CENTREXION THERAPEUTICS CORPORATION You should read the following discussion of our financial condition and results of operations together with our unaudited condensed consolidated financial statements and the notes thereto included elsewhere in this Quarterly Report on Form 10-Q and other financial information included in this report and our audited consolidated financial statements and related notes thereto and management's discussion and analysis of financial condition and results of operations included in our Annual Report on Form 10-K for the year endedDecember 31, 2021 as filed with theSecurities and Exchange Commission , orSEC , onMarch 23, 2022 . In addition to historical information, the following discussion contains a number of forward-looking statements, all of which are based on our current expectations and could be affected by the uncertainties and risks referred to under Part I, Item 1A. "Risk Factors" of our Annual Report on Form 10-K . Please also see the section entitled "Special Note Regarding Forward-Looking Statements."
Overview
We are a clinical-stage biopharmaceutical company dedicated to improving the lives of women living with cancer. Our development team is advancing a pipeline of innovative therapies with a primary focus on treating female cancers, including breast, ovarian, and endometrial (uterine) cancer. Our first program and lead product candidate, ONA-XR, builds upon a foundation of successful drug development by our management team and advisors in the field of hormone-dependent cancers. ONA-XR is a potent and selective antagonist of the progesterone receptor, which has been linked to resistance to multiple classes of cancer therapeutics, including anti-estrogen therapies, across female hormone-dependent cancers. In 2020, we initiated a Phase 2 investigator-sponsored trial in collaboration withJefferson Health to evaluate ONA-XR in combination with Arimidex (anastrozole) in PR+ endometrial cancer and preliminary data is expected in mid-2022. Also, in 2020 we initiated a Phase 0 trial of ONA-XR in a window of opportunity study in primary breast cancer, and we reported preliminary data at the San Antonio Breast Cancer Symposium inDecember 2021 . In 2021, a Phase 1b/2 investigator-sponsored trial was initiated in collaboration withMemorial Sloan Kettering Cancer Center (MSK) to evaluate ONA-XR in combination with Ibrance (palbociclib) and Femara (leterozole) in first line (1L) metastatic breast cancer patients with biochemically recurrent disease, defined as circulating tumor DNA (ctDNA) positive. This is potentially a new clinical opportunity for the estimated 20% of 1L patientswho are at high risk of early disease progression on Ibrance plus Femara combination therapy and Phase 1b data is expected in the second half of 2022. In 2021, the first stage of a Phase 2 investigator-sponsored trial initiated by MSK to evaluate ONA-XR in recurrent granulosa cell tumors (GCT) of the ovary was completed. InJuly 2021, MSK initiated the second stage of this trial evaluating ONA-XR in combination with Arimidex, and preliminary data is expected in the second half of 2022. Also in 2021, a Phase 2 investigator-sponsored trial was initiated in collaboration with Wisconsin Oncology Network (WON) to evaluate ONA-XR in combination with Faslodex (fulvestrant) in second line (2L) or third line (3L) metastatic breast cancer. This trial is intended to evaluate potential ONA-XR plus Faslodex drug synergy after treatment failure of CDK4/6 and/or PIK3? inhibitors, and preliminary data is expected in the second half of 2022. In 2022, WON initiated a sub-study of its Phase 2 trial in 2L/3L metastatic breast cancer that evaluates the uptake of radiolabeled progesterone (F-FFNP) via PET imaging in breast tumors. Our second program, CLDN6xCD3 bsAb, is an anti-CD3 x anti-Claudin 6 (CLDN6) antigen bispecific monoclonal antibody (bsAbs) that is intended to redirect T-cell-mediated lysis toward malignant cells expressing CLDN6. CLDN6 is a tight junction membrane protein target expressed in multiple cancers, including ovarian and endometrial tumors, and absent from healthy adult tissues. We expect to select a candidate to support IND-enabling studies for CLDN6xCD3 bsAb in the second half of 2022. Beyond these two product candidates, we continue to evaluate opportunities to expand our pipeline. We were incorporated inApril 2015 under the laws of theState of Delaware . Since inception, we have devoted substantially all of our resources to developing product and technology rights, conducting research and development, organizing and staffing our company, business planning and raising capital. We operate as one business segment and have incurred recurring losses, the majority of which are attributable to research and development activities, and negative cash flows from operations. We have funded our operations primarily through the issuance of convertible debt, convertible preferred stock and sale of common stock. Our net loss was$3.4 million for the three months endedMarch 31, 2022 . As ofMarch 31, 2022 , we had an accumulated deficit of$32.7 million . 20 -------------------------------------------------------------------------------- Table of Contents InOctober 2021 , we closed an initial public offering ("IPO") on theNasdaq Stock Market , in which we issued and sold 5,750,000 shares at a public offering price of$5.00 per share. We received gross proceeds of approximately$28.8 million as a result of the offering. InDecember 2021 , we sold 5,000,000 shares of common stock together with warrants to purchase 5,000,000 shares of common stock in a private placement for gross proceeds of approximately$31.3 million . We expect our existing cash and cash equivalents will be sufficient to fund our operations into 2024. Currently, our primary use of cash is to fund operating expenses, which consist primarily of research and development expenditures as well as general and administrative expenditures. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our current or future product candidates. We expect to continue to incur significant expenses and operating losses for the foreseeable future as we advance our product candidates through all stages of development and clinical trials and, ultimately, seek regulatory approval. In addition, if we obtain regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product manufacturing, marketing, sales and distribution. Furthermore, in connection with the closing of our initial public offering, we have incurred and continue to incur additional costs associated with operating as a public company, including significant legal, accounting, investor relations and other expenses that we did not incur as a private company. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical trials and our expenses on other research and development activities. We expect to continue to incur net operating losses for at least the next several years, and we expect our research and development expenses, general and administrative expenses, and capital expenditures will continue to increase. We expect our expenses and capital requirements will increase significantly in connection with our ongoing activities as we:
•continue our ongoing and planned research and development of our first program and lead product candidate ONA-XR;
•continue nonclinical studies and initiate clinical trials for our anti-claudin 6 ("CLDN6") bispecific monoclonal antibody ("BsMAb") product and for any additional product candidates that we may pursue;
•continue to scale up external manufacturing capacity with the aim of securing sufficient quantities to meet our capacity requirements for clinical trials and potential commercialization; •establish a sales, marketing and distribution infrastructure to commercialize any approved product candidates and related additional commercial manufacturing costs;
•develop, maintain, expand, protect and enforce our intellectual property portfolio, including patents, trade secrets and know how;
•acquire or in-license other product candidates and technologies;
•attract, hire and retain additional executive officers, clinical, scientific, quality control, and manufacturing management and administrative personnel;
•add clinical, operational, financial and management information systems and personnel, including personnel to support our product development and planned future commercialization efforts;
•expand our operations in
•incur additional legal, accounting, investor relations and other expenses associated with operating as a public company.
We will need to raise substantial additional capital to support our continuing
operations and pursue our growth strategy. Until such time as we can generate
significant revenue from product sales, if ever, we plan to finance our
operations through the sale of equity, debt financings and/or other capital
sources, which may include collaborations with other companies or other
strategic transactions. There are no assurances that we will be successful in
obtaining an adequate level of financing as and when needed to finance our
operations on terms acceptable to us, or at all. Any failure to raise capital as
and when needed could have a negative impact on our financial condition and on
our ability to pursue our business plans and strategies. If we are unable to
secure adequate additional funding, we may have to significantly delay, scale
back or discontinue the development and commercialization of one or more product
candidates or delay our pursuit of potential in-licenses or acquisitions.
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The COVID-19 Pandemic and its Impacts on Our Business
InMarch 2020 , theWorld Health Organization declared the outbreak of COVID-19 a global pandemic. The spread of COVID-19 has caused worldwide economic instability and significant volatility in the financial markets. There is significant uncertainty as to the likely effects of this disease which may, among other things, materially impact the Company's ongoing or planned clinical trials. This pandemic or outbreak could result in difficulty securing clinical trial site locations, contract research organizations ("CROs"), and/or trial monitors and other critical vendors and consultants supporting the trial. In addition, outbreaks or the perception of an outbreak near a clinical trial site location could impact the Company's ability to enroll patients. These situations, or others associated with COVID-19, could cause delays in the Company's clinical trial plans and could increase expected costs, all of which could have a material adverse effect on the Company's business and its financial condition. At the current time, the Company is unable to quantify the potential effects of this pandemic on its future consolidated financial statements.
Components of Our Results of Operations
Operating Expenses
Research and Development Expenses
Research and development expenses have consisted primarily of costs incurred in connection with the discovery and development of our product candidates. We expense research and development costs as incurred, including:
•expenses incurred to conduct the necessary discovery-stage laboratory work, preclinical studies and clinical trials required to obtain regulatory approval;
•personnel expenses, including salaries, benefits and share-based compensation expense for our employees and consultants engaged in research and development functions;
•costs of funding research performed by third parties, including pursuant to agreements with clinical research organizations, or CROs, that conduct our clinical trials, as well as investigative sites, consultants and CROs that conduct our preclinical and clinical studies;
•expenses incurred under agreements with contract manufacturing organizations, or CMOs, including manufacturing scale-up expenses, milestone-based payments, and the cost of acquiring and manufacturing preclinical study and clinical trial materials;
•fees paid to consultants
•expenses related to regulatory activities, including filing fees paid to regulatory agencies; and
•allocated expenses for facility costs, including rent, utilities and maintenance.
We track outsourced development costs and other external research and
development costs to specific product candidates on a program-by-program basis,
fees paid to CROs, CMOs and research laboratories in connection with our
preclinical development, process development, manufacturing and clinical
development activities. However, we do not track our internal research and
development expenses on a program-by-program basis as they primarily relate to
compensation, early research and other costs which are deployed across multiple
projects under development.
Research and development activities are central to our business model. Product
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 significantly over
the next several years as we increase personnel costs, including share-based
compensation, conduct our clinical trials, including later-stage clinical
trials, for current and future product candidates and prepare regulatory filings
for our product candidates.
22-------------------------------------------------------------------------------- Table of Contents General and Administrative Expenses General and administrative expenses have consisted primarily of personnel expenses, including salaries, benefits and share-based compensation expense, for employees and consultants in executive, finance and accounting, legal, operations support, information technology and business development functions. General and administrative expense also includes corporate facility costs not otherwise included in research and development expense, including rent, utilities and insurance, as well as legal fees related to intellectual property and corporate matters and fees for accounting and consulting services. We expect that our general and administrative expenses will increase in the future to support our continued research and development activities, potential commercialization efforts and increased costs of operating as a public company. These increases will likely include increased costs related to the hiring of additional personnel and fees to outside consultants, legal support and accountants, among other expenses. Additionally, we anticipate increased costs associated with being a public company, including expenses related to services associated with maintaining compliance with the requirements of Nasdaq and theSecurities and Exchange Commission , orSEC , insurance and investor relations costs. If any of our current or future product candidates obtainU.S. regulatory approval, we expect that we would incur significantly increased expenses associated with building a sales and marketing team.
Interest Expense
Interest expense has consisted primarily of interest related to our convertible
promissory notes that converted to Series A stock in 2021. All of the
outstanding Convertible Promissory Notes were converted as of
Results of Operations
Comparison of the Three Months Ended
The following table sets forth our results of operations for the three months
ended
Three months ended March 31
2022 2021 $ Change % Change
Operating expenses:
Research and development $ 1,351,495 $ 438,739 912,756 208 %
General and administrative 2,091,467 401,579 1,689,888 421 %
Loss from operations (3,442,962) (840,318) (2,602,644) 310 %
Interest income (expense), net 5,864 (62,985) 68,849 -109 %
Change in fair value of convertible
promissory notes - 9,317 (9,317) -100 %
Other (expense) income (1,239) 1,937 (3,176) 100 %
Net loss $ (3,438,337) $ (892,049) (2,546,288) 285 %
Research and Development Expenses
Research and development expenses increased by approximately$0.9 million from$0.4 million for the three months endedMarch 31, 2021 to$1.4 million for the three months endedMarch 31, 2022 . The increase was primarily due to an increase in contract manufacturing costs of$0.4 million for ONA-XR, an increase of$0.2 million in preclinical costs mainly associated with conducting research for the development of a CLDN6 BsMAb for gynecologic cancer therapy, and an increase of$0.1 million in clinical trial costs related to our Phase 2 trials evaluating ONA-XR. Additionally, salaries and related benefits increased by approximately$0.1 million due to a higher headcount from the prior year.
General and Administrative Expenses
General and administrative expenses increased by approximately$1.7 million from$0.4 million for the three months endedMarch 31, 2021 to$2.1 million for the three months endedMarch 31, 2022 . The increase was mainly due to an increase of$0.8 million in compensation and share-based compensation as a result of an increase in our general and administrative headcount and changes to compensation arrangements. Additionally, expenses increased by$0.8 million due to higher insurance costs of 23
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Interest Income (Expense), net
Interest income (expense), net, decreased by approximately$0.1 million from$0.1 million for the three months endedMarch 31, 2021 to$6,000 for the three months endedMarch 31, 2022 , primarily due to the conversion of all convertible promissory notes during 2021.
Change in Fair Value of Convertible Promissory Notes
The change in fair value of convertible promissory notes was
Liquidity and Capital Resources
Overview
Since our inception, we have not recognized any revenue and have incurred operating losses and negative cash flows from our operations. We have not yet commercialized any product and we do not expect to generate revenue from sales of any products for several years, if at all. Since our inception throughMarch 31, 2022 , we have funded our operations through the sale of convertible debt, convertible preferred stock and common stock. As ofMarch 31, 2022 , we had$45.7 million in cash and cash equivalents and had an accumulated deficit of$32.7 million . InOctober 2021 , we closed an initial public offering ("IPO") on theNasdaq Stock Market , in which we issued and sold 5,750,000 shares at a public offering price of$5.00 per share. We received gross proceeds of approximately$28.8 million as a result of the offering. InDecember 2021 , we sold 5,000,000 shares of common stock together with warrants to purchase 5,000,000 shares of common stock in a private placement for gross proceeds of approximately$31.3 million . We expect our existing cash and cash equivalents will be sufficient to fund our operations into 2024. We have based these estimates on assumptions that may prove to be imprecise, and we could utilize our available capital resources sooner than we expect.
Funding Requirements
Our primary use of cash is to fund operating expenses, which consist of research and development expenditures and various general and administrative expenses. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable, accrued expenses and prepaid expenses.
Because of the numerous risks and uncertainties associated with research, development and commercialization of pharmaceutical products, we are unable to estimate the exact amount of our operating capital requirements. Our future funding requirements will depend on many factors, including, but not limited to:
•the scope, timing, progress and results of discovery, preclinical development, laboratory testing and clinical trials for our product candidates;
•the costs of manufacturing our product candidates for clinical trials and in preparation for regulatory approval and commercialization;
•the extent to which we enter into collaborations or other arrangements with additional third parties in order to further develop our product candidates;
•the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims;
•the costs and fees associated with the discovery, acquisition or in-license of additional product candidates or technologies;
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•expenses needed to attract and retain skilled personnel;
•costs associated with being a public company;
•the costs required to scale up our clinical, regulatory and manufacturing capabilities;
•the costs of future commercialization activities, if any, including establishing sales, marketing, manufacturing and distribution capabilities, for any of our product candidates for which we receive regulatory approval; and
•revenue, if any, received from commercial sales of our product candidates, should any of our product candidates receive regulatory approval.
We will need additional funds to meet our operational needs and capital requirements for clinical trials, other research and development expenditures, and general and administrative expenses. We currently have no credit facility or committed sources of capital. Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations through a combination of equity offerings, debt financings, collaborations, strategic alliances and/or marketing, distribution or licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our shareholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures or declaring dividends. If we raise additional funds through collaborations, strategic alliances or marketing, distribution 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 grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, limit, reduce or terminate our research, 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.
Cash Flows
The following table shows a summary of our cash flows for the periods indicated:
Three months ended March 31,
2022 2021
Cash used in operating activities $ (3,820,281) $ (1,715,251)
Cash used in investing activities (34,999) -
Cash (used in) provided by financing activities (102,071) 3,034,526
Net increase (decrease) in cash, cash equivalents and restricted cash
$ (3,957,351)
Comparison of the Three Months Ended
Operating Activities
During the three months endedMarch 31, 2022 , we used$3.8 million of cash in operating activities. Cash used in operating activities reflected our net loss of$3.4 million and a net change in our operating assets and liabilities of$0.6 million . This was offset by non-cash share-based compensation of$0.2 million . The primary uses of cash were to fund our operations related to the development of our product candidates. During the three months endedMarch 31, 2021 , we used$1.7 million of cash in operating activities. Cash used in operating activities reflected our net loss of$0.9 million and an increase in our operating assets and liabilities of$0.9 million . This was offset by non-cash interest expense and share-based compensation of$0.1 million . The primary uses of cash were to fund our operations related to the development of our product candidates and fees incurred in connection with our initial public offering. 25
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During the three months ended
We did not have cash flows from investing activities during the three months
ended
Financing Activities During the three months endedMarch 31, 2022 , cash used in financing activities was$0.1 million , consisting of the payment of offering costs related to ourDecember 2021 private placement. During the three months endedMarch 31, 2021 , financing activities provided$3.0 million , consisting of net proceeds from the sale of Series A preferred stock and warrants for common stock.
Off-Balance Sheet Arrangements
During the periods presented, we did not have, nor do we currently have, any relationships with unconsolidated entities or financial partnerships, including entities sometimes referred to as structured finance or special purpose entities that were established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes. We do not engage in off-balance sheet financing arrangements. In addition, we do not engage in trading activities involving non-exchange traded contracts. We therefore believe that we are not materially exposed to any financing, liquidity, market or credit risk that could arise if we had engaged in these relationships.
Critical Accounting Policies
During the three months endedMarch 31, 2022 , there were no material changes to our critical accounting policies and estimates from those described in our Annual Report on Form 10-K for the year endedDecember 31, 2021 , as filed with theSEC onMarch 23, 2022 .
Recent Accounting Pronouncements
See Note 3 to our unaudited condensed consolidated financial statements found elsewhere in this Quarterly Report for a description of recent accounting pronouncements applicable to our condensed consolidated financial statements.
Emerging Growth Company and Smaller Reporting Company Status
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 the extended transition period provided in Section 7(a)(2)(B) of the Securities Act of 1933, as amended, 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 elected to avail ourselves of this exemption from complying with new or revised accounting standards and, therefore, will not be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies. As a result, our financial statements may not be comparable to companies that comply with new or revised accounting pronouncements as of public company effective dates. We are in the process of evaluating the benefits of relying on other exemptions and reduced reporting requirements under the JOBS Act, including without limitation, exemption to the requirements for providing an auditor's attestation report on our system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act. We will remain an emerging growth company until the earlier to occur of (a) the last day of the fiscal year (i) following the fifth anniversary of the completion of this offering, (ii) in which we have total annual gross revenues of at least$1.07 billion or (iii) in which we are deemed to be a "large accelerated filer" under the rules of theSEC , which means that we have been required to file annual and quarterly reports under the Exchange Act for a period of at least 12 months and have filed at least one annual report pursuant to the Exchange Act and either (a) the market value of our common stock that is held by non-affiliates exceeds$700.0 million as of the priorJune 30th , or (b) the date on which we have issued more than$1.0 billion in non-convertible debt during the prior three-year period. 26
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We are also a "smaller reporting company," meaning that the market value of our stock held by non-affiliates plus the aggregate amount of gross proceeds to us as a result of our IPO is less than$700.0 million and our annual revenue is less than$100.0 million during the most recently completed fiscal year. We may continue to be a smaller reporting company after this offering if either (i) the market value of our stock held by non-affiliates is less than$250.0 million or (ii) our annual revenue is less than$100.0 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than$700.0 million . If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation. 27
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