Skip to main content

AI assistant

Sign in to chat with this filing

The assistant answers questions, extracts KPIs, and summarises risk factors directly from the filing text.

BIOTRON LIMITED Capital/Financing Update 2018

May 9, 2018

64528_rns_2018-05-09_aace0aa1-586e-4609-b34e-86cad76b8b54.pdf

Capital/Financing Update

Open in viewer

Opens in your device viewer

==> picture [286 x 45] intentionally omitted <==

Level 2, 66 Hunter Street SYDNEY NSW 2000 AUSTRALIA

Telephone: +61 2 9300 3344 Facsimile: +61 2 9221 6333 E-mail: [email protected] Website: www.biotron.com.au

10 May 2018

The Manager Companies ASX Limited 20 Bridge Street SYDNEY NSW 2000

(23 pages by email)

Dear Madam

RENOUNCEABLE RIGHTS ISSUE

  • Renounceable rights offered at 1.5 cent per share to raise up to $1.47 million.

  • 1 attaching option (5 cent expiring 12 December 2019) offered for every new share to be listed.

  • Partially underwritten up to $800,000.

  • Directors will participate in the rights issue.

  • Attractive pricing – 42% discount to 1 month VWAP of 2.6 cent.

  • Shareholders can renounce their rights or apply for additional shares and attaching options.

  • Rights to start trading from 15 May 2018 .

Sydney, Australia, 10 May 2018 – Australian drug development company Biotron Limited (ASX:BIT) today announced a partially underwritten renounceable rights issue to raise up to approximately $1.47 million. Net proceeds, in conjunction with existing cash reserves, will be used:

  • For expansion of the Company’s Hepatitis B virus (HBV) program, including testing of promising compounds in new models of infection.

  • Continued evaluation of additional Biotron compounds against an expanded range of viral diseases including respiratory viruses, Dengue virus, and others.

  • For commercialisation and negotiation activities, legal fees, travel and personnel costs.

  • For general working capital.

The offer of securities will be made to eligible shareholders on the basis of one (1) new share and one (1) attaching listed option for every four (4) existing shares held on the record date (16 May 2018) at an issue price of 1.5 cent per share, which represents a 42% discount to the 1 month volume weighted average price (VWAP) of 2.6 cent.

Shareholders will be given the opportunity to apply for additional securities in excess of their entitlement, however, allocations are not guaranteed. The issue is renounceable and shareholders will be able to guarantee an increase to entitlements by the purchase of additional rights.

Directors have indicated they intend to participate in some or all of their entitlement under the rights issue.

CPS Capital Group Pty Ltd acts as Lead Manager and the Underwriter.

The proposed timetable* for the offer is as follows:

==> picture [518 x 187] intentionally omitted <==

----- Start of picture text -----

Shares trade ex-entitlement (Ex Date) 15 May 2018
Rights trading starts
Record date to determine Entitlements (Record Date) 16 May 2018
Prospectus with Entitlement and Acceptance Form dispatched 21 May 2018
Offer opens for receipt of Applications
Rights trading ends 30 May 2018
Deferred settlement trading starts 31 May 2018
Closing date for acceptances 6 June 2018
Notify ASX of under-subscriptions 12 June 2018
Issue of New Shares 14 June 2018
Deferred settlement trading ends
Dispatch of shareholding statements 14 June 2018
Normal trading of New Shares expected to commence 15 June 2018
----- End of picture text -----

*The above timetable is indicative and may change, subject to the Corporations Act and Listing Rules.

A prospectus for the offer and a personalised entitlement and acceptance form will be sent to eligible shareholders in accordance with the above timetable. Furthermore, from 21 May 2018, eligible shareholders can view their personalised entitlement and acceptance form online at www.investorcentre.com.

Shareholders should consider the disclosure document in deciding whether to acquire the securities. Anybody wanting to acquire securities will need to complete the application form that will be in or will accompany the disclosure document.

This announcement lifts the trading halt entered on 8 May 2018.

Yours sincerely

==> picture [105 x 67] intentionally omitted <==

Peter J. Nightingale Company Secretary

Enquiries

Peter J. Nightingale Company Secretary Biotron Limited +61-2 9300 3344

Rudi Michelson Monsoon Communications +61-3 9620 3333

2

About Biotron and BIT225

A presentation on the Company’s activities is attached.

Biotron Limited is engaged in the research, development, and commercialisation of drugs targeting significant viral diseases with unmet medical need. The Company has BIT225 in clinical development for HIV-1, and a promising preclinical program for HBV. In addition, Biotron has several earlier stage programs designing drugs that target a class of virus protein known as viroporins which have a key role in the virus life cycle of a very broad range of viruses, many of which have caused worldwide health issues such as Dengue, Ebola, Middle East Respiratory virus, Influenza and Zika viruses.

pjn9393

3

BIOTRON LIMITED (ASX:BIT)

Investor Update, May 2018

==> picture [720 x 50] intentionally omitted <==

business achievements/performance of Biotron Limited (ACN 086 399 144) and certain of the plans and objec,ves of its management. These statements are statements that are not historical facts. Words such as “should”, “expects”, “an,cipates”, “es,mates”, “believes” or similar expressions, as they relate to Biotron Limited, are intended to iden,fy forward-looking statements. By their nature, forward-looking statements involve risk and uncertainty because they reflect Biotron’s current expecta,ons and assump,ons as to future events and circumstances that may not prove accurate. There is no guarantee that the expected events, trends or results will actually occur. Any changes in such assump,ons or expecta,ons could cause actual results to differ materially from current expecta,ons.

==> picture [720 x 50] intentionally omitted <==

Biotron Limited

  • Biotron is designing, developing and commercialising a plaUorm of an,viral drugs with a novel mode of ac,on – able to target a wide variety of viral infec,ons

  • Pipeline of programs in high value, high need markets

  • Progress in clinical lead program (BIT225) provides valida,on for Biotron’s broader an,viral plaUorm

==> picture [720 x 50] intentionally omitted <==

Biotron Limited – Snap Shot

BROAD PLATFORM WITH NEW CLASS OF ANTIVIRAL DRUGS

HIV-1 ERADICATION HEPATITIS C VIRUS (HCV) HBV & EARLY STAGE PROGRAMS
- Targe,ng HIV-1 in long- - New class of HCV drug -
Pipeline of early stage
lived reservoirs - Phase 2 completed programs, including:
- Phase 2 trial complete; - Seeking partnerships in -
Hepa,,s B virus
data an,cipated mid-2018 China -
Respiratory viruses
-
Flaviviruses (Dengue)
CLINICAL VALIDATION – COMPLETED 8 CLINICAL TRIALS WITH
GOOD SAFETY & EFFICACY OUTCOMES

Key Recent Achievements

  • Phase 2 HIV-1 clinical trial of BIT225 and Combina,on An,retroviral Therapy (cART) complete

  • Post-trial analyses of pa,ent samples in progress; data pending (an,cipated mid-2018)

  • model of HIV-1 infec,on

  • Independent Nature publica,on validated Biotron’s approach of targe,ng HIV-1 in macrophages as a key step in HIV-1 eradica,on

  • Reduce levels of key HBV proteins; compounds appear to target a cri,cal part of the HBV life cycle

==> picture [720 x 50] intentionally omitted <==

HIV-1 EradicaSon

==> picture [216 x 303] intentionally omitted <==

Current drugs do not eradicate HIV-1 virus

  • HIV-1 remains hidden in reservoirs, leading to chronic, life-long infec,on

  • Invisible to body’s immune defenses

  • Not sensi,ve to an,-HIV-1 drugs

  • New mode of ac,ons drugs are needed to eradicate or cure HIV-1 infec,on

Why is HIV-1 eradicaSon necessary?

  • Long-term health implica,ons e.g. HAND, immune ac,va,on, drug-drug interac,ons

  • Cost of treatment

  • ~ $20 billion p.a. world wide

  • Major burden on healthcare systems

BIT225 has potenSal to be used in combinaSon with other drugs to eradicate HIV-1 reservoirs Mario Stevenson Scien.fic American 299 , 78 - 83 (2008)

==> picture [720 x 50] intentionally omitted <==

----- Start of picture text -----

299 , 78 - 83 (2008)
----- End of picture text -----

Current Drugs Do Not Eradicate HIV-1

==> picture [720 x 349] intentionally omitted <==

Macrophages are Key HIV-1 Reservoirs

Study published in Nature Medicine in April 2017 confirmed that macrophages are key viral reservoirs

==> picture [410 x 112] intentionally omitted <==

==> picture [402 x 144] intentionally omitted <==

==> picture [720 x 50] intentionally omitted <==

BIT225 Targets HIV-1 in Reservoir Cells

  • BIT225 inhibits assembly and budding of new virus in macrophage reservoirs

  • Phase 1b/2a trial (004) demonstrated that BIT225 can reduce HIV-1 levels in macrophage cells in vivo , paralleling in vitro studies (Wilkinson et al , J An,microb Chemother. 2015)

  • Phase 2 trial (009) complete (BIT225 in combina,on with ART); data an,cipated mid-2018

==> picture [171 x 172] intentionally omitted <==

----- Start of picture text -----

A
----- End of picture text -----

==> picture [166 x 171] intentionally omitted <==

----- Start of picture text -----

B
----- End of picture text -----

==> picture [303 x 175] intentionally omitted <==

(A) Untreated Controls (B) BIT225 treated cells

BIT225 – Proven Clinical AcSvity Against HIV-1

  • BIT225-004: Phase 1b/2a randomised, placebo controlled, doubleblind trial

  • 21 pa,ents, HIV-1 posi,ve, treatment-naïve ; 10 days dosing with BIT225 (monotherapy)

  • Results demonstrated that BIT225:

1. reduces virus in these cells

2. Crosses the blood-brain barrier, opening up the possibility of treatment of AIDS-related demenSa

2. trial

==> picture [228 x 219] intentionally omitted <==

----- Start of picture text -----

16
Placebo
14 BIT225
12
10
8
6
4
2
5 10 15 20 25
Time in Co-culture (days)
HIV-1 Replica,on (pg/200uL)
----- End of picture text -----

PotenSal role for BIT225:

  • AddiSon to current ART to eradicate key reservoirs, impacSng immune acSvaSon

  • Key component of cure/eradicaSon strategies

==> picture [720 x 48] intentionally omitted <==

HIV-1 EradicaSon: BIT225-009 Trial

==> picture [524 x 179] intentionally omitted <==

----- Start of picture text -----

BIT225 or placebo
added to ART
----- End of picture text -----

  • 36 HIV-1[+ve] , treatment-naïve subjects commencing ART

  • Randomised 2:1 (drug:placebo)

  • Read-out

  • Impact on virus levels; reduc,on of immune ac,va,on markers

  • Fully recruited; completed dosing with BIT225/placebo. AnScipate data mid-2018

==> picture [720 x 50] intentionally omitted <==

  • Focused on the design and development of a new class of an,viral drugs targe,ng viralencoded viroporin proteins

  • Dengue and West Nile (M protein), SARS (E protein) and others

  • Broad plaUorm:

  • Rapid, proprietary primary bacterial cell-based screening assays for target proteins

  • Focused library of compounds that target these viral proteins

  • for key markets

==> picture [720 x 50] intentionally omitted <==

  • Small hydrophobic proteins with ion channel ac,vity

  • Form hydrophilic pores in host cell membranes

• Key stages of the viral cycle such as virus ~~uncoa,ng, transport and matura,o~~ n are ~~ion-infuenced processes in many v~~ iral ~~species • Crucial for viral pathogenicity due t~~ o involvement in various steps of virus life cycles

  • Biotron’s HIV-1 program (BIT225)

Nature Reviews Microbiology 10 , 563-574

==> picture [720 x 50] intentionally omitted <==

Unlocking Value for Other Virus Targets

Biotron’s Viroporin approach enables the targe,ng of a wide range of viral diseases; examples include:

  • cause of “common cold”)

  • Flaviviruses such as Zika Virus and Dengue

  • Transplant viruses such as BK virus

  • Epstein Barr virus (EBV) - par,cular interest in Asia where it is causa,ve agent of Nasopharyngeal Carcinoma

Biotron’s Viroporin-targeSng pladorm has the potenSal to become an important tool in the development of anSviral therapies

==> picture [720 x 50] intentionally omitted <==

HepaSSs B Virus Program

  • companies

  • against HBV

  • Screening in Hep G2 and AD38 cell lines, as well as studies in primary human hepatocytes (PHH)

  • In vitro data includes evidence of reducSon of industry recognised markers, including cccDNA

  • Biotron compounds appear to have a novel mechanism of ac,on

  • Poten,al for use in combina,on approaches to treatment of HBV

  • Expands Biotron’s partnering opportuni,es

==> picture [720 x 50] intentionally omitted <==

Dengue Virus Program

  • 2.5 billion people (40% world popula,on) live in areas at risk

  • of Dengue

  • ~100 million people infected yearly

  • A leading cause of illness and death in tropics and subtropics

  • Transmission is by mosquito; most preven,on programs target the vector

==> picture [255 x 125] intentionally omitted <==

  • Vaccine trials have had disappoin,ng results

  • Biotron is targe,ng Dengue M protein – Similar target to HIV-1/Vpu and HCV/p7

  • Several compounds with promising ac,vity have been generated; tests are on-going

  • Poten,al for pan-Flavivirus therapeu,c

==> picture [255 x 141] intentionally omitted <==

----- Start of picture text -----

www.sciencenews.org
----- End of picture text -----

==> picture [720 x 50] intentionally omitted <==

  • The new HCV drugs may cause reac,va,on of HBV in HCV/HBV coinfected pa,ents

  • Resulted in US FDA “Black Box” Warning on new HCV drugs

  • 30 million HCV-infected people in China, compared to 3-5 million in USA

  • 93 million chronically infected with HBV in China, compared to 2.2 million in USA

  • High HCV/HBV co-infec,on rate in China (es,mated to be 10 million)

  • Reac,va,on of HBV has poten,al to be a major health & economic issue in China

  • pa,ents in combina,on with Interferon & Ribavirin (IFN/RBV)

  • IFN/RBV have several poten,al advantages over new HCV drugs in some setngs

  • HBV reac,va,on is less common and less severe in HCV/HBV co-infected pa,ents with IFN/RBV

  • Seeking partnerships for Biotron’s HCV program in China

==> picture [720 x 50] intentionally omitted <==

CommercialisaSon and Partnering

  • HIV-1 Program

  • HCV Program - BIT225 par,cularly well suited to Asia, with high numbers of HCVinfected pa,ents including a high propor,on of HCV/HBV co-infected pa,ents

  • • Early stage collabora,on opportuni,es for pre-clinical targets, such as:

  • Hepa,,s B

  • Dengue

  • Addi,onal development collabora,on poten,al for “other” pharma targets

  • Seeking partners for individual targets or en,re plaUorm

==> picture [720 x 50] intentionally omitted <==

Investment Highlights

TargeSng viroporin proteins with a rapid screening proprietary primary VIROPORIN-TARGETING bacterial cell-based pladorm - a library of over 350 compounds with acSvity ANTIVIRAL PLATFORM against a range of viruses.

Clinical and Preclinical programs in indicaSons with high unmet clinical need BROAD ANTIVIRAL or large paSent populaSons such as HIV-1, HCV & Dengue, HBV, Zika & PIPELINE

CLINICAL VALIDATION

outcomes; 1 addiSonal trial recently completed with data pending (mid-2018)

INTELLECTUAL PROPERTY Pordolio of patents and patent applicaSons directed to the Company’s anSPOSITION viral drug pordolio

==> picture [719 x 45] intentionally omitted <==

==> picture [720 x 66] intentionally omitted <==

Dr Michelle Miller Managing Director +61 412 313329 [email protected] www.biotron.com.au

==> picture [720 x 50] intentionally omitted <==