TIDMROQ
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]
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]
-- 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 GBP1,379,021 and for the 6 months to 30
June 2023, net loss of GBP742,833
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] . 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 , 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 GBP742,833, mostly relating to administrative expenses and
research & development expenses, and held cash at the period
end of GBP1,379,021.
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.
S
Enquiries:
Roquefort Therapeutics plc
Stephen West (Chairman) / Ajan +44 (0)20 3290
Reginald (CEO) 9339
Hybridan LLP (Joint Broker)
Claire Louise Noyce
Optiva Securities Limited (Joint +44 (0)203 764
Broker) 2341
+44 (0)20 3411
Christian Dennis 1881
Buchanan (Public Relations)
Ben Romney / Jamie Hooper / George +44 (0)20 7466
Beale 5000
LEI: 254900P4SISIWOR9RH34
U naudited U naudited Audited
6 Month 6 Month Year ended
Period Period 31 December
ended 30 ended 30 2022
June 2023 June 2022
Note GBP GBP GBP
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
As at As at As at
30 June 30 June 31 December
2023 2022 2022
Note GBP GBP GBP
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 Year ended 31 December 2022
Period ended 2022
30 June 2023
GBP GBP GBP
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
Share
Ordinary Based Merger
Share Share Payment relief Retained Translation Total
capital Premium Reserve reserve earnings Reserve equity
GBP GBP GBP GBP GBP GBP GBP
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 202 2 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 GBP 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 GBP
GBP GBP
License fee revenue 200,000 - -
200,000 - -
------------- ------------- ------------------
7 Earnings per Ordinary Share
Unaudited Unaudited Audited
Period ended Period Year ended
30 June ended 31 December
2023 30 June 2022
GBP 2022 GBP
GBP
Loss attributable to equity ( 782,358
shareholders ) (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
2023 2022 2022
GBP GBP GBP
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
2023 2022 2022
GBP GBP GBP
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. GBP GBP GBP
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
2023 2022 2022
GBP GBP GBP
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:
Risk
Number Share Exercise Expected Expected free Expected
Warrant of warrants Price Price volatility life rate dividends
----------------- ------------- -------- --------- ------------ --------- ------ -----------
Director 750,000 GBP0.05 GBP0.05 50.00% 5 0.15% 0.00%
Director 750,000 GBP0.05 GBP0.10 50.00% 5 0.15% 0.00%
Broker 1,500,000 GBP0.05 GBP0.01 50.00% 0.08 0.15% 0.00%
Broker Placing 480,000 GBP0.05 GBP0.05 50.00% 3 0.15% 0.00%
Completion 3,000,000 GBP0.10 GBP0.10 50.00% 3 0.15% 0.00%
Senior Mgt 4,500,000 GBP0.10 GBP0.15 50.00% 5 0.15% 0.00%
Optiva 1,320,000 GBP0.10 GBP0.10 50.00% 3 0.15% 0.00%
Orana 175,000 GBP0.10 GBP0.10 50.00% 3 0.15% 0.00%
NED and Advisor 900,000 GBP0.08 GBP0.15 50.00% 5 0.15% 0.00%
----------------- ------------- -------- --------- ------------ --------- ------ -----------
TOTAL 13,375,000
----------------- ------------- -------- --------- ------------ --------- ------ -----------
Number of Warrants Exercise
Warrants Price Expiry date
---------------------------- ------------------ -------- -------------
At 31 December 2021 34,475,000 GBP0.105
Issued on 28 April 2022(1) 900,000 GBP0.15 28 April 2027
---------------------------- ------------------ -------- -------------
At 30 June 2022 35,375,000 GBP0.106
---------------------------- ------------------ -------- -------------
At 31 December 2022 35,375,000 GBP0.106
---------------------------- ------------------ -------- -------------
Expired in the period (11,500,000) - 22 March 2023
---------------------------- ------------------ -------- -------------
As at 30 June 2023 23,875,000 GBP0.109
---------------------------- ------------------ -------- -------------
(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] 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]
https://www.orpha.net/consor/cgi-bin/Education_AboutOrphanDrugs.php?lng=EN&stapage=ST_EDUCATION_EDUCATION_ABOUTORPHANDRUGS_COMPARISON
[3]
https://mergers.whitecase.com/highlights/european-biotech-enjoys-a-burst-of-deal-making-activity#!
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END
IR UNVNROSUKUAR
(END) Dow Jones Newswires
September 27, 2023 02:00 ET (06:00 GMT)
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