UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from ___________________ to ___________________
Commission File Number:
(Exact Name of Registrant as Specified in its Charter)
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer |
(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including area code:
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
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Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
As of May 4, 2023, the registrant had
Table of Contents
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PART I. |
3 |
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Item 1. |
3 |
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3 |
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4 |
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5 |
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6 |
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Notes to Unaudited Condensed Consolidated Financial Statements |
7 |
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
16 |
Item 3. |
24 |
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Item 4. |
24 |
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PART II. |
25 |
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Item 1. |
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Item 1A. |
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Item 2. |
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Item 3. |
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Item 4. |
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Item 5. |
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Item 6. |
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28 |
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i
Cautionary Note Regarding Forward-Looking Statements
This Quarterly Report on Form 10-Q contains forward-looking statements with respect to, among other things, our operations and financial performance. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q, including statements regarding our future results of operations and financial position, business strategy and plans and our objectives for future operations, are forward-looking statements. The words “believe,” “may,” “will,” "estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “could,” “target,” “predict,” “seek” and similar expressions are intended to identify forward-looking statements. We include forward-looking information in our discussion of the following, among other topics, the initiation, timing, progress and results of our current and future clinical trials, including disclosing initial or preliminary data from our CYT-0851 combination cohorts with capecitabine and gemcitabine in mid-2023, advancing CYT-0851 into one or more expansion cohorts in 2023, advancing CYT-0851 into a randomized phase 2 clinical trial with registrational intent in platinum resistant ovarian cancer; and our estimates regarding our cash runway, expenses, future revenue, capital requirements and needs for additional financing.
These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those referenced in the section titled “Risk Factors,” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022, filed with the U.S. Securities and Exchange Commission on March 23, 2023, which could cause actual results to differ materially. Moreover, we operate in a very competitive and rapidly changing environment and new risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in or implied by any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this Quarterly Report on Form 10-Q may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements.
The forward-looking statements included in this Quarterly Report on Form 10-Q are made only as of the date of this report. You should not rely upon forward-looking statements as predictions of future events. We cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. Moreover, neither we nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements. We undertake no obligation to update publicly any forward-looking statements for any reason after the date of this Quarterly Report on Form 10-Q to conform these statements to actual results or reflect interim developments, except as required by law.
Some of the key factors that could cause actual results to differ include that:
• Our announced strategic prioritization and workforce reduction may not result in CYT-0851 being successfully advanced, may not result in anticipated savings, and may disrupt our business, and we may pursue additional strategic alternatives.
• We have a limited operating history and have no products approved for commercial sale, which may make it difficult for you to evaluate our current business and predict our future success and viability.
• We have incurred significant losses since inception. We expect to incur losses for the foreseeable future and may never achieve or maintain profitability.
• We will need substantial additional funding. If we are unable to raise capital when needed, we will be forced to delay, reduce, or eliminate our research and product development programs or future commercialization efforts.
• We have never successfully completed any clinical trials, and we may be unable to do so for CYT-0851 or any future drug candidates we develop.
• Our clinical trials may fail to demonstrate adequately the safety and efficacy of CYT-0851 or any future drug candidates, which would delay or prevent further clinical development of those candidates, or prevent marketing approval from FDA or similar regulatory authorities.
• Positive results from the clinical trials and preclinical studies of our drug candidates are not necessarily predictive of the results of later clinical trials or preclinical studies. If we cannot replicate the positive results from our clinical trials and preclinical studies of our drug candidates in our later clinical trials preclinical studies, we may be unable to successfully develop, obtain regulatory approval for and commercialize our drug candidates.
• Our clinical trials may fail to demonstrate adequately the safety and efficacy of any of our drug candidates, which would delay or prevent further clinical development of those candidates, or prevent marketing approval from FDA or similar regulatory authorities.
• We are developing CYT-0851 for use in combination with other therapies, which exposes us to additional risks.
1
• If we are unable to successfully develop and commercialize companion diagnostic tests for our drug candidates, or experience significant delays in doing so, we may not realize the full commercial potential of our drug candidates.
• Synthetic lethality represents an emerging class of precision medicine targets, and negative perceptions of the efficacy, safety or tolerability of this class of targets, including any that we develop, could adversely affect our ability to conduct our business, advance our drug candidates or obtain regulatory approvals.
• If we are unable to adequately protect and enforce our intellectual property or obtain and maintain patent protection for our technology and products or if the scope of the patent protection obtained is not sufficiently broad, our competitors or other third parties could develop and commercialize technology and products similar or identical to ours, and our ability to successfully develop and commercialize our technology and products may be impaired.
• Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations.
2
PART I—FINANCIAL INFORMATION
Item 1. Financial Statements.
CYTEIR THERAPEUTICS, INC.
Condensed consolidated balance sheets
(in thousands, except share and per share amounts) |
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March 31, |
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December 31, |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
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$ |
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Prepaid expenses and other current assets |
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Total current assets |
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$ |
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$ |
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Property and equipment, net |
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Other assets |
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Total assets |
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$ |
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$ |
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Liabilities and stockholders’ equity |
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Current liabilities: |
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Accounts payable |
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$ |
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$ |
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Accrued expenses and other current liabilities |
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Total current liabilities |
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$ |
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$ |
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Other long term liabilities |
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Total liabilities |
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$ |
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$ |
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Stockholders’ equity: |
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, $ |
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— |
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— |
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Common stock, $ |
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Additional paid-in capital |
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Accumulated deficit |
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( |
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( |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity |
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$ |
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$ |
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See accompanying notes to condensed consolidated financial statements.
3
CYTEIR THERAPEUTICS, INC.
Condensed consolidated statements of operations
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Three Months Ended |
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(in thousands, except share and per share amounts) |
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2023 |
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2022 |
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Operating expenses: |
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Research and development |
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$ |
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$ |
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General and administrative |
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Total operating expenses |
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Loss from operations |
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( |
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( |
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Other income (expense): |
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Interest income |
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Loss on disposal of property and equipment |
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( |
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- |
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Gain on lease terminations and modification |
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- |
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Total other income (expense) |
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Net loss |
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$ |
( |
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$ |
( |
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Net loss per share—basic and diluted |
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$ |
( |
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$ |
( |
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Weighted-average common stock outstanding—basic and diluted |
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See accompanying notes to condensed consolidated financial statements.
4
CYTEIR THERAPEUTICS, INC.
Condensed consolidated statements of stockholders’ equity
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Common stock |
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(in thousands, except share and per share amounts) |
Shares |
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Amount |
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Additional |
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Accumulated |
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Total |
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Balance At December 31, 2021 |
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$ |
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$ |
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$ |
( |
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$ |
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Exercise of common stock options |
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— |
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— |
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Vesting of early exercised options |
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— |
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— |
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Stock-based compensation expense |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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( |
) |
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( |
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Balance At March 31, 2022 |
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$ |
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$ |
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$ |
( |
) |
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$ |
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Common stock |
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(in thousands, except share and per share amounts) |
Shares |
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Amount |
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Additional |
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Accumulated |
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Total |
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Balance At December 31, 2022 |
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$ |
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$ |
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$ |
( |
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$ |
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Exercise of common stock options |
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— |
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— |
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Vesting of early exercised options |
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— |
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— |
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Issuance of common stock under ESPP |
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— |
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— |
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Stock-based compensation expense |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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( |
) |
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( |
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Balance At March 31, 2023 |
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$ |
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$ |
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$ |
( |
) |
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$ |
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See accompanying notes to condensed consolidated financial statements.
5
CYTEIR THERAPEUTICS, INC.
Condensed consolidated statements of cash flows
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Three Months Ended |
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(in thousands) |
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2023 |
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2022 |
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Cash flows from operating activities: |
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Net loss |
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$ |
( |
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$ |
( |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization expense |
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Stock-based compensation |
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Non-cash lease expense |
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Loss on disposal of property and equipment |
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— |
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Gain on lease terminations and modification |
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( |
) |
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— |
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Changes in operating assets and liabilities: |
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Prepaid expenses and other current assets |
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( |
) |
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Accounts payable |
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( |
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Accrued expenses and other current liabilities |
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( |
) |
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( |
) |
Net cash used in operating activities |
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$ |
( |
) |
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$ |
( |
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Cash flows from investing activities: |
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Purchases of property and equipment |
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— |
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( |
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Proceeds from sales of property and equipment |
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— |
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Net cash provided by (used) in investing activities |
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$ |
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$ |
( |
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Cash flows from financing activities: |
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Proceeds from issuance of common stock under ESPP |
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— |
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Proceeds from exercise of stock options |
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Net cash provided by financing activities |
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$ |
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$ |
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Net decrease in cash, cash equivalents, and restricted cash |
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( |
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( |
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Cash, cash equivalents and restricted cash at beginning of period |
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Cash, cash equivalents and restricted cash at end of period |
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$ |
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$ |
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Supplemental disclosure of cash flows |
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Property and equipment purchases in accounts payable |
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$ |
— |
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$ |
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Remeasurement of operating lease liabilities and right-of-use assets |
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$ |
( |
) |
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— |
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Vesting of early exercised options |
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$ |
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$ |
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The following table provides a reconciliation of the cash, cash equivalents, and restricted cash balances as of each of the dates shown below:
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Three Months Ended |
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2023 |
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2022 |
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Cash and cash equivalents |
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$ |
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$ |
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Total cash, cash equivalents, and restricted cash |
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$ |
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$ |
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See accompanying notes to condensed consolidated financial statements.
6
CYTEIR THERAPEUTICS, INC.
Notes to condensed consolidated financial statements – (unaudited)
1. Nature of the business
Cyteir Therapeutics, Inc., (the “Company”) is a clinical-stage oncology company that is focused on the development of CYT-0851, an oral investigational drug candidate that inhibits monocarboxylate transporters. Cyteir’s current priority in CYT-0851 development is in combination with capecitabine or gemcitabine in a phase 1/2 clinical study, including patients with advanced ovarian cancer or other solid tumors, respectively. Through 2022, the Company used its expertise in DNA damage response biology and a disciplined approach to select targets for other novel, differentiated programs with the aim of building a patient-centric portfolio of effective cancer therapies. In January 2023, the Company announced a strategic prioritization that included the discontinuation of these preclinical efforts.
The Company was formed as a Delaware corporation on June 4, 2012, pursuant to the General Corporation Law of the State of Delaware. The Company has a principal office in Lexington, Massachusetts.
Liquidity
The Company has incurred net operating losses since inception and has funded its operations primarily with proceeds from the sale of redeemable convertible preferred stock and the issuance of common stock in its initial public offering, or IPO. As of March 31, 2023, the Company had cash and cash equivalents of $
The Company expects that its cash and cash equivalents as of March 31, 2023 will be sufficient to fund its operating expenses and capital expenditure requirements for at least twelve months from the date these condensed consolidated financial statements are available to be issued.
The Company will need additional funding to support its planned operating activities. There can be no assurances, however, that the current operating plan will be achieved or that additional funding will be available on terms acceptable to the Company, or at all. If the Company is unable to obtain sufficient funding, it could be required to delay its development efforts, limit activities and reduce research and development costs, which could adversely affect its business prospects.
COVID-19 considerations
The development of the Company’s product candidates could be disrupted and materially adversely affected in by a pandemic, epidemic or outbreak of an infectious disease, such as the ongoing COVID-19 pandemic. These disruptions related to the COVID pandemic could affect the Company’s business, including, but not limited to, the ability of the Company's clinical research organizations, or CROs, to conduct clinical trials in countries outside of the United States, the Company’s ability to identify suitable clinical sites or open those sites for enrollment due to competing business needs, the Company’s ability to enroll patients due to their fear of coming into medical facilities and their perceived risk of becoming infected at such facilities, and the Company’s ability to monitor the clinical data generated at its clinical sites, required for completion of clinical trials.
7
2. Summary of significant accounting policies
The Company's significant accounting policies are disclosed in the audited consolidated financial statements for the years ended December 31, 2022 and 2021 ("audited financial statements"), which are included in the Company's Annual Report on Form 10-K that was filed with the SEC on March 23, 2023. Since the date of the financial statements, there have been no changes to the Company's significant accounting policies, except as noted below.
Interim Financial Information
8
3. Fair value measurement
The following tables present information about the Company’s financial assets and liabilities measured at fair value on a recurring basis (in thousands):
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March 31, 2023 |
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Assets: |
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Total |
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Quoted prices in |
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Significant |
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Significant |
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Cash equivalents: |
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Money market funds |
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$ |
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$ |
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$ |
— |
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$ |
— |
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Total assets |
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$ |
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$ |
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$ |
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$ |
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December 31, 2022 |
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Assets |
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Total |
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Quoted prices in |
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Significant |
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Significant |
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Cash equivalents: |
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Money market funds |
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$ |
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$ |
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$ |
— |
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$ |
— |
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Total assets |
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$ |
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$ |
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$ |
— |
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$ |
— |
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During the three months ended March 31, 2023 and the year ended December 31, 2022, there were
The Company uses the carrying amounts of its restricted cash, prepaid expenses and other current assets, accounts payable and accrued expenses and other current liabilities to approximate their fair value due to the short-term nature of these amounts.
4. Prepaid expenses and other current assets
Prepaid expenses and other current assets consisted of the following (in thousands):
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March 31, |
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December 31, |
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Prepaid research and development expenses |
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$ |
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$ |
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Prepaid insurance |
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Prepaid other |
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Other receivables |
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Total |
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$ |
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$ |
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9
5. Property and equipment, net
On January 19, 2023, the Company announced a strategic prioritization of clinical development of CYT-0851, which included the discontinuation of preclinical efforts and a workforce reduction by approximately
Property and equipment, net consisted of the following (in thousands):
Acquisition cost |
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Laboratory and computer equipment |
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Leasehold improvements |
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Total |
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As of December 31, 2022 |
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$ |
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$ |
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$ |
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Disposals |
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( |
) |
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( |
) |
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( |
) |
As of March 31, 2023 |
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$ |
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$ |
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$ |
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Accumulated depreciation and amortization |
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Laboratory and computer equipment |
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Leasehold improvements |
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Total |
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As of December 31, 2022 |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
Depreciation expense |
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( |
) |
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( |
) |
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( |
) |
Disposals |
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As of March 31, 2023 |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
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Carrying amount |
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Laboratory and computer equipment |
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Leasehold improvements |
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Total |
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As of December 31, 2022 |
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$ |
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$ |
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$ |
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As of March 31, 2023 |
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$ |
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$ |
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$ |
|
|||
For both the three months ended March 31, 2023 and 2022, depreciation and amortization expense related to property and equipment was $
6. Accrued expenses and other current liabilities
Accrued expenses and other current liabilities consisted of the following (in thousands):
|
|
March 31, |
|
|
December 31, |
|
||
Accrued research and development expenses |
|
$ |
|
|
$ |
|
||
Accrued compensation |
|
|
|
|
|
|
||
Accrued other |
|
|
|
|
|
|
||
Operating lease liabilities |
|
|
|
|
|
|
||
Total accrued expenses and other current liabilities |
|
$ |
|
|
$ |
|
||
7. Common stock
The voting, dividend and liquidation rights of the holders of the Company’s common stock are subject to and qualified by the rights, powers and preferences of the holders of the preferred stock as set forth in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2022.
As of March 31, 2023 and December 31, 2022, the Company has reserved the following shares of common stock for the potential exercise of stock options:
10
|
|
March 31, |
|
|
December 31, |
|
||
|
|
2023 |
|
|
2022 |
|
||
Options to purchase common stock |
|
|
|
|
|
|
||
Remaining shares reserved for future issuance |
|
|
|
|
|
|
||
Total |
|
|
|
|
|
|
||
8. Stock-based compensation
2012 Stock Incentive Plan
The Company adopted the 2012 Stock Incentive Plan (the “2012 Plan”) in November 2012 pursuant to which the Company can issue incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards and other stock awards. Recipients of stock options or stock appreciate rights shall be eligible to purchase shares of the Company’s common stock at an exercise price equal to the estimated fair market value of such stock on the date of grant. The exercise price may be less than fair market value if the stock award is granted pursuant to an assumption or substitution for another stock award in the event of a merger or sale of the Company. The maximum term of options granted under the 2012 Plan is
2021 Equity Incentive Plan
In June 2021, the Company’s board of directors adopted and the Company’s stockholders approved the 2021 Plan, which became effective immediately prior to the effectiveness of the registration statement for the IPO. The 2021 Plan provides for the grant of incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock awards, restricted stock units and other stock-based awards. Upon effectiveness of the 2021 Plan, the number of shares of common stock reserved for issuance under the 2021 Plan was
At March 31, 2023,
2021 Employee Stock Purchase Plan
In June 2021, the Company’s board of directors adopted, and the Company’s stockholders approved, the 2021 Employee Stock Purchase Plan (the “ESPP”), which became effective immediately prior to the effectiveness of the registration statement for the IPO. The ESPP is administered by the compensation committee of the Company’s board of directors, except that the Company’s board of directors may at any time act as the administrator of the ESPP. The ESPP provides participating employees with the opportunity to purchase shares of common stock, with an initial aggregate share pool of
11
The ESPP allows eligible employees to authorize payroll deductions of between 1% and 15% of their regular base salary or wages to be applied toward the purchase of shares of the Company's common stock on the last trading day of the offering period, subject to certain limitations contained in the ESPP. Participating employees will purchase shares of the Company's common stock at a discount of 15% on the lesser of the closing price of the Company's common stock on the Nasdaq Global Select Market (i) on the first trading day of the offering period or (ii) the last trading day of the offering period. The Company utilizes the Black Scholes option pricing model to compute the fair market value of the shares subject to outstanding options under the ESPP and compensation expense is recognized over the offering period.
Participation in the ESPP is voluntary. Eligible employees become participants in the ESPP by enrolling in the plan and authorizing payroll deductions in accordance with the terms of the ESPP. At the end of each offering period, accumulated payroll deductions are used to purchase the Company’s shares at the discounted price. The Company makes no contributions to the ESPP. A participant may withdraw from the ESPP or reduce contributions to the ESPP during an offering period. If the participant elects to withdraw during an offering period, all contributions are refunded as soon as administratively practicable. If a participant elects to withdraw during an offering period, the participant may not re-enroll in the current offering but may elect to participate in future offerings, subject to the terms of the ESPP. Only whole shares of the Company may be purchased under the ESPP.
The Company issued
Early exercise of unvested stock options
Shares purchased by employees pursuant to the early exercise of stock options are not deemed, for accounting purposes, to be outstanding shares until those shares vest according to their respective vesting schedules. Cash received from employee exercises of unvested options is included in long-term liabilities on the condensed consolidated balance sheets. Amounts recorded are reclassified to common stock and additional paid-in capital as the shares vest. As of March 31, 2023 and December 31, 2022, there were
Stock option valuation
The assumptions that the Company used in the Black Scholes option-pricing model to determine the grant date fair value of stock options granted were as follows:
|
|
March 31, |
December 31, |
Risk-free interest rate range |
|
||
Dividend yield |
|
||
Expected life of options (years) |
|
||
Volatility rate range |
|
The following table summarizes the Company’s stock option activity during the three months ended March 31, 2023:
|
|
Number of |
|
|
Weighted average |
|
|
Weighted average |
|
|
Aggregate intrinsic |
|
||||
Outstanding as of December 31, 2022 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Granted |
|
|
|
|
$ |
|
|
|
— |
|
|
|
— |
|
||
Exercised |
|
|
( |
) |
|
$ |
|
|
|
— |
|
|
|
— |
|
|
Forfeited or cancelled |
|
|
( |
) |
|
$ |
|
|
|
— |
|
|
|
— |
|
|
Outstanding as of March 31, 2023 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Options vested and exercisable as of March 31, 2023 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
As of March 31, 2023, there was $
12
The aggregate intrinsic value of options is calculated as the difference between the exercise price of the stock options and the fair value of the Company’s common stock for those stock options that had exercise prices lower than the fair value of the common stock as of the end of the reporting period. The weighted-average grant date fair value of the Company’s stock options granted during the three months ended March 31, 2023 and 2022 was $
The total fair value of options vested during the three months ended March 31, 2023 and 2022 was $
Stock-based compensation expense
Stock-based compensation expense included in the Company’s condensed consolidated statements of operations is as follows (in thousands):
|
Three Months Ended |
|
|||||
|
2023 |
|
|
2022 |
|
||
Research and development |
$ |
|
|
$ |
|
||
General and administrative |
|
|
|
|
|
||
Total stock-based compensation expense |
$ |
|
|
$ |
|
||
9. Net loss per share
The Company’s potentially dilutive securities have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted-average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same.
|
|
Three Months Ended |
|
|||||
|
|
2023 |
|
|
2022 |
|
||
Options to purchase common stock |
|
|
|
|
|
|
||
Unvested shares from early exercises |
|
|
|
|
|
|
||
10. Commitments and Contingencies
Legal proceedings
From time to time, in the ordinary course of business, the Company is subject to litigation and regulatory examinations as well as information gathering requests, inquiries and investigations. As of March 31, 2023, there were no matters which would have a material impact on the Company’s financial results.
11. Leases
Operating Lease
In August 2018, the Company entered into an operating lease agreement (the "Lease") for office and laboratory space within the building complex located in Lexington, Massachusetts. The Lease commenced in November 2018, and as subsequently amended, is approximately
13
On March 29, 2023, the Company entered into a Lease Amendment and Termination Agreement (the “Amendment”) with respect to the operating lease with 99 Hayden LLC, which covers certain laboratory and office space at Ledgemont Technology Center at 99 Hayden Avenue, Lexington, Massachusetts (the “Premises”). The Amendment amends the terms of the Lease to terminate the Lease as of March 31, 2023, subject to completion of the requisite surrender requirements, with respect to approximately
The following table summarizes the presentation of the Company's operating leases on its consolidated balance sheet:
Leases |
Balance sheet classification |
|
March 31, 2023 |
|
December 31, |
|
||
Assets |
|
|
|
|
|
|
||
Operating lease assets |
|
$ |
— |
|
$ |
|
||
Liabilities |
|
|
|
|
|
|
||
Current |
|
|
|
|
|
|
||
Operating lease liabilities |
|
$ |
|
$ |
|
|||
Noncurrent |
|
|
|
|
|
|
||
Operating lease liabilities |
|
|
— |
|
|
|
||
Total lease liabilities |
|
|
$ |
|
$ |
|
||
The components of lease cost under ASC 842 included in the Company’s condensed consolidated statement of operations for the three months ended March 31, 2023 and 2022 were as follows:
|
|
|
Three Months Ended |
|
|||||
Lease Cost |
Statement of operations classification |
|
2023 |
|
|
2022 |
|
||
Operating lease cost |
Research and development |
|
$ |
|
|
$ |
|
||
Operating lease cost |
General and administrative |
|
|
|
|
|
|
||
Variable lease cost |
Research and development |
|
|
|
|
|
|
||
Variable lease cost |
General and administrative |
|
|
|
|
|
|
||
Total lease cost |
|
|
$ |
|
|
$ |
|
||
The weighted average remaining lease term and weighted average discount rate of the operating leases was
Future minimum lease payments under non-cancellable operating leases as of March 31, 2023 were as follows (in thousands):
Maturity of lease liabilities |
|
Amount |
|
|
2023 (excluding the three months ended March 31, 2023) |
|
$ |
|
|
2024 |
|
|
— |
|
2025 |
|
|
— |
|
2026 |
|
|
— |
|
2027 |
|
|
— |
|
Total lease payments |
|
|
|
|
Less: interest |
|
|
( |
) |
Present value of operating lease liabilities |
|
$ |
|
|
14
12. Employee benefit plans
The Company has a 401(k) retirement plan for its employees, which is designed to be qualified under Section 401(k) of the Internal Revenue Code. Eligible employees are permitted to contribute to the 401(k) plan within statutory and 401(k) plan limits. The Company implemented a matching contribution in 2022 and has made $
13. Restructuring
On January 19, 2023, the Company announced a strategic prioritization of clinical development of CYT-0851, which included the discontinuation of preclinical efforts and a workforce reduction by approximately
The following table outlines our restructuring activities for the three months ended March 31, 2023 (in thousands):
Opening Balance - December 31, 2022 |
|
$ |
|
|
Employee termination-related charges |
|
|
|
|
Payments |
|
|
( |
) |
Balance - March 31, 2023 |
|
$ |
|
15
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our consolidated financial statements and the related notes to those statements included elsewhere in this Quarterly Report on Form 10-Q and our audited financial statements and notes thereto for the year ended December 31, 2021, included in our Annual Report on Form 10-K that was filed on March 23, 2023 with the U.S. Securities and Exchange Commission, or SEC.
In addition to historical financial information, the following discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions. Some of the numbers included herein have been rounded for the convenience of presentation. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of many factors, including those discussed under “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022.
Overview
We are a clinical-stage oncology company focused on the development of CYT-0851, an oral investigational drug candidate that inhibits monocarboxylate transporters.
CYT-0851 is an investigational monocarboxylate transporter inhibitor, or MCT inhibitor, initially evaluated in a phase 1/2 study to treat patients with hematologic malignancies and solid tumors as a monotherapy and in combination with standard of care therapies. Inhibiting MCT function in glycolytic cancer cells leads to an accumulation of intracellular lactate that impairs glycolysis and inhibits tumor cell growth, making MCTs an attractive target for cancer therapy.
In January 2023, we reported encouraging preliminary clinical activity in a small number of patients observed in the phase 1 dose-escalation cohort with CYT-0851 in combination with capecitabine in advanced ovarian cancer. In this combination dose-escalation cohort, we enrolled a total of thirteen patients at dose levels of 100 mg to 400 mg of CYT-0851, which included five patients with advanced ovarian cancer. Based on preliminary data for these five patients, we observed one confirmed partial response, two disease stabilizations and two patients that were non-evaluable. Overall, CYT-0851 was generally well tolerated. At the highest tested dose, no dose-limiting toxicities were observed. Based on these results, we determined that 400 mg of CYT-0851 was the recommended phase 2 dose in combination with capecitabine, and we expanded enrollment in the CYT-0851 and capecitabine combination cohort to enroll additional patients with advanced ovarian cancer. Enrollment is ongoing and we expect to disclose initial data from these additional patients in mid-2023. If the data from these additional patients further support our focus on ovarian cancer, we intend to add a phase 2 expansion cohort of this combination and, if warranted, pursue further development and potential registration of CYT-0851 in combination with capecitabine as an all-oral treatment for platinum resistant ovarian cancer.
We also continue to evaluate CYT-0851 in combination with gemcitabine in phase 1 dose-escalation cohorts, and we expect to disclose preliminary results from these cohorts in mid-2023. In January 2023, we announced the suspension of enrollment in the CYT-0851 phase 2 monotherapy cohort due to insufficient activity observed with CYT-0851 alone. In addition to prioritizing CYT-0851 development as a potential combination therapy to treat advanced ovarian cancer, we deferred all other research and development activities and reduced our headcount to 15 employees.
Since our inception in 2012, we have focused primarily on organizing and staffing our company, business planning, raising capital, establishing our intellectual property portfolio and performing research and development of novel therapeutics. We do not have any drug candidates approved for sale and have not generated any revenue from product sales. Since our inception, we have funded our operations primarily with proceeds from the sale of securities, including an aggregate of approximately $141.0 million of gross proceeds from the sale of redeemable convertible preferred stock and approximately $149.1 million of gross proceeds from the sale of common stock in our IPO, as of March 31, 2023.
We have incurred significant operating losses since inception, including net losses of $12.5 million and $14.1 million for the three months ended March 31, 2023 and 2022, respectively. As of March 31, 2023 and December 31, 2022 we had an accumulated deficit of $150.6 million and $138.1 million, respectively. These losses have resulted primarily from costs incurred in connection with research and development activities and general and administrative costs associated with our operations. We expect to continue to generate operating losses and negative operating cash flows for the foreseeable future as we:
16
We will not generate any revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for one or more of our drug candidates, if ever. If we obtain regulatory approval for any of our drug candidates, we expect to incur significant expenses related to developing our internal commercialization capability to support product sales, marketing and distribution.
As of March 31, 2023, we had cash and cash equivalents of $137.2 million. We believe that our existing cash and cash equivalents as of March 31, 2023 will enable us to fund our operating expenses and capital expenditure requirements into 2026. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. See “—Liquidity and Capital Resources.”
Components of results of operations
Revenue
To date, we have not generated any revenue from product sales. If our development efforts for our drug candidates and preclinical programs are successful and result in regulatory approval, we may generate revenue in the future from product sales.
Operating expenses
Research and development expenses
Research and development expenses consist primarily of costs incurred in connection with the preclinical and clinical development and manufacture of our drug candidates, and include:
Costs for external development activities are recognized based on an evaluation of the progress to completion of specific tasks using information provided to us by our vendors and our clinical investigative sites. Payments for these activities are based on the terms of the individual agreements, which may differ from the pattern of costs incurred, and are reflected in our consolidated financial statements as prepaid or accrued research and development expenses. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses and expensed as the related goods are delivered or the services are performed.
A significant portion of our research and development costs have been external costs, which we tracked on a program-by-program basis after a clinical drug candidate was been identified. Our internal research and development costs are primarily personnel-related costs, internal lab costs and other indirect costs. The majority of our external research and development expenses to date have been incurred in connection with CYT-0851.
We do not allocate employee costs, costs associated with our discovery efforts, and facilities, including depreciation or other indirect costs, to specific programs because these costs are deployed across multiple programs and, as such, are not separately classified. We use internal resources and third-party consultants primarily to conduct our research and discovery activities as well as for managing our process development, manufacturing and clinical development activities.
17
We cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the development and commercialization of our future drug candidates. Our level of costs may be highly variable on a quarterly basis. However, we generally expect research and development expenses to decrease in the near-term compared to prior periods due to the strategic prioritization of CYT-0851 development and the corresponding deferral of other research and development activities and the reduction in headcount announced in January 2023. We are also unable to predict when, if ever, material net cash inflows will commence from the sale of CYT-0851 or potential future drug candidates, if approved. This is due to the numerous risks and uncertainties associated with developing drug candidates, including the uncertainty of:
Any changes in the outcome of any of these variables with respect to the development of our drug candidates in preclinical and clinical development could mean a significant change in the costs and timing associated with the development of these drug candidates. We may never succeed in achieving regulatory approval for any of our drug candidates. We may obtain unexpected results from our clinical trials. We may elect to discontinue, delay or modify clinical trials of some drug candidates or focus on others. For example, if the FDA or another regulatory authority were to delay our planned start of clinical trials or require us to conduct clinical trials or other testing beyond those that we currently expect or if we experience significant delays in enrollment in any of our planned clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development of that drug candidate.
General and administrative expenses
General and administrative expenses consist primarily of salaries and other related costs, including stock-based compensation, for personnel in our executive, finance, corporate and business development and administrative functions. General and administrative expenses also include professional fees for legal, patent, accounting, auditing, tax and consulting services, and facility-related expenses, which include direct depreciation costs and allocated expenses for rent and maintenance of facilities and other operating costs.
We expect that our general and administrative expenses may increase in the future as we increase our general and administrative headcount to support our continued research activities and development of our drug candidates.
Other income (expense)
Other income (expense) primarily consists of interest income earned on cash equivalents that generate interest on a monthly basis.
18
Results of operations
Comparison of the three months ended March 31, 2023 and 2022
The following table summarizes our results of operations:
|
|
Three Months Ended |
|
|
|
|
||||||
(in thousands) |
|
2023 |
|
|
2022 |
|
|
Change |
|
|||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|||
Research and development |
|
$ |
9,312 |
|
|
$ |
10,088 |
|
|
$ |
(776 |
) |
General and administrative |
|
|
4,110 |
|
|
|
4,043 |
|
|
|
67 |
|
Total operating expenses |
|
|
13,422 |
|
|
|
14,131 |
|
|
|
(709 |
) |
Loss from operations |
|
|
(13,422 |
) |
|
|
(14,131 |
) |
|
|
709 |
|
Other income(expense): |
|
|
|
|
|
|
|
|
|
|||
Interest income |
|
|
1,543 |
|
|
|
29 |
|
|
|
1,514 |
|
Loss on disposal of property and equipment |
|
|
(925 |
) |
|
|
— |
|
|
|
(925 |
) |
Gain on lease terminations and modification |
|
|
318 |
|
|
|
— |
|
|
|
318 |
|
Total other income(expense) |
|
|
936 |
|
|
|
29 |
|
|
|
907 |
|
Net loss |
|
$ |
(12,486 |
) |
|
$ |
(14,102 |
) |
|
$ |
1,616 |
|
Research and development expenses
The following table summarizes our research and development costs for each of the periods presented:
|
|
Three Months Ended |
|
|
|
|
||||||
(in thousands) |
|
2023 |
|
|
2022 |
|
|
Change |
|
|||
Direct research and development expenses by program: |
|
|
|
|
|
|
|
|
|
|||
MCT inhibitor programs |
|
$ |
3,892 |
|
|
$ |
5,510 |
|
|
$ |
(1,618 |
) |
Unallocated research and development expenses: |
|
|
|
|
|
|
|
|
|
|||
Personnel expenses (including stock-based compensation) |
|
|
4,137 |
|
|
|
2,916 |
|
|
|
1,221 |
|
Other expenses |
|
|
1,283 |
|
|
|
1,662 |
|
|
|
(379 |
) |
Total research and development expenses |
|
$ |
9,312 |
|
|
$ |
10,088 |
|
|
$ |
(776 |
) |
Research and development expenses for the three months ended March 31, 2023 were $9.3 million, which decreased by $0.8 million from $10.1 million for the three months ended March 31, 2022. The decrease in research and development expenses was primarily attributable to the following:
General and administrative expenses
General and administrative expenses for the three months ended March 31, 2023 were $4.1 million, which increased by $0.1 million from $4.0 million for the three months ended March 31, 2022. The increase in general and administrative expenses was primarily attributable to the following:
19
Total other income (expense)
Total other income (expense) for the three months ended March 31, 2023 was $0.9 million, which increased by $0.9 million from an immaterial amount for the three months ended March 31, 2022. The increase in other income (expense) was attributable to the following:
20
Liquidity and capital resources
Sources of liquidity
Since our inception, we have not recognized any product 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.
We have funded our operations primarily with proceeds from the sale of redeemable convertible preferred stock and the sale of our common stock in our IPO. From inception through March 31, 2023, we have raised an aggregate of approximately $141.0 million from the sale of redeemable convertible preferred stock and $136.1 million in net proceeds from the sale of our common stock with the completion of the IPO.
Funding requirements
As of March 31, 2023, our cash and cash equivalents on hand were $137.2 million. We believe that our existing cash and cash equivalents as of March 31, 2023 will enable us to fund our operating expenses and capital expenditure requirements into 2026. We have based this estimate on assumptions that may prove to be wrong, and we could expend our capital resources sooner than we expect.
We expect to incur significant expenses and operating losses for the foreseeable future as we advance CYT-0851 through clinical development, seek regulatory approval and pursue commercialization of any approved drug candidates. We expect our operating expenses to decrease in the near-term compared to prior periods due to the strategic prioritization of CYT-0851 development and the corresponding deferral of other research and development activities and the reduction in headcount announced in January 2023. If we receive regulatory approval for CYT-0851 or any of our future drug candidates, we expect to incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution, depending on where we choose to commercialize. We may also require additional capital to pursue in-licenses or acquisitions of other drug candidates.
Because of the numerous risks and uncertainties associated with research, development and commercialization of our drug candidates, we are unable to estimate the exact amount of our working capital requirements. Our future capital requirements will depend on many factors, including:
Until such time, if ever, as we can generate substantial product revenue to support our cost structure, we expect to finance our cash needs through a combination of equity offerings, debt financings, collaborations and other similar arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our shareholders could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common shareholders. Debt financing and 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 capital expenditures or declaring dividends. If we raise funds through collaborations or other similar arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or drug candidates or grant licenses on terms that may not be favorable to us and/or may reduce the value of our common stock. If we are unable to raise additional funds when needed, we may be required to
21
delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market our drug candidates even if we would otherwise prefer to develop and market such drug candidates ourselves.
Cash flows
The following table summarizes our cash flows for each of the periods presented:
|
|
Three Months Ended |
|
|||||
(in thousands) |
|
2023 |
|
|
2022 |
|
||
Net cash used in operating activities |
|
$ |
(10,167 |
) |
|
$ |
(12,168 |
) |
Net cash provided (used) in investing activities |
|
|
150 |
|
|
|
(191 |
) |
Net cash provided by financing activities |
|
|
103 |
|
|
|
19 |
|
Net decrease in cash, cash equivalents and restricted cash |
|
$ |
(9,914 |
) |
|
$ |
(12,340 |
) |
Operating activities
Net cash used in operating activities for the three months ended March 31, 2023 was $10.2 million, compared to $12.2 million for the same period in 2022. Significant factors in the $2.0 million decrease in net cash used in operating activities include:
Investing activities
Net cash provided by investing activities for the three months ended March 31, 2023 and 2022 was $0.2 million due to sale of property and equipment.
Net cash used in investing activities for during the three months ended March 31, 2022. was $0.2 million due to purchases of property and equipment.
Financing activities
Net cash provided by financing activities for the three months ended March 31, 2023 was $0.1 million, consisting of proceeds from issuance of common stock under our ESPP and proceeds from exercise of stock options.
Critical accounting estimates
Our management’s discussion and analysis of financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States. The preparation of our consolidated financial statements and related disclosures requires us to make judgments, estimates and assumptions that affect the reported amounts of assets and liabilities, 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.
There have been no significant changes to our critical accounting policies from those described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” included in our Annual Report on Form 10-K for the year ended December 31, 2022.
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Emerging growth company status
We are an “emerging growth company”, or EGC, under the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. Section 107 of the JOBS Act provides that an EGC 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 EGC can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected to avail ourselves of delayed adoption of new or revised accounting standards and, therefore, we will be subject to the same requirements to adopt new or revised accounting standards as private entities.
As an EGC, we have elected to take advantage of certain exemptions and reduced reporting requirements under the JOBS Act. Subject to certain conditions, as an EGC:
We will remain an EGC until the earliest of (i) the last day of the fiscal year following the fifth anniversary of the completion of our IPO, (ii) the last day of the fiscal year in which we have total annual gross revenues of $1.235 billion or more, (iii) the date on which we have issued more than $1.0 billion in non-convertible debt during the previous rolling three-year period or (iv) the date on which we are deemed to be a large accelerated filer under the Securities Exchange Act of 1934, as amended, or the Exchange Act.
We are also a “smaller reporting company,” meaning that the market value of our stock held by non-affiliates is less than $700 million and our annual revenue was less than $100 million during the most recently completed fiscal year. We may continue to be a smaller reporting company if either (i) the market value of our stock held by non-affiliates is less than $250 million or (ii) our annual revenue was less than $100 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700 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.
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Item 3. Quantitative and Qualitative Disclosures About Market Risk.
Interest rate risk
Our primary exposure to market risk is interest rate sensitivity, which is impacted by changes to the general level of U.S. interest rates, particularly because our cash equivalents are in the form of money market funds that are invested in U.S. Treasury securities. As of March 31, 2023 and December 31, 2022, we had cash, cash equivalents and restricted cash of $137.5 million and $149.4 million, respectively. Interest income is sensitive to changes in the general level of interest rates; however, due to the nature of these investments, an immediate 10% change in interest rates would not have a material effect on the fair market value of our investment portfolio.
As of March 31, 2023 and December 31, 2022, we had no debt outstanding, and therefore we are not subject to interest rate risk related to debt.
Foreign currency exchange risk
We are not currently exposed to significant market risk related to changes in foreign currency exchange rates.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our President and Chief Executive Officer and our Chief Financial Officer (our principal executive officer and principal financial officer, respectively), evaluated the effectiveness of our disclosure controls and procedures as of March 31, 2023. The term "disclosure controls and procedures," as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the "Exchange Act"), means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC's rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclose by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company's management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of March 31, 2023, our principal executive officer and principal financial officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
Changes in Internal Control over Financial Reporting
No change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) occurred during the fiscal three months ended March 31, 2023 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
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PART II—OTHER INFORMATION
Item 1. Legal Proceedings.
From time to time, we may become involved in litigation or other legal proceedings. We are not currently a party to any litigation or legal proceedings that, in the opinion of our management, are probable to have a material adverse effect on our business. Regardless of outcome, litigation can have an adverse impact on our business, financial condition, results of operations and prospects because of defense and settlement costs, diversion of management resources and other factors.
Item 1A. Risk Factors.
Investing in our common stock involves a high degree of risk. You should carefully consider the risks and uncertainties described in the section titled "Risk Factors" in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022 together with all of the other information contained in this Quarterly Report on Form 10-Q, including our consolidated financial statements and related notes appearing in this Quarterly Report on Form 10-Q, before deciding to invest in our common stock.
There have been no material changes to our risk factors as previously disclosed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
Use of Proceeds
On June 22, 2021, we completed our IPO pursuant to which we issued and sold 7,400,000 shares of our common stock at a public offering price of $18.00 per share. On July 1, 2021, we sold an additional 885,644 shares of our common stock at a public offering price of $18.00 per share. The offer and sale of all of our common shares were registered under the Securities Act pursuant to a registration statement on Form S-1, as amended (File No. 333-256601), which was declared effective by the SEC on June 17, 2021.
Our planned use of the net proceeds from the IPO as described in our final prospectus dated June 17, 2021 has changed due to the prioritization of development of our CYT-0851 program and suspension of internal research. As a result, we currently expect to use our cash and cash equivalents, which include the net proceeds from our IPO, to advance the clinical development of CYT-0851 through the enrollment period of a randomized phase 2 trial with registrational intent as a combination therapy in combination with capecitabine or gemcitabine, and for working capital and other general corporate purposes.
Based on our planned use our existing cash and cash equivalents, we estimate that such funds will be sufficient to fund our operating expenses and capital expenditure requirements into 2026. We expect that the completion of the randomized phase 2 combination trial with CYT-0851 or any further development or commercialization of CYT-0851 will require substantial additional capital. The sources of this additional required capital may include subsequent equity or debt financings, and/or funding from potential partnerships with biopharmaceutical companies to develop and commercialize one or more of our drug candidate programs. We have based these estimates on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we expect.
Our expected use of our cash and cash equivalents represents our current intentions based upon our present plans and business condition and we cannot predict with complete certainty all of the particular uses for our proceeds. We may find it necessary or advisable to use our cash and cash equivalents for other purposes, and we have broad discretion in the application of these proceeds.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not applicable.
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Item 5. Other Information.
None.
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Item 6. Exhibits.
Exhibit Number |
|
Description |
3.1 |
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|
3.2 |
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|
10.1+ |
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|
10.2*+ |
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Employment Agreement between Cyteir Therapeutics, Inc. and Adam Veness, dated April 15, 2022 |
10.3 |
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|
31.1* |
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|
31.2* |
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|
32.1** |
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32.2** |
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|
101.INS |
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Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document. |
101.SCH |
|
Inline XBRL Taxonomy Extension Schema Document |
101.CAL |
|
Inline XBRL Taxonomy Extension Calculation Linkbase Document |
101.DEF |
|
Inline XBRL Taxonomy Extension Definition Linkbase Document |
101.LAB |
|
Inline XBRL Taxonomy Extension Label Linkbase Document |
101.PRE |
|
Inline XBRL Taxonomy Extension Presentation Linkbase Document |
104 |
|
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
|
|
|
* Filed herewith.
** Furnished herewith.
+ Indicates management contract or compensatory plan or arrangement.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on
its behalf by the undersigned thereunto duly authorized.
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Cyteir Therapeutics, Inc. |
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|
|
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Date: May 10, 2023 |
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By: |
/s/ Markus Renschler |
|
|
|
Markus Renschler, M.D. |
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|
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President and Chief Executive Officer (Principal Executive Officer) |
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|
|
|
Date: May 10, 2023 |
|
By: |
/s/ David Gaiero |
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|
David Gaiero |
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|
|
Chief Financial Officer and Treasurer (Principal Financial Officer) |
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