Talaris Therapeutics Announces First Quarter Financial Results and Corporate Update
May 12 2022 - 4:01PM
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-month period ended March 31, 2022, and provided an
update on its business.
“It has been a productive start to the year,” stated Scott
Requadt, Chief Executive Officer of Talaris. “We recently presented
at the 2022 Cutting Edge of Transplantation (CEoT) meeting and are
excited to present five abstracts at the upcoming American
Transplant Congress annual meeting that continue to highlight the
growing body of scientific evidence supporting FCR001’s potential
to achieve durable immune tolerance in kidney transplant patients.
Alongside the meeting, we also plan to provide an interim update on
our open-label FREEDOM-1 clinical study. With a strong balance
sheet to support our development initiatives, we look forward to
reporting on additional progress in our pipeline programs.”
Corporate Highlights
- Updated data from the Phase 3 (FREEDOM-1) clinical
trial of FCR001 in living donor kidney transplant (LDKT) to be
presented mid-year. 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. In November 2021,
the Company announced that all three evaluable patients treated
with FCR001 following kidney transplant demonstrated >50%
chimerism at 3-, 6- and 12-month timepoints post-transplant, and
that the two patients who were transplanted and dosed more than 12
months prior had successfully discontinued the use of chronic
immunosuppressive therapies. The Company continues to enroll
patients in this trial and has activated additional sites across
the United States. The Company will provide a further update on
this trial next month at ATC.
- Multiple abstracts to be presented at
the American Transplant Congress (ATC) taking place June 4-8,
2022. Five abstracts will be presented including new
long-term follow-up data from the successful Phase 2 study of
FCR001 in LDKT patients. In addition, the Company is presenting a
poster reflecting the results of a retrospective real-world
evidence analysis of the long-term health outcomes of Phase 2
patients treated with FCR001 compared to a cohort of matched
patients treated with standard of care.
- Presented data on COVID-19 outcomes among kidney
transplant patients treated with FCR001. In April, the
Company presented data at the 2022 Cutting Edge of Transplantation
(CEoT) meeting organized by the American Society of Transplantation
highlighting that a low rate of COVID-19 infection was observed in
vaccinated, durably chimeric patients off immunosuppression. No
evidence of acute kidney injury or impaired renal function was seen
in these patients and no patients lost chimerism as a result of
COVID-19 vaccination or infection. The Company will present
additional updated data on COVID-19 outcomes among kidney
transplant patients treated with FCR001 at ATC.
- Phase 2 (FREEDOM-2) clinical trial of FCR001 in LDKT
delayed tolerance induction. FREEDOM-2 is evaluating the
potential of FCR001 to induce durable immune tolerance in patients
who have previously received a kidney from a living donor (delayed
tolerance). Success in FREEDOM-2 would expand the LDKT patient
population and market potential for FCR001 by an estimated
6,000-10,000 patients annually.1 The Company recently activated its
second trial site for FREEDOM-2.
- Phase 2 (FREEDOM-3) clinical trial of FCR001 in
scleroderma. FREEDOM-3 is evaluating the safety and
efficacy of FCR001 in adults with a severe form of scleroderma, a
debilitating, complex and heterogeneous systemic autoimmune disease
affecting multiple tissues and organs. In systemic autoimmune
diseases, hematopoietic stem cell transplantation (HSCT) has
already been observed to be potentially curative. The Company
believes that positive proof-of-concept data from FREEDOM-3 has the
potential to both support the use of FCR001 in scleroderma as well
as other severe, systemic autoimmune diseases.
First Quarter Financial Results
- Cash, Cash Equivalents and Marketable Securities: Talaris
finished the first quarter of 2022 with $225.5 million in cash,
cash equivalents and marketable securities compared with $140.1
million as of March 31, 2021.
- R&D Expenses: Research and development expenses increased
to $14.2 million in the first quarter of 2022, up from $6.5 million
in the first 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, and increases
in facilities and other expenses.
- G&A Expenses: General and administrative expenses totaled
$4.2 million in the first quarter of 2022, up from $2.5 million in
the first quarter of 2021, primarily due to an increase in employee
headcount, increased professional fees, and an increase in
executive risk insurance premiums.
- Net Loss: The Company reported a net loss of $18.3 million, or
$0.45 per share, in the first quarter of 2022, compared with a net
loss of $9.3 million, or $1.30 per share, in the first 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, its cell
processing facility in Louisville, KY, and additional research
operations 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 FCR002; expectations regarding the timing and
data from the planned clinical update of FREEDOM-1, FREEDOM-2 or
FREEDOM-3; and expectations regarding Talaris’ use of capital,
expenses and other financial results during the first quarter ended
on March 31, 2022 and in the future. 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, 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 any additional
indications for FCR001; 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 the potential
urinary biomarker of immune quiescence, 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 March 31, 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 31, |
|
|
|
2022 |
|
|
|
2021 |
|
Operating expenses |
|
|
|
|
Research and development |
|
$ |
14,196 |
|
|
$ |
6,468 |
|
General and administrative |
|
|
4,218 |
|
|
|
2,537 |
|
Total operating expenses |
|
|
18,414 |
|
|
|
9,005 |
|
Loss from operations |
|
|
(18,414 |
) |
|
|
(9,005 |
) |
Interest and other income (expense), net |
|
|
155 |
|
|
|
(294 |
) |
Net loss |
|
$ |
(18,259 |
) |
|
$ |
(9,299 |
) |
Net loss per common share, basic and diluted |
|
$ |
(0.45 |
) |
|
$ |
(1.30 |
) |
Weighted average number of common shares outstanding used in
computation of net loss per common share, basic and diluted |
|
|
40,980,213 |
|
|
|
7,160,631 |
|
|
|
|
|
|
|
|
|
|
|
Balance Sheets Selected Financial Data |
(Unaudited, in thousands) |
|
|
|
|
|
|
|
As of March 31, |
|
As of December 31, |
|
|
|
2022 |
|
|
|
2021 |
|
Cash, cash equivalents and marketable securities |
|
$ |
225,529 |
|
|
$ |
243,971 |
|
Working capital |
|
|
220,353 |
|
|
|
238,527 |
|
Total assets |
|
|
237,246 |
|
|
|
251,422 |
|
Other liabilities |
|
|
3,151 |
|
|
|
626 |
|
Total liabilities |
|
|
11,216 |
|
|
|
8,613 |
|
Total stockholders' equity |
|
|
226,030 |
|
|
|
242,809 |
|
|
|
|
|
|
Media ContactLisa RaffenspergerTen Bridge
Communicationslisa@tenbridgecommunications.com(617)
903-8783
Investor ContactChris BrinzeyICR
Westwickechris.brinzey@westwicke.com (339)
970-2843
____________________1 Organ transplant population estimates
based on UNOS/OPTN data for patients 1 year to 18 months delayed
from incident LDKT
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