OPERATIONS AND FINANCING	9 Months Ended
Jun. 30, 2022
OPERATIONS AND FINANCING
Operations And Financing	B. OPERATIONS AND FINANCING On June 28, 2021, the Company announced results from its 9.5-year pivotal Phase 3 study for its immunotherapy Multikine® (Leukocyte Interleukin, Injection) in the treatment of advanced (stages III and IV) primary (previously untreated) squamous cell carcinoma of the head and neck (SCCHN). The Phase 3 results showed a long-term 5-year overall survival (OS) benefit in the treatment arm that received Multikine treatment followed by surgery and radiation. This survival benefit was robust and durable, with no safety issues, something not commonly seen with cancer drugs. In fact, the survival benefit increased over time and at 5 years the overall survival benefit reached an absolute 14.1% advantage for the Multikine treated arm over control (n=380, total study patients treated with surgery plus radiation), control arm 48.6%, Multikine arm 62.7% survival. The study used the standard of care treatment for advanced primary head and neck cancer patients as a comparison. The patients received surgery followed by either radiation or chemoradiation (chemotherapy and radiation at the same time), as determined by the physician. This meant that there were two treatment arms: (1) surgery plus radiation or (2) surgery plus chemoradiation. The arm that received Multikine treatment followed by surgery and radiation showed great survival benefit, but when chemotherapy was added in the second treatment arm, the immunological effect of Multikine was negated. Therefore, when the two treatment arms were combined the study did not achieve its primary endpoint of a 10% improvement in overall survival. Multikine is given for three weeks after cancer diagnosis, but before surgery and other treatments. In the peer-reviewed abstract presented at ASCO, a clear survival advantage for patients treated with Multikine prior to surgery in the surgery-plus-radiation arm of the IT-MATTERS study was described. The survival advantage was driven by objective data derived from patients in the intent-to-treat (ITT) population who had a significant number of early complete and partial tumor responses which occurred prior to surgery. Five patients in the study had their tumors completely disappear (confirmed by pathology) before surgery. In the ITT population as a whole, 8.5% of all Multikine-treated patients had a tumor response before surgery, but not a single tumor response before surgery was seen in the ITT control group before surgery, statistically a highly significant finding (p-value of less than 0.00000000001). This indicates that the likelihood of seeing these results by chance is less than 1 in ten billion. These results confirm findings from the Phase 1 and 2 studies with Multikine and provide direct evidence of Multikine’s anticancer activity. Liquidity The Company has incurred significant costs since its inception for the acquisition of certain proprietary technology and scientific knowledge relating to the human immunological defense system, patent applications, research and development, administrative costs, construction and expansion of manufacturing and laboratory facilities, and participation in clinical trials. The Company has funded such costs primarily with proceeds from loans and the public and private sale of its securities. The Company will be required to raise additional capital or find additional long-term financing to continue with its efforts to bring Multikine to market. The ability to raise capital may be dependent upon market conditions that are outside the control of the Company. The ability of the Company to obtain approval from the U.S. Food and Drug Administration (FDA) for the sale of products to be developed on a commercial basis is uncertain. Ultimately, the Company must complete the development of its products, obtain the appropriate regulatory approvals and obtain sufficient revenues to support its cost structure. The Company believes there is a high likelihood that it will continue to receive funds from private and public offerings and warrant exercises similar to the way it has funded operations in the past. However, there can be no assurance that the Company will be able to raise sufficient capital to support its operations. To finance the Company through marketing approval, the Company plans to raise additional capital in the form of warrant exercises, corporate partnerships, and debt and/or equity financings. The Company believes that it will be able to obtain additional financing because it has done so consistently in the past and because it showed great survival benefit in the Phase 3 study in one of the two treatment arms for advanced primary head and neck cancer. However, there can be no assurance that the Company will be successful in raising additional funds on a timely basis or that the funds will be available to the Company on acceptable terms or at all. If the Company does not raise the necessary amounts of money, it may have to curtail its operations until such time as it is able to raise the required funding. Primarily because of the losses incurred to date, the expected continued future losses, and the uncertainties associated with obtaining regulatory approval and ultimately commercializing its products, management has identified conditions and events that raise substantial doubt about the Company’s ability to continue as a going concern. Management has evaluated the significance of those conditions and has concluded that there is sufficient cash on hand to meet the Company’s budgeted cash requirements. As a result, substantial doubt about the Company’s ability to continue as a going concern for more than twelve months from the date of these financial statements has been alleviated. Impact of the COVID-19 Pandemic In response to the global outbreak of COVID-19 and the World Health Organization’s classification of the outbreak as a pandemic, the Company continues to take the necessary precautions to ensure the safety of its employees and to minimize interruptions to its operations. Management follows the Centers for Disease Control and Prevention’s (CDC) guidance and the recommendations and restrictions provided by state and local authorities. The full impact of the COVID-19 outbreak continues to evolve as of the date of this report. As such, it is uncertain as to the full impact the pandemic will have on the Company’s future financial condition, liquidity and results of operations. Management is actively monitoring the risks to public health and the impact of overall global business activity on the Company’s financial condition, liquidity, operations, suppliers, industry, and workforce.

OPERATIONS AND FINANCING

9 Months Ended

Jun. 30, 2022

B. OPERATIONS AND FINANCING

On June 28, 2021, the Company announced results from its 9.5-year pivotal Phase 3 study for its immunotherapy Multikine® (Leukocyte Interleukin, Injection) in the treatment of advanced (stages III and IV) primary (previously untreated) squamous cell carcinoma of the head and neck (SCCHN). The Phase 3 results showed a long-term 5-year overall survival (OS) benefit in the treatment arm that received Multikine treatment followed by surgery and radiation. This survival benefit was robust and durable, with no safety issues, something not commonly seen with cancer drugs. In fact, the survival benefit increased over time and at 5 years the overall survival benefit reached an absolute 14.1% advantage for the Multikine treated arm over control (n=380, total study patients treated with surgery plus radiation), control arm 48.6%, Multikine arm 62.7% survival.

The study used the standard of care treatment for advanced primary head and neck cancer patients as a comparison. The patients received surgery followed by either radiation or chemoradiation (chemotherapy and radiation at the same time), as determined by the physician. This meant that there were two treatment arms: (1) surgery plus radiation or (2) surgery plus chemoradiation. The arm that received Multikine treatment followed by surgery and radiation showed great survival benefit, but when chemotherapy was added in the second treatment arm, the immunological effect of Multikine was negated. Therefore, when the two treatment arms were combined the study did not achieve its primary endpoint of a 10% improvement in overall survival.

Multikine is given for three weeks after cancer diagnosis, but before surgery and other treatments. In the peer-reviewed abstract presented at ASCO, a clear survival advantage for patients treated with Multikine prior to surgery in the surgery-plus-radiation arm of the IT-MATTERS study was described. The survival advantage was driven by objective data derived from patients in the intent-to-treat (ITT) population who had a significant number of early complete and partial tumor responses which occurred prior to surgery. Five patients in the study had their tumors completely disappear (confirmed by pathology) before surgery. In the ITT population as a whole, 8.5% of all Multikine-treated patients had a tumor response before surgery, but not a single tumor response before surgery was seen in the ITT control group before surgery, statistically a highly significant finding (p-value of less than 0.00000000001). This indicates that the likelihood of seeing these results by chance is less than 1 in ten billion. These results confirm findings from the Phase 1 and 2 studies with Multikine and provide direct evidence of Multikine’s anticancer activity.

Liquidity

The Company has incurred significant costs since its inception for the acquisition of certain proprietary technology and scientific knowledge relating to the human immunological defense system, patent applications, research and development, administrative costs, construction and expansion of manufacturing and laboratory facilities, and participation in clinical trials. The Company has funded such costs primarily with proceeds from loans and the public and private sale of its securities. The Company will be required to raise additional capital or find additional long-term financing to continue with its efforts to bring Multikine to market. The ability to raise capital may be dependent upon market conditions that are outside the control of the Company. The ability of the Company to obtain approval from the U.S. Food and Drug Administration (FDA) for the sale of products to be developed on a commercial basis is uncertain. Ultimately, the Company must complete the development of its products, obtain the appropriate regulatory approvals and obtain sufficient revenues to support its cost structure. The Company believes there is a high likelihood that it will continue to receive funds from private and public offerings and warrant exercises similar to the way it has funded operations in the past. However, there can be no assurance that the Company will be able to raise sufficient capital to support its operations.

To finance the Company through marketing approval, the Company plans to raise additional capital in the form of warrant exercises, corporate partnerships, and debt and/or equity financings. The Company believes that it will be able to obtain additional financing because it has done so consistently in the past and because it showed great survival benefit in the Phase 3 study in one of the two treatment arms for advanced primary head and neck cancer. However, there can be no assurance that the Company will be successful in raising additional funds on a timely basis or that the funds will be available to the Company on acceptable terms or at all. If the Company does not raise the necessary amounts of money, it may have to curtail its operations until such time as it is able to raise the required funding.

Primarily because of the losses incurred to date, the expected continued future losses, and the uncertainties associated with obtaining regulatory approval and ultimately commercializing its products, management has identified conditions and events that raise substantial doubt about the Company’s ability to continue as a going concern. Management has evaluated the significance of those conditions and has concluded that there is sufficient cash on hand to meet the Company’s budgeted cash requirements. As a result, substantial doubt about the Company’s ability to continue as a going concern for more than twelve months from the date of these financial statements has been alleviated.

Impact of the COVID-19 Pandemic

In response to the global outbreak of COVID-19 and the World Health Organization’s classification of the outbreak as a pandemic, the Company continues to take the necessary precautions to ensure the safety of its employees and to minimize interruptions to its operations. Management follows the Centers for Disease Control and Prevention’s (CDC) guidance and the recommendations and restrictions provided by state and local authorities. The full impact of the COVID-19 outbreak continues to evolve as of the date of this report. As such, it is uncertain as to the full impact the pandemic will have on the Company’s future financial condition, liquidity and results of operations. Management is actively monitoring the risks to public health and the impact of overall global business activity on the Company’s financial condition, liquidity, operations, suppliers, industry, and workforce.