Kintara Therapeutics(KTRA)

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Kintara Therapeutics(KTRA) - 2021 Q3 - Quarterly Report
2021-05-13 20:16
Mergers and Acquisitions - The company completed a merger with Adgero Biopharmaceuticals Holdings, resulting in the conversion of Adgero common stock into 1.5740 shares of the company's common stock[120]. - The company incurred merger costs of $500,000 during the nine months ended March 31, 2021[228]. - The company recognized an expense of $16,094,000 for acquired in-process research and development assets in connection with the Adgero merger[247]. Financial Performance - The net loss for the period attributable to common stockholders for the nine months ended March 31, 2021 was $34,768,000, compared to $5,315,000 for the same period in 2020[228]. - The net loss for the three months ended March 31, 2021, was $6,635,000, up from $1,957,000 for the same period in 2020, reflecting an increase of 239%[232]. - The net loss for the nine months ended March 31, 2021, was $31,566,000, compared to $5,303,000 for the same period in 2020, an increase of 496%[250]. - Total cash and cash equivalents increased from $2,392,000 in June 30, 2020 to $15,718,000 in March 31, 2021[226]. - Cash flows from operating activities decreased to $(14,171,000) for the nine months ended March 31, 2021, from $(5,350,000) for the same period in 2020, a 165% increase in cash used[249]. - Total stockholders' equity increased from $263,000 in June 30, 2020 to $16,118,000 in March 31, 2021[226]. Research and Development - The company has two ongoing Phase 2 studies for VAL-083 targeting MGMT-unmethylated GBM, with a focus on patients resistant to standard treatments[137]. - VAL-083 is being evaluated in the GBM AGILE Study, which is an adaptive clinical trial for glioblastoma, and is the only therapeutic agent assessed in all three GBM patient subtypes[139]. - The company announced positive data updates from ongoing Phase 2 clinical studies for GBM at the AACR Annual Meeting[125]. - VAL-083 has received orphan drug designation from the FDA for the treatment of ovarian cancer, gliomas, and medulloblastoma[144]. - The company is focused on developing anti-cancer therapies for patients with solid tumors that are resistant to current treatments, particularly in orphan cancer indications[122]. - The company plans to conduct a Phase 3 clinical study for REM-001 Therapy following initial open-label studies to confirm dosing[193]. Clinical Trials and Results - The Phase 2 study of VAL-083 in newly-diagnosed MGMT-unmethylated GBM patients reported a median progression-free survival (PFS) of 9.3 months[156]. - The median overall survival (mOS) for 83 efficacy evaluable patients in the recurrent GBM study was reported at 7.5 months[166]. - For the 48 efficacy evaluable patients receiving the intended treatment dose of 30 mg/m2/day, the mOS was 7.9 months[166]. - The Phase 2 studies showed a tumor response rate of 33% ± 37% for study CA008 and 39% ± 47% for study CA009, both achieving statistical significance (p < 0.001)[213]. - Clinical Success rates for studies CA008 and CA009 were 60% and 50% respectively, with confidence intervals of 39%-81% and 28%-72%[215]. - In studies CA013 and CA019, Clinical Success rates were 88% and 83% respectively, with confidence intervals of 71%-97% and 45%-86%[216]. Regulatory Designations - The FDA has granted Fast Track designation for VAL-083 in recurrent GBM, which may expedite the review process and increase access for patients[167][168]. - The FDA granted orphan drug designation for tin ethyl etiopurpurin (REM-001's active ingredient) for treatment of Basal Cell Carcinoma Nevus Syndrome (BCCNS)[194]. Financial Management and Expenses - Research and development expenses for the three months ended March 31, 2021 were $3,843,000, compared to $899,000 for the same period in 2020[227]. - General and administrative expenses rose to $2,762,000 for the three months ended March 31, 2021, compared to $1,077,000 for the same period in 2020, marking a 156% increase[236]. - For the nine months ended March 31, 2021, research and development expenses totaled $7,784,000, compared to $2,332,000 for the same period in 2020, a 234% increase[240]. - General and administrative expenses for the nine months ended March 31, 2021, were $7,091,000, up from $3,045,000 for the same period in 2020, indicating a 133% increase[243]. Strategic Direction - The company is evaluating options for strategic direction, including potential acquisitions and raising additional capital[146]. - The company has established a strategic partnership with GCAR for the GBM AGILE trial, which aims to expedite the discovery of effective therapies for glioblastoma[141]. Safety and Efficacy - REM-001 has been safely administered to over 1,100 patients in prior clinical studies, indicating a strong safety profile[204]. - Myelosuppression, particularly thrombocytopenia, is the main dose-limiting toxicity associated with VAL-083, but modern medicine allows for better management of these side effects[184]. - VAL-083's anti-tumor mechanism is active independent of MGMT status, suggesting its potential as a new standard-of-care treatment for GBM[150]. - VAL-083 demonstrated activity against MGMT-unmethylated GBM cells resistant to temozolomide, indicating potential for treating resistant tumors[182].
Kintara Therapeutics(KTRA) - 2021 Q2 - Quarterly Report
2021-02-12 11:03
PART I - FINANCIAL INFORMATION [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements.) Unaudited interim financials show a net loss of $24.9 million and a going concern uncertainty due to merger costs Condensed Consolidated Interim Balance Sheet (in thousands) | | Dec 31, 2020 | June 30, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $17,158 | $2,392 | | Total current assets | $17,717 | $2,851 | | Total assets | $20,489 | $2,938 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $2,727 | $2,675 | | Total liabilities | $2,904 | $2,675 | | Total stockholders' equity | $17,585 | $263 | | Total liabilities and stockholders' equity | $20,489 | $2,938 | Condensed Consolidated Interim Statements of Operations (in thousands, except per share amounts) | | Six months ended Dec 31, 2020 | Six months ended Dec 31, 2019 | | :--- | :--- | :--- | | Research and development | $3,941 | $1,434 | | General and administrative | $4,329 | $1,967 | | Merger costs | $500 | $— | | In-process research and development | $16,094 | $— | | **Net loss for the period** | **$24,931** | **$3,346** | | Net loss attributable to common stockholders | $28,125 | $3,355 | | Basic and fully diluted loss per share | $1.34 | $0.35 | Condensed Consolidated Interim Statements of Cash Flows (in thousands) | | Six months ended Dec 31, 2020 | Six months ended Dec 31, 2019 | | :--- | :--- | :--- | | Net cash used in operating activities | ($9,541) | ($3,977) | | Net cash provided by investing activities | $972 | $— | | Net cash provided by financing activities | $23,335 | $6,606 | | **Decrease in cash and cash equivalents** | **$14,766** | **$2,629** | - On August 19, 2020, the company completed its merger with Adgero Biopharmaceuticals, resulting in a significant one-time expense of **$16.1 million for acquired in-process research and development (IPR&D)**[25](index=25&type=chunk)[42](index=42&type=chunk)[48](index=48&type=chunk) - Management notes that **recurring losses ($24.9M)** and **negative cash flow from operations ($9.5M)** raise substantial doubt about the company's ability to continue as a going concern[31](index=31&type=chunk)[32](index=32&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=23&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) The company discusses its financial condition, product pipeline, and increased operating expenses following the Adgero merger [Background and Recent Highlights](index=23&type=section&id=Background%20and%20Recent%20Highlights) The company details its merger with Adgero, subsequent rebranding, and initiation of the GBM AGILE trial - Completed a merger with Adgero Biopharmaceuticals on August 19, 2020, and subsequently **changed its name to Kintara Therapeutics, Inc. (KTRA)**[118](index=118&type=chunk)[119](index=119&type=chunk) - Raised **net proceeds of approximately $21.6 million** from a private placement of Series C Preferred Stock in conjunction with the merger[124](index=124&type=chunk) - In January 2021, initiated patient recruitment for the **VAL-083 arm of the GBM AGILE registrational Phase 2/3 clinical trial**[126](index=126&type=chunk) [Product Pipeline](index=25&type=section&id=Product%20Pipeline) The pipeline features two late-stage candidates, VAL-083 for GBM and REM-001 for CMBC, with promising clinical data - The two lead candidates are **VAL-083 for glioblastoma multiforme (GBM)** and **REM-001 for cutaneous metastatic breast cancer (CMBC)**[122](index=122&type=chunk) - VAL-083 is being evaluated in the **GBM AGILE Study**, an adaptive platform trial intended to serve as the basis for an NDA submission[136](index=136&type=chunk)[137](index=137&type=chunk) VAL-083 Phase 2 GBM Study Results vs. Historical Controls | Study Population | Metric | Result | Historical Control | Source Chunk | | :--- | :--- | :--- | :--- | :--- | | Newly-Diagnosed MGMT-unmethylated (SYSUCC) | Median PFS | 8.7 months | 5.3 - 6.9 months | [153] | | Recurrent MGMT-unmethylated (MDACC) | Median OS | 8.5 months | 7.2 months (lomustine) | [157] | | Newly-Diagnosed Adjuvant (MDACC) | Median PFS | 10.0 months | 5.3 - 6.9 months | [160] | - REM-001 Therapy, acquired from Adgero, showed a **complete response in approximately 80% of evaluable tumor sites** in prior studies[183](index=183&type=chunk)[217](index=217&type=chunk) [Results of Operations](index=43&type=section&id=Results%20of%20Operations) Net loss increased to $24.9 million from $3.3 million YoY, driven by a $16.1 million IPR&D charge Comparison of Results of Operations (Six Months Ended Dec 31, in thousands) | Item | 2020 | 2019 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $3,941 | $1,434 | $2,507 | 175% | | General and administrative | $4,329 | $1,967 | $2,362 | 120% | | Merger costs | $500 | $0 | $500 | N/A | | In-process R&D | $16,094 | $0 | $16,094 | N/A | | **Net loss** | **$24,931** | **$3,346** | **$21,585** | **645%** | - The significant increase in net loss was primarily due to a **$16.1 million non-recurring expense** for acquired in-process research and development from the Adgero merger[249](index=249&type=chunk) - Research and development expenses **increased by 175% YoY**, driven by costs for the GCAR GBM AGILE Study and development for REM-001[241](index=241&type=chunk)[242](index=242&type=chunk) - General and administrative expenses **rose by 120% YoY**, mainly due to higher non-cash compensation, personnel costs, and insurance premiums[245](index=245&type=chunk)[246](index=246&type=chunk) [Liquidity and Capital Resources](index=45&type=section&id=Liquidity%20and%20Capital%20Resources) The company holds $17.2 million in cash but has substantial doubt about its ability to continue as a going concern Cash and Liquidity (in thousands) | Metric | Dec 31, 2020 | June 30, 2020 | | :--- | :--- | :--- | | Cash and cash equivalents | $17,158 | $2,392 | | Working capital | $14,990 | $176 | - Net cash used in operating activities for the six months was **$9.5 million, a 140% increase** from the prior-year period[251](index=251&type=chunk)[252](index=252&type=chunk) - Financing activities provided **$23.3 million in cash**, primarily from **$21.6 million in net proceeds** from the Series C Preferred Stock private placement[251](index=251&type=chunk)[254](index=254&type=chunk) - Management has concluded there is **substantial doubt about the company's ability to continue as a going concern**, with cash expected to fund operations into Q4 2021[116](index=116&type=chunk)[257](index=257&type=chunk)[258](index=258&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=48&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk.) This disclosure is not required as the company qualifies as a smaller reporting company - As a **smaller reporting company**, this section is not required[265](index=265&type=chunk) [Controls and Procedures](index=48&type=section&id=Item%204.%20Controls%20and%20Procedures.) Disclosure controls and procedures were deemed not effective due to a previously identified material weakness - Management concluded that **disclosure controls and procedures were not effective** due to a material weakness in internal control over financial reporting[266](index=266&type=chunk) - There were **no changes in internal control over financial reporting** during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[267](index=267&type=chunk) PART II - OTHER INFORMATION [Legal Proceedings](index=49&type=section&id=Item%201.%20Legal%20Proceedings.) The company is not currently a party to any legal proceedings - The company is **not party to any legal proceedings**[270](index=270&type=chunk) [Risk Factors](index=49&type=section&id=Item%201A.%20Risk%20Factors.) No new or materially changed risk factors were reported for the period - **No new risk factors** are reported in this section[271](index=271&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=49&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds.) The company issued unregistered common stock as dividends and stock purchase warrants for services - Issued **3,479 shares of common stock** as dividends on outstanding Series B Preferred Stock[272](index=272&type=chunk) - Issued **50,000 stock purchase warrants** for services with an exercise price of $1.824 per share[272](index=272&type=chunk) [Defaults Upon Senior Securities](index=49&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities.) The company reports no defaults upon its senior securities - **None**[274](index=274&type=chunk) [Mine Safety Disclosures](index=49&type=section&id=Item%204.%20Mine%20Safety%20Disclosures.) This section is not applicable to the company's operations - **Not applicable**[275](index=275&type=chunk) [Other Information](index=49&type=section&id=Item%205.%20Other%20Information.) The Board approved retention bonuses totaling $97,250 and a change to an unlimited vacation policy - On February 11, 2021, the Board approved retention bonuses for John Liatos (**$56,000**) and Steve Rychnovsky (**$41,250**)[276](index=276&type=chunk) - On February 11, 2021, the Board approved the modification of the company's vacation policy to an **unlimited policy**[277](index=277&type=chunk) [Exhibits](index=50&type=section&id=Item%206.%20Exhibits.) This section lists all exhibits filed with the report, including SOX certifications and XBRL data - Lists exhibits filed with the report, including **officer certifications** pursuant to the Sarbanes-Oxley Act and **XBRL data files**[279](index=279&type=chunk)
Kintara Therapeutics(KTRA) - 2021 Q1 - Quarterly Report
2020-11-12 21:11
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2020 or ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-37823 Kintara Therapeutics, Inc. (858) 350-4364 (Registrant's telephone number, including area code) N/A (Former name, former add ...
Kintara Therapeutics(KTRA) - 2020 Q4 - Annual Report
2020-09-18 21:27
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D. C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended June 30, 2020 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from Commission file number 001-37823 Kintara Therapeutics, Inc. (Exact name of registrant as specified in its charter) Indicate by check mark whether the registrant (1) has filed all ...
Kintara Therapeutics (KTRA) Investor Presentation - Slideshow
2020-09-04 17:34
CONFIDENTIAL erape Developing Advanced Oncology Therapies for Rare Unmet Medical Needs Corporate Presentation August 2020 Copyright © 2020 Kintara Therapeutics, Inc. Forward Looking Statements This presentation contains forward-looking statements based upon Kintara's current expectations. This communication contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are identified by terminology such as "may," "should," "expect ...
Kintara Therapeutics(KTRA) - 2020 Q3 - Quarterly Report
2020-05-13 12:49
þ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2020 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) or ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to ________________ Commission file number: 001-37823 DelMar Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Nevada 99-036 ...
Kintara Therapeutics(KTRA) - 2020 Q2 - Quarterly Report
2020-02-13 13:03
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) þ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2019 or ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to ________________ Commission file number: 001-37823 DelMar Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) (State or ...
Kintara Therapeutics(KTRA) - 2020 Q1 - Quarterly Report
2019-11-13 21:56
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) þ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2019 or ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to ________________ Commission file number: 001-37823 DelMar Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) (State or ...
DelMar Pharmaceuticals (DMPI) Presents At MicroCap Rodeo Investor Conference - Slideshow
2019-10-17 18:56
Breakthrough Cancer Therapeutics VAL-083: Validated DNA-targeting Agent for Multiple Drug Resistant Solid Tumor Indications October 2019 NASDAQ: DMPI Forward Looking Statements Any statements contained in this presentation that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein or made in the course of the presentation are based on current expectations, but ...
Kintara Therapeutics(KTRA) - 2019 Q4 - Annual Report
2019-09-09 20:18
Part I [Business](index=3&type=section&id=Item%201.%20Business.) DelMar Pharmaceuticals is a clinical-stage biopharmaceutical company developing VAL-083 for drug-resistant cancers, primarily MGMT-unmethylated glioblastoma multiforme, with two Phase 2 studies underway - The company's lead product candidate is **VAL-083**, a novel DNA-targeting agent for treating drug-resistant solid tumors, particularly glioblastoma multiforme (GBM)[13](index=13&type=chunk)[14](index=14&type=chunk) - DelMar's development strategy focuses on biomarker-selected patient populations, specifically **MGMT-unmethylated GBM**, which represents over **60%** of GBM patients and is associated with resistance to the standard chemotherapy, temozolomide (TMZ)[15](index=15&type=chunk)[17](index=17&type=chunk) - VAL-083 has received Orphan Drug designation from the FDA for glioma, medulloblastoma, and ovarian cancer, and from the EMA for glioma, providing potential market exclusivity[21](index=21&type=chunk)[196](index=196&type=chunk) - The company is conducting two Phase 2 studies in MGMT-unmethylated GBM: one at MD Anderson Cancer Center for recurrent and adjuvant settings, and another at Sun Yat-sen University Cancer Center for newly-diagnosed patients[17](index=17&type=chunk)[58](index=58&type=chunk)[67](index=67&type=chunk) Research and Development Expenses | Category | FY 2019 ($) | FY 2018 ($) | | :--- | :--- | :--- | | **Research and Development Expenses** | 3,662,056 | 7,132,952 | [Recent Developments and Financing](index=5&type=section&id=Item%201.%20Business.%20-%20Recent%20Developments) DelMar completed significant financing activities in fiscal year 2019, raising over $9 million to fund clinical studies, relocated its headquarters, and regained Nasdaq compliance - In August 2019, the company closed an underwritten public offering, raising net proceeds of approximately **$6.7 million** to fund clinical studies and general corporate purposes[27](index=27&type=chunk)[31](index=31&type=chunk)[32](index=32&type=chunk) - In June 2019, the company raised approximately **$3.2 million** in net proceeds from a registered direct offering of common stock and warrants[29](index=29&type=chunk)[38](index=38&type=chunk) - The company regained compliance with Nasdaq stockholders' equity requirements in September 2019 following its recent financing activities[29](index=29&type=chunk) - The company relocated its headquarters from Vancouver, British Columbia to San Diego, California as of September 1, 2019[27](index=27&type=chunk) [Clinical Pipeline: VAL-083](index=9&type=section&id=Item%201.%20Business.%20-%20Clinical%20Pipeline%3A%20VAL-083) VAL-083's clinical development focuses on glioblastoma multiforme with two Phase 2 trials ongoing, showing promising preliminary data, while ovarian cancer strategy is being reassessed - The company is conducting a Phase 2 study at MD Anderson Cancer Center for MGMT-unmethylated GBM patients in two arms: recurrent (Avastin-naïve) and adjuvant (post-chemoradiation)[53](index=53&type=chunk)[58](index=58&type=chunk) - A Phase 2 study in newly diagnosed MGMT-unmethylated GBM patients is ongoing at SYSUCC in China, evaluating VAL-083 with radiotherapy. As of August 1, 2019, of 17 evaluable patients, **53% achieved a complete response** and **41% had stable disease**[67](index=67&type=chunk)[71](index=71&type=chunk)[72](index=72&type=chunk) - Preliminary data from the SYSUCC study indicates that VAL-083 crosses the blood-brain barrier, with concentrations in cerebrospinal fluid (CSF) generally higher than in plasma two hours post-infusion[72](index=72&type=chunk)[73](index=73&type=chunk)[74](index=74&type=chunk) - The FDA has granted Fast Track designation for VAL-083 in recurrent GBM, which may expedite the review process[77](index=77&type=chunk)[78](index=78&type=chunk) - The company is reassessing its ovarian cancer program and evaluating strategic options, including potential combinations with PARP inhibitors, despite having an allowed IND for a Phase 1/2 study[19](index=19&type=chunk)[76](index=76&type=chunk) [Intellectual Property](index=27&type=section&id=Item%201.%20Business.%20-%20Intellectual%20Property) DelMar protects VAL-083 through a broad patent portfolio extending to 2038 and Orphan Drug designations in the U.S. and E.U., providing potential market exclusivity - The company's patent portfolio is organized into fourteen series, covering synthesis, methods of use for various cancers (GBM, NSCLC, ovarian), analytical methods, and combination therapies, with some patents expected to expire as late as **2038**[182](index=182&type=chunk)[194](index=194&type=chunk) - VAL-083 has been granted Orphan Drug designation by the FDA for glioma, medulloblastoma, and ovarian cancer, and by the EMA for glioma[196](index=196&type=chunk)[197](index=197&type=chunk) - The company intends to rely on the Hatch-Waxman Amendments, which could provide **five years of data exclusivity** for VAL-083 as a new chemical entity upon approval[199](index=199&type=chunk) [Competition](index=36&type=section&id=Item%201.%20Business.%20-%20Competition) The oncology market is highly competitive, with DelMar facing larger pharmaceutical companies and other GBM developers, requiring strong efficacy and regulatory success to compete - The company faces competition from large pharmaceutical and biotechnology companies with greater resources, including those with currently marketed products for GBM such as Merck (Temodar) and Genentech (Avastin)[227](index=227&type=chunk)[229](index=229&type=chunk) - Other companies developing oncology immunotherapy products for GBM include Northwest Biotherapeutics (DCVax-L) and Celldex Therapeutics (Rindopepimut)[229](index=229&type=chunk) - Competitive success depends on demonstrating superior safety and efficacy, obtaining timely regulatory approvals, maintaining a strong proprietary position, and building an effective sales and marketing infrastructure[233](index=233&type=chunk) [Risk Factors](index=38&type=section&id=Item%201A.%20Risk%20Factors.) The company faces substantial risks including a history of losses, reliance on VAL-083, internal control weaknesses, Nasdaq listing concerns, and dependence on third parties for operations - The company has a history of operating losses and expects to incur significant additional losses. It will need to raise more capital to fund operations beyond the **fourth quarter of calendar 2020**[244](index=244&type=chunk)[245](index=245&type=chunk) - The company's success is highly dependent on a single product candidate, VAL-083. Failure of this product in clinical trials would severely impact the business[258](index=258&type=chunk) - A material weakness in internal control over financial reporting has been identified due to inadequate segregation of duties, which could affect the accuracy of financial reporting[255](index=255&type=chunk)[569](index=569&type=chunk) - The company has previously faced non-compliance with Nasdaq's listing requirements (e.g., minimum bid price) and may be delisted if it fails to maintain compliance in the future[251](index=251&type=chunk)[253](index=253&type=chunk) - The company relies on third parties for manufacturing clinical supplies and conducting clinical trials, which reduces control over these critical activities and exposes the company to risks of delay or non-performance[342](index=342&type=chunk)[344](index=344&type=chunk)[355](index=355&type=chunk) [Properties](index=61&type=section&id=Item%202.%20Properties.) The company's corporate headquarters are in San Diego, with an administrative office in Vancouver and clinical operations in Menlo Park, facilities deemed sufficient for immediate needs - Corporate headquarters are located at 12707 High Bluff Dr., Suite 200, San Diego, CA, 92130, having recently relocated from Vancouver, BC[366](index=366&type=chunk) - The Vancouver office is maintained on a month-to-month lease for **C$3,725 per month**[366](index=366&type=chunk) [Legal Proceedings](index=61&type=section&id=Item%203.%20Legal%20Proceedings.) As of the report date, DelMar Pharmaceuticals, Inc. is not a party to any legal proceedings, nor is any of its property the subject of such proceedings - There are no legal proceedings to which the company is a party[367](index=367&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=62&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities.) The company's common stock trades on Nasdaq under 'DMPI', with approximately 314 holders of record, and it has no plans to pay cash dividends in the foreseeable future - The company's common stock is traded on The Nasdaq Capital Market under the symbol '**DMPI**'[371](index=371&type=chunk) - The company has never paid cash dividends and does not intend to in the foreseeable future[373](index=373&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=63&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) For FY2019, net loss decreased to $8.0 million due to reduced R&D expenses, while G&A increased, with post-fiscal year financing alleviating going concern doubts Financial Performance Comparison | | Years ended June 30, | Change | | :--- | :--- | :--- | | | **2019 ($)** | **2018 ($)** | **$** | **%** | | Research and development | 3,662,056 | 7,132,952 | (3,470,896) | (49) | | General and administrative | 4,736,440 | 4,041,711 | 694,729 | 17 | | Net loss and comprehensive loss | 8,048,221 | 11,138,312 | (3,090,091) | (28) | - R&D expenses decreased by **49% to $3.7 million** in FY2019, largely due to the termination of the STAR-3, Phase 3 study, which had incurred significant start-up costs in the prior year[395](index=395&type=chunk)[397](index=397&type=chunk) - G&A expenses increased by **17% to $4.7 million** in FY2019, primarily due to professional fees of **$555,664** related to a terminated Rights Offering and increased personnel costs[399](index=399&type=chunk)[400](index=400&type=chunk) Cash Flows | | Years ended June 30, | | :--- | :--- | | | **2019 ($)** | **2018 ($)** | | Cash flows from operating activities | (6,327,425) | (9,850,850) | | Cash flows from financing activities | 4,074,188 | 9,249,480 | - The company's ability to continue as a going concern was in substantial doubt, but this was alleviated by a post-year-end financing in August 2019 that raised approximately **$6.7 million** in net proceeds[441](index=441&type=chunk) [Financial Statements and Supplementary Data](index=71&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data.) Audited financial statements for FY2019 show the company in a development stage with no revenue, a net loss of $8.0 million, and subsequent financing alleviating going concern doubts Balance Sheet Data | | June 30, 2019 ($) | June 30, 2018 ($) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | 3,718,758 | 5,971,995 | | Total assets | 4,037,255 | 7,074,855 | | **Liabilities & Equity** | | | | Total liabilities | 2,069,725 | 1,639,632 | | Total stockholders' equity | 1,967,530 | 5,435,223 | Income Statement Data | | Year ended June 30, 2019 ($) | Year ended June 30, 2018 ($) | | :--- | :--- | :--- | | Research and development | 3,662,056 | 7,132,952 | | General and administrative | 4,736,440 | 4,041,711 | | Net and comprehensive loss | 8,048,221 | 11,138,312 | | Basic and fully diluted loss per share | 3.16 | 5.42 | - The independent auditor's report from Ernst & Young LLP provides an unqualified opinion on the consolidated financial statements[426](index=426&type=chunk) - Subsequent to year-end, in August 2019, the company completed an underwritten public offering for net proceeds of approximately **$6.7 million**, which alleviated substantial doubt about its ability to continue as a going concern[441](index=441&type=chunk)[557](index=557&type=chunk)[558](index=558&type=chunk) [Controls and Procedures](index=69&type=section&id=Item%209A.%20Controls%20and%20Procedures.) Management concluded that disclosure controls and internal control over financial reporting were ineffective as of June 30, 2019, due to inadequate segregation of duties, with remediation efforts underway - Management concluded that disclosure controls and procedures were not effective as of June 30, 2019[567](index=567&type=chunk) - A material weakness in internal control over financial reporting was identified due to inadequate segregation of duties over authorization, review, and recording of transactions[569](index=569&type=chunk) - The company's remediation plan includes engaging an external consulting firm to assist with internal accounting functions and enhance internal controls[570](index=570&type=chunk) Part III [Directors, Executive Officers, and Corporate Governance](index=71&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%2C%20and%20Corporate%20Governance.) This section details biographical information for directors and executive officers, the Board's committee structure, and the company's adopted Code of Ethics and Business Conduct Key Personnel | Name | Age | Position | | :--- | :--- | :--- | | Robert E. Hoffman | 53 | Chairman of the Board | | Saiid Zarrabian | 67 | President, Chief Executive Officer and Director | | Dennis Brown, PhD | 70 | Chief Scientific Officer | | Scott Praill, CPA | 53 | Chief Financial Officer | | John K. Bell, FCPA, CPA | 72 | Director | | Lynda Cranston, BScN, MScN, ICD.D | 72 | Director | | Napoleone Ferrara, MD | 63 | Director | | Robert J. Toth, Jr., MBA | 56 | Director | - The Board of Directors has an Audit Committee, a Nominating and Corporate Governance Committee, and a Compensation Committee[590](index=590&type=chunk)[591](index=591&type=chunk)[592](index=592&type=chunk) - The company has adopted a Code of Ethics and Business Conduct, which is available on its website[597](index=597&type=chunk) [Executive Compensation](index=75&type=section&id=Item%2011.%20Executive%20Compensation.) Executive compensation for FY2019 included salaries, bonuses, and equity awards, with director compensation comprising retainers and stock options, and all PSUs cancelled in April 2019 Named Executive Officer Compensation | Name and Principal Position | Period | Salary (US$) | Bonus (US$) | Equity Awards (US$) | Total (US$) | | :--- | :--- | :--- | :--- | :--- | :--- | | **Saiid Zarrabian, President and CEO** | **FY 2019** | **470,000** | **165,665** | **—** | **635,665** | | | FY 2018 | 237,412 | 85,631 | 615,992 | 939,035 | | **Dennis Brown, PhD, Chief Scientific Officer** | **FY 2019** | **200,000** | **—** | **—** | **200,000** | | | FY 2018 | 200,000 | — | — | 200,000 | | **Scott Praill, Chief Financial Officer** | **FY 2019** | **220,000** | **52,250** | **30,627** | **302,877** | | | FY 2018 | 200,000 | 10,000 | — | 210,000 | - Independent directors received an annual retainer of **$35,000**, with additional retainers for committee chairs and the board chairman. They also received stock option grants in November 2018[609](index=609&type=chunk)[610](index=610&type=chunk) - All outstanding Performance Stock Units (PSUs) held by directors were cancelled on April 30, 2019[521](index=521&type=chunk)[610](index=610&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=79&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters.) As of September 6, 2019, directors and executive officers collectively owned 2.93% of common stock, with no single beneficial owner exceeding 5%, and shares available under the equity incentive plan - As of September 6, 2019, all officers and directors as a group beneficially owned **335,019 shares**, representing **2.93%** of the outstanding common stock[613](index=613&type=chunk) - No stockholder was reported as beneficially owning more than **5%** of the common stock[612](index=612&type=chunk) Equity Compensation Plan Information | Plan Category | Securities to be issued upon exercise | Weighted-average exercise price | Securities remaining available for future issuance | | :--- | :--- | :--- | :--- | | Equity compensation plans approved by security holders | 122,698 | $8.81 | 491,817 | | Equity compensation plans not approved by security holders | 165,485 | $32.32 | - | | **Totals** | **288,183** | **$22.31** | **491,817** | [Certain Relationships and Related Transactions, and Director Independence](index=81&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence.) The company has a related party transaction with Valent Technologies LLC for VAL-083 rights, and five directors are deemed independent under Nasdaq Marketplace Rules - The company acquired the rights to VAL-083 from Valent Technologies LLC, an entity controlled by Chief Scientific Officer Dr. Dennis Brown, in exchange for future royalties[618](index=618&type=chunk)[620](index=620&type=chunk) - A **$250,000** loan from Valent was settled in 2014 through the issuance of **278,530 shares** of Series A Preferred Stock, which carry a **3% annual dividend**[619](index=619&type=chunk) - Five directors are deemed independent under Nasdaq Marketplace Rules: John K. Bell, Robert J. Toth, Jr., Lynda Cranston, Robert E. Hoffman, and Napoleone Ferrara, MD[621](index=621&type=chunk) [Principal Accountant Fees and Services](index=81&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services.) The company paid Ernst & Young LLP $315,600 in fees for FY2019, primarily for audit and audit-related services, all pre-approved by the audit committee Auditor Fees | Fee Category | Year Ended June 30, 2019 ($) | Year Ended June 30, 2018 ($) | | :--- | :--- | :--- | | Audit fees | 132,800 | 137,800 | | Audit related fees | 182,800 | 22,000 | | Tax fees | - | - | | All other fees | - | - | | **Total fees** | **315,600** | **159,800** | - Ernst & Young LLP (E&Y) was appointed as the company's auditor on October 7, 2016[622](index=622&type=chunk) Part IV [Exhibits](index=82&type=section&id=Item%2015.%20Exhibits.) This section lists all exhibits filed with the Form 10-K, including corporate governance documents, material contracts, and required certifications from management and the auditor - Lists key corporate documents such as Articles of Incorporation (3.1), Bylaws (3.4), and various amendments[631](index=631&type=chunk) - Includes material agreements such as the collaboration agreement with Guangxi Wuzhou Pharmaceutical (10.5), the Patent Assignment Agreement with Valent (10.6), and various financing and employment agreements[633](index=633&type=chunk)[634](index=634&type=chunk) - Contains required certifications from the CEO and CFO under Sections 302 and 906 of the Sarbanes-Oxley Act, and the consent of the auditor, Ernst & Young, LLP[634](index=634&type=chunk)