false 0001789972 0001789972 2021-11-09 2021-11-09





Washington, D.C. 20549







Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 9, 2021




(Exact name of registrant as specified in its charter)




Delaware   001-39856   81-3879991
(State or other jurisdiction
of incorporation)


File Number)

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


Cullinan Oncology, Inc.
One Main Street, Suite 520
Cambridge, MA 02142
(Address of principal executive offices, including zip code)

(617) 410-4650

(Registrant’s telephone number, including area code)

Not Applicable

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



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 (see General Instruction A.2):


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:


Title of each class





Name of each exchange

on which registered

Common Stock, $0.0001 par value per share   CGEM   The Nasdaq Global Select Market

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.




Item 2.02

Results of Operations and Financial Condition

On November 9, 2021, Cullinan Oncology, Inc. announced its financial results for the quarter ended September 30, 2021. A copy of the press release is being furnished as Exhibit 99.1 to this Report on Form 8-K.

The information in this Item 2.02 and Exhibit 99.1 attached hereto is intended to be 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 otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.


Item 9.01.

Financial Statements and Exhibits

(d) Exhibits


Exhibit No.   


99.1    Press release issued by Cullinan Oncology, Inc. on November 9, 2021, furnished herewith.
104    Cover page from this Current Report on Form 8-K, formatted in Inline XBRL


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 hereunto duly authorized.


Dated: November 9, 2021     By:  

/s/ Jeffrey Trigilio

      Jeffrey Trigilio
      Chief Financial Officer

Exhibit 99.1



Cullinan Oncology Provides Corporate Update and

Reports Third Quarter 2021 Financial Results

Cullinan Pearl clinical update, including data from patients enrolled in the Phase 2a expansion 100 mg BID cohort, planned for fourth quarter 2021

Cullinan MICA and Cullinan Florentine programs to advance into clinical trials by year end 2021

Strong balance sheet with cash and investments of $445.4 million

Cambridge, MA, November 9, 2021 – Cullinan Oncology, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on developing a diversified pipeline of targeted therapies, today reported on recent and upcoming business highlights and announced its financial results for the third quarter ended September 30, 2021.

“Our organization has made great progress advancing our pipeline of novel, targeted oncology programs across multiple modalities, positioning us to deliver on our 2021 milestones,” stated Nadim Ahmed, Chief Executive Officer of Cullinan Oncology. “We are encouraged by the clinical profile emerging from our lead program, Pearl (CLN-081), in heavily pretreated advanced NSCLC patients that harbor EGFR exon 20 insertion mutations and are looking forward to providing a clinical update from our ongoing Phase 1/2a trial later this quarter. We are also excited to advance Cullinan MICA and Cullinan Florentine into clinical trials this quarter. With our evolution into a late stage oncology company, we are utilizing our significant financial resources of over $445 million of cash and investments on hand to advance multiple programs into the clinic across a wide range of cancer indications.”

Portfolio Highlights



Cullinan Pearl: Continued advancing the Phase 1/2a trial evaluating CLN-081 in non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) exon 20 mutations who progressed on platinum-based chemotherapy. Cullinan intends to provide a clinical update on Pearl in the fourth quarter of 2021. The update will include 67 patients enrolled across all five dose cohorts, including 36 response-evaluable patients at the 100 mg BID dose cohort.



Cullinan MICA: CLN-619 is a monoclonal antibody designed to promote an antitumor response by engaging both natural killer (NK) and T cells through the MICA/B–NKG2D axis, with broad therapeutic potential across multiple cancer indications. Cullinan remains on track to open for enrollment a first-in-human clinical trial evaluating CLN-619 in patients with advanced solid tumors in the fourth quarter of 2021. The trial will include a dose escalation cohort followed by dose expansion cohorts as a monotherapy and in combination with checkpoint inhibitor therapy. Cullinan expects CLN-619 to be the first therapeutic candidate targeting MICA/B to enter clinical trials.


Cullinan Florentine: CLN-049 is a bispecific antibody designed to simultaneously bind to FLT3 on target leukemic cells and to CD3 on T cells, triggering T cells to kill the targeted cancer cells. Cullinan remains on track to open for enrollment a first-in-human clinical trial evaluating CLN-049 in patients with relapsed/refractory acute myeloid leukemia in the fourth quarter of 2021.



Cullinan Amber: CLN-617 is a collagen binding fusion protein that contains both IL-12 and IL-2 in a single molecule. CLN-617 has now advanced to the IND-enabling phase. Cullinan will present preclinical data at the upcoming Society for Immunotherapy of Cancer annual meeting.



Cullinan NexGem: CLN-978 is a half-life extended T cell engaging antibody construct designed to simultaneously engage CD19 and CD3. Cullinan continues to advance CLN-978 through IND-enabling development.

Third Quarter 2021 Financial Results



Cash Position: Cash, cash equivalents and investments were $445.4 million as of September 30, 2021.



R&D Expenses: Research and development (R&D) expenses were $12.7 million for the third quarter of 2021, compared to $11.8 million for the second quarter of 2021. The increase in R&D expenses is primarily related to expanded clinical and CMC activity associated with portfolio advancement.



G&A Expenses: General and administrative (G&A) expenses were $5.7 million for the third quarter of 2021, compared to $4.8 million for the second quarter of 2021. The change in G&A expenses is primarily related to increased professional services fees and equity-based compensation expenses.



Net Loss: The Company’s net loss (before items attributable to noncontrolling interest) was $18.3 million for the third quarter of 2021, compared to $16.4 million for the second quarter of 2021.

About Cullinan Oncology

Cullinan Oncology is a biopharmaceutical company with a diversified pipeline of targeted therapeutic candidates across multiple modalities. The Company’s strategy is to focus on advanced stage assets with novel technology platforms and differentiated mechanisms, developed through both internal discovery and external collaboration. Learn more about Cullinan at www.cullinanoncology.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding Cullinan’s beliefs and expectations regarding our preclinical and clinical development plans, clinical trial designs, clinical and therapeutic potential, and strategy of our product candidates, including but not limited to: the timing and success of our planned preclinical and clinical development of our programs, including for CLN-081, CLN-619, and CLN-049, and the timing and success of our planned regulatory submissions; our expectations and beliefs around the safety and activity of CLN-081 in our Phase 1/2a trial in patients with NSCLC harboring EGFRex20ins mutations that have had at

least one prior treatment; our ability to evaluate strategic opportunities to accelerate development timelines; the presentation of additional data at upcoming scientific conferences in 2021; our ability to optimize the impact of our collaborations and license agreements with external parties; our ability to continue our growth; and our expectations regarding our use of capital. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “hope,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “target,” “should,” “would,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

Any forward-looking statements in this press release are based on management’s current expectations and beliefs of future events, and are subject to known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: uncertainty regarding the timing and results of regulatory submissions; success of our clinical trials and preclinical studies; risks related to our ability to protect and maintain our intellectual property position; risks related to manufacturing, supply, and distribution of our product candidates; risks related to the impact of COVID-19 affecting countries or regions in which we have operations or do business, including potential negative impacts on our employees, customers, supply chain and production as well as global economies and financial markets; the risk that any one or more of our product candidates, including those that are co-developed, will not be successfully developed and commercialized; the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies; and success of any collaboration, partnership, license or similar agreements. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission (SEC), including under the caption “Risk Factors” in our most recent Annual Report on Form 10-K and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except to the extent required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Moreover, except as required by law, neither Cullinan nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made.

Cullinan Oncology, Inc.

Consolidated Balance Sheets (Unaudited)

(in thousands, except shares and per share amounts)


     December 31,
    September 30,



Current assets:


Cash and cash equivalents

   $ 168,198     $ 88,105  

Short-term investments

     42,008       232,939  

Prepaid expenses and other current assets

     2,072       7,794  







Total current assets

     212,278       328,838  

Property and equipment, net

     130       89  

Other assets

     2,300       147  

Long-term investments

     —         124,330  







Total assets

   $ 214,708     $ 453,404  







Liabilities and Stockholders’ Equity


Current liabilities:


Accounts payable

   $ 9,679     $ 2,024  

Accrued expenses and other current liabilities

     4,641       5,839  







Total current liabilities

     14,320       7,863  

Long-term liabilities:


Deferred rent

     74       67  







Total liabilities

     14,394       7,930  







Commitments and contingencies


Stockholders’ equity:


Common stock, $0.0001 par value, 34,900,878 and 150,000,000 shares authorized as of December 31, 2020 and September 30, 2021, respectively; 29,831,125 and 43,660,909 shares issued and outstanding as of December 31, 2020 and September 30, 2021, respectively.

     3       4  

Additional paid-in capital

     292,348       569,835  

Accumulated other comprehensive loss

     (2     (58

Accumulated deficit

     (93,339     (126,395







Total Cullinan stockholders’ equity

     199,010       443,386  







Noncontrolling interests

     1,304       2,088  







Total stockholders’ equity

     200,314       445,474  







Total liabilities and stockholders’ equity

   $ 214,708     $ 453,404  







Cullinan Oncology, Inc.

Consolidated Statements of Operations and Comprehensive Loss (Unaudited)

(in thousands, except shares and per share amounts)


     Three Months Ended
September 30,
    Nine Months Ended
September 30,
     2020     2021     2020     2021  

License revenue

   $ —       $ —       $ —       $ 18,943  

Operating expenses:


Research and development

     9,913       12,680       26,582       36,873  

General and administrative

     1,586       5,695       4,580       15,677  













Total operating expenses

     11,499       18,375       31,162       52,550  













Loss from operations

     (11,499     (18,375     (31,162     (33,607

Other income (expense):


Interest income

     185       118       809       340  

Other income (expense), net

           (2     1       (12













Net loss

     (11,314     (18,259     (30,352     (33,279

Net loss attributable to noncontrolling interest

     (1,456     (909     (6,899     (223













Net loss attributable to common stockholders of Cullinan

   $ (9,858   $ (17,350   $ (23,453   $ (33,056













Net loss per share, basic and diluted

   $ (0.50   $ (0.40   $ (1.21   $ (0.76













Total weighted-average shares used in computing net loss per share, basic and diluted

     19,721,992       43,438,861       19,453,479       43,254,230  













Comprehensive loss:


Net loss

   $ (11,314   $ (18,259   $ (30,352   $ (33,279

Unrealized gain/(loss) on investments

     (144     57       63       (56













Comprehensive loss

     (11,458     (18,202     (30,289     (33,335

Comprehensive loss attributable to noncontrolling interest

     (1,456     (909     (6,899     (223













Comprehensive loss attributable to Cullinan

   $ (10,002   $ (17,293   $ (23,390   $ (33,112














Investor Relations


Jeffrey Trigilio

+1 617.410.4650