UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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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:
Securities registered pursuant to Section 12(b) of the Act:
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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.
Item 2.02 Results of Operations and Financial Condition.
On March 14, 2024, Cullinan Oncology, Inc. announced its financial results for the quarter and year ended December 31, 2023. 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. |
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Description |
99.1 |
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Press release issued by Cullinan Oncology, Inc. on March 14, 2024, furnished herewith |
104 |
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Cover page from this Current Report on Form 8-K, formatted in Inline XBRL |
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 hereunto duly authorized.
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CULLINAN ONCOLOGY, INC. |
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Date: |
March 14, 2024 |
By: |
/s/ Jeffrey Trigilio |
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Jeffrey Trigilio |
Exhibit 99.1
Cullinan Oncology Provides Corporate Update and Reports Fourth Quarter and Full Year 2023 Financial Results
Cullinan remains on track to report additional solid tumor dose escalation data for CLN-619 in the second quarter of 2024 and recently received FDA clearance for an IND to evaluate CLN-619 in relapsed/refractory multiple myeloma
The company is exploring development of its CD19xCD3 T cell engager CLN-978 in autoimmune disorders
Cash and investments of $468.3 million as of December 31, 2023 continues to provide runway into the second half of 2026
CAMBRIDGE, Mass., March 14, 2024 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (Nasdaq: CGEM; “Cullinan”), a biopharmaceutical company focused on developing modality-agnostic targeted oncology therapies, today reported on recent and upcoming business highlights and announced its financial results for the fourth quarter and full year ended December 31, 2023. The company also announced that Chief Financial Officer Jeff Trigilio will depart the company effective March 29. Following his departure, Jeff has agreed to support the company through a transition period.
“With the remarkable progress we made in 2023, we are positioned for an exciting, data-rich 2024,” said Nadim Ahmed, Chief Executive Officer of Cullinan Oncology, “We are on track to present clinical data across multiple programs, starting first with our lead unpartnered program, CLN-619. We plan to present initial data assessing CLN-619 in combination with checkpoint inhibitor therapy, along with updated data from the monotherapy dose escalation module, at a major medical meeting in the second quarter. We are exploring development of CLN-978, our next generation CD19xCD3 T cell engager, for the treatment of autoimmune diseases, where we believe it has significant potential as a potent, off-the-shelf, patient-friendly alternative to CAR T cell therapy. We continue to advance a broad zipalertinib development program in collaboration with Taiho, and we are on track to complete enrollment in the pivotal Phase 2b portion of the REZILIENT1 study by the end of the year. Lastly, we thank Jeff Trigilio for playing an important role in transitioning the company from an early-stage private biotechnology company to a public company with a diversified and deep pipeline and we wish him the best in his future endeavors.”
Portfolio Highlights
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Fourth Quarter 2023 Financial Results
Full Year 2023 Financial Results
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About Cullinan Oncology
Cullinan Oncology, Inc. (Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients with cancer. We innovate without borders to find the most promising clinic-ready cancer therapies, whether from our own discovery efforts or through exceptional engagement with our academic and industry partners. Anchored in a deep understanding of immuno-oncology and translational cancer medicine, we leverage our scientific excellence in small molecules and biologics to create differentiated ideas, identify unique targets, and select the optimal modality to develop transformative therapeutics across cancer indications. Powered by our novel research model, we push conventional boundaries from candidate selection to cancer therapeutic, applying rigorous early experimentation to fast-track only the most promising assets to the clinic and ultimately commercialization. As a result, our diversified pipeline is strategically built with assets that activate the immune system or inhibit key oncogenic drivers across a wide range of modalities, each with the potential to be the best or first in their class.
Our people possess deep scientific expertise, seek innovation openly, and exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients with cancer. Learn more about our Company at www.cullinanoncology.com, and follow us on LinkedIn and Twitter.
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 and timelines, clinical trial designs, clinical and therapeutic potential, and strategy of our product candidates; our ability to evaluate strategic opportunities to accelerate development timelines; our ability to optimize the impact of our collaborations and license agreements with external parties; our ability to continue our growth; our expectations regarding our cash runway and use of capital; and our plans regarding future data presentations. 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.
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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 future results, performance or achievements 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; 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, 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.
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Cullinan Oncology, Inc.
Condensed Consolidated Balance Sheets
(unaudited)
(in thousands)
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December 31, 2023 |
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December 31, 2022 |
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Cash, cash equivalents, investments, and interest receivable |
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$ |
468,264 |
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$ |
550,118 |
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Total assets |
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$ |
484,182 |
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$ |
561,117 |
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Total current liabilities |
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$ |
28,137 |
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$ |
22,498 |
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Total liabilities |
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$ |
30,287 |
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$ |
26,088 |
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Total stockholders’ equity |
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$ |
453,895 |
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$ |
535,029 |
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Total liabilities and stockholders’ equity |
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$ |
484,182 |
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$ |
561,117 |
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Cullinan Oncology, Inc.
Consolidated Statements of Operations
(unaudited)
(in thousands, except per share amounts)
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Three Months Ended |
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Twelve Months Ended |
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December 31, 2023 |
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September 30, 2023 |
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December 31, 2023 |
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December 31, 2022 |
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Operating expenses: |
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Research and development |
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$ |
34,848 |
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$ |
33,821 |
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$ |
148,156 |
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$ |
91,948 |
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General and administrative |
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10,637 |
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10,982 |
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42,493 |
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40,189 |
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Total operating expenses |
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45,485 |
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44,803 |
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190,649 |
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132,137 |
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Impairment of long-lived assets |
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— |
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(440 |
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(440 |
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- |
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Gain on sale of Cullinan Pearl |
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— |
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— |
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— |
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276,785 |
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Income (loss) from operations |
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(45,485 |
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(45,243 |
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(191,089 |
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144,648 |
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Other income (expense): |
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Interest income |
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5,917 |
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5,880 |
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21,627 |
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6,611 |
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Other income (expense), net |
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(117 |
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180 |
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239 |
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57 |
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Net income (loss) before income taxes |
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(39,685 |
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(39,183 |
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(169,223 |
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151,316 |
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Income tax expense (benefit) |
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(14,122 |
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— |
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(14,122 |
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42,121 |
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Net income (loss) |
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(25,563 |
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(39,183 |
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(155,101 |
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109,195 |
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Net loss attributable to noncontrolling interests |
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(1,760 |
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— |
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(1,939 |
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(2,019 |
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Net income (loss) attributable to common stockholders of Cullinan |
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$ |
(23,803 |
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$ |
(39,183 |
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$ |
(153,162 |
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$ |
111,214 |
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Net income (loss) per share attributable to common stockholders of Cullinan: |
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Basic |
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$ |
(0.54 |
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$ |
(0.91 |
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$ |
(3.69 |
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$ |
2.46 |
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Diluted |
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$ |
(0.54 |
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$ |
(0.91 |
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$ |
(3.69 |
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$ |
2.38 |
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Weighted-average shares used in computing net income (loss) per share attributable to common stockholders of Cullinan: |
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Basic |
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42,794 |
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42,734 |
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41,550 |
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45,164 |
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Diluted |
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42,794 |
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42,734 |
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41,550 |
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46,640 |
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Contacts:
Investors
Chad Messer
+1 203.464.8900
cmesser@cullinanoncology.com
Media
Rose Weldon
+1 215.801.7644
rweldon@cullinanoncology.com
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