Rights Issue Investor Slide Deck
Released
Released
Announcement PDF
DISCLAIMER
This presentation (Presentation) has been prepared by Amplia Therapeutics Limited ACN 165 160 841 (the Company or
Future performance and forward-looking statements: This Presentation contains certain references to forecasts, estimates,
Amplia) and is dated 16 April 2024. This Presentation has been prepared in relation to a 2 for 5 pro rata non-renounceable
assumptions and other forward-looking statements and statements regarding the intent, belief or current expectations of Amplia.
entitlement offer of new ordinary fully paid shares (New Shares) in Amplia (Entitlement Offer or Offer). The Entitlement
The words “likely”, “expect”, “aim”, “should”, “could”, “may”, “anticipate”, “predict”, “believe”, “plan” and other similar expressions are
Offer will be made under an Offer Booklet to be made available to eligible shareholders when the Entitlement Offer opens
intended to identify forward-looking statements.
(Offer Booklet).
Forward-looking statements, opinions and estimates provided in this Presentation are based on assumptions and contingencies
Summary Information: This Presentation contains summary information about Amplia and its activities as at the date of
which are subject to change without notice, as are statements about market and industry trends, which are based on interpretations
this Presentation. The information in this Presentation is of a general nature and does not purport to be complete or
of current market conditions. Forward-looking statements are provided as a general guide only and should not be relied upon as an
comprise all information which a shareholder or potential investor may require in order to determine whether to deal in
indication or guarantee of future performance. This Presentation contains such statements, which are subject to risk factors
Amplia shares or that would be required in a prospectus or product disclosure statement prepared in accordance with the
associated with an investment in Amplia. The Company believes that these statements are reasonable, but they may be affected by a
requirements of the Corporations Act 2001 (Cth). It should be read in conjunction with Amplia’s other periodic and
range of variables which could cause actual results or trends to differ materially. Forward-looking statements involve known and
continuous disclosure announcements lodged with the Australian Securities Exchange, which are available at
unknown risks, uncertainties and assumptions and other important factors that could cause actual results, performance or
www.asx.com.au.
achievements of Amplia to be materially different from future results, performances or achievements expressed or implied by such
Not an offer: This Presentation is not a prospectus, product disclosure statement or other offering document under
statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date
Australian law, or any other law. This Presentation is for information purposes only and is not an invitation or offer of
of this Presentation.
securities for subscription, purchase or sale in any jurisdiction. In particular, this Presentation has been prepared for
Market and industry data: This Presentation contains data relating to the industries, segments and markets in which the Company
release in Australia and is not for distribution or release in the United States. The Offer Booklet will be available following its
operates (Industry Data). Unless otherwise stated, this information has been prepared by the Company using both publicly available
lodgment with ASX. Any eligible shareholder who wishes to participate in the Entitlement Offer should consider the Offer
data and its own internally generated data. The Company’s internally generated data is based on estimates and assumptions that the
Booklet in deciding whether to apply under the Entitlement Offer. Anyone who wishes to apply for Amplia shares under the
directors and management of the Company believe are reasonable. In addition to the Industry Data, the Presentation contains third
Entitlement Offer will need to apply in accordance with the instructions contained in the Offer Booklet.
party market data, estimates and projections. There is no assurance regarding the accuracy of such information and the third party
Restrictions: Any securities offered in connection with this Presentation have not been, and will not be, registered under
information, and the Industry Data, has not been independently verified by the Company.
the U.S. Securities Act of 1933, as amended (US Securities Act) or the securities laws of any state or other jurisdiction of the
Financial Information: All financial information disclosed in this Presentation is presented in Australian dollars unless otherwise
United States, and may not be offered or sold in the United States except in transactions exempt from, or not subject to,
noted. Any discrepancies between totals and sums of components in tables and figures contained in this Presentation are due to
registration under the US Securities Act and applicable US state securities laws. This Presentation may not be distributed in
rounding.
the United States, or any other jurisdiction, except in accordance with the legal requirements applicable in such jurisdiction.
Disclaimer: No representation or warranty, express or implied, is made as to the fairness or correctness of the information,
The distribution of this Presentation outside Australia may be restricted by law, and persons into whose possession this
opinions and conclusions contained in this Presentation. To the maximum extent permitted by law, Taylor Collison Limited (Lead
Presentation comes should observe any such restrictions. Any failure to comply with such restrictions may violate
applicable securities laws.
Not financial product advice: This Presentation does not, and does not purport to, contain all information necessary to
make an investment decision, is not intended as investment or financial advice (nor tax, accounting or legal advice) and
Presentations are tools that
Manager) and Amplia and their respective officers, directors, employees, agents and advisers: (1) disclaim all responsibility and
can be used as lectures,
liability (including, without limitation, any liability arising from fault, negligence or negligent misstatement) for any loss arising from
this Presentation or reliance on anything contained in or
omitted from it or otherwise arising in connection with this Presentation; (2)
speeches
disclaim any obligation or undertaking to release any update or revision to the information in this Presentation to reflect any change
must not be relied upon as such. This Presentation does not take into account the investment objectives, financial situation
in expectations or assumptions; and (3) do not make any representation or warranty, express or implied, as to the accuracy,
or needs of any particular investor. Investors are encouraged to seek independent professional advice when deciding if an
reliability, completeness of the information in this Presentation or that this Presentation contains all material information about
investment in the Company is appropriate. The Company is not licensed to provide financial product advice in respect of its
Amplia or that a prospective investor or purchaser may require in evaluating a possible investment in Amplia or acquisition of
own securities. This Presentation is not a prospectus, product disclosure statement or other offering document under
shares, or the likelihood of fulfilment of any forward-looking statement. The Lead Manager and its advisers, affiliates, related bodies
Australian law (or any other law). It is not, and does not constitute, an invitation or offer of securities for subscription,
corporate, directors, officers, employees and agents (Lead Manager Parties) make no recommendations as to whether you should
purchase or sale in any jurisdiction.
participate in the Entitlement Offer nor do they make any representations or warranties to you concerning the Entitlement Offer,
Investment risk and past performance: An investment in Amplia shares is subject to known and unknown risks, some of
and you represent, warrant and agree that you have not relied on any statements made by the Lead Manager Parties in relation to
which are beyond the control of the Company and its directors. The Company does not guarantee any particular rate of
the Entitlement Offer and you expressly disclaim any fiduciary duty with any of them.
return or the performance of Amplia. Past performance is not, and should not be relied on as being, indicative of future
performance. Investors should have regard to the ‘Risks’ section of this Presentation.
2
KEY DETAILS OF ENTITLEMENT OFFER
•
Structure
and size
•
•
A fully underwritten non-renounceable rights issue on a two (2) for five (5) basis raising ~$4.27 million via the issue of 77.6 million shares (New
Shares) (Entitlement Offer or the Offer).
The Entitlement Offer will be offered to eligible shareholders in Australia and New Zealand (Eligible Shareholders) on the Record Date.
The Rights Issue includes a top-up facility for existing eligible shareholders who take up their rights in full to apply for additional New Shares in
excess of their rights representing up to 100% of their Entitlement (Top-up Facility).
Offer Price
Offer Price of A$0.055 per New Share represents a:
• 35.3% discount to the last traded price on Thursday, 11 April 2024 (A$0.085).
• 29.6% discount to the 15-day VWAP (A$0.07818).
• 28.0% discount to theoretical ex rights price (TERP) (of A$.07643).
Record Date
•
Director
participation
The directors of the Company have committed to participate in the Entitlement Offer as follows, totalling ~A$227.9k.
• Managing Director and CEO, Dr Chris Burns, has committed to take up 60% of his entitlements under the Entitlement Offer, totalling ~A$33.4k.
• Director, Jane Bell, committed to take 100% of her entitlements under the Entitlement Offer, totalling ~A$44.6k.
• Director, Dr Robert Peach, has committed to sub-underwrite A$150k of New Shares under the Entitlement Offer, which represents ~4.2x his
entitlement. Refer to Appendix for further details.
Ranking
•
New Shares issued under the Entitlement Offer will rank equally with existing shares
Underwriting
•
Taylor Collison (Lead Manager) has fully underwritten the Entitlement Offer (refer to Appendix for further details).
Use of proceeds
•
•
•
Provide sufficient funding to undertake the Interim Analysis for ongoing Phase 2a ACCENT trial.
Undertake production of additional narmafotinib, and manufacture a further batch of 25,000 capsules.
Support a pilot Investigator Initiated Trial in ovarian cancer.
Friday 19 April 2024
29
NEAR TERM PLAN & CAPITAL REQUIREMENTS
Amplia is raising capital to:
• Provide sufficient funding to undertake the Interim Analysis for ongoing Phase 2a ACCENT trial
• Undertake production of additional narmafotinib, and manufacture a further batch of 25,000 capsules
• Support a pilot Investigator Initiated Trial in ovarian cancer
Results from the Interim Analysis available in 3rd quarter 2024
• To identify 6 or more confirmed partial responses from 26 (or less) patients in Phase 2a cohort
Process for production of narmafotinib and manufacture of capsules takes 7-9 months
• Will provide sufficient capsules for:
⚬ Initiation of clinical study in pancreatic cancer in USA (under IND)
⚬ Investigator initiated trial in ovarian cancer (in discussion)
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TIMETABLE
Company in trading halt
9am Friday, 12 April 2024
Company announces Entitlement Offer and resumes trading
Tuesday, 16 April 2024
Ex date
Thursday, 18 April 2024
Record Date
Entitlement Offer opens & booklet despatched
Friday, 19 April 2024
Wednesday, 24 April 2024
Entitlement Offer Closes
Wednesday, 8 May 2024
Issue of New Shares
Wednesday, 15 May 2024
*All dates are indicative only and subject to change.
32
KEY RISKS
RISK
DESCRIPTION
Clinical development risk
The nature of clinical drug development has inherent risks, with many drug candidates entering clinical trial failing to be successfully
developed into marketable products. The Company is currently undertaking a clinical trial with its lead drug narmafotinib in advanced
pancreatic cancer patients. Clinical trials have many associated risks which may impact commercial potential and therefore future
profitability. Such trials may fail to recruit patients at a sufficient rate, be terminated for safety reasons, or fail to be completed within
acceptable timeframes. Clinical trialling may reveal drug candidates to be unsafe or poorly tolerated in the patient population being
tested. The drugs may also be shown to be only modestly effective, thereby limiting commercial potential, or ineffective. Any of these
outcomes will likely have a significant adverse effect on the Company, the value of its securities and the future commercial development
of its drug candidates, including narmafotinib. Clinical trials might also potentially expose the Company to product liability claims in the
event its products in development have unexpected effects on clinical subjects.
Regulatory approvals necessary for
clinical trials
The Company may be unable to secure and maintain necessary approvals from regulatory agencies and institutional bodies (clinics and
hospitals) to conduct its clinical trials. Using funds raised in the Offer, the Company plans to initiate a Phase 2 clinical trial (as an
Investigator Initiated Trial) in advanced ovarian cancer patients. There is no assurance that regulatory bodies and local ethics committees
will approve the Company’s plans to recruit these patients.
Regulatory and reimbursement approvals
The research, development, manufacture, marketing and sale of products developed by the Company are subject to varying degrees of
regulation by a number of government authorities in Australia and overseas. Pharmaceutical products under development, such as drug
candidate narmafotinib, must undergo a comprehensive and highly regulated development and review process before receiving approval
for marketing. The process includes the provision of clinical data relating to the quality, safety and efficacy of the products for their
proposed use. There is no guarantee that such regulatory approvals will be granted.
Products may also be submitted for cost reimbursement approval. The availability and timing of that reimbursement approval may have
an impact upon the uptake and profitability of products in some jurisdictions. There is no guarantee that such approvals will be granted.
Chemistry, Manufacturing and Controls
The ACCENT clinical trial currently underway requires supply of narmafotinib drug product (capsules). There are risks in the shipment,
storage and handling of drug product that may render the material unavailable or inappropriate for clinical usage. For clinical trial sites in
South Korea, supplies of the chemotherapies gemcitabine and Abraxane are also required. There are risks in the supply, shipment,
storage and handling of drug product that may render the material unavailable or inappropriate for clinical usage.
34
KEY RISKS
RISK
DESCRIPTION
Commercialisation of products and
potential market failure
The Company has not yet commercialised any products and as yet has no revenues. The Company is also dependent on commercially
attractive markets remaining available to it during the commercialisation phase and there is a risk that, once developed and ready for
sale, commercial sales may not be achieved.
Furthermore, any products developed by the Company may prove to be uneconomical to market or compete with alternative products
marketed by third parties, or not be as attractive or efficacious as alternative treatments.
Competition and regulation
The biotechnology and pharmaceutical industries are intensely competitive and subject to rapid and significant change. A number of
companies, both in Australia and abroad, may be pursuing the development of products that target the same markets and/or diseases
that the Company is targeting.
The Company’s products may compete with existing products that are already available to customers. The Company may face
competition from parties who have substantially greater resources than the Company. Competing products may be superior to the
Company’s products, which would adversely impact the commercial viability of the Company’s products.
Dependence upon key personnel
The Company’s ability to attract and retain personnel will have a direct impact on its ability to deliver its project commitments. The
Company depends on the talent and experience of its personnel as an important asset. There may be a negative impact on the Company
if any of its key personnel leave. It may be difficult to replace them, or to do so in a timely manner or at comparable expense. Additionally,
any key personnel of the Company who leave to work for a competitor may adversely impact the Company.
Additionally, increases in recruitment fees, wages and contractor costs may adversely impact upon the financial performance of the
Company.
Research & Development (R&D) Tax
Rebate
The Company is currently entitled to receive an R&D rebate on part of its expenditure in research and development. There is a risk that
the Australian Government may make material changes to the rebate scheme, which may adversely impact the funding available to the
Company to fund its operations.
In order to obtain an R&D rebate on that part of its expenditure that is incurred out of Australia the Company must first gain approval for
that expenditure from the Australian Government. Such an approval is called an Advanced Finding. The Company has received Advanced
Findings for R&D work which is planned for its lead assets narmafotinib and AMP886.
35
KEY RISKS
RISK
DESCRIPTION
Growth
There is a risk that the Company may be unable to manage its future growth successfully. The ability to hire and retain skilled personnel
as outlined above may be a significant obstacle to growth.
Commercial partners
The Company’s growth strategy may be impacted if it is unable to find suitable commercialisation partners. The Company's due diligence
processes may not be successful and a commercial partnership may not perform to the level expected.
Intellectual property
The Company’s ability to commercialise any product depends upon its ability to protect its intellectual property and any improvements to
it. The intellectual property may not be capable of being legally protected, it may be the subject of unauthorised disclosure or be
unlawfully infringed, or the Company may incur substantial costs in asserting or defending its intellectual property rights.
Revenues and profitability
The Company does not currently generate revenue from product sales nor are revenues anticipated in the short to medium term. The
Company’s ability to achieve both revenues and profitability is dependent on a number of factors, including its ability to complete
successful clinical trials, obtain regulatory approval for its products and successfully commercialise those products. There is no guarantee
that the Company’s products (including the drug narmafotinib) will be commercially successful.
36
GENERAL RISKS
RISK
DESCRIPTION
Economic
General economic conditions, movements in interest and inflation rates and currency exchange rates may have an adverse effect on the
Company's business and production activities, as well as on its ability to fund those activities.
Market conditions
Share market conditions may affect the value of the Company's quoted shares (and options to acquire quoted shares) regardless of the
Company's operating performance. Share market conditions are affected by many factors such as:
a) general economic outlook;
b) introduction of tax reform or other new legislation;
c) interest rates and inflation rates;
d) changes in investor sentiment toward particular market sectors;
e) the demand for, and supply of, capital; and
f) terrorism or other hostilities.
The market price of securities can fall as well as rise and may be subject to varied and unpredictable influences on the market for equities
in general and pharmaceutical stocks in particular. Neither the Company nor the Directors warrant the future performance of the
Company or any return on an investment in the Company.
Litigation
There is a risk that the Company may in future be the subject of or required to commence litigation. There is, however, no litigation,
mediation, conciliation or administrative proceeding taking place, pending or threatened against the Company.
Tax risks
Changes to the rate of taxes imposed on the Company (including in overseas jurisdictions in which the Company operates now or in the
future) or tax legislation generally may affect the Company and its shareholders. In addition, an interpretation of Australian tax laws by
the Australian Taxation Office that differs to the Company’s interpretation may lead to an increase in the Company’s tax liabilities and a
reduction in shareholder returns. Personal tax liabilities are the responsibility of each individual investor. The Company is not responsible
either for tax or tax penalties incurred by investors.
37
GENERAL RISKS
RISK
DESCRIPTION
Additional requirements for capital
The Company's capital requirements depend on numerous factors. The Company may require further financing in addition to amounts
raised under the capital raising. Any additional equity financing will dilute shareholdings, and debt financing, if available, may involve
restrictions on financing and operating activities. If the Company is unable to obtain additional financing as needed, it may be required to
reduce the scope of its operations, its production levels, or scale back its research and development and/or clinical trials as the case may
be. There is no guarantee that the Company will be able to secure any additional funding or be able to secure funding on terms
favourable to the Company.
Underwriting Risk
The Company has entered into an underwriting agreement with the Lead Manager (Underwriting Agreement) pursuant to which the
Lead Manager has agreed to fully underwrite the Entitlement Offer, subject to the terms and conditions of the Underwriting Agreement.
The obligations of the Lead Manager to underwrite the Entitlement Offer are conditional on certain customary matters, including the
Company delivering certain certificates, sign-offs and opinions. If certain events occur, the Lead Manager may terminate the Underwriting
Agreement – see Appendix A for further details.
Termination of the Underwriting Agreement would have an adverse impact on the amount of proceeds raised under the Entitlement
Offer. In these circumstances, the Company would need to source alternative funding to meet its capital needs, which could adversely
affect the financial condition of the Company. There is no certainty that alternative funding could be obtained on satisfactory terms, or at
all.
38
UNDERWRITING AGREEMENT
Taylor Collison Limited (Lead Manager) is acting as lead manager, underwriter and bookrunner of the Entitlement Offer. Amplia has entered into an underwriting agreement with the Lead Manager in respect of the
Entitlement Offer (Underwriting Agreement). The Underwriting Agreement contains representations and warranties, and indemnities, in favour of the Lead Manager. There are also conditions precedent to the Lead
Manager’s obligations under the Underwriting Agreement (including in respect of its underwriting and settlement obligations).
The Lead Manager may, in certain circumstances, terminate its obligations under the Underwriting Agreement on the occurrence of certain termination events, including where:
a)
the Company ceases to be admitted to the official list of ASX or its shares cease trading or are suspended from quotation on ASX other than in connection with the Entitlement Offer;
b)
the Company, or a subsidiary which represents 5% or more of the consolidated assets or earnings of the Company and its Related Bodies Corporate (Amplia Group), is or becomes insolvent or there is an act or
omission which may result in the Company or a Amplia Group member becoming insolvent;
c)
the Company withdraws the Entitlement Offer or any part of it;
d)
there is an event or occurrence, including any statute, order, rule, regulation, directive or request of any Governmental Agency, which makes it illegal for the Lead Manager to satisfy a material obligation of the
Underwriting Agreement or to market, promote or settle the Entitlement Offer; or
e)
the Company is unable to issue or prevented from issuing any New Shares as contemplated by the Underwriting Agreement by virtue of the ASX Listing Rules, applicable laws, a Governmental Agency or an order
of a court of competent jurisdiction;
f)
any of the following occurs:
(i) a Director or any member of the senior management of the Amplia Group is charged with an indictable offence or fraudulent conduct;
(ii) any Director of the Company is disqualified under the Corporations Act from managing a corporation; or
(iii) any Government Agency commences any public action against an Amplia Group Member, any of the Directors or any member of the senior management of the Amplia Group, or announces that it intends
to take any such action;
g)
there is a change (or a change is announced) in the chief executive officer, chief financial officer or chairman of the Company, other than one which has already been disclosed to ASX or the Lead Manager or in
any public and other media statements made by or (with the Company’s prior approval) on behalf of the Company in relation to the affairs of the Company or the Amplia Group, including announcements lodged
with ASX (Public Information);
h)
there is an alteration to the Company’s capital structure without the prior consent of the Lead Manager, except as disclosed on the announcement date or as otherwise provided in the Underwriting Agreement
or as a result of the Entitlement Offer;
i)
the S&P/ASX Small Ordinaries Index falls to a level which is 10% or more below the level of that index on the close of trading on the Business Day before the date of the Underwriting Agreement and closes at or
below that level on:
(i)
any two consecutive Business Days after the date of the Underwriting Agreement and on or before the Business Day immediately prior to the Settlement Date; or
(ii) at the close of trading on the Business Day immediately prior to the Settlement Date;
40
UNDERWRITING AGREEMENT
j)
ASIC:
(i) applies for an order under Part 9.5 of the Corporations Act in relation to the Entitlement Offer, the issue of the New Shares or any document lodged with ASX on the Announcement Date (Information Document);
(ii) holds, or gives notice of intention to hold, a hearing, inquiry or investigation in relation to the Entitlement Offer, the issue of the New Shares or any Information Document under the Corporations Act or the
Australian Securities and Investments Commission Act 2001 (Cth);
(iii) prosecutes or gives notice of an intention to prosecute, or commences proceedings against, or gives notice of an intention to commence proceedings against, the Company or any of its officers, employees or
agents in relation to the Entitlement Offer, the issue of the New Shares or any Information Document under the Corporations Act or the Australian Securities and Investments Commission Act 2001 (Cth),
except in circumstances where the existence of the application, hearing, inquiry, investigation, prosecution or notice has not become public and it has been withdrawn by the date that is the earlier of:
(i) the Business Day immediately preceding the Settlement Date; or
(ii)the date that is 3 Business Days after the application, hearing, inquiry, investigation, prosecution or notice is commenced or received;
k)
there is an application to a Governmental Agency (including the Takeovers Panel) for an order, declaration (including of unacceptable circumstances) or other remedy in connection with the Entitlement Offer (or any
part of it), except in circumstances where the existence of the application has not become public and has been withdrawn, discontinued or terminated by the date that is the earlier of:
(i) the Business Day immediately preceding the Settlement Date; or
(ii) the date that is 3 Business Days after the application, hearing, inquiry, investigation, prosecution or notice is commenced or received;
l)
ASIC makes a determination under subsection 708AA(3) of the Corporations Act;
m)
in the opinion of the Lead Manager (acting reasonably), the Company becomes required to give, or gives, in respect of a Cleansing Notice issued in connection with the Entitlement Offer which is defective, a notice in
accordance with subsection 708AA(12) of the Corporations Act to correct that Cleansing Notice;
n)
any:
(i) material licence, lease, permit, concession, tenement, authorisation or concession of the Amplia Group (Authorisation) is, or is likely to be, invalid, revoked or unenforceable, including as a result of the introduction
of new legislation in the relevant jurisdiction; or
(ii) Authorisation is breached or not complied with in a material respect;
o)
the Company commits a breach of the Corporations Act, ASX Listing Rules, its Constitution or other applicable laws;
p)
a certificate which is required to be furnished by the Company under the Underwriting Agreement is not furnished when required, or is untrue, incorrect or misleading or deceptive in any material respect (including
by omission);
q)
unconditional approval (or conditional approval, provided such condition would not have a material adverse effect on the success or settlement of the Entitlement Offer) by ASX for official quotation of the
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