REG - Roquefort Theraptcs. - Interim Results to 30 June 2023
27/09/2023 07:00
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RNS Number : 7420N Roquefort Therapeutics PLC 27 September 2023
27 September 2023
Roquefort Therapeutics plc
("Roquefort Therapeutics" or the "Company")
Interim Results to 30 June 2023
Roquefort Therapeutics (LSE:ROQ, OTCQB:ROQAF), the Main Market listed biotech
company focused on developing first-in-class medicines in the high value and
high growth oncology market, is pleased to present its interim results for the
six-month period ended 30 June 2023 (the "period" or "H1").
Highlights
· Signed exclusive worldwide license agreement (excluding Japan)
with Randox Laboratories for 10 years to utilise Midkine antibodies in the
non-core medical diagnostics field:
o highly synergistic - allows the Company to remain focused on the higher
value therapeutic market while accelerating the diagnosis of patients with
Midkine cancers to establish the Midkine cancer market
o reduces the time and cost of clinical trials, and diagnostics have been
shown to increase trial success rates 1 (#_ftn1)
o highlights the Company's leadership position in Midkine and the Company's
in-house deal making capabilities and is expected to strengthen the balance
sheet
· Formation of an expert Scientific Advisory Board of Professors Jo
Martin, Trevor Jones and Armand Keating to review and advise on the
development of the portfolio
· Key milestone achieved with ROQ-A1 and ROQ-A2 Midkine antibody
programs, targeting metastatic breast cancer, and lung and liver metastasis,
successfully demonstrated in vivo safety in pre-clinical development
programs and progressed into in vivo efficacy studies
· The Company's first Orphan drug indication targets osteosarcoma
in which, ROQ-A1 and ROQ-A2 demonstrated in vivo efficacy. This creates
significant commercial potential for an Orphan drug designation which, if
successful, would confer market exclusivity in multiple jurisdictions
including seven years in the USA and 10 years in the EU and UK 2 (#_ftn2)
· Portfolio further enhanced to a total of five programmes with the
in-house development of a family of novel mRNA cancer medicines, which have
demonstrated in vitro efficacy in validated models of breast and liver cancer
· siRNA, MK cell therapy and Midkine oligonucleotide programs
progressing into pre-clinical development
· Cash at period end of £1,379,021 and for the 6 months to 30 June
2023, net loss of £742,833
Post Period End Highlights
· Patent portfolio significantly expanded with filing of the
international phase PCT (Patent Treaty Cooperation) patent for proprietary
anti-cancer mRNA and RNA oligonucleotide therapeutics, and new patent filing
for its family of novel anti-cancer siRNA therapeutics
Outlook
· On course with targets for clinical readiness for one of the
Company's development programs during H2 2023
· Near-term IND and licensing opportunities from advanced stage of
development of Midkine portfolio products, MK cell and siRNA products
· Strategic goal to take advantage of the paradigm shift that 90%
of successful biotech programs are acquired by big pharma
· Create value by identifying early innovation, developing it
either in-house or with a research partner towards clinical trials and utilise
experience to licence or sell to big pharma
Commenting on the Interim Results, Roquefort Therapeutics CEO Ajan Reginald
said:
"In H1 2023, we have met the Company's strategic R&D targets, expanded our
product portfolio to five programs with the addition of an innovative mRNA
program, enhanced our IP leadership position in Midkine and STAT-6 siRNA and
completed the partnership with Randox, one of the UK's leading medical
diagnostics providers.
"To provide an industry context, our product portfolio now includes three
programs (antibodies, siRNA and MK cell) with robust in vivo efficacy results,
and so, our portfolio is more advanced in development than some leading UK
biotech companies recently valued at US$100M. The STAT-6 siRNA is a good
example of our strategy to discover and acquire unvalidated targets before big
pharma realises the value. In July, Sanofi completed a US$1.2B deal with
Recludix for their pre-clinical STAT-6 program, which is in the same
pre-clinical stage of development as our STAT-6 siRNA program. Even though
STAT-6 had been worked by pharma for circa 20 years, before this deal it was
still an unvalidated target. After Sanofi's $Billion valuation and validation,
many of the big pharma companies are seeking STAT-6 programs.
"Similarly, the Randox deal for diagnostics demonstrates the significant
(under) valuation of the Midkine market, in which we have an IP leadership
position. Randox, a sophisticated diagnostics company, acquired the rights for
diagnostics only, and while diagnostics are highly synergistic and very
important, this is a far less commercially valuable market than the Midkine
therapeutics market.
"This industry context underpins our strategy to acquire and develop medicines
in novel targets such as STAT-6 and Midkine before they are highly valued to
create the potential for a step-change increase in value and M&A interest
with validation. Until this external (big pharma) validation, we will continue
to deliver the critical R&D milestones on time and within budget and
continue to progress our business development discussions. However, the
application of AI to drug development, has rapidly increased the speed of
validation of novel targets e.g., Recludix' validated STAT-6 in just
approximately 18 months. Therefore, rapid consolidation is predicted,
particularly in the UK and Europe in which 46 M&A deals totalling US$5.6
billion were completed in Q1 2023, the second biggest year in recent
records 3 (#_ftn3) . Roquefort Therapeutics is well positioned in this
dynamic market, and we will of course update the market as our ongoing
discussions progress."
Chairman's Statement
I am pleased to present the interim results to shareholders for the six months
ended 30 June 2023. 2022 was an incredibly busy period for the Company
having completed the integration of the Oncogeni portfolio and enhanced our
network of partnerships with leading cancer research centres. These
partnerships complement our own world-class in-house expertise and laboratory
infrastructure, enabling us to implement a broader and more effective
development strategy and this distributed R&D model remains highly
scalable and cost effective.
Building on the foundations laid in 2022 the Company has made significant
R&D and strategic progress across the preclinical portfolio, particularly
within our anti-cancer target, Midkine, where the Company has the leading
portfolio and intellectual property suite. Our patent protected Midkine
antibody programs achieved the relevant development milestones in the period
on time and within budget. In January we announced our Midkine antibody
programs, targeting metastatic breast cancer and metastatic lung cancer,
demonstrated in vivo safety.
During the period Roquefort Therapeutics formed its first Scientific Advisory
Board (SAB) in order to help support its strategy and drive value through our
preclinical programs. Professors Jo Martin, Trevor Jones and Armand Keating
all with a wealth of experience formed the SAB during March, working closely
with Chief Scientific Officer Martin Evans. This is a strong team of
researchers, biopharmaceutical innovators and clinicians with an emphasis on
linking pre-clinical research, clinical trials, production of medicines and
the care of patients. The Company is using its drug development expertise to
complete pre-clinical development to reach valuation milestones for licensing
transactions or a sale of a clinical program.
Pre-clinical progress
Further progress has since been made with our research partner, La Trobe
University, and Roquefort Therapeutics is releasing further in vivo efficacy
results for our lead antibody programs, CAB-101 (ROQA2) and CAB-102 (ROQA1) as
well as a new program for an osteosarcoma orphan drug indication.
Osteosarcoma is the Company's first orphan drug indication and reflects the
strategic decision to target cancer niches in which, there remains a high
unmet clinical need. There are significant commercial benefits of an orphan
drug indication such as market exclusivity for seven years in the USA and ten
years in the EU and UK(
(https://www.roquefortplc.com/regulatory-news/39338#_ftn4) ), tax credits for
the clinical drug testing cost, fee reductions and, on average, have a higher
success rate in clinical trials with a biomarker, in this case Midkine.
The in vivo efficacy study tested the anti-cancer killing ability of CAB-101
and CAB-102 in a validated experimental model of osteosarcoma. Treatment with
CAB-101 was found to produce a statistically significant reduction in lung
metastasis, and CAB-102 was found to reduce proliferation (growth rate) of the
primary tumour. The more detailed experimental results remain under embargo
pending publication at a leading cancer research conference. This is a
particularly promising scientific and commercial strategy which was delivered
on time and on budget and we will announce more updates on our pre-clinical
progress and business development activities during H2.
Our anti-cancer RNA oligonucleotide program targeting Midkine expressing
cancers produced >90% in vitro efficacy (at the mRNA level) in human
liver and neuroblastoma cancer cells. This work has been conducted through
strategic research partnerships at the Faculty of Medicine and Health at the
University of Sydney and the Immune Oncology Laboratory at the School of
Biomedical Sciences, University of New South Wales (UNSW). These experiments
have unveiled a promising breakthrough in liver cancer treatment. Through the
utilisation of these novel oligonucleotides, we have achieved remarkable in
vitro efficacy, successfully inducing a significant reduction in full-length
Midkine and generating a non-functional Midkine variant within liver cancer
cells. This discovery holds immense potential for patients battling liver
cancer, offering a new avenue for therapeutic intervention. The Company's
anti-cancer RNA oligonucleotide program will now progress into in
vivo studies which are planned to complete in Q4 2023.
During the period, the Company's portfolio grew materially. In March, the drug
discovery team developed four mRNA pre-clinical therapeutics targeting
Roquefort Therapeutics' novel Midkine target. This new program has been
developed in-house within the Company's existing budget and schedule.
The significance of the mRNA program is twofold. First, it highlights
Roquefort Therapeutics' internal R&D capacity to develop cutting edge
pre-clinical cancer medicines within the Company's strategy and which
complements the Company's ability to select and acquire external programs; and
second, anti-cancer mRNA is a commercially attractive field, which is highly
synergistic with the Company's existing oligonucleotide Midkine program.
Further, in June 2023, Roquefort Therapeutics announced the successful
completion of in vitro studies for the anti-cancer mRNA therapeutic in breast
and liver cancer. The studies demonstrated a statistically significant
reduction in both proliferation and migration.
mRNA is a very attractive field in biotech with a market size of circa $31
billion, led by Pfizer, Moderna and BioNTech and, within this highly
innovative field, we are developing a Midkine niche which is unique for a
biotech company of our size. These early in vitro results validate our
strategy that demonstrating a significant reduction in both proliferation and
migration are an early proxy for metastasis. Additionally, our intellectual
property portfolio has been enhanced through updated patent filing.
The Company will look to achieve synergies across our Midkine antibody,
anti-cancer RNA oligonucleotide and mRNA programs which will make R&D and
pre-clinical development more cost effective.
The other two programs within our portfolio are also progressing. Our STAT-6
siRNA program has already demonstrated in vivo efficacy in colon cancer, and
now the therapy is being combined with a lipid nanoparticle for delivery.
Further results on our STAT-6 siRNA program will be reported in due course.
The MK Cell program is also completing testing in a combination therapy with
results expected in Q4 2023.
Our five pre-clinical programs, which are in in vivo and in vitro studies,
continue to progress on track and we look forward to announcing further
progress in due course.
Commercial Progress
In February 2023, the Company made significant strategic and commercial
progress by completing a licence and royalty agreement with Randox
Laboratories to utilise the Group's Midkine antibody portfolio for clinical
diagnostics. The transaction highlights the Group's in-house deal making
capabilities and strategic focus in therapeutics. The partnership with Randox
for cancer diagnostics validates the Company's strategy to target Midkine and
brings a companion diagnostic.
This highly complementary and synergistic partnership increases the likelihood
of clinical trial success, in which diagnostics is an essential element, in
addition to reducing the associated time and cost for the Company.
Post Period End
In August 2023, the Company announced the development of four additional siRNA
sequences to complement the existing siRNA portfolio. These new siRNA
sequences expand the Company's portfolio of siRNA medicines that attack the
targets STAT-6 (Signal Transducer and Activator of Transcription) and its SH2
(Src-homology-2) domain. The Company's siRNA sequences are being developed
in combination with nano-particle delivery systems to target the
hard-to-treat, high mortality solid cancers including colon and breast cancer
with results expected in Q4 2023.
Strategy & Outlook
The Company's strategy is to discover and develop first-in-class cancer
medicines within the oncology market and to seek out and secure licencing
opportunities to crystalise value and fund the business going forward. Within
this field, Roquefort Therapeutics focuses on the cancers that are resistant
to current medicines including breast, colon and liver cancer, where patient
survival rates remain poor. The Company's programs focus on the novel cancer
targets Midkine and STAT-6, both of which are associated with this poor
survival. By blocking Midkine and STAT-6, the Company has shown in in vivo
studies, that both the cancer growth rate and metastasis are reduced, which
are the characteristics of first-in-class cancer medicines. The significant
developments made during the period speak to the Company's strategic
objectives of developing value accretive programs which have significant
potential as first-in-class medicines where survival rates are poor.
The pre-clinical progress across all our programs is highly encouraging and
within budget and in-keeping with our strategy and we look forward to updating
shareholders on our pre-clinical and business development progress in due
course.
Financial Review
For the six months to 30 June 2023, the Group reported a net loss of
£742,833, mostly relating to administrative expenses and research &
development expenses, and held cash at the period end of £1,379,021.
Directors
The following directors have held office during the period to 30 June 2023:
· Mr Stephen West, Executive Chairman
· Mr Ajan Reginald, Chief Executive Officer
· Prof. Sir Martin Evans, Chief Scientific Officer
· Dr Darrin Disley, Non-Executive Director
· Ms Jean Duvall, Non-Executive Director
· Mr Simon Sinclair, Non-Executive Director
· Dr Michael Stein, Non-Executive Director
Corporate Governance
The UK Corporate Governance Code (September 2014) ("the Code"), as appended to
the Listing Rules, sets out the Principles of Good Corporate Governance and
Code Provisions which are applicable to listed companies incorporated in the
United Kingdom. As a Standard listed company on the Main Market, the Company
is not subject to the Code; however, the Board acknowledges the importance of
high standards of corporate governance and endeavours, given the Company's
size and the constitution of the Board, to comply with the principles set out
in the QCA Corporate Governance Code. The QCA Code sets out a standard of
minimum best practice for small and mid-size quoted companies and the Company
has analysed its corporate governance with respect to that code which can be
found on its website at https://www.roquefortplc.com/corporate-governance.
Responsibility Statement
The Directors are responsible for preparing the Unaudited Interim Condensed
Financial Statements in accordance with the Disclosure and Transparency Rules
of the United Kingdom's Financial Conduct Authority ("DTR") and with
International Accounting Standard 34 on Interim Reporting ("IAS 34"). The
Directors confirm that, to the best of their knowledge, this condensed interim
report has been prepared in accordance with IAS 34 as adopted by the European
Union. The interim management report includes a fair review of the information
required by DTR 4.2.7 and DTR 4.2.8, namely:
• an indication of important events that have occurred during the
six months ended 30 June 2023 and their impact on the condensed financial
statements for the period, and a description of the principal risks and
uncertainties for the remaining six months of the financial year; and
• related party transactions that have taken place in the six
months ended 30 June 2023 and that have materially affected the financial
position of the performance of the business during that period.
ENDS
Enquiries:
Roquefort Therapeutics plc
Stephen West (Chairman) / Ajan Reginald (CEO) +44 (0)20 3290 9339
Hybridan LLP (Joint Broker)
Claire Louise Noyce +44 (0)203 764 2341
Optiva Securities Limited (Joint Broker)
Christian Dennis +44 (0)20 3411 1881
Buchanan (Public Relations)
Ben Romney / Jamie Hooper / George Beale +44 (0)20 7466 5000
LEI: 254900P4SISIWOR9RH34
Unaudited Unaudited Audited
6 Month 6 Month Period ended 30 June 2022 Year ended
Period ended 30 June 2023 31 December 2022
Note £ £ £
Revenue 6 200,000 - -
Cost of goods - - -
Gross profit 200,000 - -
Administrative expenses (765,611) (485,530) (1,306,561)
Research and development (365,435) (69,288) (319,315)
Share based payments - directors and senior managers (5,201) (57,511) (8,427)
Depreciation (1,189) - -
Amortisation of intangible assets - (149,952) -
Operating loss (937,436) (762,281) (1,634,303)
Finance income - - -
Loss before taxation (937,436) (762,281) (1,634,303)
Income tax 155,078 - 18,886
Total loss for the period attributable to equity holders of the Company (782,358) (762,281) (1,615,417)
Other comprehensive income / (loss) 39,525 - (14,989)
Total comprehensive loss attributable to equity holders of the Company (742,833) (762,281) (1,630,406)
Basic and diluted earnings per ordinary share (pence) 7 (0.64) (2.05) (1.56)
The notes form an integral part of the Unaudited Condensed Interim Financial
Statements
Unaudited Unaudited Audited
Note As at As at As at
30 June 30 June 31 December
2023 2022 2022
£ £ £
Assets
Non-current assets
Property, Plant & Equipment 52,855 - -
Intangible assets 5,343,505 1,331,578 5,343,505
Total non-current assets 5,396,360 1,331,578 5,343,505
Current assets
Trade and other receivables 8 345,832 98,520 101,738
Cash and cash equivalents 1,379,021 3,328,573 2,322,974
Total current assets 1,724,853 3,427,093 2,424,712
Total assets 7,121,213 4,758,671 7,768,217
Equity and liabilities
Equity attributable to shareholders
Share capital 10 1,291,500 719,000 1,291,500
Share premium 10 4,403,094 3,460,595 4,403,094
Share based payments reserve 11 380,336 424,219 375,135
Merger relief reserve 3,700,000 450,000 3,700,000
Retained deficit (3,331,086) (1,676,602) (2,548,728)
Currency translation reserve 25,160 5,159 (14,365)
Total equity 6,469,004 3,382,371 7,206,636
Liabilities
Non-Current liabilities
Deferred tax liabilities 281,911 281,911 281,911
Current liabilities
Trade and other payables 9 370,298 1,094,389 279,670
Total liabilities 652,209 1,376,300 561,581
Total equity and liabilities 7,121,213 4,758,671 7,768,217
The notes form an integral part of the Unaudited Condensed Interim Financial
Statements
Unaudited Unaudited Audited
6 Month 6 Month Period ended 30 June 2022 Year ended 31 December 2022
Period ended
30 June 2023
£ £ £
Cash flow from operating activities
Loss before income tax (937,436) (762,281) (1,634,303)
Adjustments for:
Share based payment 5,201 57,511 8,427
Foreign exchange 31,865 (5,160) (9,918)
Taxation - - 18,886
Depreciation 1,189 - -
Amortisation of intangible asset - 149,952 -
Changes in working capital:
(increase) /decrease in receivables (86,268) 2,083,286 (20,318)
Increase / (decrease) in payables 96,922 (121,325) 59,750
Net cash (used in)/ from operating activities (888,527) 1,401,983 (1,577,476)
Cash flow from investing activities
Acquisition of subsidiary, net of cash acquired - - (103,478)
Purchase of Property, Plant & Equipment (54,043) - -
Net cash used in investing activities (54,043) - (103,478)
Cashflows from financing activities
Proceeds from fundraise - 1,015,000 3,121,202
Share issue costs - - (18,990)
Net cash from financing activities - 1,015,000 3,102,212
Net increase/(decrease) in cash and cash equivalents (942,570) 2,416,983 1,421,258
Cash and cash equivalents at beginning of the period 2,322,974 899,721 899,721
Foreign exchange impact on cash (1,383) 11,869 1,995
Cash and cash equivalents at end of the period 1,379,021 3,328,573 2,322,974
The notes form an integral part of the Unaudited Condensed Interim Financial
Statement
Ordinary Share Premium Share Merger relief reserve Translation Reserve
Share capital Based Payment Reserve Retained earnings Total equity
£ £ £ £ £ £ £
As at 1 January 2022 719,000 3,460,595 366,708 450,000 (914,321) 624 4,082,606
Loss for the period - - 57,511 - (762,281) 4,535 (700,235)
As at 30 June 2022 719,000 3,460,595 424,219 450,000 (1,676,602) 5,159 3,382,371
Loss for the period - - - - (853,136) - (853,136)
Exchange differences - - - - - (19,524) (19,524)
Total comprehensive loss for the period - - - - (853,136) (19,524) (872,660)
Transactions with owners
Ordinary shares issued 572,500 942,499 - 3,250,000 - - 4,764,999
Stamp duty on share issue - - - - (18,990) - (18,990)
Warrants charge - - (49,084) - - - (49,084)
Total transactions with owners 572,500 942,499 (49,084) 3,250,000 (18,990) - 4,696,925
As at 31 December 2022 1,291,500 4,403,094 375,135 3,700,000 (2,548,728) (14,365) 7,206,636
Loss for the period - - - - (782,358) - (782,358)
Exchange differences - - - - - 39,525 39,525
Total comprehensive loss for the year - - - - (782,358) 39,525 (742,833)
Transactions with owners
Ordinary shares issued - - - - - - -
Stamp duty on share issue - - - - - - -
Warrants charge - - 5,201 - - - 5,201
Total transactions with owners - - 5,201 - - - 5,201
As at 30 June 2023 1,291,500 4,403,094 380,336 3,700,000 (3,331,086) 25,160 6,469,004
The notes form an integral part of the Unaudited Condensed Interim Financial
Statements
1 General Information
The Company was incorporated on 17 August 2020 as a public company in England
and Wales with company number 12819145 under the Companies Act.
The address of its registered office is 85 Great Portland Street, First Floor,
London W1W 7LT, United Kingdom.
The principal activity of the Company during the period ended 30 June 2023 was
to develop pre-clinical next generation medicines focused on hard-to-treat
cancers.
The Company listed on the London Stock Exchange ("LSE") on 22 March 2021.
The condensed consolidated interim financial statements of the Group have been
prepared in accordance with UK adopted International Accounting Standards as
issued by the UK Accounting Standards Board (ASB). They have been prepared
under the assumption that the Group operates on a going concern basis.
2 New Standards and Interpretations
New and revised accounting standards adopted for the period ended 30 June 2023
did not have any material impact on the Group's accounting policies. There are
a number of standards, amendments to standards, and interpretations which have
been issued by the IASB that are effective in future accounting periods that
the Group has decided not to adopt early. The following amendments are
effective for the period beginning 1 January 2024:
· FRS 16 Leases (Amendment - Liability in a Sale and Leaseback);
· IAS 1 Presentation of Financial Statements (Amendment -
Classification of Liabilities as Current or Non-current); and
· IAS 1 Presentation of Financial Statements (Amendment - Non-current
Liabilities with Covenants)
The Group is currently assessing the impact of these new accounting standards
and amendments. The Group does not believe that the amendments to IAS 1 will
have a significant impact on the classification of its liabilities. The Group
does not expect any other standards issued by the IASB, but not yet effective,
to have a material impact on the Group.
3 Summary of Significant Accounting Policies
Basis of Preparation
These condensed consolidated interim financial statements do not comprise
statutory accounts within the meaning of section 434 of the Companies Act
2006. Statutory accounts for the year ended 31 December 2022 were approved by
the Board of Directors on 4 June 2023 and delivered to the Registrar of
Companies. The report of the auditors on those accounts was unqualified and
did not contain any statement under section 498 of the Companies Act 2006;
however, it did contain an emphasis of matter paragraph relating to a material
uncertainty in relation to going concern identified by the directors and
appropriately disclosed in the financial statements
These condensed consolidated interim financial statements have been prepared
in accordance with the Disclosure Guidance and Transparency Rules of the
Financial Conduct Authority and with IAS 34 "Interim Financial Statements."
The condensed consolidated interim financial statements do not include all
disclosures that would otherwise be required in a complete set of financial
statements but have been prepared in accordance with the existing accounting
policies of the Group. The condensed consolidated interim financial statements
should be read in conjunction with the annual financial statements for the
year ended 31 December 2022, which have been prepared in accordance with UK
adopted International Accounting Standards and the Companies Act 2006.
The condensed consolidated interim financial statements for the period ended
30 June 2023 are unaudited.
The condensed consolidated interim financial statements are presented in £
unless otherwise stated, which is the Company's functional and presentational
currency.
Going concern
The preparation of the financial statements requires an assessment on the
validity of the going concern assumption.
After due consideration of financial forecasts, current cash resources and the
Group's plan to complete licencing deals, the Directors are of the opinion
that the Company and the Group have adequate working capital to execute its
operations over the next 12 months. As a result, the Directors have adopted
the going concern basis of accounting in the preparation of the interim
financial statements.
Accounting policies
The same accounting policies, presentation and methods of computation have
been followed in these condensed consolidated interim financial statements as
were applied in the preparation of the Company's and the Group's financial
statements for the period ended 31 December 2022.
Segment reporting
The Group considers it has one operating segment and therefore the results are
as presented in the primary statements.
Forward-looking statements
Certain statements in this condensed set of consolidated interim financial
statements are forward looking. Although the Group believes that the
expectations reflected in these forward-looking statements are reasonable, we
can give no assurance that these expectations will prove to be correct. As
these statements involve risks and uncertainties, actual results may differ
materially from those expressed or implied by these forward-looking
statements. We undertake no obligation to update any forward-looking
statements, whether as a result of new information, future events or
otherwise.
4 Critical accounting estimates and judgments
In preparing the condensed consolidated interim financial statements, the
Directors have to make judgments on how to apply the Company's accounting
policies and make estimates about the future. Estimates and judgments are
continuously evaluated based on historical experiences and other factors,
including expectations of future events that are believed to be reasonable
under the circumstances. In the future, actual experience may deviate from
these estimates and assumptions.
Actual results may differ from these estimates. In preparing these condensed
consolidated interim financial statements, the significant judgments made by
management in applying the Group's accounting policies and the key sources of
estimation uncertainty were the same as those that applied to the financial
statements for the year ended 31 December 2022.
5 Financial risk management
The Group's activities expose it to a variety of financial risks, including
market risk (which includes currency risk and interest rate risk), credit risk
and liquidity risk. The condensed consolidated interim financial statements do
not include all financial risk management information and disclosures required
in the annual financial statements; they should be read in conjunction with
the Group's annual financial statements as at 31 December 2022. There have
been no changes in any risk management policies since the year end.
6 Revenue
Unaudited Unaudited Audited
Period ended Period ended Year ended
30 June 30 June 31 December 2022
2023 2022 £
£ £
License fee revenue 200,000 - -
200,000 - -
7 Earnings per Ordinary Share
Unaudited Unaudited Audited
Period ended Period ended Year ended
30 June 30 June 31 December 2022
2023 2022 £
£ £
Loss attributable to equity shareholders (782,358) (762,281) (1,615,417)
Weighted number of ordinary shares in issue 121,850,000 37,209,663 103,479,476
Basic and diluted loss per share in pence (0.64) (2.05) (1.56)
8 Trade and other receivables
Unaudited Unaudited Audited
30 June 30 June 31 December 2022
2023 2022 £
£ £
Other receivables 127,330 65,344 45,124
Prepayments and accrued income 109,436 33,176 56,614
R&D tax credit receivable 109,066 - -
345,832 98,520 101,738
9 Trade and other payables
Unaudited Unaudited Audited
30 June 30 June 31 December 2022
2023 2022 £
£ £
Trade creditors 274,755 36,997 68,379
Accruals and other creditors 95,543 42,392 211,291
Sundry creditor - 1,015,000 -
370,298 1,094,389 279,670
10 Share Capital
Ordinary Shares Share Capital Share Premium Total
No. £ £ £
At 31 December 2021 71,900,000 719,000 3,460,595 4,179,595
At 30 June 2022 71,900,000 719,000 3,460,595 4,179,595
Issue of ordinary shares 50,000,000 500,000 - 500,000
Issue of ordinary shares 7,249,998 72,500 942,499 1,014,999
At 31 December 2022 129,149,998 1,291,500 4,403,094 5,694,594
Movement for the period - - - -
As at 30 June 2023 129,149,998 1,291,500 4,403,094 5,694,594
11 Share Based Payment Reserves
Unaudited Unaudited Audited
30 June 30 June 31 December 2022
2023 2022 £
£ £
Opening balance 375,135 366,708 366,708
NED and Advisor warrants vesting 5,201 57,511 8,427
380,336 424,219 375,135
The fair value of the services received in return for the warrants granted are
measured by reference to the fair value of the warrants granted. The estimate
of the fair value of the warrants granted is measured based on the
Black-Scholes valuations model. Measurement inputs and assumptions are as
follows:
Warrant Number of warrants Share Price Exercise Price Expected volatility Expected life Risk free rate Expected dividends
Director 750,000 £0.05 £0.05 50.00% 5 0.15% 0.00%
Director 750,000 £0.05 £0.10 50.00% 5 0.15% 0.00%
Broker 1,500,000 £0.05 £0.01 50.00% 0.08 0.15% 0.00%
Broker Placing 480,000 £0.05 £0.05 50.00% 3 0.15% 0.00%
Completion 3,000,000 £0.10 £0.10 50.00% 3 0.15% 0.00%
Senior Mgt 4,500,000 £0.10 £0.15 50.00% 5 0.15% 0.00%
Optiva 1,320,000 £0.10 £0.10 50.00% 3 0.15% 0.00%
Orana 175,000 £0.10 £0.10 50.00% 3 0.15% 0.00%
NED and Advisor 900,000 £0.08 £0.15 50.00% 5 0.15% 0.00%
TOTAL 13,375,000
Warrants Number of Warrants Exercise Price Expiry date
At 31 December 2021 34,475,000 £0.105
Issued on 28 April 2022(1) 900,000 £0.15 28 April 2027
At 30 June 2022 35,375,000 £0.106
At 31 December 2022 35,375,000 £0.106
Expired in the period (11,500,000) - 22 March 2023
As at 30 June 2023 23,875,000 £0.109
(1)50% of the warrants vest on 28 April 2023 and the remainder vest on 28
April 2024
The weighted average time to expiry of the warrants as at 30 June 2023 is 2.7
years (30 June 2022: 3.10 years).
The expected volatility was calculated using the Exponentially Weighted Moving
Average Mode. Due to limited trading history comparable listed peer company
information was used.
12 Related Party Transactions
There were no related party transactions during the period ended 30 June 2023.
13 Post Balance Sheet Events
There has been no significant change in either the financial performance or
the financial position of the Group since 30 June 2023.
14 Ultimate Controlling Party
As at 30 June 2023, there was no ultimate controlling party of the Company.
15 Nature of the Consolidated Condensed Interim Financial Statements
The Company Financial Information presented above does not constitute
statutory accounts for the period under review.
16 Approval of the Condensed Interim Financial Statements
The Condensed Interim Financial Statements were approved by the Board of
Directors on 26 September 2023.
1 (#_ftnref1) Thomas D. W., Burns J., Audette J., Carroll C., Dow-Hygelund
C., Hay C. (2016). Clinical development success rates (2006-2015). Retrieved
from www.bio.org
2 (#_ftnref2)
https://www.orpha.net/consor/cgi-bin/Education_AboutOrphanDrugs.php?lng=EN&stapage=ST_EDUCATION_EDUCATION_ABOUTORPHANDRUGS_COMPARISON
3 (#_ftnref3)
https://mergers.whitecase.com/highlights/european-biotech-enjoys-a-burst-of-deal-making-activity#!
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