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RNS Number : 1227G  Genflow Biosciences PLC  30 September 2024

PRESS RELEASE

 

30 September 2024

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 2024.

 

 

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 2024.

 

Over the six months to 30 June 2024, the Company has made strides in its
principal longevity programs: MASH (Metabolic Dysfunction-Associated
Steatohepatitis) and Werner Syndrome.

 

In June, we updated shareholders on the momentum created with respect to our
pre-clinical programs in MASH, and the guidance expected to be received from
the FDA in the future. This guidance, which we anticipate receiving in the
future, is expected to come through the FDA's Initial Targeted Engagement for
Regulatory Advice on CBER Products (INTERACT), as a result of the Company
submitting a comprehensive briefing package conducted with our lead drug
candidate, GF-1002, for the treatment of MASH. In the meantime, the FDA has
encouraged Genflow to proceed with its plans to identify appropriate animal
models through pilot proof-of-concept ("POC") studies. Specifically, we have
established a functional 3-D organoids of liver using cells from Werner
patients.  This organoid testing helps reduce the need for animal models in
our scientific research. Organoids are miniature, lab-grown versions of human
organs or tissues that mimic the structure and function of their real
counterparts. By using these organoids, we can model human Werner Syndrome and
better test response of our SIRT6 based gene therapy in a more human-relevant
environment, rather than relying on unreliable animal models.

 

Additionally, we have initiated a feasibility study with a Contract
Development Manufacturing Organization (CDMO), Exothera S.A, to assess the
ability to produce its future MASH clinical lot in accordance with Good
Manufacturing Practices (GMP). We are also in the process of selecting
Contract Research Organizations (CROs) to conduct our upcoming dog clinical
trial, aimed at studying our simplified Nake DNA version of our Centenarian
SIRT6 drug candidate, GF-1004. We will provide updates in relation to our
veterinary study in due course.

 

Over the period, we have also been working on two exciting collaborations
supported by non-diluting and non-reimbursable research grants from the
Government of Wallonia in Belgium, as follows;

 

·      Sarcopenia research program with Revatis SA - focusing on the
development of muscle progenitor cells which will be loaded with Genflow's
proprietary SIRT6 for the prevention and treatment of sarcopenia, the
age-related loss of muscle mass and function. Genflow aims to counteract the
detrimental effects of aging on muscle tissue with our sarcopenia program,
which holds potential for significantly improving the quality of life for
older adults affected by muscle loss and weakness.

 

·      Exosome-mRNA project with EXO Biologics - which aims to deliver a
therapeutic product composed of exosomes encapsulating an AAV or mRNA encoding
SIRT6. The exosome therapy will be designed to target liver fibrosis (MASH)
and Werner Syndrome, potentially leading to groundbreaking treatments for both
diseases.

 

During the period, the Company has received grant funding of totalling
€777,281 in respect of these projects, with further financial support
committed in the first half of 2025.

 

In addition, Genflow Biosciences SRL, received €350,000 in April 2024, from
the regional government of Wallonia - Belgium Service Public de Wallonie,
representing the second tranche of this awarded grant recognised in the
previous year, 2023.

 

Further strengthening the Company's financial position and increasing its
institutional investor base, the Company completed a placing and subscription
to which raised £715,000 (before expenses) during the period. We were
privileged to have Premier Miton, a well-known UK institution, participate in
this fundraise.

 

Financial Overview

 

As of 30 June 2024, the Group had cash reserves of £1,139,859 (31 December
2023: £683,974) which has been derived from equity fundraising of £663,600
(net of expenses) and the receipt of research and development grants of
£664,219 (€777,281) and £299,145 (€350,000) The Company remains debt
free.

 

Administration expenses for 30 June 2024 totalled £1,316,368 (30 June 2023:
£815,477), which primarily consisted of research and development costs of
£938,109 (30 June 2023: £415,157), legal and professional fees totalling
£90,654 (30 June 2023: £103,366) and Directors' fees of £178,656 (30 June
2023: £178,783).

 

The significant jump in research and development costs for 2024 is in relation
to the advancement of testing, which has transitioned to the in vivo stage,
which is inherently more costly.

 

Other Comprehensive Income was charged with a translation gain of £8,652 upon
converting the Subsidiary's results for the period to GBP.

 

Future

 

On behalf of the Board, I thank you for your continued support. Our commitment
to pioneering therapeutic solutions for longevity has been strengthened by the
support of our collaborative partners and promising feedback from the FDA
during the six-months to 30 June 2024. This encouragement reinforces our
commitment to developing effective therapeutic solutions for age-related
diseases. We remain focused on our mission to improve healthspan, and I look
forward to providing you with further updates as we progress through our work
programs, including clinical dog trials.

 

 

Tamara Joseph

Chairman

 

 

CONSOLIDATED STATEMENT OF FINANCIAL POSITION
AS AT 30 June 2024

 

                                  Note  Unaudited        Audited            Unaudited

                                        6 Months ended   12 Months ended    6 Months ended

                                        30 June 2024     31 December 2023   30 June 2023

 Non-current assets
 Property, plant & equipment            3,456            3,394              3,991
 Total non-current assets               3,456            3,394              3,991

 Current assets
 Trade and other receivables      6     207,791          384,285            400,891
 Cash and cash equivalents              1,139,859        683,974            1,507,437
 Total current assets                   1,347,650        1,068,259          1,908,328
 Total assets                           1,351,106        1,071,653          1,912,319

 Current liabilities
 Trade and other payables         7     492,761          345,738            194,134
 Total current liabilities              492,761          345,738            194,134

 Total liabilities                      492,761          345,738            194,134
 Net Assets                             858,345          725,915            1,718,185

 Equity
 Share capital                    8     104,912          87,752             87,752
 Share premium                    8     4,837,340        4,190,900          4,190,900
 Other reserves                   9     212,577          219,488            204,592
 Retained earnings                      (4,296,484)      (3,772,225)        (2,765,059)
 Total equity                           858,345          725,915            1,718,185

 

 

 

CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME

FOR THE SIX MONTHS ENDED 30 JUNE 2024

 

                                                                                                                                           Notes     Unaudited               Audited                Unaudited

                                                                                                                                                     6 Months ended          12 Months ended        6 Months ended

                                                                                                                                                     30 June 2024            31 December 2023       30 June 2023

 Other operating income                                                                                                                              792,109                 169,854                194,068
 Administrative expenses                                                                                                                   4         (1,316,368)             (1,798,559)            (815,477)
 Operating loss                                                                                                                                      (524,259)               (1,628,705)            (621,409)

 Finance costs                                                                                                                                       -                       -                      (130)

 Loss before tax                                                                                                                                     (524,259)               (1,628,705)            (621,539)

 Tax                                                                                                                                                 -                       -                      -
 expense

 Loss for the period / year attributable to owners of the parent                                                                                     (524,259)               (1,628,705)            (621,539)

 Other Comprehensive loss:
 Items that could be reclassified to profit or loss
 Exchange differences on translation of foreign operations                                                                                           (8,652)                 (11,853)               (26,749)

 Total comprehensive loss for the period / year attributable to owners of the                                                                        (532,911)               (1,640,558)            (648,288)
 parent

 Loss per share (pence) from continuing operations attributable to owners of                                                               5         (0.165)                 (0.557)                (0.210)
 the Parent - Basic & Diluted

 

                  CONSOLIDATED STATEMENT OF CASH FLOWS

                  FOR THE SIX MONTHS ENDED 30 JUNE 2024

                                                                Unaudited           Audited            Unaudited

                                                                6 Months ended      12 Months ended    6 months ended

                                                                30 June 2024        31 December 2023   30 June 2023
 Cash flows used in operating activities:
 Loss after taxation                                            (524,259)           (1,628,705)        (621,539)
 Adjustments for:
 Depreciation & amortisation                                    605                 1,034              413
 Share based payments                                           1,741               -                  -
 Decrease/(increase) in trade and other receivables             168,964             (131,014)          (142,229)
 Increase/(decrease) in trade and other payables                154,185             103,228            (107,585)
 Foreign exchange                                               -                   -                  26,749
 Net cash outflow from operating activities                     (198,764)           (1,655,457)        (844,191)

 Cash flow used in investing activities:
 Purchase of property, plant & equipment                        (743)               (2,439)            (4,528)
 Net cash used in investing activities                          (743)               (2,439)            (4,528)

 Cash flow from financing activities:
 Proceeds from issue of shares                                  715,000             -                  -
 Cost of share issue                                            (51,400)            -                  -
 Net cash generated from financing activities                   663,600             -                  -

 Net increase/(decrease) in cash and cash equivalents           464,093             (1,657,896)        (848,719)
 Cash and cash equivalents at beginning of period / year        683,974             2,356,225          2,356,225
 FX on cash                                                     (8,208)             (14,355)           (69)
 Cash and cash equivalents at end of period                     1,139,859           683,974            1,507,437

 

 

 

 

CONSOLIDATED STATEMENT OF CHANGES IN EQUITY

FOR THE SIX MONTHS ENDED 30 JUNE 2024

 

                                                            Share capital  Share

                                                                           premium    Other reserves   Retained earnings/loss

                                                                                                                                Total
 Unaudited- 30 June 2024
 At 1 January 2024                                          87,752         4,190,900  219,488          (3,772,225)              725,915
 Loss of the period                                         -              -          -                (524,259)                (524,259)
 Exchange differences on translation of foreign operations  -              -          (8,652)          -                        (8,652)
 Total comprehensive loss for the period                    -              -          (8,652)          (524,259)                (532,911)
 Transactions with owners
 Issue of share capital                                     17,160         697,840    -                -                        715,000
 Costs of issue                                             -              (51,400)   -                -                        (51,400)
 Share based payments                                       -              -          1,741            -                        1,741
 Total Transactions with owners                             17,160         646,440    1,741            -                        665,341
 At 30 June 2024 (unaudited)                                104,912        4,837,340  212,577          (4,296,484)              858,345

 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 loss for the period                    -              -          (26,749)         (621,539)                (648,288)
 Total Transactions with owners                             -              -          -                -                        -
 At 30 June 2023 (unaudited)                                87,752         4,190,900  204,592          (2,765,059)              1,718,185

 Audited- 31 December 2023
 At 1 January 2023                                          87,752         4,190,900  231,341          (2,143,520)              2,366,473
 Loss for the year                                          -              -          -                (1,628,705)              (1,628,705)
 Exchange differences on translation of foreign operations  -              -          (11,853)         -                        (11,853)
 Total comprehensive loss for the period                    -              -          (11,853)         (1,628,705)              (1,640,558)
 Total Transactions with owners                             -              -          -                -                        -
 At 31 December 2023 (audited)                              87,752         4,190,900  219,488          (3,772,225)              725,915

 

 

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 2024 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 2023 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 of the Group for the 6 months ended 30 June 2024 was
approved and authorised for issue by the Board of the Company on 30 September
2024. 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 2023 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 2023 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 2024. The corresponding amounts are for the year ended 31
December 2023 and for the 6 month period ended 30 June 2023.

 

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 2024 and will be adopted in the 2024
annual financial statements.

 

A number of new standards and amendments became effective on 1 January 2024
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 2025.
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 12 months from the date of approval of
these financial statements.

 

As at 30 June 2024, the Group has cash resources of £1,139,859. The Group
received funding during the period to support working capital requirements and
to support its scientific research and development work streams. In April
2024, the Company completed a placing and subscription which raised £715,000
(before expenses); and received the second tranche of the grant from the
Wallonia Region, totalling €350,000. In May 2024, the Group secured further
grant funding of €1.55m, of which €777,273 has been received and the
remainder will be received in 2025.

 

Management plan to use these funds, and future grant funding, to meet the
working capital requirements of the Group and to further its research and
development activities. In early 2024, management prepared a forecast covering
18-months and believe that current cash reserves plus the receipt of committed
grant funding in 2025 will adequately cover the working capital requirements
of the Group. Notably, all research and development costs are discretionary
and therefore, can be reduced if necessary. However, the Group will need to
seek further funding to progress the Group's research workstreams and to
progress to the clinical trial phase.

 

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   12 Months ended    6 Months ended

                                                                                 30 June 2024     31 December 2023   30 June 2023

                                                                                 £                £                  £

 Directors' fees                                                                 178,656          362,312            178,783
 Directors' pensions                                                             713              1,093              381
 Directors' social security contributions                                        5,069            14,945             8,245
 Fees payable to the Company's auditors for the audit of the Parent Company and  5,000            53,285             -
 group financial statements
 Professional, legal and consulting fees                                         90,654           215,971            103,366
 PR and marketing                                                                48,535           106,819            63,903
 Accounting related services                                                     3,780            7,839              8,638
 Insurance                                                                       19,595           22,476             19,563
 Office and administrative expenses                                              10,777           18,897             5,092
 IT and software services                                                        7,377            5,828              1,492
 Travel and entertainment                                                        927              23,830             13,255
 Research and development costs                                                  938,109          960,314            415,157
 Share based payments                                                            1,741            -                  -
 Depreciation                                                                    610              1,034              -
 Other expenses                                                                  4,825            3,196              (2,398)
 Total administrative expenses                                                   1,316,368        1,798,559          815,477

 

 

 

5.             LOSS PER SHARE

 

 

                                                                         Unaudited        Audited            Unaudited

                                                                         6 Months ended   12 Months ended    6 Months ended

                                                                         30 June 2024     31 December 2023   30 June 2023

                                                                         £                £                  £

 Net loss for the year from continued operations attributable to equity  524,259          1,628,705          621,539
 shareholders

 Weighted average number of shares for the period/year                   318,085,714      292,506,618        292,506,618

 Basic loss per share for continued operations (expressed in pence)      (0.165)          (0.557)            (0.210)

 

 

6.                TRADE AND OTHER DEBTORS

 

 Trade and other debtors    Unaudited

                            6 Months ended   Audited            Unaudited

                            30 June 2024     12 Months ended    6 Months ended

                            £                31 December 2023   30 June 2023

                                             £                  £
 VAT receivable             46,011           36,278             48,205
 Prepayments                158,748          41,041             22,854
 Other receivables          3,032            306,966            329,832
                            207,791          384,285            400,891

 

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.

 

 

7.                TRADE AND OTHER PAYABLES

 

                 Unaudited

                 6 Months ended   Audited            Unaudited

                 30 June 2024     12 Months ended    6 Months ended

                 £                31 December 2023   30 June 2023

                                  £                  £
 Trade payables  442,221          254,695            143,654
 Accruals        32,841           60,014             34,012
 Other payables  17,699           31,029             16,468
                 492,761          345,738            194,134

All trade and other payables are due for payment within twelve months. Trade
payables are settled within normal commercial terms, usually between 30-60
days.

 

8.             Share capital

 

 Company                       Number of shares  Ordinary shares  Share premium  Total

                                                 £                £              £
 Issued and fully paid
 At 1 January 2023             292,506,618       87,752           4,190,900      4,278,652
 At 30 December 2023           292,506,618       87,752           4,190,900      4,278,652
 Issue of Ordinary Shares      57,200,000        17,160           697,840        715,000
 Deduction of cost of capital  -                 -                (51,400)       (51,400)
 At 30 June 2024               349,706,618       104,912          4,837,340      4,942,252

 

On 9 Aril 2024, the Company issued and allotted 57,200,000 new Ordinary Shares
at a price of 0.0125 pence per share for gross proceeds of £715,000
(excluding expenses).

 

 
9.             Share WARRANT reserve
 

The balance held in the share options reserve relates to the fair value of the
share warrants that have been charged to the profit or loss since adoption of
IFRS 2 'Share-based payment'.

 

Warrants:

 

At 30 June 2024, 2,860,000 warrants over shares were exercisable (31 December
2023: No warrants were exercisable).

 

2,860,000 warrants were granted during the year (31 December 2023: No warrants
granted) pursuant to the terms of a placing of shares.

 

During the period ended 30 June 2024, no warrants were exercised (year ended
31 December 2023: No warrants were exercised) and no warrants expired in the
period (year ended 31 December 2023: No warrants expired).

 

£1,741 was charge to loss for the year in respect of outstanding warrants
(2023: Nil).

 

10.          COMMITMENTS

 

The commitments stated in the Group's Annual Financial Statements for the year
ended 31 December 2023 remain in place.

 

11.          EVENTS AFTER THE REPORTING DATE

 

There were no events after the reporting period.

 

 

 

Market Abuse Regulation (MAR) Disclosure

The information contained within this announcement is deemed to constitute
inside information as stipulated under the Market Abuse Regulation ("MAR")
(EU) No. 596/2014, as incorporated into UK law by the European Union
(Withdrawal) Act 2018. Upon the publication of this announcement, this inside
information is now considered to be in the public domain.

 

Contacts

 

 Genflow Biosciences  Harbor Access
 Dr Eric Leire, CEO   Jonathan Paterson, Investor Relations
 +32-477-495-881      +1 475 477 9401
                      Jonathan.Paterson@Harbor-access.com

 

 Corporate Brokers
 Capital Plus Partners Ltd
 Keith Swann, +44 0203 821 6169
 Jon Critchley, +44 0203 821 6168

 

About Genflow Biosciences

 

Founded in 2020, Genflow Biosciences Plc. (LSE:GENF) (OTCQB:GENFF), a
biotechnology company headquartered in the UK with R&D facilities in
Belgium, is pioneering gene therapies to decelerate the aging process, with
the goal of promoting longer and healthier lives while mitigating the
financial, emotional, and social impacts of a fast-growing aging global
population. Genflow's lead compound, GF-1002, works through the delivery of a
centenarian variant of the SIRT6 gene which has yielded promising preclinical
results. Scheduled to begin in 2025, Genflow's clinical trial aims to explore
the potential benefits of GF-1002 in treating MASH (Metabolic
Dysfunction-Associated Steatohepatitis), the most prevalent chronic liver
disease for which there is no effective treatments. Please
visit www.genflowbio.com (http://www.genflowbio.com/)   and follow the
Company on LinkedIn and Twitter/X.

 

DISCLAIMER

 

The contents of this announcement have been prepared by, and are the sole
responsibility of, the Company.

This announcement may contain forward-looking statements. The forward-looking
statements include, but are not limited to, statements regarding the Company's
or the Directors' expectations, hopes, beliefs, intentions or strategies
regarding the future. In addition, any statement that refers to projections,
forecasts or other characterisations of future events or circumstances,
including any underlying assumptions, is a forward-looking statement. The
words "anticipate", "believe", "continue", "could", "estimate", "expect",
"intend", "may", "might", "plan", "possible", "potential", "predict",
"project", "seek", "should", "would" and similar expressions, or in each case
their negatives, may identify forward-looking statements, but the absence of
these words does not mean that a statement is not forward-looking.

Forward-looking statements include all matters that are not historical facts.
Forward-looking statements are based on the current expectations and
assumptions regarding the Company, the business, the economy and other future
conditions. Because forward-looking statements relate to the future, by their
nature, they are subject to inherent uncertainties, risks and changes in
circumstances that are difficult to predict. Forward-looking statements are
not guarantees of future performance and the Company's actual financial
condition, actual results of operations and financial performance, and the
development of the industries in which it operates or will operate, may differ
materially from those made in or suggested by the forward-looking statements
contained in this announcement. In addition, even if the Company's financial
condition, results of operations and the development of the industries in
which it operates or will operate, are consistent with the forward-looking
statements contained in this announcement, those results or developments may
not be indicative of financial condition, results of operations or
developments in subsequent periods. Important factors that could cause actual
results to differ materially from those in the forward-looking statements
include regional, national or global, political, economic, social, business,
technological, competitive, market and regulatory conditions.

Any forward-looking statement contained in this announcement applies only as
of the date of this announcement and is expressly qualified in its entirety by
these cautionary statements. Factors or events that could cause the Company's
actual plans or results to differ may emerge from time to time, and it is not
possible for the Company to predict all of them. The Company expressly
disclaims any obligation or undertaking to release publicly any updates or
revisions to any forward-looking statements contained in this announcement to
reflect any change in its expectations or any change in events, conditions or
circumstances on which any forward-looking statement contained in this
announcement is based, unless required to do so by applicable law, the
Prospectus Regulation Rules, the Listing Rules, the Disclosure Guidance and
Transparency Rules of the FCA or the UK Market Abuse Regulation.

 

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