Nature of Business	12 Months Ended
Mar. 31, 2021
Organization Consolidation And Presentation Of Financial Statements [Abstract]
Nature of Business	Note 1. Nature of Business Tyme Technologies, Inc. is a Delaware corporation headquartered in Bedminster, New Jersey, with a wholly owned subsidiary, Tyme Inc. (together, “TYME” or the “Company”). The majority of the Company’s research, development and other business activities are conducted by Tyme Inc., which was incorporated in Delaware in 2013. TYME is an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs^TM) that are intended to be effective across a broad range of solid tumors and hematologic cancers, while also maintaining patients’ quality of life through relatively low toxicity profiles. TYME’s therapeutic approach is designed to take advantage of a cancer cell’s innate metabolic requirements to cause cancer cell death. The Company’s lead clinical CMBT compound, SM-88, is an oral investigational modified proprietary tyrosine derivative that is hypothesized to interrupt the metabolic processes of cancer cells by breaking down the cells’ key defenses and leading to cell death through oxidative stress and exposure to the body’s natural immune system. Clinical trial data have shown that SM-88 has achieved confirmed tumor responses across 15 different cancers, both solid and liquid tumors, including pancreatic, lung, breast, prostate, sarcoma and lymphoma cancers with minimal drug-related serious Grade 3 or higher adverse events, which the Company believes is rare for investigational compounds. Ongoing Studies The Company has partnered with Pancreatic Cancer Action Network (“PanCAN”) to study SM-88 in an adaptive randomized Phase II/III trial with registration intent known as Precision Promise^SM. The objective of Precision Promise is to expedite the study and approval of promising therapies for pancreatic cancer by bringing multiple stakeholders together, including academic, industry and regulatory entities. In this trial which began in early 2020, SM-88 with the conditioning agents methoxalen, phenytoin, and sirolimus (“MPS”) is being studied as monotherapy treatment arm for patients who have failed one prior line of chemotherapy. PanCAN is sponsoring Precision Promise and providing funding and other support. While TYME’s SM-88 is included in the trial, we do not oversee, conduct or control the trial. In early 2020, the open-label Phase 2 investigator sponsored trial of SM-88 therapy in sarcoma, HoPES, opened. This trial has two cohorts each expecting to enroll 12 patients. The first is SM-88 with MPS as salvage treatment in patients with mixed rare sarcomas, and the other is SM-88 with MPS as maintenance treatment for patients with metastatic Ewing’s sarcoma who had not progressed on prior therapy. The primary objectives are to measure ORR and PFS. Secondary objectives include duration of response, OS, CBR using RECIST, and incidence of treatment-emergent adverse events. The Joseph Ahmed Foundation is providing funding and patient support for this trial and the trial is being conducted by principal investigator Dr. Chawla at the Sarcoma Oncology Center in Santa Monica, CA. We also recently announced an agreement with Georgetown University to support a Phase II trial, OASIS, for SM-88 in patients with metastatic breast cancer who have hormone receptor positive (“HR+”) and human epidermal growth factor receptor 2 negative (“HER2-“) disease (“HR+/HER2-“). This represents approximately 73% of the annual breast cancer diagnosis in the US each year. The OASIS trial is an investigator-initiated prospective open-label Phase II trial evaluating the efficacy and safety of SM-88 with MPS for the treatment of metastatic hormone-receptor positive, HER2- breast cancer after treatment with a CDK4/6 inhibitor. This trial is designed as a two-stage trial, enrolling up to 50 patients to receive SM-88 with MPS without additional therapies in patients who have failed or progressed after receiving two hormonal agents and a CDK4/6 inhibitor. The primary endpoint of this trial is ORR, with secondary endpoints including duration of response (“DOR”), clinical benefit rate (“CBR”) at >24 weeks, progression free survival (“PFS”), and safety. The trial will be conducted at Georgetown University at a total of five sites within the Georgetown/MEDSTAR system located in Washington DC, Maryland, and New Jersey. Patient enrollment is expected to begin in the third quarter of calendar year 2021. In calendar year 2019, the Company presented final SM-88 prostate Phase II clinical data showing encouraging clinical benefit in patients with bio-marker recurrent prostate cancer, with the final results published in the peer-reviewed journal, Investigational New Drugs, on September 13, 2020. Preclinical Pipeline Programs TYME-19 is an oral synthetically produced member of the bile acid family that is being developed for the potential treatment of COVID-19. From the Company’s metabolic understanding of bile acids, it was able to identify TYME-19 as a well characterized candidate and a potential treatment of corona viruses. A patent has been issued for TYME-19 for the treatment of COVID-19. Bile acids can cellular modulate lipid and glucose metabolism and can remediate dysregulated protein folding, each that are relevant to viral infection of a host cell. Existing literature has shown that certain bile acids can have antiviral properties in a range of different viruses, including prior corona viruses. Our initial preclinical in vitro experiments displayed effectiveness against COVID-19 infection and replication, and we continue to conduct additional tests to support the potential utility of TYME-19 in the treatment of COVID-19 and disease variants. With the ever-changing dynamics of this disease area, the company’s intent with this program is to prepare this agent for clinical testing, while learning from the ongoing work in an effort to identify an optimal clinical setting where TYME-19 could potentially offer clinical benefits, and for which there may be a sustainable market. TYME-18 is a pre-clinical CMBT compound under development that is delivered intratumorally. TYME-18 is a combination of a proprietary surfactant system and natural sulfonic/bile acid that is designed to disrupt energy metabolism and have lytic function for potential treatment of inoperable tumors. TYME-18 is distinct in composition from SM-88. However, like SM-88, it aims to enhance the susceptibility of a cancer to the highly acidic and toxic tumor microenvironment, while minimizing the impact to normal tissues. In initial preclinical xenograft mouse studies, TYME-18 was able to completely resolve over 90 percent (11 of 12 mice) of established colorectal tumors within 12 days versus an average of over 600 percent growth in the control animals. TYME-18 is currently in preclinical development, and as with TYME-19, we expect at the proper time, to identify a potential partner with a focus on surgical oncology to assist in the ongoing development of TYME-18. Discontinuing Programs TYME-88-PANC (Part 2) (third-line Metastatic Pancreatic Cancer) In fiscal year 2020, we launched our pivotal study for SM-88 in the third-line treatment of pancreatic cancer through an amendment to our ongoing TYME-88-Panc trial (Part 2), with the first patient dosed in the third quarter of the fiscal year. As described previously, the COVID-19 pandemic significantly impacted enrollment of this trial such that it appears it is likely to complete enrollment in a similar timeline to the second-line Precision Promise pancreatic cancer trial. There has also been a higher than expected dropout of patients randomized to the chemotherapy control arm, which could potentially impact the interpretative and regulatory utility of the data. Following a comprehensive strategic review, considering, in part, the timeline and regulatory utility for this trial compared to the parallel Precision Promise trial and concentration of investment in this specific cancer, management concluded that it would be best to focus on the second-line Precision Promise trial that offers treatment options to patients earlier in their disease. Furthermore, the trial includes tumor biopsy and biomarker analyses that aligns with the Company’s overall strategic focus to identifying patients with the best chance of benefit from our therapies. Therefore, the Company has decided to stop enrollment and begin the process of closing down the trial. Patients currently on therapy will be allowed to continue treatment until progression or unacceptable toxicity. The closing of this trial may require several months to complete, with anticipated close out costs to be $2 million to $3 million. Liquidity The consolidated financial statements have been prepared on a going-concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company has historically funded its operations primarily through equity offerings. In February 2021, the Company raised $100 million in gross proceeds through a registered direct offering of 40,000,000 shares of its common stock, at a purchase price of $2.50 per share. The Company incurred $6.2 million of related costs which offset such proceeds. On January 7, 2020, the Company entered into a Securities Purchase Agreement with Eagle Pharmaceuticals, (“Eagle”), pursuant to which the Company raised $20,000,000 through the issuance and sale to Eagle of 10,000,000 shares of common stock, at a price of $2.00 per share. In April 2019, the Company raised net proceeds of $11.3 million after underwriting discounts and before expenses through an underwritten registered offering. On October 18, 2019, TYME entered into an Open Market Sale Agreement^SM(the “Sale Agreement”) with Jefferies LLC (“Jefferies”) as sales agent, pursuant to which the Company may, from time to time, sell shares of Common Stock through Jefferies having an aggregate offering price of up to $30.0 million (the “Jefferies ATM”). In the year ended March 31, 2021, the Company raised approximately $6.1 million in aggregate gross proceeds before commissions and expenses through the Sale Agreement and paid commissions and expenses of $0.3 million. In the year ended March 31, 2020, the Company raised approximately $1.7 million in aggregate gross proceeds before commissions and expenses through the Sale Agreement and paid commissions and expenses of $0.2 million. At March 31, 2021, there remained approximately $22.2 million of availability to sell shares through the Jefferies ATM. The proceeds of the aforementioned offerings are being used by the Company for continued clinical studies, drug commercialization and development activities and other general corporate and operating expenses. For the year ended March 31, 2021, the Company had negative cash flow from operations of $23.6 million and net loss of $29.0 million, which included non-cash expenses of $3.9 million related to the change in fair value of warrant liability and $3.5 million non-cash equity compensation, partially offset by non-cash gain on warrant exchange of $2.2 million. As of March 31, 2021, the Company had working capital of approximately $104.0 million. Management has concluded that substantial doubt does not exist regarding the Company’s ability to satisfy its obligations as they come due during the twelve-month period following the issuance of these financial statements. This conclusion is based on the Company’s assessment of qualitative and quantitative conditions and events, considered in aggregate as of the date of issuance of these financial statements that are known and reasonably knowable. Among other relevant conditions and events, the Company has considered its operational plans, liquidity sources, obligations due or expected, funds necessary to maintain the Company’s operations, and potential adverse conditions or events as of the issuance date of these financial statements.

Nature of Business

12 Months Ended

Mar. 31, 2021

Organization Consolidation And Presentation Of Financial Statements [Abstract]

Note 1. Nature of Business

Tyme Technologies, Inc. is a Delaware corporation headquartered in Bedminster, New Jersey, with a wholly owned subsidiary, Tyme Inc. (together, “TYME” or the “Company”). The majority of the Company’s research, development and other business activities are conducted by Tyme Inc., which was incorporated in Delaware in 2013.

TYME is an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs^TM) that are intended to be effective across a broad range of solid tumors and hematologic cancers, while also maintaining patients’ quality of life through relatively low toxicity profiles. TYME’s therapeutic approach is designed to take advantage of a cancer cell’s innate metabolic requirements to cause cancer cell death.

The Company’s lead clinical CMBT compound, SM-88, is an oral investigational modified proprietary tyrosine derivative that is hypothesized to interrupt the metabolic processes of cancer cells by breaking down the cells’ key defenses and leading to cell death through oxidative stress and exposure to the body’s natural immune system. Clinical trial data have shown that SM-88 has achieved confirmed tumor responses across 15 different cancers, both solid and liquid tumors, including pancreatic, lung, breast, prostate, sarcoma and lymphoma cancers with minimal drug-related serious Grade 3 or higher adverse events, which the Company believes is rare for investigational compounds.

Ongoing Studies

The Company has partnered with Pancreatic Cancer Action Network (“PanCAN”) to study SM-88 in an adaptive randomized Phase II/III trial with registration intent known as Precision Promise^SM. The objective of Precision Promise is to expedite the study and approval of promising therapies for pancreatic cancer by bringing multiple stakeholders together, including academic, industry and regulatory entities. In this trial which began in early 2020, SM-88 with the conditioning agents methoxalen, phenytoin, and sirolimus (“MPS”) is being studied as monotherapy treatment arm for patients who have failed one prior line of chemotherapy. PanCAN is sponsoring Precision Promise and providing funding and other support. While TYME’s SM-88 is included in the trial, we do not oversee, conduct or control the trial.

In early 2020, the open-label Phase 2 investigator sponsored trial of SM-88 therapy in sarcoma, HoPES, opened. This trial has two cohorts each expecting to enroll 12 patients. The first is SM-88 with MPS as salvage treatment in patients with mixed rare sarcomas, and the other is SM-88 with MPS as maintenance treatment for patients with metastatic Ewing’s sarcoma who had not progressed on prior therapy. The primary objectives are to measure ORR and PFS. Secondary objectives include duration of response, OS, CBR using RECIST, and incidence of treatment-emergent adverse events. The Joseph Ahmed Foundation is providing funding and patient support for this trial and the trial is being conducted by principal investigator Dr. Chawla at the Sarcoma Oncology Center in Santa Monica, CA.

We also recently announced an agreement with Georgetown University to support a Phase II trial, OASIS, for SM-88 in patients with metastatic breast cancer who have hormone receptor positive (“HR+”) and human epidermal growth factor receptor 2 negative (“HER2-“) disease (“HR+/HER2-“). This represents approximately 73% of the annual breast cancer diagnosis in the US each year.

The OASIS trial is an investigator-initiated prospective open-label Phase II trial evaluating the efficacy and safety of SM-88 with MPS for the treatment of metastatic hormone-receptor positive, HER2- breast cancer after treatment with a CDK4/6 inhibitor. This trial is designed as a two-stage trial, enrolling up to 50 patients to receive SM-88 with MPS without additional therapies in patients who have failed or progressed after receiving two hormonal agents and a CDK4/6 inhibitor. The primary endpoint of this trial is ORR, with secondary endpoints including duration of response (“DOR”), clinical benefit rate (“CBR”) at >24 weeks, progression free survival (“PFS”), and safety. The trial will be conducted at Georgetown University at a total of five sites within the Georgetown/MEDSTAR system located in Washington DC, Maryland, and New Jersey. Patient enrollment is expected to begin in the third quarter of calendar year 2021.

In calendar year 2019, the Company presented final SM-88 prostate Phase II clinical data showing encouraging clinical benefit in patients with bio-marker recurrent prostate cancer, with the final results published in the peer-reviewed journal, Investigational New Drugs, on September 13, 2020.

Preclinical Pipeline Programs

TYME-19 is an oral synthetically produced member of the bile acid family that is being developed for the potential treatment of COVID-19. From the Company’s metabolic understanding of bile acids, it was able to identify TYME-19 as a well characterized candidate and a potential treatment of corona viruses. A patent has been issued for TYME-19 for the treatment of COVID-19.

Bile acids can cellular modulate lipid and glucose metabolism and can remediate dysregulated protein folding, each that are relevant to viral infection of a host cell. Existing literature has shown that certain bile acids can have antiviral properties in a range of different viruses, including prior corona viruses.

Our initial preclinical in vitro experiments displayed effectiveness against COVID-19 infection and replication, and we continue to conduct additional tests to support the potential utility of TYME-19 in the treatment of COVID-19 and disease variants. With the ever-changing dynamics of this disease area, the company’s intent with this program is to prepare this agent for clinical testing, while learning from the ongoing work in an effort to identify an optimal clinical setting where TYME-19 could potentially offer clinical benefits, and for which there may be a sustainable market.

TYME-18 is a pre-clinical CMBT compound under development that is delivered intratumorally. TYME-18 is a combination of a proprietary surfactant system and natural sulfonic/bile acid that is designed to disrupt energy metabolism and have lytic function for potential treatment of inoperable tumors. TYME-18 is distinct in composition from SM-88. However, like SM-88, it aims to enhance the susceptibility of a cancer to the highly acidic and toxic tumor microenvironment, while minimizing the impact to normal tissues. In initial preclinical xenograft mouse studies, TYME-18 was able to completely resolve over 90 percent (11 of 12 mice) of established colorectal tumors within 12 days versus an average of over 600 percent growth in the control animals.

TYME-18 is currently in preclinical development, and as with TYME-19, we expect at the proper time, to identify a potential partner with a focus on surgical oncology to assist in the ongoing development of TYME-18.

Discontinuing Programs

TYME-88-PANC (Part 2) (third-line Metastatic Pancreatic Cancer)

In fiscal year 2020, we launched our pivotal study for SM-88 in the third-line treatment of pancreatic cancer through an amendment to our ongoing TYME-88-Panc trial (Part 2), with the first patient dosed in the third quarter of the fiscal year. As described previously, the COVID-19 pandemic significantly impacted enrollment of this trial such that it appears it is likely to complete enrollment in a similar timeline to the second-line Precision Promise pancreatic cancer trial. There has also been a higher than expected dropout of patients randomized to the chemotherapy control arm, which could potentially impact the interpretative and regulatory utility of the data.

Following a comprehensive strategic review, considering, in part, the timeline and regulatory utility for this trial compared to the parallel Precision Promise trial and concentration of investment in this specific cancer, management concluded that it would be best to focus on the second-line Precision Promise trial that offers treatment options to patients earlier in their disease. Furthermore, the trial includes tumor biopsy and biomarker analyses that aligns with the Company’s overall strategic focus to identifying patients with the best chance of benefit from our therapies.

Therefore, the Company has decided to stop enrollment and begin the process of closing down the trial. Patients currently on therapy will be allowed to continue treatment until progression or unacceptable toxicity. The closing of this trial may require several months to complete, with anticipated close out costs to be $2 million to $3 million.

Liquidity

The consolidated financial statements have been prepared on a going-concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company has historically funded its operations primarily through equity offerings.

In February 2021, the Company raised $100 million in gross proceeds through a registered direct offering of 40,000,000 shares of its common stock, at a purchase price of $2.50 per share. The Company incurred $6.2 million of related costs which offset such proceeds.

On January 7, 2020, the Company entered into a Securities Purchase Agreement with Eagle Pharmaceuticals, (“Eagle”), pursuant to which the Company raised $20,000,000 through the issuance and sale to Eagle of 10,000,000 shares of common stock, at a price of $2.00 per share.

In April 2019, the Company raised net proceeds of $11.3 million after underwriting discounts and before expenses through an underwritten registered offering.

On October 18, 2019, TYME entered into an Open Market Sale Agreement^SM(the “Sale Agreement”) with Jefferies LLC (“Jefferies”) as sales agent, pursuant to which the Company may, from time to time, sell shares of Common Stock through Jefferies having an aggregate offering price of up to $30.0 million (the “Jefferies ATM”). In the year ended March 31, 2021, the Company raised approximately $6.1 million in aggregate gross proceeds before commissions and expenses through the Sale Agreement and paid commissions and expenses of $0.3 million. In the year ended March 31, 2020, the Company raised approximately $1.7 million in aggregate gross proceeds before commissions and expenses through the Sale Agreement and paid commissions and expenses of $0.2 million. At March 31, 2021, there remained approximately $22.2 million of availability to sell shares through the Jefferies ATM.

The proceeds of the aforementioned offerings are being used by the Company for continued clinical studies, drug commercialization and development activities and other general corporate and operating expenses.

For the year ended March 31, 2021, the Company had negative cash flow from operations of $23.6 million and net loss of $29.0 million, which included non-cash expenses of $3.9 million related to the change in fair value of warrant liability and $3.5 million non-cash equity compensation, partially offset by non-cash gain on warrant exchange of $2.2 million. As of March 31, 2021, the Company had working capital of approximately $104.0 million.

Management has concluded that substantial doubt does not exist regarding the Company’s ability to satisfy its obligations as they come due during the twelve-month period following the issuance of these financial statements. This conclusion is based on the Company’s assessment of qualitative and quantitative conditions and events, considered in aggregate as of the date of issuance of these financial statements that are known and reasonably knowable. Among other relevant conditions and events, the Company has considered its operational plans, liquidity sources, obligations due or expected, funds necessary to maintain the Company’s operations, and potential adverse conditions or events as of the issuance date of these financial statements.