Full Press Release Details
Cullinan Oncology Provides Corporate Update and
Reports Fourth Quarter and Full Year 2022 Financial Results
Expanded clinical stage portfolio through licensing of U.S. rights to CLN-418
Received FDA clearance of IND application for CLN-978; submitted IND application for CLN-617
Initial clinical data updates for CLN-049 and CLN-619 on track for mid-2023
Potential for 6 clinical
stage programs by year end and cash runway into 2026
CAMBRIDGE, Mass., March 9, 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 fourth
quarter and full year ended December 31, 2022.
2022 was a year of remarkable execution at Cullinan Oncology, and the momentum with which we
ended the year has continued into early 2023. With our partners at Taiho Oncology, we initiated the pivotal study of zipalertinib in the fourth quarter, while continuing to advance enrollment in the Phase 1 trials of
CLN-049 and CLN-619, with initial clinical data expected mid-year said Nadim Ahmed, Chief Executive Officer of Cullinan.
The first two months of 2023 have resulted in similarly exciting developments, as we recently expanded our pipeline through the licensing of U.S. development and commercial rights to CLN-418, a potential
first-in-class B7H4x4-1BB bispecific immune activator currently in a Phase 1 study across a variety of solid-tumor indications.
This transaction provides us with the opportunity to have six programs in the clinic by the end of the year, as we recently received IND clearance for CLN-978 and also recently filed the IND for CLN-617, consistent with prior guidance. Importantly, our cash position following the CLN-418 transaction provides us with runway into 2026 which gives us the flexibility
needed to fund our ongoing development efforts and reach multiple potential value creating milestones.
Portfolio Highlights
Fourth Quarter 2022 Financial Results
Full Year 2022 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
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; 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, 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
| December 31, 2022 | September 30, 2022 | |||||||
| (unaudited) | (unaudited) | |||||||
| Cash, cash equivalents, investments, and interest receivable | $ | 550,118 | $ | 606,737 | ||||
| Total assets | $ | 561,117 | $ | 617,237 | ||||
| Total current liabilities | $ | 22,498 | $ | 27,117 | ||||
| Total liabilities | $ | 26,088 | $ | 31,109 | ||||
| Total stockholders equity | $ | 535,029 | $ | 586,128 | ||||
| Total liabilities and stockholders equity | $ | 561,117 | $ | 617,237 |
Cullinan Oncology, Inc.
Consolidated Statements of Operations
(in thousands, except per share amounts)
| Three Months Ended | Year Ended | |||||||||||||||
| December 31, 2022 | September 30, 2022 | December 31, 2022 | December 31, 2021 | |||||||||||||
| (unaudited) | (unaudited) | (unaudited) | (audited) | |||||||||||||
| License revenue | $ | $ | $ | $ | 18,943 | |||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 21,321 | 19,680 | 91,948 | 57,751 | ||||||||||||
| General and administrative | 11,287 | 10,086 | 40,189 | 29,146 | ||||||||||||
| Total operating expenses | 32,608 | 29,766 | 132,137 | 86,897 | ||||||||||||
| Gain on sale of Cullinan Pearl | 276,785 | |||||||||||||||
| Income (loss) from operations | (32,608 | ) | (29,766 | ) | 144,648 | (67,954 | ) | |||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 3,364 | 2,353 | 6,611 | 477 | ||||||||||||
| Other income (expense), net | 298 | 57 | (8 | ) | ||||||||||||
| Net income (loss) before income taxes | (28,946 | ) | (27,413 | ) | 151,316 | (67,485 | ) | |||||||||
| Income tax expense (benefit) | (1,858 | ) | (2,523 | ) | 42,121 | |||||||||||
| Net income (loss) | (27,088 | ) | (24,890 | ) | 109,195 | (67,485 | ) | |||||||||
| Net loss attributable to noncontrolling interests | (306 | ) | (86 | ) | (2,019 | ) | (1,915 | ) | ||||||||
| Net income (loss) attributable to common stockholders of Cullinan | $ | (26,782 | ) | $ | (24,804 | ) | $ | 111,214 | $ | (65,570 | ) | |||||
| Earnings (net loss) per share: | ||||||||||||||||
| Basic | $ | (0.59 | ) | $ | (0.54 | ) | $ | 2.46 | $ | (1.52 | ) | |||||
| Diluted | $ | (0.59 | ) | $ | (0.54 | ) | $ | 2.38 | $ | (1.52 | ) | |||||
| Weighted-average shares used in computing earnings (net loss) per share: | ||||||||||||||||
| Basic | 45,751 | 45,611 | 45,164 | 43,077 | ||||||||||||
| Diluted | 45,751 | 45,611 | 46,640 | 43,077 |