Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Feb. 27, 2020 | Jun. 28, 2019 | |
Document and Entity Information | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2019 | ||
Document Fiscal Year Focus | 2019 | ||
Document Fiscal Period Focus | FY | ||
Entity Registrant Name | BIO-PATH HOLDINGS INC | ||
Entity Central Index Key | 0001133818 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Public Float | $ 37,456,677.18 | ||
Trading Symbol | BPTH | ||
Entity Common Stock, Shares Outstanding | 3,691,857 | ||
Entity Shell Company | false | ||
Entity Emerging Growth Company | false | ||
Entity Small Business | true |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Current assets | ||
Cash | $ 20,426 | $ 1,004 |
Prepaid drug product for testing | 776 | 332 |
Other current assets | 788 | 803 |
Total current assets | 21,990 | 2,139 |
Fixed assets | ||
Furniture, fixtures & equipment | 1,029 | 998 |
Less accumulated depreciation | (726) | (592) |
Property, Plant and Equipment, Net | 303 | 406 |
Right of use operating assets | 367 | 0 |
Total Assets | 22,660 | 2,545 |
Current liabilities | ||
Accounts payable | 486 | 587 |
Accrued expenses | 673 | 740 |
Current portion of lease liabilities | 85 | 0 |
Total current liabilities | 1,244 | 1,327 |
Noncurrent lease liabilities | 330 | 0 |
Total Liabilities | 1,574 | 1,327 |
Shareholders' equity | ||
Preferred stock, $.001 par value; 10,000 shares authorized; no shares issued and outstanding | 0 | 0 |
Common stock, $.001 par value; 200,000 shares authorized; 3,692 and 680 shares issued and outstanding, respectively | 4 | 1 |
Additional paid in capital | 77,421 | 48,957 |
Accumulated deficit | (56,339) | (47,740) |
Total shareholders' equity | 21,086 | 1,218 |
Total Liabilities & Shareholders' Equity | $ 22,660 | $ 2,545 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares shares in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
CONSOLIDATED BALANCE SHEETS | ||
Preferred Stock, par value | $ 0.001 | $ 0.001 |
Preferred Stock, shares authorized | 10,000 | 10,000 |
Preferred Stock, shares issued | 0 | 0 |
Preferred Stock, shares outstanding | 0 | 0 |
Common Stock, par value | $ 0.001 | $ 0.001 |
Common Stock, shares authorized | 200,000 | 200,000 |
Common Stock, shares issued | 3,692 | 680 |
Common Stock, shares outstanding | 3,692 | 680 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Operating expenses | ||
Research and development | $ 4,585 | $ 4,603 |
General and administrative | 4,108 | 3,379 |
Impairment of technology license | 0 | 608 |
Total operating expenses | 8,693 | 8,590 |
Net operating loss | (8,693) | (8,590) |
Other income (loss) | ||
Interest income | 94 | 7 |
Total other income | 94 | 7 |
Net loss | $ (8,599) | $ (8,583) |
Net loss per share, basic and diluted (in dollars) | $ (3.24) | $ (14.38) |
Basic and diluted weighted average number of common shares outstanding | 2,657 | 597 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Cash flow from operating activities | ||
Net loss | $ (8,599) | $ (8,583) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Stock-based compensation | 684 | 554 |
Amortization of technology license | 0 | 161 |
Amortization of right of use assets | 96 | 0 |
Depreciation | 134 | 265 |
Impairment of technology license | 0 | 608 |
(Increase) decrease in operating assets | ||
Prepaid drug product for testing | (444) | 785 |
Other current assets | 15 | (450) |
Increase (decrease) in operating liabilities | ||
Accounts payable and accrued expenses | (168) | 536 |
Lease liabilities | (79) | 0 |
Net cash used in operating activities | (8,361) | (6,124) |
Cash flow from investing activities | ||
Purchases of furniture, fixtures & equipment | 0 | (17) |
Net cash used in investing activities | 0 | (17) |
Cash flow from financing activities | ||
Net proceeds from sale of common stock | 26,700 | 1,180 |
Net proceeds from exercise of warrants | 1,083 | 0 |
Net cash provided by financing activities | 27,783 | 1,180 |
Net increase (decrease) in cash | 19,422 | (4,961) |
Cash, beginning of period | 1,004 | 5,965 |
Cash, end of period | 20,426 | 1,004 |
Non-cash investing activities | ||
Addition to leasehold improvements | $ 31 | $ 0 |
CONSOLIDATED STATEMENTS OF SHAR
CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY - USD ($) shares in Thousands, $ in Thousands | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Total |
Beginning Balance at Dec. 31, 2017 | $ 1 | $ 47,223 | $ (39,157) | $ 8,067 |
Beginning Balance (in shares) at Dec. 31, 2017 | 567 | |||
Issuance of common stock, net of fees | 1,180 | 1,180 | ||
Issuance of common stock, net of fees (in shares) | 113 | |||
Stock-based compensation | 554 | 554 | ||
Net loss | (8,583) | (8,583) | ||
Ending Balance at Dec. 31, 2018 | $ 1 | 48,957 | (47,740) | 1,218 |
Ending Balance (in shares) at Dec. 31, 2018 | 680 | |||
Issuance of common stock, net of fees | $ 3 | 26,697 | 26,700 | |
Issuance of common stock, net of fees (in shares) | 2,602 | |||
Exercise of warrants, net of fees | 1,083 | 1,083 | ||
Exercise of warrants, net of fees (in shares) | 410 | |||
Stock-based compensation | 684 | 684 | ||
Net loss | (8,599) | (8,599) | ||
Ending Balance at Dec. 31, 2019 | $ 4 | $ 77,421 | $ (56,339) | $ 21,086 |
Ending Balance (in shares) at Dec. 31, 2019 | 3,692 |
Organization and Business
Organization and Business | 12 Months Ended |
Dec. 31, 2019 | |
Organization and Business | |
Organization and Business | 1. Organization and Business The Company is a clinical and preclinical stage oncology focused RNAi nanoparticle drug development company utilizing a novel technology that achieves systemic delivery for target specific protein inhibition for any gene product that is over-expressed in disease. Our drug delivery and antisense technology, called DNAbilize®, is a platform that uses P-ethoxy, which is a deoxyribonucleic acid (DNA) backbone modification that is intended to protect the DNA from destruction by the body’s enzymes when circulating in vivo, incorporated inside of a neutral charged lipid bilayer. We believe this combination allows for high efficiency loading of antisense DNA into non-toxic, cell-membrane-like structures for delivery of the antisense drug substance into cells. In vivo, the DNAbilize® delivered antisense drug substances are systemically distributed throughout the body to allow for reduction or elimination of target proteins in blood diseases and solid tumors. DNAbilize® is a registered trademark of the Company. Using DNAbilize® as a platform for drug development and manufacturing, we currently have three antisense drug candidates in development to treat at least five different cancer disease indications. Bio-Path Subsidiary was founded in May 2007 as a Utah corporation. In February 2008, Bio-Path Subsidiary completed a reverse merger with the Company, which at the time was traded over the counter and had no current operations. The prior name of Company was changed to Bio-Path Holdings, Inc. and the directors and officers of Bio-Path Subsidiary became the directors and officers of Bio-Path Holdings, Inc. The Company’s operations to date have been limited to organizing and staffing the Company, acquiring, developing and securing its technology and undertaking product development for a limited number of product candidates. In June 2015, the Company established an “at the market” (“ATM”) program through which it may offer and sell up to $25.0 million of its common stock from time to time, at Bio-Path’s discretion, through an investment banking firm, acting as sales agent. Sales of Bio-Path common stock under the ATM program will be made directly on or through The Nasdaq Capital Market, among other methods. The ATM program may be terminated by either the investment banking firm or the Company upon ten days’ notice. We are subject to certain restrictions on our ability to offer and sell shares of our common stock under the ATM program. To date, the Company has not offered or sold any shares of its common stock under the ATM program. On January 17, 2019, we effected a reverse stock split of our outstanding shares of common stock at a ratio of 1–for–20, and our common stock began trading on the split-adjusted basis on the Nasdaq Capital Market at the commencement of trading on January 18, 2019. All common stock share and per share amounts in our consolidated financial statements have been adjusted to give effect to the 1–for–20 reverse stock split. As the Company has not begun its planned principal operations of commercializing a product candidate, the Company’s activities are subject to significant risks and uncertainties, including the potential requirement to secure additional funding, the outcome of the Company’s clinical trials, and failing to operationalize the Company’s current drug candidates before another company develops similar products. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2019 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Principles of Consolidation — The consolidated financial statements include the accounts of Bio-Path Holdings, Inc., and its wholly-owned subsidiary Bio-Path, Inc. All intercompany accounts and transactions have been eliminated in consolidation. Cash and Cash Equivalents — The Company considers all highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. Concentration of Credit Risk — Financial instruments that potentially subject us to a significant concentration of credit risk consist of cash. The Company maintains its cash balances with one major commercial bank, JPMorgan Chase Bank. The balances are insured by the Federal Deposit Insurance Corporation (the “FDIC”) up to $250,000. As a result, as of December 31, 2019, approximately $20.2 million of our cash balance was not covered by the FDIC. As of December 31, 2018, we had approximately $1.0 million in cash on-hand, of which approximately $0.8 million was not covered by the FDIC. To date, the Company has not incurred any losses on its cash balances. Furniture, fixtures and equipment — Furniture, fixtures and equipment are stated at cost and depreciated using the straight-line method over the estimated useful lives of the assets. Depreciation expense was $0.1 million and $0.3 million for the years ended December 31, 2019 and 2018, respectively. The estimated useful lives are as follows: Computers and equipment – 3 years Furniture and fixtures – 7 years Scientific equipment –7 years Leasehold improvements – Lesser of useful life or lease term Major additions and improvements are capitalized, while costs for minor replacements, maintenance and repairs that do not increase the useful life of an asset are expensed as incurred. Long-Lived Assets — Our long-lived assets consist of furniture, fixtures and equipment, and leasehold improvements and right-of-use operating assets. Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of the asset is measured by a comparison of the asset’s carrying amount to the estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated undiscounted future cash flows, an impairment charge is recognized by the amount by which the carrying amount of the asset exceeds the fair value of the asset. Research and Development Costs — Costs and expenses that can be clearly identified as research and development are charged to expense. Advance payments, including nonrefundable amounts, for goods or services that will be used or rendered for future research and development activities are deferred and capitalized. Such amounts will be recognized as an expense as the related goods are delivered or the related services are performed. If the goods will not be delivered, or services will not be rendered, then the capitalized advance payment is charged to expense. The Company estimates its clinical trial expense each period based on a cost per patient calculation which is derived from estimated start-up costs, clinical trial costs based on the number of patients and length of treatment and clinical study report costs. These services are performed by the Company’s third-party clinical research organizations, laboratories and clinical investigative sites. The expense is recorded in research and development expense each period. Amounts that have been prepaid in advance of work performed are recorded in other current assets. For each of the years ended December 31, 2019 and 2018, we had $4.6 million of costs classified as research and development expense. Stock-Based Compensation — The Company has accounted for stock-based compensation under the provisions of generally accepted accounting principles (“GAAP”). The provisions require us to record an expense associated with the fair value of stock-based compensation. We currently use the Black-Scholes option valuation model to calculate stock-based compensation at the date of grant. Option pricing models require the input of highly subjective assumptions, including the expected price volatility. Changes in these assumptions can materially affect the fair value estimate. Net Loss Per Share — Basic net loss per common share is computed by dividing net loss attributable to common stockholders for the period by the weighted average number of common shares outstanding during the period. Although there were warrants and stock options outstanding during 2019 and 2018, no potential common shares shall be included in the computation of any diluted per-share amount when a loss exists, as it would be anti-dilutive. Consequently, diluted net loss per share as presented in the financial statements is equal to basic net loss per share for the years 2019 and 2018. The calculation of diluted earnings per share for 2019 did not include 67,681 shares and 858,699 shares issuable pursuant to the exercise of outstanding common stock options and warrants, respectively, as of December 31, 2019 as the effect would be anti-dilutive. The calculation of diluted earnings per share for 2018 did not include 37,067 shares and 183,714 shares issuable pursuant to the exercise of outstanding common stock options and warrants, respectively, as of December 31, 2018 as the effect would be anti-dilutive. Use of Estimates — The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States (“U.S.”) requires management to make estimates and assumptions that affect the amounts reported in the Company’s consolidated financial statements and accompanying notes. On an ongoing basis, the Company evaluates its estimates and judgments, which are based on historical and anticipated results and trends as well as on various other assumptions that the Company believes to be reasonable under the circumstances. By their nature, estimates are subject to an inherent degree of uncertainty and, as such, actual results may differ from the Company’s estimates. These estimates include accrued clinical trial costs, stock-based compensation expense, valuation of warrants and valuation of deferred tax assets. Income Taxes — Deferred income tax assets and liabilities are determined based upon differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. Liquidity — Since its inception, the Company has devoted substantially all of its efforts to product development, raising capital and building infrastructure, and has not generated significant revenues from its planned principal operations. The Company does not anticipate generating significant revenues for the foreseeable future. The Company’s activities are subject to significant risks and uncertainties. The Company has experienced significant losses since its inception, including net losses of $ 8.6 million for each of the years ended December 31, 2019 and 2018. As of December 31, 2019, the Company had an accumulated deficit of $56.3 million and $20.4 million in cash and cash equivalents. The Company has no debt commitments. Substantially all of the Company’s net losses have resulted from costs incurred in connection with its research and development activities and its general and administrative expenses to support operations. The Company’s net losses may fluctuate significantly from quarter to quarter and year to year. The Company believes that its available cash at December 31, 2019 will be sufficient to fund liquidity and capital expenditure requirements for at least the next 12 months from the date of issuance of these consolidated financial statements. However, the Company expects to continue to incur net losses for the foreseeable future . The Company expects to continue to incur significant operating expenses in connection with its ongoing activities, including conducting clinical trials, manufacturing development and seeking regulatory approval of its drug candidates, prexigebersen, BP1002 and BP1003. Accordingly, the Company will continue to require substantial additional capital to fund its projected operating requirements. Such additional capital may not be available when needed or on terms favorable to the Company. In addition, the Company may seek additional capital due to favorable market conditions or strategic considerations, even if it believes it has sufficient funds for our current and future operating plan. There can be no assurance that the Company will be able to continue to raise additional capital through the sale of securities in the future. If the Company is not able to secure adequate additional funding, the Company may be forced to make reductions in spending, extend payment terms with suppliers, and/or suspend or curtail planned programs. Any of these actions could materially harm the Company’s business, results of operations, financial condition and future prospects. Recent Accounting Pronouncements — From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (FASB) that are adopted by the Company as of the specified effective date. If not discussed, management believes that the impact of recently issued standards, which are not yet effective, will not have a material impact on the Company’s consolidated financial statements upon adoption. In February 2016, the FASB issued ASU No. 2016‑02, Leases . The new standard establishes a right-of-use (“ROU”) model that requires a lessee to record a ROU asset and a lease liability initially measured at the present value of the lease payments on the balance sheet for all leases with terms longer than 12 months. The new standard is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. In 2018, the FASB issued ASU 2018-01 and ASU 2018-11, which collectively adds two practical expedients and provides an alternative modified retrospective transition method in the year of adoption. Management adopted the new standard on January 1, 2019 using the modified retrospective transition approach with no restatement of prior periods or cumulative adjustment to accumulated deficit. We elected the "package of practiced expedients", which permits us not to reassess under the new standard our prior conclusions about lease identification, lease classification and indirect costs. We also elected the short-term lease exemption and therefore do not recognize ROU assets or corresponding liabilities for lease agreements with an original term of 12 months or less. Consequently, prior year financials statements have not been updated and the disclosures required under the new standard have not been provided for periods prior to the adoption date. Upon adoption of the new standards, the Company recognized $0.1 million for ROU assets and corresponding lease liabilities on the consolidated balance sheet related to leases for office and lab space. The adoption of these ASU's on January 1, 2019 did not have a significant impact on our consolidated financial statements. In August 2018, the FASB issued ASU No. 2018‑13, Fair Value Measurement (Topic 820): Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement . The new standard eliminates certain disclosure requirements for fair value measurements for all entities, requires public entities to disclose certain new information and modifies some disclosure requirements. This standard is effective for fiscal years beginning after December 15, 2019, with early adoption permitted. Management does not believe there will be a significant impact on our consolidated financial statements as the Company does not currently have any fair value measurements to disclose. Management has reviewed all other recently issued pronouncements and has determined they will have no material impact on the Company’s consolidated financial statements. Correction of Immaterial Errors in Previously Issued Financial Statements - In evaluating the consolidated financial statements as of and for the year ended December 31, 2018, the Company subsequently identified immaterial errors within the Company's consolidated balance sheet as of December 31, 2018 and consolidated statement of cash flows for the year ended December 31, 2018. The Company has assessed the effects of these errors and based upon quantitative and qualitative factors, determined that the errors were not material to the previously issued consolidated financial statements. The following table summarizes the correction of immaterial errors as of and for the year ended December 31, 2018: 2018 As Reported Adjustments As Corrected (in thousands) Consolidated Balance Sheet Other current assets $ 593 $ $ Total current assets Total Assets Accounts payable (226) Accrued expenses Total current liabilities Total Liabilities Total Liabilities & Shareholders’ Equity Consolidated Statement of Cash Flows Other current assets (240) (210) (450) Accounts payable and accrued expenses |
Prepaid Drug Product for Testin
Prepaid Drug Product for Testing | 12 Months Ended |
Dec. 31, 2019 | |
Prepaid Drug Product For Testing | |
Prepaid Drug Product for Testing | 3. Prepaid Drug Product for Testing Advance payments, including nonrefundable amounts, for goods or services that will be used or rendered for future clinical development activities are deferred and capitalized. Such amounts will be recognized as an expense as the related goods are delivered or the related services are performed. The Company recognized certain expenses and incurred installment costs for its contract drug manufacturing and raw material suppliers with prepayments totaling $0.3 million through 2018 pursuant to drug supply contracts for the manufacture and delivery of prexigebersen for testing in two Phase 2 clinical trials and Bcl‑2 for testing in a Phase 1 clinical trial. This amount was carried on the Balance Sheet as of December 31, 2018 at cost as Prepaid Drug Product for Testing. The Company recognized certain expenses and incurred additional installment costs during 2019, with advanced payments totaling $0.8 million, which are carried on the Balance Sheet as of December 31, 2019 as Prepaid Drug Product for Testing (See Note 11). |
Other Current Assets
Other Current Assets | 12 Months Ended |
Dec. 31, 2019 | |
Other Current Assets | |
Other Current Assets | 4. Other Current Assets As of December 31, 2019, Other Current Assets included prepaid expenses of $0.8 million, comprised primarily of prepayments made for our clinical trials for prexigebersen in AML and CML of $0.6 million and prepaid insurance of $0.2 million. As of December 31, 2018, Other Current Assets included prepaid expenses of $0.8 million, comprised primarily of prepayments made for our clinical trial for prexigebersen in AML of $0.6 million, prepaid insurance of $0.1 million and other prepaid expenses of $0.1 million. |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2019 | |
Property and Equipment | |
Property and Equipment | 5. Property and Equipment The following table summarizes property and equipment as of December 31, 2019 and 2018: December 31, Estimated Useful Lives 2019 2018 (in years) (in thousands) Leasehold improvements 2 to 5 $ 463 $ 432 Computers and office equipment 3 60 60 Furniture and fixtures 7 46 46 Scientific equipment 7 460 460 Total 1,029 998 Less: Accumulated depreciation (726) (592) Net property and equipment $ 303 $ 406 |
Accounts Payable
Accounts Payable | 12 Months Ended |
Dec. 31, 2019 | |
Accounts Payable | |
Accounts Payable | 6. Accounts Payable As of December 31, 2019, Current Liabilities included accounts payable of $0.5 million, comprised primarily of amounts owed for external research expenses related to manufacturing costs of $0.3 million and legal and patent fess of $0.2 million. As of December 31, 2018, Current Liabilities included accounts payable of $0.6 million , comprised primarily of preclinical expenses of $0.2 million, amounts owed to the Company’s clinical research organizations for our clinical trials for prexigebersen in AML and CML of $0.1 million, an annual license maintenance fee of $0.1 million, manufacturing costs of $0.1 million and other payables of $0.1 million. |
Accrued Expense
Accrued Expense | 12 Months Ended |
Dec. 31, 2019 | |
Accrued Expense | |
Accrued Expense | 7. Accrued Expense As of December 31, 2019, Current Liabilities included accrued expenses of $0.7 million, comprised primarily of accrued employee vacation and bonus expenses of $0.4 million, clinical and preclinical expenses of $0.2 million and other accrued expenses of $0.1 million. As of December 31, 2018, Current Liabilities included accrued expenses of $0.7 million, comprised primarily of accrued clinical and preclinical expenses of $0.5 million, employee vacation and bonus expenses of $0.1 million and legal and professional fees of $0.1 million. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2019 | |
Stockholders' Equity | |
Stockholders' Equity | 8. Stockholders’ Equity Issuances of Common Stock –On September 20, 2018, we entered into a securities purchase agreement with certain investors pursuant to which we agreed to sell, in a registered direct offering, an aggregate of 98,454 shares of our common stock and pre-funded warrants to purchase up to 14,624 shares of our common stock for gross proceeds of approximately $1.5 million (the “2018 Registered Direct Offering”). In a concurrent private placement, we also agreed pursuant to the securities purchase agreement to issue to such investors Series A warrants to purchase up to 113,077 shares of our common stock (the “2018 Private Placement”). Additionally, we issued warrants to purchase up to 6,785 shares of our common stock in a private placement to H.C. Wainwright & Co., LLC as compensation for its services as a placement agent in connection with the 2018 Registered Direct Offering and the 2018 Private Placement. The 2018 Registered Direct Offering and the 2018 Private Placement closed on September 25, 2018. The net proceeds to the Company from the offerings, after deducting the placement agent’s fees and expenses, our offering expenses, and excluding the proceeds, if any, from the exercise of the warrants issued in the offerings, were approximately $1.2 million. On January 14, 2019, we entered into an underwriting agreement with H.C. Wainwright & Co., LLC relating to an underwritten public offering of 429,616 shares of our common stock for gross proceeds of approximately $1.1 million (the "2019 Underwritten Offering"). The offering price to the public in the 2019 Underwritten Offering was $2.60 per share, and H.C. Wainwright & Co., LLC agreed to purchase the shares in the 2019 Underwritten Offering from the Company pursuant to the underwriting agreement at a price of $2.418 per share. Additionally, we issued warrants to purchase up to 25,777 shares of our common stock in a private placement to H.C. Wainwright & Co., LLC as compensation for its services as underwriter in connection with the 2019 Underwritten Offering. The 2019 Underwritten Offering closed on January 17, 2019. The net proceeds to the Company from the 2019 Underwritten Offering, after deducting the underwriting discounts and commissions and expenses and the Company's estimated offering expenses, and excluding the proceeds, if any, from the exercise of the underwriter warrants, were approximately $0.9 million. On January 18, 2019, we entered into a securities purchase agreement with certain investors pursuant to which we agreed to sell, in a registered direct offering, an aggregate of 648,233 shares of our common stock for gross proceeds of approximately $1.7 million (the "January 2019 Registered Direct Offering"). In a concurrent private placement, we also agreed pursuant to the securities purchase agreement to issue to such investors Series A warrants to purchase up to 324,117 shares of our common stock (the "January 2019 Private Placement"). Additionally, we issued warrants to purchase up to 38,894 shares of our common stock in a private placement to H.C. Wainwright & Co., LLC as compensation for its services as a placement agent in connection with the 2019 Registered Direct Offering and the 2019 Private Placement. The 2019 Registered Direct Offering and the 2019 Private Placement closed on January 23, 2019. The net proceeds to the Company from the offerings, after deducting the placement agent's fees and expenses, our offering expenses, and excluding the proceeds, if any, from the exercise of the warrants issued in the offerings, were approximately $1.5 million. On March 12, 2019, we entered into a securities purchase agreement with certain investors pursuant to which we agreed to sell, in a registered direct offering, an aggregate of 712,910 shares of our common stock for gross proceeds of approximately $18.5 million (the "March 2019 Registered Direct Offering"). Additionally, we issued warrants to purchase up to 42,775 shares of our common stock in a private placement to H.C. Wainwright & Co., LLC as compensation for its services as a placement agent in connection with the March 2019 Registered Direct Offering. The March 2019 Registered Direct Offering closed on March 14, 2019. The net proceeds to us from the offerings, after deducting the placement agent's fees and expenses, our offering expenses, and excluding the proceeds, if any, from the exercise of the warrants issued in the offerings, were approximately $17.0 million. On November 21, 2019, we entered into a securities purchase agreement with certain investors pursuant to which we agreed to sell, in a registered direct offering, an aggregate of 808,080 shares of our common stock and warrants to purchase up to 606,060 shares of our common stock for gross proceeds of approximately $8.0 million under the 2019 Shelf Registration Statement (the "November 2019 Registered Direct Offering"). Additionally, we issued warrants to purchase up to 48,485 shares of our common stock to H.C. Wainwright & Co., LLC as compensation for its services as a placement agent in connection with the November 2019 Registered Direct Offering, which warrants and the common stock issuable upon exercise of such warrants were registered under the 2019 Shelf Registration Statement. The November 2019 Registered Direct Offering closed on November 25, 2019. The net proceeds to us from the offerings, after deducting the placement agent's fees and expenses, our offering expenses, and excluding the proceeds, if any, from the exercise of the warrants issued in the offerings, were approximately $7.3 million. During the fiscal year ended December 31, 2019, we issued an aggregate of 409,875 shares of our common stock pursuant to the exercise of warrants at a weighted average exercise price of approximately $2.67 per share. The net proceeds to us from the exercise of the warrants were approximately $1.1 million. Stockholders’ Equity totaled $21.1 million as of December 31, 2019 compared to $1.2 million as of December 31, 2018. There were 3,691,857 shares of common stock issued and outstanding as of December 31, 2019. There were no preferred shares outstanding as of December 31, 2019. |
Stock-Based Compensation Plan
Stock-Based Compensation Plan | 12 Months Ended |
Dec. 31, 2019 | |
Stock-Based Compensation Plan | |
Stock-Based Compensation Plan | 9. Stock-Based Compensation Plan The 2017 Plan – On December 21, 2017, the Company’s stockholders approved the Bio-Path Holdings, Inc. 2017 Stock Incentive Plan (as amended, the “2017 Plan”), which replaced the First Amended 2007 Stock Incentive Plan, as amended (the “2007 Plan”). The 2007 Plan expired by its terms in January 2018, and no awards were made under the 2007 Plan from the approval of the 2017 Plan on December 21, 2017 until the expiration of the 2007 Plan. The 2017 Plan provides for the grant of Incentive Stock Options, Non-Qualified Stock Options, Restricted Shares, Restricted Share Units, Stock Appreciation Rights, Performance-Based Awards and other stock-based awards, or any combination of the foregoing to the Company’s employees, non-employee directors and consultants. On December 19, 2019, the Company's stockholders approved an amendment to the 2017 Plan to increase the number of shares reserved for grant and issuance pursuant to the 2017 Plan by 600,000 shares to 660,000 shares. As of December 31, 2019, there were 609,121 additional shares of common stock reserved for future issuance of awards under the 2017 Plan. Under the 2017 Plan, the exercise price of awards is determined by the Board of Directors or the compensation committee of the Board of Directors, and for options intended to qualify as qualified Incentive Stock Options, may not be less than the fair market value as determined by the closing stock price at the date of the grant. Each option and award under the 2017 Plan shall vest and expire as determined by the Board of Directors or the compensation committee. Options expire no later than ten years from the date of grant. All grants provide for accelerated vesting if there is a change of control, as defined in the 2017 Plan. Stock option awards granted for the years 2019 and 2018 were estimated to have a weighted average fair value per share of $16.26 and $26.55, respectively. The fair value calculation is based on stock options granted during the year using the Black-Scholes option-pricing model on the date of grant. In addition, for all stock options granted, exercise price was determined based on the fair market value as determined by the closing stock price at the date of the grant. For stock options granted during 2019 and 2018 the following weighted average assumptions were used in determining fair value: 2019 2018 Risk-free interest rate 2.23 % 2.70 % Expected volatility 126 % 90 % Expected term in years 6.1 Dividend yield — % — % The Company determines the expected term of its stock option awards using the simplified method based on the weighted average of the length of the vesting period and the term of the exercise period. Expected volatility is determined by the volatility of the Company’s historical stock price over the expected term of the grant. The risk-free interest rate for the expected term of each option granted is based on the U.S. Treasury yield curve in effect at the time of grant. Option activity under the Plans for the year ended December 31, 2019, was as follows (in thousands, except as noted): Weighted Weighted- Average Average Remaining Aggregate Exercise Contractual Intrinsic Options Price Term Value (per share) (in years) Year Ended December 31, 2019 Outstanding at December 31, 2018 37 $ 112.60 $ — Granted 35 18.40 Forfeited (3) 36.68 Expired (1) 61.18 Outstanding at December 31, 2019 68 $ 68.56 $ — Vested and expected to vest December 31, 2019 58 $ 76.12 $ — Exercisable at December 31, 2019 26 $ 138.77 $ — The aggregate intrinsic value represents the total pretax intrinsic value (the difference between the Company’s closing stock price on December 31, 2019 and the exercise price, multiplied by the number of in-the-money options) that would have been received by the option holders had all option holders exercised their options on December 31, 2019. This amount changes based on the fair market value of the Company’s stock. Option activity under the Plans for the year ended December 31, 2018, was as follows (in thousands, except as noted): Weighted Weighted- Average Average Remaining Aggregate Exercise Contractual Intrinsic Options Price Term Value (per share) (in years) Year Ended December 31, 2018 Outstanding at December 31, 2017 32 $ 232.00 4.0 $ — Granted 20 34.60 9.3 Forfeited — — Expired (15) 267.20 Outstanding at December 31, 2018 37 $ 112.60 7.5 $ — Vested and expected to vest December 31, 2018 31 $ 124.60 7.2 $ — Exercisable at December 31, 2018 15 $ 181.00 5.1 $ — The aggregate intrinsic value represents the total pretax intrinsic value (the difference between the Company’s closing stock price on December 31, 2018 and the exercise price, multiplied by the number of in-the-money options) that would have been received by the option holders had all option holders exercised their options on December 31, 2018. This amount changes based on the fair market value of the Company’s stock. Stock-Based Compensation Expense – Total stock-based compensation expense for the year ended 2019 was $0.7 million which consisted of research and development expense of $0.1 million and general and administrative expense of $0.6 million. As of December 31, 2019, future stock-based compensation expense for all outstanding unvested options was $0.6 million, which is expected to be recognized over a weighted-average vesting period of 2.2 years. Total stock-based compensation expense for the year ended 2018 was $0.6 million which consisted of research and development expense of $0.1 million and general and administrative expense of $0.5 million. |
Warrants
Warrants | 12 Months Ended |
Dec. 31, 2019 | |
Warrants | |
Warrants | 10. Warrants A summary of warrants outstanding and exercisable as of December 31, 2019 (in thousands, except as noted): Warrants Outstanding Warrants Exercisable Weighted Average Weighted Weighted Remaining Average Average Number Contractual Exercise Number Exercise Year Issued Outstanding Life Price Exercisable Price (in years) (per share) (per share) 2016 6 2.0 $ 466.26 6 $ 466.26 2017 23 2.4 118.95 23 118.95 2018 120 4.2 19.20 120 19.20 2019 710 4.8 11.31 710 11.31 859 4.7 $ 18.67 859 $ 18.67 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2019 | |
Commitments and Contingencies | |
Commitments and Contingencies | 11. Commitments and Contingencies Drug Supplier Project Plan – The amounts paid for manufacture of the Company’s Grb2 drug substance, prexigebersen, prexigebersen-A, Bcl‑2 drug substance and BP1002 drug product that have not been expensed total $0.8 million and are carried on the balance sheet as of December 31, 2019 as Prepaid Drug Product for Testing (See Note 3). Total commitments for the Company’s drug supplier project plan are $1.4 million as of December 31, 2019, comprised of $1.1 million to the manufacturer of prexigebersen, prexigebersen-A and BP1002 drug product, $0.2 million for manufacture of our Grb2 and Bcl‑2 drug substances, and $0.1 million for manufacturing development. We expect to incur $0.9 million of these commitments over the next 12 months. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2019 | |
Leases | |
Leases | 12. In April 2014, the Company entered into a five-year lease agreement for administrative office space located in Bellaire, Texas. The term of the lease began on August 1, 2014 and was set to expire on July 31, 2019; however, in May 2019, we entered into an amendment to the lease agreement to extend the term of the lease for a period of five years, beginning on August 1, 2019 and ending on October 31, 2024. In April 2016, the Company entered into a three-year lease agreement for lab space located in Bellaire, Texas that required Bio-Path to pay $2,500 per month over the term of the lease. The term of lease began on May 1, 2016 and was set to expire on April 30, 2019; however, in December 2018, we entered into an amendment to the lease agreement to extend the term for a period of three years, beginning on May 1, 2019 and ending on April 30, 2022. The amendment also amended the monthly rent from $2,500 per month to $2,575 per month over the term of the lease. At the inception of an agreement, the Company determines if the agreement is a lease based on the unique facts and circumstances in each agreement. Lease classification, recognition, and measurement are then determined at the lease commencement date. For agreements that contain a lease, we identify lease and non-lease components, determine the consideration in the contract, determine whether the lease is an operating or financing lease and recognize ROU assets and lease liabilities. Lease liabilities and their corresponding ROU assets are recorded based on the present value of lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not readily determinable so we use an incremental borrowing rate based on the information available at the lease commencement date, which represents an estimated rate that would be incurred to borrow over a similar term in a similar economic environment. The weighted average incremental borrowing rate utilized on our lease liabilities as of December 31, 2019 was 8.0%. Our current leases include options to renew which can impact the lease term. The exercise of these options is at the Company's discretion and we do not include any of these options within the expected lease term as we are not reasonably certain we will exercise these options. Fixed lease payments on operating leases are recognized over the expected term of the lease on a straight-line basis within our consolidated financial statements. Our leases are included in ROU assets, current portion of lease liabilities and noncurrent lease liabilities in our consolidated balance sheet for the year ended December 31, 2019. The following table summarizes our operating lease assets and liabilities as of December 31, 2019: ROU Assets and Liabilities (in thousands) Assets: Operating lease assets $ Liabilities: Current portion of lease liabilities Noncurrent lease liabilities Total operating lease liabilities $ The following table summarizes our lease related costs for the year ended December 31, 2019: Lease Costs (in thousands) Operating lease costs $ Variable lease costs Total lease costs $ The Company made cash payments for its operating leases of $0.1 million for the year ended December 31, 2019. The Company recognized $0.3 million in 2019 for ROU assets and corresponding lease liabilities related to the amendment of our office lease in addition to the $0.1 million recognized upon adoption of the new lease standard on January 1, 2019 (See Note 2). Additionally, the Company recognized $31,000 of non-cash leasehold improvements for the year ended December 31, 2019. The following table summarizes our expected minimum lease payments as of December 31, 2019: As of December 31, 2019 (in thousands) 2020 $ 2021 2022 2023 2024 and thereafter Future minimum lease payments Less: Interest (80) Present value of operating lease liabilities $ As of December 31, 2019, the weighted average remaining lease term was 4.4 years. ASC 840 Disclosures The following table summarizes our expected minimum lease payments as of December 31, 2018: As of December 31, 2018 (in thousands) 2019 $ 82 2020 31 2021 31 2022 10 Future minimum lease payments $ 154 The Company recognized $120,000 in rent expense for office and lab space for the year ended December 31, 2019. |
Benefit Plan
Benefit Plan | 12 Months Ended |
Dec. 31, 2019 | |
Benefit Plan | |
Benefit Plan | 13. Benefit Plan The Company initiated a contribution savings plan under Section 401(k) of the Internal Revenue Code in 2016. Under the plan, all eligible employees may contribute up to the statutory allowable amount governed by the Internal Revenue Service for any calendar year. We make matching contributions equal to 100% of the first 3% and 50% of the next 2% of each employee’s base salary up to the allowable amount which is fully vested on the date the matching contributions are made. For the years ended December 31, 2019 and 2018, matching contributions totaled $29,000 and $35,000, respectively. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2019 | |
Income Taxes | |
Income Taxes | 14. Income Taxes At December 31, 2019, the Company had a net operating loss carryforward for federal income tax purposes of $51.4 million, $35.8 million of which begins to expire in varying amounts in tax year 2026. $15.6 million of net operating losses, incurred after December 31, 2017, carryforward indefinitely. During the years ended December 31, 2019 and 2018, the Company raised additional equity capital. IRC Section 382 imposes certain limitations on the use of a net operating losses to offset future taxable income when an ownership change has occurred. The Company has yet to determine whether an ownership change occurred in 2019 or 2018. If an ownership change is determined to have occurred, additional limitations on the Company’s net operating losses incurred prior to the ownership change may apply. The Company has a research and development tax credit carryforward of $2.1 million for federal income tax purposes that begins to expire in varying amounts in tax year 2028. In assessing the ability to realize its deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Management considers evidence such as the reversal of deferred tax liabilities, projected future results of operations, and tax planning strategies in making this assessment. Based upon the level of historical taxable income, significant book losses during the current and prior periods, and projections for future results of operations over the periods in which the deferred tax assets are deductible, among other factors, management continues to conclude that the Company does not meet the “more likely than not” requirement of ASC 740 in order to recognize deferred tax assets. As such, a valuation allowance has been recorded to offset the Company’s net deferred tax assets at December 31, 2019. The Company recorded an increase in the valuation allowance of $2.0 million for the year ended December 31, 2019. On December 22, 2017, the U.S. enacted the Tax Cuts and Jobs Act (the “2017 Tax Act”). The 2017 Tax Act significantly changes corporate income tax laws in the U.S. including reducing the corporate income tax rate from a maximum of 35% to a flat rate of 21%, effective January 1, 2018. As a result of the reduction in the corporate income tax rate under the 2017 Tax Act, an adjustment was recorded in 2017 to the deferred tax asset of $4.9 million. Due to the uncertainty surrounding the realization of the benefits of its deferred assets, including NOL carryforwards, the Company has provided a 100% valuation allowance on its deferred tax assets at December 31, 2019 and 2018. The valuation allowance was $13.4 million and $11.4 million as of December 31, 2019 and 2018, respectively. The components of the Company’s deferred tax asset are as follows: December 31, 2019 2018 (in thousands) Deferred tax assets – non-current Accrued bonuses $ 64 $ 12 Accrued vacation 16 15 Net operating loss (NOL) carryover 10,789 9,191 Technology license amortization - - Research & development tax credits 2,070 1,780 Share based expense 401 310 Other 4 5 Fixed asset depreciation 61 50 Total deferred tax asset 13,405 11,363 Less: valuation allowance (13,405) (11,363) Net deferred tax asset — — Deferred tax liability- non-current — — Net deferred tax asset $ — $ — Reconciliation between income taxes at the statutory tax rate (21%) and the actual income tax provision for continuing operations follows: December 31, 2019 2018 (in thousands) Loss before income taxes $ (8,599) $ (8,583) Tax (benefit) at statutory tax rate (1,806) (1,802) Effects of: Exclusion of incentive stock option expense 53 47 R&D tax credits (290) (238) Increase (decrease) in valuation allowance 2,041 1,845 FMV of warrants — — Prior year adjustments — — Carryforward adjustment 2 2 ASC 718 additional paid in capital adjustment — 146 Rate change on net deferred tax asset — — Provision for income taxes $ — $ — As of December 31, 2019, the Company had no unrecognized income tax benefits. The Company’s policy for classifying interest and penalties associated with unrecognized income tax benefits is to include such items as tax expense. No interest or penalties have been recorded as of the year ended December 31, 2019, and no interest or penalties have been accrued as of December 31, 2019 and 2018. The Company’s open years for Internal Revenue Service (IRS) examination purposes due to normal statute of limitation are 2016, 2017 and 2018. However, since the Company has operating loss carryforwards, the IRS has the ability to make adjustments to items that originate in a year otherwise barred by the statute of limitations under Section 6501 of the Internal Revenue Code of 1986, as amended (the “code”), in order to redetermine tax for an open year to which those items are carried. Therefore, in a year in which a net operating loss deduction was claimed, the IRS may examine the year in which the net operating loss was generated and adjust it accordingly for purposes of assessing additional tax in the year the net operating loss was claimed. The Company is not currently under examination by the IRS or any other taxing authorities. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2019 | |
Summary of Significant Accounting Policies | |
Principles of Consolidation | Principles of Consolidation — The consolidated financial statements include the accounts of Bio-Path Holdings, Inc., and its wholly-owned subsidiary Bio-Path, Inc. All intercompany accounts and transactions have been eliminated in consolidation. |
Cash and Cash Equivalents | Cash and Cash Equivalents — The Company considers all highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. |
Concentration of Credit Risk | Concentration of Credit Risk — Financial instruments that potentially subject us to a significant concentration of credit risk consist of cash. The Company maintains its cash balances with one major commercial bank, JPMorgan Chase Bank. The balances are insured by the Federal Deposit Insurance Corporation (the “FDIC”) up to $250,000. As a result, as of December 31, 2019, approximately $20.2 million of our cash balance was not covered by the FDIC. As of December 31, 2018, we had approximately $1.0 million in cash on-hand, of which approximately $0.8 million was not covered by the FDIC. To date, the Company has not incurred any losses on its cash balances. |
Furniture, fixtures and equipment | Furniture, fixtures and equipment — Furniture, fixtures and equipment are stated at cost and depreciated using the straight-line method over the estimated useful lives of the assets. Depreciation expense was $0.1 million and $0.3 million for the years ended December 31, 2019 and 2018, respectively. The estimated useful lives are as follows: Computers and equipment – 3 years Furniture and fixtures – 7 years Scientific equipment –7 years Leasehold improvements – Lesser of useful life or lease term Major additions and improvements are capitalized, while costs for minor replacements, maintenance and repairs that do not increase the useful life of an asset are expensed as incurred. |
Long-Lived Assets | Long-Lived Assets — Our long-lived assets consist of furniture, fixtures and equipment, and leasehold improvements and right-of-use operating assets. Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of the asset is measured by a comparison of the asset’s carrying amount to the estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated undiscounted future cash flows, an impairment charge is recognized by the amount by which the carrying amount of the asset exceeds the fair value of the asset. |
Research and Development Costs | Research and Development Costs — Costs and expenses that can be clearly identified as research and development are charged to expense. Advance payments, including nonrefundable amounts, for goods or services that will be used or rendered for future research and development activities are deferred and capitalized. Such amounts will be recognized as an expense as the related goods are delivered or the related services are performed. If the goods will not be delivered, or services will not be rendered, then the capitalized advance payment is charged to expense. The Company estimates its clinical trial expense each period based on a cost per patient calculation which is derived from estimated start-up costs, clinical trial costs based on the number of patients and length of treatment and clinical study report costs. These services are performed by the Company’s third-party clinical research organizations, laboratories and clinical investigative sites. The expense is recorded in research and development expense each period. Amounts that have been prepaid in advance of work performed are recorded in other current assets. For each of the years ended December 31, 2019 and 2018, we had $4.6 million of costs classified as research and development expense. |
Stock-Based Compensation | Stock-Based Compensation — The Company has accounted for stock-based compensation under the provisions of generally accepted accounting principles (“GAAP”). The provisions require us to record an expense associated with the fair value of stock-based compensation. We currently use the Black-Scholes option valuation model to calculate stock-based compensation at the date of grant. Option pricing models require the input of highly subjective assumptions, including the expected price volatility. Changes in these assumptions can materially affect the fair value estimate. |
Net Loss Per Share | Net Loss Per Share — Basic net loss per common share is computed by dividing net loss attributable to common stockholders for the period by the weighted average number of common shares outstanding during the period. Although there were warrants and stock options outstanding during 2019 and 2018, no potential common shares shall be included in the computation of any diluted per-share amount when a loss exists, as it would be anti-dilutive. Consequently, diluted net loss per share as presented in the financial statements is equal to basic net loss per share for the years 2019 and 2018. The calculation of diluted earnings per share for 2019 did not include 67,681 shares and 858,699 shares issuable pursuant to the exercise of outstanding common stock options and warrants, respectively, as of December 31, 2019 as the effect would be anti-dilutive. The calculation of diluted earnings per share for 2018 did not include 37,067 shares and 183,714 shares issuable pursuant to the exercise of outstanding common stock options and warrants, respectively, as of December 31, 2018 as the effect would be anti-dilutive. |
Use of Estimates | Use of Estimates — The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States (“U.S.”) requires management to make estimates and assumptions that affect the amounts reported in the Company’s consolidated financial statements and accompanying notes. On an ongoing basis, the Company evaluates its estimates and judgments, which are based on historical and anticipated results and trends as well as on various other assumptions that the Company believes to be reasonable under the circumstances. By their nature, estimates are subject to an inherent degree of uncertainty and, as such, actual results may differ from the Company’s estimates. These estimates include accrued clinical trial costs, stock-based compensation expense, valuation of warrants and valuation of deferred tax assets. |
Income Taxes | Income Taxes — Deferred income tax assets and liabilities are determined based upon differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. |
Liquidity | Liquidity — Since its inception, the Company has devoted substantially all of its efforts to product development, raising capital and building infrastructure, and has not generated significant revenues from its planned principal operations. The Company does not anticipate generating significant revenues for the foreseeable future. The Company’s activities are subject to significant risks and uncertainties. The Company has experienced significant losses since its inception, including net losses of $ 8.6 million for each of the years ended December 31, 2019 and 2018. As of December 31, 2019, the Company had an accumulated deficit of $56.3 million and $20.4 million in cash and cash equivalents. The Company has no debt commitments. Substantially all of the Company’s net losses have resulted from costs incurred in connection with its research and development activities and its general and administrative expenses to support operations. The Company’s net losses may fluctuate significantly from quarter to quarter and year to year. The Company believes that its available cash at December 31, 2019 will be sufficient to fund liquidity and capital expenditure requirements for at least the next 12 months from the date of issuance of these consolidated financial statements. However, the Company expects to continue to incur net losses for the foreseeable future . The Company expects to continue to incur significant operating expenses in connection with its ongoing activities, including conducting clinical trials, manufacturing development and seeking regulatory approval of its drug candidates, prexigebersen, BP1002 and BP1003. Accordingly, the Company will continue to require substantial additional capital to fund its projected operating requirements. Such additional capital may not be available when needed or on terms favorable to the Company. In addition, the Company may seek additional capital due to favorable market conditions or strategic considerations, even if it believes it has sufficient funds for our current and future operating plan. There can be no assurance that the Company will be able to continue to raise additional capital through the sale of securities in the future. If the Company is not able to secure adequate additional funding, the Company may be forced to make reductions in spending, extend payment terms with suppliers, and/or suspend or curtail planned programs. Any of these actions could materially harm the Company’s business, results of operations, financial condition and future prospects. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements — From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (FASB) that are adopted by the Company as of the specified effective date. If not discussed, management believes that the impact of recently issued standards, which are not yet effective, will not have a material impact on the Company’s consolidated financial statements upon adoption. In February 2016, the FASB issued ASU No. 2016‑02, Leases . The new standard establishes a right-of-use (“ROU”) model that requires a lessee to record a ROU asset and a lease liability initially measured at the present value of the lease payments on the balance sheet for all leases with terms longer than 12 months. The new standard is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. In 2018, the FASB issued ASU 2018-01 and ASU 2018-11, which collectively adds two practical expedients and provides an alternative modified retrospective transition method in the year of adoption. Management adopted the new standard on January 1, 2019 using the modified retrospective transition approach with no restatement of prior periods or cumulative adjustment to accumulated deficit. We elected the "package of practiced expedients", which permits us not to reassess under the new standard our prior conclusions about lease identification, lease classification and indirect costs. We also elected the short-term lease exemption and therefore do not recognize ROU assets or corresponding liabilities for lease agreements with an original term of 12 months or less. Consequently, prior year financials statements have not been updated and the disclosures required under the new standard have not been provided for periods prior to the adoption date. Upon adoption of the new standards, the Company recognized $0.1 million for ROU assets and corresponding lease liabilities on the consolidated balance sheet related to leases for office and lab space. The adoption of these ASU's on January 1, 2019 did not have a significant impact on our consolidated financial statements. In August 2018, the FASB issued ASU No. 2018‑13, Fair Value Measurement (Topic 820): Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement . The new standard eliminates certain disclosure requirements for fair value measurements for all entities, requires public entities to disclose certain new information and modifies some disclosure requirements. This standard is effective for fiscal years beginning after December 15, 2019, with early adoption permitted. Management does not believe there will be a significant impact on our consolidated financial statements as the Company does not currently have any fair value measurements to disclose. Management has reviewed all other recently issued pronouncements and has determined they will have no material impact on the Company’s consolidated financial statements. |
Correction of Immaterial Errors in Previously Issued Financial Statements | Correction of Immaterial Errors in Previously Issued Financial Statements - In evaluating the consolidated financial statements as of and for the year ended December 31, 2018, the Company subsequently identified immaterial errors within the Company's consolidated balance sheet as of December 31, 2018 and consolidated statement of cash flows for the year ended December 31, 2018. The Company has assessed the effects of these errors and based upon quantitative and qualitative factors, determined that the errors were not material to the previously issued consolidated financial statements. The following table summarizes the correction of immaterial errors as of and for the year ended December 31, 2018: 2018 As Reported Adjustments As Corrected (in thousands) Consolidated Balance Sheet Other current assets $ 593 $ $ Total current assets Total Assets Accounts payable (226) Accrued expenses Total current liabilities Total Liabilities Total Liabilities & Shareholders’ Equity Consolidated Statement of Cash Flows Other current assets (240) (210) (450) Accounts payable and accrued expenses |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Summary of Significant Accounting Policies | |
Summary of the correction of immaterial errors | The following table summarizes the correction of immaterial errors as of and for the year ended December 31, 2018: 2018 As Reported Adjustments As Corrected (in thousands) Consolidated Balance Sheet Other current assets $ 593 $ $ Total current assets Total Assets Accounts payable (226) Accrued expenses Total current liabilities Total Liabilities Total Liabilities & Shareholders’ Equity Consolidated Statement of Cash Flows Other current assets (240) (210) (450) Accounts payable and accrued expenses |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Property and Equipment | |
Property, Plant and Equipment | The following table summarizes property and equipment as of December 31, 2019 and 2018: December 31, Estimated Useful Lives 2019 2018 (in years) (in thousands) Leasehold improvements 2 to 5 $ 463 $ 432 Computers and office equipment 3 60 60 Furniture and fixtures 7 46 46 Scientific equipment 7 460 460 Total 1,029 998 Less: Accumulated depreciation (726) (592) Net property and equipment $ 303 $ 406 |
Stock-Based Compensation Plan (
Stock-Based Compensation Plan (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions | Option activity under the Plans for the year ended December 31, 2019, was as follows (in thousands, except as noted): Weighted Weighted- Average Average Remaining Aggregate Exercise Contractual Intrinsic Options Price Term Value (per share) (in years) Year Ended December 31, 2019 Outstanding at December 31, 2018 37 $ 112.60 $ — Granted 35 18.40 Forfeited (3) 36.68 Expired (1) 61.18 Outstanding at December 31, 2019 68 $ 68.56 $ — Vested and expected to vest December 31, 2019 58 $ 76.12 $ — Exercisable at December 31, 2019 26 $ 138.77 $ — Option activity under the Plans for the year ended December 31, 2018, was as follows (in thousands, except as noted): Weighted Weighted- Average Average Remaining Aggregate Exercise Contractual Intrinsic Options Price Term Value (per share) (in years) Year Ended December 31, 2018 Outstanding at December 31, 2017 32 $ 232.00 4.0 $ — Granted 20 34.60 9.3 Forfeited — — Expired (15) 267.20 Outstanding at December 31, 2018 37 $ 112.60 7.5 $ — Vested and expected to vest December 31, 2018 31 $ 124.60 7.2 $ — Exercisable at December 31, 2018 15 $ 181.00 5.1 $ — |
Warrant [Member] | |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions | For stock options granted during 2019 and 2018 the following weighted average assumptions were used in determining fair value: 2019 2018 Risk-free interest rate 2.23 % 2.70 % Expected volatility 126 % 90 % Expected term in years 6.1 Dividend yield — % — % |
Warrants (Tables)
Warrants (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Warrants | |
Schedule of Stockholders' Equity Note, Warrants or Rights | A summary of warrants outstanding and exercisable as of December 31, 2019 (in thousands, except as noted): Warrants Outstanding Warrants Exercisable Weighted Average Weighted Weighted Remaining Average Average Number Contractual Exercise Number Exercise Year Issued Outstanding Life Price Exercisable Price (in years) (per share) (per share) 2016 6 2.0 $ 466.26 6 $ 466.26 2017 23 2.4 118.95 23 118.95 2018 120 4.2 19.20 120 19.20 2019 710 4.8 11.31 710 11.31 859 4.7 $ 18.67 859 $ 18.67 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Leases | |
Operating Lease Assets and Liabilities | The following table summarizes our operating lease assets and liabilities as of December 31, 2019: ROU Assets and Liabilities (in thousands) Assets: Operating lease assets $ Liabilities: Current portion of lease liabilities Noncurrent lease liabilities Total operating lease liabilities $ |
Lease, Cost | The following table summarizes our lease related costs for the year ended December 31, 2019: Lease Costs (in thousands) Operating lease costs $ Variable lease costs Total lease costs $ |
Lessee, Operating Lease, Liability, Maturity | The following table summarizes our expected minimum lease payments as of December 31, 2019: As of December 31, 2019 (in thousands) 2020 $ 2021 2022 2023 2024 and thereafter Future minimum lease payments Less: Interest (80) Present value of operating lease liabilities $ |
Schedule of Future Minimum Rental Payments for Operating Leases | The following table summarizes our expected minimum lease payments as of December 31, 2018: As of December 31, 2018 (in thousands) 2019 $ 82 2020 31 2021 31 2022 10 Future minimum lease payments $ 154 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Income Taxes | |
Schedule of Deferred Tax Assets and Liabilities | The components of the Company’s deferred tax asset are as follows: December 31, 2019 2018 (in thousands) Deferred tax assets – non-current Accrued bonuses $ 64 $ 12 Accrued vacation 16 15 Net operating loss (NOL) carryover 10,789 9,191 Technology license amortization - - Research & development tax credits 2,070 1,780 Share based expense 401 310 Other 4 5 Fixed asset depreciation 61 50 Total deferred tax asset 13,405 11,363 Less: valuation allowance (13,405) (11,363) Net deferred tax asset — — Deferred tax liability- non-current — — Net deferred tax asset $ — $ — |
Schedule of Effective Income Tax Rate Reconciliation | Reconciliation between income taxes at the statutory tax rate (21%) and the actual income tax provision for continuing operations follows: December 31, 2019 2018 (in thousands) Loss before income taxes $ (8,599) $ (8,583) Tax (benefit) at statutory tax rate (1,806) (1,802) Effects of: Exclusion of incentive stock option expense 53 47 R&D tax credits (290) (238) Increase (decrease) in valuation allowance 2,041 1,845 FMV of warrants — — Prior year adjustments — — Carryforward adjustment 2 2 ASC 718 additional paid in capital adjustment — 146 Rate change on net deferred tax asset — — Provision for income taxes $ — $ — |
Organization and Business (Deta
Organization and Business (Details) - USD ($) $ in Thousands | Jan. 18, 2019 | Jan. 18, 2019 | Jan. 17, 2019 | Jun. 30, 2015 | Dec. 31, 2019 | Dec. 31, 2018 |
Organization and Nature of Operations [Line Items] | ||||||
Stock issued during period, value, new issues | $ 1,700 | $ 26,700 | $ 1,180 | |||
Notice period for termination of ATM program | 10 days | |||||
Stockholders' Equity, Reverse Stock Split | 1–for–20 | common stock at a ratio of 1–for–20, and our common stock began trading on the split-adjusted basis on the Nasdaq Capital Market at the commencement of trading on January 18, 2019. All common stock share and per share amounts in our consolidated financial statements have been adjusted to give effect to the 1–for–20 reverse stock split. | ||||
Warrant [Member] | ||||||
Organization and Nature of Operations [Line Items] | ||||||
Stock issued during period, value, new issues | $ 25,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Jan. 01, 2019 | |
Significant Accounting Policies [Line Items] | |||
Amortization of Intangible Assets | $ 0 | $ 161,000 | |
Cash | 20,426,000 | 1,004,000 | |
Depreciation | 134,000 | 265,000 | |
Research and Development Costs Expenses | $ 4,600,000 | $ 4,600,000 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 67,681 | 37,067 | |
Net Income (Loss) Attributable to Parent | $ (8,599,000) | $ (8,583,000) | |
Retained Earnings (Accumulated Deficit) | (56,339,000) | (47,740,000) | |
Debt commitments | 0 | ||
Operating Lease, Right-of-Use Asset | 367,000 | $ 0 | |
Operating Lease, Liability | 415,000 | ||
Accounting Standards Update 2018-11 [Member] | |||
Significant Accounting Policies [Line Items] | |||
Operating Lease, Right-of-Use Asset | 300,000 | $ 100,000 | |
Operating Lease, Liability | $ 300,000 | $ 100,000 | |
Warrant [Member] | |||
Significant Accounting Policies [Line Items] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 858,699 | 183,714 | |
Furniture and fixtures | |||
Significant Accounting Policies [Line Items] | |||
Property, Plant and Equipment, Useful Life | 7 years | ||
Computers and equipment | |||
Significant Accounting Policies [Line Items] | |||
Property, Plant and Equipment, Useful Life | 3 years | ||
Scientific equipment | |||
Significant Accounting Policies [Line Items] | |||
Property, Plant and Equipment, Useful Life | 7 years | ||
Jp Morgan Chase Bank [Member] | |||
Significant Accounting Policies [Line Items] | |||
Cash, FDIC Insured Amount | $ 20,200,000 | $ 800,000 | |
Federal Deposit Insurance | $ 250,000 | ||
Cash | $ 1,000,000 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Summary of the correction of immaterial errors (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Consolidated Balance Sheet | ||
Other current assets | $ 788 | $ 803 |
Total current assets | 21,990 | 2,139 |
Total Assets | 22,660 | 2,545 |
Accounts payable | 486 | 587 |
Accrued expense | 673 | 740 |
Total current liabilities | 1,244 | 1,327 |
Total Liabilities | 1,574 | 1,327 |
Total Liabilities & Shareholders' Equity | 22,660 | 2,545 |
Consolidated Statement of Cash Flows | ||
Other current assets | 15 | (450) |
Accounts payable and accrued expenses | $ (168) | 536 |
As Reported [Member] | ||
Consolidated Balance Sheet | ||
Other current assets | 593 | |
Total current assets | 1,929 | |
Total Assets | 2,335 | |
Accounts payable | 813 | |
Accrued expense | 304 | |
Total current liabilities | 1,117 | |
Total Liabilities | 1,117 | |
Total Liabilities & Shareholders' Equity | 2,335 | |
Consolidated Statement of Cash Flows | ||
Other current assets | (240) | |
Accounts payable and accrued expenses | 326 | |
Adjustment [Member] | ||
Consolidated Balance Sheet | ||
Other current assets | 210 | |
Total current assets | 210 | |
Total Assets | 210 | |
Accounts payable | (226) | |
Accrued expense | 436 | |
Total current liabilities | 210 | |
Total Liabilities | 210 | |
Total Liabilities & Shareholders' Equity | 210 | |
Consolidated Statement of Cash Flows | ||
Other current assets | (210) | |
Accounts payable and accrued expenses | $ 210 |
Prepaid Drug Product for Test_2
Prepaid Drug Product for Testing (Details) - USD ($) $ in Millions | Dec. 31, 2019 | Dec. 31, 2018 |
Prepaid Drug Product For Testing | ||
Other Prepaid Expense, Current | $ 0.8 | $ 0.3 |
Other Current Assets (Details)
Other Current Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Other Assets, Current | $ 788 | $ 803 |
Prepaid Expenses [Member] | ||
Other Assets, Current | 800 | 800 |
Prepaid Insurance | 100 | |
Prepaid Expenses [Member] | Acute Myeloid Leukemia [Member] | ||
Other Assets, Current | 600 | |
Prepaid Expenses [Member] | AcuteMyeloidLeukemia and Chronic Myelogenous Leukemia Member | ||
Other Assets, Current | 600 | |
Prepaid Insurance | $ 200 | |
Other Prepaid Expenses [Member] | ||
Other Assets, Current | $ 100 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | $ 1,029 | $ 998 |
Less accumulated depreciation | (726) | (592) |
Net property and equipment | 303 | 406 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | $ 463 | 432 |
Leasehold Improvements [Member] | Minimum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Useful Life | 2 years | |
Leasehold Improvements [Member] | Maximum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Useful Life | 5 years | |
Computer And Office Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Useful Life | 3 years | |
Property, Plant and Equipment, Gross | $ 60 | 60 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Useful Life | 7 years | |
Property, Plant and Equipment, Gross | $ 46 | 46 |
Scientific equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Useful Life | 7 years | |
Property, Plant and Equipment, Gross | $ 460 | $ 460 |
Accounts Payable (Details)
Accounts Payable (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Accounts Payable [Line Items] | ||
Accounts Payable, Current | $ 486 | $ 587 |
Other Payables [Member] | ||
Accounts Payable [Line Items] | ||
Accounts Payable, Current | 100 | |
Preclinical Expenses [Member] | ||
Accounts Payable [Line Items] | ||
Accounts Payable, Current | 200 | |
License Maintenance Fee [Member] | ||
Accounts Payable [Line Items] | ||
Accounts Payable, Current | 100 | |
Manufacturing Costs [Member] | ||
Accounts Payable [Line Items] | ||
Accounts Payable, Current | 300 | 100 |
Legal and Patent [Member] | ||
Accounts Payable [Line Items] | ||
Accounts Payable, Current | $ 200 | |
Clinical Research Organizations [Member] | ||
Accounts Payable [Line Items] | ||
Accounts Payable, Current | $ 100 |
Accrued Expense (Details)
Accrued Expense (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Accrued Expense | ||
Accrued expense | $ 673 | $ 740 |
Accrued Vacation And Bonus | 400 | 100 |
Accrued Clinical And Preclinical Expenses | 200 | 500 |
Other Accrued Liabilities | $ 100 | |
Accrued Legal And Professional Fee | $ 100 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) $ / shares in Units, $ in Thousands | Nov. 21, 2019 | Mar. 12, 2019 | Jan. 18, 2019 | Jan. 14, 2019 | Sep. 20, 2018 | Jun. 30, 2015 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Shareholders Equity [Line Items] | |||||||||
Stockholders' Equity Attributable to Parent | $ 21,086 | $ 1,218 | $ 8,067 | ||||||
Common Stock, shares issued | 3,692,000 | 680,000 | |||||||
Common Stock, Shares, Outstanding | 3,692,000 | 680,000 | |||||||
Preferred Stock, Shares Issued | 0 | 0 | |||||||
Preferred Stock, Shares Outstanding | 0 | 0 | |||||||
Stock Issued During Period, Value, New Issues | $ 1,700 | $ 26,700 | $ 1,180 | ||||||
Stockholders' Equity Attributable to Parent | 21,086 | 1,218 | 8,067 | ||||||
Proceeds from Issuance of Common Stock | $ 17,000 | $ 1,500 | $ 900 | $ 26,700 | $ 1,180 | ||||
Preferred Stock, shares outstanding | 0 | 0 | |||||||
Stock Issued During Period Shares Warrants Exercised | 409,875 | ||||||||
Weighted Average Excercise Price | $ 2.67 | ||||||||
Proceeds from Stock Options Exercised | $ 1,083 | $ 0 | |||||||
Warrant [Member] | |||||||||
Shareholders Equity [Line Items] | |||||||||
Stock Issued During Period, Value, New Issues | $ 25,000 | ||||||||
Proceeds from Issuance of Common Stock | $ 7,300 | $ 1,200 | |||||||
Warrants issued | 42,775 | ||||||||
Common Stock | |||||||||
Shareholders Equity [Line Items] | |||||||||
Stockholders' Equity Attributable to Parent | $ 4 | $ 1 | 1 | ||||||
Stock Issued During Period, Shares, New Issues | 2,602,000 | 113,000 | |||||||
Stock Issued During Period, Value, New Issues | $ 3 | ||||||||
Stockholders' Equity Attributable to Parent | $ 4 | $ 1 | $ 1 | ||||||
IPO [Member] | |||||||||
Shareholders Equity [Line Items] | |||||||||
Stock Issued During Period, Shares, New Issues | 429,616 | ||||||||
Proceeds from Issuance of Common Stock | $ 1,100 | ||||||||
Shares Issued, Price Per Share | $ 2.60 | ||||||||
2018 Registered Direct Offering [Member] | |||||||||
Shareholders Equity [Line Items] | |||||||||
Stock Issued During Period, Shares, New Issues | 98,454 | ||||||||
Stock Issued During Period, Value, New Issues | $ 1,500 | ||||||||
2018 Registered Direct Offering [Member] | Warrant [Member] | |||||||||
Shareholders Equity [Line Items] | |||||||||
Warrants issued | 14,624 | ||||||||
2019 Registered Direct Offering [Member] | |||||||||
Shareholders Equity [Line Items] | |||||||||
Stock Issued During Period, Shares, New Issues | 808,080 | 712,910 | 648,233 | ||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 324,117 | ||||||||
Stock Issued During Period, Value, New Issues | $ 8,000 | $ 18,500 | |||||||
2019 Registered Direct Offering [Member] | Warrant [Member] | |||||||||
Shareholders Equity [Line Items] | |||||||||
Warrants issued | 606,060 | ||||||||
Private Placement [Member] | |||||||||
Shareholders Equity [Line Items] | |||||||||
Warrants issued | 25,777 | ||||||||
Private Placement [Member] | Series A Warrants [Member] | |||||||||
Shareholders Equity [Line Items] | |||||||||
Warrants issued | 113,077 | ||||||||
HC Wainwright Co [Member] | |||||||||
Shareholders Equity [Line Items] | |||||||||
Shares Issued, Price Per Share | $ 2.418 | ||||||||
HC Wainwright Co [Member] | 2018 Registered Direct Offering [Member] | |||||||||
Shareholders Equity [Line Items] | |||||||||
Warrants issued | 6,785 | ||||||||
HC Wainwright Co [Member] | 2019 Registered Direct Offering [Member] | |||||||||
Shareholders Equity [Line Items] | |||||||||
Warrants issued | 48,485 | ||||||||
HC Wainwright Co [Member] | Private Placement [Member] | Common Stock | |||||||||
Shareholders Equity [Line Items] | |||||||||
Warrants issued | 38,894 |
Stock-Based Compensation Plan -
Stock-Based Compensation Plan - Weighted Average Assumptions (Details) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Stock-Based Compensation Plan | ||
Risk-free interest rate | 2.23% | 2.70% |
Expected volatility | 126.00% | 90.00% |
Expected term in years | 6 years | 6 years 1 month 6 days |
Dividend yield | 0.00% | 0.00% |
Stock-Based Compensation Plan_2
Stock-Based Compensation Plan - Option Activity Under Plan (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Stock-Based Compensation Plan | |||
Outstanding | 37 | 32 | |
Granted | 35 | 20 | |
Forfeited | (3) | ||
Expired | (1) | (15) | |
Outstanding | 68 | 37 | 32 |
Vested and expected to vest | 58 | 31 | |
Exercisable | 26 | 15 | |
Weighted - Average Exercise Price, Outstanding | $ 112.60 | $ 232 | |
Weighted - Average Exercise Price, Granted | 18.40 | 34.60 | |
Weighted - Average Exercise Price, Forfeited | 36.68 | ||
Weighted - Average Exercise Price, Expired | 61.18 | 267.20 | |
Weighted - Average Exercise Price, Outstanding | 68.56 | 112.60 | $ 232 |
Weighted - Average Exercise Price, Vested and expected to vest | 76.12 | 124.60 | |
Weighted - Average Exercise Price, Exercisable | $ 138.77 | $ 181 | |
Weighted Average Remaining Contractual Term (In years), Outstanding | 7 years 8 months 12 days | 7 years 6 months | 4 years |
Weighted Average Remaining Contractual Term (In years), Granted | 9 years 2 months 12 days | 9 years 3 months 18 days | |
Weighted Average Remaining Contractual Term (In years), Vested and expected to vest | 7 years 4 months 24 days | 7 years 2 months 12 days | |
Weighted Average Remaining Contractual Term (In years), Exercisable | 5 years 6 months | 5 years 1 month 6 days | |
Aggregate Intrinsic Value, Outstanding | $ 0 | ||
Aggregate Intrinsic Value, Outstanding | 0 | $ 0 | |
Aggregate Intrinsic Value, Vested and expected to vest | 0 | 0 | |
Aggregate Intrinsic Value, Exercisable | $ 0 | $ 0 |
Stock-Based Compensation Plan_3
Stock-Based Compensation Plan - Additional Information (Details) - USD ($) | Dec. 21, 2017 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 19, 2019 |
Stock Based Compensation Plans [Line Items] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 35,000 | 20,000 | ||
Common Stock Shares Available For Future Issuance Value | $ 609,121 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period | 10 years | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 16.26 | $ 26.55 | ||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Stock Options | $ 600,000 | |||
Stock-based compensation expense | $ 700,000 | $ 600,000 | ||
Share-based Compensation Arrangement By Share-based Payment Award, Options Outstanding And Unvested, Weighted Average Remaining Contractual Term | 2 years 2 months 12 days | |||
Stock Incentive Plan 2007 [Member] | ||||
Stock Based Compensation Plans [Line Items] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 0 | |||
Incremental number of shares reserved for grant and issuance | 600,000 | |||
Stock Incentive Plan 2007 [Member] | Maximum [Member] | ||||
Stock Based Compensation Plans [Line Items] | ||||
Incremental number of shares reserved for grant and issuance | 660,000 | |||
Research and Development Expense [Member] | ||||
Stock Based Compensation Plans [Line Items] | ||||
Stock-based compensation expense | $ 100,000 | 100,000 | ||
General and Administrative Expense [Member] | ||||
Stock Based Compensation Plans [Line Items] | ||||
Stock-based compensation expense | $ 600,000 | $ 500,000 |
Warrants - Outstanding and Exer
Warrants - Outstanding and Exercisable (Details) shares in Thousands | 12 Months Ended |
Dec. 31, 2019$ / sharesshares | |
Class of Warrant or Right [Line Items] | |
Warrants Outstanding, Number Outstanding | shares | 859 |
Warrants Outstanding, Weighted Average Remaining Contractual Life (Years) | 4 years 8 months 12 days |
Warrants Outstanding, Weighted Average Exercise Price (per share) | $ / shares | $ 18.67 |
Warrants Exercisable, Number Exercisable | shares | 859 |
Warrants Exercisable, Weighted Average Exercise Price (per share) | $ / shares | $ 18.67 |
Warrants 2016 [Member] | |
Class of Warrant or Right [Line Items] | |
Warrants Outstanding, Number Outstanding | shares | 6 |
Warrants Outstanding, Weighted Average Remaining Contractual Life (Years) | 2 years |
Warrants Outstanding, Weighted Average Exercise Price (per share) | $ / shares | $ 466.26 |
Warrants Exercisable, Number Exercisable | shares | 6 |
Warrants Exercisable, Weighted Average Exercise Price (per share) | $ / shares | $ 466.26 |
Warrants 2017 [Member] | |
Class of Warrant or Right [Line Items] | |
Warrants Outstanding, Number Outstanding | shares | 23 |
Warrants Outstanding, Weighted Average Remaining Contractual Life (Years) | 2 years 4 months 24 days |
Warrants Outstanding, Weighted Average Exercise Price (per share) | $ / shares | $ 118.95 |
Warrants Exercisable, Number Exercisable | shares | 23 |
Warrants Exercisable, Weighted Average Exercise Price (per share) | $ / shares | $ 118.95 |
Warrants 2018 [Member] | |
Class of Warrant or Right [Line Items] | |
Warrants Outstanding, Number Outstanding | shares | 120 |
Warrants Outstanding, Weighted Average Remaining Contractual Life (Years) | 4 years 2 months 12 days |
Warrants Outstanding, Weighted Average Exercise Price (per share) | $ / shares | $ 19.20 |
Warrants Exercisable, Number Exercisable | shares | 120 |
Warrants Exercisable, Weighted Average Exercise Price (per share) | $ / shares | $ 19.20 |
Warrants 2019 [Member] | |
Class of Warrant or Right [Line Items] | |
Warrants Outstanding, Number Outstanding | shares | 710 |
Warrants Outstanding, Weighted Average Remaining Contractual Life (Years) | 4 years 9 months 18 days |
Warrants Outstanding, Weighted Average Exercise Price (per share) | $ / shares | $ 11.31 |
Warrants Exercisable, Number Exercisable | shares | 710 |
Warrants Exercisable, Weighted Average Exercise Price (per share) | $ / shares | $ 11.31 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) - USD ($) $ in Millions | Dec. 31, 2019 | Dec. 31, 2018 |
Product Liability Contingency [Line Items] | ||
Other Prepaid Expense, Current | $ 0.8 | $ 0.3 |
Other Commitment, Due in Next Twelve Months | 0.9 | |
Drug Supplier Project Plan [Member] | ||
Product Liability Contingency [Line Items] | ||
Other Commitment | 1.4 | |
Manufacturer Of Prexigebersen [Member] | ||
Product Liability Contingency [Line Items] | ||
Other Commitment | 1.1 | |
Manufacture Of Drug Substance [Member] | ||
Product Liability Contingency [Line Items] | ||
Other Commitment | 0.2 | |
Manufacturing Development [Member] | ||
Product Liability Contingency [Line Items] | ||
Other Commitment | $ 0.1 |
Leases - operating lease assets
Leases - operating lease assets and liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Assets: | ||
Operating lease assets | $ 367 | $ 0 |
Liabilities: | ||
Current portion of lease liabilities | 85 | 0 |
Noncurrent lease liabilities | 330 | $ 0 |
Total operating lease liabilities | $ 415 |
Leases- Lease Related Costs (De
Leases- Lease Related Costs (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Leases | |
Operating lease costs | $ 114 |
Variable lease costs | 6 |
Total lease costs | $ 120 |
Leases - Expected Minimum Lease
Leases - Expected Minimum Lease Payments (Details) $ in Thousands | Dec. 31, 2019USD ($) |
Leases | |
2020 | $ 115 |
2021 | 117 |
2022 | 98 |
2023 | 89 |
2024 and thereafter | 76 |
Future minimum lease payments | 495 |
Less: Interest | (80) |
Present value of operating lease liabilities | $ 415 |
Leases - Future Minimum Lease P
Leases - Future Minimum Lease Payments (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Leases | |
2019 | $ 82 |
2020 | 31 |
2021 | 31 |
2022 | 10 |
Future minimum lease payments | $ 154 |
Leases - Additional Information
Leases - Additional Information (Details) - USD ($) | May 01, 2019 | May 31, 2019 | Apr. 30, 2016 | Dec. 31, 2019 | Dec. 31, 2018 | Jan. 01, 2019 | Apr. 30, 2014 |
Operating Lease, Term of Contract | 5 years | ||||||
Operating Lease, Renewal Term | 5 years | ||||||
Option to extend the term of the lease term | true | ||||||
Operating Lease Monthly Rental Payments | $ 2,500 | ||||||
Operating Lease Incremental Borrowing Rate Utilized | 8.00% | ||||||
Operating Lease, Payments | $ 100,000 | ||||||
Operating Lease, Right-of-Use Asset | 367,000 | $ 0 | |||||
Operating Lease, Liability | 415,000 | ||||||
Addition to leasehold improvements | $ 31,000 | $ 0 | |||||
Operating Lease, Weighted Average Remaining Lease Term | 4 years 4 months 24 days | ||||||
Operating Leases, Rent Expense, Net | $ 120,000 | ||||||
Accounting Standards Update 2018-11 [Member] | |||||||
Operating Lease, Right-of-Use Asset | 300,000 | $ 100,000 | |||||
Operating Lease, Liability | 300,000 | $ 100,000 | |||||
Extended Lab Space [Member] | |||||||
Operating Lease Monthly Rental Payments | $ 2,575 | ||||||
Lab Space [Member] | |||||||
Operating Lease, Term of Contract | 3 years | ||||||
Operating Lease Monthly Rental Payments | $ 2,500 |
Benefit Plan (Details)
Benefit Plan (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Benefit Plan | ||
Defined Contribution Plan, Employer Matching Contribution, Percent of Match on First 3% of Base Salary | 100.00% | |
Defined Contribution Plan, Employer Matching Contribution, First Tranche, Percent of Employees' Gross Pay | 3.00% | |
Defined Contribution Plan, Employer Matching Contribution, Percent of Match on Next 2% of Base Salary | 50.00% | |
Defined Contribution Plan, Employer Matching Contribution, Second Tranche, Percent Of Employees Gross Pay | 2.00% | |
Defined Benefit Plan, Accumulated Benefit Obligation | $ 29,000 | $ 35,000 |
Income Taxes - Components Of Co
Income Taxes - Components Of Company's deferred Tax Asset (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Deferred Tax Assets, Net of Valuation Allowance [Abstract] | ||
Accrued bonuses | $ 64 | $ 12 |
Accrued vacation | 16 | 15 |
Net operating loss (NOL) carryover | 10,789 | 9,191 |
Technology licenses amortization | 0 | 0 |
Research & development tax credits | 2,070 | 1,780 |
Share based expense | 401 | 310 |
Other | 4 | 5 |
Fixed asset depreciation | 61 | 50 |
Total deferred tax asset | 13,405 | 11,363 |
Less: valuation allowance | (13,405) | (11,363) |
Net deferred tax asset | 0 | 0 |
Deferred tax liability- non-current | 0 | 0 |
Net deferred tax asset | $ 0 | $ 0 |
Income Taxes - Reconciliation B
Income Taxes - Reconciliation Between Income Taxes at Statutory Tax Rate (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Income Taxes | ||
Loss before income taxes | $ (8,599) | $ (8,583) |
Tax (benefit) at statutory tax rate | (1,806) | (1,802) |
Effects of: | ||
Exclusion of incentive stock option expense | 53 | 47 |
R&D tax credits | (290) | (238) |
Increase (decrease) in valuation allowance | 2,041 | 1,845 |
FMV of warrants | 0 | 0 |
Prior year adjustments | 0 | 0 |
Carryforward adjustment | 2 | 2 |
ASC 718 additional paid in capital adjustment | 0 | 146 |
Rate change on net deferred tax asset | 0 | 0 |
Provision for income taxes | 0 | 0 |
Unrecognized tax benefits | 0 | |
Unrecognized tax benefits, interest and penalties recorded | 0 | |
Unrecognized tax benefits, interest and penalties accrued | $ 0 | $ 0 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax [Line Items] | |||
Operating Loss Carryforwards | $ 51,400 | ||
Deferred Tax Assets, Tax Credit Carryforwards, Research | 2,070 | $ 1,780 | |
Effective Income Tax Rate Reconciliation, Change in Deferred Tax Assets Valuation Allowance, Amount | $ 2,041 | 1,845 | |
Operating Loss Carryforwards, Expiration Date | Dec. 31, 2026 | ||
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 21.00% | 35.00% | |
Effective Income Tax Rate Reconciliation, Change in Enacted Tax Rate, Amount | $ 4,900 | ||
Percentage of deferred tax assets that have been included in the valuation allowance | 100.00% | ||
Valuation Allowance, Deferred Tax Asset, Increase (Decrease), Amount | $ 13,400 | $ 11,400 | |
Deferred Tax Assets, Operating Loss Carryforwards, Subject to Expiration | 35,800 | ||
Deferred Tax Assets, Operating Loss Carryforwards, Not Subject to Expiration | 15,600 | ||
Scenario, Plan [Member] | |||
Income Tax [Line Items] | |||
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 21.00% | ||
Research and Development [Member] | |||
Income Tax [Line Items] | |||
Deferred Tax Assets, Tax Credit Carryforwards, Research | $ 2,100 | ||
Tax Credit Carryforward, Expiration Date | Dec. 31, 2028 |