Kazia Therapeutics Ltd 6-K, filed Nov 16, 2022
Kazia Therapeutics Ltd (KZIA)
About this 6-K
Kazia Therapeutics Ltd filed this 6-K on November 16, 2022.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of November, 2022
Commission File Number 000-29962
Kazia Therapeutics Limited
(Translation of registrant’s name into English)
Three International Towers Level 24 300 Barangaroo Avenue Sydney NSW 2000
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
INFORMATION CONTAINED IN THIS FORM 6-K REPORT
On November 16, 2022, Kazia Therapeutics Limited (the “Company”) issued an ASX release titled, “AGM Materials.” A copy of this release is attached hereto as Exhibit 99.1 and is incorporated herein by reference. Also on November 16, 2022, the Company filed with the ASX the Chairman’s Address and the CEO’s Presentation to the Annual General Meeting held on November 16, 2022, copies of which are attached hereto as Exhibits 99.2 and Exhibit 99.3, respectively, and are incorporated herein by reference.
EXHIBIT LIST
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Kazia Therapeutics Limited (Registrant)
| /s/ Karen Krumeich |
| Karen Krumeich |
| Chief Financial Officer |
Date: November 16, 2022
Exhibit 99.1
ASX RELEASE
16 November 2022
AGM MATERIALS
Sydney, 16 November 2022 – Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA), an oncology-focused drug development company, is pleased to provide a copy of the Chairman’s Address and CEO corporate update, to be presented at the Company’s AGM later today.
About Kazia Therapeutics Limited
Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA) is an oncology-focused drug development company, based in Sydney, Australia.
Our lead program is paxalisib, a brain-penetrant inhibitor of the PI3K / Akt / mTOR pathway, which is being developed to treat multiple forms of brain cancer. Licensed from Genentech in late 2016, paxalisib is or has been the subject of ten clinical trials in this disease. A completed phase II study in glioblastoma reported promising signals of efficacy in 2021, and a pivotal study for registration, GBM AGILE, is ongoing, with final data expected in 2H CY2023. Other clinical trials are ongoing in brain metastases, diffuse midline gliomas, and primary CNS lymphoma, with several of these having reported encouraging interim data.
Paxalisib was granted Orphan Drug Designation for glioblastoma by the US FDA in February 2018, and Fast Track Designation for glioblastoma by the US FDA in August 2020. In addition, paxalisib was granted Rare Pediatric Disease Designation and Orphan Designation by the US FDA for DIPG in August 2020, and for atypical teratoid / rhabdoid tumours (AT/RT) in June 2022 and July 2022, respectively.
Kazia is also developing EVT801, a small-molecule inhibitor of VEGFR3, which was licensed from Evotec SE in April 2021. Preclinical data has shown EVT801 to be active against a broad range of tumour types and has provided compelling evidence of synergy with immuno-oncology agents. A phase I study commenced recruitment in November 2021.
For more information, please visit www.kaziatherapeutics.com or follow us on Twitter @KaziaTx.
This document was authorized for release to the ASX by James Garner, Chief Executive Officer, Managing Director.
Exhibit 99.2
KAZIA ANNUAL GENERAL MEETING
16 NOVEMBER 2022
CHAIRMAN’S ADDRESS
Ladies and Gentlemen,
On behalf of the Board of Directors, welcome to the 2022 Annual General Meeting for Kazia Therapeutics Limited. I am grateful that we are able to return to a live format this year, and to have the opportunity to reconnect with shareholders in person.
I will say from the outset that this past year has been one of the most challenging, not only for our industry but particularly for Kazia. We have seen a rapid and very substantial contraction of equity investment in life sciences, which has greatly depressed valuations across the sector and the few financing transactions that have occurred have generally taken place on arduous terms, with the majority of companies having to rely upon the support of existing shareholders to see them through this period of turbulence.
Against this backcloth of turbulence, Kazia has had to deal with a number of additional challenges, none more than the untimely but mandatory disclosure by the Company of an ambiguous update on the GBM Agile trial, which led to an immediate 50% one day fall in the share price. In addition, the Company has been overly reliant on its ATM facility for funding, which has been a point of concern for some shareholders. We recognise the need to restore this instrument to its intended place – an occasional tool to strengthen the balance sheet opportunistically, but not a primary source of funding.
Nevertheless, the notion that a company with two high-quality clinical stage assets, boasting a wealth of positive data from almost a dozen clinical trials, could trade at a market capitalization of less than 20 million Australian dollars would have been unthinkable eighteen months ago. As a shareholder myself, I can fully appreciate the extent to which this situation tests the nerve of our members. The complex, technical progress of drug development is difficult, whereas the day-to-day movements of a share price are readily visible and appear straightforward. It is easy for short-term fluctuations in the latter to eclipse the underlying bedrock of scientific achievement and commercial opportunity.
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Let me then take this opportunity to restate the fundamentals of our company.
We have two world-class oncology drugs in our pipeline. They were invented by two of the most successful companies in the industry, and entrusted to us on competitive commercial terms because this team was judged to know how to develop them. We have gone on to initiate eleven clinical trials at some of the premier cancer research centres in the world, with the collaboration of some of the leading global experts in the field. So compelling is the science, that many of these institutions have made substantial in-kind and even financial contributions to the work, and we have benefited from many millions of dollars of competitive grant funding.
This year alone, we have presented ten data read-outs at international scientific conferences. Every one of these data read-outs has been positive, and several have been little short of remarkable. The US FDA has awarded two special designations to our lead program, paxalisib. As of today, we are managing clinical research activity across nine clinical trials in eight countries, with a team comprising just eight full-time employees. Approximately eighty cents out of every dollar that we spend is invested in progressing our pipeline.
The news that paxalisib would not graduate to the second stage of the GBM AGILE trial in August was an unwelcome surprise. I will not reiterate here the reasons why we believe this event may have lesser implications than the market has assumed. I will simply point out that the study remains ongoing, with all patients continuing on paxalisib or in follow-up according to the protocol. The paxalisib arm has not been declared futile, nor has it been terminated due to any concern over safety. We are completely blinded to data, which continues to mature on a daily basis as patients proceed through the study. We expect to see first and final data from the study in the second half of 2023, and there is every chance that this data will support a marketing authorisation for paxalisib in glioblastoma.
Regardless of the eventual outcome of the GBM AGILE trial, there are many other ways for us to win with paxalisib. Over the past several years, we have carefully deployed a broad clinical trial program, partly to expand the field of opportunity for the drug, and partly to hedge against risks such as this. That work is already paying off, with stellar data in brain metastases and growing excitement around childhood brain cancer emerging as just two of the most promising paths forward for paxalisib.
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I would argue therefore that the movements in the share price this year do not reflect any part of the underlying reality of the company. At times, share prices are driven more by abstract sentiment than by any objective consideration of science and economics.
The primary tasks for the Board and management of Kazia, as we head into 2023, are to reconnect the company with investors, to reaffirm the enormous value of our pipeline, and to restore some sensible valuation to our stock. Those tasks are summarised in the plan that has been described by the CEO, and work is already underway. I am entirely confident that, by executing carefully and patiently on our plans, we will return our company to its rightful standing.
Kazia has been through difficult times before, but I can assure you that we have the experience, the commitment, and the resolve to see the job through. Quite simply, there is too much at stake to do otherwise.
I will conclude by once again thanking my fellow directors, our CEO, Dr James Garner, and his management team for their hard work throughout the year, despite a challenging backdrop. It is a testament both to the value of our pipeline and the professionalism of our team that sentiment within Kazia remains entirely positive and forward-looking.
Finally, I wish to thank you, our shareholders, for your continuing support of the company. It has not been the easiest twelve months to be an investor in Kazia. However, you remain invested in a company with enormous potential, and your Board will leave no stone unturned to ensure that this potential is realised and recognised.
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Exhibit 99.3 Annual General Meeting of Shareholders CEO Presentation Sydney, NSW 16 November 2022 ASX: KZA | NASDAQ: KZIA | Twitter: @KaziaTx
Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements involve substantial risks and uncertainties, not all of which may be known at the time. All statements contained in this presentation, other than statements of historical fact, including statements regarding our strategy, research and development plans, collaborations, future operations, future financial position, future revenues, projected costs, prospects, plans, and objectives of management, are forward-looking statements. Not all forward-looking statements in this presentation are explicitly identified as such. Many factors could cause the actual results of the Company to differ materially from the results expressed or implied herein, and you should not place undue reliance on the forward-looking statements. Factors which could change the Company’s expected outcomes include, without limitation, our ability to: advance the development of our programs, and to do so within any timelines that may be indicated herein; the safety and efficacy of our drug development candidates; our ability to replicate experimental data; the ongoing validity of patents covering our drug development candidates, and our freedom to operate under third party intellectual property; our ability to obtain necessary regulatory approvals; our ability to enter into and maintain partnerships, collaborations, and other business relationships necessary to the progression of our drug development candidates; the timely availability of necessary capital to pursue our business objectives; and our ability to attract and retain qualified personnel; changes from anticipated levels of customer acceptance of existing and new products and services and other factors. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, there can therefore be no assurance that such expectations will prove to be correct. The Company has no obligation as a result of this presentation to clinical trial outcomes, sales, partnerships, future international, national or regional economic and competitive conditions, changes in relationships with customers, access to capital, difficulties in developing and marketing new products and services, or marketing existing products. In addition, the extent to which the COVID-19 outbreak continues to impact our workforce and our discovery research, supply chain and clinical trial operations activities, and the operations of the third parties on which we rely, will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the duration and severity of the outbreak, additional or modified government actions, and the actions that may be required to contain the virus or treat its impact. Any forward-looking statements contained in this presentation speak only as of the date this presentation is made, and we expressly disclaim any obligation to update any forward-looking statements, whether because of new information, future events or otherwise. 1
Kazia has made excellent progress in advancing its pipeline over the past year >350 10 2 8 Patients treated to Data read-outs at FDA special Countries involved date with paxalisib international designations in paxalisib clinical conferences granted to paxalisib development 2 9 85 25 Paxalisib clinical Ongoing clinical Patient-weeks of CT scans evaluated studies advanced to studies across two treatment to date in to date in EVT801 expansion stage clinical programs EVT801 phase I phase I 2
Paxalisib news flow during 2022 has been almost completely positive, with several promising new indications arising Disease Study Sponsor Key Developments Next Milestone Brain Radiotherapy Combination Positive data presented at SNO / ASCO conference Final data: ✓ Metastases Phase I in August 2022 – all patients respond to therapy CY2023 Brain Genomically-Guided Therapy Graduation to Stage 2 after positive efficacy Further data: ✓ Metastases Phase II signals in Stage 1 in breast cancer brain mets CY2023 Brain Breast Cancer Brain Mets Recruitment ongoing Initial data: u Metastases Phase II CY2023 Glioblastoma GBM AGILE Completion of recruitment to Stage 1; no Final data: 2H ? Phase II / III graduation to Stage 2 CY2023 Glioblastoma Newly Diagnosed GBM Positive final data presented at ASCO, ESMO, and Publication in ✓ Phase II SNO – OS of 15.7 mths, vs 12.7 for existing drug CY2023 Glioblastoma Ketogenesis Combination Recruitment ongoing Initial data: u Phase II CY2023 Diffuse Midline ONC201 Combination International expansion Initial data: ✓ Gliomas Phase II CY2023 Diffuse Midline Monotherapy Follow-up ongoing Final data: u Gliomas Phase I CY2023 Primary CNS Monotherapy Recruitment ongoing Initial data: u Lymphoma Phase II CY2023 Melanoma Preclinical Research Positive data presented at SMR conference in Further data: ✓ October 2022 CY2023 AT/RT Preclinical Research Positive data presented at AACR and ISPNO in Further data: ✓ June 2022 CY2023 DIPG Preclinical Research Positive data presented at ISPNO and SNO in Publication in ✓ combination with ONC201 CY2023 3
Newly-constituted Scientific Advisory Board provides ongoing validation and guidance to the development of paxalisib Priscilla K Brastianos, MD John de Groot, MD Alan Olivero, PhD Patrick Y Wen, MD Associate Professor of Medicine Division Chief, Neuro-Oncology Drug Development Consultant Professor of Neurology Harvard Medical School UCSF Harvard Medical School formerly Assistant Physician in Medicine, formerly Senior Director, Discovery Director of the Center for Neuro- Hematology/Oncology Director of Clinical Research Chemistry & Head of Research Oncology Massachusetts General Hospital MD Anderson Cancer Center Operations Dana-Farber Cancer Institute Genentech, Inc >400 peer- >100 brain Extensive relationships reviewed cancer clinical >40 patent with NIH, NCI, SNO, academic trials as principal inventorships NBTS, and other publications investigator organizations 4
Paxalisib has evolved into a ‘pipeline in a molecule’ with the potential to provide benefit in many potential indications Brain Metastases Glioblastoma Diffuse Midline Gliomas Cancer that has spread to the brain Most common and most aggressive Most lethal cancer of childhood with from elsewhere in the body primary brain cancer no FDA-approved drug therapy • 200,000 new cases pa in US• 13,000 new cases pa in US• 800 new cases pa in US • 3 ongoing trials of paxalisib• 2 ongoing trials of paxalisib• 2 ongoing trials of paxalisib Primary CNS Lymphoma Melanoma AT/RT Non-Hodgkin’s Lymphoma that Most lethal form of skin cancer Rare form of childhood brain cancer occurs in the brain with no FDA-approved drug therapy • 2,000 new cases pa in US• 100,000 new cases pa in US• 200 new cases pa in US • 1ongoing trial of paxalisib• Ongoing research with paxalisib• Ongoing research with paxalisib Low-Grade Glioma Breast Cancer Less aggressive form of brain Most common cancer of female cancer, mainly in younger adults patients • 3,000 new cases pa in US• 290,000 new cases pa in US • Area of research interest• Area of research interest 5 EXPLORATORY AREAS CORE FOCUS
Our lead indications of childhood brain cancer, glioblastoma, and brain mets each provide clear paths to commercialisation Diffuse Midline Gliomas Initial data from • Potential path to accelerated approval via phase II study Fully-funded to ongoing phase II study with ONC201 completion • Existing Rare Pediatric Disease Designation 1H CY2023 creates possibility of priority review voucher Glioblastoma Final data from • Potential path to approval via first stage of GBM AGILE study Fully-funded to Paxalisib ongoing GBM AGILE pivotal study completion • Existing Fast Track Designation allows for 2H CY2023 greater consultation with FDA Brain Metastases Potential launch of External funding • Possible registration study in combination registration study opportunities in with whole brain radiotherapy is under discussion discussion with key opinion leaders CY2023 6
Kazia’s share price has not captured the positive progress in advancing the pipeline, but does reflect a challenging market Change in Share Price / Index (31 Oct 21 to 31 Oct 22) KZIA (US$) 16 Indices Biotech ETFs PI3K Companies Brain Cancer Co’s 14 ^GSPC ^IXIC ^NBI XBI BIB CNCR TGTX VSTM MEIP CMRX YMAB KTRA 0% 12 10 -20% -16% -18% 8 -29% -34% 6 -40% -39% -44% 4 -60% 2 -66% 0 2016 2018 2020 2022 -80% -81% -84% -85% -88% -88% -92% -100% (31 Oct 21 – 31 Oct 22) Source: Bloomberg 7
GBM AGILE was designed as a two-stage study; paxalisib has not graduated to second stage OVERALL STUDY DESIGN up to 150 patients 50 patients Stage 1 (‘Exploratory’) Stage 2 (‘Confirmatory’) Full FDA Approval Blinded Graduation Analysis POTENTIAL CONTRIBUTORY FACTORS TO GRADUATION RESULT Graduation threshold is high, and may Back-loaded recruitment may have Treatment effect typically becomes 1 2 3 exceed FDA requirements reduced statistical power at graduation clearer as study matures 100% efficacy ILLUSTRATIVE Recruitment ILLUSTRATIVE % Survival ILLUSTRATIVE Graduation to Potential Stage 2 Treatment range of Number of efficacy that patients may support Control FDA approval Paxalisib is in Time Time this range B A Time in study A At an early point in the study, there is limited Termination separation of curves for futility Statistical Number of Time in = x B As the study matures over time, treatment effect Power Patients study 0% efficacy becomes more apparent ® Avastin (bevacizumab) was approved for GBM AGILE has recruited ~3-4 times faster Final analysis will be performed 12 months recurrent glioblastoma by FDA in 2009 with no than originally anticipated; many paxalisib after last patient enrolled; graduation analysis evidence of any survival benefit patients likely have limited time in study likely includes <60% of final study information 8
There remain multiple paths to potential registration for paxalisib with data from Stage 1 OVERALL STUDY DESIGN up to 150 patients 50 patients Stage 1 (‘Exploratory’) Stage 2 (‘Confirmatory’) Full FDA Approval Blinded Graduation Analysis POTENTIAL OUTCOMES FOR PAXALISIB, GIVEN DECISION IN AUGUST 2022 NOT TO GRADUATE TO STAGE 2 Stage 1 (‘Exploratory’) Full FDA Approval Stage 1 (‘Exploratory’) Accelerated Approval Post-Marketing Study Stage 1 (‘Exploratory’) Additional Study Full FDA Approval Stage 1 (‘Exploratory’) Approval in a Subgroup Stage 1 (‘Exploratory’) Negative Result 9
The company has been funded dynamically via capital markets Cashflows (AU$ ,000) 30,000 Cash Position Forex Cash AU$ 7.4M 25,000 Financing (at 30 Jun 22) ~US$ 5M Licensing 20,000 G&A Burn Rate and Runway R&D 15,000 Average Monthly (AU$ 1.9M) Expenditure (FY22) ~US$ 1.2M 10,000 Runway 1Q CY2023 5,000 Operating Efficiency % Spend on R&D ~80% 0 -5,000 -10,000 -15,000 3Q CY20 4Q CY20 1Q CY21 2Q CY21 3Q CY21 4Q CY21 1Q CY22 2Q CY22 3Q CY22 Cash 6,543 19,366 19,655 27,587 19,624 15,189 6,958 7,361 5,303 Source: Company ASX Appendix 4C Filings 10
Access to capital remains challenging for listed biotech companies Fewer companies are successfully …and deal terms are generally …leading to poor market raising capital… onerous… performance post-transaction Number of secondary market Average file-to-offer discount in Share price performance 30 days offerings secondary market offerings post transaction 300 247 60% 187 200 100 66 40% 0% 0 20% 2020 2021 2022 YTD -5% Capital raised in secondary market 0% offerings (US$, billions) 60 -9% -10% 48.9 -20% 40 -11% -12% -12% 24.8 -15% 20 -40% 10.2 0 2020 2021 2022 YTD -20% -60% -19% Source: William Blair; HC Wainwright 11
ATM facility has raised ~US$ 7.2 million at an average 9.4% premium with no measurable suppression of KZIA share price May 22 Jun 22 Jul 22 Aug 22 Sep 22 Oct 22 TOTAL Number of days on which ATM used 1 7 1 5 2 2 18 ATM as % of total monthly KZIA volume 0.1% 3.1% 0.8% 5.7% 5.0% 7.2% 4.8% KZIA change vs XBI on ‘ATM days’ * 4.6% -5.5% -1.5% 0.2% 0.0% -0.8% -1.9% KZIA change vs XBI on ‘non-ATM days’ * 0.0% -6.9% -1.4% -16.3% -1.6% -9.0% -8.3% Total proceeds (US$) 5,829 2,951,350 275,757 2,261,870 102,710 1,560,985 7,158,500 Volume-weighted average price (US$) 5.83 6.08 4.81 2.19 1.51 1.20 2.43 Premium to KZIA daily VWAP -5.4% 8.5% 12.0% 8.0% -2.2% 11.5% 9.4% Key Takeaways • ATM is used sparingly (on average 3 days per month) • Kazia’s issuances are <5% of total volume on NASDAQ (less than 1 in 20 shares sold are sold by Kazia) • Price attrition is less on days when ATM is used than on days when it is not used (ATM does not measurably suppress price) • Shares are placed, on average at a 9%+ premium to market, with no warrants, and with modest banking fees Source: Yahoo Finance; Kazia Appendix 2A filings to ASX * price changes are averaged on a volume-weighted basis 12
Kazia Board has deployed a broad-ranging plan to drive recovery in share price Reduce overall costs by 50% in CY2023 1 Reduce reliance on ATM facility by exploring other opportunities to access capital 2 Pursue non-dilutive sources of funding, including grant funding 3 Further diversify paxalisib program to reduce dependence on glioblastoma results 4 Aggressively pursue DIPG / brain mets as co-lead indications on basis of positive data 5 Work with investigators to accelerate and enrich data read-outs in CY2023 6 Accelerate partnering activity once additional DIPG / brain mets data is available 7 Increase shareholder engagement to better articulate company’s strategy and progress 8 13
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