CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of
conditionally activated, localized biologics, today reported second
quarter 2023 financial results and provided a business update.
“In recent months, we have continued to advance
our innovative Probody® Therapeutic pipeline, while making
significant progress with our partners across a wide range of
programs and therapeutic modalities,” said Sean McCarthy, D.Phil.,
chief executive officer and chairman of CytomX Therapeutics. “With
a recent strategic financing completed with long-term CytomX
shareholder, BVF Partners, we have strengthened our financial
position and extended our cash runway into the second half of
2025.”
Continued Dr. McCarthy, “During Q2 we also
further strengthened our management team with the addition of Dr.
Wayne Chu as Chief Medical Officer and the advancement of Dawn
Benson to Senior Vice President of Quality and Product
Manufacturing. Wayne’s extensive experience in oncology drug
development across multiple therapeutic formats will be invaluable
as we optimize our clinical development strategy and execution
across our broad pipeline. Dawn’s contributions to CytomX during
her tenure to date, and her 25-year biotech career leading quality
and manufacturing-related activities, uniquely qualify her for this
expanded role. We are poised to enter a period of considerable
opportunity for CytomX in which we expect to reach multiple
clinical milestones for key pipeline programs over the next 12 to
18 months.”
Second Quarter Business Highlights and
Recent Developments
Pipeline
- CX-904, T-cell-engaging
bispecific (TCB) targeted to EGFRxCD3, progressing
towards initiation of backfill cohorts by the end of 2023
with initial Phase 1 dose escalation data anticipated in the first
half of 2024 – CX-904 is a conditionally activated TCB
designed to target the epidermal growth factor receptor (EGFR) on
cancer cells and the CD3 receptor on T cells within the tumor
microenvironment. CX-904 is partnered with Amgen in a global
co-development alliance and is being evaluated by CytomX in an
ongoing Phase 1 study in patients with advanced solid tumors. The
primary goal of the ongoing initial dose escalation portion of the
study is to assess safety and reach dose levels and exposures by
the end of 2023 that support enrollment into backfill cohorts in
select EGFR positive tumors. Initial Phase 1 dose escalation data
for CX-904 is anticipated in the first half of 2024. Also, a
decision to initiate expansion cohorts is anticipated in 2024,
which will support future selection of the recommended Phase 2
dose.
- IND filings for CX-2051
(EpCAM-directed ADC) and CX-801 (Interferon alpha-2b) expected in
the fourth quarter of 2023 – CytomX’s next wave of
molecules to enter the clinic leverage validated anti-cancer
pathways and mechanisms of action that have historically been
limited in their potential due to systemic toxicities. The
molecular design of CX-2051 and CX-801 incorporated CytomX’s
platform expertise and clinical learnings to optimize the predicted
therapeutic index and potentially broaden the clinical utility of
these promising targets through tumor localized conditional
activation.
- Continued progress in Phase
2 clinical evaluation of Bristol Myers Squibb’s Anti-CTLA-4
non-fucosylated Probody®, BMS-986288 – In Q1 2023, BMS
prioritized the BMS-986288 Probody® program as its lead
next-generation CTLA-4 program and advanced the program to Phase 2.
BMS-986288 is a masked version of a non-fucosylated anti-CTLA-4
antibody, BMS-986218, which is designed to be a more potent version
of ipilimumab (YERVOY®). The non-fucosylated Probody, BMS-986288,
utilizes CytomX’s masking technology to potentially localize the
potent effect of a non-fucosylated CLTA-4 antibody to tumors while
reducing systemic toxicity. The Phase 2 clinical evaluation of
BMS-986288 is ongoing and includes a study arm evaluating third
line or later colorectal cancer. CytomX and BMS also continue to
collaborate on multiple preclinical research programs.
Corporate
- Strategic financing extends
cash runway into the 2nd half of
2025 and through multiple potential clinical milestones –
In July 2023, CytomX entered into an agreement with BVF Partners
L.P. (“BVF”) for a private placement that resulted in initial gross
proceeds of approximately $30.0 million. In the private placement,
CytomX sold pre-funded warrants and accompanying tranche warrants
at a combined price of $2.08 per share. CytomX also has the
potential to receive up to an additional $60.0 million if all
tranche warrants are fully exercised for cash.
- Yu-Waye (Wayne) Chu, M.D.,
joins CytomX as Chief Medical Officer –
In July 2023, CytomX announced the appointment of Yu-Waye (Wayne)
Chu, M.D., as Chief Medical Officer (CMO). Dr. Chu joins CytomX
with over 20 years of experience in oncology, in roles ranging from
research to medicine to global clinical development. His drug
development experiences have contributed to multiple approvals and
span therapeutic modalities including antibody drug conjugates,
checkpoint inhibitors, and bispecific immunotherapies. As CMO, Dr.
Chu will oversee clinical development of the Company’s diversified
portfolio of Probody® therapeutic candidates.
- Dawn Benson promoted to
Senior Vice President of Quality and Product Manufacturing
– In July 2023, CytomX announced the promotion of Dawn
Benson from Vice President of Quality to Senior Vice President of
Quality and Product Manufacturing. Ms. Benson brings more than 25
years of CMC experience in the biotechnology industry. Prior to
joining CytomX, she was the Senior Vice President, Head of Quality
at Coherus BioSciences and also has held various leadership
positions at Sutro Biopharma, Jazz Pharmaceuticals, VaxGen and Nabi
Biopharmaceuticals (acquired by Biotest Pharmaceuticals). Ms.
Benson graduated from the University of North Carolina at
Wilmington with a Bachelor of Chemistry and Biology.
- Continued progress in
strategic alliances – As a core component of the company
business model, CytomX has leveraged strategic partnerships to
extend the reach of its science, broaden its pipeline, and bring
non-dilutive capital to the company. As part of this initiative,
CytomX currently has five major partnerships, including the two
most recently announced partnerships with Regeneron and Moderna.
CytomX continues to make progress across its partnered research
activities which has extended the reach of the Company’s technology
and pipeline and provides for potential to build value through the
achievement of future milestones and royalties over time.
Priorities for 2023
- CX-904 (EGFRxCD3):
Continue patient enrollment and dose escalation in ongoing Phase 1
study and initiate backfill cohorts by the end of 2023
- File 2 New INDs
(wholly-owned): CX-801 (IFNa2b) and CX-2051 (EpCAM) INDs
projected in the fourth quarter of 2023
- Next-Generation CTLA-4
Program: Continued clinical progress for BMS-986288
- CX-2029 (CD71):
Determine next steps for CD71 program, including CX-2029
- Collaborations:
Continuation of drug discovery activities within R&D alliances
including those with our newest collaborators, Regeneron and
Moderna
Second Quarter 2023 Financial
Results
Cash, cash equivalents and investments totaled
$180.9 million as of June 30, 2023, compared to $204.5 million as
of March 31, 2023. The cash balance as of June 30, 2023 does not
include approximately $30.0 million of gross proceeds from the
financing transaction that closed with BVF Partners L.P. in July of
2023.
Total revenue was $24.7 million for the three
months ended June 30, 2023, compared to $12.9 million for the
corresponding period in 2022 and was driven primarily by a higher
percentage of completion for research programs in the Bristol Myers
Squibb collaboration, partially offset by a reduction in revenue
from the AbbVie collaboration as a result of termination of the
AbbVie CD71 agreement in the first quarter of 2023.
Research and development expenses decreased by
$10.5 million during the three months ended June 30, 2023 to $20.7
million, compared to $31.2 million for the corresponding period in
2022. The reduction in research and development expenses was
primarily due to a decrease in personnel related expenses, as well
as winding down of laboratory contract services and clinical study
activities related to the CX-2009 and CX-2029 programs, partially
offset by an increase in laboratory contract services related to
IND enabling activities.
General and administrative expenses decreased by
$4.3 million during the three months ended June 30, 2023 to $7.4
million, compared to $11.7 million for the corresponding period in
2022. The reduction in general and administrative expenses was
primarily due to a decrease in personnel related expenses as a
result of the workforce reduction in 2022 and patent related legal
expenses.
Conference Call &
WebcastCytomX management will host a conference call and
simultaneous webcast today at 5 p.m. EDT (2 p.m. PDT) to discuss
the financial results and provide a business update. Participants
may access the live webcast of the conference call from the Events
and Presentations page of CytomX’s website at
https://ir.cytomx.com/events-and-presentations. Participants may
register for the conference call here and are advised to do so at
least 10 minutes prior to joining the call. An archived replay of
the webcast will be available on the company’s website.
About CytomX
TherapeuticsCytomX is a clinical-stage, oncology-focused
biopharmaceutical company focused on developing novel conditionally
activated biologics localized to the tumor microenvironment. By
pioneering a novel class of conditionally activated biologics,
powered by its Probody® technology platform, CytomX’s goal is to
transcend the limits of current cancer treatments. CytomX’s robust
and differentiated pipeline comprises therapeutic candidates across
multiple treatment modalities including antibody-drug conjugates
(“ADCs”), T-cell engaging bispecific antibodies, and immune
modulators such as cytokines and checkpoint inhibitors. CX-2029 is
an investigational conditionally ADCs directed toward CD71.
CytomX’s clinical pipeline also includes cancer immunotherapeutic
candidates against validated targets such as the CTLA-4-targeting
Probody therapeutic BMS-986288, partnered with Bristol Myers
Squibb, as well as CX-904, a conditionally activated
T-cell-engaging bispecific antibody targeting the epidermal growth
factor receptor (EGFR) on tumor cells and the CD3 receptor on T
cells, which is partnered with Amgen. In addition, CytomX has a
diverse preclinical portfolio of wholly-owned assets including
CX-801, an interferon alpha-2b Probody cytokine that has broad
potential applicability in traditionally immuno-oncology sensitive
as well as insensitive (cold) tumors and CX-2051, a conditionally
activated ADC directed toward EpCAM, with potential applicability
across multiple EpCAM-expressing epithelial cancers. CytomX has
also established strategic collaborations with multiple leaders in
oncology, including Amgen, Astellas, Bristol Myers Squibb,
Regeneron and Moderna. For more information about CytomX and how it
is working to make conditionally activated treatments the new
standard-of-care in the fight against cancer,
visit www.cytomx.com and follow us
on LinkedIn and Twitter.
CytomX Therapeutics Forward-Looking
StatementsThis press release includes forward-looking
statements. Such forward-looking statements involve known and
unknown risks, uncertainties and other important factors that are
difficult to predict, may be beyond our control, and may cause the
actual results, performance, or achievements to be materially
different from any future results, performance or achievements
expressed or implied in such statements, including those related to
the future potential of partnerships or collaboration agreements.
Accordingly, you should not rely on any of these forward-looking
statements, including those relating to the potential benefits,
safety and efficacy or progress of CytomX’s or any of its
collaborative partners’ product candidates, including CX-2029,
BMS-986288, CX-904, CX-801, and CX-2051, the potential benefits or
applications of CytomX’s Probody platform technology, CytomX’s
ability to develop and advance product candidates into and
successfully complete clinical trials, including the ongoing and
planned clinical trials of BMS-986288, and CX-904, the timing of
the commencement of clinical trials or initial and ongoing data
availability, and the timing of investigational new drug
applications, including for CX-801 and CX-2051, and other
development milestones. Risks and uncertainties that contribute to
the uncertain nature of the forward-looking statements include: the
unproven nature of CytomX’s novel Probody Platform technology;
CytomX’s clinical trial product candidates are in the initial
stages of clinical development and its other product candidates are
currently in preclinical development, and the process by which
preclinical and clinical development could potentially lead to an
approved product is long and subject to significant risks and
uncertainties, including the possibility that the results of
preclinical research and early clinical trials may not be
predictive of future results; the possibility that CytomX’s
clinical trials will not be successful; the possibility that
current preclinical research may not result in additional product
candidates; CytomX’s dependence on the success of CX-2029,
BMS-986288, CX-904, CX-801, and CX-2051; CytomX’s reliance on third
parties for the manufacture of the Company’s product candidates;
possible regulatory developments in the United States and foreign
countries; and the risk that we may incur higher costs than
expected for research and development or unexpected costs and
expenses. Additional applicable risks and uncertainties include
those relating to our preclinical research and development,
clinical development, and other risks identified under the heading
"Risk Factors" included in CytomX’s Quarterly Report on Form 10-Q
filed with the SEC on August 8, 2023. The forward-looking
statements contained in this press release are based on information
currently available to CytomX and speak only as of the date on
which they are made. CytomX does not undertake and specifically
disclaims any obligation to update any forward-looking statements,
whether as a result of any new information, future events, changed
circumstances or otherwise.
Probody is a U.S. registered trademark of CytomX
Therapeutics, Inc.
Investor Contact:Chris
OgdenSVP, Finance and Accountingcogden@cytomx.comDirect: (317)
767-4764
Investor and Media
Contact:Stern Investor RelationsStephanie
Ascherstephanie.ascher@sternir.com212-362-1200
|
|
CYTOMX THERAPEUTICS, INC.CONDENSED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(in
thousands, except share and per share
data)(Unaudited) |
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Revenues |
|
$ |
24,724 |
|
|
$ |
12,853 |
|
|
$ |
48,223 |
|
|
$ |
21,893 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
20,671 |
|
|
|
31,159 |
|
|
|
41,846 |
|
|
|
61,718 |
|
General and administrative |
|
|
7,401 |
|
|
|
11,748 |
|
|
|
15,378 |
|
|
|
22,291 |
|
Total operating expenses |
|
|
28,072 |
|
|
|
42,907 |
|
|
|
57,224 |
|
|
|
84,009 |
|
Loss
from operations |
|
|
(3,348 |
) |
|
|
(30,054 |
) |
|
|
(9,001 |
) |
|
|
(62,116 |
) |
Interest income |
|
|
2,308 |
|
|
|
262 |
|
|
|
4,635 |
|
|
|
330 |
|
Other income (expense), net |
|
|
(47 |
) |
|
|
296 |
|
|
|
(32 |
) |
|
|
309 |
|
Net
loss |
|
$ |
(1,087 |
) |
|
$ |
(29,496 |
) |
|
$ |
(4,398 |
) |
|
$ |
(61,477 |
) |
Other
comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss) on short term investments, net of tax |
|
|
9 |
|
|
|
(243 |
) |
|
|
25 |
|
|
|
(920 |
) |
Comprehensive loss |
|
$ |
(1,078 |
) |
|
$ |
(29,739 |
) |
|
$ |
(4,373 |
) |
|
$ |
(62,397 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
per share: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
|
$ |
(0.02 |
) |
|
$ |
(0.45 |
) |
|
$ |
(0.07 |
) |
|
$ |
(0.94 |
) |
Shares used in computing basic and diluted net loss per share |
|
|
66,536,202 |
|
|
|
65,542,762 |
|
|
|
66,393,391 |
|
|
|
65,468,638 |
|
|
CYTOMX THERAPEUTICS, INC.CONDENSED BALANCE
SHEETS(in thousands) |
|
|
|
June 30, |
|
|
December 31, |
|
|
2023 |
|
|
2022 |
|
|
|
(Unaudited) |
|
|
(1) |
|
Assets |
|
|
|
|
|
Current
assets: |
|
|
|
|
|
Cash and cash equivalents |
|
$ |
57,536 |
|
|
$ |
193,650 |
|
Short-term investments |
|
|
123,322 |
|
|
|
— |
|
Accounts receivable |
|
|
1,903 |
|
|
|
35,986 |
|
Prepaid expenses and other current assets |
|
|
5,040 |
|
|
|
7,466 |
|
Total
current assets |
|
|
187,801 |
|
|
|
237,102 |
|
Property
and equipment, net |
|
|
4,499 |
|
|
|
5,072 |
|
Intangible assets, net |
|
|
802 |
|
|
|
875 |
|
Goodwill |
|
|
949 |
|
|
|
949 |
|
Restricted cash |
|
|
917 |
|
|
|
917 |
|
Operating lease right-of-use asset |
|
|
14,126 |
|
|
|
15,949 |
|
Other
assets |
|
|
91 |
|
|
|
27 |
|
Total
assets |
|
$ |
209,185 |
|
|
$ |
260,891 |
|
Liabilities and Stockholders' Equity
(Deficit) |
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Accounts payable |
|
$ |
1,029 |
|
|
$ |
2,809 |
|
Accrued liabilities |
|
|
20,068 |
|
|
|
28,532 |
|
Deferred revenue, current portion |
|
|
120,280 |
|
|
|
121,267 |
|
Total
current liabilities |
|
|
141,377 |
|
|
|
152,608 |
|
Deferred
revenue, net of current portion |
|
|
140,873 |
|
|
|
180,059 |
|
Operating lease liabilities - long term |
|
|
11,746 |
|
|
|
13,975 |
|
Other
long term liabilities |
|
|
216 |
|
|
|
— |
|
Total
liabilities |
|
|
294,212 |
|
|
|
346,642 |
|
Commitments and contingencies |
|
|
|
|
|
Stockholders' equity (deficit): |
|
|
|
|
|
Convertible preferred stock |
|
|
— |
|
|
|
— |
|
Common stock |
|
|
1 |
|
|
|
1 |
|
Additional paid-in capital |
|
|
642,214 |
|
|
|
637,117 |
|
Accumulated other comprehensive income |
|
|
35 |
|
|
|
10 |
|
Accumulated deficit |
|
|
(727,277 |
) |
|
|
(722,879 |
) |
Total
stockholders' deficit |
|
|
(85,027 |
) |
|
|
(85,751 |
) |
Total
liabilities and stockholders' equity (deficit) |
|
$ |
209,185 |
|
|
$ |
260,891 |
|
__________________ |
(1) |
The condensed balance sheet as of December 31, 2022 was derived
from the audited financial statements included in the Company's
Annual Report on Form 10-K for the year ended December 31,
2022. |
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