Cullinan Oncology, Inc. (Nasdaq: CGEM), a biopharmaceutical company
focused on developing a diversified pipeline of targeted therapies
for patients with cancer, today reported on recent and upcoming
business highlights and announced its financial results for the
first quarter ended March 31, 2022.
“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 Nadim Ahmed, Chief
Executive Officer of Cullinan Oncology. “Our March clinical and
regulatory update for CLN-081 further affirmed its differentiated
profile, and we are looking forward to sharing an additional
clinical update in an oral presentation at the upcoming ASCO
meeting. We also announced a U.S. co-development and
co-commercialization agreement for CLN-081 with Taiho, the original
innovators of the molecule, and an ideal partner with whom to
advance this asset into later stage development and
commercialization. The proceeds from this transaction will also
allow us to accelerate and expand the development of our diverse
pipeline as well as discover and obtain promising new oncology
therapeutic candidates.”
Mr. Ahmed continued, “We are also pleased to continue the
progression of our pipeline programs. Dosing in the Phase I trials
of CLN-619 and CLN-049 was initiated in December 2021 and the
studies are continuing on track to deliver initial data readouts by
mid-2023. We are also on track to file INDs for two additional
programs, CLN-617 and CLN-978, in the first half of next year.
Importantly, we are in an even stronger financial position to
continue advancing our strategically built pipeline of diversified
assets, each with the potential to be the first or best in their
class. We ended the first quarter of 2022 with approximately $410
million in cash and investments2, which, when added to proceeds
from the Taiho deal, aggregates to $685 million, and extends our
cash runway through 2026.”
Portfolio Highlights
- CLN-081
(Pearl): Cullinan announced the simultaneous sale of
Cullinan Pearl and a U.S. co-development and co-commercialization
collaboration of CLN-081 with Taiho 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 potential
U.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.
First Quarter 2022 Financial Results
- Cash Position: Cash
and investments2 were $410 million as of March 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 of Cullinan 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 Cullinan
OncologyCullinan 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, 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 Securities and Exchange Commission (SEC),
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)
|
March 31, 2022 |
|
December 31, 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 December 31, 2021 is derived from the audited consolidated
financial statements as of that date.
Cullinan Oncology,
Inc.Consolidated Statements of
Operations(in thousands, except shares and per
share amounts)
|
Three Months Ended |
|
March 31, 2022 |
|
December 31, 2021 |
|
(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:
InvestorsChad Messer+1
203.464.8900cmesser@cullinanoncology.com
Media Rose Weldon +1
215.801.7644 rweldon@cullinanoncology.com
1 Include cash, cash equivalents, investments, and interest
receivable of $410 million as of March 31, 2022 and $275 million
upfront to be received upon closing. 2 Include cash, cash
equivalents, investments, and interest receivable.
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