GLYCOMIMETICS: MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL POSITION AND OPERATING RESULTS (Form 10-Q)
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Certain statements contained in this Quarterly Report on Form 10-Q may constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words or phrases "would be," "will allow," "intends to," "will likely result," "are expected to," "will continue," "is anticipated," "estimate," "project," or similar expressions, or the negative of such words or phrases, are intended to identify "forward-looking statements." We have based these forward-looking statements on our current expectations and projections about future events. Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to these differences include those below and elsewhere in this Quarterly Report on Form 10-Q, our Annual Report on Form 10-K, particularly in Part I - Item 1A, "Risk Factors," and our other filings with theSecurities and Exchange Commission . Statements made herein are as of the date of the filing of this Form 10-Q with theSecurities and Exchange Commission and should not be relied upon as of any subsequent date. Unless otherwise required by applicable law, we do not undertake, and we specifically disclaim, any obligation to update any forward-looking statements to reflect occurrences, developments, unanticipated events or circumstances after the date of such statement. The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited financial statements and related notes that appear in Item 1 of this Quarterly Report on Form 10-Q and with our audited financial statements and related notes for the year endedDecember 31, 2020 , which are included in our Annual Report on Form 10-K filed with theSecurities and Exchange Commission onMarch 2, 2021 .
Overview
We are a clinical-stage biotechnology company focused on the discovery and development of novel glycomimetic drugs to address unmet medical needs resulting from diseases in which carbohydrate biology plays a key role. We are developing a pipeline of proprietary glycomimetics, which are small molecules that mimic the structure of carbohydrates involved in important biological processes, to inhibit disease-related functions of carbohydrates such as the roles they play in inflammation, cancer and infection. We believe this represents an innovative approach to drug discovery to treat a wide range of diseases. We are focusing our efforts on drug candidates for diseases that we believe will qualify for orphan drug designation. Our proprietary glycomimetics platform is based on our expertise in carbohydrate chemistry and our understanding of the role carbohydrates play in key biological processes. Most human proteins are modified by the addition of complex carbohydrate structures to the surface of such proteins, which affects the functions of the proteins and their interactions with other molecules. Our initial research and development efforts have focused on drug candidates targeting selectins, which are proteins that serve as adhesion molecules and bind to carbohydrates that are involved in the inflammatory component and progression of a wide range of diseases, including hematologic disorders, cancer and cardiovascular disease. For example, we believe that members of the selectin family play a key role in tumor metastasis and resistance to chemotherapy. Inhibiting specific carbohydrates from binding to selectins has long been viewed as a potentially attractive approach for therapeutic intervention. The ability to successfully develop drug-like carbohydrate compounds that inhibit binding with selectins, known as selectin antagonists, has historically been limited by their potency and the complexities of carbohydrate chemistry. We believe our expertise in the rational design of potent glycomimetic antagonists with drug-like properties and in carbohydrate chemistry enable us to design highly effective selectin antagonists and other glycomimetics that may inhibit the disease-related functions of certain carbohydrates in order to develop novel drug candidates to address orphan diseases with high unmet medical need. Our lead glycomimetic drug candidate, uproleselan, is a specific E-selectin inhibitor that we are developing to be used in combination with chemotherapy to treat patients with acute myeloid leukemia, or AML, a life-threatening hematologic cancer, and potentially other hematologic cancers. In 2018, we commenced a randomized, double-blind, placebo-controlled Phase 3 pivotal clinical trial to evaluate uproleselan in individuals with relapsed/refractory AML, the design of which was based on guidance received from theU.S. Food and Drug Administration , or FDA. We intend to enroll approximately 380 adult patients with relapsed or refractory AML at centers inthe United States ,Canada ,Europe andAustralia . We expect to complete enrollment of the trial
by
year-end 2021.
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In 2018, we also signed a Cooperative Research and Development Agreement, or
CRADA, with the National Cancer Institute , or NCI, part of the National
Institutes of Health , to conduct a Phase 2/3 randomized, controlled clinical
trial testing the addition of uproleselan to a standard chemotherapy regimen.
The trial opened for enrollment in early 2019 and enrolled the first patient in
April 2019 .
Uproleselan is also being studied in several researcher-sponsored trials (ISTs). In
in
InJuly 2021 , clinicians at theUniversity of California (UC) Davis Comprehensive Cancer Center initiated dosing of the first patient in a clinical study of uproleselan combined with venetoclax and azacitidine for the treatment of older or unfit patients with treatment-naïve AML. The goal of the two-part IST is first to determine a recommended Phase 2 dose, and then to explore efficacy in a dose expansion cohort. We are providing uproleselan for the IST. Up to 31 patients will be enrolled, and a preliminary/interim readout is expected in 2022. InJuly 2021 , clinicians at theUniversity of Texas MD Anderson Cancer Center treated the first patient in a Phase 1b/2 study evaluating uproleselan, added to cladribine plus low dose cytarabine in patients with treated secondary AML (ts-AML). We are providing uproleselan for the IST. The Phase 1b/2 single-arm trial is enrolling patients 18 years or older, with a diagnosis of ts-AML who have not received therapy for their AML. Considered a distinct high-risk subset of AML with an adverse prognosis, ts-AML is defined as AML arising from a previously treated antecedent myeloid neoplasm (myelodysplastic syndrome or myeloproliferative neoplasm). Clinicians plan to enroll approximately 25 patients in the trial and a preliminary/interim readout is expected in 2022. We have rationally designed an innovative antagonist of E-selectin, GMI-1687, that could be a subcutaneously administered treatment. Initially developed as a potential life-cycle extension to uproleselan, we believe that GMI-1687 could be developed to broaden the clinical usefulness of an E-selectin antagonist to conditions where outpatient treatment is preferred or required. We are currently conducting preclinical activities and studies with GMI-1687 to support our planned submission of an investigational new drug application, or IND, to the FDA. We are also developing a drug candidate, GMI-1359, that simultaneously targets both E-selectin and a chemokine receptor known as CXCR4. In the fourth quarter of 2019, we initiated a Phase 1b trial of GMI-1359 in hormone receptor positive breast cancer patients whose tumors have spread to bone, and the first patient was dosed inJanuary 2020 . We are also advancing other preclinical-stage programs, including small-molecule glycomimetic compounds that inhibit the protein galectin-3, which we believe may have potential to be used for the treatment of fibrosis, cancer and cardiovascular disease. We have financed our operations primarily through private placements of our securities, up-front and milestone payments under our license and collaboration agreements and the net proceeds from public offerings of common stock, including sales of common stock under at-the-market sales facilities withCowen and Company LLC , or Cowen. We have no approved drugs currently available for sale, and substantially all of our revenue to date has been revenue from up-front and milestone payments under license and collaboration agreements. Since inception, we have incurred significant operating losses. We had an accumulated deficit of$338.1 million as ofJune 30, 2021 and we expect to continue to incur significant expenses and operating losses over at least the next several years. Our net losses may fluctuate significantly from quarter to quarter and year to year, depending on the timing of our clinical trials and our expenditures on other research and development activities. We anticipate that our expenses will increase substantially as we:
initiate and conduct our planned clinical trials on uproleselan, GMI-1359 and
? GMI-1687, including meeting our funding and procurement commitments related to
the clinical trial of uproleselan conducted in collaboration with the NCI;
? carry out NDA clearance activities related to manufacturing, toxicology and
the pharmacology of our product candidates;
? manufacture additional uproleselan drug supplies for validation and prepare for
commercialization;
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? seek to discover and develop other drug candidates;
? seek regulatory approvals for any successful drug candidate
clinical tests;
finally establish a sales, marketing and distribution infrastructure and
? increase external manufacturing capacities to market any drug
applicants for whom we can obtain regulatory approval;
? maintain, expand and protect our intellectual property portfolio;
? hire additional clinical, quality control, regulatory and scientific staff;
? maintain a sufficient level of insurance, including product liability and
directors, officers and corporate liability insurance policies; and
add operational, financial and management information systems and personnel,
? including staff to support our drug development and our potential future
marketing efforts.
To fund further operations, we will need to raise capital. We may obtain additional financing in the future through the issuance of our common stock, through other equity or debt financings, potentially including the use of our at-the-market sales facility with Cowen, or through collaborations or partnerships with other companies. We may not be able to raise additional capital on terms acceptable to us, or at all, and any failure to raise capital as and when needed could compromise our ability to execute on our business plan. For example, the current global COVID-19 pandemic presents material uncertainty and its disruption of the capital markets may have a material adverse impact on our ability to raise additional capital if we decide to do so. Although it is difficult to predict future liquidity requirements, we believe that our existing cash and cash equivalents will be sufficient to fund our operations into the fourth quarter of 2022. However, our ability to successfully transition to profitability will be dependent upon achieving a level of revenues adequate to support our cost structure. We cannot assure you that we will ever be profitable or generate positive cash flow from operating activities.
Impact of COVID-19 on our business
The imposition of "lockdown," "social distancing" and "shelter in place" directives by state and federal governments inthe United States as well as governments in other regions of the world in response to the COVID-19 pandemic, including in locations in which our Phase 3 clinical trial of uproleselan is being conducted, resulted in slowed clinical site initiation, patient recruitment and enrollment rates early in the pandemic. Enrollment rates have returned to forecasted rates since the beginning of the lockdowns. However, COVID-19 infection rates continue to fluctuate, which could negatively affect enrollment going forward. We cannot at this time fully assess the effect of the COVID-19 pandemic on our continued enrollment and whether the pandemic would potentially materially adversely impact the timing of completion of enrollment of our Phase 3 clinical trial. We continue to closely monitor the COVID-19 situation and any potential impact to our planned activities. We have also implemented business continuity plans designed to address and mitigate the impact of the COVID-19 pandemic on our employees and our business. While to date we have experienced limited impacts beyond the earlier delays in recruitment in our ongoing uproleselan Phase 3 clinical trial, given the global economic slowdown, the overall disruption of global healthcare systems and the other risks and uncertainties associated with the pandemic, our business, financial condition, results of operations and growth prospects could be materially adversely affected. We continue to closely monitor the COVID-19 situation as we evolve our business continuity plans and response strategy. InMarch 2020 , our workforce transitioned to working remotely in accordance with federal and state declarations. We have partially reopened to allow certain employees to return to the office based on a phased approach that is consistent with federal and state guidelines, with a focus on employee safety and optimal work environment.
Our collaboration and license agreements
Apollomic
InJanuary 2020 , we entered into an exclusive collaboration and license agreement with Apollomics (Hong Kong ) Limited, or Apollomics, for the development and commercialization of uproleselan and GMI-1687 in Mainland China,Hong Kong ,Macau andTaiwan , also known asGreater China . Under the terms of the agreement, Apollomics will be responsible for clinical development and commercialization inGreater China . We will also collaborate with Apollomics 21 Table of Contents to advance the preclinical and clinical development of GMI-1687. We received an upfront cash payment of$9.0 million and inSeptember 2020 received a$1.0 million development milestone payment. Subject to the terms of the agreement, we will be eligible to receive potential further milestone payments totaling approximately$179.0 million , as well as tiered royalties ranging from the high single digits to 15%, as a percentage of net sales. Apollomics will be responsible for all costs related to development, regulatory approvals, and commercialization activities for uproleselan and GMI-1687 inGreater China , and we and Apollomics expect to enter into clinical and commercial supply agreements with respect to our provision of uproleselan and GMI-1687 to Apollomics. We retain all rights for both compounds in the rest of the world. InSeptember 2020 , theChina National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) granted IND approval for uproleselan (APL-106) enabling the initiation of a Phase 1 pharmacokinetics and tolerability study and includes acceptance of a Phase 3 bridging study of APL-106 in combination with chemotherapy in relapsed/refractory AML. InJanuary 2021 , APL-106 was granted Breakthrough Therapy Designation from the China NMPA CDE for the treatment of relapsed/refractory AML. InJune 2020 , we entered into a clinical supply agreement with Apollomics under which we will manufacture and supply uproleselan product to Apollomics at agreed upon prices. Apollomics has the option to begin manufacture after appropriate material transfer requirements are met. During the six months endedJune 30, 2021 , we recognized$1.1 million in revenue from the sale of clinical supplies to Apollomics under the clinical supply agreement.
Critical accounting policies and significant judgments and estimates
Our management's discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance withU.S. generally accepted accounting principles. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses in our financial statements. On an ongoing basis, we evaluate our estimates and judgments, including those related to our revenue recognition, accrued research and development expenses, stock-based compensation expense and income taxes. We base our estimates on historical experience, known trends and events and various other factors that we believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other resources. Actual results may differ from these estimates and judgments under different assumptions or conditions. We periodically review our estimates in light of changes in circumstances, facts and experience. The effects of material revisions in estimates are reflected in our financial statements prospectively from the date of the change in estimate. We define our critical accounting policies as those accounting principles generally accepted inthe United States that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations, as well as the specific manner in which we apply those principles. For a description of our critical accounting policies, please see the disclosures in Part II, Item 7 of our Annual Report on Form 10-K for the year endedDecember 31, 2020 . There have not been any material changes to our critical accounting policies sinceDecember 31, 2020 .
Components of operating results
Income
To date, we have not generated any revenue from the sale of our drug candidates and do not expect to generate any revenue from the sale of drugs in the near future. Substantially all of our historical revenue consisted of upfront and milestone payments under license and collaboration agreements.
Research and development
Research and development expenses consist of expenses incurred in performing
research and development activities, including compensation and benefits for
full-time research and development employees, facilities expenses, overhead
expenses, cost of laboratory supplies, clinical trial and related clinical
manufacturing expenses, fees paid to CROs and other consultants and other
outside expenses. Other preclinical research and platform programs include
activities related to exploratory efforts, target validation, lead optimization
for our earlier programs and our proprietary
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glycomimetic platform. Our research and development expenses are mainly related to the development of rivipansel, uproleselan and our other drug candidates.
We do not currently utilize a formal time allocation system to capture expenses on a project-by-project basis because we are organized and record expense by functional department and our employees may allocate time to more than one development project. Accordingly, we only allocate a portion of our research and development expenses by functional area and by drug candidate. Research and development costs are expensed as incurred. Non-refundable advance payments for goods or services to be received in the future for use in research and development activities are deferred and capitalized. The capitalized amounts are expensed as the related goods are delivered or the services are performed. Research and development activities are central to our business model. Drug candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later stage clinical trials. We expect our research and development expenses to increase over the next several years as we seek to progress uproleselan, GMI-1359 and our other drug candidates into and through clinical development. However, it is difficult to determine with certainty the duration and completion costs of our current or future preclinical studies and clinical trials of our drug candidates, or if, when or to what extent we will generate revenues from the commercialization and sale of any of our drug candidates that obtain regulatory approval. We may never succeed in achieving regulatory approval for any of our drug candidates.
The length, cost and timing of clinical trials and development of our drug candidates will depend on a variety of factors, including:
? trial costs per patient;
? the number of patients participating in the trials;
? the number of sites included in the trials;
? the countries in which the trial is being conducted;
? the length of time needed to enroll eligible patients, which could be
extended due to the ongoing COVID-19 pandemic;
? the number of doses patients receive;
? patient abandonment or abandonment rates;
? potential additional safety monitoring or other studies required by regulation
agencies;
? the duration of patient follow-up; and
? the safety and efficacy profile of the drug candidate.
In addition, the probability of success for each drug candidate will depend on numerous factors, including competition, manufacturing capability and commercial viability. We will determine which programs to pursue and how much to fund each program in response to the scientific and clinical success of each drug candidate, as well as an assessment of each drug candidate's commercial potential.
General and administrative
General and administrative expenses consist primarily of salaries and other
related costs, including stock-based compensation, for personnel in executive,
finance, accounting, business development and human resources functions. Other
significant costs include facility costs not otherwise included in research and
development expenses, legal fees relating to patent and corporate matters, fees
for accounting and consulting services and corporate insurance premiums. We
anticipate that our general and administrative expenses will increase in the
future to support our continued research and development activities.
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Interest Income
Interest income consists of interest income earned on our cash and cash equivalents.
Operating results for the three and six months ended
The following tables present our operating results for the three and six months ended.
Three Months Ended June 30 , Increase/Decrease
(in thousands) 2021 2020 Revenue $ - $ - $ - NA Costs and expenses:
Research and development expense 10,167 9,871 296 3 % General and administrative expense 4,237
4,235 2 0 % Total costs and expenses 14,404 14,106 298 2 % Loss from operations (14,404) (14,106) (298) 2 % Interest income 5 27 (22) (81) %
Net loss and comprehensive loss$ (14,399) $
(14,079)$ (320) 2 % Six Months Ended June 30, Increase/Decrease (in thousands) 2021 2020 Revenue $ 1,056 $ 9,000$ (7,944) (88) % Costs and expenses: Research and development expense 21,315 22,539 (1,224) (5) % General and administrative expense 8,425
8,675 (250) (3) % Total costs and expenses 29,740 31,214 (1,474) (5) % Loss from operations (28,684) (22,214) (6,470) 29 % Interest income 11 472 (461) (98) %
Net loss and comprehensive loss$ (28,673) $
(21,742)$ (6,931) 32 % Revenue During the six months endedJune 30, 2021 and 2020, revenue was$1.1 million and$9.0 million , respectively, all of which was the result of payments received under the Apollomics Agreement for the development and commercialization of uproleselan and GMI-1687 inGreater China . During the six months endedJune 30, 2021 , we recognized$1.1 million in revenue from the sale of clinical supplies to Apollomics under the clinical supply agreement. InJanuary 2020 , we recognized$9.0 million in revenue from an upfront milestone payment.
Research and development costs
The following tables summarize our research and development expenses by functional area for the three and six months ended.
Three Months Ended June 30 , Increase/Decrease
(in thousands) 2021
2020
Clinical development $ 4,469$ 3,578 $ 891 25 % Manufacturing and formulation 1,584 2,089 (505) (24) % Contract research services, consulting and other costs 696 440 256 58 % Laboratory costs 492 436 56 13 % Personnel-related 2,317 2,581 (264) (10) %
Stock-based compensation 609 747 (138) (18) % Research and development expense$ 10,167 $
9,871$ 296 3 % 24 Table of Contents Six Months Ended June 30, Increase/Decrease (in thousands) 2021 2020 Clinical development$ 9,122 $ 8,601 $ 521 6 % Manufacturing and formulation 3,875 5,226 (1,351) (26) % Contract research services, consulting and other costs 1,239 1,007 232 23 % Laboratory costs 1,005 1,010 (5) (0) % Personnel-related 4,776 5,212 (436) (8) %
Stock-based compensation 1,298 1,483 (185) (12) % Research and development expense$ 21,315 $ 22,539 $ (1,224) (5) %
The following tables summarize our research and development expenses by drug candidate for the three and six months ended.
Three Months Ended June 30, Increase/Decrease
(in thousands) 2021 2020
Uproleselan $ 5,766 $ 5,708 $ 58 1 %
GMI-1359 180 69 111 161 %
Other research and development 1,295 766 529 69 % Personnel-related and stock-based compensation 2,926 3,328 (402) (12) % Research and development expense$ 10,167 $
9 871
Six Months Ended June 30, Increase/Decrease
(in thousands) 2021 2020
Uproleselan $ 12,493 $ 13,869 $ (1,376) (10) %
GMI-1359 414 173 241 139 %
Other research and development 2,334 1,802 532 30 % Personnel-related and stock-based compensation 6,074 6,695 (621) (9) % Research and development expense$ 21,315 $
22,539$ (1,224) (5) % Our research and development expense for the three months endedJune 30, 2021 increased by$300,000 compared to the three months endedJune 30, 2020 primarily due to increased clinical trial and development costs related to our ongoing global Phase 3 clinical trial of uproleselan in individuals with relapsed/refractory AML. The increase in clinical expenses was due to the higher enrollment in the trial in 2021 as compared to the same period in 2020. The increase was partially offset by a decrease in manufacturing and formulation relating to uproleselan.
Our research and development expense for the six months endedJune 30, 2021 decreased by$1.2 million compared to the six months endedJune 30, 2020 primarily due to a decrease in manufacturing and formulation costs relating to uproleselan. This decrease was offset by higher clinical trial and development costs related to our ongoing global Phase 3 clinical trial of uproleselan in individuals with relapsed/refractory AML.
General and administrative expenses
The following tables summarize the components of our general and administrative expenses for the three and six months ended.
Three Months Ended June 30 , Increase/Decrease
(in thousands) 2021 2020 Personnel-related$ 1,502 $ 1,602 $ (100) (6) % Stock-based compensation 953 1,015 (62) (6) %
Legal, consulting and other professional expenses 1,649 1,471 178 12 % Other 133 147 (14) (10) % General and administrative expense$ 4,237 $ 4,235 $ 2 0 % 25 Table of Contents Six Months Ended June 30, Increase/Decrease (in thousands) 2021 2020 Personnel-related$ 3,107 $ 3,209 $ (102) (3) % Stock-based compensation 1,878 2,101 (223) (11) %
Legal, consulting and other professional expenses 3,117 2,979 138 5 % Other 323 386 (63) (16) % General and administrative expense$ 8,425 $
8,675$ (250) (3) %
General and administrative expenses remained stable for the three and six months ended
Interest Income
During the three and six months ended
Liquidity and capital resources
Sources of Liquidity We have historically financed our operations primarily through public offerings and private placements of our capital stock, including sales agreements with Cowen, and upfront and milestone payments from our license and collaboration agreements. As ofJune 30, 2021 , we had$118.9 million in cash and cash equivalents. InOctober 2020 , we filed a prospectus supplement to a shelf registration statement that we filed inMay 2019 and entered into a new at-the-market sales agreement, or the 2020 Sales Agreement, with Cowen. Under the 2020 Sales Agreement, we may sell up to$100.0 million of our common stock registered under the shelf registration statement that we filed inMay 2019 . During the year endedDecember 31, 2020 , we sold 1,024,760 shares of common stock under the 2020 Sales Agreement at a weighted average price of$3.74 , for aggregate net proceeds of$3.7 million , after deducting commissions and offering expenses. During the six months endedJune 30, 2021 , we sold an additional 2,517,603 shares of common stock under the 2020 Sales Agreement at a weighted average price of$3.92 , for aggregate net proceeds of$9.6 million , after deducting commissions and offering expenses. As ofJune 30, 2021 , we have approximately$86.3 million remaining available to be sold the terms of the 2020 Sales Agreement. Subsequent toJune 30, 2021 , there have been no additional sales under the 2020 Sales Agreement. We entered into a collaboration and license agreement with Apollomics inJanuary 2020 and are potentially eligible to earn milestone payments and royalties under that agreement. InJanuary 2020 , Apollomics made an upfront payment to us of$9.0 million . We also received a non-refundable payment of$1.0 million inSeptember 2020 as a clinical development milestone payment. Our ability to earn additional milestone payments and potential royalty payments and their timing will be dependent upon the outcome of Apollomics' activities and is therefore uncertain at this time. Funding Requirements Our primary uses of capital are, and we expect will continue to be, compensation and related expenses, third-party clinical research and development services, laboratory and related supplies, clinical costs, legal and other regulatory expenses and general overhead costs. The successful development of any of our drug candidates is highly uncertain. As such, at this time, we cannot reasonably estimate or know the nature, timing and costs of the efforts that will be necessary to complete the remainder of the development of uproleselan or our other drug candidates. We are also unable to predict when, if ever, material net cash inflows will commence from uproleselan or our other drug candidates. This is due to the numerous risks and uncertainties associated with developing drugs, including the uncertainty of:
? successful enrollment and completion of clinical trials;
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? receipt of marketing authorizations from the applicable regulatory authorities;
? establish commercial manufacturing capabilities or enter into agreements with
third-party manufacturers;
? obtain and maintain the protection and regulation of patents and trade secrets
the exclusivity of drug candidates;
? initiate commercial sales of drugs, if and when approved, whether alone or in
collaboration with others; and
? obtain and maintain adequate health coverage and reimbursement.
A change in the outcome of any of these variables with respect to the development of any of our drug candidates would significantly change the costs and timing associated with the development of that drug candidate. Because our drug candidates are in various stages of clinical and preclinical development and the outcome of these efforts is uncertain, we cannot estimate the actual amounts necessary to successfully complete the development and commercialization of our drug candidates or whether, or when, we may achieve profitability. Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through a combination of equity or debt financings and collaboration arrangements, including our existing license agreement with Apollomics. Except for Apollomics' conditional obligations to make milestone and royalty payments to us under our license agreement, we do not have any committed external source of liquidity. To the extent that we raise additional capital through the future sale of equity or debt, the ownership interest of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our existing common stockholders. If we raise additional funds through the issuance of convertible debt securities, these securities could contain covenants that would restrict our operations. We may require additional capital beyond our currently anticipated amounts. Additional capital may not be available on reasonable terms, or at all. If we raise additional funds through collaboration arrangements in the future, we may have to relinquish valuable rights to our drug candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our drug development or future commercialization efforts or grant rights to develop and market drug candidates that we would otherwise prefer to develop and market ourselves. Outlook Based on our research and development plans and our timing expectations related to the progress of our programs, we expect that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements into the fourth quarter of 2022. We have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we expect. Additionally, the process of testing drug candidates in clinical trials is costly, and the timing of progress in these trials is uncertain. Cash Flows The following is a summary of our cash flows for the six months endedJune 30, 2021 and 2020: Six Months Ended June 30, (in thousands) 2021 2020 Net cash provided by (used in): Operating activities$ (27,737) $ (18,052) Investing activities (8) (15) Financing activities 9,564 9,710
Net change in cash and cash equivalents
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Operating Activities
Net cash used in operating activities for the six months ended June 30, 2021 and
2020 was primarily the result of ongoing costs associated with our uproleselan
clinical development programs which includes costs for project support,
investigator site start-up and administrative costs and patient enrollment fees.
These cash expenses were offset by non-cash expenses for stock-based
compensation, lease expense and depreciation, and for the six months ended June
30, 2020 , the upfront and clinical development milestone payment of $9.0 million
received from Apollomics.
Investing Activities
Net cash used in investing activities for the half-year ended
Fundraising activities
Net cash provided by financing activities during the six months endedJune 30, 2021 primarily consisted of the net proceeds received from our at-the-market facility with Cowen of$9.6 million . Net cash provided by financing activities of$9.7 million during the six months endedJune 30, 2020 consisted of the net proceeds received from our prior at-the-market facility with Cowen of$9.6 million and$136,000 in proceeds from stock option exercises.
Off-balance sheet provisions
During the three months ended
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