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REG - Immupharma PLC - P140 Update; Fundraise, Related Party Transaction

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RNS Number : 8626W  Immupharma PLC  17 March 2026

17 March 2026

 

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION AS STIPULATED UNDER THE UK
VERSION OF THE MARKET ABUSE REGULATION NO 596/2026 WHICH IS PART OF ENGLISH
LAW BY VIRTUE OF THE EUROPEAN UNION (WITHDRAWAL) ACT 2018, AS AMENDED BY THE
EUROPEAN UNION (WITHDRAWAL) ACT 2020 (UK MAR).  ON PUBLICATION OF THIS
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IN ADDITION, MARKET SOUNDINGS (AS DEFINED IN UK MAR) WERE TAKEN IN RESPECT OF
THE MATTERS CONTAINED IN THIS ANNOUNCEMENT, WITH THE RESULT THAT CERTAIN
PERSONS BECAME AWARE OF SUCH INSIDE INFORMATION AS PERMITTED BY UK MAR. UPON
THE PUBLICATION OF THIS ANNOUNCEMENT, THIS INSIDE INFORMATION IS NOW
CONSIDERED TO BE IN THE PUBLIC DOMAIN AND SUCH PERSONS SHALL THEREFORE CEASE
TO BE IN POSSESSION OF INSIDE INFORMATION.

 

 

 

ImmuPharma PLC

 

("ImmuPharma" or the "Company")

 

P140 Update - remains on track for licensing deal in 2026

 

Accelerated Development of Kapiglucagon for Type 1 Diabetes

 

Subscription & WRAP Retail Offer to raise up to £7.5 million

 

Sharing Agreement

 

Related Party Transaction

 

 

ImmuPharma PLC (LSE AIM: IMM), the specialist drug discovery and development
company, is pleased to announce a P140 update and an equity fundraise of £6
million (the "Subscription") with up to an additional £1.5 million to be
offered through a retail offering (the "WRAP Retail Offer") (together the
"Fundraise"), at a price of 6.0 pence per share (the "Issue Price"). The net
proceeds of the Fundraise will be used by the Company to accelerate
development of its Kapiglucagon program in Type 1 diabetes as described below.
The Fundraise is subject to approval by the Company's shareholders at a
General Meeting.

 

Highlights

 

·      ImmuPharma is recognised for P140, its lead program in Autoimmune
diseases. Significant progress has been achieved with P140 in recent years,
culminating in the filing of a new patent in September 2025. These
achievements have generated significant interest from a variety of potential
licensing partners and the Board believes that the Company remains on track to
conclude a licensing deal in 2026.

 

·      Progressing P140 to its next stage of development remains the
management's priority however, quite separately, the Company has been
approached by long-standing shareholders with the opportunity to provide
funding to strengthen and broaden its development portfolio. In response to
this clear mandate, the Board has agreed to progress the accelerated
development of Kapiglucagon, a proprietary form of glucagon and an asset in
the Company's portfolio, for the treatment of Type 1 diabetes. Lanstead
Capital Investors L.P ("Lanstead"), a long-standing shareholder in the
Company, has committed to invest £6 million (its largest single investment
into ImmuPharma over the last 10 years) to fund this development of
Kapiglucagon utilising the FDA's 505(b)(2) regulatory pathway.

 

·      Kapiglucagon has the potential to generate significant revenues
for the Company by meeting the challenging technical requirements for use in
the supply of glucagon in dual-hormone artificial pancreas devices which are
expected to replace the current insulin-only pump devices and the Board
believes it could potentially add significant value for the Company's
shareholders.

 

·      The Fundraise comprises a) a subscription for £6 million with
Lanstead through the issue of 100,000,000 new Ordinary Shares at the Issue
Price (the "Lanstead Subscription") and the Company will enter into a sharing
agreement ("Sharing Agreement") with Lanstead) and b) a retail offer which
will be undertaken via the Winterflood Retail Access Platform ("WRAP"), to
raise up to an additional £1.5 million of gross proceeds by the issue of up
to 25,000,000 shares ("WRAP Retail Offer Shares"). The WRAP Retail Offer is
being undertaken to allow existing Shareholders and new investors in the
United Kingdom an opportunity to participate in the Fundraise at the Issue
Price.

 

·      It is expected that the WRAP Retail Offer will launch later today
on 17 March 2026 and will be open for applications until 2.00 p.m. on 20 March
2026 (or such later time and date as the Company, Stanford Capital, the
Company's brokers, and WRAP may agree). There can be no guarantee that the
WRAP Retail Offer, which is not underwritten, will be fully subscribed. The
WRAP Retail Offer is conditional on, but is not part of, the Subscription. A
further announcement will be made shortly regarding the WRAP Retail Offer and
detailing its terms.

 

·      Subscription for 100,000,000 new Ordinary Shares (the
"Subscription Shares") by Lanstead at the Issue Price of 6.0 pence per share
(the "Lanstead Subscription"), with an associated Sharing Agreement ("Sharing
Agreement") (together the "2026 Lanstead Agreements").

 

·      The Issue Price of 6.0 pence represents a 13.7 per cent. discount
to the closing mid-market price (of 6.95 pence) of the Ordinary Shares on 16
March 2026, the latest business date prior to the announcement of the
Fundraise.

 

·      The £6 million gross proceeds of the Lanstead Subscription will
be pledged by the Company pursuant to a Sharing Agreement with Lanstead. The
Sharing Agreement, details of which are set out below, entitles the Company to
receive back those proceeds on a pro rata monthly basis over a period of 20
months, subject to adjustment upwards or downwards each month depending on the
Company's share price at the time. The monthly settlement amounts for the
Sharing Agreement are structured to commence around one month following
Admission. The Sharing Agreement provides the opportunity for the Company to
benefit from positive future share price performance.

 

·      The gross proceeds of the Fundraise will be used primarily to
fund:

 

·       Accelerated development of Kapiglucagon in Type 1 diabetes
through a 505(b)(2) regulatory pathway (described below); and

 

·       cash expenses associated with the Fundraise of c. £446,500.

 

The Subscription has been arranged by the Company's broker, Stanford Capital
Partners Limited ("Stanford Capital").

Funding & Cash Runway

The Directors are confident that the Fundraise, together with existing
funding, will provide the Company with a clear cash runway to at least H2
2028. As the WRAP Retail Offer is not underwritten, no receipts relating to
issue of WRAP Retail Offer Shares have been budgeted in this runway and any
receipts under the WRAP Retail Offer will increase the cash runway
accordingly.

This cash runway is based on the assumption that, the total level of receipts
under the 2026 Lanstead Agreement (which are variable and depend upon the
level of the Company's Measured Price versus the Benchmark Price each month),
will be equal to the Subscription of £6 million.

However, the Directors have an expectation that this new 2026 Lanstead
Agreement will yield a net gain due to the expectation of positive news flow
and share price appreciation, around the progression of both P140 and
Kapiglucagon through their development programs.

In the event of share price appreciation in excess of the assumption made of
receiving £6 million from the 2026 Lanstead Agreements, the Company would
have a longer cash runway as there would be a higher level of cash receipts.
In addition, a higher share price may increase the likelihood of the exercise
of outstanding options and warrants, which would result in further cash
receipts for the Company, though there is no guarantee this will occur.

 

Commenting,  Tim McCarthy, Chairman and CEO of ImmuPharma, said:

 

"We are delighted that, with the support and investment from Lanstead, we can
now accelerate the development of Kapiglucagon over the next two years and, in
doing so, create a meaningful uplift in the overall value of the Company.

 

Kapiglucagon is one of the earlier‑stage development programs, we have
previously alluded to, as a potential high‑quality asset in our portfolio.
Securing this funding, we expect it to deliver a strong stream of positive
news flow over the next two years, as we advance it rapidly through its next
stages of development.

 

At the same time, I would like to reassure shareholders that P140 remains a
core value driver for ImmuPharma. We continue to make good progress in
detailed discussions with a number of potential partners and remain focused on
completing a value‑enhancing licensing deal in 2026."

 

Kapiglucagon Opportunity in Type 1 Diabetes (T1D)

Introduction

Kapiglucagon, a proprietary form of glucagon for use in T1D was discovered in
2017 by Dr Sébastien Goudreau and his team at ImmuPharma Biotech and the
innovation was protected by a patent filed in 2018, which has been granted in
the US and other major markets. Early development activities quickly
demonstrated the molecule's strong potential, and initial work was carried out
to prepare the project for future manufacturing. Research has concentrated in
the context of artificial pancreas technologies, which confirmed
Kapiglucagon's opportunity in this rapidly growing field. The Company has a
clear strategic focus to advance Kapiglucagon as a key component of
next-generation artificial pancreas systems.

T1D: A Lifelong and Rising Global Burden

T1D is a chronic autoimmune disease affecting an estimated 8-9 million people
worldwide, with incidence continuing to rise, particularly among children and
adolescents. Despite major advances in glucose monitoring, insulin
formulations, and delivery technologies, the standard of care still relies on
lifelong insulin replacement therapy, which manages symptoms but does not
address the underlying autoimmune destruction of pancreatic beta cells.

T1D imposes a substantial and enduring burden on patients, healthcare systems,
and society. Individuals must continuously manage blood glucose levels to
avoid acute complications such as hypoglycaemia and diabetic ketoacidosis, as
well as long-term risks including cardiovascular disease, neuropathy,
nephropathy, and retinopathy. The condition requires constant monitoring,
intensive daily management with injected insulin and specialised medical care,
resulting in significant healthcare costs and a profound impact on quality of
life. As global incidence continues to increase, particularly in younger
populations, there is a growing need for innovative approaches that improve
real-time glucose control beyond insulin replacement alone, creating an
opportunity for dual-hormone therapies incorporating both insulin and
glucagon.

Dual-Hormone Artificial Pancreas: Promise and Formulation Challenges

Over the past two decades, insulin pump therapy combined with continuous
glucose monitoring (CGM) has significantly improved the management of T1D.
Hybrid closed-loop systems are now capable of automatically adjusting insulin
delivery based on real-time glucose measurements, leading to better glycaemic
control and a reduced risk of severe hypoglycaemia compared with traditional
multiple daily injections. These technologies have eased part of the daily
burden of disease management and improved quality of life for many patients.
However, insulin-only systems still have limitations, particularly in their
ability to rapidly correct hypoglycaemia, often requiring patient intervention
through carbohydrate intake or manual adjustments.

Dual-hormone artificial pancreas systems (combining insulin with glucagon)
represent one of the most promising advances toward fully automated glucose
control in T1D. By delivering small, controlled doses of glucagon to prevent
or correct hypoglycaemia, these systems have the potential to more closely
replicate the body's natural glucose regulation and significantly reduce the
daily burden of disease management for patients. However, the widespread
development and deployment of such systems has been constrained by a major
pharmaceutical challenge: the difficulty of obtaining stable, soluble glucagon
formulations suitable for continuous pump delivery. Native glucagon is
inherently unstable in aqueous solution, rapidly forming aggregates and
fibrils that compromise both potency and device compatibility. As a result,
the development of glucagon analogues or prodrugs capable of maintaining high
solubility and stability in pump reservoirs remains a critical enabling step
toward fully reliable artificial pancreas systems.

Kapiglucagon: A Next-Generation Glucagon Prodrug Designed for Stability

Kapiglucagon has been developed to address the key pharmaceutical limitations
associated with native glucagon. It is a water-soluble glucagon prodrug
designed to maintain high stability in aqueous solution while regenerating
native glucagon in vivo following subcutaneous administration. Unlike native
glucagon, which rapidly aggregates and forms fibrils in solution, Kapiglucagon
demonstrates excellent solubility and formulation stability, enabling the
development of clean, saline-based formulations that do not clog pump-based
delivery systems. This improved physicochemical profile makes Kapiglucagon
particularly well suited for continuous or intermittent delivery in advanced
diabetes technologies, including next-generation artificial pancreas systems.
By combining the therapeutic activity of native glucagon with a formulation
that overcomes its inherent instability, Kapiglucagon has the potential to
provide more reliable and practical dual-hormone automated glucose control
solutions for patients with T1D and avoid the long-term health complications
of inadequate blood glucose control.

Our Vision

ImmuPharma's vision is to position Kapiglucagon as a key enabling solution for
next-generation artificial pancreas technologies. By overcoming the
long-standing instability of native glucagon in aqueous formulations,
Kapiglucagon offers the potential to deliver a stable, pump-compatible
glucagon source, allowing dual-hormone closed-loop systems to operate safely
and effectively. Through this innovation, ImmuPharma aims to contribute to a
new generation of diabetes care in which artificial pancreas systems can
significantly reduce the daily burden of disease while improving metabolic
control and patient quality of life.

Further information on the Lanstead Subscription

 

Pursuant to the subscription agreement between the Company and Lanstead (the
"Subscription Agreement"), 100,000,000 new Ordinary Shares will be allotted
and issued, conditional upon Admission, to Lanstead at 6.0 pence per
Subscription Share for an aggregate subscription value of £6 million. The
allotment requires prior approval at the General Meeting.

 

The Lanstead Subscription proceeds of £6 million will immediately following
Admission be pledged to Lanstead under the Sharing Agreement under which
Lanstead will then make, subject to the terms and conditions of the Sharing
Agreement, monthly settlements (subject to adjustment upwards or downwards) to
the Company over a period of 20 months, commencing around one month following
Admission, as detailed below. As a result of entering into the Sharing
Agreement, the aggregate amount received by the Company under the Lanstead
Subscription and the Sharing Agreement may be more or less than £6 million,
as further explained below. Notwithstanding the Subscription Price of 6.0
pence, shareholders should note that the share price of the Company needs to
be on average over the 20 months of the Sharing Agreement at or above the
Benchmark Price of 8.0 pence per share for the Company to receive at least, or
more than, the gross Subscription of £6 million.

 

The Subscription Shares will be issued credited as fully paid and will rank
pari passu in all respects with the Company's existing issued Ordinary Shares.

The Lanstead Subscription is conditional, inter alia, on admission of the
Subscription Shares to trading on AIM, and there being: (i) no breach of
certain customary warranties given by the Company to Lanstead at any time
prior to Admission (which following approval of the requisite resolutions at
the General Meeting, is expected on or around 7 April 2026); and (ii) no force
majeure event occurring prior to Admission.

 

The Sharing Agreement

 

In addition to the Subscription Agreement, the Company has entered into the
Sharing Agreement, pursuant to which ImmuPharma will pledge the £6 million
gross proceeds of the Lanstead Subscription to Lanstead. The Sharing Agreement
will enable the Company to share in any share price appreciation over the
Benchmark Price (as defined below). However, if the Company's share price is
less than the Benchmark Price then the amount received by the Company under
the Sharing Agreement will be less than the gross proceeds of the Lanstead
Subscription which were pledged by the Company to Lanstead at the outset.

 

The Sharing Agreement provides that the Company will receive 20 monthly
settlement amounts of £300,000 as measured against a benchmark share price of
8.0 pence per Ordinary Share (the "Benchmark Price"). The monthly settlement
amounts for the Sharing Agreement are structured to commence around one month
following Admission.

 

If the measured share price (the "Measured Price"), calculated as the average
of each day's volume weighted share price ("VWAP") of the Company's Ordinary
Shares over a 20 day period prior to the monthly settlement date, exceeds the
Benchmark Price, the Company will receive more than 100 per cent. of that
monthly settlement due on a pro rata basis according to the excess of the
Measured Price over the Benchmark Price. There is no upper limit placed on the
additional proceeds receivable by the Company as part of the monthly
settlements and the amount available in subsequent months is not affected.
Should the Measured Price be below the Benchmark Price, the Company will
receive less than 100 per cent. of the monthly settlement calculated on a pro
rata basis and the Company will not be entitled to receive the shortfall at
any later date. As such, the final determination of the total amounts to be
received under the Sharing Agreement will only be known after the twenty
months have elapsed.

 

For example, if on a monthly settlement date the calculated Measured Price
exceeds the Benchmark Price by 10 per cent., the settlement on that monthly
settlement date will be 110 per cent. of the amount due from Lanstead on that
date.  If on the monthly settlement date the calculated Measured Price is
below the Benchmark Price by 10 per cent., the settlement on the monthly
settlement date will be 90 per cent. of the amount due on that date. Each
settlement as so calculated will be in final settlement of Lanstead's
obligation on that settlement date.

 

Assuming the Measured Price equals the Benchmark Price on the date of each and
every monthly settlement, ImmuPharma would receive aggregate proceeds of £6
million (before expenses) from the Lanstead Subscription and Sharing
Agreements. Examples of the proceeds from the Sharing Agreement to be received
each month, based upon varying levels of average share price in the month, are
shown in the Appendix to this announcement.

The Company will pay Lanstead's legal costs of approximately £15,000 incurred
in connection with the Lanstead Subscription and in entering into the Sharing
Agreement and, in addition, has agreed to issue to Lanstead 12,000,000 new
Ordinary Shares ("Value Payment Shares") in connection with entering into the
Sharing Agreement.

In no event will fluctuations in the Company's share price result in any
increase in the number of Subscription Shares issued by the Company or
received by Lanstead. The Sharing Agreement allows both Lanstead and the
Company to benefit from future share price appreciation.

 

In total, Lanstead will be issued with 112,000,000 new Ordinary Shares (the
Lanstead Subscription Shares and Value Payment Shares) which, when issued,
will equate to approximately 17.5 per cent. of the Company's enlarged issued
share capital following the Subscription (assuming the WRAP Retail Offer is
fully subscribed).

 

No shares, warrants or additional fees are due to be issued to Lanstead at any
point during this agreement other than those disclosed above.

 

The Sharing Agreement is similar in structure to those undertaken by the
Company with Lanstead in February 2016, June 2019, March 2020, December 2021,
August 2022, August 2023 and February 2025 respectively. All of these
arrangements have completed their settlement periods.

 

The February 2016 agreement yielded a net gain to ImmuPharma of approximately
£0.6 million more than originally subscribed by Lanstead. The June 2019 and
March 2020 agreements yielded approximately £0.9 million and £1.0 million
less than originally subscribed by Lanstead respectively. The December 2021,
August 2022 and August 2023 arrangements yielded £1.7 million, £0.7 million
and £0.14 million less than originally subscribed by Lanstead respectively.
The February 2025 arrangements yielded a net gain to ImmuPharma of
approximately £0.12 million more than originally subscribed by Lanstead.

 

The February 2016 agreement yielded a net gain due to the share price
appreciation during its duration, which coincided with the progression of P140
through its first Phase 3 clinical trial in Lupus. The subsequent agreements
have all coincided with a prolonged period of share price underperformance due
to multiple factors, including the negative macro-economic environment and a
period of complete reorganisation of the Company and its development
portfolio, following a change in the Board of Directors and the appointment of
a new management team in 2021.

 

The Directors believe that the Sharing Agreement potentially provides a number
of benefits to the Company and its shareholders including: the certainty of
additional investment, albeit the quantum of returns under the agreement is
dependent on the Company's share price; the opportunity to benefit from
positive future share price performance; and that the amount of shares issued
is fixed, together with the cost of their issue.

 

Related Party Transaction

 

Until 18 August 2025 Lanstead was a substantial shareholder in the Company,
therefore the participation by Lanstead in the 2026 Lanstead Agreements
(including the issue of the Value Payment Shares) constitute related party
transactions under the AIM Rules for Companies.

 

The Directors (all of whom are independent of Lanstead), having consulted with
SPARK Advisory Partners Limited ("SPARK"), the Company's nominated adviser,
consider that the terms of the 2026 Lanstead Agreements are fair and
reasonable insofar as the Company's shareholders are concerned.

 

Other Share Issues

 

The Company will issue 1,250,000 new Ordinary Shares to Stanford and 125,000
new Ordinary Shares to SPARK at an issue price of 6.0 pence per share in lieu
of fees ("Fee Shares"). The Fee Shares will be issued credited as fully paid
and will rank pari passu in all respects with the Company's existing issued
Ordinary Shares.

 

Application for admission to trading on AIM ("Admission"), and expected dates
of Admission

 

Application will be made for the Subscription Shares, the Value Payment
Shares, the WRAP Retail Offer Shares and the Fee Shares to be admitted to
trading on the AIM market of the London Stock Exchange ("Admission").

 

It is anticipated that Admission of the Subscription Shares, the Value Payment
Shares, the WRAP Retail Offer Shares and the Fee Shares will occur at 8.00
a.m. on or around 8 April 2026.

 

Notice of General Meeting

The Company does not currently have authority to allot the shares to be
issued. Therefore, the issuance of the Subscription Shares, the Value Payment
Shares, the WRAP Retail Offer Shares and the Fee Shares will be conditional,
inter alia, on the passing of the Resolutions being proposed at the General
Meeting.

The General Meeting is expected to be held at 11.00 a.m. on 7 April 2026.

A circular and Notice of Meeting is expected to be sent to shareholders on 19
March 2026 convening the meeting.

 

EXPECTED TIMETABLE OF PRINCIPAL EVENTS

                                                     2026
 Date of this announcement                           17 March

 WRAP Retail Offer opens                             17 March

 Publication of Circular convening General Meeting   19 March

 Closing of WRAP Retail Offer                        2.00 p.m. on 20 March
 Last date and time for receipt of Forms of Proxy    5.30 p.m. on 2 April
 General Meeting                                     11:00 a.m. on 7 April
 Announcement of Result of Meeting                   7 April

 Admission                                            8 April

 

If any of the details contained in the timetable above should change, the
revised times and dates will be notified to Shareholders by means of a
Regulatory Information Service announcement. All events listed in the above
timetable following the General Meeting are conditional on the passing of the
Resolution at the General Meeting.

References to time in this document and the Notice of General Meeting are to
London times, unless otherwise stated.

 

 

About Lanstead

 

Lanstead is a global investment firm that provides funding for ongoing
business objectives to listed small and mid-cap growth companies. In London,
Lanstead focuses on equity investments in companies already listed or quoted
on the London Stock Exchange or European exchanges and on management teams
with a clear growth strategy.

 

Lanstead's extensive experience allows it to invest in most industries,
focusing on providing supportive, longer term capital that rewards company
growth. Companies with Lanstead on the shareholder register via an equity
placement to Lanstead with an accompanying sharing agreement can benefit from
a unique and flexible approach to finance growth. This provides the
opportunity for companies to benefit from additional cash beyond the original
subscription proceeds without having to issue additional shares.

 

Further information is available at www.Lanstead.com

 

 

Appendix - example Lanstead Sharing Agreement Returns

 

In relation to each of the months in the 20 month calculation period:

 

Average 20 Day VWAP
                          6.0 pence
                  8.0 pence
             10.0 pence

 

Benchmark Price
                           8.0
pence                   8.0
pence                    8.0
pence
 

20 day VWAP as % of Benchmark Price
 75%
100%                           125%

 

Settlement from Lanstead in the month        £225,000
            £300,000
£375,000

 

Proceeds over 20 month period if Average

20 Day VWAP is at this level

for the entire
period
        £4.5m                   £6m
                               £7.5m

 
 

 For further information please contact:

ImmuPharma PLC (www.immupharma.com (http://www.immupharma.com) )  + 44 (0) 207 152 4080

 Tim McCarthy, Chief Executive Officer

 Lisa Baderoon, Head of Investor Relations                         + 44 (0) 7721 413496

 SPARK Advisory Partners Limited (NOMAD)                           +44 (0) 203 368 3550 (about:blank)

 Neil Baldwin

 Stanford Capital Partners (Joint Broker)                          +44 20 3650 3650

 Patrick Claridge

 Bob Pountney

 SI Capital (Joint Broker)

 Nick Emerson

                                                                   +44 (0) 1483 413500

 

Notes to Editors

 

About ImmuPharma PLC

ImmuPharma PLC (LSE AIM: IMM) is a specialty biopharmaceutical company that
discovers and develops peptide-based therapeutics. The Company's portfolio
includes novel peptide therapeutics for autoimmune diseases, type 1 diabetes
and anti-infectives. The lead program, P140, is a unique non-immunosuppressive
peptide for the treatment of SLE (Systemic Lupus Erythematosus) and CIDP
(Chronic Idiopathic Demyelinating Polyneuropathy) and preclinical models
suggest therapeutic activity for many other autoimmune diseases. Kapiglucagon
is being developed for the treatment of type 1 diabetes.

 

For additional information about ImmuPharma please visit www.immupharma.co.uk

 

ImmuPharma's LEI (Legal Entity Identifier) code: 213800VZKGHXC7VUS895.

 

 

About 505(b)(2) regulatory approval

 

A 505(b)(2) is a U.S. Food & Drug Administration ("FDA") drug approval
pathway that sits between a full NDA and a generic. The 505(b)(2) approval
route allows a company to obtain approval for a modified version of an
existing drug by relying partly on data which the FDA already has for the
reference product, in this case a glucagon brand. The timeframe, cost and
clinical study requirements for completing such a program  may be
considerably reduced compared to a normal NDA (new drug application) that
follows a full 505(b)(1) NDA development pathway.   A (PTE) Patent Term
Extension of 5 years may also be applied to the existing patent life of
Kapiglucagon which could result in a patent expiry extension to 2043.

 

Kapiglucagon has established a strong scientific rationale and a growing body
of supporting manufacturing and preclinical data, which the Company believes
provides a solid foundation for further development. The first step is
expected to be a Pre-IND meeting with the FDA to align on the proposed
regulatory pathway and the scope of the required CMC, preclinical and clinical
program. Following this interaction, the Company intends to advance the
remaining development activities, including IND-enabling work, with the
objective of entering a focused clinical study designed to generate safety,
pharmacokinetic and pharmacodynamic data to support the next stage of value
creation for Kapiglucagon.

 

 

 

 

 

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