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Form 10-Q Cyteir Therapeutics, For: Jun 30

August 8, 2022 4:18 PM EDT

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM 10-Q

 

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2022

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: 001-40499

 

Cyteir Therapeutics, Inc.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

45-5429901

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer
Identification No.)

128 Spring St, Building A, Suite 510

Lexington, MA

02421

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: 857-285-4140

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange on which registered

Common Stock, par value $0.001 per share

 

CYT

 

Nasdaq Global Select Market

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. Yes No

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). Yes No

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

 

 

Accelerated filer

 

 

 

 

 

Non-accelerated filer

 

 

Smaller reporting company

 

 

 

 

 

 

 

 

 

 

 

 

Emerging growth company

 

 

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 August 3, 2022, the registrant had 35,413,426 shares of common stock, $0.001 par value per share, outstanding.

 

 

 


 

Table of Contents

 

 

 

Page

PART I.

FINANCIAL INFORMATION

3

Item 1.

Financial Statements (Unaudited)

3

 

Condensed Consolidated Balance Sheets

3

 

Condensed Consolidated Statements of Operations

4

 

Condensed Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit)

5

 

Condensed Consolidated Statements of Cash Flows

6

 

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.

Quantitative and Qualitative Disclosures About Market Risk

25

Item 4.

Controls and Procedures

25

PART II.

OTHER INFORMATION

26

Item 1.

Legal Proceedings

26

Item 1A.

Risk Factors

26

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

26

Item 3.

Defaults Upon Senior Securities

26

Item 4.

Mine Safety Disclosures

26

Item 5.

Other Information

26

Item 6.

Exhibits

27

Signatures

28

 

 

 

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 "anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “likely,” “may,” “might,” “plan,” “potential,” “project,” “seek,” “will,” “would," and similar expressions are intended to identify forward-looking statements. For example, all statements we make relating to our clinical trial plans and milestones, including data from our phase 1/2 clinical trial of CYT-0851 in the fourth quarter of 2022 and the first half of 2023, safety data and early efficacy data from combination studies of CYT-0851 in the first half of 2023, our expectation of reaching the drug candidate nomination phase for our drug discovery projects in 2023 and our plans to nominate additional targets from our synthetic lethality platform, are forward looking statements.

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, 2021, filed with the U.S. Securities and Exchange Commission on March 16, 2022, 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:

• 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 any drug candidates we develop.

• We may not be able to file Investigational New Drug, or IND, applications or IND amendments to commence additional clinical trials on the timelines we expect, and even if we are able to, the FDA or a comparable foreign regulatory may not permit us to proceed.

• 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 intend to develop CYT-0851, and potentially future drug candidates, for use in combination with other therapies, which exposes us to additional risks.

• 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.

 

1


 

• 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.

• The continuing outbreak of COVID-19 in the United States and other countries may adversely affect our business and the market price of our common stock.

• 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)
(unaudited)

 

June 30,
2022

 

 

December 31,
2021

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

166,396

 

 

$

189,723

 

Prepaid expenses and other current assets

 

 

3,309

 

 

 

3,354

 

Total current assets

 

$

169,705

 

 

$

193,077

 

Property and equipment, net

 

 

2,029

 

 

 

2,055

 

Other assets

 

 

2,631

 

 

 

256

 

Total assets

 

$

174,365

 

 

$

195,388

 

Liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit)

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

3,613

 

 

$

1,785

 

Accrued expenses and other current liabilities

 

 

4,893

 

 

 

5,726

 

Total current liabilities

 

$

8,506

 

 

$

7,511

 

Deferred rent, net of current portion

 

 

 

 

 

384

 

Other long term liabilities

 

 

2,075

 

 

 

201

 

Total liabilities

 

$

10,581

 

 

$

8,096

 

Commitments and contingencies (Note 10)

 

 

 

 

 

 

Stockholders’ equity (deficit):

 

 

 

 

 

 

Preferred stock, $0.001 par value: 40,000,000 shares authorized
   as of June 30, 2022 and December 31, 2021;
no shares issued and
   outstanding as of June 30, 2022 and December 31, 2021

 

 

 

 

 

 

Common stock, $0.001 par value: 280,000,000 shares
   authorized as of June 30, 2022 and December 31, 2021;
   
35,413,426 and 35,389,453 shares issued as of June 30, 2022
   and December 31, 2021, respectively;
35,303,144 and
   
35,219,834 shares outstanding as of June 30, 2022 and
   December 31, 2021, respectively

 

 

35

 

 

 

35

 

Additional paid-in capital

 

 

282,025

 

 

 

279,310

 

Accumulated deficit

 

 

(118,276

)

 

 

(92,053

)

Total stockholders’ equity (deficit)

 

 

163,784

 

 

 

187,292

 

Total liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit)

 

$

174,365

 

 

$

195,388

 

 

See accompanying notes to condensed consolidated financial statements.

 

3


 

CYTEIR THERAPEUTICS, INC.

Condensed consolidated statements of operations

 

 

 

Three Months Ended
June 30,

 

 

Six Months Ended
June 30,

 

(in thousands, except share and per share amounts)
(unaudited)

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

8,794

 

 

$

8,886

 

 

$

18,882

 

 

$

14,499

 

General and administrative

 

 

3,433

 

 

 

2,422

 

 

 

7,476

 

 

 

4,146

 

Total operating expenses

 

 

12,227

 

 

 

11,308

 

 

 

26,358

 

 

 

18,645

 

Loss from operations

 

 

(12,227

)

 

 

(11,308

)

 

 

(26,358

)

 

 

(18,645

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

Other income (expense)

 

 

106

 

 

 

13

 

 

 

135

 

 

 

38

 

Total other income (expense)

 

 

106

 

 

 

13

 

 

 

135

 

 

 

38

 

Net loss

 

$

(12,121

)

 

$

(11,295

)

 

$

(26,223

)

 

$

(18,607

)

Net loss per share—basic and diluted

 

$

(0.34

)

 

$

(4.83

)

 

$

(0.74

)

 

$

(8.29

)

Weighted-average common stock outstanding—basic and diluted

 

 

35,279,376

 

 

 

2,337,947

 

 

 

35,260,378

 

 

 

2,245,243

 

 

See accompanying notes to condensed consolidated financial statements.

4


 

 

CYTEIR THERAPEUTICS, INC.

Condensed consolidated statements of redeemable convertible preferred stock and stockholders’ equity (deficit)

 

 

 

 

Redeemable convertible preferred stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Series A

 

 

Series B

 

 

Series C

 

 

 

Common stock

 

 

 

 

 

 

 

 

 

 

(in thousands, except share and per share amounts)
(unaudited)

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

Additional
paid-in
capital

 

 

Accumulated
deficit

 

 

Total
stockholders’
equity (deficit)

 

Balance At December 31, 2020

 

 

5,817,996

 

 

$

5,696

 

 

 

55,200,000

 

 

$

51,715

 

 

 

 

 

$

 

 

 

 

2,044,284

 

 

$

2

 

 

$

1,894

 

 

$

(49,927

)

 

$

(48,031

)

Exercise of common stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

49,235

 

 

 

 

 

 

154

 

 

 

 

 

 

154

 

Issuance of Series C redeemable convertible preferred
   stock, net of issuance costs of $
345

 

 

 

 

 

 

 

 

 

 

 

 

 

 

21,784,885

 

 

 

79,655

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Vesting of early exercised options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

172,640

 

 

 

 

 

 

196

 

 

 

 

 

 

196

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

488

 

 

 

 

 

 

488

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(7,312

)

 

 

(7,312

)

Balance At March 31, 2021

 

 

5,817,996

 

 

$

5,696

 

 

 

55,200,000

 

 

$

51,715

 

 

 

21,784,885

 

 

$

79,655

 

 

 

 

2,266,159

 

 

$

2

 

 

$

2,732

 

 

$

(57,239

)

 

$

(54,505

)

Exercise of common stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

15,987

 

 

 

 

 

 

40

 

 

 

 

 

 

40

 

Vesting of early exercised options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

131,861

 

 

 

 

 

 

150

 

 

 

 

 

 

150

 

Initial public offering, net of underwriting discounts, commissions and offering costs

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

7,400,000

 

 

 

7

 

 

 

121,620

 

 

 

 

 

 

121,627

 

Conversion of convertible preferred stock into common stock upon initial public offering

 

 

(5,817,996

)

 

 

(5,696

)

 

 

(55,200,000

)

 

 

(51,715

)

 

 

(21,784,885

)

 

 

(79,655

)

 

 

 

24,290,875

 

 

 

25

 

 

 

137,041

 

 

 

 

 

 

137,066

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

772

 

 

 

 

 

 

772

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(11,295

)

 

 

(11,295

)

Balance At June 30, 2021

 

 

 

 

$

 

 

 

 

 

$

 

 

 

 

 

$

 

 

 

 

34,104,882

 

 

$

34

 

 

$

262,355

 

 

$

(68,534

)

 

$

193,855

 

 

 

 

Redeemable convertible preferred stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Series A

 

 

Series B

 

 

Series C

 

 

 

Common stock

 

 

 

 

 

 

 

 

 

 

(in thousands, except share and per share amounts)
(unaudited)

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

Additional
paid-in
capital

 

 

Accumulated
deficit

 

 

Total
stockholders’
equity (deficit)

 

Balance At December 31, 2021

 

 

 

 

$

 

 

 

 

 

$

 

 

 

 

 

$

 

 

 

 

35,219,834

 

 

$

35

 

 

$

279,310

 

 

$

(92,053

)

 

$

187,292

 

Exercise of common stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

19,575

 

 

 

 

 

 

19

 

 

 

 

 

 

19

 

Vesting of early exercised options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

32,605

 

 

 

 

 

 

39

 

 

 

 

 

 

39

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,255

 

 

 

 

 

 

1,255

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(14,102

)

 

 

(14,102

)

Balance At March 31, 2022

 

 

 

 

$

 

 

 

 

 

$

 

 

 

 

 

$

 

 

 

 

35,272,014

 

 

$

35

 

 

$

280,623

 

 

$

(106,155

)

 

$

174,503

 

Exercise of common stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4,398

 

 

 

 

 

 

5

 

 

 

 

 

 

5

 

Vesting of early exercised options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

26,732

 

 

 

 

 

 

32

 

 

 

 

 

 

32

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,365

 

 

 

 

 

 

1,365

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(12,121

)

 

 

(12,121

)

Balance At June 30, 2022

 

 

 

 

$

 

 

 

 

 

$

 

 

 

 

 

$

 

 

 

 

35,303,144

 

 

$

35

 

 

$

282,025

 

 

$

(118,276

)

 

$

163,784

 

 

See accompanying notes to condensed consolidated financial statements.

5


 

 

CYTEIR THERAPEUTICS, INC.

Condensed consolidated statements of cash flows

 

 

 

Six Months Ended
June 30,

 

(in thousands)
(unaudited)

 

2022

 

 

2021

 

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$

(26,223

)

 

$

(18,607

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

Depreciation and amortization expense

 

 

328

 

 

 

214

 

Stock-based compensation

 

 

2,620

 

 

 

1,260

 

Non-cash lease expense

 

 

398

 

 

 

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Prepaid expenses and other current assets

 

 

(30

)

 

 

(475

)

Other assets

 

 

 

 

 

61

 

Accounts payable

 

 

1,828

 

 

 

1,696

 

Accrued expenses and other current liabilities

 

 

(1,969

)

 

 

2,484

 

Deferred rent

 

 

 

 

 

(118

)

Net cash used in operating activities

 

$

(23,048

)

 

$

(13,485

)

Cash flows from investing activities: