Talaris Therapeutics Announces Second Quarter Financial Results and Corporate Update
August 15 2022 - 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 and
severe immune and blood disorders, today reported financial results
for the three- and six-month periods ended June 30, 2022 and
provided an update on its business.
“The interim data from our Phase 3 FREEDOM-1 trial update this
quarter highlighted that all patients treated with FCR001 at least
three months prior to the data cutoff date had achieved and
maintained chimerism at all measured timepoints post-transplant,”
stated Scott Requadt, Chief Executive Officer of Talaris. “In
addition, all patients 12-months post-transplant, including the
first patient now 24 months out, had been successfully weaned off
chronic anti-rejection drugs and continued to remain off these
drugs. With 17 centers actively recruiting patients, we expect to
increase the enrollment rate of our Phase 3 FREEDOM-1 trial.”
Mr. Requadt added: “I also would like to take a moment to
acknowledge the extraordinary contributions of Dr. Suzanne Ildstad
who will be stepping into the newly created role of Senior
Scientific Advisor at the end of the month. On behalf of the Board
and the entire Talaris Team, I want to thank Suzanne for her
contributions in advancing the field of immune tolerance, for her
entrepreneurialism in forming what has become Talaris today, and
most notably, for her vision and compassion for patients who want
to live a life free of immunosuppression.”
Corporate Highlights
- Dr. Suzanne Ildstad, Chief Scientific Officer and
Founder, to become Senior Scientific Advisor. Effective
August 31, 2022, Dr. Ildstad will transition from her current role
as CSO to being a Senior Scientific Advisor to Talaris. Dr. Ildstad
will continue to advise the company on key scientific matters,
remain on Talaris’ Scientific Advisory Board and continue as a
member of Talaris’ Board of Directors.
- Further strengthened Board of Directors with the
appointment of Karen Smith, M.D., Ph.D., MBA, LLM. Dr.
Smith joined the Board following the resignation of Nicholas
Galakatos, Ph.D., in May. Dr. Smith brings with her over 20 years
of experience in the biopharmaceutical industry overseeing more
than 50 clinical trials and more than 20 regulatory approvals
leading to global product launches of small molecules, biologics
and devices.
Pipeline Highlights
- Provided update as of the June 15 data cut-off date
from Phase 3 (FREEDOM-1) clinical trial evaluating FCR001 in living
donor kidney transplant (LDKT) recipients. 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 June 2022, the Company announced that all
evaluable patients treated with FCR001 following kidney transplant
had achieved and maintained >50% chimerism levels at each of the
3-, 6- and 12-month timepoints post-transplant, and that the three
patients who were transplanted and dosed more than 12 months prior,
with the first patient dosed 24 months prior, had successfully
discontinued the use of chronic anti-rejection drugs.The safety
profile observed was generally consistent with that expected in
patients receiving a kidney transplant and an allogeneic
hematopoietic stem cell transplant (HSCT). Three cases of
low-grade, acute graft-versus-host disease were reported, all of
which were treatment-responsive and had resolved. One of these
patients subsequently developed chronic graft-versus-host disease,
which responded to treatment. The Company continues to enroll
patients and is in the process of expanding its eligibility
criteria to certain additional patient groups to accelerate patient
recruitment. The Company has 17 active sites across the United
States.
- Presented multiple oral presentations and posters at
the American Transplant Congress 2022. Data from a
real-world, retrospective analysis of Phase 2 patients dosed with
FCR001 versus matched controls found that FCR001-treated patients
had improved kidney function and fewer cardiometabolic
complications than patients on immunosuppression after five years.
Additionally, an oral presentation highlighted long-term follow up
data from the Company’s Phase 2 trial showing that all patients who
were originally weaned off chronic anti-rejection drugs continued
to remain off without rejecting their donated kidney.
- 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). Positive results from FREEDOM-2 could potentially
expand the LDKT patient population and market 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, HSCT has already been observed to be potentially
curative, albeit with significant risks. 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.
Second Quarter Financial Results
- Cash, Cash Equivalents and Marketable Securities: Talaris
finished the second quarter of 2022 with $207.1 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 $13.2 million in the second quarter of 2022, up from $7.6
million in the second 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
$5.2 million in the second quarter of 2022, up from $3.5 million in
the second 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 $18.1 million, or
$0.44 per share, in the second quarter of 2022, compared with a net
loss of $11.4 million, or $0.41 per share, in the second 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 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
second quarter ended on June 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 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 June 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 June 30, |
|
|
|
|
2022 |
|
|
|
2021 |
|
|
Operating
expenses |
|
|
|
|
|
Research and development |
|
$ |
13,187 |
|
|
$ |
7,570 |
|
|
General and administrative |
|
|
5,228 |
|
|
|
3,487 |
|
|
Total operating expenses |
|
|
18,415 |
|
|
|
11,057 |
|
|
Loss from
operations |
|
|
(18,415 |
) |
|
|
(11,057 |
) |
|
Interest and
other income (expense), net |
|
|
319 |
|
|
|
(295 |
) |
|
Net loss |
|
$ |
(18,096 |
) |
|
$ |
(11,352 |
) |
|
Net loss per
common share, basic and diluted |
|
$ |
(0.44 |
) |
|
$ |
(0.41 |
) |
|
Weighted
average number of common shares outstanding used in computation of
net loss per common share, basic and diluted |
|
|
41,088,085 |
|
|
|
27,373,165 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance Sheets Selected Financial Data |
|
(Unaudited, in thousands) |
|
|
|
|
|
|
|
|
|
As of June 30, |
|
As of December 31, |
|
|
|
|
2022 |
|
|
|
2021 |
|
|
Cash, cash equivalents and marketable securities |
|
$ |
207,112 |
|
|
$ |
243,971 |
|
|
Working capital |
|
|
204,706 |
|
|
|
238,527 |
|
|
Total assets |
|
|
220,916 |
|
|
|
251,422 |
|
|
Other liabilities |
|
|
2,843 |
|
|
|
626 |
|
|
Total liabilities |
|
|
10,174 |
|
|
|
8,613 |
|
|
Total stockholders' equity |
|
|
210,742 |
|
|
|
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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