−Removed: Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
−Removed: Our common stock has been listed on the
−Removed: NASDAQ Capital Market under the symbol “CNSP”
−Removed: since November 8, 2019.
+Added: Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
+Added: Our common stock has been listed on the NASDAQ
+Added: Capital Market under the symbol “CNSP” since November 8, 2019.
Holders of Common Equity
−Removed: As of January 29, 2021, we had approximately
+Added: As of February 7, 2022, we had approximately
11,000 stockholders of record of our common stock.
This does not include beneficial owners of our common stock.
−Removed: We have never declared or paid any cash
−Removed: dividends on our capital stock.
+Added: We have never declared or paid any cash dividends
+Added: on our capital stock.
We currently intend to retain earnings, if any, to finance the growth and development of our business.
−Removed: We do not expect to pay any cash dividends on our common stock in the foreseeable future.
−Removed: Payment of future dividends, if any,
−Removed: will be at the discretion of our board of directors and will depend on our financial condition, results of operations, capital
−Removed: requirements, restrictions contained in any financing instruments, provisions of applicable law and other factors the board deems
+Added: expect to pay any cash dividends on our common stock in the foreseeable future.
+Added: Payment of future dividends, if any, will be at the discretion
+Added: of our board of directors and will depend on our financial condition, results of operations, capital requirements, restrictions contained
+Added: in any financing instruments, provisions of applicable law and other factors the board deems relevant.
Recent Sales of Unregistered Securities
−Removed: There have been no sales of unregistered
−Removed: securities during the quarter ended December 31, 2020.
−Removed: Purchases of Equity Securities by the Issuer and Affiliated
−Removed: We did not repurchase any of our equity
−Removed: securities during the year ended December 31, 2020.
+Added: There have been no sales of unregistered securities
+Added: during the quarter ended December 31, 2021.
+Added: Purchases of Equity Securities by the Issuer and Affiliated Purchasers
+Added: We did not repurchase any of our equity securities
+Added: during the year ended December 31, 2021.
Equity Compensation Plan Information
−Removed: See Part III, Item 12 to this Form 10-K
−Removed: for information relating to securities authorized for issuance under our equity compensation plans.
−Removed: Selected Financial Data.
−Removed: We are a smaller reporting company as defined
−Removed: by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item.
−Removed: Management’s Discussion and Analysis of Financial Condition and Results of Operations.
−Removed: You should read the following discussion
−Removed: and analysis of our financial condition and results of operations in conjunction with the financial statements and the related
−Removed: notes appearing elsewhere in this Form 10-K.
−Removed: This discussion contains forward-looking statements reflecting our current expectations
−Removed: that involve risks and uncertainties, including those set forth under “Cautionary Statement About Forward-Looking Statements.”
−Removed: Actual results and experience could differ materially from the anticipated results and other expectations expressed in our forward-looking
−Removed: statements as a result of a number of factors, including but not limited to those discussed in this Item and in Item 1A - “Risk
−Removed: Factors.”
−Removed: Actual results and the timing of events could differ materially from those discussed in our forward-looking statements
−Removed: as a result of many factors, including those set forth under “Risk Factors”
−Removed: and elsewhere in this Form 10-K.
−Removed: We are a preclinical stage pharmaceutical
−Removed: company organized as a Nevada corporation in July 2017 to focus on the development of anti-cancer drug candidates for the treatment
−Removed: of brain and central nervous system tumors, based on intellectual property that we license under a license agreements with HPI
−Removed: and The University of Texas M.D.
−Removed: Anderson Cancer Center and own pursuant to a collaboration and asset purchase agreement with Reata.
−Removed: We believe our lead drug candidate, Berubicin,
−Removed: if approved by the FDA, may be a significant discovery in the treatment of glioblastoma.
−Removed: Glioblastoma are tumors that arise from
−Removed: astrocytes, which are star-shaped cells making up the supportive tissue of the brain.
−Removed: These tumors are usually highly malignant
−Removed: (cancerous) because the cells reproduce quickly, and they are supported by a large network of blood vessels.
−Removed: Berubicin is an anthracycline,
−Removed: which is a class of drugs that are among the most powerful chemotherapy drugs known.
−Removed: Based on limited clinical data, we believe
−Removed: Berubicin is the first anthracycline that appears to have crossed the Blood Brain Barrier and target brain cancer cells.
−Removed: our current focus is solely on the development of Berubicin, we are also in the process of attempting to secure intellectual property
−Removed: rights in additional compounds that may be developed into drugs to treat cancers.
−Removed: Berubicin was discovered at MD Anderson
−Removed: Waldemar Priebe, the founder of the Company.
−Removed: Through a series of transactions, Berubicin was initially licensed to Reata.
−Removed: Reata conducted a Phase I clinical trial on Berubicin but subsequently allowed their IND with the FDA to lapse for strategic reasons.
−Removed: This will require us to obtain a new IND for Berubicin before beginning further clinical trials.
−Removed: We do not have manufacturing facilities
−Removed: and all manufacturing activities are contracted out to third parties.
−Removed: Additionally, we do not have a sales organization.
−Removed: On November 21, 2017, we entered into a
−Removed: Collaboration and Asset Purchase Agreement with Reata (the “Reata Agreement”).
−Removed: Pursuant to the Reata Agreement we purchased
−Removed: all of Reata’s intellectual property and development data regarding Berubicin, including all trade secrets, knowhow, confidential
−Removed: information and other intellectual property rights, which we refer to as the Reata Data.
−Removed: On December 28, 2017, we obtained the rights
−Removed: to a worldwide, exclusive royalty-bearing, license to the chemical compound commonly known as Berubicin from HPI in an agreement
−Removed: we refer to as the HPI License.
−Removed: Under the HPI License we obtained the exclusive right to develop certain patented chemical compounds
−Removed: for use in the treatment of cancer anywhere in the world.
−Removed: In the HPI License we agreed to pay HPI:
−Removed: (i) development fees of $750,000
−Removed: over a three-year period beginning November 2019;
−Removed: (ii) a 2% royalty on net sales;
−Removed: (iii) a $50,000 per year license fee;
−Removed: (iv) milestone
−Removed: payments of $100,000 upon the commencement of a Phase II trial and $1.0 million upon the approval of an NDA for Berubicin;
−Removed: (v) 200,000 shares of our common stock.
−Removed: With the Reata Agreement and the HPI License,
−Removed: we believe we have obtained all rights and intellectual property necessary to develop Berubicin.
−Removed: As stated earlier, it is our plan
−Removed: to obtain additional intellectual property covering other compounds which, subject to the receipt of additional financing, may
−Removed: be developed into drugs for brain and other cancers.
−Removed: On January 10, 2020, we entered into a Patent
−Removed: and Technology License Agreement (the “1244 Agreement”) with The Board of Regents of The University of Texas System,
−Removed: an agency of the State of Texas, on behalf of The University of Texas M.
−Removed: Anderson Cancer Center (“UTMDACC”).
−Removed: to the 1244 Agreement, we obtained a royalty-bearing, worldwide, exclusive license to certain intellectual property rights, including
−Removed: patent rights, related to our WP1244 drug technology.
−Removed: In consideration, we must make payments to UTMDACC including an up-front
−Removed: license fee, annual maintenance fee, milestone payments and royalty payments (including minimum annual royalties) for sales of
−Removed: licensed products developed under the 1244 Agreement.
−Removed: The term of the 1244 Agreement expires on the last to occur of:
−Removed: (a) the expiration
−Removed: of all patents subject to the 1244 Agreement, or (b) fifteen years after execution;
−Removed: provided that UTMDACC has the right to terminate
−Removed: the 1244 Agreement in the event that we fail to meet certain commercial diligence milestones.
−Removed: On May 7, 2020, pursuant to the WP1244 Portfolio
−Removed: license agreement described above, the Company entered into a Sponsored Research Agreement with UTMDACC to perform research relating
−Removed: to novel anticancer agents targeting CNS malignancies.
−Removed: The Company agreed to fund approximately $1,134,000 over a two-year period.
−Removed: The Company paid and recorded $334,000 in 2020 related to this agreement in research and development expenses
−Removed: in the Company’s Statements of Operations.
−Removed: The remaining $720,000 will be paid in 2021, of which $400,000 was accrued at
−Removed: December 31, 2020.
−Removed: The principal investigator for this agreement is Dr.
−Removed: Results of Operations for the Year Ended December 31, 2020
−Removed: Compared to the Year Ended December 31, 2019
−Removed: General and Administrative Expense
−Removed: General and administrative expense was
−Removed: $4,392,873 for the year ended December 31, 2020 compared to $1,978,643 for 2019.
−Removed: The increase in general and administrative expense,
−Removed: was mainly the result of closing our IPO in November 2019 which allowed us to substantially increase our operations.
−Removed: of the change is attributable to an increase of approximately $480,000 for stock-based compensation, an increase of $667,000
−Removed: in employee compensation and taxes, compensation to the Board of Directors of $180,000, an increase of $302,000 in professional
−Removed: fees, an increase of $495,000 in insurance expenses, and an increase of $431,000 in other corporate expenses.
−Removed: These changes were
−Removed: offset by a decrease of $154,000 in recruiting fees in 2020.
−Removed: Research and Development Expense
−Removed: Research and development expense was $5,061,734
−Removed: for the year ended December 31, 2020 compared to $1,854,334 for 2019.
−Removed: The expenses incurred during the year were related to patent
−Removed: maintenance cost and contract labor related to the preparation of our Phase II study.
−Removed: We expect to incur increased research and
−Removed: development costs in the future as our product development activities expand.
−Removed: Interest Expense
−Removed: Interest expense was $3,264 and $26,152
−Removed: for the years ended December 31, 2020 and 2019, respectively.
−Removed: The decrease in interest expense was mainly the result of the payoff
−Removed: of our convertible notes payable issued in 2017 bearing interest at the rate of 10% per annum.
−Removed: The net loss for the year ended December
−Removed: 31, 2020 was $9,457,871 compared to $3,877,211 for 2019.
−Removed: The change in net loss is attributable to increased personnel and activity
−Removed: associated with preparing for our clinical trials in 2020.
−Removed: Liquidity and Capital Resources
−Removed: On December 31, 2020, we had cash of $14,039,493
−Removed: and we had working capital of $13,590,415.
−Removed: We have historically funded our operations from proceeds from debt and equity sales.
−Removed: On November 13, 2019, we closed our IPO
−Removed: of 2,125,000 shares of common stock at a price to the public of $4.00 per share, followed shortly by the exercise of the over-allotment
−Removed: option issued to the underwriter which resulted in an additional 318,750 shares of common stock being issued at the IPO price of
−Removed: $4.00 per share.
−Removed: On December 28, 2020, we closed a follow-on
−Removed: offering of 5,750,000 shares of common stock at a price to the public of $2.00 per share (including a full over-allotment option).
−Removed: Each share issued included 0.5 warrants to purchase a common share at a price of $2.20.
−Removed: We believe that the proceeds from this
−Removed: issuance and our cash on hand are sufficient to fund our planned operations through, but not beyond, 2021.
−Removed: Our plan of operations is primarily focused
−Removed: on using the proceeds from the follow-on offering to complete a Phase II clinical trial for Berubicin.
−Removed: We estimate that we will
−Removed: require additional financing, beyond the proceeds of the offering, of approximately $18 million to complete the trial, approximately
−Removed: $2.0 million to support near-term WP1244 preclinical work, plus such additional working capital to fund our operations during the
−Removed: pendency of the trial.
−Removed: The timing and costs of clinical trials are difficult to predict and as such the foregoing estimates may
−Removed: prove to be inaccurate.
−Removed: We will need to raise additional capital
−Removed: in order to meet our obligations and execute our business plan.
−Removed: If we are unable to raise sufficient funds, we will be required
−Removed: to develop and implement an alternative plan to further extend payables, reduce overhead or scale back our business plan until
−Removed: sufficient additional capital is raised to support further operations.
−Removed: There can be no assurance that such a plan will be successful.
−Removed: Summary of Cash Flows
−Removed: Cash used in operating activities
−Removed: Net cash used in operating activities was
−Removed: $7,318,018 and $3,553,472 for the years ended December 31, 2020 and 2019, respectively, and mainly included payments made for clinical
−Removed: trial preparation, officer compensation, marketing and professional fees to our consultants, attorneys and accountants.
−Removed: Cash used in investing activities
−Removed: Net cash used in operating activities was
−Removed: $17,945 and $20,120 for the years ended December 31, 2020 and 2019 and included payments furniture and equipment.
−Removed: Cash provided by financing activities
−Removed: Net cash provided by financing activities
−Removed: was $14,134,168 and $10,259,747 for the years ended December 31, 2020 and 2019.
−Removed: We received net proceeds of $14,222,249 from
−Removed: the issuance of common stock during the year ended December 31, 2020.
−Removed: On November 13, 2019, we closed our IPO
−Removed: of 2,125,000 shares of common stock at a price to the public of $4.00 per share, followed shortly by the exercise of the over-allotment
−Removed: option issued to the underwriter which resulted in an additional 318,750 shares of common stock being issued at the IPO price of
−Removed: $4.00 per share.
−Removed: On December 28, 2020, we closed a follow-on
−Removed: offering of 5,750,000 shares of common stock at a price to the public of $2.00 per share (including a full over-allotment option).
−Removed: Each share issued included 0.5 warrants to purchase a common share at a price of $2.20.
−Removed: Off-balance Sheet Arrangements
−Removed: As of December 31, 2020, we did not have
−Removed: any relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance
−Removed: or special purpose entities, established for the purpose of facilitating off-balance sheet arrangements or other contractually
−Removed: narrow or limited purposes.
−Removed: Purchase Commitments
−Removed: We do not have any material commitments
−Removed: for capital expenditures, although we are required to pay certain development fees to HPI as described in the section “Overview”
−Removed: JOBS Act Accounting Election
−Removed: The Jumpstart Our Business Startups Act
−Removed: of 2012, or the JOBS Act, exempts an “emerging growth company”
−Removed: such as us from being required to comply with new or
−Removed: revised financial accounting standards until private companies are required to comply with the new or revised financial accounting
−Removed: The JOBS Act provides that a company can elect to opt out of the extended transition period and comply with the requirements
−Removed: that apply to non-emerging growth companies but any such election to opt out is irrevocable.
−Removed: We elected not to opt out of such
−Removed: extended transition period which means that when a standard is issued or revised and it has different application dates for public
−Removed: or private companies, we, as an emerging growth company, can adopt the new or revised standard at the time private companies adopt
−Removed: the new or revised standard.
−Removed: This may make comparison of our financial statements with another public company which is neither
−Removed: an emerging growth company nor an emerging growth company which has opted out of using the extended transition period difficult
−Removed: or impossible because of the potential differences in accounting standards used.
−Removed: Critical Accounting Policies and Estimates
−Removed: The preparation of financial statements
−Removed: in conformity with accounting principles generally accepted in the United States of America requires management to make estimates,
−Removed: assumptions and judgments that affect the amounts reported in the financial statements, including the notes thereto.
−Removed: critical accounting policies to be those that require more significant judgments and estimates in the preparation of our financial
−Removed: statements, including the following:
−Removed: long lived assets;
−Removed: intangible assets valuations;
−Removed: and income tax valuations.
−Removed: Management relies
−Removed: on historical experience and other assumptions believed to be reasonable in making its judgment and estimates.
−Removed: Actual results could
−Removed: differ materially from those estimates.
−Removed: Management believes its application
−Removed: of accounting policies, and the estimates inherently required therein, are reasonable.
−Removed: These accounting policies and estimates
−Removed: are periodically reevaluated, and adjustments are made when facts and circumstances dictate a change.
−Removed: Stock-based Compensation –
−Removed: Employee and non-employee share-based compensation is measured at the grant date, based on the fair value of the award, and is
−Removed: recognized as an expense over the requisite service period.
−Removed: Research and Development Costs -
−Removed: Research and development costs are expensed as incurred.
−Removed: Quantitative and Qualitative Disclosure About Market
−Removed: We are a smaller reporting company as defined
−Removed: by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item.
+Added: See Part III, Item 12 to this Form 10-K for information
+Added: relating to securities authorized for issuance under our equity compensation plans.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.