TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage
biopharmaceutical company focused on the development of T cell
receptor (TCR)-engineered T cell (TCR-T) therapies for the
treatment of patients with cancer, today reported financial results
for the first quarter ended March 31, 2024, and provided a
corporate update.
“During the first quarter we advanced our
clinical pipeline, most recently marked by the dosing of the first
patient in our Phase 1 solid tumor program. This is a significant
milestone on the way to developing enhanced, customized, multiplex
TCR-T therapy. We continue to prioritize screening patients for
this study to enable rapid enrollment, and I am pleased to announce
that we are on track to sharing initial data later this year,” said
Gavin MacBeath, Ph.D., Chief Executive Officer. “At the same time,
we remain focused on enrolling and following patients in our heme
malignancies study. We plan to complete Phase 1 enrollment and open
expansion cohorts at the proposed recommended Phase 2 dose in the
third quarter of 2024 and provide a data update near the end of
2024. With the recent closing of our public offering, TScan is
well-funded to execute on anticipated milestones into the fourth
quarter of 2026.”
Recent Corporate Highlights
- The Company recently announced that
the first patient has been dosed in its Phase 1 clinical trial
evaluating TCR-T therapy for the treatment of various solid tumors.
The Company is initially dosing patients with singleplex therapy to
establish safety prior to initiating dosing with multiplex TCR-T
(T-Plex). Patients are prospectively assigned to a treatment cohort
based on expression of cancer-associated antigens and human
leukocyte antigens (HLAs) in their tumor samples. The first
patient, who has metastatic melanoma, was dosed with TSC-203-A0201,
a TCR-T targeting PReferentially expressed Antigen in MElanoma
(PRAME) on HLA-A*02:01. The Company expects robust patient
enrollment as over 60 patients have completed all biomarker testing
in the screening protocol. Of these patients, approximately 55%
qualify for at least one TCR-T in the ImmunoBank and approximately
30% could qualify for multiplex therapy.
- The Company recently provided an
update on its Phase 1 heme malignancies program designed to treat
residual disease and prevent relapse in patients with acute myeloid
leukemia (AML), acute lymphocytic leukemia (ALL), or
myelodysplastic syndromes (MDS). The update included additional
follow-up on all eight treatment-arm patients as well as data on
two additional control-arm patients. With a median follow-up of
>10 months, all eight patients treated with TSC-100 or TSC-101
remain relapse-free with no detectable disease. No dose-limiting
toxicities were observed. In contrast, two control-arm patients
relapsed approximately six months post-transplant and one of these
patients died approximately three months later. A third control-arm
patient required clinical intervention because of concerns of
impending relapse, and a fourth control-arm patient died
post-transplant.
- In April 2024, the Company
announced the closing of an upsized $167.8 million underwritten
public offering with participation from new and existing
high-quality healthcare investors. The financing extends the
Company’s cash runaway into the fourth quarter of 2026. The Company
intends to use the net proceeds to advance its heme and solid tumor
programs and expand and optimize its manufacturing capabilities, as
well as for general corporate purposes.
- The Company announced two upcoming
poster presentations at the 2024 American Society of Clinical
Oncology (ASCO) Annual Meeting being held May 31–June 4 both in
Chicago and virtually. Details on the respective presentations can
be found here.
- The Company recently presented at
two major medical meetings:
- American Society of Gene and Cell
Therapy (ASGCT) 27th Annual Meeting
- American Association for Cancer
Research (AACR) Annual Meeting 2024
Presentation materials from the meetings can be
found on the “Publications” tab of TScan’s website at
tscan.com.
Upcoming Anticipated
Milestones
Heme Malignancies Program: TScan’s two lead
TCR-T therapy candidates, TSC-100 and TSC-101, are designed to
treat residual disease and prevent relapse in patients with AML,
ALL, or MDS undergoing allogeneic hematopoietic cell
transplantation (HCT) (NCT05473910).
- Opening of expansion cohorts at the
proposed recommended Phase 2 dose level to further characterize
safety and evaluate translational and efficacy endpoints is planned
for the third quarter of 2024.
- Completion of Phase 1 enrollment
and reporting of one-year clinical and translational data on
initial patients is anticipated in the second half of 2024.
- Expects to initiate registration
trial pending feedback from regulatory authorities and report
two-year clinical and translational data in 2025.
Solid Tumor Program: TScan continues to expand
the ImmunoBank, a collection of therapeutic TCR-Ts that target
different cancer-associated antigens presented on diverse HLA
types. TScan’s strategy is to treat patients with multiple TCR-Ts
to overcome tumor heterogeneity and prevent resistance that may
arise from either target or HLA loss (screening
protocol: NCT05812027; treatment
protocol: NCT05973487).
- Phase 1 solid tumor clinical study
has been initiated; first patient dosed in early May, with three
additional patients enrolled and manufacturing underway.
- Initial data expected in the second
half of 2024.
- Additional investigational new drug
(IND) filings planned to continue to expand the ImmunoBank.
- Long-term duration of response data
for multiplex therapy anticipated in 2025.
First Quarter 2024 Financial
Results
Revenue: Revenue for the first
quarter of 2024 was $0.6 million, compared to $6.8 million for the
first quarter of 2023. The decrease was primarily due to the timing
of research activities pursuant to the Company’s collaboration
agreements. Revenue for the first quarter of 2024 was related
solely to the collaboration agreement with Amgen which commenced in
May 2023. Revenue for the first quarter of 2023 was related solely
to the collaboration agreement with Novartis, which concluded in
March 2023.
R&D Expenses: Research and
development expenses for the first quarter of 2024 were $24.9
million, compared to $21.8 million for the first quarter of 2023.
The increase of $3.1 million was primarily driven by an increase in
personnel expenses due to additional headcount in support of
expanded research and development activities, as well as an
increase in clinical studies expense associated with the ongoing
enrollment of our Phase 1 heme study and start-up activities for
the Phase 1 solid tumor clinical trial. Research and development
expenses included non-cash stock compensation expense of $1.1
million and $0.4 million for the first quarter of 2024 and 2023,
respectively.
G&A Expenses: General and
administrative expenses for the first quarter of 2024 were $7.1
million, compared to $7.8 million for the first quarter of 2023.
The decrease of $0.7 million was primarily driven by lower
facility-related and personnel costs. General and administrative
expenses included non-cash stock compensation expense of $0.9
million and $0.7 million for the first quarter of 2024 and 2023,
respectively.
Net Loss: Net loss was $30.1
million for the first quarter of 2024, compared to $22.6 million
for the first quarter of 2023, and included net interest income of
$1.2 million and $0.2 million, respectively.
Cash Position: Cash, cash
equivalents, and marketable securities as of March 31, 2024, were
$162.8 million, excluding $5.0 million of restricted cash. The
Company believes that its existing cash resources along with the
$161.4 million net proceeds received from its April 2024
underwritten public offering will be sufficient to fund its current
operating plan into the fourth quarter of 2026.
Share Count: As of March 31,
2024, the Company had issued and outstanding shares of 47,904,737,
which consists of 43,628,149 shares of voting common stock and
4,276,588 shares of non-voting common stock, and outstanding
pre-funded warrants to purchase 47,010,526 shares of voting common
stock at an exercise price of $0.0001 per share.
Subsequent to the end of the first quarter of
2024, in connection with its April 2024 underwritten public
offering, the Company issued an additional 4,958,068 shares of
voting common stock, and pre-funded warrants to purchase up to
18,577,419 shares of voting common stock with an exercise price of
$0.0001 per share.
About TScan Therapeutics,
Inc.
TScan is a clinical-stage biopharmaceutical
company focused on the development of T cell receptor
(TCR)-engineered T cell (TCR-T) therapies for the treatment of
patients with cancer. The Company’s lead TCR-T candidates, TSC-100
and TSC-101, are in development for the treatment of patients with
hematologic malignancies to prevent relapse following allogeneic
hematopoietic cell transplantation. The Company is also developing
TCR-T candidates for the treatment of various solid tumors. The
Company has developed and continues to expand its ImmunoBank, the
Company’s repository of therapeutic TCRs that recognize diverse
targets and are associated with multiple HLA types, to provide
customized multiplex therapeutic TCR-Ts for patients with a variety
of cancers.
Forward-Looking Statements
This release contains forward-looking statements
within the meaning of the Private Securities Litigation Reform Act
of 1995, including, but not limited to, express or implied
statements regarding the Company’s plans, progress, and timing
relating to the Company’s hematologic malignancies program,
including potential indicators of treatment success, completion of
enrollment and opening of expansion cohorts, the presentation of
data, and initiation of registration trials; the Company’s plans,
progress, and timing relating to the Company’s solid tumor
programs, including treatment of patients and the presentation of
data; the progress of the solid tumor and hematologic malignancies
programs being indicative or predictive of the success of each
program; the Company’s current and future research and development
plans or expectations; the structure, timing and success of the
Company’s planned preclinical development, submission of INDs, and
clinical trials; the potential benefits of any of the Company’s
proprietary platforms, multiplexing, or current or future product
candidates in treating patients; the Company’s ability to fund its
operating expenses and capital expenditure requirements with its
existing cash and cash equivalents; and the Company’s goals and
strategy, focus, and anticipated financial performance. TScan
intends such forward-looking statements to be covered by the safe
harbor provisions for forward-looking statements contained in
Section 21E of the Securities Exchange Act of 1934 and the Private
Securities Litigation Reform Act of 1995. In some cases, you can
identify forward-looking statements by terms such as, but not
limited to, “may,” “might,” “will,” “objective,” “intend,”
“should,” “could,” “can,” “would,” “expect,” “believe,”
“anticipate,” “project,” “target,” “design,” “estimate,” “predict,”
“potential,” “plan,” “on track,” or similar expressions or the
negative of those terms. Such forward-looking statements are based
upon current expectations that involve risks, changes in
circumstances, assumptions, and uncertainties. The express or
implied forward-looking statements included in this release are
only predictions and are subject to a number of risks,
uncertainties and assumptions, including, without limitation: the
beneficial characteristics, safety, efficacy, therapeutic effects
and potential advantages of TScan’s TCR-T therapy candidates;
TScan’s expectations regarding its preclinical studies being
predictive of clinical trial results; TScan’s recently approved
INDs being indicative or predictive of bringing TScan closer to its
goal of providing customized TCR-T therapies to treat patients with
cancer; the timing of the launch, initiation, progress, expected
results and announcements of TScan’s preclinical studies, clinical
trials and its research and development programs; TScan’s ability
to enroll patients for its clinical trials within its expected
timeline; TScan’s plans relating to developing and commercializing
its TCR-T therapy candidates, if approved, including sales
strategy; estimates of the size of the addressable market for
TScan’s TCR-T therapy candidates; TScan’s manufacturing
capabilities and the scalable nature of its manufacturing process;
TScan’s estimates regarding expenses, future milestone payments and
revenue, capital requirements and needs for additional financing;
TScan’s expectations regarding competition; TScan’s anticipated
growth strategies; TScan’s ability to attract or retain key
personnel; TScan’s ability to establish and maintain development
partnerships and collaborations; TScan’s expectations regarding
federal, state and foreign regulatory requirements; TScan’s ability
to obtain and maintain intellectual property protection for its
proprietary platform technology and our product candidates; the
sufficiency of TScan’s existing capital resources to fund its
future operating expenses and capital expenditure requirements; and
other factors that are described in the “Risk Factors” and
“Management’s Discussion and Analysis of Financial Condition and
Results of Operations” sections of TScan’s most recent Annual
Report on Form 10-K and any other filings that TScan has made or
may make with the SEC in the future. Any forward-looking statements
contained in this release represent TScan’s views only as of the
date hereof and should not be relied upon as representing its views
as of any subsequent date. Except as required by law, TScan
explicitly disclaims any obligation to update any forward-looking
statements.
Contacts
Heather SavelleTScan Therapeutics, Inc.VP,
Investor Relations857-399-9840hsavelle@tscan.com
Maghan MeyersArgot
Partners212-600-1902TScan@argotpartners.com
|
TScan Therapeutics, Inc. |
Condensed Consolidated Balance Sheet Data |
(unaudited, in thousands, except share
amount) |
|
|
|
|
|
March 31,2024 |
|
December 31, 2023 |
Assets |
|
|
|
Cash and cash equivalents |
$ |
140,513 |
|
$ |
133,359 |
Other assets |
|
100,319 |
|
|
138,790 |
Total assets |
$ |
240,832 |
|
$ |
272,149 |
Liabilities and
Stockholders' Equity |
|
|
|
|
Total liabilities |
$ |
117,865 |
|
$ |
121,282 |
Total stockholders' equity |
|
122,967 |
|
|
150,867 |
Total liabilities and stockholders' deficit |
$ |
240,832 |
|
$ |
272,149 |
Common stock and pre-funded warrants outstanding (1) |
|
94,915,263 |
|
94,840,055 |
|
(1) Both periods
include outstanding pre-funded warrants to purchase 47,010,526
shares of voting common stock at an exercise price of $0.0001 per
share. |
|
TScan Therapeutics, Inc. |
Condensed Consolidated Statements of
Operations |
(unaudited, in thousands, except share and per share
amounts) |
|
|
|
|
|
Three Months Ended March 31, |
|
2024 |
|
2023 |
Revenue |
|
|
|
Collaboration and license revenue |
$ |
566 |
|
|
$ |
6,803 |
|
Operating expenses: |
|
|
|
Research and development |
|
24,857 |
|
|
|
21,779 |
|
General and administrative |
|
7,082 |
|
|
|
7,767 |
|
Total operating expenses |
|
31,939 |
|
|
|
29,546 |
|
Loss from operations |
|
(31,373 |
) |
|
|
(22,743 |
) |
Interest and other income, net |
|
2,190 |
|
|
|
1,136 |
|
Interest expense |
|
(959 |
) |
|
|
(956 |
) |
Net loss |
$ |
(30,142 |
) |
|
$ |
(22,563 |
) |
Net loss per share, basic and
diluted |
$ |
(0.32 |
) |
|
$ |
(0.93 |
) |
Weighted average common shares
outstanding—basic and diluted (2) |
|
94,875,893 |
|
|
|
24,225,954 |
|
|
(2) For the three
months ended March 31, 2024, 47,010,526 shares of the Company's
voting common stock issuable upon exercise of the pre-funded
warrants are included as outstanding common stock in the
calculation of basic and diluted net loss per share. |
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