REG - Genflow Biosciences - Half-year Report
28/09/2023 07:00
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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 £1,507,437 (31 December
2022: £2,356,225) 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 £815,477 (30 June 2022:
£696,402), which primarily consisted of research and development costs of
£415,157 (30 June 2022: £97,304), legal and professional fees totalling
£87,428 (30 June 2022: £267,535) and Directors' fees of £187,409 (30 June
2022: £172,851).
Other Comprehensive Income was charged with a translation gain of £26,749
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
Note
Unaudited Audited Unaudited
30 June 2023 31 December 2022 30 June 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 MONTHS ENDED 30 JUNE 2023
Notes Unaudited Audited Unaudited
6 Months ended 12 Months ended 6 Months ended
30 June 2023 31 December 2022 30 June 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 (648,288) (1,260,167) (759,777)
owners of the parent
Loss per share (cents) from continuing operations attributable to owners of 5 (0.210) (0.457) (0.267)
the Parent - Basic & Diluted
CONSOLIDATED STATEMENT OF CASH FLOWS
FOR THE SIX MONTHS ENDED 30 JUNE 2023
Unaudited Audited Unaudited
6 Months ended 12 Months ended 6 Months ended
30 June 2023 31 December 2022 30 June 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 MONTHS ENDED 30 JUNE 2023
Share capital Share
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 at genflowbio.com
(http://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 €3.375m 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 Unaudited
6 Months ended Year ended 6 Months ended
30 June 2023 31 December 2022 30 June 2022
£ £ £
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 Audited Unaudited
6 Months ended Year ended 6 Months ended
30 June 2023 31 December 2022 30 June 2022
£ £ £
Net loss for the year from continued operations attributable to equity (621,539) (1,335,321) (773,794)
shareholders
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 Unaudited Audited
6 Months ended Year ended Unaudited
30 June 2023 31 December 2022 6 Months ended
£ £ 30 June 2022
£
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, £324,830 (31 December 2022: £92,535) in 'other
receivables' relates to grant receivable.
7. Share capital
Company Number of shares Ordinary shares Share premium Total
£ £ £
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 £3,762,920. On
the same day, the Company issued and allotted 900,000 new Ordinary Shares at
nominal value in lieu of fees of £72,000.
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 +32 477 495 881
Chief Executive
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 (http://www.genflowbio.com)
-Ends-
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