UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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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 August 10, 2023, Cullinan Oncology, Inc. announced its financial results for the quarter ended June 30, 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 August 10, 2023, furnished herewith |
104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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: |
August 10, 2023 |
By: |
/s/ Jeffrey Trigilio |
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Jeffrey Trigilio |
Cullinan Oncology Provides Corporate Update and Reports Second Quarter 2023 Financial Results
Phase 3 first-line study of zipalertinib in EGFR exon 20 insertion mutation non-small-cell lung cancer (NSCLC) patients (REZILIENT-3) open to enrollment
Initial monotherapy clinical data for CLN-619 presented at ASCO 2023 Annual Meeting; initiated monotherapy expansion cohorts in endometrial and cervical cancers
First patient dosed in Phase 1 study of CLN-978 in relapsed/refractory (R/R) B Cell non-Hodgkin lymphoma (B-NHL)
Cash and investment position of $512.1 million as of June 30, 2023 continues to provide runway into 2026
CAMBRIDGE, Mass., August 10, 2023 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (Nasdaq: CGEM; “Cullinan”) a biopharmaceutical company focused on modality-agnostic targeted oncology therapies, today reported on recent and upcoming business highlights and announced its financial results for the second quarter ended June 30, 2023.
“We have continued to advance our broad portfolio of modality-agnostic cancer therapies during the first half of this year and are poised to continue our momentum,” said Nadim Ahmed, Chief Executive Officer of Cullinan. “With our partners at Taiho Oncology, we recently announced the launch of the REZILIENT-3 study, a randomized Phase 3 trial which will evaluate zipalertinib as a first-line treatment for EGFR exon 20 NSCLC patients. We also shared encouraging initial clinical monotherapy data for CLN-619 at ASCO in June. Based on that data, we announced monotherapy expansion cohorts in endometrial and cervical cancers. We look forward to presenting the first data from the pembrolizumab combination arm at a medical congress in the future. Further, we recently brought our fifth development program into the clinic with the dosing of the first patient in our Phase 1 study of CLN-978 in relapsed/refractory B cell non-Hodgkin lymphoma. Following an IND clearance earlier this year, we remain on track to bring our sixth program, CLN-617, into the clinic by year-end. With $512.1 million in cash and investments at the end of Q2, we remain well capitalized to continue executing on our strategic objectives and creating value for all of our key stakeholders.”
Portfolio Highlights
Second Quarter 2023 Financial Results
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.
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; 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.
Cullinan Oncology, Inc.
Condensed Consolidated Balance Sheets
(unaudited)
(in thousands)
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June 30, 2023 |
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December 31, 2022 |
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Cash, cash equivalents, investments, and interest receivable |
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$ |
512,117 |
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$ |
550,118 |
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Total assets |
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$ |
521,984 |
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$ |
561,117 |
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Total current liabilities |
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$ |
19,676 |
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$ |
22,498 |
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Total liabilities |
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$ |
22,410 |
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$ |
26,088 |
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Total stockholders’ equity |
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$ |
499,574 |
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$ |
535,029 |
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Total liabilities and stockholders’ equity |
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$ |
521,984 |
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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 June 30 |
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Six Months Ended June 30 |
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2023 |
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2022 |
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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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$ |
27,391 |
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$ |
26,411 |
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$ |
79,487 |
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$ |
50,947 |
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General and administrative |
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10,214 |
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10,695 |
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20,874 |
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18,816 |
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Total operating expenses |
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37,605 |
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37,106 |
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100,361 |
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69,763 |
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Gain on sale of Cullinan Pearl |
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— |
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276,785 |
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- |
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276,785 |
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Income (loss) from operations |
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(37,605 |
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239,679 |
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(100,361 |
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207,022 |
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Other income (expense): |
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Interest income |
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5,322 |
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697 |
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9,830 |
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894 |
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Other income (expense), net |
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69 |
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(241 |
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176 |
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(241 |
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Net income (loss) before income taxes |
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(32,214 |
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240,135 |
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(90,355 |
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207,675 |
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Income tax expense |
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— |
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66,070 |
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— |
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46,502 |
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Net income (loss) |
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(32,214 |
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174,065 |
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(90,355 |
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161,173 |
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Net loss attributable to noncontrolling interests |
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— |
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(833 |
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(179 |
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(1,627 |
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Net income (loss) attributable to common stockholders of Cullinan |
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$ |
(32,214 |
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$ |
174,898 |
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$ |
(90,176 |
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$ |
162,800 |
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Net income (loss) per share: |
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Basic |
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$ |
(0.82 |
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$ |
3.90 |
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$ |
(2.24 |
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$ |
3.65 |
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Diluted |
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$ |
(0.82 |
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$ |
3.77 |
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$ |
(2.24 |
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$ |
3.51 |
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Weighted-average shares used in computing net income (loss) per share: |
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Basic |
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39,952 |
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44,873 |
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40,315 |
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44,654 |
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Diluted |
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39,952 |
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46,381 |
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40,315 |
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46,389 |
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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