The following discussion and analysis of our financial condition and the results of operations should be read in conjunction with our consolidated financial statements and related notes thereto included elsewhere in this Quarterly Report on Form 10-Q, or Quarterly Report, and our audited financial statements included in our Annual Report on Form 10-K for the year endedDecember 31, 2019 filed with theSecurities and Exchange Commission , or theSEC , onMarch 10, 2020 , or the Annual Report. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including information with respect to our plans and strategy for our business, includes forward looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the "Risk Factors" section in our Annual Report and in this Quarterly Report, our actual results could differ materially from the results described, in or implied by, the forward-looking statements contained in the following discussion and analysis. Such factors may be amplified by the COVID-19 pandemic and its potential impact on our business and the global economy. Overview We are a clinical stage biopharmaceutical company committed to the discovery and development of novel therapeutics to treat cystic fibrosis, or CF, through theratyping, or the process of matching modulators to individual response to treatment regardless of cystic fibrosis transmembrane conductance regulator, or CFTR, mutations. CF is a disease caused by defects in the function or abundance of CFTR protein. Since our inception in 2006, we have devoted substantially all our resources to organizing and staffing our company, business planning, raising capital, acquiring and developing product and technology rights, and conducting research and development activities for our product candidates. We do not have any products approved for sale and have not generated any revenue from product sales. We have funded our operations to date with proceeds received from equity offerings, the issuance of convertible promissory notes and, to a lesser extent, payments received in connection with collaboration agreements and a research grant. In addition, we have entered into a sales agreement withH.C. Wainwright & Co., LLC , or HCW, with respect to an at-the-market, or ATM, offering program, or the ATM program. As ofDecember 31, 2019 , we have sold 987,653 shares of our common stock for total net proceeds of approximately$3.5 million under the ATM program. We did not sell any shares of our common stock under the ATM program during the nine months endedSeptember 30, 2020 . To date, we have not generated significant revenue and have incurred significant operating losses. Our net losses were$8.2 million and$26.9 million for the three and nine months endedSeptember 30, 2020 , respectively. As ofSeptember 30, 2020 , we had an accumulated deficit of$363.6 million . We require additional funding to fund our CF-focused pipeline and namely, our CHOICES program, and to advance our proprietary combination therapy candidates posenacaftor, dirocaftor, and nesolicaftor, through regulatory approval and into commercialization, if approved. InAugust 2020 , we announced that after consideration of various financing and strategic alternatives for our CF portfolio, with the goal of maximizing stockholder value of these assets, we have decided to continue our operations while exploring business and strategic options related to our research and discovery platform and intellectual property portfolio. After conducting a diligent and extensive process of evaluating our strategic alternatives and careful evaluation and consideration of those proposals, and following extensive negotiation, onAugust 22, 2020 , we entered into an Agreement and Plan of Merger and Reorganization, or the Merger Agreement, withYumanity Therapeutics, Inc. , aDelaware corporation, or Yumanity,Yumanity Holdings, LLC , aDelaware limited liability company, or Holdings, andPangolin Merger Sub, Inc. , aDelaware corporation and our wholly-owned subsidiary, or the Merger Sub. Upon the terms and subject to the satisfaction of the conditions described in the Merger Agreement, including approval of the transaction by our stockholders and Yumanity's stockholders and the consolidation of Yumanity and Holdings prior to the closing of the Merger, Merger Sub will be merged with and into Yumanity, or the Merger, with Yumanity surviving the Merger as our wholly-owned subsidiary and the surviving corporation of the Merger. If the Merger is completed, our business will become the business of Yumanity. OnAugust 22, 2020 , due to the entry into of the Merger Agreement with Yumanity, our Board of Directors, or the Board, committed to reducing our workforce by approximately 79% to a total of five full-time employees, who will remain with us until the closing of the Merger to assist with our day-to-day business operations, including the maintenance of the sale and disposition of intellectual property and assets relating to our cystic fibrosis clinical program, or the CF Assets, and those activities necessary to complete the proposed Merger. We have retained our core intellectual property, licenses, collaborations with research institutions and universities, and proprietary equipment. We have incurred certain restructuring charges related to a reduction in our workforce, totaling$2.4 million throughSeptember 30, 2020 . AtSeptember 30, 2020 we have accrued one-time termination benefits of$1.7 million , of which the majority are anticipated to be incurred in the fourth quarter of 2020. We believe that our existing cash and cash equivalents will be sufficient to fund our anticipated stand-alone operating expenses and capital expenditures for the foreseeable 18
-------------------------------------------------------------------------------- future; however, there can be no assurances as to the amount or timing of available cash, if any, left to distribute to our stockholders after paying the debts and our other obligations and setting aside funds for potential future claims.
We and Yumanity believe that the Merger will result in a clinical-stage biopharmaceutical company focused on discovering and developing disease-modifying treatments for neurodegenerative diseases based on Yumanity's discovery engine and pipeline of novel targets and product candidates.
We may not be successful in completing the Merger. If, for any reason, the Merger does not close and the Merger Agreement is terminated, the Board may elect to, among other things, attempt to complete another strategic transaction including a transaction similar to the Merger, continue to operate our business or to dissolve and liquidate our assets. If we decides to dissolve and liquidate our assets, we would be required to pay all of our debts and contractual obligations, and to set aside certain reserves for potential future claims. As ofSeptember 30, 2020 , we had cash and cash equivalents and short-term investments totaling approximately$40.8 million .
COVID-19 Business Update
The novel coronavirus, or COVID-19, pandemic continues to rapidly evolve and has already resulted in a significant disruption of global financial markets and may affect our operations and those of third parties on which we rely. While the potential economic impact brought by, and the duration of, the COVID-19 pandemic is difficult to assess or predict, the impact of the COVID-19 pandemic on the global financial markets may reduce our ability to access capital, which could negatively impact our short-term and long-term liquidity and our ability and Yumanity's ability to complete the Merger on a timely basis or at all. The ultimate impact of the COVID-19 pandemic is highly uncertain and subject to change. We do not yet know the full extent of potential delays or impacts on our business, financing or other activities or on healthcare systems or the global economy as a whole. However, these effects could have a material impact on our liquidity, capital resources, operations and business and those of the third parties on which we rely.
Components of our Results of Operations
Revenue
To date, we have not generated any revenue from product sales and do not expect to generate any revenue from the sale of products in the foreseeable future. We did not recognize any revenue during the three and nine months endedSeptember 30, 2020 . All our revenue during the nine months endedSeptember 30, 2019 was derived from our Genentech Agreement.
Operating Expenses
Research and Development Expenses
Research and development expenses, which include costs of research services incurred in connection with our collaboration agreements and research grant, have historically consisted primarily of costs incurred in connection with the discovery and development of our product candidates, which include:
• employee-related expenses, including salaries, related benefits, travel,
and stock-based compensation expense for employees engaged in research and
development functions; • expenses incurred in connection with the preclinical and clinical development of our product candidates under agreements with contract
research organizations, or CROs, and contract manufacturing organizations,
or CMOs;
• facilities, depreciation, and other expenses, which include direct and
allocated expenses for rent and maintenance of facilities, insurance, and
supplies; and • payments made under third-party licensing agreements.
We expense research and development costs as incurred. We recognize external development costs based on an evaluation of the progress to completion of specific tasks using information provided to us by our service providers.
Our direct research and development expenses are tracked on a program-by-program basis and consist primarily of external costs, such as fees paid to consultants, central laboratories, contractors, CROs, and CMOs in connection with our clinical trials and preclinical development activities. We do not allocate employee costs, costs associated with our platform technology, facility expenses, including depreciation, or other indirect costs, to specific product development programs because these costs are deployed across multiple product development programs and, as such, are not separately classified. We use internal resources to manage our preclinical development activities and perform data analysis for such activities. These employees work across multiple development programs and, therefore, we do not track their costs by program. 19
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The table below summarizes our research and development expenses incurred by program (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2020 2019 2020 2019 CF $ 674 $ 6,084 $ 6,285$ 30,546 UPR - 91 13 303 Unallocated expenses: Employee-related 11 2,755 4,412 8,107 Facility-related 186 499 908 1,577 Other 369 716 724 2,684 Total research and development expenses $ 1,240 $ 10,145$ 12,342 $ 43,217 InAugust 2020 , after consideration of various financing and strategic alternatives for our CF portfolio, with the goal of maximizing stockholder value of these assets, our Board approved our entry into the proposed Merger. As a result of this decision, we stopped further research and development of our product pipeline and our pre-clinical programs, including the Unfolded Protein Response, or UPR, program, to reduce operating expenses. As a result, our research and development expenses for the fiscal year endingDecember 31, 2020 will decrease as compared to the fiscal year endedDecember 31, 2019 .
General and Administrative Expenses
General and administrative expenses consist primarily of salaries and related benefits, travel, and stock-based compensation for personnel in executive, finance, and administrative functions. General and administrative expenses also include facilities, which include direct and allocated expenses for rent and maintenance of facilities, depreciation, insurance, and supplies, as well as professional fees for legal, consulting, accounting, and audit services. We anticipate that our general and administrative expenses in the fiscal year endingDecember 31, 2020 will decrease from the fiscal year endedDecember 31, 2019 , with the exception of severance payments, as we continue to focus our efforts on preserving cash while we seek to maximize stockholder value. Over the longer term, however, these expenses could increase due to professional fees associated with the proposed Merger with Yumanity.
Restructuring Costs
Restructuring costs consist primarily of severance-related costs associated with the reduction in force in connection with the proposed Merger with Yumanity.
Interest Income
Interest income consists of interest earned on cash equivalents and short-term investments held by us during the reporting periods.
Interest Expense
Interest expense consists of interest paid on our short-term borrowings during the reporting periods.
Other Income (Expense), Net Other income (expense), net, primarily consists of the amortization of premiums and discounts on our short-term investments and the gains or losses associated with the changes in the fair values of our derivative liability. 20
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Critical Accounting Policies and Significant Judgments and Estimates
Our financial statements are prepared in accordance with generally accepted accounting principles inthe United States , or GAAP. The preparation of our financial statements and related disclosures requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenue, costs and expenses, and the disclosure of contingent assets and liabilities in our financial statements. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions. These unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements, and notes thereto, which are contained in the Company's Annual Report on Form 10-K for the year endedDecember 31, 2019 , filed with theSEC onMarch 10, 2020 . During the nine months endedSeptember 30, 2020 , there were no material changes to our critical accounting policies. Our critical accounting policies are described under the heading, "Management's Discussion and Analysis of Financial Condition and Results of Operations- Critical Accounting Policies and Significant Judgments and Estimates," in our Annual Report on Form 10-K for the year endedDecember 31, 2019 and the notes to the financial statements appearing elsewhere in this Quarterly Report. We believe that of our critical accounting policies, the following accounting policies involve the most judgment and complexity: • revenue recognition; • accrued research and development expenses; and • stock-based compensation. Accordingly, we believe the policies set forth above are critical to fully understanding and evaluating our financial condition and results of operations. If actual results or events differ materially from the estimates, judgments and assumptions used by us in applying these policies, our reported financial condition and results of operations could be materially affected.
Results of Operations
Comparison of Three Months Ended
The following table summarizes our results of operations for the three months
ended
Three Months Ended September 30, Increase 2020 2019 (Decrease) Revenue $ - $ - $ - Operating expenses: Research and development 1,240 10,145 (8,905 ) General and administrative 4,536 3,154 1,382 Restructuring costs 2,401 - 2,401 Total operating expenses 8,177 13,299 (5,122 ) Loss from operations (8,177 ) (13,299 ) (5,122 ) Interest income 8 224 (216 ) Interest expense (4 ) - (4 ) Other income, net 4 242 (238 ) Net loss$ (8,169 ) $ (12,833 )$ (4,664 ) Revenue
There was no revenue for the three months ended
Research and Development Expenses
Research and development expenses decreased to$1.2 million for the three months endedSeptember 30, 2020 , compared to$10.1 million for the three months endedSeptember 30, 2019 due to our strategic shift in strategy related to our pursuit of the Merger with Yumanity. The decrease of$8.9 million was related to a decrease of approximately$5.4 million in clinical-related research activities as we wind down our CF programs,$2.7 million in employee-related expenses as we reduced our workforce,$0.5 million in professional fees, and$0.3 million in facility expenses. 21
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General and Administrative Expenses
General and administrative expenses were$4.5 million for the three months endedSeptember 30, 2020 , compared to$3.2 million for the three months endedSeptember 30, 2019 . The increase of$1.3 million in general and administrative expenses was primarily due to an increase of$1.5 million in professional fees primarily related to our proposed Merger with Yumanity,$0.2 million in facility expenses, and$0.2 million in insurance expenses, offset by a decrease of$0.6 million in employee-related expenses.
Restructuring Costs
Restructuring costs were$2.4 million for the three months endedSeptember 30, 2020 , consisting primarily of severance-related costs associated with a reduction in force in connection with the proposed Merger with Yumanity. There were no restructuring costs for the three months endedSeptember 30, 2019 .
Interest Income
Interest income was less than$0.1 million for the three months endedSeptember 30, 2020 , compared to$0.2 million for the three months endedSeptember 30, 2019 . The decrease of$0.2 million in interest earned on cash equivalents and short-term investments is due to a decrease in average balance of invested cash held during the three months endedSeptember 30, 2020 , compared to the three months endedSeptember 30, 2019 .
Interest Expense
Interest expense was less than
Other Income, Net
Other income was less than$0.1 million and$0.2 million for the three months endedSeptember 30, 2020 and 2019, respectively. The decrease of$0.1 million in other income is primarily due to a decrease in net accretion of discounts on short-term securities in the three months endedSeptember 30, 2020 compared to the three months endedSeptember 30, 2019 .
Comparison of Nine Months Ended
The following table summarizes our results of operations for the nine months
ended
Nine Months Ended September 30, Increase 2020 2019 (Decrease) Revenue $ - $ 5,000$ (5,000 ) Operating expenses: Research and development 12,342 43,217 (30,875 ) General and administrative 12,489 10,781 1,708 Restructuring costs 2,401 - 2,401 Total operating expenses 27,232 53,998 (26,766 ) Loss from operations (27,232 ) (48,998 ) (21,766 ) Interest income 269 879 (610 ) Interest expense (13 ) - (13 ) Other income, net 36 850 (814 ) Net loss$ (26,940 ) $ (47,269 ) $ (20,329 ) Revenue There was no revenue for the nine months endedSeptember 30, 2020 , as compared to revenue of$5.0 million related to the Genentech Agreement recognized in the nine months endedSeptember 30, 2019 .
Research and Development Expenses
Research and development expenses decreased to$12.3 million for the nine months endedSeptember 30, 2020 , compared to$43.2 million for the nine months endedSeptember 30, 2019 due to our strategic shift in strategy related to our pursuit of the Merger with Yumanity. The decrease of$30.9 million was due to a decrease of approximately$24.8 million in clinical-related research 22 -------------------------------------------------------------------------------- activities as we wind down our CF programs,$3.8 million in employee-related expenses as we reduced our workforce,$1.7 million in professional fees, and$0.6 million in facility expenses.
General and Administrative Expenses
General and administrative expenses were$12.5 million for the nine months endedSeptember 30, 2020 , compared to$10.8 million for the nine months endedSeptember 30, 2019 . The increase of$1.7 million in general and administrative expenses was due to an increase of$1.3 million in professional fees primarily related to our proposed Merger with Yumanity, an increase of$0.5 million in facility expenses, and$0.5 million in insurance expenses, partially offset by a decrease of$0.5 million in employee-related expenses.
Restructuring Costs
Restructuring costs were$2.4 million for the nine months endedSeptember 30, 2020 , consisting primarily of severance-related costs associated with a reduction in force in connection with the proposed Merger with Yumanity. There were no restructuring costs for the nine months endedSeptember 30, 2019 .
Interest Income
Interest income was$0.3 million for the nine months endedSeptember 30, 2020 , compared to$0.9 million for the nine months endedSeptember 30, 2019 . The decrease of$0.6 million in interest earned on cash equivalents and short-term investments is due to a decrease in average balance of invested cash held during the nine months endedSeptember 30, 2020 , compared to the nine months endedSeptember 30, 2019 .
Interest Expense
Interest expense was less than
Other Income, Net
Other income was less than$0.1 million and$0.9 million for the nine months endedSeptember 30, 2020 and 2019, respectively. The decrease of$0.8 million in other income is primarily due to a decrease in net accretion of discounts on short-term securities in the nine months endedSeptember 30, 2020 compared to the nine months endedSeptember 30, 2019 .
Liquidity and Capital Resources
Sources of Liquidity
Since our inception, we have incurred significant operating losses. We have generated limited revenue to date from our collaboration agreements and research grant. We have not yet commercialized any of our product candidates, which are in various phases of preclinical development and clinical trials and we do not expect to generate revenue from sales of any product for several years, if at all. We have funded our operations to date with proceeds received from equity offerings, the issuance of convertible promissory notes and, to a lesser extent, payments received in connection with collaboration agreements and a research grant. We also received an aggregate of approximately$3.5 million under our ATM program. As ofSeptember 30, 2020 , we had cash, cash equivalents and short-term investments of approximately$40.8 million and an accumulated deficit of$363.6 million . During the nine months endedSeptember 30, 2020 , we incurred a loss of$26.9 million and used$29.2 million of cash in operations.
Cash Flows
The following table summarizes our sources and uses of cash for each of the periods presented (in thousands):
Nine Months Ended September 30, 2020 2019 Cash used in operating activities$ (29,173 ) $
(41,555 )
Cash provided by investing activities 39,490
47,968
Cash provided by financing activities 427
81
Net increase in cash, cash equivalents and
restricted cash $ 10,744 $ 6,494 23
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Operating Activities
Net cash used in operating activities was$29.2 million during the nine months endedSeptember 30, 2020 , primarily driven by our net loss of$26.9 million and changes in operating assets and liabilities of$4.9 , partially offset by non-cash charges of$2.6 million . Our net loss was primarily attributed to our research and development activities associated with our clinical trials and preclinical studies. Changes in operating assets and liabilities were primarily related to a decrease of$3.2 million in accrued expenses, a decrease of$1.4 million in accounts payable, a decrease of$0.9 million in operating lease liabilities, and an increase in prepaid and other current assets of$0.6 million . Non-cash charges include$1.6 million of stock-based compensation and$0.9 million of non-cash lease expense. Net cash used in operating activities was$41.6 million during the nine months endedSeptember 30, 2019 , primarily driven by our net loss of$47.3 million , offset by non-cash charges of$3.2 million and changes in operating assets and liabilities of$2.6 million . Our net loss was primarily attributed to our research and development activities associated with our preclinical studies and clinical trials. Non-cash charges include$2.7 million of stock-based compensation,$1.1 million of depreciation and amortization and non-cash lease expense,$0.2 million of stock issued for consulting services, partially offset by$0.8 million of accretion of short-term investments. Changes in operating assets and liabilities were primarily related to an increase of$2.2 million in accounts payable and an increase of$0.7 million in accrued expenses and a decrease in prepaid and other current assets of$0.5 million , partially offset by a decrease of$0.8 million in operating lease liabilities.
Investing Activities
During the nine months endedSeptember 30, 2020 , net cash provided by investing activities was$39.5 million , consisting of proceeds received from maturities of short-term investments of$55.7 million , partially offset by purchases of our short-term investments of$16.2 million . During the nine months endedSeptember 30, 2019 , net cash provided by investing activities was$48.0 million , consisting of proceeds received from maturities of short-term investments of$111.0 million , partially offset by purchases of short-term investments of$63.0 million .
Financing Activities
During the nine months endedSeptember 30, 2020 , net cash provided by financing activities was$0.4 million , primarily related to proceeds from the issuance of short-term borrowings of$1.2 million , offset by payments made on short-term borrowings of$0.9 million . During the nine months endedSeptember 30, 2019 , net cash provided by financing activities was less than$0.1 million , resulting from the issuance of common stock pursuant to our employee stock purchase plan as well as stock option exercises.
Future Funding Requirements
We expect that our cash, cash equivalents, and short-term investments as ofSeptember 30, 2020 will enable us to fund our operating expenses and capital requirements, based upon our current operating plan, for at least 12 months from the date of this filing and through the completion of the Merger. If the Merger is not successful, and we determine to operate as a stand-alone entity, we will require additional funding to fund our pipeline and advance our proprietary candidates through regulatory approval and into commercialization, if approved. If, for any reason, the Merger does not close and the Merger Agreement is terminated, the Board may elect to, among other things, attempt to complete another strategic transaction including a transaction similar to the Merger, continue to operate our business or to dissolve and liquidate our assets, including the CF Assets. In addition, if our Board were to approve and recommend, and our stockholders were to approve, a dissolution and liquidation of our Company, we would be required underDelaware corporate law to pay our outstanding obligations, as well as to make reasonable provision for contingent and unknown obligations, prior to making any distributions in liquidation to our stockholders. As a result of this requirement, a portion of our remaining cash assets may need to be reserved pending the resolution of such obligations. In addition, we may be subject to litigation or other claims related to a dissolution and liquidation of our Company. If a dissolution and liquidation were pursued, our Board, in consultation with its advisors, would need to evaluate these matters and make a determination about a reasonable amount to reserve. As ofSeptember 30, 2020 , we had cash and cash equivalents and short-term investments totaling approximately$40.8 million . However, there can be no assurances as to the amount or timing of available cash, if any, left to distribute to our stockholders after paying the debts and our other obligations and setting aside funds for potential future claims. 24 -------------------------------------------------------------------------------- In the event we are unable to complete the Merger, we continue will to pursue cost saving initiatives to reduce operating expenses, but we will also need to raise additional funds to pursue our business strategy and explore sources of equity or debt financing. We may seek to raise such capital through a combination of equity offerings, debt financings, collaborations, strategic alliances and licensing arrangements. We do not currently have any committed external source of funds and additional funding may not be available on favorable terms or at all.
Contractual Obligations and Commitments
Under various agreements, we will be required to make milestone payments and pay royalties and other amounts to third parties.
We enter into contracts in the normal course of business with CROs for clinical trials, preclinical research studies, testing and other services, and products for operating purposes. These contracts generally provide for termination upon notice, and therefore we believe that our non-cancelable obligations under these agreements are not material. JOBS Act InApril 2012 , the Jumpstart Our Business Startups Act of 2012, or the JOBS Act, was enacted. Section 107 of the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. Thus, an emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have irrevocably elected not to avail ourselves of this extended transition period and, as a result, we will adopt new or revised accounting standards on the relevant dates on which adoption of such standards is required for other public companies.
Off-Balance Sheet Arrangements
We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of theSEC .
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