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-

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our Privacy Policy.

END

IR EVLBLXKLZBBX

(END) Dow Jones Newswires

September 28, 2023 02:00 ET (06:00 GMT)

Genflow Biosciences (LSE:GENF)
過去 株価チャート
から 4 2024 まで 5 2024 Genflow Biosciencesのチャートをもっと見るにはこちらをクリック
Genflow Biosciences (LSE:GENF)
過去 株価チャート
から 5 2023 まで 5 2024 Genflow Biosciencesのチャートをもっと見るにはこちらをクリック