Announced
CLN-049 and CLN-619 Phase I dosing continues with initial clinical data on track for mid-2023; CLN-081 and CLN-978 IND submissions on track for 1H 2023
Cash of
“We made excellent progress in the first quarter of 2022, substantially advancing our lead asset, CLN-081, and continuing to progress our diversified pipeline,” said
Portfolio Highlights
- CLN-081 (Pearl): Cullinan announced the simultaneous sale of
Cullinan Pearl and aU.S. co-development and co-commercialization collaboration of CLN-081 withTaiho Pharmaceutical Co., Ltd. (Taiho). Cullinan will receive$275 million upfront and is eligible for an additional$130 million tied to EGFR exon20 NSCLC regulatory milestones, in addition to sharing 50/50 in the future potentialU.S. profits and losses for CLN-081. In January, Cullinan announced that CLN-081 was granted Breakthrough Therapy Designation (BTD) for the treatment of non-small cell lung cancer (NSCLC) patients harboring epidermal growth factor (EGFR) exon 20 insertion mutations who have previously received platinum-based systemic chemotherapy. In March, Cullinan reported a clinical and regulatory update for CLN-081, which included an improved 41% confirmed overall response rate at 100mg BID and a continued favorable safety and tolerability profile. - CLN-049 (Florentine): In
December 2021 , patient dosing was initiated in a first-in-human clinical trial evaluating CLN-049 in patients with relapsed/refractory AML and MDS. Initial clinical data are expected by mid-2023. CLN-049 is a FLT3/CD3-bispecific T cell-engaging antibody in an IgG format for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). CLN-049 targets the extracellular domain of FLT3, regardless of mutant or wild type expression. - CLN-619 (MICA): In
December 2021 , patient dosing was initiated in a first-in-human clinical trial evaluating CLN-619 alone and in combination with pembrolizumab in patients with advanced tumors. Initial clinical data are expected by mid-2023. CLN-619 is a first-in-class monoclonal antibody that stabilizes MICA/MICB on the tumor cell surface to promote an antitumor response via activation of both natural killer (NK) cells and certain T cells, with broad therapeutic potential across multiple cancer indications. - Preclinical Portfolio: Continued advancement of five additional oncology programs with the following highlights:
- Preclinical data across five distinct programs were presented at the
American Association for Cancer Research (AACR) 2022 Annual Meeting in April, including CLN-049, CLN-619, CLN-617 (Amber), CLN-978 (NexGem) and Opal. Cullinan Oncology continues to advance two programs through Investigational New Drug (IND)-enabling studies: CLN-617, a cytokine fusion protein uniquely combining IL-12 and IL-2 with a collagen binding domain for retention in the tumor microenvironment (TME), and CLN-978, a novel CD19/CD3-bispecific construct with extended serum half-life and high potency against target cells expressing very low levels of CD19. Cullinan expects to submit INDs for both programs by the end of the first half of 2023.
- Preclinical data across five distinct programs were presented at the
First Quarter 2022 Financial Results
- Cash Position: Cash and investments2 were
$410 million as ofMarch 31, 2022 . Including the$275 million upfront payment related to the Taiho transaction, we expect to have$685 million in cash and investments2. As a result of the transaction and based on current operating plans, we expect to have cash runway through 2026, compared to our previous guidance of through 2024. - R&D Expenses: Research and development (R&D) expenses were
$24.5 million for the first quarter of 2022, compared to$20.9 million for the fourth quarter of 2021. R&D expenses for each of the first quarter of 2022 and fourth quarter of 2021 included$2.6 million of equity-based compensation expenses. The increase in R&D expenses is primarily related to expanded clinical and chemistry, manufacturing, and controls (CMC) activity for CLN-081 and CLN-619, IND-enabling activities for CLN-617, and discovery and development of our preclinical programs. - G&A Expenses: General and administrative (G&A) expenses were
$8.1 million for the first quarter of 2022, compared to$13.5 million for the fourth quarter of 2021. G&A expenses in the first quarter of 2022 and fourth quarter of 2021 included$3.8 million and$9.6 million of equity-based compensation expenses, respectively. The decrease in G&A expenses was primarily driven by a decrease in equity-based compensation expenses, partially offset by a$0.3 million increase in professional services. - Net Loss: The Company’s net loss (before items attributable to noncontrolling interest) was
$12.9 million for the first quarter of 2022 compared to$34.2 million for the fourth quarter of 2021. The decrease in net loss was primarily related income tax benefits recorded for the expected utilization of current quarter losses and the release of valuation allowance of certain historical tax losses against the expected gain on the sale ofCullinan Pearl , as well as a decrease in equity-based compensation expenses, which were partially offset by increases in R&D costs to advance our portfolio.
About
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, clinical trial designs, clinical and therapeutic potential, and strategy of our product candidates; our ability to evaluate strategic opportunities to accelerate development timelines; the presentation of additional data at upcoming scientific conferences in 2022; 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
Condensed Consolidated Balance Sheets
(in thousands)
2022 | 2021 | |||||
(unaudited) | (1) | |||||
Cash, cash equivalents, investments, and interest receivable | $ | 410,063 | $ | 432,495 | ||
Total assets | $ | 437,463 | $ | 437,185 | ||
Total current liabilities | $ | 17,257 | $ | 11,746 | ||
Total liabilities | $ | 17,993 | $ | 11,811 | ||
Total stockholders’ equity | $ | 418,702 | $ | 425,374 | ||
Total liabilities and stockholders’ equity | $ | 437,463 | $ | 437,185 |
(1) The condensed consolidated balance sheet as of the year ended
Consolidated Statements of Operations
(in thousands, except shares and per share amounts)
Three Months Ended | |||||||
(unaudited) | (unaudited) | ||||||
License revenue | $ | — | $ | — | |||
Operating expenses: | |||||||
Research and development | 24,536 | 20,878 | |||||
General and administrative | 8,121 | 13,468 | |||||
Total operating expenses | 32,657 | 34,346 | |||||
Income/(loss) from operations | (32,657 | ) | (34,346 | ) | |||
Other income (expense): | |||||||
Interest income | 197 | 137 | |||||
Other income (expense), net | — | 4 | |||||
Net income/(loss) before income taxes | (32,460 | ) | (34,205 | ) | |||
Income tax expense/(benefit) | (19,568 | ) | — | ||||
Net income/(loss) | (12,892 | ) | (34,205 | ) | |||
Net income/(loss) attributable to noncontrolling interest | (794 | ) | (1,692 | ) | |||
Net loss attributable to common stockholders of Cullinan | $ | (12,098 | ) | $ | (32,513 | ) | |
Net loss per share, basic and diluted | $ | (0.27 | ) | $ | (0.74 | ) | |
Total weighted-average shares used in computing net loss per share, basic and diluted | 44,431,657 | 43,643,397 |
Contacts:
Investors
+1 203.464.8900
cmesser@cullinanoncology.com
Media
+1 215.801.7644
rweldon@cullinanoncology.com
1 Include cash, cash equivalents, investments, and interest receivable of
2 Include cash, cash equivalents, investments, and interest receivable.
Source:
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