Talaris Therapeutics Announces Second Quarter 2021 Financial Results and Provides Business Update
August 12 2021 - 7:00AM
Talaris Therapeutics, Inc. (Nasdaq: TALS), a late-clinical stage
cell therapy company developing therapies with the potential to
transform the standard of care in solid organ transplantation,
certain severe autoimmune diseases, and certain severe
non-malignant blood, immune and metabolic disorders, today reported
financial results for the three- and six-month periods ended June
30, 2021, and provided an update on its business.
“As we enter the second half of 2021, we remain on track to
provide the first clinical update on our first FREEDOM-1 patients,”
stated Scott Requadt, Chief Executive Officer of Talaris. “Based on
what we observed in our Phase 2 trial, we believe that chimerism,
as early as three months post-transplant, has the potential to be
highly predictive of establishing durable tolerance to the donated
organ without chronic immunosuppression. We are also continuing to
advance the rest of our pipeline as we plan for two phase 2
clinical trial initiations in FCR001 in delayed tolerance induction
(FREEDOM-2) and in patients with a severe form of scleroderma
(FREEDOM-3). We also expect to announce an additional
indication for FCR001 before the end of this year.”
Corporate Highlights
- Initial safety and chimerism data from the Phase 3
FREEDOM-1 trial to be provided later this year. FREEDOM-1
is a randomized, controlled, open-label Phase 3 registrational
trial of FCR001 in 120 adult living donor kidney transplant
(“LDKT”) recipients in the United States. The primary endpoint of
FREEDOM-1 is the proportion of living donor kidney transplant
recipients treated with FCR001 who are free from chronic
immunosuppression, without proven biopsy rejection (“BPAR”), at
month 24 post-transplant. The Company plans to update investors on
both safety and chimerism status of evaluable patients who have
been followed for at least three months since dosing. Chimerism
refers to a condition whereby both the donor’s and the recipient’s
hematopoietic stem cells (“HSCs”) co-exist in the recipient’s bone
marrow. In the Company’s Phase 2 trial, achievement and maintenance
of >50% donor T-cell chimerism in the transplant recipient at
three-, six- and twelve months after administration of FCR001 all
correlated strongly with the transplant recipient’s ability to
durably discontinue chronic immunosuppression approximately one
year after transplant, without subsequent graft rejection.
- Added new clinical sites to its Phase 3 FREEDOM-1
trial. The Company has expanded its clinical trial
footprint to 14 active sites in the United States. The Company’s
clinical trial sites are geographically dispersed across the United
States and are all recognized as transplant centers of
excellence.
Program Updates and Milestones
- FCR001 in living donor kidney transplant
(LDKT). The Company’s lead product candidate, FCR001, is
currently in a randomized, controlled, open-label, multi-center
Phase 3 (FREEDOM-1) trial in the United States. FCR001 has been
granted Regenerative Medicine Advanced Therapy (“RMAT”) and Orphan
Drug designations by the U.S. Food and Drug Administration (“FDA”)
in this indication.
- FCR001 in delayed tolerance induction. The
Company remains on track to initiate a Phase 2 (FREEDOM-2) trial
for FCR001 in delayed tolerance induction in the fourth quarter of
2021. In FREEDOM-2, the Company will evaluate the potential for
FCR001 to induce immune tolerance to a transplanted kidney in
patients who received a kidney transplant from a living donor up to
a year prior to administration of FCR001.
- FCR001 in scleroderma. The Company remains on
track to initiate its first clinical trial in autoimmune diseases
with its FREEDOM-3 trial in the fourth quarter of 2021. FREEDOM-3
is a multi-center, single-arm, open-label, proof-of-concept Phase 2
trial assessing the safety and efficacy of FCR001 in adults with a
severe form of scleroderma at risk for organ failure.
- Potential applications in deceased donor organ
transplant. The Company continues to perform preclinical
research to explore the feasibility of developing a product
candidate similar to FCR001 from bone marrow procured from deceased
organ donors, for potential administration to recipients of a
deceased donor organ transplant.
- FCR001 in non-malignant blood, immune and metabolic
disorders. The Company remains on track to announce an
additional target indication for FCR001 relating to a severe
non-malignant blood, immune or metabolic disorder before the end of
2021.
Second Quarter 2021 Financial Results
- Cash, Cash Equivalents and Marketable Securities: Talaris
finished the second quarter of 2021 with $266.2 million in cash,
cash equivalents and marketable securities compared with $149.5
million as of December 31, 2020. Current cash and cash equivalents
are expected to fund pipeline development and operations into
2025.
- R&D Expenses: Research and development expenses increased
to $7.6 million in the second quarter of 2021, up from $3.4 million
in the second quarter of 2020. The increase in research and
development expenses was primarily due to an increase in employee
headcount necessary to support the growth of the Company’s research
and development efforts, increased clinical trials costs and an
increase in facilities and other expenses.
- G&A Expenses: General and administrative expenses totaled
$3.5 million in the second quarter of 2021, up from $1.3 million in
the second quarter of 2020, primarily due to an increase in
employee headcount, increased professional fees and an increase in
facilities and other expenses.
- Net Loss: The Company reported a net loss of $11.4 million, or
$0.41 per share, in the second quarter of 2021, compared with a net
loss of $4.7 million, or $0.73 per share, in the second quarter of
2020.
About Talaris TherapeuticsTalaris Therapeutics,
Inc. is a late-clinical stage biopharmaceutical company developing
investigational, one-time, allogeneic cell therapies with the
potential to transform the standard of care in solid organ
transplantation, certain severe autoimmune diseases, and certain
severe non-malignant blood, immune and metabolic disorders. Talaris
maintains corporate offices in Boston, MA, and at its cell
processing facility in Louisville, KY.
Cautionary Note Regarding Forward-Looking
StatementsThis press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995, as amended, including, without limitation,
implied and express statements regarding Talaris Therapeutics,
Inc.’s (“Talaris,” the “Company,” “we,” or “our”) strategy,
business plans and focus; the progress and timing of the
preclinical and clinical development of Talaris’ programs,
including FCR001 and FCR002; expectations regarding the timing and
data from the planned clinical update of FREEDOM-1; expectations
regarding Talaris’ use of capital, expenses and other financial
results during 2021 and in the future, and its ability to fund
operations into 2025. The words “may,” “might,” “will,” “could,”
“would,” “should,” “expect,” “plan,” “anticipate,” “intend,”
“believe,” “expect,” “estimate,” “seek,” “predict,” “future,”
“project,” “potential,” “continue,” “target” or the negative of
these terms and similar words or 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 and are subject to
a number of risks, uncertainties and important factors that may
cause actual events or results to differ materially from those
expressed or implied by any forward-looking statements contained in
this press release, including, without limitation, risks associated
with: the impact of COVID-19 on countries or regions in which the
Company has operations or does business, as well as on the timing
and anticipated timing and results of its clinical trials, strategy
and future operations, including the expected timing and results
from FREEDOM-1, the planned initiation of FREEDOM-2 and FREEDOM-3,
the planned initiation and timing of IND-enabling studies of FCR001
and FCR002 in deceased donor transplants and the announcement of an
additional indication for FCR001; the Company’s expectations
regarding its management hires; the risk that the results of
Talaris’ clinical trials may not be predictive of future results in
connection with future clinical trials; the Company’s ability to
successfully demonstrate the safety and efficacy of its drug
candidates; the timing and outcome of Talaris’ planned interactions
with regulatory authorities; and obtaining, maintaining and
protecting its intellectual property. These and other risks and
uncertainties are described in greater detail in the section
entitled “Risk Factors” in the Company’s Quarterly Report on Form
10-Q for the quarter ended June 30, 2021, as well as any subsequent
filings with the Securities and Exchange Commission. In addition,
any forward-looking statements represent Talaris’ views only as of
today and should not be relied upon as representing our views as of
any subsequent date. Talaris explicitly disclaims any obligation to
update any forward-looking statements. No representations or
warranties (expressed or implied) are made about the accuracy of
any such forward-looking statements.
Media ContactLisa RaffenspergerTen Bridge
Communicationslisa@tenbridgecommunications.com(617)
903-8783
Investor ContactChris BrinzeyWestwicke, an ICR
Companychris.brinzey@westwicke.com(339)
970-2843
|
TALARIS THERAPEUTICS, INC (TALS) |
Statements of Operations |
(Unaudited, in thousands, except share and per share
amounts) |
|
|
Three months ended June 30, |
|
2021 |
|
2020 |
Operating expenses |
|
|
|
Research and development |
$ |
7,570 |
|
|
$ |
3,402 |
|
General and administrative |
|
3,487 |
|
|
|
1,335 |
|
Total operating expenses |
|
11,057 |
|
|
|
4,737 |
|
Loss from operations |
|
(11,057 |
) |
|
|
(4,737 |
) |
Interest and other income (expense), net |
|
(295 |
) |
|
|
74 |
|
Net loss |
$ |
(11,352 |
) |
|
$ |
(4,663 |
) |
Net loss per common share, basic and diluted |
$ |
(0.41 |
) |
|
$ |
(0.73 |
) |
Weighted average number of common shares outstanding used in
computation of net loss per common share, basic and diluted |
|
27,373,165 |
|
|
|
6,397,025 |
|
|
|
|
|
|
|
|
|
Balance Sheets Selected Financial Data |
|
|
|
|
|
As ofJune 30, |
|
As ofDecember 31, |
|
2021 |
|
2020 |
Cash, cash equivalents and marketable securities |
$ |
266,220 |
|
|
$ |
149,488 |
|
Working capital |
|
265,809 |
|
|
|
147,347 |
|
Total assets |
|
272,814 |
|
|
|
152,778 |
|
Other liabilities |
|
800 |
|
|
|
1,369 |
|
Total liabilities |
|
5,461 |
|
|
|
4,774 |
|
Total convertible preferred stock and stockholders' deficit |
|
267,353 |
|
|
|
148,004 |
|
|
|
|
|
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