On November 17, 2022 Rakovina Therapeutics Inc. (TSX-V: RKV, the "Company") a biopharmaceutical company committed to advancing new cancer therapies based on novel DNA-damage response technologies reported the financial results for the quarter ended September 30, 2022 and provided a corporate update (Press release, Rakovina Therapeutics, NOV 17, 2022, View Source,September%2030%2C%202022%2C%20respectively. [SID1234624211]).

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Corporate Update

Rakovina Therapeutics has continued to communicate progress in the Company’s research and development programs through presentations at peer-reviewed scientific meetings and publications:

On October 31, 2022, the Company announced our presentation at the 34th Annual AACR (Free AACR Whitepaper)-NCI-EORTC Molecular Targets and Cancer Therapeutics Symposium;
On November 14, 2022, the Company announced the preprint publication of a manuscript entitled ‘A bi-functional PARP-HDAC inhibitor with activity in Ewing sarcoma’. The manuscript reports research results of our kt-3000 dual PARP-HDAC inhibitor drug candidate in HR-proficient Ewing sarcoma models.
"Our data support advancing lead compounds from our kt-3000 PARP-HDAC inhibitor series as a novel approach in the treatment of Ewing sarcoma," stated Prof. Mads Daugaard Rakovina Therapeutics’ president and chief scientific officer. "This concept will likely be relevant in the treatment of cancer indications beyond Ewing sarcoma and potentially offer an opportunity to overcome therapeutic resistance to PARP-inhibitor treatment."

Rakovina Therapeutics’ kt-3000 series is a novel class of bi-functional small-molecule drug candidates that has been designed to combine inhibition of both poly(ADP)-ribose polymerase (PARP) and histone deacetylase (HDAC) in a single molecule as a novel approach to providing meaningful clinical benefit to cancer patients.

Data presented demonstrate that the kt-3000 prototype lead compound performs 30-40 times better than the FDA-approved PARP inhibitor olaparib (Lynparza) and 5-10 times better than the FDA-approved HDAC-inhibitor vorinostat (Zolina) in Ewing sarcoma 3D spheroid models. In an Ewing sarcoma metastasis model, a kt-3000 drug candidate prevented metastatic cancer growth in the lungs of mice inoculated with an aggressive Ewing sarcoma cell line. The Company believes that these data provide proof-of-concept validation of kt-3000 drug candidates to address significant unmet needs in the treatment of Ewing sarcoma and other solid tumors.

Ewing sarcoma is a cancer that occurs primarily in the bone or soft tissues and is the second most common type of bone cancer affecting children and young adults. The development of new and improved treatments for Ewing sarcoma represents a significant unmet medical need. Approximately thirty percent of patients will experience recurrence within five years following treatment. The prognosis for patients with recurrent or progressive Ewing sarcoma is poor with average survival from the time of relapse of only 14 months.

A kt-3000 series drug candidate for the treatment of recurrent Ewing sarcoma may qualify for an FDA priority review voucher. Under this program, a sponsor who receives an approval for a drug or biologic for a "rare pediatric disease" may qualify for a voucher that can be redeemed to receive a priority review of a subsequent marketing application for a different product.

If received, a priority review voucher could be used to accelerate the regulatory review of another Rakovina Therapeutics drug candidate or it could be sold to a third party. During 2022, multiple companies sold priority review vouchers at prices ranging from US$100 million to US$110 million.

"Based on our progress to date, we are confident that we may be in a position to file regulatory documentation to begin human clinical trials with a kt-3000 series drug candidate in the second half of 2023," stated Prof. Daugaard. "Because early-stage clinical trials in the cancer field are often ‘open label’, we will have the opportunity to report continued progress of our future clinical trials at peer-reviewed scientific meetings."

The Company also reported continued progress within its other research programs.

kt-2000 series drug candidates are being optimized to achieve PARP-1 selectivity and therapeutically relevant brain penetration. Recent research has suggested an improved safety profile for PARP-1 selective compounds vs. PARP-1/2 inhibitors.

Currently, the four FDA-approved PARPi are all PARP-1/2 inhibitors with limited brain penetration. Rakovina Therapeutics believes that a PARP-1 selective brain-penetrant drug candidate from our kt-2000 series will provide attractive opportunities to establish collaborations with leading pharmaceutical companies.
kt-4000 series drug candidates combine a targeted DNA-damaging functionality with potent PARP inhibition in a single molecule. Earlier this year, the Company presented data at the American Association of Cancer Research Annual Meeting demonstrating that treatment with kt-4000 series candidates leads to G2/M cell cycle arrest and cell death in HR-proficient cancer cells, normally resistant to PARP inhibitor treatment.
Summary Financial Results for the quarter ended September 30, 2022

The Company commenced operations on March 25, 2021, concurrent with the closing of the qualifying transaction with Vincero Capital Corp. and began trading on the Toronto Venture Exchange under the symbol RKV on April 1, 2021. At September 30, 2022, the Company had positive working capital of approximately $1.4 million.

For the three and nine months ended September 30, 2022, the Company reported a net loss of $715,880 and $2,143,808 respectively. Research and development expenses were $541,447 and $1,427,949 for the three and nine months ended September 30, 2022, respectively. General and administrative expenses were $185,903 and $736,671 for the three and nine months ended September 30, 2022, respectively. Total cash expenses related to research and development and general and administrative expenses for the three months ended September 30, 2022 were $529,462.