TIDMGENF
RNS Number : 9740N
Genflow Biosciences PLC
28 September 2023
PRESS RELEASE
28 September 2023
Genflow Biosciences Plc
("Genflow" or "the Company")
HALF YEAR RESULTS
Genflow (LSE: GENF) is pleased to announce its half year results
for the six-month period ended 30 June 2023.
Chairman's Statement
It is with pleasure that I take this opportunity to update
shareholders of Genflow Biosciences Plc ("Genflow" or the
"Company") on the Company's performance during the first six months
of 2023.
The Company continues to maintain a secure financial position
and has sufficient cash reserves until March 2025. This is
inclusive of grant funding which has been approved at the time of
reporting and is due to be received in the coming months. The
Company continues to seek further non-dilutive research grants
which management will use to expedite specific phases of planned
research and development.
The Company has continued to make progress with its two
principal longevity programs:
1. NASH (Non-Alcoholic Steatohepatitis) - where the Company is
seeking to reverse aging fibrotic livers to normal functionality.
The Company is seeking to ensure swift first-in-human trials;
and
2. Werner Syndrome - where the Company is seeking to improve the
lives of patients suffering with this accelerated aging
disease.
Most notably in relation to our NASH program, the Company
submitted a detailed application dossier for the Chemistry,
Manufacturing, and Controls (CMC) of the Group's proposed medical
treatment of NASH, which was presented to the Belgian regulatory
authorities (FAMHP) in early June 2023. The Company was pleased
with the advice received from the FAHMP to advance clinical trials
of its drug, GF-1002, with patients suffering from NASH (rather
than in healthy volunteers). This follows promising results from
the Company's research in in-vitro human cells and in-vivo rodent
studies.
The Company's NASH clinical trials are scheduled to begin in
approximately 18 months following dialogue and subsequent agreement
with the European Medicine Agency.
Other notable progress with the Group's two longevity programs
includes:
-- The Company is conducting in-vivo evaluations of its
centenarian SIRT6 gene therapy in four different NASH mice models
in conjunction with four leading partners in the field: The
University of Liverpool, UK, The University of Rochester, US, the
International Clinical Research Center (FNUSA-ICRC) , Czech
Republic and Physiogenex, France.
These studies have been wide reaching and have included the
analysation of over 700 mice, with the intention of understanding
the efficacy and safety of the Company's drug candidate in animal
models with NASH and has generated essential information in
preparation for clinical trials in humans. Final reports are
expected by the end of 2023.
-- The Company has initiated a manufacturing program under Good
Manufacturing Practices (GMP) conditions, which will applied in
both the NASH and Werner Syndrome projects.
-- The Company's partnership with Organips in France, has made
it possible to limit the use of animal models in our research by
opting for the use of artificial organs built with human cell
organoids. These organoids mimic the function of a natural organ,
therefore they deliver more relevant information on the potential
safety and efficacy of the drug in humans. While organoids offer
several advantages, they also have limitations and do not fully
replicate the complexity and multicellular interactions of whole
organs in the human body.
-- The Group has expanded its intellectual property portfolio
through a provisional patent application focussing on the ability
to edit its SIRT6 gene. If granted, the patent will represent a
significant breakthrough in the field of gene editing, with
potential implications for longevity and other forms of gene
therapy.
Admittance to the OTCQB
In June 2023, the Company was pleased to announce that, after a
successful application process, its Ordinary Shares began trading
on the OTCQB Venture Market in the United States ("U.S."). The new
U.S. trading avenue expands access to a broader pool of investors
and enables investors in the U.S. to trade during U.S. trading
hours and in U.S. dollars, thereby easing cross-border trading.
The move is particularly exciting for Genflow as it not only
expands the Company's reach to a larger investor base and has the
potential to enhance liquidity for our shares, but also provides
the Company with a platform to showcase our innovative solutions
and technologies to a wider audience, raising our profile and
increasing visibility within the global biotech industry, and
specifically, longevity.
Governance and the Board
To enhance the Company's current objectives and priorities in
the U.S., including the Company's admission to OTCQB, the Board of
Directors proactively restructured both itself and the Company's
Scientific Advisory Board ("SAB").
In May 2023, I was pleased to be promoted to Chairperson of the
Board and Vera Gorbunova PhD was promoted to Chairperson of the
SAB. My experience in financing, coupled with a familiarity with
the U.S. public markets, I hope will play a crucial role as the
Company seeks to strengthen its links with the U.S. market and
investors. We believe that Dr. Gorbunova's outstanding
contributions to the field of longevity and her invaluable insights
in this sector will be instrumental in guiding the Company's
scientific research.
Yassine Bendiabdallah remains a key member of our Board and will
continue to act as a Non-Executive Director, and Dr Eric Verdin
remains a key member of the SAB.
The SAB also welcomed Professor Dr Sven Francque, a renowned
expert in the field of non-alcoholic fatty liver disease (NAFLD)
and NASH.
Financial Overview
As of 30 June 2023, the Group had cash reserves of GBP1,507,437
(31 December 2022: GBP2,356,225) which has been derived from equity
fundraising consecutive with admission to the London Stock Exchange
in January 2022 and the receipt of research and development grants.
The Company remains debt free.
Administration expenses for 30 June 2023 totalled GBP815,477 (30
June 2022: GBP696,402), which primarily consisted of research and
development costs of GBP415,157 (30 June 2022: GBP97,304), legal
and professional fees totalling GBP87,428 (30 June 2022:
GBP267,535) and Directors' fees of GBP187,409 (30 June 2022:
GBP172,851).
Other Comprehensive Income was charged with a translation gain
of GBP26,749 upon converting the Subsidiary's results for the
period to GBP.
Future
On behalf of the Board, I thank you for your continued support
and look forward to growing the Company's presence and continuing
to build upon Genflow's position in the longevity sector both in
Europe and the US. The recent recommendation from the FAHMP to
commence Phase I/II clinical trials in NASH patients is a key
milestone for Genflow, and I am excited for the Company to progress
further towards gaining approval from the European Medicine Agency
to commence human clinical trials over the next 18 months.
Tamara Joseph
Chairman
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
AS AT 30 June 2023
Unaudited Audited Unaudited
30 June 31 December 30 June
Note 2023 2022 2022
Non-Current assets
Property, plant & equipment 3,991 2,351 -
------------ -------------- ------------
Total Non-Current assets 3,991 2,351 -
------------ -------------- ------------
Current assets
Trade and other receivables 6 400,891 258,885 70,527
Cash and cash equivalents 1,507,437 2,356,225 2,945,624
------------ -------------- ------------
Total Current assets 1,908,328 2,615,110 3,016,151
------------ -------------- ------------
Total assets 1,912,319 2,617,461 3,016,151
------------ -------------- ------------
Current liabilities
Trade and other payables 194,134 250,988 149,288
------------ -------------- ------------
Total Current liabilities 194,134 250,988 149,288
------------ -------------- ------------
Total liabilities 194,134 250,988 149,288
============ ============== ============
Net Assets 1,718,185 2,366,473 2,866,863
============ ============== ============
Equity
Share capital 7 87,752 87,752 87,752
Share premium 7 4,190,900 4,190,900 4,190,900
Other reserves 204,592 231,341 170,200
Retained earnings/loss (2,765,059) (2,143,520) (1,581,989)
============ ============== ============
Total equity 1,718,185 2,366,473 2,866,863
============ ============== ============
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
FOR THE SIX MONTHSED 30 JUNE 2023
Notes Unaudited Audited Unaudited
6 Months 12 Months 6 Months
ended ended ended
30 June 31 December 30 June
2023 2022 2022
Other operating income 194,068 487,293 -
Operating profit
------------- ------------ ----------
Administrative expenses 4 (815,477) (1,822,236) (696,402)
Other losses - - (77,082)
----------
Operating loss (621,409) (1,334,943) (773,484)
Finance income/(costs) (130) (382) (310)
Profit/(Loss) before tax (621,539) (1,335,325) (773,794)
Tax expense - - -
------------- ------------ ----------
Profit/ (Loss) for the period
/ year attributable to owners
of the parent (621,539) (1,335,325) (773,794)
============= ============ ==========
Other Comprehensive (loss)
/ income:
Items that could be reclassified
to profit or loss
Exchange differences on translation
of foreign operations (26,749) 75,158 14,017
Total comprehensive (loss)
/ income for the period / year
attributable to owners of the
parent (648,288) (1,260,167) (759,777)
============= ============ ==========
Loss per share (cents) from
continuing operations attributable
to owners of the Parent - Basic
& Diluted 5 (0.210) (0.457) (0.267)
CONSOLIDATED STATEMENT OF CASH FLOWS
FOR THE SIX MONTHSED 30 JUNE 2023
Unaudited Audited Unaudited
6 Months 12 Months 6 Months
ended ended ended
30 June 31 December 30 June
2023 2022 2022
Cash flows used in operating activities:
Loss after taxation (621,539) (1,335,325) (773,794)
Adjustments for:
Depreciation & amortisation 413 129 -
Share based payments - 72,000 -
Net finance income - - 90
Increase in trade and other receivables (142,229) (206,339) (17,980)
Increase in trade and other payables (107,585) 29,561 (139)
Foreign exchange 26,749 71,120 14,017
--------------------------------------------------- ---------- --------------- ------------
Net cash outflow from operating
activities (844,191) (1,368,324) (777,806)
--------------------------------------------------- ---------- --------------- ------------
Cash flow used in investing activities:
Purchase of property, plant & equipment (4,528) (2,480) -
Cash acquired through business combinations - - -
Net cash used in investing activities (4,528) (2,480) -
--------------------------------------------------- ---------- --------------- ------------
Cash flow from financing activities:
Proceeds from issue of shares - 3,762,920 3,762,830
Cost of share issue - (263,404) (263,404)
--------------------------------------------------- ---------- --------------- ------------
Net cash generated from financing
activities - 3,499,516 3,499,426
--------------------------------------------------- ---------- --------------- ------------
Net (decrease)/increase in cash
and cash equivalents (848,719) 2,128,183 2,721,620
Cash and cash equivalents at beginning
of period / year 2,356,225 224,004 224,004
FX on cash (69) 4,038 -
Cash and cash equivalents at end
of period 1,507,437 2,356,225 2,945,624
--------------------------------------------------- ---------- --------------- ------------
Non- Cash Investing and Financing Activities
Unaudited 6 months ended 30 June 2022 and audited 12 months
ended 31 December 2022- 900,000 Ordinary shares were issued at
nominal value as non-cash consideration to three Directors of the
Company in lieu of fees.
Unaudited 6 months ended 30 June 2022 and audited 12 months
ended 31 December 2022 - 203,833,878 Ordinary shares were issued at
nominal value as non-cash consideration for the acquisition of
Genflow Biosciences Srl, as part of a share for share exchange
arrangement.
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
FOR THE SIX MONTHSED 30 JUNE 2023
Share
Share capital premium Other reserves Retained earnings/loss Total
------------- --------- ---------------- ------------------------ ------------
Unaudited- 30 June 2023
At 1 January 2023 87,752 4,190,900 231,341 (2,143,520) 2,366,473
Loss of the period - - - (621,539) (621,539)
Exchange differences on
translation of foreign operations - - (26,749) - (26,749)
------------- --------- ---------------- ------------------------ ------------
Total comprehensive income for the
period - - (26,749) (621,539) (648,288)
------------- --------- ---------------- ------------------------ ------------
Transactions with owners
Issue of share capital - - - - -
Costs of issue - - - - -
Share based payments - - - - -
------------- --------- ---------------- ------------------------ ------------
Total Transactions with owners - - - - -
------------- --------- ---------------- ------------------------ ------------
At 30 June 2023 (unaudited) 87,752 4,190,900 204,592 (2,765,059) 1,718,185
============= ========= ================ ======================== ============
Unaudited- 30 June 2022
At 1 January 2022 73,371 633,765 156,183 (808,195) 55,124
Loss of the period - - - (773,794) (773,794)
Exchange differences on
translation of foreign operations - - 14,017 - 14,017
------------- --------- ---------------- ------------------------ ------------
Total comprehensive income for the
period - - 14,017 (773,794) (759,777)
------------- --------- ---------------- ------------------------ ------------
Transactions with owners
Issue of share capital 14,111 3,748,809 - - 3,762,920
Costs of issue - (263,404) - - (263,404)
Share based payments 270 71,730 - - 72,000
------------- --------- ---------------- ------------------------ ------------
Total Transactions with owners 14,381 3,557,135 - - 3,571,516
------------- --------- ---------------- ------------------------ ------------
At 30 June 2022 (unaudited) 87,752 4,190,900 170,200 (1,581,989) 2,866,863
============= ========= ================ ======================== ============
Audited- 31 December 2022
At 1 January 2022 73,371 633,765 156,183 (808,195) 55,124
Loss for the year - - - (1,335,325) (1,335,325)
Exchange differences on
translation of foreign operations - - 75,158 - 75,158
Total comprehensive profit/(loss)
for the period - - 75,158 (1,335,325) (1,260,163)
------------- --------- ---------------- ------------------------ ------------
Transactions with Owners
Issue of ordinary shares 14,381 3,820,539 - - 3,834,920
Cost of issue - (263,404) - - (263,404)
Merger of entity under common - - - - -
control
------------- --------- ---------------- ------------------------ ------------
Total Transactions with owners 14,381 3,557,135 - - 3,571,516
------------- --------- ---------------- ------------------------ ------------
At 31 December 2022 (audited) 87,752 4,190,900 231,341 (2,143,520) 2,366,473
============= ========= ================ ======================== ============
1. Reporting Entity
Genflow Biosciences Plc (the "Company") is a company domiciled
in the United Kingdom. The consolidated interim financial
information as at, and for the six months ended, 30 June 2023
comprise the results of the Company and its subsidiaries (together
referred to as the "Group").
The consolidated financial statements of the Group as at, and
for the year ended, 31 December 2022 are available upon request
from the Company's registered office at 6 Heddon Street, London,
W1B 4BT or a t genflowbio.com.
2. BASIS OF PREPARATION
The financial information set out in this report is based on the
consolidated financial information of the Company and its
subsidiary companies. The financial information of the Group for
the 6 months ended 30 June 2023 was approved and authorised for
issue by the Board of the Company on 27 September 2023. The interim
results have not been audited. This financial information has been
prepared in accordance with the accounting policies that are
expected to be applied in the Report and Accounts of the Company
for the year ended 31 December 2022 and are consistent with the
recognition and measurement requirements of IFRS as adopted by the
United Kingdom. The comparative information for the full year ended
31 December 2022 is not the Group's full annual accounts for that
period but has been derived from the annual financial statements
for that period.
The consolidated financial information incorporates the results
of the Group as at 30 June 2023. The corresponding amounts are for
the year ended 31 December 2022 and for the 6 month period ended 30
June 2022.
The Group financial information is presented in Pound Sterling
and values are rounded to the nearest pound.
The same accounting policies, presentation and methods of
computation are followed in the interim consolidated financial
information as were applied in the Group's latest annual audited
financial statements except for those that relate to new standards
and interpretations effective for the first time for periods
beginning on (or after) 1 January 2023 and will be adopted in the
2023 annual financial statements.
A number of new standards and amendments became effective on 1
January 2023 and have been adopted by the Group. None of these
standards have materially affected the Group.
3. GOING CONCERN
As the Group's assets are not generating revenue an operating
loss has been reported and an operating loss is expected in the 12
months to 30 June 2024. However, the Directors believe that the
Group will have sufficient funds to meet its immediate working
capital requirements and undertake its targeted operating
activities over the next 18 months from the date of approval of
these financial statements.
In March 2022, Genflow Biosciences Srl was awarded a
non-dilutive research grant of up to EUR3.375m from the regional
government of Wallonia in southern Belgium. The total grant has
been approved by the relevant authorities, however it has not yet
been received at the time of reporting. Once received, management
will use the funds to expedite specific phases of planned research
and development. Management has prepared a forecast covering an
18-month post-period end and believes that current cash reserves
will adequately meet the working capital requirements of the Group
in addition to meeting research and development commitments.
As such, the Directors have a reasonable expectation that the
Group has, and will have, future access to adequate resources to
continue in operational existence for the foreseeable future and,
therefore, continue to adopt the going concern basis in preparing
the interim financial statements.
4. EXPENSES BY NATURE
Unaudited Audited
6 Months Year ended Unaudited
ended 31 December 6 Months ended
30 June 2023 2022 30 June 2022
GBP GBP GBP
------------------------------- -------------- ------------- ----------------
Directors' fees 187,409 360,495 172,851
Professional, legal and
consulting fees 87,428 423,324 267,535
PR and marketing 63,903 165,889 89,935
Accounting related services 8,638 7,245 591
Insurance 19,563 33,423 17,305
Office and administrative
expenses 5,092 4,496 2,303
IT and software services 1,492 2,249 396
Travel and entertainment 13,255 14,193 15,062
Research and development
costs 415,157 724,465 97,304
Share based payments - 72,000 -
AIM costs 15,938 - 26,177
Other expenses (2,398) 14,457 6,943
------------------------------- -------------- ------------- ----------------
Total administrative expenses 815,477 1,822,236 696,402
------------------------------- -------------- ------------- ----------------
5. PROFIT/(LOSS) PER SHARE
Unaudited Unaudited
6 Months Audited 6 Months
ended Year ended ended
30 June 31 December 30 June
2023 2022 2022
GBP GBP GBP
Net loss for the year from
continued operations attributable
to equity shareholders (621,539) (1,335,321) (773,794)
Weighted average number of
shares for the period/year 292,506,618 292,506,618 289,858,193
Basic profit/(loss) per
share for continued operations
(expressed in pence) (0.210) (0.457) (0.267)
------------ ------------- ------------
6. TRADE AND OTHER DEBTORS
Trade and other debtors Audited
Year ended Unaudited
Unaudited 31 December 6 Months
6 Months ended 2022 ended
30 June 2023 GBP 30 June 2022
GBP GBP
------------------------- ---------------- ------------- ---------------
VAT receivable 48,205 32,612 37,230
Prepayments 22,854 131,414 30,076
Other receivables 329,832 94,859 3,221
------------------------- ---------------- ------------- ---------------
400,891 258,885 70,527
------------------------- ---------------- ------------- ---------------
Trade and other receivables are all due within one year. The
fair value of all receivables is the same as their carrying values
stated above. These assets, excluding prepayments, are the only
form of financial asset within the Group, together with cash and
cash equivalents. There are no trade receivables therefore an aging
analysis has not been provided.
As at 30 June 2023, GBP324,830 (31 December 2022: GBP92,535) in
'other receivables' relates to grant receivable.
7. Share capital
Company Number of Ordinary Share Total
shares shares premium GBP
GBP GBP
------------------------------ ------------ --------- ---------- ----------
Issued and fully paid
At 1 January 2022 244,570,118 73,371 633,765 707,136
Issue of Ordinary Shares -
17 January 2022 47,936,500 14,381 3,820,539 3,834,920
------------------------------ ------------ --------- ---------- ----------
Deduction of cost of capital - - (263,404) (263,404)
At 30 June 2022 292,506,618 87,752 4,190,900 4,278,652
------------------------------ ------------ --------- ---------- ----------
At 30 June 2023 292,506,618 87,752 4,190,900 4,278,652
------------------------------ ------------ --------- ---------- ----------
On 17 January 2022, the Company issued and allotted 47,036,500
new Ordinary Shares at a price of 8 pence per share for gross
proceeds of GBP3,762,920. On the same day, the Company issued and
allotted 900,000 new Ordinary Shares at nominal value in lieu of
fees of GBP72,000.
8. COMMITMENTS
The commitments stated in the Group's Annual Financial
Statements for the year ended 31 December 2022 remain in place.
9. EVENTS AFTER THE REPORTING DATE
On 20 September 2023, the Company announced that it received a
recommendation from the FAHMP to commence clinical trials of its
drug, GF-1002, with patients suffering from NASH (rather than in
healthy volunteers).
Market Abuse Regulation (MAR) Disclosure
Certain information contained in this announcement would have
been deemed inside information for the purposes of Article 7 of
Regulation (EU) No 596/2014 until the release of this
announcement.
For further information please contact:
Genflow Biosciences Plc
Dr Eric Leire
Chief Executive +32 477 495 881
-----------------
Clear Capital Markets Ltd
-----------------
Corporate Broker +44 203 869 6080
-----------------
About Genflow
Genflow is a UK-based biotechnology company established in 2020.
The Company is developing gene therapies designed to target the
aging process and to reduce and delay the incidence of age-related
diseases. This will be done through novel therapeutics targeting
aging in humans by using adeno-associated virus ("AAV") vectors to
deliver copies of the Sirtuin-6 ("SIRT6") gene variant that is
found in centenarians into cells.
Its mission is to increase understanding of the factors that
control and impact lifespan. Genflow researches, develops, and
commercialises therapeutic solutions to lengthen health span, the
amount of time we live in good health, creating biological
interventions that enable longer and healthier lives. Genflow is
dedicated to the development and commercialisation of novel
therapeutics targeting aging in dogs and humans. By treating aging,
Genflow can contribute to a decrease in healthcare costs and lessen
the emotional and societal burden that comes with an aging
population.
To learn more visit www.genflowbio.com
-Ends-
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