# EDGAR Filing Document

**Accession Number:** 0001662244
**File Stem:** 0000950170-23-001771
**Filing Date:** 2023-2
**Character Count:** 20910
**Document Hash:** 40773554f2ba551df710933e60ba98f3
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0000950170-23-001771.hdr.sgml**: 20230203

**ACCESSION NUMBER**: 0000950170-23-001771

**CONFORMED SUBMISSION TYPE**: 8-K/A

**PUBLIC DOCUMENT COUNT**: 13

**CONFORMED PERIOD OF REPORT**: 20230112

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Cost Associated with Exit or Disposal Activities

**ITEM INFORMATION**: Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230203

**DATE AS OF CHANGE**: 20230203

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Cyteir Therapeutics, Inc.
- **CENTRAL INDEX KEY:** 0001662244
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **IRS NUMBER:** 455429901
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K/A
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-40499
- **FILM NUMBER:** 23585798

**BUSINESS ADDRESS:**
- **STREET 1:** 128 SPRING STREET
- **STREET 2:** BUILDING A, SUITE 510
- **CITY:** LEXINGTON
- **STATE:** MA
- **ZIP:** 02421
- **BUSINESS PHONE:** 857-285-4140

**MAIL ADDRESS:**
- **STREET 1:** 128 SPRING STREET
- **STREET 2:** BUILDING A, SUITE 510
- **CITY:** LEXINGTON
- **STATE:** MA
- **ZIP:** 02421

?xml version="1.0" encoding="ASCII"? 8-K/A

**UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549**

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**FORM** 8-K/A

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**CURRENT REPORT**

**Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934**

**Date of Report (Date of earliest event reported):** January 12, 2023<br>

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Cyteir Therapeutics, Inc.

**(Exact name of Registrant as Specified in Its Charter)**

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| | | |
|:---|:---|:---|
| Delaware | 001-40499 | 45-5429901 |
| **(State or Other Jurisdiction<br>of Incorporation)** | **(Commission File Number)** | **(IRS Employer<br>Identification No.)** |
| 128 Spring St, Building A**,** Suite 510 |  |  |
| Lexington**,** Massachusetts |  | 02421 |
| **(Address of Principal Executive Offices)** |  | **(Zip Code)** |

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**Registrant's Telephone Number, Including Area Code:** 857 285-4140<br>

**Not Applicable**<br>

**(Former Name or Former Address, if Changed Since Last Report)**

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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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

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| | | |
|:---|:---|:---|
| **<br>Title of each class** | **Trading<br>Symbol(s)** | **<br>Name of each exchange on which registered** |
| Common Stock, $0.001 par value per share | CYT | The Nasdaq Global Select Market |

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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

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. ☐

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**EXPLANATORY NOTE**

This Amendment No. 1 on Form 8-K/A ("Amendment No. 1") amends the Current Report on Form 8-K of Cyteir Therapeutics, Inc. (the "Company") filed with the Securities and Exchange Commission on January 19, 2023. The purpose of this Amendment No. 1 is to add Item 2.02, which had been inadvertently omitted from the original filing.

**Item 2.02 Results of Operations and Financial Condition.**

On January 19, 2023, the Company issued a press release, which included a preliminary unaudited statement of the Company's cash and cash equivalents as of December 31, 2022. A copy of this press release is attached to this Current Report on Form 8-K as Exhibit 99.1.

The information contained in Item 2.02 of this Current Report on Form 8-K and Exhibit 99.1 hereto is being furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act") or for any other purpose, and shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in any such filing, except as expressly set forth by specific reference in such a filing.

**Item 2.05 Costs Associated with Exit or Disposal Activities.**

On January 12, 2023, the Board of Directors of the Company approved a workforce reduction by approximately 70% of the Company's workforce, to better align with current research and development priorities and scope of business. The Company expects to substantially complete the reduction in its workforce in the first quarter of 2023. Following the changes, the Company expects to have 15 or fewer full-time employees.

The Company estimates that, in connection with these changes, it will incur aggregate charges of approximately $2.5 million to $3 million, all of which are anticipated to result in future cash expenditures, primarily for one-time employee severance and benefit costs, the majority of which are expected to be incurred in the first quarter of 2023.

This Current Report on Form 8-K includes forward-looking statements including, the size and timing of the Company's workforce reduction, the number of the Company's employees following the workforce reduction, and the amount and timing of the charges and cash expenditures resulting from the workforce reduction. 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, although not all forward-looking statements contain these identifying words. Actual results could differ materially from those included in the forward-looking statements due to various factors, risks and uncertainties. Applicable risks and uncertainties include, among others, that the workforce reduction may be larger than currently anticipated, the Company may incur additional costs not currently contemplated, and other risks and uncertainties are identified under the heading "Risk Factors" in the Company's most recent Annual Report on Form 10-K and in any subsequent filings with the Securities and Exchange Commission. The forward-looking statements contained in this press release are based on management's current views, plans, estimates, assumptions, and projections with respect to future events, and Cyteir does not undertake and specifically disclaims any obligation to update any forward-looking statements.

**Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.**

(b) Due to the Company's change in research and development priorities and scope of business, the roles of Chief Business Officer and Chief Scientific Officer have been eliminated as part of the workforce reduction. Andrew Gengos, the Company's Chief Business Officer will separate from the Company effective February 3, 2023 and Paul Secrist, Ph.D., the Company's Chief Scientific Officer will separate from the Company effective April 1, 2023. In connection with their terminations of employment, each executive officer will receive the severance benefits provided in the case of a termination of employment by the Company without cause in accordance with the terms of their employment agreements. In addition, on January 17, 2023, the Compensation Committee of the Company's Board of Directors (the "Compensation Committee") approved the accelerated vesting as of the date of such termination of employment of that portion of the stock options held by each of Mr. Gengos and Dr. Secrist that would have vested by its terms on February 24, 2023, in the case of Mr. Gengos, and on June 15, 2023, in the case of Dr. Secrist.

(e) On January 17, 2023, the Compensation Committee also approved a retention program under which the Company's Chief Executive Officer, Dr. Markus Renschler, will be entitled to a retention bonus in amount equal to 150%

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of his target annual bonus amount if he remains employed with the Company until at least December 31, 2023, with earlier payment of a pro rata amount on an involuntary termination of employment by the Company without cause. On this same date, the Compensation Committee approved a retention program under which Dr. Secrist will be entitled to a bonus equal to two months' base salary, which will be paid on April 1, 2023, subject to his continued employment through such date. The foregoing description of Dr. Renschler and Dr. Secrist's retention agreements does not purport to be complete and is qualified in its entirety by reference to the full text of the agreements, which will be filed as exhibits to a subsequent periodic report filed with the Securities and Exchange Commission.

**Item 7.01 Regulation FD Disclosure.**

On January 19, 2023, the Company issued a press release related to the workforce reduction and strategic plans. A copy of this press release is attached to this Current Report on Form 8-K as Exhibit 99.1.

The information contained in Item 7.01 of this Current Report on Form 8-K and Exhibit 99.1 hereto is being furnished and shall not be deemed "filed" for purposes of Section 18 of the Exchange Act or for any other purpose, and shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in any such filing, except as expressly set forth by specific reference in such a filing.

**Item 9.01 Financial Statements and Exhibits.**

**(d) Exhibits**

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| | |
|:---|:---|
| **Exhibit**<br>**No.** | **Description** |
| 99.1 | [<u>Press Release of Cyteir Therapeutics, Inc. dated January 19, 2023</u>](cyt-ex99_1.htm) |
| 104 | Cover Page Interactive Data File (embedded within the inline XBRL document) |

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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.** |
| Date: | February 3, 2023 | By:  | /s/ Adam M. Veness, Esq. |
|  |  |  | Name: Adam M. Veness, Esq.<br>Title: General Counsel and Secretary |

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## Exhibit 99.1

**Exhibit 99.1**

**Cyteir Therapeutics Announces Prioritization of CYT-0851 Development and Extended Cash Runway**

-Encouraging early clinical results observed in treating ovarian cancer with CYT-0851 combination therapy

-Strategic prioritization of clinical development of CYT-0851 combination therapy for ovarian cancer, together with deferral of other development activities, is expected to extend cash runway into 2026

LEXINGTON, MA — January 19, 2023 — Cyteir Therapeutics, Inc. ("Cyteir") (Nasdaq: CYT) today announced the strategic prioritization of clinical development of CYT-0851, an investigational monocarboxylate transporter inhibitor, as a potential combination therapy for the treatment of ovarian cancer. The prioritization follows 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. Cyteir plans to expand its evaluation of CYT-0851 in combination with capecitabine to treat advanced ovarian cancer and enroll additional patients in the first half of 2023 to further support these early signals. If successful, the combination of CYT-0851 with capecitabine has the potential to be an all-oral treatment for ovarian cancer. In conjunction with focusing clinical activities on ovarian cancer, Cyteir is reducing headcount by approximately 70% and deferring research and development in other areas, which is expected to extend Cyteir's cash runway into 2026.

**CYT-0851 Development to Prioritize Combination Therapy**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Phase 1 dose escalation cohorts with CYT-0851 in combination with capecitabine for the treatment of advanced ovarian cancer have shown encouraging preliminary clinical activity. To date, thirteen patients have been treated with CYT-0851 (from 100-400mg daily) and capecitabine, including five patients with advanced ovarian cancer. Responses and disease stabilization observed in these ovarian cancer patients in the 300mg and 400mg CYT-0851 dose levels are encouraging, and have led to Cyteir's decision to focus on further development of this capecitabine combination in advanced ovarian cancer. Overall, CYT-0851 continues to be generally well tolerated with no new safety concerns.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•In the first quarter of 2023, Cyteir expects to determine a maximum tolerated dose ("MTD") for CYT-0851 in combination with capecitabine and focus its efforts on enrolling and treating additional patients with advanced ovarian cancer at the MTD. If the data from these additional patients further support Cyteir's focus on ovarian cancer, Cyteir intends to pursue development and potential registration of CYT-0851 in combination with capecitabine as an all-oral treatment for platinum resistant ovarian cancer.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•In addition, Cyteir is evaluating CYT-0851 in Phase 1 dose escalation cohorts in combination with gemcitabine. To date, ten patients have been treated with CYT-0851 (from 100-200mg daily) and gemcitabine. Cyteir will continue the ongoing dose escalation cohorts with CYT-0851 and gemcitabine in solid tumor patients to identify an MTD, which could provide an additional opportunity to develop CYT-0851 as a combination therapy to treat patients with platinum resistant ovarian cancer.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Enrollment in the Phase 2 monotherapy cohorts with CYT-0851 will be suspended due to insufficient monotherapy activity observed to date. Cyteir plans to disclose the Phase 1 combination data for CYT-0851 in mid-2023.

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"We are encouraged by these early signals and believe that an initial focus on the combination of CYT-0851 and capecitabine represents the greatest likelihood of success and an opportunity to serve patients with advanced ovarian cancer that have a high unmet medical need. This combination, if successful, has the potential to be an all-oral treatment regimen for patients with platinum resistant ovarian cancer," said Markus Renschler, MD, Cyteir's President and CEO. "This strategic prioritization and the difficult decision to reduce our workforce is expected to extend our cash runway into 2026 and, if supported by the data and regulatory feedback, allows us to advance CYT-0851 into a potentially registrational trial as early as the second half of 2024. I personally would like to thank all of our dedicated employees and express my gratitude for their hard work in advancing our pipeline, and I wish them the best in the future."

In the United States, it is estimated that a total of approximately 13,000 patients are available for drug treatment per year who are platinum resistant and have progressed after two lines of prior therapy, or have progressed after at least three prior lines of therapy.

**Deferral of R&D Activities Beyond Clinical Development of CYT-0851 to Extend Cash Runway**

In conjunction with focusing development activities on CYT-0851, Cyteir announced that it will be suspending all preclinical research. Specific actions include:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Ceasing drug discovery projects focused on identifying inhibitors of DNA damage repair; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Reducing company headcount to approximately 15 full-time employees.

Based on current estimates, including assumptions for continuation of clinical development of CYT-0851 towards registration as a combination therapy, Cyteir expects that these actions will extend its cash runway into 2026. As of December 31, 2022, on an unaudited basis, Cyteir had approximately $147 million in cash and cash equivalents. Cyteir estimates that it will incur aggregate charges of approximately $2.5 million to $3 million, all of which are anticipated to result in future cash expenditures, primarily for one-time employee severance and benefit costs, the majority of which are expected to be incurred in the first quarter of 2023.

**About Cyteir Therapeutics, Inc.**

Cyteir is a clinical-stage oncology company that is focused on the development of CYT-0851, an oral investigational drug that inhibits monocarboxylate transporters. Cyteir's current priority in CYT-0851 development is in combination with capecitabine and gemcitabine in a Phase 1/2 clinical study, including patients with advanced ovarian cancer. Follow Cyteir on social media: LinkedIn and Twitter and at <u>www.cyteir.com</u>.

**About Capecitabine and Gemcitabine**

Capecitabine is a nucleoside metabolic inhibitor that is approved in the U.S. for the treatment of patients with adjuvant colon cancer, metastatic colorectal cancer, and metastatic breast cancer. It is an orally administered systemic prodrug of 5'-deoxy-5-fluorouridine (5'-DFUR) which is converted to 5-fluorouracil. Gemcitabine is approved in the U.S. in combination with carboplatin for the treatment of ovarian cancer, in combination with paclitaxel for the treatment of breast cancer, in combination with cisplatin for treatment of non-small cell lunch cancer, and as a single agent for the treatment of pancreatic cancer. Gemcitabine kills cells undergoing DNA synthesis and blocks the progression of cells through the G1/S-phase boundary.

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**Forward-Looking Statements**

This press release contains 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, although not all forward-looking statements contain these identifying words. These forward-looking statements include: the benefits and potential impact of our portfolio prioritization; expected timing to receive clinical data from current ongoing clinical studies and to determine an MTD; expected cost savings from these changes; and our expected extended cash runway.

Actual results could differ materially from those included in the forward-looking statements due to various factors, risks and uncertainties, including, but not limited to: that the reduction in headcount may be larger than currently anticipated; that Cyteir may incur additional costs not currently anticipated; that the rate of enrollment in Cyteir's current clinical studies may not proceed as anticipated; that Cyteir's clinical trials may fail to demonstrate adequately the safety and efficacy of any of its drug candidates; that early clinical results in a small number of patients may not be predictive of future results; that preclinical testing of Cyteir's compounds may not be predictive of the results or success of clinical trials; that the preclinical and clinical development of Cyteir's compounds may be delayed or otherwise take longer and/or cost more than planned; and other risks and uncertainties are identified under the heading "Risk Factors" in Cyteir's most recent Annual Report on Form 10-K and other filings Cyteir has made and may make with the Securities and Exchange Commission ("SEC") in the future, available on the SEC's website at www.sec.gov.

The forward-looking statements contained in this press release are based on management's current views, plans, estimates, assumptions, and projections with respect to future events, and Cyteir does not undertake and specifically disclaims any obligation to update any forward-looking statements, except as may be required by applicable law.

**CONTACT:**

Lisa Hayes<br>Vice President, Investor Relations and Corporate Communications<br>908-868-8926<br>Lisa.Hayes@cyteir.com

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