CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of
conditionally activated, localized biologics, today reported third
quarter 2023 financial results and provided a business update.
“2023 has been a year of highly focused
execution against our key priorities, including continued progress
in Phase 1 dose escalation for CX-904 and the advancement of our
next-generation molecules CX-2051 and CX-801 towards IND filings
later this year. We have continued to diligently manage our
financial resources and drive towards value-inflecting pipeline
milestones,” said Sean McCarthy, D.Phil., chief executive officer
and chairman of CytomX Therapeutics.
Continued Dr. McCarthy, “Looking ahead to 2024,
we are on track to provide initial CX-904 Phase 1 dose escalation
data and to initiate our clinical evaluation of CX-2051 and CX-801,
leading to a potentially milestone-rich 2024 and 2025.”
Third Quarter Business Highlights and
Recent Developments
Pipeline
- CX-904, T-cell-engaging bispecific (TCB) targeted to
EGFRxCD3, 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 in an ongoing Phase
1 study in patients with advanced solid tumors. Backfilling of
certain dose escalation cohorts is being initiated during Q4 2023.
Initial Phase 1a data for CX-904 is anticipated in the first half
of 2024. A decision to initiate Phase 1b expansion cohorts in
certain EGFR positive tumor types is anticipated in 2024.
- Preclinical profile of EpCAM-directed antibody drug
conjugate CX-2051 presented at 2023 World ADC Conference –
In October 2023, Dr. Marcia Belvin, chief scientific officer,
CytomX Therapeutics, presented data characterizing the preclinical
profile for CX-2051. CX-2051 is tailored for treatment of
EpCAM-expressing cancers by matching target expression and tumor
sensitivity with a topoisomerase-1 inhibitor payload. EpCAM is a
broadly expressed, previously validated anti-cancer target that to
date has been limited in its development potential due to systemic,
on-target off-tumor dose-limiting toxicities. CX-2051 is designed
to mask target binding in normal tissues to potentially mitigate
systemic toxicities and open a therapeutic window. CX-2051 could
potentially address a large patient population as EpCAM is highly
expressed across many indications including colorectal, gastric,
endometrial, and ovarian cancers. The IND for CX-2051 is expected
to be filed by the end of 2023. CX-2051 Phase 1 dose escalation in
solid tumors is anticipated in 2024, with metastatic colorectal
cancer as a priority indication.
- IND filing for CX-801 (Interferon alpha-2b) expected by
year-end 2023 – CX-801 is a dually masked, Probody®
Therapeutic interferon alpha-2b. Interferon-alpha 2b was the first
approved cancer immunotherapy but has been limited in its clinical
use due to systemic toxicities. Preclinically, Probody® IFN-a2b has
demonstrated a widened predicted therapeutic index with an improved
tolerability profile compared to unmasked interferon alpha-2b,
including preferential anti-cancer activity in the tumor
microenvironment and increased anti-tumor effects when combined
with checkpoint inhibitors. In November 2023, at the Society for
Immunotherapy for Cancer (SITC) 38th Annual Meeting, additional
preclinical data were presented demonstrating enhancement of PD-1
anti-tumor efficacy and inflammation of the tumor microenvironment
by Probody IFN-a2b. An IND filing for CX-801 is expected by the end
of 2023 with planned clinical initiation in 2024.
- Continued progress in Phase 2 clinical evaluation of
Bristol Myers Squibb’s anti-CTLA-4 non-fucosylated Probody®,
BMS-986288 – In the first quarter of 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 more potent than ipilimumab (YERVOY®).
BMS-986288 utilizes CytomX’s Probody technology to potentially
localize the potent effect of the non-fucosylated CLTA-4 antibody
to tumors while reducing systemic toxicity. The Phase 2 clinical
evaluation of BMS-986288 is ongoing and includes proof of concept
studies for microsatellite stable (MSS) colorectal cancer (CRC) and
non-small cell lung cancer (NSCLC). BMS anticipates data from the
study will be available in 2024. CytomX and BMS continue to
collaborate on multiple preclinical research programs.
Corporate Alliances
- Continued progress in
strategic alliances – Throughout 2023, CytomX made
substantial progress across its research alliances including with
Astellas, where, in January, the first T-cell engaging bispecific
clinical candidate was nominated to proceed to IND enabling
activities. Additionally, CytomX initiated activities under its
newest collaborations with Regeneron and Moderna. Preclinical
research programs continue to progress across each of the Company’s
collaborations (Bristol Myers Squibb, Amgen, Astellas, Regeneron,
and Moderna) which extend the reach of the Company’s Probody
pipeline and provide for the potential to build value through the
achievement of future milestones and royalties.
Company Priorities and Potential
Milestones for 2023 and 2024
- CX-904 (EGFRxCD3): Continue enrollment into
Phase 1a dose escalation. Phase 1a dose escalation data are
expected in the first half of 2024. A decision to initiate Phase 1b
expansion cohorts in certain EGFR positive tumor types is
anticipated in 2024.
- CX-2051 (EpCAM):
File IND by the end of 2023 and begin Phase 1 dose escalation in
solid tumors with known EpCAM expression in 2024, with metastatic
colorectal cancer as a priority indication
- CX-801 (IFNa2b):
File IND by the end of 2023, with clinical initiation in 2024
- Next-Generation CTLA-4
Program: Continued clinical progress for BMS-986288
including proof-of-concept studies in MSS CRC and NSCLC. BMS
anticipates data from the study will be available in 20241.
- CX-2029 (CD71): Based on current priorities,
the Company will not be directing significant additional investment
in this program in the near-term.
- Collaborations:
Continuation of drug discovery activities with Bristol Myers
Squibb, Amgen, Astellas, Regeneron, and Moderna
Third Quarter 2023 Financial
Results
Cash, cash equivalents and investments totaled
$194.1 million as of September 30, 2023, compared to $180.9 million
as of June 30, 2023. The cash balance as of September 30, 2023,
includes approximately $30.0 million of gross proceeds from the
financing transaction that closed with BVF Partners L.P. in July of
2023, partially offset by cash burn of $16.8 million during the
third quarter of 2023.
Total revenue was $26.4 million for the three
months ended September 30, 2023, compared to $11.1 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 and the recent collaborations with Regeneron
and Moderna.
Research and development expenses decreased by $14.0 million
during the three months ended September 30, 2023, to $16.4 million,
compared to $30.4 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
$3.7 million during the three months ended September 30, 2023, to
$6.8 million, compared to $10.5 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, reduced
external vendor services, and lower building rent as a result of a
partial sublease of the Company’s headquarters.
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 activated ADC 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, and 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, 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-20512, a conditionally activated
ADC directed toward EpCAM, with potential applicability across
multiple EpCAM-expressing epithelial cancers. CytomX has
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 X
(formerly 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-2051,
CX-2029, BMS-986288, CX-904, and CX-801, 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 November 7, 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.com(212) 362-1200
___________________________
1 Bristol Myers Squibb Research and Development
Day, September 14, 20232 Licensed from Immunogen
CYTOMX THERAPEUTICS, INC. |
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS |
(in thousands, except share and per share
data) |
(Unaudited) |
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
September 30, |
|
|
September 30, |
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Revenues |
$ |
26,384 |
|
|
$ |
11,147 |
|
|
$ |
74,607 |
|
|
$ |
33,040 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
16,448 |
|
|
|
30,367 |
|
|
|
58,294 |
|
|
|
92,085 |
|
General and administrative |
|
6,813 |
|
|
|
10,490 |
|
|
|
22,191 |
|
|
|
32,782 |
|
Total operating expenses |
|
23,261 |
|
|
|
40,857 |
|
|
|
80,485 |
|
|
|
124,867 |
|
Income (loss) from
operations |
|
3,123 |
|
|
|
(29,710 |
) |
|
|
(5,878 |
) |
|
|
(91,827 |
) |
Interest income |
|
2,699 |
|
|
|
616 |
|
|
|
7,334 |
|
|
|
946 |
|
Other (expense) income, net |
|
(7 |
) |
|
|
30 |
|
|
|
(39 |
) |
|
|
339 |
|
Income (loss) before income
taxes |
|
5,815 |
|
|
|
(29,064 |
) |
|
|
1,417 |
|
|
|
(90,542 |
) |
Provision for income taxes |
|
2,823 |
|
|
|
— |
|
|
|
2,823 |
|
|
|
— |
|
Net income (loss) |
$ |
2,992 |
|
|
$ |
(29,064 |
) |
|
$ |
(1,406 |
) |
|
$ |
(90,542 |
) |
Other comprehensive income
(loss): |
|
|
|
|
|
|
|
|
|
|
|
Unrealized (loss) gain on short term investments, net of tax |
|
(98 |
) |
|
|
367 |
|
|
|
(73 |
) |
|
|
(553 |
) |
Comprehensive income (loss) |
$ |
2,894 |
|
|
$ |
(28,697 |
) |
|
$ |
(1,479 |
) |
|
$ |
(91,095 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per share: |
|
|
|
|
|
|
|
|
|
|
|
Basic |
$ |
0.04 |
|
|
$ |
(0.44 |
) |
|
$ |
(0.02 |
) |
|
$ |
(1.38 |
) |
Diluted |
$ |
0.04 |
|
|
$ |
(0.44 |
) |
|
$ |
(0.02 |
) |
|
$ |
(1.38 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Shares used to compute net income
(loss) per share |
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
80,731,951 |
|
|
|
65,912,334 |
|
|
|
71,225,433 |
|
|
|
65,618,162 |
|
Diluted |
|
80,991,722 |
|
|
|
65,912,334 |
|
|
|
71,225,433 |
|
|
|
65,618,162 |
|
CYTOMX THERAPEUTICS, INC. |
CONDENSED BALANCE SHEETS |
(in thousands, except share and per share
data) |
|
|
September 30, |
|
|
December 31, |
|
2023 |
|
|
2022 |
|
(Unaudited) |
|
|
(1) |
Assets |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
$ |
26,024 |
|
|
$ |
193,650 |
|
Short-term investments |
|
168,086 |
|
|
|
— |
|
Accounts receivable |
|
2,419 |
|
|
|
35,986 |
|
Prepaid expenses and other current assets |
|
4,675 |
|
|
|
7,466 |
|
Total current assets |
|
201,204 |
|
|
|
237,102 |
|
Property and equipment, net |
|
4,060 |
|
|
|
5,072 |
|
Intangible assets, net |
|
766 |
|
|
|
875 |
|
Goodwill |
|
949 |
|
|
|
949 |
|
Restricted cash |
|
917 |
|
|
|
917 |
|
Operating lease right-of-use
asset |
|
13,184 |
|
|
|
15,949 |
|
Other assets |
|
87 |
|
|
|
27 |
|
Total assets |
$ |
221,167 |
|
|
$ |
260,891 |
|
Liabilities and
Stockholders' Deficit |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
$ |
1,705 |
|
|
$ |
2,809 |
|
Accrued liabilities |
|
20,689 |
|
|
|
28,532 |
|
Deferred revenue, current portion |
|
124,396 |
|
|
|
121,267 |
|
Total current liabilities |
|
146,790 |
|
|
|
152,608 |
|
Deferred revenue, net of current
portion |
|
112,261 |
|
|
|
180,059 |
|
Operating lease liabilities -
long term |
|
10,597 |
|
|
|
13,975 |
|
Other long-term liabilities |
|
2,757 |
|
|
|
— |
|
Total liabilities |
|
272,405 |
|
|
|
346,642 |
|
Commitments and
contingencies |
|
|
|
|
Stockholders' deficit: |
|
|
|
|
Convertible preferred stock |
|
— |
|
|
|
— |
|
Common stock |
|
1 |
|
|
|
1 |
|
Additional paid-in capital |
|
673,109 |
|
|
|
637,117 |
|
Accumulated other comprehensive (loss) income |
|
(63 |
) |
|
|
10 |
|
Accumulated deficit |
|
(724,285 |
) |
|
|
(722,879 |
) |
Total stockholders' deficit |
|
(51,238 |
) |
|
|
(85,751 |
) |
Total liabilities and
stockholders' deficit |
$ |
221,167 |
|
|
$ |
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.
CytomX Therapeutics (NASDAQ:CTMX)
Gráfica de Acción Histórica
De Ago 2024 a Sep 2024
CytomX Therapeutics (NASDAQ:CTMX)
Gráfica de Acción Histórica
De Sep 2023 a Sep 2024