TYME Provides Business Update and Announces Second Quarter Fiscal 2021 Financial and Operating Results

TYME Provides Business Update and Announces Second Quarter Fiscal 2021 Financial and Operating Results

  • TYME revealed potential new oral therapy, TYME-19, in the fight against COVID-19 based on its cancer metabolism research program
  • TYME-88-Panc pivotal trial enrolling patients using oral SM-88 as a potential treatment for third-line pancreatic cancer
  • PanCAN enrolling patients in its Precision PromiseSM adaptive randomized Phase II/III registration-intent trial evaluating oral SM-88 as second-line monotherapy for pancreatic cancer
  • Joseph Ahmed Foundation’s HopES Sarcoma study enrolling patients for the investigator-initiated Phase II trial studying oral SM-88 as maintenance monotherapy in previously treated metastatic Ewing’s sarcoma and salvage monotherapy in clinically advanced sarcomas
  • TYME published results of SM-88 study in patients with non-metastatic recurrent prostate cancer in the journal, Investigational New Drugs
  • TYME announced orphan drug designation for SM-88 as potential treatment for patients with pancreatic cancer
  • TYME announced positive outcome of interim futility review for HopES Sarcoma Phase II study

BEDMINSTER, N.J.–(BUSINESS WIRE)–Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs™), announced financial and operating results for its second quarter ended September 30, 2020. During the quarter, TYME revealed a potential new therapeutic approach in the fight against COVID-19; was granted orphan drug designation for SM-88 as a potential treatment for patients with pancreatic cancer; expanded its body of peer-reviewed publications on SM-88 and clinical significance in treating advanced cancers; continued enrolling patients in multiple studies including, second and third-line pancreatic cancer trials and the HopES Sarcoma Phase II trial; advanced planning for clinical trials in metastatic breast cancer and hematological cancers; and continued ongoing preclinical studies.

“Our second quarter performance accurately reflects TYME’s commitment to achieve our corporate goals and objectives in the interest of all stakeholders as we navigate the unknown impact of the ongoing COVID-19 pandemic.” said Steve Hoffman, Chairman and Chief Executive Officer of TYME. “We continue to make important progress across our cancer metabolism pipeline and in the critical work at hand to advance the development of TYME-19 as a potential new therapeutic approach for patients in need in the fight against COVID-19.”

Second Quarter Fiscal 2021 Financial Results

As of the second quarter ended September 30, 2020, the Company had approximately $19.4 million in cash and cash equivalents compared to $21.3 million as of the first quarter ended June 30, 2020.

TYME’s operational cash burn rate for the second quarter of fiscal year 2021 was $6.6 million compared to $6.7 million for the first quarter of fiscal year 2021 and $4.2 million for the second quarter of fiscal year 2020. The burn rate was generally consistent with our previous projections and predominantly reflected costs associated with the ongoing clinical trials in pancreatic and sarcoma cancers as well as the increased supply build to support these ongoing trials. Based on active clinical trials and other business developments, TYME continues to anticipate that its quarterly cash usage, or “cash burn rate”, will average between $6.0 to $7.0 million per quarter for fiscal year 2021.

Anticipated Upcoming Key Events

The extent to which COVID-19 impacts TYME’s development of product candidates and business, including patients’ willingness to participate and/or remain in clinical trials, the timing of meeting enrollment expectations, the ability of third-party partners to remain operational and TYME’s access to capital markets and financing sources depends on numerous evolving factors that are highly uncertain and cannot be accurately predicted. To that end, TYME currently expects the following key events in fiscal year 2021:

  • Initiate the proof-of-concept RESPOnD trial to evaluate TYME-19 as a potential new approach against COVID-19; expect data readout in first half of calendar year 2021
  • Continue to advance enrollment in TYME-88-Panc pivotal study; primarily because of unpredictable pandemic-related delays, full enrollment and data readout are not expected before calendar year 2022
  • Continue to advance enrollment in the HopES Sarcoma Phase II Trial; expect data readout in calendar year 2021
  • Continue to advance enrollment in PanCAN’s Precision PromiseSM adaptive randomized Phase II/III registration-intent trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy; expect data readout in calendar year 2022
  • Publish preclinical findings on TYME-19
  • Initiate plans for SM-88 clinical programs into other tumor types potentially including metastatic breast, recurrent prostate and/or hematological cancers
  • Present and/or publish data from Part 1 of TYME-88-Panc study
  • Continue proof-of-concept and IND-enabling activities for TYME-18
  • Evaluate opportunity in PanCAN’s Precision PromiseSM adaptive Phase II/III trial investigating SM-88 in patients with first-line pancreatic cancer in combination with gemcitabine and Abraxane®

Corporate Developments

On August 19, 2020, the Company announced the appointment of John Rothman Ph.D. as Executive Vice President, Product Development. Dr. Rothman has more than 30 years of experience in product development across many disciplines and markets. He was a clinical scientist at the pharmaceutical companies, Schering Plough and Roche, where he was also a clinical director for a number of different therapeutic areas and senior director for all of Roche’s data acquisition, statistical analysis and report writing for all experimental and approved drugs in the Roche portfolio. His work on Interferon-α in AIDs-related Kaposi’s Sarcoma resulted in the approval of first recombinant drug and AIDS treatment called Referon-A.

Dr. Rothman later held R&D director positions at Roche and was associated with a number of development programs that resulted in marketed drugs, including Rocephin, Coactin, Rimadyl, Larotid, Dalmane, Rimantidine, Gantrisin, Versed and more. Dr. Rothman was later an executive vice president of science and operations at the biotech company, Advaxis, where he was responsible for R&D, toxicology, regulatory, chemistry, data management, manufacturing and intellectual property. Dr. Rothman has since held chief executive roles with several biopharmaceutical companies. Also, previously, during his career, Dr. Rothman filed numerous patents and managed a portfolio of over 80 issued patents and patent applications.

On September 15, 2020, Ben R. Taylor gave notice of his decision to resign as President and Chief Financial Officer of the Company. Mr. Taylor’s resignation was effective September 30, 2020, and he is currently serving in a consulting role with the Company until November 30, 2020, providing certain financing and strategic consulting4 services.

Summary of Recent Developments

TYME’s Phase II Prostate Cancer Study Evaluating SM-88 in Patients with Non-Metastatic Recurrent Prostate Cancer Published in the Journal, Investigational New Drugs

On September 15, 2020, TYME announced that the final results of its SM-88 Phase II Prostate Cancer study designed to evaluate the safety, tolerability and efficacy of SM-88 in patients with non-metastatic biochemical recurrent prostate cancer, were published on September 13, 2020 in the peer-reviewed journal Investigational New Drugs. The article, titled “Phase II Trial of SM-88, a Cancer Metabolism Based Therapy, in Non-Metastatic Biochemical Recurrent Prostate Cancer,” is available online at https://doi.org/10.1007/s10637-020-00993-4.

The study demonstrated that SM-88 had promising efficacy and safety outcomes for prostate cancer patients while sparing testosterone. The study also demonstrated a reduction of circulating tumor cells (CTCs), an important prognostic indicator, that may prove to be a better surrogate for patient outcomes than prostate-specific antigen (PSA), particularly for SM-88. Highlights of the study were as follows:

  • The Phase II Prostate Cancer study demonstrated that oral SM-88 (racemetyrosine) was associated with disease control while maintaining quality of life
  • Based on study results, SM-88 may have a clinically meaningful role in postponing medical castration in prostate cancer patients with rising PSA
  • At 6 months, 100% of patients (23/23) were free of metastatic progression, and 87% of patients (20/23) remained free of any radiographic progression
  • After 12 weeks, 78% of patients (18/23) demonstrated a 65% decrease in median Circulating Tumor Cells from baseline
  • 52% of patients (12/23) showed improvement in median PSA doubling time
  • No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

TYME is evaluating regulatory strategies in the interest of advancing SM-88 for patients with non-metastatic recurrent prostate cancer

TYME’s Oncology Research Reveals Potential New Oral Therapy TYME-19 in the Fight Against COVID-19

On August 26, 2020, TYME announced a potential new approach to treating COVID-19 using a metabolic agent, TYME-19. TYME-19 is a synthetic bile acid, a family of metabolic agents that the Company also uses in its anticancer compound, TYME-18. Because of its expertise in metabolic therapies, the Company was able to quickly identify TYME-19 as a potent, well characterized antiviral bile acid and has performed preclinical experiments establishing effectiveness against COVID-19. Bile acids have primarily been used for liver disease; however, they represent a family of critical cellular regulators across cardiovascular, neurologic, and metabolic systems1,2, with some also having antiviral properties.

In preclinical testing, TYME-19 repeatedly prevented COVID-19 viral replication without cytotoxicity to the treated cells. Previous preclinical research has also shown select bile acids like TYME-19 have had broad antiviral activity. TYME-19 is part of a family of metabolic agents called bile acids that have formerly been associated with liver disease but are becoming recognized for their potential utility to treat multiple diseases. TYME believes it is emerging as a leader in the development of bile acids as potential therapies for cancer and COVID-19.1

TYME has partnered with physicians from Massachusetts General Hospital and the Weill Cornell Medical Center to design a trial for recently diagnosed, symptomatic patients. The proof-of-concept trial is expected to start as soon as customary trial site approvals are completed.

HopES Sarcoma Phase II Study Interim Futility Review Outcome

On August 11, 2020, TYME announced a positive outcome of an interim futility review for the investigator-initiated HopES Sarcoma Phase II clinical trial, sponsored by the Sarcoma Oncology Research Center, that is evaluating TYME’s lead cancer metabolism-based candidate, SM-88, as a potential oral treatment for patients with Ewing’s Sarcoma and other high-risk sarcomas.

The interim futility review was completed in late July and, based on the analysis of the data and recommendations of Sant Chawla, M.D., founder of the Sarcoma Oncology Center, Santa Monica, CA and principal investigator for the HopES Sarcoma trial, the study will proceed with the current trial design as planned. The next major milestone in the HopES Sarcoma trial is expected in calendar year 2021. Sarcomas represents a great unmet medical need and significant opportunity for all stakeholders. There are more than 12,000 patients diagnosed each year without meaningful treatment options.

The HopES Sarcoma trial is a prospective open-label Phase II trial evaluating the efficacy and safety of SM-88, with the conditioning agents methoxsalen, phenytoin and sirolimus, in two cohorts of patients. Up to 24 evaluable patients (12 per cohort) will be enrolled. The trial’s primary objectives are to measure efficacy events, including overall response, stable disease and progression free survival. Secondary objectives include duration of response, overall survival, clinical benefit rate using response evaluation criteria in solid tumors (RECIST 1.1), and incidence of treatment-emergent adverse events.

TYME Announced Orphan Drug Designation for SM-88 as Potential Treatment for Patients with Pancreatic Cancer

On August 3, 2020, TYME announced that the U.S. Food and Drug Administration (“FDA”) had granted it Orphan Drug Designation for its lead pipeline candidate, SM-88 (racemetyrosine), as a potential treatment for patients with pancreatic cancer.

The FDA’s Office of Orphan Drug Products grants orphan status to support development of medicines for underserved patient populations, or rare disorders, that affect fewer than 200,000 people in the United States. Orphan Drug Designation provides certain benefits, including market exclusivity upon regulatory approval, if received, exemption of FDA application fees and tax credits for qualified clinical trials.

About SM-88

SM-88 is an oral investigational modified proprietary tyrosine derivative that is believed 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 demonstrated encouraging tumor responses across 15 different cancers, including pancreatic, lung, breast, prostate and sarcoma cancers with minimal serious grade 3 or higher adverse events. SM-88 is an investigational therapy that is not approved for any indication in any disease. Learn more.

About TYME-18

TYME-18 is composed of a proprietary surfactant delivery agent with a specific sulfonic acid component.3 It is designed for intra-tumoral administration of difficult to treat tumors and leverages the acidic tumor microenvironment and signaling pathways to kill cancer cells. TYME-18 is distinct in composition, but like SM-88, aims to leverage susceptibilities of a cancer that are related to its altered metabolism. Initial preclinical data for TYME-18 in animal tumor models demonstrate rapid and complete tumor regression, with no reported local or systemic toxicities. TYME-18 continues to be studied as a potential therapy for difficult to treat tumors that may not be eligible for surgical or other interventions. Learn more.

About TYME-19

TYME-19 is a potent, well characterized synthetic antiviral bile acid that is being evaluated as a potential oral therapy for COVID-19. In preclinical testing, TYME-19 repeatedly prevented COVID-19 viral replication without attributable cytotoxicity in treated cells. Viruses, including COVID-19 hijack a cell’s ability to make proteins and lipids and divert these processes to make viral proteins and lipids in order to reproduce. Viruses accomplish this by inducing stress in the endoplasmic reticulum (ER), where cells process proteins, which enables a virus to remodel protein and lipid synthesis. In preclinical testing, TYME-19 has been shown to counteract these effects, preventing viral replication, by reducing ER stress.4,5 TYME-19 is believed to physically degrade viruses by solubilizing the protective lipid layer and other structural components, which prevent a virus from binding to and infecting a cell.

About TYME-88-Panc Pivotal Trial

The TYME-88-Panc pivotal trial applies the latest advances in the field of cancer metabolism by evaluating the efficacy and safety of an oral investigational compound that targets the metabolic mechanisms of the disease at its source. A prospective, open label pivotal trial in metastatic pancreatic cancer for patients who have failed two lines of any prior systemic therapy. The trial is designed to evaluate the safety and efficacy of SM-88 used with MPS (methoxsalen, phenytoin and sirolimus) in advanced pancreatic cancer and will measure multiple endpoints, including overall survival, progression free survival, relevant biomarkers, quality of life, safety, and overall response rate. Learn more.

About Tyme Technologies

Tyme Technologies, Inc., is an emerging biotechnology company developing cancer therapeutics that are intended to be broadly effective across tumor types and have low toxicity profiles. Unlike targeted therapies that attempt to regulate specific mutations within cancer, the Company’s therapeutic approach is designed to take advantage of a cancer cell’s innate metabolic weaknesses to compromise its defenses, leading to cell death through oxidative stress and exposure to the body’s natural immune system. With the development of TYME-18 and TYME-19, the Company believes that it is also emerging as a leader in the development of bile acids as potential therapies for cancer and COVID-19. For more information, visit www.tymeinc.com. Follow us on social media: Follow us on social media: @tyme_Inc, LinkedIn, Instagram, Facebookand YouTube.

Forward-Looking Statements/Disclosure Notice

In addition to historical information, this press release contains forward-looking statements under the Private Securities Litigation Reform Act that involve substantial risks and uncertainties. Such forward-looking statements within this press release include, without limitation, statements regarding our drug candidates, including SM-88 and TYME- 18, and their clinical potential and non-toxic safety profiles, our drug development plans and strategies, ongoing and planned preclinical and clinical trials, including the proposed TYME-19 proof-of-concept study, preliminary data results and the therapeutic design and mechanisms of our drug candidates; and readers can identify forward-looking statements by sentences or passages involving the use of terms such as “believes,” “expects,” “hopes,” “may,” “will,” “plan,” “intends,” “estimates,” “could,” “should,” “would,” “continue,” “seeks,” or “anticipates,” and similar words including their use in the negative or by discussions of future matters such as effect of the novel coronavirus (COVID-19) pandemic and the associated economic downturn and impacts on the Company’s ongoing clinical trials and ability to analyze data from those trials, the cost of development and potential commercialization of our lead drug candidate and of other new products, expected releases of interim or final data from our clinical trials, possible collaborations, the timing, scope and objectives of our ongoing and planned clinical trials, the success of management transitions and other statements that are not historical. The forward-looking statements contained in this press release are based on management’s current expectations, which are subject to uncertainty, risks and changes in circumstances that are difficult to predict and many of which are outside of TYME’s control. These statements involve known and unknown risks, uncertainties and other factors which may cause the Company’s actual results, performance or achievements to be materially different from any historical results and future results, performances or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include, but are not limited to, the severity, duration, and economic and operational impact of the COVID-19 pandemic; that the information is of a preliminary nature and may be subject to change; uncertainties inherent in the cost and outcomes of research and development, including the cost and availability of acceptable-quality clinical supply and the ability to achieve adequate clinical study design and start and completion dates; the possibility of unfavorable study results, including unfavorable new clinical data and additional analyses of existing data; risks associated with early, initial data, including the risk that the final data from any clinical trial may differ from prior or preliminary study data; final results of additional clinical trials that may be different from the preliminary data analysis and may not support further clinical development; that past reported data are not necessarily predictive of future patient or clinical data outcomes; whether and when any applications or other submissions for SM-88 may be filed with regulatory authorities; whether and when regulatory authorities may approve any applications or submissions; decisions by regulatory authorities regarding labeling and other matters that could affect commercial availability of SM-88; the ability of TYME and its collaborators to develop and realize collaborative synergies; competitive developments; and the factors described in the section captioned “Risk Factors” of TYME’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission on May 22, 2020, as well as subsequent reports we file from time to time with the U.S. Securities and Exchange Commission available at www.sec.gov.

The information contained in this press release is as of its release date and TYME assumes no obligation to update forward-looking statements contained in this release as a result of future events or developments.

1) Marin, J.J., et al., Bile Acids in Physiology, Pathology and Pharmacology. Curr Drug Metab, 2015.17(1): p. 4-29.

2) Claudel, T., B. Staels, and F. Kuipers, The Farnesoid X receptor: a molecular link between bile acid and lipid and glucose metabolism. Arterioscler Thromb Vasc Biol, 2005. 25(10): p. 2020-30.

3) Thuangtong R, Bentow JJ, Knopp K, Mahmood NA, David NE, Kolodney MS. Tissue-selective effects of injected deoxycholate. Dermatol Surg. 2010;36(6):899‐908. doi:10.1111/j.1524-4725.2010.01566.x

4) Yang, X, et al., Activation of autophagy by unfolded proteins during endoplasmic reticulum stress. The Plant Journal (2016) 85, 83–95

5) Umut O¨ zcan, U., et al., Chemical Chaperones Reduce ER Stress and Restore Glucose Homeostasis in a Mouse Model of Type 2 Diabetes. Sciencemag.org/cgi/content/full/313/5790/1137/DC1

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