You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited condensed consolidated financial statements and the related notes and other financial information included elsewhere in this Quarterly Report on Form 10-Q and the audited consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the year endedDecember 31, 2021 , or the 2021 Annual Report on Form 10-K. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. You should review the sections entitled "Risk Factors" and "Summary of the Material Risks Associated with Our Business" in our 2021 Annual Report on Form 10-K for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis. This section provides additional information regarding our business, current developments, results of operations, cash flows, financial condition, contractual commitments and critical accounting policies and estimates that require significant judgement and have the most potential impact on our unaudited condensed consolidated financial statements. This discussion and analysis is intended to better allow investors to view the Company from management's perspective.
summary
We are a biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics. Our mission is to bring hope with life-changing therapies to patients and families that are affected by rare and niche allergic and immunological diseases. Our lead product candidate is STAR-0215, a potential best-in-class monoclonal antibody inhibitor of plasma kallikrein in preclinical development for the treatment of hereditary angioedema, or HAE, a rare, debilitating and potentially life-threatening disease. STAR-0215 has the potential to be the most patient-friendly chronic treatment option for HAE, based on the preclinical data generated to date and the existing HAE treatment landscape. InJanuary 2021 , we acquiredQuellis Biosciences, Inc. , or Quellis, including the STAR-0215 program, and announced a private placement that, upon closing inFebruary 2021 , resulted in gross proceeds to us of approximately$110.0 million before deducting placement agent and other offering expenses, which we refer to as theFebruary 2021 Financing. InNovember 2020 , after we stopped the development of our edasalonexent program as a potential treatment for Duchenne Muscular Dystrophy, or DMD,we decided to explore and evaluate strategic options. The acquisition of Quellis was the result of our evaluation of strategic options. InSeptember 2021 , we formally changed our name toAstria Therapeutics, Inc. fromCatabasis Pharmaceuticals, Inc. The name "Astria" originates from the Greek word for star, demonstrating our commitment to patients who serve as our guiding stars. HAE is a rare, debilitating and potentially life-threatening disease. The treatment options for patients with HAE have improved, however, there is remaining unmet medical need and the global market for HAE therapy is strong and growing. The vision for our lead program, STAR-0215, is to develop a best-in-class monoclonal antibody inhibitor of plasma kallikrein able to provide long-acting, effective attack prevention for HAE with dosing once every three months or longer. Targeted plasma kallikrein inhibition can prevent HAE attacks by suppressing the pathway that generates bradykinin and causes excessive swelling. STAR-0215 is currently in preclinical development and we expect to submit an Investigational New Drug application, or IND, for STAR-0215 in mid-2022 and plan to initiate a Phase 1a clinical trial shortly thereafter with initial results anticipated by year end 2022. We believe that this clinical trial has the opportunity to establish proof of concept for the differentiated profile of STAR-0215. We expect the Phase 1a clinical trial to be conducted in a single center with healthy volunteers and evaluate several single escalating dose cohorts with subcutaneous administration. Our goals for this trial with STAR-0215 are to demonstrate safety and tolerability, establish the prolonged half-life, demonstrate the duration of inhibition of plasma kallikrein activity and to refine dose and dosing regimen for studies in HAE patients. Assuming positive data from the Phase 1a trial, we plan to initiate a Phase 1b/2 trial in patients withHAE in 2023. We expect the Phase 1b/2 trial, if initiated, would be a randomized, placebo-controlled, global multi-center trial in HAE patients, and that the primary goals for the trial would be to demonstrate safety and tolerability, establish prolonged half-life, demonstrate inhibition of plasma kallikrein activity, and provide an initial assessment of the impact of STAR-0215 on HAE attack rate. 16 Table of Contents Our vision for STAR-0215 is supported by preclinical data showing potent inhibition of the production of bradykinin by plasma kallikrein and a long plasma half-life that could potentially enable patients to dose less frequently. Multiple experiments have confirmed that STAR-0215 is approximately 10-fold more potent than lanadelumab, a monoclonal antibody inhibitor of plasma kallikrein commercialized under the name TAKHZYRO and an approved preventative treatment forHAE, in inhibiting bradykinin production. In cynomolgus monkey studies, lanadelumab was observed to have a half-life of approximately 10 days, which is consistent with what has been reported inU.S. Food and Drug Administration , or FDA, review documents and publications for lanadelumab in non-human primates. STAR-0215 was administered at the same dose as lanadelumab and the observed half-life was approximately 34 days, which is about a three to four-fold longer half-life than observed for lanadelumab. We believe this could translate to a half-life of several months for STAR-0215 in humans. If this longer half-life is demonstrated in clinical trials, it has the potential to enable dosing once every three months or longer. We presented preclinical data from the STAR-0215 program at theAmerican College of Allergy, Asthma and Immunology , or ACAAI, Annual Scientific Meeting inNovember 2021 , demonstrating the high potency of STAR-0215 for binding to and inhibition of plasma kallikrein on a different site than lanadelumab and supporting the ability of YTE technology to extend half-life. YTE modifications in STAR-0215 are designed to enable a longer duration of action. In cynomolgus monkeys dosed with STAR-0215, the YTE modifications protected STAR-0215 from antibody clearance leading to a more than three-fold increase in plasma half-life compared to an antibody without the YTE modifications. Additional preclinical data presented at theAmerican Academy of Allergy , Asthma, and Immunology, or AAAAI, Annual Meeting inFebruary 2022 demonstrated how STAR-0215 binds to plasma kallikrein. At theFc Receptor and IgG Targeted Therapies Conference inApril 2022 , we presented pharmacokinetic modeling data supporting that STAR-0215 has the potential to effectively inhibit plasma kallikrein and prevent HAE attacks with subcutaneous dosing volumes appropriate for a self-injectable device dosed once every three months or longer. The preclinical and modeling data to date suggest that at equal or potentially lower doses STAR-0215 would have a significantly longer duration of action than lanadelumab and could result in STAR-0215 being an effective preventative therapy for patients with HAE due to inhibition of the pathologic activity of plasma kallikrein for an extended time period.
InJanuary 2021 , we acquired Quellis pursuant to an Agreement and Plan of Merger, or the Merger Agreement, by and among us,Cabo Merger Sub I, Inc. , aDelaware corporation and our wholly owned subsidiary, or the First Merger Sub,Cabo Merger Sub II, LLC , aDelaware limited liability company and our wholly owned subsidiary, or the Second Merger Sub, and Quellis, or the Quellis Acquisition. Pursuant to the Merger Agreement, the First Merger Sub merged with and into Quellis, pursuant to which Quellis was the surviving entity and became a wholly owned subsidiary of ours, or the First Merger. Immediately following the First Merger, Quellis merged with and into the Second Merger Sub, pursuant to which the Second Merger Sub was the surviving entity, or the Second Merger and, together with the First Merger, the Merger. Under the terms of the Merger Agreement, at the closing of the Merger, we issued to the Quellis stockholders 555,444 shares of our common stock, and 50,504 shares of newly designated Series X Preferred Stock (as described below). In addition, we assumed outstanding Quellis stock options, which became options for 55,414 shares of our common stock, and assumed a warrant exercisable for Quellis common stock, which became a warrant to purchase 2,805 shares of Series X Preferred Stock at an exercise price of$341.70 per share, and a warrant to purchase 30,856 shares of our common stock at an exercise price of$2.10 per share. Upon stockholder approval of the Conversion Proposal (as defined below) onJune 2, 2021 , the warrant to purchase Series X Preferred Stock was converted into the right to purchase 467,500 shares of our common stock, at a per share exercise price of$2.10 per share. We concluded that the Quellis Acquisition was not the acquisition of a business, as substantially all of the fair value of the non-monetary assets acquired was concentrated in a single identifiable asset, STAR-0215. InJanuary 2021 , we also entered into a Stock Purchase Agreement, or the Purchase Agreement, with certain institutional and accredited investors pursuant to which we sold an aggregate of 35,573 shares of Series X Preferred Stock for an aggregate purchase price of$110.0 million , or theFebruary 2021 Financing. Our stockholders approved the conversion of the Series X Preferred Stock into shares of common stock in accordance with Nasdaq Listing Rule 5635(a), or the Conversion Proposal, at our Annual Meeting of Stockholders onJune 2, 2021 . On the fourth business day after the approval of the Conversion Proposal, each share of Series X Preferred Stock automatically converted into 166.67 shares of common stock, subject to certain beneficial ownership limitations, including that a holder of Series X Preferred Stock is prohibited from converting shares of Series X Preferred Stock into shares of common stock if, as a result of such conversion, such holder, together with its affiliates, would beneficially own more than a specified percentage (as ofMarch 31, 2022 , these percentages are set at 4.99% to 9.99% and can be adjusted by the holder to a number between 4.99% and 19.99%) of the total number of shares of common stock issued and outstanding immediately after giving effect to such conversion. Shares of Series X Preferred Stock not converted automatically are thereafter subject to conversion at the option of the holder, subject to certain beneficial ownership limitations. As ofApril 29, 2022 , 54,622 shares of Series X Preferred Stock have been converted into 9,103,664 17
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shares of common stock and 31,455 shares of Series X Preferred Stock remained outstanding. Each share of Series X Preferred Stock is convertible into 166.67 shares of common stock and therefore the number of shares of underlying common stock issuable upon conversion of the outstanding shares Series X Preferred Stock is 5,242,501. Outstanding shares of Series X Preferred Stock are subject to conversion at the option of the holder.
Reverse stock split
OnAugust 4, 2021 , our Board of Directors approved a reverse stock split of our outstanding shares of common stock at a ratio of one-for-six (1:6). The reverse stock split became effective onAugust 19, 2021 . The reverse stock split was approved by our stockholders at our Annual Meeting of Stockholders onJune 2, 2021 . All share and per share amounts of the common stock included in this Quarterly Report on Form 10-Q, including in the accompanying unaudited condensed consolidated financial statements, have been retrospectively adjusted to give effect to the reverse stock split for all periods presented, including reclassifying an amount equal to the reduction in par value to additional paid-in capital. As ofApril 29, 2022 , we had 13,016,955 shares of outstanding common stock and approximately 31,455 shares of outstanding Series X Preferred Stock, which we issued in the Quellis Acquisition and theFebruary 2021 Financing, which are convertible into 5,242,501 shares of common stock.
financial evaluation
Our business is almost entirely dependent on the success of STAR-0215, which is in the preclinical stage of development, and has only produced results in preclinical and nonclinical settings. Our net losses were$15.3 million and$170.1 million (including$164.6 million of in-process research and development expenses) for the three months endedMarch 31, 2022 and 2021, respectively. As ofMarch 31, 2022 , we had an accumulated deficit of$471.1 million . We have financed our operations to date primarily through private placements of preferred stock before we became a public company and our private placement of preferred stock in theFebruary 2021 Financing, registered offerings of our common stock and our at-the-market programs, and have devoted substantially all of our financial resources and efforts to research and development, including preclinical studies and clinical development programs. As ofMarch 31, 2022 , we had$112.8 million in cash, cash equivalents and short-term investments. We expect that our existing cash, cash equivalents and short-term investments are sufficient to support our operating expenses and capital expenditures through 2023. Advancing the development of STAR-0215 or any future product candidates will require a significant amount of capital. Our existing cash , cash equivalents and short-term investments will not be sufficient to fund STAR-0215 or any future product candidates through regulatory approval. We will need to obtain substantial additional funding to complete the development and commercialization of STAR-0215 or any future product candidates and support our continuing operations, future clinical trials and expansion of our pipeline. Furthermore, our operating plan may change as a result of many factors currently unknown to us, and we may need to seek additional financing to fund our long-term operations sooner than planned. See the section titled "Liquidity and Capital Resources" below for additional information.
Research and development expenditures
Research and development expenses consist primarily of costs incurred for our research activities, including our drug discovery efforts, and the development of our product candidates, which include:
? Employee related expenses including salaries, benefits and shares
Compensation Calculation
Expenses incurred under agreements with third parties, including contract
? Research organizations that conduct clinical trials and research and
development and preclinical activities on our behalf;
? cost of consultants.
? Cost of laboratory supplies and study of acquisition, development and manufacture
Materials; And
? Facilities and other expenses, which include direct and allotted expenses for
Rent and maintenance of facilities, insurance and other supplies.
Research and development costs are expensed as incurred. Nonrefundable 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.
We typically use our employee, consultant and infrastructure resources across
our development programs. We track outsourced development costs by product
candidate or development program, but we do not allocate personnel costs, other
internal costs or external
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Consultant costs for specific product candidates or development programs. We record our R&D expenditures without any R&D tax incentives that we are entitled to receive from government authorities.
The following table summarizes our research and development expenses by program
(in thousands):
Three Months Ended March 31,
2022 2021
STAR-0215 $ 6,269 $ 458
Edasalonexent 64 456
Other research programs 301 -
Costs not directly allocated to programs: employee expenses including cash compensation, benefits, and stock-based compensation
1,375 1,227 Facilities 80 88 Consultants and professional expenses, including stock-based compensation 2,226 276 Other 43 88 Total costs not directly allocated to programs 3,724 1,679 Total research and development expenses $
10358
Based on results from the PolarisDMD Phase 3 trial of edasalonexent for the treatment of DMD, in
We expect to incur significant research and development expenses in the year endingDecember 31, 2022 and in future periods in connection with the preclinical and clinical activities related to the development of STAR-0215. Because of this, we expect that our research and development expenses over the next several quarters will be higher than the prior year periods. Development of STAR-0215 and any future product candidates is highly uncertain and we cannot reasonably estimate at this time the nature, timing and costs of the efforts that would be necessary to complete the development of any such product candidates. We are also unable to predict when, if ever, material net cash inflows would commence from any such product candidates. This is due to the fact that we would need to raise substantial additional capital to fund the clinical development of any such product candidates and the numerous risks and uncertainties associated with developing and commercializing product candidates, including the uncertainties of:
? Create an appropriate safety profile with toxicology that enables IND
studies;
? Successful enrollment and completion of clinical trials;
? Feedback from the Food and Drug Administration and foreign regulatory authorities on the planned trial
designs, preclinical studies, manufacturing capabilities and plans;
? Changes in the Food and Drug Administration and foreign regulatory approval processes or views
may delay or prevent approval of new products;
? receiving marketing approvals from the relevant regulatory authorities;
? Establishing or making arrangements with commercial manufacturing capabilities
Third Party Manufacturers
? Obtaining, maintaining and regulating the protection of patents and trade secrets
exclusivity.
Commercial sales launch, if we can get marketing approval,
? Whether alone or in cooperation with others, our ability to compete
successfully combined with other products; And
? Acceptable security file continues after approval.
Any change in the outcome of any of these variables with respect to the development of STAR-0215 or any future candidate product would significantly alter the costs and timing associated with the development of that candidate product.
General and administrative expenses
General and administrative expenses consist primarily of salaries and other
related costs, including stock-based compensation, for personnel in executive,
finance, accounting, commercial, business development, legal 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, and fees for accounting and consulting services.
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We anticipate that in the near term our general and administrative expenses will remain relatively consistent with their current levels, although as we continue to develop STAR-0215 and potentially expand our pipeline to include other product candidates, our general and administrative expenses may increase.
Acquired in-process research and development ("IPR&D") expense resulted from the
Quellis Acquisition in January 2021 . The acquisition cost allocated to acquire
IPR&D with no alternative future use was recorded as expense at the acquisition
date and no additional IPR&D expense relating to the Quellis Acquisition is
expected to be reported in future periods.
Manpower Reduction
InDecember 2020 , following the decision to stop development of edasalonexent, we announced that we were reducing our workforce during the quarter endedDecember 31, 2020 . The reduction resulted in total expenses for employee severance and employee benefits of$0.6 million , of which$0.2 million was recorded during the three months endedMarch 31, 2021 . As ofMarch 31, 2022 , all severance and employee benefits related to the reduction of workforce has been paid. Other Income (Expense), Net
Other net income (expenses) consists of interest income earned on cash and cash equivalents and our short-term investments and net depreciation expenses on short-term investments, and gains and losses related to foreign currency fluctuations.
Significant accounting policies, judgments and estimates
This discussion and analysis of our financial condition and results of operations is based on our financial statements, which we have prepared in accordance withUnited States generally accepted accounting principles. We believe that several accounting policies are important to understanding our historical and future performance. We refer to these policies as critical because these specific areas generally require us to make judgments and estimates about matters that are uncertain at the time we make the estimate, and different estimates-which also would have been reasonable-could have been used. On an ongoing basis, we evaluate our estimates and judgments. We base our estimates on historical experience and other market-specific or other relevant assumptions that we believe 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 sources. Actual results may differ from these estimates under different assumptions or conditions. During the three months endedMarch 31, 2022 , there were no material changes to our critical accounting policies as reported in our 2021 Annual Report on Form 10-K. 20 Table of Contents Results of Operations
We anticipate that the results of our operations may fluctuate in the foreseeable future due to several factors, such as the progress of our research and development efforts and the timing and outcome of regulatory submissions.
Comparison of the three months ended
The following table summarizes our results of operations for the three months endedMarch 31, 2022 and 2021, together with the dollar change in those items (in thousands): Three Months Ended March 31, Period-to- 2022 2021 Period Change Operating expenses: Research and development$ 10,358 $ 2,593 $ 7,765 General and administrative 5,020 2,880 2,140 Acquired in-process research and development -
164,612 (164,612) Total operating expenses 15,378 170,085 (154,707) Loss from operations (15,378) (170,085) 154,707 Other income, net 55 1 54 Net loss$ (15,323) $ (170,084) $ 154,761
Research and development expenditures
Research and development expenses increased by$7.8 million to$10.4 million for the three months endedMarch 31, 2022 from$2.6 million for the three months endedMarch 31, 2021 , an increase of 299%. The substantial increase in research and development expenses was primarily attributable to a$5.8 million increase in direct costs to support preclinical development of the STAR-0215 program, a$2.0 million increase to professional service expenses primarily due to expense recognized on vested warrants inherited in the Quellis Acquisition as described in Note 1, "Organization and Operations", a$0.3 million increase in other research and programs, and a$0.1 million increase in employee expenses. These increases were offset by a$0.4 million decrease in costs to support the edasalonexent program due to stopping all development activities associated with the program.
General and administrative expenses
General and administrative expenses increased by$2.1 million to$5.0 million for the three months endedMarch 31, 2022 from$2.9 million for the three months endedMarch 31, 2021 , an increase of 74%. The increase was attributable to a$0.7 million increase in professional services expense primarily due to new product planning and business development activities, a$0.6 million increase in employee related costs, a$0.5 million increase in stock-based compensation expense, a$0.2 million increase in ourDelaware franchise tax fee, and a$0.1 million increase in insurance expense.
Acquired IPR&D expense was$164.6 million for the three months endedMarch 31, 2021 . Acquired IPR&D expense resulted from the Quellis Acquisition inJanuary 2021 . The acquisition cost allocated to acquire IPR&D with no alternative future use was recorded as an expense as of the closing date of the Quellis Acquisition. No acquired IPR&D expenses were incurred for the three months
endedMarch 31, 2022 . Other Income, Net Other income, net increased by$54,000 to$55,000 for the three months endedMarch 31, 2022 from$1,000 for the three months endedMarch 31, 2021 . The increase was primarily attributable to an increase in interest and investment income due to higher interest yields and an increase in our interest-earning assets. 21 Table of Contents
Liquidity and capital resources
From our inception throughMarch 31, 2022 , we raised an aggregate of$426.0 million through private placements of preferred stock before we became a public company and our private placement of preferred stock in theFebruary 2021 Financing, registered offerings of our common stock and our at-the-market programs. As ofMarch 31, 2022 , we had cash, cash equivalents and short-term investments of$112.8 million . We expect that our existing cash , cash equivalents and short-term investments are sufficient to support our operating expenses and capital expenditures through 2023. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we anticipate. We will need to obtain substantial additional funding to complete the development and commercialization of STAR-0215 or any future product candidates and support our continuing operations, future clinical trials and expansion of our pipeline. In addition, STAR-0215 or any future product candidates, if approved, may not achieve commercial success. Our commercial revenues, if any, will be derived from sales of product candidates that we do not expect to be commercially available for years, if at all. Accordingly, we will need to continue to rely on additional financing to achieve our business objectives. Adequate additional financing may not be available to us on acceptable terms, or at all. The terms of any financing may adversely affect the holdings or the rights of our stockholders. Market volatility, inflation, interest rate fluctuations and concerns related to the COVID-19 pandemic may have a significant impact on the availability of funding sources and the terms on which any funding may be available. If we fail to raise capital as, and when, needed, we may be unable to continue our operations at planned levels and be forced to modify our business strategies and reduce or terminate our operations.
employment
Total Returns Deadline Approx
Put on the market
We had entered into various sales agreements withCowen and Company LLC , or Cowen, pursuant to which we could issue and sell shares of common stock, under at-the-market offering programs. OnMay 20, 2021 , we terminated our sales agreement with Cowen. OnJune 30, 2021 , we entered into an Open Market Sale AgreementSM withJefferies LLC , or Jefferies, pursuant to which we can issue and sell shares of common stock, of up to$25.0 million under at-the-market offering programs (collectively, with the Cowen at-the-market offering program, the ATM Programs). We pay the sales agent commissions of 3% of the gross proceeds from any common stock sold through the ATM Programs. As ofMarch 31, 2022 , we have not sold any shares of common stock pursuant to the Jefferies agreement. There was also no activity from the ATM Programs during the three months endedMarch 31, 2021 .
cash flow
Comparison of the three months ended
The following table provides information regarding our cash flows for the three months ended
Three Months Ended March 31,
2022 2021
Net cash used in operating activities $ (12,559) $ (8,716)
Net cash (used in) provided by investing activities (27,099) 26,445
Net cash provided by financing activities - 104,261
Net (decrease) increase in cash and cash equivalents and restricted cash
$
(39,658)
Net cash used in operating activities was
Adjusted to calculate compensation based on stock of
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Net cash used in operating activities was$8.7 million for the three months endedMarch 31, 2021 and consisted primarily of a net loss of$170.1 million adjusted for the non-cash portion of acquired IPR&D of$164.6 million and other non-cash items such as stock-based compensation expense of$0.4 million and a net increase in operating assets of$3.6 million , which resulted primarily from a decrease in accrued expenses of$2.7 million and a decrease in accounts payable of$1.7 million , partially offset by a decrease in prepaid expenses of$0.8 million .
Net cash used in investing activities was$27.1 million for the three months endedMarch 31, 2022 and consisted primarily of proceeds from purchases of short-term investments of$81.7 million offset by maturities of short-term investments of$54.6 million . Net cash provided by investing activities was$26.4 million for the three months endedMarch 31, 2021 and consisted primarily of proceeds from maturities of short-term investments of$20.0 million and cash acquired in the Quellis Acquisition of$6.4 million .
Net cash generated from financing activities
Net cash provided by financing activities was$104.3 million during the three months endedMarch 31, 2021 , which was attributable to net proceeds of$104.3 million from theFebruary 2021 Financing.
Funding requirements
Our primary uses of capital are compensation and related expenses, manufacturing costs for preclinical and clinical materials, third party preclinical research and development services, and other legal and regulatory and overhead expenses.
From
As ofMarch 31, 2022 , we had available cash, cash equivalents and short-term investments of$112.8 million . We expect that our existing cash , cash equivalents and short-term investments are sufficient to support our operating expenses and capital expenditures through 2023. Our estimate as to how long we expect our cash, cash equivalents and short-term investments to be able to fund our operations is based on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect. Because of the numerous risks and uncertainties associated with research, development and commercialization of biotechnology products, we are unable to estimate the exact amount of our operating capital requirements. Further, changing circumstances, some of which may be beyond our control, could cause us to consume capital significantly faster than we currently anticipate, and we may need to seek additional funds sooner than planned. Our future funding requirements will depend on many factors, including:
Progress, timing, costs, and results of clinical trials, research, and
? Preclinical development efforts for STAR-0215 and any future product
Candidates, including potential future clinical trials;
? Our ability to enter into any additional terms and conditions and timing
cooperation, licensing or other arrangements we may make;
? The number and characteristics of future product candidates we are following and
their development requirements;
? the outcome, timing and costs of obtaining regulatory approvals;
The costs of marketing activities for any of our product candidates
which obtain marketing approval to the extent that these costs are not
The responsibility of any future collaborators, including costs and timing
? Create product sales, marketing, market reach, distribution, and sourcing
Chain and manufacturing capabilities, expanding the scope of pharmaceutical manufacturing
material and drug product on clinical and commercial scale, securing all raw materials
The materials needed to make such an expansion and successfully complete the whole
other related activities;
? If we obtain marketing approval for any of the candidates for our products, the revenue, if
any of the commercial sales of our product candidates;
If we obtain marketing approval for any of the candidates for our products, our ability
? To successfully compete with other approved products that have been approved or
They are used as the indications for which our products are approved,
Including with respect to STAR-0215 in HAE;
? Our headcount growth and associated costs;
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Costs of preparing, filing, following-up and maintaining patent applications
? Protect and defend our intellectual property rights
intellectual property claims;
Progress, timing, costs, and results of clinical trials, research, and
? Preclinical development efforts for STAR-0215 and any future product
Candidates, including potential future clinical trials;
? The impact of the COVID-19 pandemic on our operations, business and prospects;
And
? The costs of operating as a public company.
Identifying potential product candidates and conducting preclinical testing and clinical trials is a time-consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve product sales. In addition, STAR-0215 or any future product candidates, if approved, may not achieve commercial success. Our commercial revenues, if any, will be derived from sales of medicines that we do not expect to be commercially available for years, if at all. Accordingly, we will need to continue to rely on additional financing to achieve our business objectives. Adequate additional financing may not be available to us on acceptable terms, or at all. Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through a combination of equity offerings, debt financings, collaborations, strategic alliances and licensing arrangements. We do not have any committed external source of funds. To the extent that we raise additional capital through the sale of equity or convertible debt securities, our stockholders' ownership interests will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our stockholders' rights. Debt financing, if available, would result in periodic payment obligations and may involve agreements that include restrictive covenants that limit our ability to take specific actions, such as incurring debt, making capital expenditures or declaring dividends, that could adversely impact our ability to conduct our business. If we raise funds through collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or to 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 product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
Physical cash requirements of known contractual obligations
The following table summarizes our significant contractual obligations as of the payment due date by period
Payments due by period
Less than 1 More than 3 (In thousands) Total Year 1 - 3 Years Years Operating lease obligations (1) 1,625 731 894 - Payments under vendor agreements (2) 766 766 - - Total contractual cash obligations$ 2,391 $ 1,497 $ 894 $ - (1)Represents future minimum lease payments under our non-cancelable operating leases. The minimum lease payments above do not include any related common area maintenance charges or real estate taxes.
(2) Represents future principal payments under vendor agreements if certain clinical milestones related to Phases 1A of the planned STAR-0215 clinical trials are met.
As ofMarch 31, 2022 , material contractual obligations included our facility leases pursuant to which we will make payments of$1.6 million . These payments include those pursuant to our current facility lease until its expiration inJune 2022 as well as a new sublease we entered into inJanuary 2022 , as described in Note 7, "Commitments", commencing inMay 2022 through its expiration inJune 2024 . As ofMarch 31, 2022 , also have material contractual obligations to certain vendors to which we will make payments of$0.8 million if certain clinical milestones related to the planned Phase 1a clinical trials of STAR-0215 are met.
We enter into agreements in the normal course of business with vendors to conduct preclinical research studies and other services and products for operational purposes. We have not included these payments in the above schedule of contractual obligations because contracts are revocable at any time by us, generally on 60 days’ prior written notice, and we therefore believe that our non-cancellable obligations under these agreements are not material.
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