Talaris Therapeutics Announces Third Quarter Financial Results and Corporate Update
10 November 2022 - 11:00PM
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 and
severe immune and blood disorders, today reported financial results
for the three- and nine-month periods ended September 30, 2022 and
provided an update on its business.
“Patient safety remains our top priority and we continue to
maintain rigorous oversight of patients participating in our
clinical trials,” stated Scott Requadt, Chief Executive Officer of
Talaris. “Our Scientific Advisory Board and the FREEDOM-1 Data
Monitoring Committee (DMC) have endorsed modifications to the
FREEDOM-1 protocol that were triggered by the higher incidence of
graft-versus-host disease (GvHD) that was reported in June 2022.
Our investigators continue to remain committed to our programs and
we continue to enroll patients in our FCR001 clinical studies.”
Corporate & Pipeline Highlights
- Presented data on FCR001 at the 2022 American Society
of Nephrology (ASN) Annual Meeting. In November, the
Company presented data on mRNA transcriptional changes following
successful tolerization with FCR001. This urinary cell mRNA
signature may help identify patients who could safely discontinue
chronic immunosuppression. In addition, the Company reported data
on the immune landscape of patients’ peripheral blood mononuclear
cells (PBMCs) following treatment with FCR001 in a small cohort of
patients enrolled in the Company’s Phase 3 FREEDOM-1 trial. The
analysis found unique patterns of immune cell types, cell states,
and transcriptional activity that may underlie FCR001’s mechanisms
of inducing immune tolerance.
- Expanded management team with the addition of Senior
Vice President of Clinical Operations. In October, the
Company added a key executive to the Talaris clinical team.
Courtney Wells brings over 20 years of clinical operations
experience at several biotech companies including AveXis, Avadel
Pharmaceuticals, and mostly recently at Jaguar Gene Therapy. Ms.
Wells will oversee clinical operations including patient
recruitment and trial management.
- Three clinical trials continue enrollment.
Talaris continues to study its investigational product FCR001 in
three clinical trials including FREEDOM-1, a Phase 3 clinical trial
in LDKT patients, FREEDOM-2, a Phase 2 clinical trial in LDKT
delayed tolerance induction, and FREEDOM-3, a Phase 2 clinical
trial evaluating the safety and efficacy of FCR001 in adults with a
severe form of scleroderma, a systemic autoimmune disease.FREEDOM-1
is a randomized, controlled, open-label, multi-center Phase 3
registrational trial of FCR001 in 120 adult LDKT recipients in the
United States. The primary endpoint of FREEDOM-1 is the proportion
of kidney transplant recipients treated with FCR001 who are free
from chronic immunosuppression, without biopsy-proven acute
rejection (BPAR), at month 24 post-transplant. The Company is
enrolling and dosing patients in this trial. On October 20, 2022,
the Company reported the death of a patient in the FREEDOM-1
clinical trial. In light of modifications to the study protocol
that were already implemented in June 2022 to mitigate the risk of
GvHD, the FREEDOM-1 DMC recommended the study may continue without
further modifications.
Third Quarter Financial Results
- Cash, Cash Equivalents and Marketable Securities: Talaris
finished the third quarter of 2022 with $193.9 million in cash,
cash equivalents, and marketable securities compared with $244.0
million as of December 31, 2021.
- R&D Expenses: Research and development expenses increased
to $15.0 million in the third quarter of 2022, up from $9.2 million
in the third quarter of 2021. 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 for
increased enrollment and additional site activations, increased
patient advocacy and recruitment efforts, and increases in
facilities and other expenses.
- G&A Expenses: General and administrative expenses totaled
$4.8 million in the third quarter of 2022, up from $3.9 million in
the third quarter of 2021, primarily due to an increase in employee
headcount and increased professional fees.
- Net Loss: The Company reported a net loss of $19.0 million, or
$0.46 per share, in the third quarter of 2022, compared with a net
loss of $12.9 million, or $0.32 per share, in the third quarter of
2021.
About Talaris TherapeuticsTalaris Therapeutics,
Inc. is a late-clinical stage cell therapy company developing
therapies with the potential to transform the standard of care in
solid organ transplantation and severe immune and blood disorders.
Talaris maintains corporate offices in Boston, MA, a GMP cell
processing facility in Louisville, KY, and research and development
laboratories in Houston, TX.
Cautionary Note Regarding Forward-Looking
Statements This 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 the rate of enrollment for its clinical
trials; expectations regarding the timing and data from the planned
clinical update of FREEDOM-1, FREEDOM-2 or FREEDOM-3, including
potential safety, tolerability and therapeutics effects;
expectations around the anticipated contribution of the members of
Talaris’ board of directors and executives to its operations and
progress; and expectations regarding Talaris’ growth as a company
and use of capital, expenses and other financial results during the
third quarter ended on September 30, 2022 and in the future as well
as Talaris’ expected cash runway through 2024. 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 risk that the results of Talaris’ clinical
trials, including the early data from the FREEDOM-1 study, may not
be predictive of future results in connection with future clinical
trials; the Company’s expectations regarding future safety and
efficacy following the implementation of a protocol amendment in
FREEDOM-1 and the Company’s ability to successfully demonstrate the
safety and efficacy of its drug candidates more generally; 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 September 30, 2022, 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.
|
|
TALARIS THERAPEUTICS, INC (TALS) |
|
Statements of Operations |
|
(Unaudited, in thousands, except share and per share
amounts) |
|
|
|
|
|
Three Months Ended September 30, |
|
|
|
|
2022 |
|
|
|
2021 |
|
|
Operating
expenses |
|
|
|
|
|
Research and development |
|
$ |
14,981 |
|
|
$ |
9,183 |
|
|
General and administrative |
|
|
4,842 |
|
|
|
3,874 |
|
|
Total operating expenses |
|
|
19,823 |
|
|
|
13,057 |
|
|
Loss from
operations |
|
|
(19,823 |
) |
|
|
(13,057 |
) |
|
Interest and
other income (expense), net |
|
|
812 |
|
|
|
116 |
|
|
Net loss |
|
$ |
(19,011 |
) |
|
$ |
(12,941 |
) |
|
Net loss per
common share, basic and diluted |
|
$ |
(0.46 |
) |
|
$ |
(0.32 |
) |
|
Weighted
average number of common shares outstanding used in computation of
net loss per common share, basic and diluted |
|
|
41,375,537 |
|
|
|
40,669,412 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance Sheets Selected Financial Data |
|
(Unaudited, in thousands) |
|
|
|
|
|
|
|
|
|
As of September 30, |
|
As of December 31, |
|
|
|
|
2022 |
|
|
|
2021 |
|
|
Cash, cash equivalents and marketable securities |
|
$ |
193,869 |
|
|
$ |
243,971 |
|
|
Working capital |
|
|
188,959 |
|
|
|
238,527 |
|
|
Total assets |
|
|
206,544 |
|
|
|
251,422 |
|
|
Other liabilities |
|
|
2,509 |
|
|
|
626 |
|
|
Total liabilities |
|
|
11,677 |
|
|
|
8,613 |
|
|
Total stockholders' equity |
|
|
194,867 |
|
|
|
242,809 |
|
|
|
|
|
|
|
|
Media ContactLisa RaffenspergerTen Bridge
Communicationslisa@tenbridgecommunications.com(617)
903-8783
Investor ContactChris BrinzeyICR
Westwickechris.brinzey@westwicke.com(339)
970-2843
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