Since Our Initiation
Since our initiation on September 9th, Kintara Therapeutics Inc. (NASDAQ:KTRA) has reported 2020 financial and operational results in a press release and in its 10-K for the fiscal year ending June 30, 2020. The company also announced notification of a Small Business Technology Transfer grant to study the use of REM-001 in the prevention of arteriovenous fistula maturation failure (AFMF). The company continues to advance its oncology candidates towards pivotal trials addressing issues such as obtaining protocol approval from the sites, shipping drug to trial locations and obtaining institutional review board (IRB) and ethics committee approval.
Full Year Fiscal 2020 Operational and Financial Results
On September 21, 2020 Kintara reported fiscal year 2020 results for the reporting period prior to the merger between DelMar Pharmaceuticals and Adgero Biopharmaceuticals Holdings that was approved on August 17. Subsequent to the merger close, Kintara raised $25 million in gross proceeds, which will support the entry of VAL-083 and REM-001 into registrational trials for glioblastoma multiforme (GBM) and cutaneous metastatic breast cancer (CMBC).
2020 was a busy year for Kintara, with advancements across GBM trials in enrollment and reporting of results including interim data from the ongoing Phase II studies presented at AACR. A strong vote of confidence for the VAL-083 program was selection by the Global Coalition for Adaptive Research (GCAR) to participate in the Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE) study. In support of trial preparation, a $500,000 loan was granted to the company from the National Brain Tumor Society and National Foundation for Cancer Research.
Other key events following the end of the reporting period include the company regaining compliance with minimum bid requirements on the NASDAQ and the receipt of a Small Business Technology Transfer grant to study REM-001 for the prevention of arteriovenous fistula maturation failure (AFMF).
Kintara, doing business as DelMar Pharmaceuticals, Inc., reported no revenues in 2020. Operating costs were $8.1 million which excludes merger costs of $1.1 million. Other income includes interest income of $75,000, partially offset by a small foreign exchange loss. Net loss was ($9.1) million or ($0.87) per share. Research and development expenses were $3.6 million, essentially flat with FY:19 levels. Lower preclinical research, personnel and intellectual property expense were offset by higher clinical development costs. General and administrative costs of $4.5 million fell 5% over prior year levels. The contraction was attributable to lower professional fees and share-based compensation partially offset by higher office and sundry expenses. Merger expenses of $1.1 million did not appear in the prior year and relate to the preparatory work for the combination of DelMar and Adgero.
Cash on the balance sheet as of June 30, 2020 was $2.4 million, compared to $3.7 million as of fiscal year end 2019. The change was the sum of ($7.9) million of cash burn offset by cash from financing of $6.6 million. Following the end of the quarter, Kintara raised $25.0 million gross and $21.7 million net from the issuance of Series C Preferred Stock.
Kintara received notification of a Small Business Technology Transfer grant to use REM-001 to prevent arteriovenous fistula maturation failure (AFMF) on July 17th. AFMF is a cardiovascular-related condition that occurs in hemodialysis patients. While it is in a non-oncology indication, it is an opportunity to use non-dilutive funds to advance a candidate in the company’s pipeline. There may be an additional grant at a later date that is likely to provide sufficient funds to advance the indication to the investigational new drug (IND) stage at which time a partner would be identified to take it into the clinic.
Kintara is developing multiple oncology assets. The first, VAL-083, is expected to yield topline results in 2023, followed by a new drug application (NDA) and a 2025 launch of the product in selected geographies. The second is REM-001, a photodynamic therapy (PDT) that consists of a drug, a laser light source and a light delivery device, which is expected to start a confirmatory trial in 2021 and later convert into a Phase III study, generating data by late 2023, followed shortly after by NDA submission and commercialization in 2024. VAL-083 presents a differentiated mechanism of action and a favorable safety profile, especially in contrast to other agents. It is a bifunctional compound that is able to alkylate N7-guanine to form interstrand crosslinks and force double strand breaks. Unlike TMZ, the response to VAL-083 is not dependent on MGMT promoter methylation status. At the target dose, only a minority of patients presented dose limiting toxicities and the drug is well tolerated.
REM-001, will begin a dose identifying confirmatory study in 2Q:21 enrolling up to 15 patients as a direct lead in to Phase III. Extensive studies have been conducted that have characterized the safety and efficacy of REM-001 to address CMBC. The cancer has no effective treatments despite minor benefits from surgery, chemotherapy, radiotherapy and other approaches.
Kintara Therapeutics was recently formed from the combination of DelMar Pharmaceuticals and Adgero Biopharmaceuticals, with the former sponsoring VAL-083 and the latter developing REM-001. Adding REM-001 provides a second Phase III-ready asset and additional pipeline expansion opportunities including future possible indications. This includes cancers such as recurrent basal cell carcinoma nevus syndrome (BCCNS), locally advanced basal cell carcinoma (laBCC) and cutaneous metastatic cancers other than breast, such as lung, ovarian and colon.
Exhibit I – Kintara Pipeline (1)
Kintara is conducting multiple clinical trials for GBM in VAL-083 and will soon launch a pivotal study for REM-001. The focus for the company is to complete the various Phase II trials underway and begin the GCAR registrational effort before year end 2020 and REM-001 by 2Q:21. Below we list recent milestones and anticipated future events.
‣ Completed enrollment, newly diagnosed GBM – 1Q:20
‣ Acquisition of Adgero announced – June 2020
‣ NBTS & NFCR Loan in Support of GCAR – June 2020
‣ Complete enrollment, recurrent GBM – 3Q:20
‣ Merger Vote/Merger Close – August 14, 2020
‣ Launch GCAR AGILE registration study, stage 1 – 4Q:20
‣ Top-line preliminary results for Newly Diagnosed Phase II GBM study – 4Q:20
‣ Top-line preliminary results for Recurrent Phase 2 GBM study – 1Q:21
‣ Initiate CMBC confirmatory trial – 2Q:21
‣ Top-line preliminary results for Adjuvant Phase 2 GBM study – 2Q:21
‣ CMBC confirmatory trial results & Phase III start – 4Q:21
‣ GCAR AGILE registration study, stage 2 – 1H:22
‣ CMBC trial complete – 2023
‣ CMBC NDA filing – 2024
‣ GCAR AGILE top-line results – 2023
Kintara is developing a pair of well-researched therapies in oncology with several characteristics that make the candidates particularly amenable to addressing GBM and CMBC. For VAL-083, the ability to cross the blood brain barrier and overcome DNA-repair enzyme resistance combined with the agent’s affinity to be absorbed by cancer cells provides a mechanism of action that may provide superior safety and efficacy to current standard of care. In the case of REM-001, the targeted nature of the approach avoids systemic exposure and addresses many of the shortcomings of surgery, chemotherapy and radiotherapy. Kintara offers exposure to two large oncology markets and is developing two assets primed to enter pivotal studies. With a wealth of data available for VAL-083 and an unmet need in CMBC, we see Kintara as diversified and undervalued.
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1. Source: Kintara September 2020 Corporate Overview Slide Deck