• Strategic collaboration with Eagle Pharmaceuticals entitles TYME to receive up to a total of $40 million, which included $20 million upfront already received and $20 million in potential milestone payments.
  • TYME-88-Panc pivotal trial started enrollment using oral SM-88 as a potential treatment for patients with third-line pancreatic cancer.
  • PanCAN opened an initial site in its Precision PromiseSM adaptive randomized Phase II/III registration-intent trial for patients with pancreatic cancer using oral SM-88 in second-line monotherapy 
  • TYME & Joseph Ahmed Foundation’s sarcoma study started enrollment for the investigator-initiated HopES Phase II trial using oral SM-88 as maintenance monotherapy in patients with previously treated metastatic Ewing’s sarcoma and salvage monotherapy in clinically advanced sarcomas.
  • Capital resources better position TYME to complete current stages of trials in pancreatic cancer and sarcoma, advance planning for clinical trials in metastatic breast, prostate and hematological cancers, as well as continue developing pre-clinical and mechanism data.              

NEW YORK, Feb. 05, 2020 (GLOBE NEWSWIRE) -- Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs™), announced financial and operating results for its fiscal third quarter ended December 31, 2019. Most recently, the TYME-88-Panc pivotal trial started enrollment using oral SM-88 (racemetyrosine) as a potential treatment for patients with third-line pancreatic cancer; in January 2020, PanCAN opened an initial site in its Precision PromiseSM adaptive randomized Phase II/III registration-intent trial for patients with pancreatic cancer using oral SM-88 in second-line monotherapy; and enrollment started in the investigator-initiated sarcoma HopES Phase II trial using oral SM-88 as maintenance monotherapy in patients with previously treated metastatic Ewing’s sarcoma and salvage monotherapy in clinically advanced sarcomas.

“We have quickly evolved our science of cancer metabolism-based therapies from the conceptual to its practical application as we begin enrollment of patients in multiple SM-88 pivotal trials this year,” said Mr. Steve Hoffman, Chairman and Chief Executive Officer of TYME. “Importantly, we continue to embark on new opportunities and build a model for sustainable growth by expanding our goals and objectives and broadening our clinical and regulatory plans. We look forward with great enthusiasm to executing on our strategy to advance potential therapies for patients with advanced cancer.”

Third Quarter Fiscal 2020 Financial Results:

As of the third quarter ended December 31, 2019, the Company had approximately $11.5 million in cash and cash equivalents compared to $15.3 million as of the second quarter ended September 30, 2019. On January 7, 2020, TYME received an additional $20.0 million from the sale and issuance of 10,000,000 shares of common stock of the Company to Eagle Pharmaceuticals in a private placement, which resulted in TYME having cash and cash equivalents of $31.5 million.   

TYME’s operational cash burn rate for the third quarter of fiscal year 2020 was $4.5 million compared to $4.2 million for the second quarter of fiscal year 2020 and $5.3 million for the third quarter of fiscal 2019. The burn rate which was generally consistent with our previous projections and predominantly reflected costs associated with our ongoing TYME-88-Panc Phase II trial as well as the launch of the pivotal phase of our TYME-88-Panc trial to evaluate SM-88 as a potential treatment for patients with third-line pancreatic cancer. Based on active clinical trials, the initiation of the Precision PromiseSM trial, and other business developments, TYME continues to anticipate that its quarterly cash usage, or “cash burn rate”, will average between $5.0 to 6.0 million per quarter for fiscal year 2020.

Based on U.S. GAAP (Generally Accepted Accounting Principles), net loss was $7.0 million for the third quarter ended December 30, 2019, or a net loss per basic and diluted share of $0.06, as compared to a net loss of $8.0 million for the third  quarter ended December  31, 2018, or a net loss per basic and diluted share of $ 0.08. The decrease in losses was substantially due to timing of activity related to Part 1 of our TYME-88-Panc trial as well our recently completed Phase II prostate clinical trial.

Adjusted net loss for the three months ended December 31, 2019 was $4.9 million, or an adjusted net loss per share of $0.05, compared to adjusted net loss of $6.0 million, or an adjusted net loss per share of $0.06, for the three months ended December 31, 2018, after adjusting for the change in fair value of warrant liability and amortization of employees, directors and consultants stock options. Adjusted net loss and adjusted net loss per share are non-GAAP measures.  See “Use of Non-GAAP Measures” below for a reconciliation to the comparable GAAP measures.

TYME has reported its full financial results for the quarter ended December 31, 2019 in the Company's Form 10-Q filed with the Securities and Exchange Commission ("SEC"). TYME’s 10-Q is located on the Company’s website under recent SEC filings at ir.tymeinc.com.

Anticipated Upcoming Key Events

TYME currently expects the following key events in calendar year 2020:

First half of calendar 2020:

  • Present preclinical data for SM-88
  • Advance enrollment in TYME-88-Panc pivotal study and the HopES Phase II Trial
  • Initiate 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 
  • Present preclinical data for TYME-18
  • Present preliminary Health Economic Outcomes study on total cost of care for pancreatic cancer patients

Second half of calendar 2020:

  • Publish SM-88 Phase II prostate study
  • Advance SM-88 clinical programs into other tumor types potentially including metastatic breast, recurrent prostate and/or hematological cancers
  • Advance PanCAN’s Precision PromiseSM adaptive Phase II/III trial evaluating SM-88 in patients with first-line pancreatic cancer in combination with gemcitabine and Abraxane
  • Present and/or publish final data from Part 1 of TYME-88-Panc study
  • Complete enrollment in TYME-88-Panc pivotal study
  • Advance plans for TYME-18 IND program

Summary of Recent Developments

Tyme Technologies and Eagle Pharmaceuticals Announce Strategic Collaboration to Advance Innovative Oral SM-88 for the Treatment of Patients with Cancer 

TYME and Eagle announced the formation of a U.S. strategic collaboration focused on the co-promotion of TYME’s lead CMBT candidate, oral SM-88, in advanced cancers. Under the terms of the securities purchase agreement, TYME received a $20 million upfront cash payment for 10 million restricted shares of TYME common stock at $2.00 per share. In addition, TYME will receive a $20 million milestone payment upon the successful completion of the first to occur of the following three events: (1) achievement of the primary endpoint of overall survival in its TYME-88-Panc pivotal trial; or (2) achievement of the primary endpoint of overall survival in the PanCAN Precision PromiseSM SM-88 registration arm; or (3) U.S. Food and Drug Administration (FDA) approval of SM-88 in any cancer. This payment would be split into a $10 million milestone cash payment and a $10 million investment in TYME at a 15% premium to the then prevailing market price. Eagle’s shares will be restricted from sale until the earlier of three months following the milestone event or the three-year anniversary of the agreement.

Under the terms of the co-promotion agreement, Eagle Pharmaceuticals will undertake 25% of the promotional sales effort for SM-88 in the U.S. oncology market and receive 15% of the net U.S. revenues of SM-88, and TYME will be responsible for the remaining promotional effort. TYME will also be responsible for clinical development, regulatory approval, commercial strategy, marketing, reimbursement and manufacturing of SM-88. TYME retains the remaining 85% of net U.S. revenues and reserves the right to repurchase Eagle’s co-promotion right for $200 million.

As part of this collaboration between TYME and Eagle, there is also the potential to evaluate oral SM-88 in combination therapy or as monotherapy through leveraging Eagle’s oncology pipeline and expertise in oncology settings, which may include trials in breast or lung cancers and other tumor types. 

TYME Announces First Patient Dosed in TYME-88-Panc Pivotal Trial to Evaluate SM-88 as Oral Treatment for Patients with Metastatic Pancreatic Cancer

The first pancreatic cancer patient was dosed in Part 2 of the TYME-88-Panc pivotal trial designed to support approval of SM-88, TYME’s leading cancer metabolism-based therapy, for the third-line treatment of patients with metastatic pancreatic cancer. CMBTs are proprietary investigational compounds that are believed to disrupt cancer cells’ protein synthesis, leading to a breakdown of the cancer’s key defenses and cell death. In clinical trials, SM-88 has demonstrated encouraging tumor responses across 15 different cancers, including pancreatic, prostate, sarcoma, breast, lung, and lymphoma cancers with minimal serious grade 3 or higher adverse events.

TYME and The Joseph Ahmed Foundation Announce First Patient Dosed in HopES Phase II Trial Evaluating the Potential Benefits of Oral SM-88 for Patients with High-Risk Sarcomas

The first sarcoma cancer patient was dosed at the Sarcoma Oncology Center in the HopES Phase II trial designed to evaluate SM-88 for the treatment of high-risk sarcomas, which are ultra-rare cancers with high unmet medical need.

TYME Rings Nasdaq Opening Bell on November 27 to Honor All Stakeholders Committed to Finding a Cure for Patients with Pancreatic Cancer

TYME rang the Nasdaq Opening Bell on Wednesday, November 27, to honor the many stakeholders who are committed to finding a cure for patients with pancreatic cancer during Pancreatic Cancer Awareness Month. TYME was joined by employees, oncologists, researchers and representatives of leading patient advocacy organizations for pancreatic cancer, namely the Pancreatic Cancer Action Network (PanCAN) and the Lustgarten Foundation.

About SM-88

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 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.

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. For more information, visit www.tymeinc.com.  Follow us on social media: @tyme_Inc, LinkedIn, Instagram, Facebook and YouTube.

Use of Non-GAAP Financial Measures

The adjusted net loss and adjusted net loss per share presented in this press release are non-GAAP measures. The adjustments relate to the change in fair value of warrant liabilities and amortization of employees, directors and consultants’ stock-based compensation. These financial measures are presented on a basis other than in accordance with U.S. generally accepted accounting principles ("Non-GAAP Measures"). In the reconciliation tables that follow, we present adjusted net loss and adjusted net loss per share, reconciled to their comparable GAAP measures, net loss and net loss per share. These items are adjusted because they are not operational or because they are significant non-cash charges and management believes these adjustments are meaningful to understanding the Company's performance during the periods presented. These Non-GAAP Measures should be considered a supplement to, not a substitute for, or superior to, the corresponding financial measures calculated in accordance with GAAP. Our definitions of adjusted net loss and adjusted loss per share may not be comparable to similar measures reported by other companies.

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 clinical trials, 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 “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 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 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, 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 June 12, 2019, 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.

For Investor Relations & Media Inquiries:
Contact:
1-212-461-2315
investorrelations@tymeinc.com
media@tymeinc.com


Tyme Technologies, Inc. and Subsidiaries
 Condensed Consolidated Statement of Operations
(Unaudited)
         
 Three Months Ended
December 31,
 Nine Months Ended
December 31,
 
  2019   2018   2019   2018  
Revenues$  $  $  $  
Operating expenses:        
Research and development 3,453,459   4,525,228   9,292,019   10,979,432  
General and administrative (including $58,500, $132,000, $307,000 and $794,000 of related party legal expenses, respectively) 3,090,223   3,550,224   9,674,401   10,827,879  
Total operating expenses 6,543,682   8,075,452   18,966,420   21,807,311  
Loss from operations (6,543,682)  (8,075,452)  (18,966,420)  (21,807,311) 
Other income (expenses):        
Change in fair value of warrant liability (425,795)     2,593,601     
Interest income 38,257   28,718   185,753   28,718  
Interest expense (26,310)  (1,222)  (88,530)  (7,279) 
Total other income (expenses) (413,848)  27,496   2,690,824   21,439  
Net loss$(6,957,530) $(8,047,956) $(16,275,596) $(21,785,872) 
Basic and diluted loss per common share$(0.06) $(0.08) $(0.15) $(0.21) 
Basic and diluted weighted average shares outstanding 112,071,354   103,009,449   111,961,971   101,963,833  
         

The non-GAAP financial measures for the three months ended December 31, 2019 and 2018 provide management with additional insight into the Company’s results of operations from period to period by excluding certain non-operational and non-cash charges, and are calculated using the following adjustments to net loss:

a) The warrants issued as part of an equity offering on April 2, 2019 are measured at fair value using a Monte Carlo model which takes into account, as of the valuation date, factors including the current exercise price, the remaining contractual term of the warrant, the current price of the underlying stock, its expected volatility, the risk-free interest rate for the term of the warrant and the estimates of the probability of a fundamental transaction occurring.  The warrant liability is revalued at each reporting period or upon exercise.  Changes in fair value are recognized in the consolidated statements of operations and are excluded from adjusted net loss and adjusted net loss per share.

b) The Company uses the Black Scholes option pricing model to determine fair value of stock options granted.  For employees and non-employees, the compensation expense is amortized over the requisite service period which approximates the vesting period. The expense is excluded from adjusted net loss and adjusted net loss per share.

Adjusted basic net loss per share is computed by dividing adjusted net loss by the weighted average number of shares of Company common stock outstanding for the period and adjusted diluted loss per share is computed by also including common stock equivalents outstanding for the period. During the periods presented, the calculation excludes any potential dilutive common shares and any equivalents as they would have been anti-dilutive as the Company incurred losses for the periods then ended.

Reconciliation of Net Loss to Adjusted Net Loss        
  Three Months Ended
December 31,
 Nine Months Ended
December 31,
   2019   2018   2019   2018 
Net loss (GAAP) $(6,958,000) $(8,048,000) $(16,276,000) $(21,786,000)
Adjustments:        
Change in fair value of warrant liability  426,000      (2,594,000)   
Amortization of employees, directors and consultants stock options  1,602,000   2,000,000   4,673,000   6,702,000 
Adjusted net loss (non-GAAP) $(4,930,000) $(6,048,000) $(14,197,000) $(15,084,000)
         
         
Reconciliation of Net Loss Per Share to Adjusted Net Loss Per Share        
  Three Months Ended
December 31,
 Nine Months Ended
December 31,
   2019   2018   2019   2018 
Net loss per share (GAAP) $(0.06) $(0.08) $(0.15) $(0.21)
Adjustments:        
Change in fair value of warrant liability  *      (0.02)   
Amortization of employees, directors and consultants stock options  0.01   0.02   0.04   0.07 
Adjusted net loss per share (non-GAAP) $(0.05) $(0.06) $(0.13) $(0.14)
         

 

* The effect of the change in fair value of the warrant liability was negligible to the adjusted net loss per share.