BREAKTHROUGH RESULTS WITH NTI164 IN PAEDIATRIC ASD

ASX Announcement 8 July 2022 BREAKTHROUGH RESULTS WITH NTI164 IN PAEDIATRIC ASD  9 3% of patients showed symptom improvement relating to the severity of illness after 28 days of daily treatment with NTI164.  GLOBAL IMPROVEMENT 64% of patients had a global improvement of "much improved'" 29% of patients had a global improvement of "minimally improved" 7% of patient s had "no change"  THERAPEUTIC EFFECT (EFFICACY INDEX) - Two patients recorded a Marked Therapeutic Index Score of 2 = vast improvement meaning: complete or near remission of all symptoms. - Ten patients recorded a Moderate Therapeutic Index Score of 5 & 6 = representing “Decided improvement” – Partial remission of symptoms.  SEVERITY OF ILLNESS The average rating for th e severity of illness at baseline was 4.4 . This was reduced to 3.6 after 28 days of NTI164 treatment .  NTI164 was well - tolerated – No serious adverse events were recorded across all doses (5, 10, 15 and 20 mg/kg). No changes were noted in blood analysis or liver function tests.  T he study has been granted HREC approval to continue for a further 54 weeks due to the positive therapeutic effects of NTI164 combined with feedback from parents and clinicians and their recent request for no “washout” period. S afety and efficacy assessments will continue .  The Company is in discussions with the US FDA regarding a pre - IND (“Investigational New Drug”) application scheduled for 2022 .  Existing prescribed medications for the treatment of symptoms associated with ASD have untoward side effects including weight gain, sedation and hormonal imbalance. G iven th at NTI164 was well - tolerated without weight gain or sedation , NTI164 shows promis e compared to these treatments 1 .  Recently completed and published paediatric ASD studies utilising CBD and/or THC d o not show any statistical efficacy and had minimal effects after three plus months and (with a THC component) had ‘sedation’ as a significant side effect 2 ,3 . NTI164 measures favourably when compared to these treatments.  The results open up opportunit ies for a potential treatment pathway s outside of ASD including a wide range of neurological disorders such as Attention Deficit Hyperactivity Disorder (“ADHD”), Multiple Sclerosis, Motor Neuron Disease, Rett’s Syndrome , Concussion and Cerebral Palsy .  Conference Call with CEO, Dr Alex andra Andrews to be held at 11am WST today – details to follow. Neurotech International Limited (ASX: NTI) ("Neurotech" or "the Company") is pleased to announce the successful outcomes relating to the safety, tolerability, and efficacy of NTI164 and on key behavioural parameters that impact ASD patients. NTI164 is one of NTI’s proprietary cannabis strains, exclusively licenced from Dolce Cann Global (Ltd) , in respect of neurological applications and is the world’s first ful l - spectrum 1 Al - Huseini, S . et al., (2022). Effectiveness and Adverse Effects of Risperidone in Children with Autism Spectrum Disorder in a Naturalistic Clinical Setting at a University Hospital in Oman. Autism research and treatment, 2022, 2313851. https://doi.org/10.1155/2022/2313851 2 Thomas, M. & Frampton, C., (2022) HOPE® 1 demonstrates improvements in Clinical Global Impression (CGI) in patients with Auti sm Spectrum Disorder. http s://zeliratx.com/wp - content/uploads/2022/04/ZEL040 - White - Paper_Hope_FA.pdf 3 Shani Poleg, et al (2 019). Cannabidiol as a suggested candidate for treatment of autism spectrum disorder. Progress in Neuro - Psychopharmacology and Biological Psychiatry. https://www.sciencedirect.com/science/article/abs/pii/S0278584618304445 medicinal cannabis product (less than 0.3% THC) to be successfully studied in children with Autism Spectrum Disorder (ASD). The study was conducted by Professor Michael Fahey, Head of Paediatric Neurology at Monash Children’s Hospital in Melbour ne. The Phase I/II s tudy was designed to rigorously assess the safety of NT I 164 in a dose - escalation regime and to detect a signal for efficacy on the behaviour, focus and related cognitive parameters using a range of validated neuro - psychological tools. This s tudy was designed to form the foundation for follow - up studies in therapies relating to the treatment of a wide range of neuro logical disorders such as Attention Deficit Hyperactivity Disorder (“ADHD”), Multiple S clerosis, M otor N euron D isease, Rett Syndrome and Cerebral Palsy. Overall Study Design and Outline:  Open - label study .  The study population: C hildren aged between eight years through to seventeen years that have a medical diagnosis of Level II and III Autism Spectrum Disorder (ASD) as confirmed by the Autism Diagnostic Observational Schedule (ADOS - 2) criteria. Study Primary Endpoints:  Safety and tolerability - across do se regime (5mg/kg, 10mg/kg, 15mg/kg and 20 mg/kg) .  Safety was monitored and measured by clinical examination, full blood examinations, liver and renal function tests in addition to parent/carer and physician questionnaires . Study Behavioural Endpoints:  Efficacy was measured through parent/carer and physician questionnaires to assess parameters including, but not limited to : – Anxiety – Participation – Irritability – Hyperactivity – Mood , and – Self - stimulation In total, over 2 , 250 assessment points were created thr ough the landmark study . KEY STUDY RESULTS SAFETY AND TOLERABILITY  T he safety data concluded that NTI164 at 5, 10, 15 and 20mg/kg administered in two doses daily, is safe and well - tolerated in this study population  No changes were observed in patients ’ full blood examination, liver function or kidney function tests. There were no changes observed in the patient s’ vital signs or weight . EFFICACY  S tatistical analysis of key assessments, including Clinical Global Impression of Severity of Illness (CGI - S) demonstrated statistical significan ce at 28 days of treatment . Paired t - test: the mean difference of CGI - S between 28 days of treatment and baseline was - 0.714, 95% Confidence Interval = - 1.332, - 0.097, p value=0.027 .  93% (13 out of 14 active patients) showed symptom improvement relating to severity of illness after 28 days of daily treatment with NTI164 .  Most importantly, p arental/carer observations also indicated consistent improvement in the trial participant’s ‘ overall functioning ’ when compared to baseline at the commencement of the trial. The average rating for the severity of illness at baseline was 4.4 (out of a score of 7 meaning extremely ill and 1 meaning, not ill) and this score was reduced to 3.6 after 28 days of NTI164 treatment. Specific instances of markedly improved behaviours ( i.e. reduction in fear, agitation and anxiety) were observed . These key areas of neuro - behavioural change will also be the key focus of the upcoming P hase II/III registration trials due to commence in calendar Q3 in 2022 . Chief Investigator Professor Fahey , Monash Children’s Hospital said , “I am very encouraged with these results. We have designed a rigorous study on all fronts to assess the potential application of NTI164 for the treatment of ASD. We are encouraged by the efficacy shown by NTI164 in this tr ial and we are looking forward to the extension of this trial, in addition to the planned initiation of a Phase II/III trial, to further assess the long - term safety and efficacy of NTI164 with the potential to lead to drug registration.” The only drug currently approved by the FDA for children with ASD is Risperidone. It is prescribed for children to assist with irritability. Common side effects include ; headaches, drowsiness, anxiety and uncontrollable muscle movements. Given the NTI tria l results show no serious adverse side effects and high patient compliance, the Company is well placed to make significant inroads into the ASD market expected to be around US$5.5bn by 2028 3 . Neurotech International Chairman , Brian Leedman said, “ We cann ot underestimate the significance of the results from our world - first landmark trial. NTI is now a significant step closer in the drug development timeline to introduc ing to the market a treatment option for paediatric ASD which is natural, safe and based on the results to date, offers substantial behavioural improvements in ASD . The fact that the results are based on a 28 day trial period with further significant results from patients who have remained on the treatment, the Company is very excited that it is genuinely opening up a new treatment pathway for not just ASD, but a wide range of neurological disorders such as Attention Deficit Hyperactivity Disorder (“ADHD”), Mu ltiple Sclerosis, Motor Neuron Disease, Rett’s Syndrome and Cerebral Palsy which are targeted for both NTI and Strategic Partner trials moving forward.” Neurotech International CEO, Dr Alexandra Andrews , said, “We are extremely pleased with these breakthrough results for NTI164. The fact that 93% of participants have shown notable improvements without any serious side effects is an outstanding outcome. We are incredibly grateful for the generous participation of patients and their families as well as the team of staff and clinicians at Monash Children’s Hospital who have made this landmark trial possible. It is heart - warming to think we are in a position to effectively support children with autism and their careg ivers by providing a new therapeutic option that may improve their quality of life . ” Neurotech International Director, Professor Allan Cripps AO commented, "This study has shown substantial benefit across a range of clinical measures in most children who participated in the trial. Based on these results, a significant advantage shown is that the treatment essentially has no side effects. These exciting clinical results and the extensive pre - clinical data that we have available pave the way for an upcoming phase II/III trial in children with ASD and potential trials in patients with many neuroinflammatory disorders." Update on Provisional Patent Applications The Company has previously announced that it has submitted key, provisional patents a pplications relating to the composition and use of NTI164 to treat various neurological disorders, including ASD 4 . NTI, through its 3 https://www.globenewswire.com/news - release/2021/12/14/2351376/0/en/Autism - Spectrum - Disorder - Therapeutics - Market - Size - 2021 - 2028 - is - Expected - to - be - Worth - USD - 5 - 15 - Billion.html) 4 14 October 2021 Provisional Patent Lodgements patent attorneys, recently completed international type searches conducted by IP Australia (Canberra) on both NTI 164 patents which demonstrated that there is no prior art concerning the inventions. This shows that the Company’s patent strategy is on track so far. If granted, its patents could add significant commercial value to the future commercialisation of NTI16 4 across ASD and other neurological disorders. Regulatory Pathway The Company has also initiated discussions with the Therapeutics Good Administration (TGA) to assess product scheduling and classification for the Australian Market . In collaboration with regulatory experts , the C ompany is now mapping out a full regulatory development roadmap /pathway for the registration and commercialisation of NTI164 for ASD and other neurological indications. The Company has initiated pre – IND (“ Investigational New Drug ”) discussions with the FDA and is the process of develop ing a clear roadmap for product registration and commercial development i n the USA with an initial face to face pre - IND meeting set for end of August 2022 . Board Appointment The Company is pleased to announce the appointment of Mr Gerald Quigley as a non - executive director. Mr Quigley is a pharmacist and consumer health commentator based in Melbourne. Mr Quigley has published extensively across multiple fields relating to natural extracts and their role in the regulation of inflammation and is a leadin g media health commentator heard each week on television and radio stations across Australia. He has extensive knowledge relating to pharmaceutical/nutraceutical product development, dispensing and marketing in addition to product positioning within the re levant regulatory landscapes (eg. TGA, FDA). Authority This announcement has been authorised for release by the Board of Neurotech International Limited. Further Information Dr Alexandra Andrews CEO [email protected] +61 (0)405 339 788 Brian Leedman Chairman [email protected] +61 (0)41 228 1780 Media: Amali e Schreurs White Noise Communications amali e @whitenoisecomms.com +61 (0) 431 636 033 Monash Media For all enquires Monash Media and Communications [email protected] or (03) 9594 7722. About Neurotech Neurotech International Limited (ASX:NTI) is a biopharmaceutical company focused on the development and commercialisation of neurological solutions that improve quality of life. Neurotech is currently conducting world - first clinical trials to assess the potential application of NTI164 for the treatment of Autism Spectrum Disorder (ASD). Results of Phase I/II indicated that 93% of participants had notable improvements relating to the severity of illness with no serious side effects. The next step will be initiation of Phase II/III of the trial to further assess the long - term safety and efficacy of NTI164, with the potential to lead to drug registration. The Company has also submitted key, provisional patents relating to the composition and use of NTI164 to treat various neurological disorders, including ASD. For more information about Neurotech and Mente Auti sm , please visit www.neurotechinternational.com . APPENDIX 1 - Study Details This study is conducted in accordance with this protocol, ICH GCP guidelines, federal and local governing regulatory requirements and laws and in accordance with HREC guidelines. Title: Phase I/II Open – Label Study to Evaluate the Safety and Efficacy of Orally Administered Full - Spectrum Medicinal Cannabis Plant Extract (0.08% THC) – NTI164 in Children with Autism Spectrum Disorder Site: Monash Children’s Hospital Clayton, Melbourne Victoria Study Population : Aged between 8 to 17 years old population that have a medical diagnosis of Level 2 or 3 Autism Spectrum Disorder (ASD) as confirmed by the Autism Diagnostic Observational Sch edule (ADOS - 2) criteria. Subject inclusion criteria: • Participant is aged 8 years to 17 years (inclusive) • Participant is at a healthy weight at the discretion of the Principal Investigator. • Parents or caregivers can give informed consent for participation in the trial with assent from individuals with autism. • Participants can comply with trial requirements. • According to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM - 5) criteria the participant has a diagnosis of Le vel 2 or 3 Autism Spectrum Disorder (ASD) confirmed by Autism Diagnostic Observational Schedule (ADOS - 2) criteria • All treatments including medications and therapies for ASD related symptoms must have been stable for 4 weeks before enrolment and for the dur ation of the trial wherever possible. • Participants must be able to swallow liquid. • Consent giver must be able to understand the requirements of the study. Subject exclusion criteria: • Current diagnosis of bipolar disorder, psychosis, schizophrenia, schizoaffective disorder, or active major depression • Has a diagnosis other than ASD that dominates the clinical presentation (e.g., Attention Deficit Hyperactivity Disorder [ADHD]) • Has a degenerative condition • Changes in anticonvulsive thera py within the last 12 weeks • Taking omeprazole, lansoprazole, tolbutamide, warfarin, sirolimus, everolimus, temsirolimus, tacrolimus, clobazam, repaglinide, pioglitazone, rosiglitazone, montelukast, bupropion, or efavirenz • Currently using or has used recrea tional or medicinal cannabis, cannabinoid - based medications (including Sativex., or Epidiolex.) within the 12 weeks prior to screening and is unwilling to abstain for the duration of the trial • Participant has any known or suspected hypersensitivity to cann abinoids or any of the excipients • Participant has moderately impaired hepatic function at screening, defined as serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 Å~ upper limit of normal (ULN) or total bilirubin (TBL) > 2 Å~ ULN. This criterion can only be confirmed once the laboratory results are available; participants enrolled into the trial who are later found to meet this criterion must b e screen - failed. • Participant is male and fertile (i.e., after puberty unless permanently sterile by bilateral orchidectomy) unless willing to ensure that they use male contraception (condom) or remain sexually abstinent during the trial and for 12 weeks thereafter. • Participant is female and with childbearing potential (i.e., following menarche and until becoming postmenopausal for ≥ 12 consecutive months unless permanently sterile by hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) unless willing to ensure that they use a highly effective method of birth control (e.g., hormonal contraception, intrauterine device/hormone - releasing system, bilateral tubal occlusion, vasectomized partner, sexual abstinence) during the trial and for 12 weeks thereafter. • Female participant who is pregnant (positive pregnancy test), lactating or planning pregnancy during the course of the trial or within 12 weeks thereafter. • Participant had brain surgery or traumatic brain injury within 1 year of screening. • Participant has any other significant disease or disorder which, in the opinion of the investigator, may either put the participant, other participants, or site staff at risk because of participation in the trial, may influence the result of the trial, or may affect the participant's ability to take part in the trial. • Any abnormalities i dentified following a physical examination of the participant that, in the opinion of the investigator, would jeopardize the safety of the participant if they took part in the trial • Any history of suicidal behaviour (lifelong) or any suicidal ideation of t ype 4 or 5 on the Columbia - Suicide Severity Rating Scale (C - SSRS) in the last 4 weeks or at screening or randomization • Participant has donated blood during the past 12 weeks and is unwilling to abstain  from donation of blood during the trial. • Participant h as any known or suspected history of alcohol or substance abuse or positive drugs of abuse test at screening (not justified by a known concurrent medication). • Participant has previously been enrolled into this trial. • Participant has plans to travel outside their country of residence during the trial, unless the participant has confirmation that the product is permitted in the destination country/state . Assessments of efficacy: Efficacy will be monitored and measured through parent/carer and physician questionnaires The secondary outcomes measures listed below will be used to assess potential improvements of: • Irritability • Hyperactivity • Mood • Self - stimulation • Sleep disorders • Seiz ures • Behavioural Crises • Social Interaction • Communication Secondary Endpoints 1. Social Responsiveness Scale, 2nd Edition (SRS - 2), School - Age Form Five domains are assessed including: Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests and Repetitive Behaviour. Items are scored on a 4 - point scale (ranging from 1=not true to 4=almost always true). 2. Anxiety, Depression and Mood Scale (ADAMS) 28 symptom items that resolve into five subscales labelled: Manic/Hyperactive Behaviour, Depressed Mood, Social Avoidance, General Anxiety, and Compulsive Behaviour. Items are rated on 4 - point scale ranging from 0=not a problem to 3=severe problem. 3. Sleep Disturbance Scale for Children (SDSC) Six subscales including Disorders of Initiating and Maintaining Sleep, Sleep Breathing Disorders, Disorders of Arousal, Sleep Wake Transition Disorders, Disorders of Excessive Somnolence, and Sleep Hyperhydrosis. Items are rated on 5 - point scale where 1=never and 5=always (daily). Subscale scores sum to equal a total score 4. Clinical Global Impression - Severity (CGI - S) Reflects clinician’s impression of severity of illness on a 7 - point scale ranging from 1=not at all to 7=among the most extremely ill. 5. Auti sm Family Experience Questionnaire (AFEQ) Parent/Caregiver form used to measure impact of autism interventions on family experience and quality of life. Items are rated on a 5 - point scale where 1=always and 5=never. 6. Anxiety Scale for Children - Autism Spectrum Disorder - Parent Versions (ASCASD - P) Parent/Caregiver form developed to detect symptoms of anxiety in youth with ASD. Composed of four subscales (Performance Anxiety, Uncertainty, Anxious Arousal, and Separation Anxiety), items are rated on a 4 - p oint scale (0=never and 3=always). Subscales sum to equal a total score. 7. Anxiety Scale for Children - Autism Spectrum Disorder (ASC - ASD - C) - Child Versions Child form developed to detect symptoms of anxiety in youth with ASD. Composed of four subscales (Performance Anxiety, Uncertainty, Anxious Arousal, and Separation Anxiety), items are rated on a 4 - point scale (0=never and 3=always). Subscales sum to equal a total score. 8. The Child Behaviour Checklist for Ages 6 – 18 (CBCL) A parent/carer measure to assess patterns of behaviour. The measure is a Likert scale rated over 3 or 4 points. 9. Caregiver Global Impression of Change in Attention (CGI - CA) Reflects clinician’s impression of change in attention on a 7 - point scale ranging from 1=not at all to 7=very severe problem. Provided as Baseline and Post - Baseline questionnaires. 10. Caregiver Global Impression of Change (CGI - C) Target Behaviour Reflects clinician’s impression of change of behaviour on a 7 - point scale ranging from 1=not at all to 7=very severe problem. Provided as Baseline and Post - Baseline questionnaires. 11. Clinical Global Impression Scale - Improvement (CGI - I) This is a 7 - point scale measuring symptom change from baseline. Provided as baseline and post - bas eline Caregiver and Clinician questionnaires. 12. Vineland Adaptive Behaviour Scales, Third Edition (Vineland - 3) Parent/Caregiver Form. Used to measure adaptive functioning across three core domains (Communication, Daily Living Skills, and Socialization), and two optional domains (Motor Skills and Maladaptive Behaviour); items are rated on a 3 - point scale (0=never; 1=sometimes; 2=usually or often). The core domains sum to a total Adaptive Behaviour Composite. APPENDIX 2 - SYNOPSIS Name of Sponsor Neurotech International Individual Study Table Referring to Part of the Dossier (For National Authority Use only) Finished Product Name NTI164 Volume n/a Name of Active Ingredient Cannabinoids Page n/a Title of Study A Phase I/II Open - Label Study to Evaluate the Safety and Efficacy of Orally Administered Full - Spectrum Medicinal Cannabis Plant Extract 0.08% THC (NTI164) in Children with Autism Spectrum Disorder – Part I. ANZCTR Registration Number: ACTRN12621000760875P Investigator Professor Michael Fahey Head of Paediatric Neurology Monash Children’s Hospital 246 Clayton Road, Clayton VIC Australia 3168 +61 3 9594 6666 Study centre Monash Children’s Hospital 246 Clayton Road, Clayton VIC Australia 3168 +61 3 9594 6666 Publication (reference) n/a Study period Date of first enrolment May 2021 Date of last enrolment February 2022 Phase of Development Phase I / II Objectives To assess the safety and efficacy of NTI164 after 28 days of daily treatment. Methodology The principal investigator assessed each patient to determine the most efficacious and tolerable dose for that individual and made changes to their treatment schedule as required. Number of patients planned and analysed 20 patients planned; 14 patients analysed. Name of Sponsor Neurotech International Individual Study Table Referring to Part of the Dossier (For National Authority Use only) Finished Product Name NTI164 Volume n/a Name of Active Ingredient Cannabinoids Page n/a Inclusion criteria  Participant is aged 8 years to 17 years (inclusive)  Participant is at a healthy weight at the discretion of the Principal Investigator.  Parents or caregivers can give informed consent for participation in the trial with assent from indi viduals with autism.  Participants can comply with trial requirements.  According the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM - 5) criteria the participant has a diagnosis of Level 2 or 3 Autism Spectrum Disorder (ASD) confirmed by Autism Diagnostic Observational Schedule (ADOS - 2) criteria  All treatments including medications and therapies for ASD related symptoms must have been stable for 4 weeks before enrolment and for the duration of the trial wherever possible.  Participan ts must be able to swallow liquid.  Consent giver must be able to understand the requirements of the study. Investigational product 53mg/ml of NTI164 administered daily at weekly doses of 5mg/kg, 10mg/kg, 15mg/kg and 20mg/kg. Duration of treatment 28 days. Reference therapy Extensive published research review and evaluation was used to determine the dose, duration and route of administration. Safety Evaluation Full blood examination, liver function test, renal function test, vital signs & adverse events. Efficacy Evaluation Parent/caregiver - led questionnaires, physician - led questionnaires:  Clinical Global Impression of Improvement for the Caregiver (CGI - I - Ca)  CGI of Improvement for the Clinician (CGI - I - C)  CGI of Change in Target Behaviour (CGI - C)  CGI of Change in Attention (CGI - CA)  CGI of Severity of Illness (CGI - S)  Anxiety Scale for Children – Child version (ASD - ASC - C)  Anxiety Scale for Children – P arent version (ASD - ASC - P)  Sleep Disturbances Scale for Children (SDSC) Statistical methods  Wilcoxon Signed - Rank Test and the Paired t - test were used to assess the statistical significance. Name of Sponsor Neurotech International Individual Study Table Referring to Part of the Dossier (For National Authority Use only) Finished Product Name NTI164 Volume n/a Name of Active Ingredient Cannabinoids Page n/a SUMMARY - CONCLUSIONS Efficacy Results Paired t - test: the mean difference of CGI - S between 28 days of treatment and baseline was - 0.714, 95% confidence interval = - 1.332, - 0.097, p value=0.027. The Wilcoxon Signed - Rank Test statistic was: - 15, the corresponding p - v alue was 0.047. 13 of the 14 patients (93%) showed symptom improvement relating to severity of illness after 28 days of daily treatment with NTI164. Safety Results A total of 21 adverse events were reported by ten participants. 28% of these reports were digestive related (n=6) ie., abdominal pain, diarrhoea, vomi ting. Stomach pain and lack/loss of appetite were the most reported adverse events and each accounted for 14% of reports (n=3). No serious adverse events were reported. Conclusion NTI164 has shown to be safe and well tolerated up to doses of 20/mg/kg/day. NTI164 has shown statistically significant efficacy in improving the symptoms associated with autism spectrum disorder after 28 - days of daily therapy. Side effects reported were not serious or severe and did not significantly interfere with patients’ functioning. No abnormal laboratory values were reported. These results, combined with the extension of this study to accommodate parents/caregivers request to continue therapy, warrant for further clinical studies on NTI164 to assess long term efficacy and safety. Date of this report July 2022 1. Clinical Global Impression – Severity (CGI - S) The CGI - S scale was used to analyse the therapeutic effect of NTI164 and its changes to severity of illness.  Global Improvement: rates the total improvement whether or not, in the clinician’s judgement, is due entirely to drug treatment.  Severity of Illness: a comparison of baseline and post - baseline (28 - days NTI164 treatment).  Efficacy Index: rated based on drug effect only. This i s a calculated score based on the degrees of therapeutic effect and side effects. 1.1. Global Improvement 93% of active patients showed improvement after 28 days of daily treatment with NTI164. 64% of these patients had a global improvement of ‘Much improved’, 29% had a global improvement of ‘Minimally improved’ and only one patient (7%) had ‘No change’ ( Figure 1 ). The Wilcoxon Signed - Rank Test and the Paired t - test were used to assess the statistical significance: Paired t - test: the mean difference of CGI - S between 28 days of treatment and baseline was - 0.714, 95% confidence interval = - 1.332, - 0.097, p value=0.027. The Wilcox on Signed - Rank Test statistic was: - 15, the corresponding p - value was 0.047. Figure 1 - CGI - S | Global Improvement at 28 days of NTI164 treatment n = 9 n = 4 n = 1 0% 10% 20% 30% 40% 50% 60% 70% Much Improved Minimally Improved No Change % of active patients Global Improvement Rating GLOBAL IMPROVEMENT RATINGS 1. Very much improved 2. Much improved 3. Minimally improved 4. No change 5. Minimally worse 6. Much worse 7. Very much worse 1.2. Severity of Illness The average rating for the severity of illness at baseline was 4.4 ( Figure 2 ). This reduced to an average rating of 3.6 after 28 days of NTI164 treatment ( Figure 3 ) Figure 2 - CGI - S | Severity of Illness after 28 days of treatment. Figure 3 - CGI - S | Severity of Illness after 28 days of treatment. 0 2 4 6 1 2 3 4 5 6 7 Count Severity Baseline Post-Baseline Baseline Post-Baseline 1.3. Therapeutic Effect After 28 - days of daily treatment with NTI164, 14% of active patients demonstrated the second highest possible efficacy index of 2: Marked therapeutic effect with side effects that do not significantly interfere with patient’s functioning. 72% of active pat ients had an efficacy index of either 5 or 6: Moderate therapeutic effect with half of these patients having no side effects and the other half having side effects that do not significantly interfere with patient’s functioning , 7% had an efficacy index of 9 : Minimal therapeutic effect with no side effects and only one patient, 7%, had an efficacy index based on seeing no change in condition, 13: Unchanged or worse with no side effects ( Figure 4 ). Figure 4 - CGI - S | Therapeutic Effect n = 2 n = 10 n = 1 n = 1 0% 10% 20% 30% 40% 50% 60% 70% 80% Marked Efficacy Index = 2 Moderate Efficacy Index = 5 & 6 Minimal Efficacy Index = 9 Unchanged or worse Efficacy Index = 13 % of active patients Therapeutic Effect EFFICACY INDEX SCORES 2 = Marked Therapeutic Effect, Vast improvement. Complete or nearly complete remission of all symptoms. Side Effects: Do not significantly interfere with patient's functioning. 5 = Moderate Therapeutic Effect, Decided improvement. Partial remission of symptoms. Side Effects: None. 6 = Moderate Therapeutic Effect, Decided improvement. Partial remission of symptoms. Side Effects: Do not significantly interfere with patient's functioning. 9 = Minimal Therapeutic Effect, Slight improvement which doesn't alter status of care of patient. Side Effects: None. 13 = Unchanged or worse. Side effects: None. 1.4. Tabulation of Individual Response Data Table 1 – Tabulation of individual response data Participant ID Severity of Illness Baseline Severity of Illness Post - Baseline Global Improvement Therapeutic Effect Side Effects Efficacy Index S00102 5. Markedly ill 4. Moderately ill 3. Minimally improved Moderate Do not significantly interfere with patient’s functioning 6 S00103 5. Markedly ill 4. Moderately ill 2. Much improved Moderate Do not significantly interfere with patient’s functioning 6 S00104 4. Moderately ill 3. Mildly ill 2. Much improved Moderate None 5 S00106 6. Severely ill 4. Moderately ill 2. Much improved Moderate Do not significantly interfere with patient’s functioning 6 S00110 3. Mildly ill 3. Mildly ill 2. Much improved Marked Do not significantly interfere with patient’s functioning 2 S00111 3. Mildly ill 4. Moderately ill 3. Minimally improved Minimal None 9 S00112 6. Severely ill 3. Mildly ill 2. Much improved Marked Do not significantly interfere with patient’s functioning 2 S00113 3. Mildly ill 3. Mildly ill 3. Minimally improved Moderate Do not significantly interfere with patient’s functioning 6 S00114 5. Markedly ill 3. Mildly ill 3. Minimally improved Moderate Do not significantly interfere with patient’s functioning 6 S00115 4. Moderately ill 4. Moderately ill 2. Much improved Moderate None 5 S00116 4. Moderately ill 4. Moderately ill 2. Much improved Moderate None 5 S00117 4. Moderately ill 4. Moderately ill 2. Much improved Moderate None 5 S00118 6. Severely ill 6. Severely ill 4. No change Unchanged or worse None 13 S00119 3. Mildly ill 2. Borderline mentally ill 2. Much improved Moderate None 5 END --------

The release as fetched from its publisher. investi.com.au ↗