Full Press Release Details
Cullinan Oncology Provides Corporate Update and Reports First Quarter 2023 Financial Results
Zipalertinib pivotal trial now enrolling at the 100mg BID dose only
First clinical data for CLN-049 and CLN-619 to be reported
at EHA 2023 Congress and ASCO 2023 Annual Meeting, respectively
Cash and investment position of $503.5 million as of
March 31, 2023 continues to give runway into 2026
CAMBRIDGE, Mass., May 11, 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 first quarter
ended March 31, 2023.
We made important progress in the first quarter of this year and believe that 2023 will be a transformational year for
Cullinan Oncology, said Nadim Ahmed, Chief Executive Officer of Cullinan. Consistent with our guidance on reporting first clinical data from two of our ongoing Phase 1 studies by mid-year,
preliminary safety data for CLN-049 were published in abstract form today as part of the 2023 EHA Congress and first clinical data for CLN-619 will be presented during a
poster session at the upcoming ASCO Annual Meeting. Additionally, enrollment in the zipalertinib pivotal study will now continue at the 100mg BID dose only. We also continue to progress our diverse pipeline: both
CLN-978 and CLN-617 received FDA clearance of IND applications in the first quarter, which will allow us to initiate first-in-human studies this year. Finally, 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.
Together, these achievements position us well with six programs in the clinic this year as we work toward our mission of creating new standards of care for patients with cancer.
Portfolio Highlights
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 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.
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
| March 31, 2023 | December 31, 2022 | |||||||
| (unaudited) | (unaudited) | |||||||
| Cash, cash equivalents, investments, and interest receivable | $ | 503,494 | $ | 550,118 | ||||
| Total assets | $ | 514,990 | $ | 561,117 | ||||
| Total current liabilities | $ | 26,171 | $ | 22,498 | ||||
| Total liabilities | $ | 29,341 | $ | 26,088 | ||||
| Total stockholders equity | $ | 485,649 | $ | 535,029 | ||||
| Total liabilities and stockholders equity | $ | 514,990 | $ | 561,117 |
Cullinan Oncology, Inc.
Consolidated Statements of Operations
(in thousands, except per share amounts)
| Three Months Ended | ||||||||
| March 31, 2023 | December 31, 2022 | |||||||
| (unaudited) | (unaudited) | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 52,096 | $ | 21,321 | ||||
| General and administrative | 10,660 | 11,287 | ||||||
| Total operating expenses | 62,756 | 32,608 | ||||||
| Income (loss) from operations | (62,756 | ) | (32,608 | ) | ||||
| Other income (expense): | ||||||||
| Interest income | 4,508 | 3,364 | ||||||
| Other income (expense), net | 107 | 298 | ||||||
| Net loss before income taxes | (58,141 | ) | (28,946 | ) | ||||
| Income tax benefit | (1,858 | ) | ||||||
| Net loss | (58,141 | ) | (27,088 | ) | ||||
| Net loss attributable to noncontrolling interests | (179 | ) | (306 | ) | ||||
| Net loss attributable to common stockholders of Cullinan | $ | (57,962 | ) | $ | (26,782 | ) | ||
| Net loss per share: | ||||||||
| Basic and diluted | $ | (1.42 | ) | $ | (0.59 | ) | ||
| Weighted-average shares used in computing net loss per share: | ||||||||
| Basic and diluted | 40,682 | 45,751 |