Cullinan Oncology Provides Corporate Update and Reports Third Quarter 2022 Financial Results
November 14 2022 - 7:00AM
Cullinan Oncology, Inc. (Nasdaq: CGEM) a biopharmaceutical
company focused on modality-agnostic targeted oncology, today
reported on recent and upcoming business highlights and announced
its financial results for the third quarter ended September 30,
2022.
“We continued to execute across our
programs through the third quarter and will deliver multiple
important milestones in 2023,” said Nadim Ahmed, Chief Executive
Officer of Cullinan Oncology. “For our lead program, zipalertinib,
we have initiated the pivotal study in patients with EGFR exon 20
non-small cell lung cancer. We remain on track to report initial
clinical data for our two additional clinical-stage programs,
CLN-049 and CLN-619, in mid-2023 and to file IND applications for
CLN-617 and CLN-978 in the first half of 2023, which will advance
our portfolio to potentially five clinical stage programs. With
$607 million of cash and investments at the end of the quarter, we
have cash runway well beyond these important milestones. We will
continue to strategically deploy our capital for pipeline
investment, acceleration, and expansion, such as our recent
purchase of additional ownership in our Cullinan MICA subsidiary.
Lastly, we made important additions to our leadership team and
Board of Directors with the appointments of Jacquelyn Sumer as
Chief Legal Officer and Dr. David Ryan as a new independent
director. Both individuals will provide important expertise to
support our evolution into a late-stage oncology company.”
Portfolio
Highlights
-
Zipalertinib (previously
CLN-081/TAS6417): Cullinan
Oncology, in collaboration with our partners at Taiho Oncology,
Inc., has initiated a pivotal study of zipalertinib in EGFR exon 20
non-small-cell lung cancer patients progressing after prior
systemic therapy. As previously planned, the study will enroll
patients at the 100 mg BID dose, and will now also include a
limited cohort of patients to evaluate safety and efficacy at 150
mg BID administered with food.
- CLN-049: CLN-049 is a FLT3/CD3 T cell-engaging
bispecific antibody being investigated in patients with
relapsed/refractory acute myeloid leukemia (AML) or myelodysplastic
syndrome (MDS). CLN-049 is currently in Phase I investigation with
initial clinical data expected in mid-2023.
- CLN-619: CLN-619 is a
monoclonal antibody that stabilizes expression of MICA/MICB on the
tumor cell surface to promote tumor cell lysis from both cytotoxic
innate and adaptive immune cells. CLN-619 has broad therapeutic
potential and is being investigated as both monotherapy and in
combination with checkpoint inhibitor therapy in an ongoing Phase I
study in patients with advanced solid tumors with initial clinical
data expected in mid-2023.
- Cullinan Oncology presented a poster at the Society for
Immunotherapy (SITC) meeting further characterizing the unique
mechanism of action of CLN-619. The preclinical data demonstrated
the requirement of Fc functionality for the potency of CLN-619, as
well as a further potential mechanism of action, antibody dependent
cellular phagocytosis (ADCP), to mediate anti-tumor activity.
- In October, Cullinan Oncology announced that it increased its
ownership in its Cullinan MICA Corp. (MICA) subsidiary, which holds
the worldwide rights to CLN-619. Ownership increased from 54% to
92% through the purchase of equity from two of MICA’s financial
investors. The Myeloma Investment Fund, a venture philanthropy fund
for the Multiple Myeloma Research Foundation (MMRF), retained its
ownership in the entity.
- CLN-617: CLN-617 is a
cytokine fusion protein uniquely combining IL-12 and IL-2 with a
collagen binding domain designed for retention in the tumor
microenvironment (TME) following intratumoral injection. Cullinan
Oncology remains on track to file an Investigational New Drug (IND)
application in the first half of 2023.
- Cullinan Oncology presented a poster at the recent Society for
Immunotherapy (SITC) meeting. The preclinical data demonstrate that
CLN-617 can mobilize a systemic, tumor-specific cellular immune
response, remodeling the tumor microenvironment in both the
injected and distal tumors.
- CLN-978: CLN-978 is a novel
CD19/CD3-bispecific therapeutic with extended serum half-life and
robust potency against target cells expressing low levels of CD19.
Cullinan Oncology remains on track to file an IND application in
the first half of 2023.
Corporate Updates
- In August, Cullinan Oncology strengthened its leadership team
by adding Jacquelyn Sumer as Chief Legal Officer.
- In November, Dr. David Ryan was appointed to Cullinan
Oncology’s Board of Directors. Dr. Ryan is Chief of
Hematology/Oncology, Massachusetts General Hospital (MGH) Cancer
Center, the Clinical Director of the MGH Cancer Center, and a
Professor of Medicine, Harvard Medical School.
Third Quarter 2022 Financial
Results
- Cash
Position: Cash and investments were $606.7 million as
of September 30, 2022. During the third quarter of 2022, we
received the remaining $5.0 million of the $275.0 million upfront
payment and paid $32.6 million in taxes from the sale of our equity
interest in Cullinan Pearl to Taiho Pharmaceutical Co. Ltd. Based
on our current estimate, we expect to pay approximately $7.0
million in cash in the fourth quarter for the remaining tax
liability resulting from the transaction. Subsequent to the end of
the quarter, we spent an additional $30.7 million in cash to
increase our ownership in our Cullinan MICA subsidiary to 92%.
- R&D
Expenses: Research and development (R&D) expenses
were $19.7 million for the third quarter of 2022, compared to $26.4
million for the prior quarter. R&D expenses for the third and
second quarters of 2022 included $1.1 million and $4.4 million of
equity-based compensation expenses, respectively. The decrease in
R&D expenses was primarily related to a decrease in chemistry,
manufacturing, and control activities for zipalertinib, CLN-619 and
CLN-617 and the initiation of expense reimbursement for
zipalertinib due to the collaboration agreement with Taiho
Oncology, Inc. in the third quarter.
- G&A
Expenses: General and administrative (G&A)
expenses were $10.1 million for the third quarter of 2022, compared
to $10.7 million for prior quarter. G&A expenses in each of the
third and second quarters of 2022 included $4.2 million of
equity-based compensation expenses. The decrease in G&A
expenses is primarily driven by nonrecurring expenses related to
the Cullinan Pearl transaction of $1.7 million in the second
quarter of 2022, partially offset by an increase in professional
services expense.
- Net Loss: Net
loss (before items attributable to noncontrolling interest) for the
third quarter of 2022 was $24.9 million.
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 StatementsThis 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 receipt of escrowed funds related to our
transaction with Taiho Pharmaceutical; 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(in thousands)
|
|
September 30, 2022 |
|
June 30, 2022 |
|
|
(unaudited) |
|
(unaudited) |
Cash, cash equivalents, investments, and interest receivable |
|
$ |
606,737 |
|
|
$ |
655,623 |
|
Total assets |
|
$ |
617,237 |
|
|
$ |
667,249 |
|
Total current liabilities |
|
|
27,117 |
|
|
|
62,035 |
|
Total liabilities |
|
|
31,109 |
|
|
|
62,631 |
|
Total stockholders’ equity |
|
|
586,128 |
|
|
|
604,618 |
|
Total liabilities and stockholders’ equity |
|
$ |
617,237 |
|
|
$ |
667,249 |
|
|
|
|
|
|
Cullinan Oncology,
Inc.Consolidated Statements of
Operations(in thousands, except per share
amounts)
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, 2022 |
|
June 30, 2022 |
|
September 30, 2022 |
|
September 30, 2021 |
|
|
(unaudited) |
|
(unaudited) |
|
(unaudited) |
|
(unaudited) |
License revenue |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
18,943 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
19,680 |
|
|
|
26,411 |
|
|
|
70,627 |
|
|
|
36,873 |
|
General and administrative |
|
|
10,086 |
|
|
|
10,695 |
|
|
|
28,902 |
|
|
|
15,677 |
|
Total operating expenses |
|
|
29,766 |
|
|
|
37,106 |
|
|
|
99,529 |
|
|
|
52,550 |
|
Gain on sale of Cullinan Pearl |
|
|
— |
|
|
|
(276,785 |
) |
|
|
(276,785 |
) |
|
|
— |
|
Income (loss) from operations |
|
|
(29,766 |
) |
|
|
239,679 |
|
|
|
177,256 |
|
|
|
(33,607 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
Interest income |
|
|
2,353 |
|
|
|
697 |
|
|
|
3,247 |
|
|
|
340 |
|
Other income (expense), net |
|
|
— |
|
|
|
(241 |
) |
|
|
(241 |
) |
|
|
(12 |
) |
Net income (loss) before income taxes |
|
|
(27,413 |
) |
|
|
240,135 |
|
|
|
180,262 |
|
|
|
(33,279 |
) |
Income tax expense (benefit) |
|
|
(2,523 |
) |
|
|
66,070 |
|
|
|
43,979 |
|
|
|
— |
|
Net income (loss) |
|
|
(24,890 |
) |
|
|
174,065 |
|
|
|
136,283 |
|
|
|
(33,279 |
) |
Net income (loss) attributable to noncontrolling interests |
|
|
(86 |
) |
|
|
(833 |
) |
|
|
(1,713 |
) |
|
|
(223 |
) |
Net income (loss) attributable to common stockholders of
Cullinan |
|
$ |
(24,804 |
) |
|
$ |
174,898 |
|
|
$ |
137,996 |
|
|
$ |
(33,056 |
) |
|
|
|
|
|
|
|
|
|
Earnings (net loss) per share: |
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.54 |
) |
|
$ |
3.90 |
|
|
$ |
3.07 |
|
|
$ |
(0.76 |
) |
Diluted |
|
$ |
(0.54 |
) |
|
$ |
3.77 |
|
|
$ |
2.96 |
|
|
$ |
(0.76 |
) |
|
|
|
|
|
|
|
|
|
Weighted-average shares used in computing earnings (net loss) per
share: |
|
|
|
|
|
|
|
|
Basic |
|
|
45,611 |
|
|
|
44,873 |
|
|
|
44,966 |
|
|
|
43,254 |
|
Diluted |
|
|
45,611 |
|
|
|
46,381 |
|
|
|
46,580 |
|
|
|
43,254 |
|
Contacts:
InvestorsChad Messer+1
203.464.8900cmesser@cullinanoncology.com
Media Rose Weldon +1
215.801.7644 rweldon@cullinanoncology.com
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