IMMray® PanCan-d. The investments
include, among other things, expanding the sales organization and
the Company's network of leading Key Opinion Leaders as well as
investing in digital marketing to drive demand and support
continued sales growth. Against the background of the capital
requirement that these investments and the Company's other
development and commercialization plans entail, Immunovia assesses
that its existing working capital, as of the date of this press
release, is not sufficient to cover the Company's capital needs
during the coming twelve-month period.
The proceeds from the Rights Issue are intended to finance the
following activities:
- Accelerated commercial rollout of IMMray®
PanCan-d
- Research and development, which includes studies and validation
of additional risk groups
- Ongoing business operations including general running costs in
accordance with the Company's communicated strategy
THE RIGHTS ISSUE
To ensure successful development in accordance with the
Company's business plan and strategy, Immunovia has decided to
carry out the Rights Issue. In case of full subscription in the
Rights Issue, the Company will receive approximately SEK 202.2 million before issue costs.
Those who are registered as shareholders on the record date of
21 March 2023 own preferential right
to subscribe for new shares in proportion to their existing
shareholdings. Subscription of shares may also take place without
preferential right.
The subscription period is expected to run from and including
23 March 2023 up until and including
6 April 2023. The Board of Directors
of Immunovia is entitled to extend the subscription period and the
time of payment. The trading in subscription rights is
expected to occur on Nasdaq Stockholm during the period from and
including 23 March 2023 up until and
including 3 April 2023 and the
trading in paid subscribed shares (Sw. betald tecknad aktie)
during the period from and including 23
March 2023 until the shares in the Rights Issue have been
registered with the Swedish Companies Registration Office (Sw.
Bolagsverket) (the "SCRO").
The Board of Directors' resolution on the Rights Issue is
subject to approval by the EGM, planned to be held on 16 March 2023. For further information, please
see the notice to the EGM which will be announced through a
separate press release.
TERMS OF THE RIGHTS ISSUE
Those who are registered shareholders in Immunovia on the record
date of 21 March 2023 will receive
one (1) subscription right for each share. The subscription rights
grant the holder a preferential right to subscribe for new shares,
whereby three (3) subscription rights entitles the shareholder to
subscribe for four (4) new shares. In addition, investors are
offered the possibility to subscribe for shares without
subscription rights.
If all of the new shares are not subscribed for with
subscription rights, the Board of Directors shall, up to the
maximum amount of the Rights Issue, resolve on allocation of new
shares which have been subscribed for without subscription rights,
in accordance with the following:
- Primarily, allocation shall be made to those who subscribed for
shares under subscription rights, regardless of whether the
subscriber was a shareholder on the record date or not, pro rata in
relation to the number of subscription rights exercised and, to the
extent that this cannot be done, by drawing lots.
- Secondly, allocation shall be made to those who have subscribed
for shares without subscriptions rights. In the event that they
cannot receive full allotment, allocation shall be made pro rata in
proportion to the number of shares subscribed for by each and, to
the extent that this cannot be done, by drawing lots.
- Thirdly, any remaining shares shall be allocated to the parties
who guaranteed the Rights Issue, in relation to the guarantee
undertakings made.
The subscription price has been set to SEK 6.70 per new share. Brokerage commission is
not charged. Assuming that the Rights Issue is fully subscribed,
the share capital will increase by a maximum of SEK 1,508,772.00, from SEK
1,131,579.05 to SEK
2,640,351.05, by a new issue of a maximum of 30,175,440 new
shares, which means that the total number of shares increases from
22,631,581 shares to 52,807,021 shares.
Shareholders who choose not to participate in the Rights Issue
will, given that the Rights Issue is fully subscribed, have their
shareholdings diluted by 57.1 percent of the shares and votes, but
are able to financially compensate for this dilution by selling
their subscription rights.
Full terms and conditions for the Rights Issue and other
information about Immunovia will be presented in the Prospectus
expected to be published by the Company on Immunovia's website,
www.immunovia.com, and Vator Securities' website,
www.vatorsecurities.se, approximately on 17
March 2023.
Subscription commitments, subscription intentions and
Guarantee commitments
In connection with the Rights Issue, the Company has received
subscription commitments amounting to approximately SEK 18.8 million, corresponding to approximately
9.3 percent of the Rights Issue, from several of the Company's
major existing shareholders, including Coeli and Ranny Davidoff. In
addition, several members of the Company's Board of Directors and
management, among others the Company's CEO Philipp Mathieu, have declared their intention
to subscribe shares in the Rights Issue, amounting to approximately
SEK 0.2 million in total,
corresponding to 0.1 percent of the Rights Issue. These investors,
which as of the date of this press release own approximately 11.9
percent of the votes in the Company, have, subject to customary
conditions, undertaken, or declared their intention to undertake,
to vote in favor of the Rights Issue at the EGM.
In addition, some of the Company's existing shareholders as well
as external investors have provided guarantee commitments in
accordance with customary terms for a total of approximately
SEK 133.0 million, corresponding to
approximately 65.8 percent of the Rights Issue. The Company has
thus obtained subscription commitments, subscription intentions and
guarantee commitments of up to a total of approximately 75 percent
of the Rights Issue. No compensation is paid for submitted
subscription commitments. For guarantee commitments, a guarantee
compensation is paid in the form of cash amounting to fourteen (14)
percent of the guaranteed amount or alternatively sixteen (16)
percent of the guaranteed amount in the form of newly issued shares
in the Company. If the guarantee compensation is to be paid in
shares, the new shares are intended to be issued following a board
resolution based on the authorization to issue shares granted by
the annual general meeting 2022 and at a subscription price
corresponding to the volume-weighted average price of the Company's
share on Nasdaq Stockholm during the subscription period for the
Rights Issue, however not lower than the subscription price in the
Rights Issue, and provided that the subscription price is deemed by
the Company to correspond to market terms. The subscription and
guarantee commitments are not secured through bank guarantees,
restricted funds, pledged assets or similar arrangements.
More detailed information on the parties who have entered into
subscription commitments and guarantee commitments will be found in
the prospectus, which is expected to be published before the
commencement of the subscription period.
COMMITMENT TO REFRAIN FROM SELLING SECURITIES
(LOCK-UP)
All board members and members of the management with holdings in
the Company have, in relation to Vator Securities, undertaken to,
with certain exceptions, waive the right to sell or otherwise
transfer or dispose of securities (does not include securities
subscribed within the scope of the Rights Issue or thereafter) in
the Company. The lock-up commitment applies for a period of 180
days from the announcement of the Rights Issue, i.e., from
20 February 2023. In addition to same
undertakings as the above, the founders and major shareholders Carl
Borrebaeck, Mats Ohlin and
Sara Andersson Ek have also
undertaken towards Vator Securities AB not to sell or otherwise
transfer the subscription rights not used for subscription in the
Rights Issue.
The transfer restrictions described above are subject to
customary restrictions and exceptions, for example intra-group
transfers, sales in connection with public takeover offers or sales
of allocated subscription rights, or where transfer of the shares
is required because of administrative or legal requirements. In
addition, Vator Securities may grant exemptions from relevant
commitments if Vator Securities, on a case-by-case basis, deems
this appropriate. After the lock-up period has expired,
shareholders who have been restricted by a lock-up commitment can
freely sell their shares in the Company.
PRELIMINARY TIMETABLE
The below timetable for the Rights Issue is preliminary and may
be adjusted.
16 March
2023
|
EGM for approval of the
Board of Directors' resolution on the Rights Issue
|
17 March
2023
|
Estimated date for
publication of the prospectus
|
17 March
2023
|
Last day of trading in
the share including right to participate in the Rights Issue with
preferential right
|
20 March
2023
|
First day of trading in
the share excluding right to participate in the Rights Issue with
preferential right
|
21 March
2023
|
Record date for
participation in the Rights Issue, i.e. holders of shares who are
registered in the share register on this date will receive
subscription rights for participation in the Rights
Issue
|
23 March
- 3 April 2023
|
Trading in subscription
rights
|
23 March - 6
April 2023
|
Subscription
period
|
23 March 2023 -
until the shares are registered with the SCRO
|
Trading in paid
subscribed shares (Sw. betald tecknad aktie)
|
12 April
2023
|
Estimated date for the
announcement of outcome in the Rights Issue
|
POSTPONED PUBLICATION OF THE QUARTERLY REPORT FOR THE FIRST
QUARTER OF 2023 AND THE ANNUAL GENERAL MEETING OF 2023
Due to the Rights Issue, the Board of Directors of Immunovia has
decided that the quarterly report for the first quarter of 2023
will be published on 23 May 2023
instead of 25 April 2023 as
previously communicated. Further, the Board of Directors of
Immunovia has decided that the annual general meeting shall be held
on 26 May 2023 instead of
26 April 2023 as previously
communicated.
ADVISERS
Vator Securities is the financial advisor to the Company in
connection with the Rights Issue. Vator Securities also acts as the
issuer agent in the Rights Issue. Advokatfirman Vinge KB is the
legal advisor to the Company in connection with the Rights
Issue.
FOR MORE INFORMATIONS, PLEASE CONTACT:
Philipp Mathieu
President and CEO
philipp.mathieu@immunovia.com
Karin Almqvist Liwendahl
CFO
+46 709 11 56 08
karin.almqvist.liwendahl@immunovia.com
This is information of the type that Immunovia AB (publ) is
obligated to make public in accordance with the EU Market Abuse
Regulation. The information was submitted for publication through
the agency of the contact persons above on 20 February 2022, at 08:00
CET.
ABOUT IMMUNOVIA
Immunovia AB is a diagnostic company with the vision to
revolutionize blood-based diagnostics and increase survival rates
for patients with cancer. The company is headquartered in
Lund, Sweden. Immunovia has been a
listed company since 2015, with shares traded (as IMMNOV) on Nasdaq
First North in Stockholm and since
3 April 2018 traded on Nasdaq
Stockholm. For more information please visit
www.immunovia.com.
IMPORTANT INFORMATION
This press release and the information herein is not for
publication, release, dissemination or distribution, in whole or in
part, directly or indirectly, in or into the United States, Australia, Canada, Hong
Kong, Japan, Singapore, Switzerland, New
Zealand or South Africa or
any other state, territory or jurisdiction in which publication,
release, dissemination or distribution would be unlawful or where
such action would require additional prospectuses, filings or other
measures in addition to those required under Swedish law.
The press release is for informational purposes only and does
not constitute an offer to sell or issue, or the solicitation of an
offer to buy or acquire, or subscribe for, any of the securities
mentioned herein (collectively, the "Securities") or any other
financial instruments in Immunovia AB (publ). Any offer in respect
of any of the Securities will only be made through the prospectus
that Immunovia AB (publ) expects to publish in due course. Offers
will not be made to, and application forms will not be approved
from, subscribers (including shareholders), or persons acting on
behalf of subscribers, in any jurisdiction where applications for
such subscription would contravene applicable laws or regulations,
or would require additional prospectuses, filings, or other
measures in addition to those required under Swedish law. Measures
in violation of the restrictions may constitute a breach of
relevant securities laws.
The Securities mentioned in this press release have not been
registered and will not be registered under any applicable
securities law in the United
States, Australia,
Canada, Hong Kong, Japan, Singapore, Switzerland, New
Zealand or South Africa and
may, with certain exceptions, not be offered or sold within, or on
behalf of a person or for the account or benefit of a person who is
registered in, these countries. The company has not made an offer
to the public to subscribe for or acquire the Securities mentioned
in this press release other than in Sweden.
None of the Securities have been or will be registered under
the United States Securities Act of 1933, as amended (the
"Securities Act"), or the securities laws of any state or other
jurisdiction in the United States
(including its territories, possessions and the District of Columbia), and unless so
registered, may not be offered, pledged, sold, delivered or
otherwise transferred, directly or indirectly, except pursuant to
an exemption from, or in a transaction not subject to, the
registration requirements of the Securities Act and in compliance
with other applicable securities laws. Only persons in the United States that are qualified
institutional buyers ("QIBs") as defined in Rule 144A under the
Securities Act or institutional "accredited investors" as defined
in Rule 501 of Regulation D under the Securities Act may
participate in the offer. There will not be any public offering of
any of the Securities in the United
States. Outside the United
States, the offer will be conducted in offshore transactions
to persons other than "U.S. persons" as defined in and in
compliance with, Regulation S under the Securities Act and in
accordance with applicable law.
In the EEA Member States, with the exception of Sweden, (each such EEA Member State, a
"Relevant State"), this press release and the information contained
herein are intended only for and directed to qualified investors as
defined in the Prospectus Regulation. The Securities mentioned in
this press release are not intended to be offered to the public in
any Relevant State and are only available to qualified investors
except in accordance with exceptions in the Prospectus Regulation.
Persons in any Relevant State who are not qualified investors
should not take any actions based on this press release, nor rely
on it.
In the United Kingdom, this
press release is directed only at, and communicated only to,
persons who are qualified investors within the meaning of article
2(e) of the Prospectus Regulation (2017/1129) who are (i) persons
who fall within the definition of "investment professional" in
article 19(5) of the Financial Services and Markets Act 2000
(Financial Promotion) Order 2005, as amended (the "Order"), or (ii)
persons who fall within article 49(2)(a) to (d) of the Order, or
(iii) persons who are existing members or creditors of Immunovia AB
(publ) or other persons falling within Article 43 of the Order, or
(iv) persons to whom it may otherwise be lawfully communicated (all
such persons referred to in (i), (ii), (iii) and (iv) above
together being referred to as "Relevant Persons"). This press
release must not be acted on or relied on by persons in the UK who
are not Relevant Persons.
This announcement does not constitute an investment
recommendation. The price and value of securities and any income
from them can go down as well as up and you could lose your entire
investment. Past performance is not a guide to future performance.
Information in this announcement cannot be relied upon as a guide
to future performance.
This press release contains forward-looking statements that
reflect Immunovia AB (publ)'s current view of future events as well
as financial and operational development. Words such as "intend",
"assess", "expect", "may", "plan", "estimate" and other expressions
involving indications or predictions regarding future development
or trends, not based on historical facts, identify forward-looking
statements and reflect Immunovia AB (publ)'s beliefs and
expectations and involve a number of risks, uncertainties and
assumptions which could cause actual events and performance to
differ materially from any expected future events or performance
expressed or implied by the forward-looking statement. The
information contained in this press release is subject to change
without notice and, except as required by applicable law, Immunovia
AB (publ) does not assume any responsibility or obligation to
update publicly or review any of the forward-looking statements
contained in it and nor does it intend to. You should not place
undue reliance on forward-looking statements, which speak only as
of the date of this press release. As a result of these risks,
uncertainties and assumptions, you should not place undue reliance
on these forward-looking statements as a prediction of actual
future events or otherwise.
1 US Pancreatic Cancer Action Network. New Early
Detection Blood Tests: What to Know. 2021.
https://pancan.org/news/new-early-detection-blood-tests-what-to-know.
2 US Pancreatic Cancer Action Network. New Early
Detection Blood Tests: What to Know. 2021.
https://pancan.org/news/new-early-detection-blood-tests-what-to-know.
3 Of the Company's assessment of the total
addressable market of over 1.8 million patients, approximately
600,000 are attributable to individuals with a familial/hereditary
risk of pancreatic cancer, over 1 million patients attributable to
the high-risk group of newly diagnosed diabetes after the age of 50
and approximately 200,000 individuals attributable to the high-risk
group with early vague symptoms.
The following files are available for download:
https://mb.cision.com/Main/13121/3718469/1859137.pdf
|
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