Tourmaline Bio Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Business Highlights
19 Março 2024 - 8:00AM
Tourmaline Bio, Inc. (Tourmaline) (NASDAQ: TRML), a late-stage
clinical biotechnology company developing transformative medicines
to dramatically improve the lives of patients with life-altering
immune and inflammatory diseases, today announced its financial
results for the fourth quarter and year ended December 31, 2023 and
outlined recent business highlights.
“2023 was a transformational year for
Tourmaline. We became a public company and continued our efforts to
lead an IL-6 renaissance with TOUR006, which we believe can achieve
a best-in-class profile by providing a long-acting,
patient-friendly treatment through low-volume subcutaneous
injections,” said Sandeep Kulkarni, MD, Co-Founder and Chief
Executive Officer of Tourmaline. “With the support of our expanding
team, the clinical and patient communities, and our shareholders,
we look forward to executing on our two strategic paths. We aim to
harness the exciting and emerging insights in the IL-6 field
towards addressing significant unmet medical needs in TED, ASCVD,
and other autoantibody and inflammation-driven diseases.”
Clinical Highlights and Upcoming
Milestones:
Tourmaline is pursuing development of TOUR006 in
two areas of high unmet need: FcRn+ and cardiovascular
inflammation.
FcRn+
- Tourmaline believes that TOUR006, a
long-acting, fully-human, anti-IL-6 monoclonal antibody, can
potentially deliver substantial therapeutic benefit to address a
wide range of autoantibody-driven disorders, including a more
durable response and patient-friendly administration than therapies
currently on the market or in clinical development by others.
- The pivotal spiriTED Phase 2b trial
in TED is currently enrolling, and Tourmaline continues to expect
topline data in the first half of 2025.
- Tourmaline plans to accelerate the
initiation of a pivotal Phase 3 trial evaluating subcutaneous
TOUR006 every 8 weeks as first-line treatment for TED in 2024, with
topline data expected in 2026.
- Tourmaline continues to explore
additional indications with significant unmet medical need under
its FcRn+ strategic path.
Cardiovascular Inflammation
- During 2023, Tourmaline reached
alignment with the U.S. Food and Drug Administration (FDA) on the
clinical development program of TOUR006 in ASCVD, and Tourmaline
received clearance for the related IND in March 2024.
- Tourmaline plans to commence a
Phase 2 trial evaluating quarterly subcutaneous dosing of TOUR006
in patients with elevated cardiovascular risk in the first half of
2024. Data from this Phase 2 trial are expected in the first half
of 2025.
Other Corporate Highlights:
- In October 2023, Tourmaline become
a publicly-traded company via reverse merger with Talaris
Therapeutics, including a concurrent private placement of $75.0
million.
- In December 2023, Tourmaline
expanded its Board of Directors with the appointment of Dr. Clay
Siegall as Chairman.
- Tourmaline also continued to expand
its executive leadership team during 2023, including the
appointments of Gerhard Hagn as SVP, Head of Commercial and
Business Development and Dr. Emil deGoma as SVP, Medical
Research.
- In December 2023, Tourmaline was
added to the NASDAQ Biotechnology Index (NASDAQ: NBI).
- In January 2024, Tourmaline
completed an underwritten follow-on public offering of its common
stock, which included the full exercise of the underwriters' option
to purchase additional shares, resulting in gross proceeds of
$172.5 million. Net proceeds were $161.3 million after deducting
underwriting discounts and offering expenses.
Fourth Quarter and Full Year 2023
Financial Results:
Cash Position
- Cash, cash equivalents and
investments were $203.0 million as of December 31, 2023, as
compared to $8.3 million as of December 31, 2022. Tourmaline
anticipates that its current cash, cash equivalents and investments
as of the date hereof, which includes $161.3 million of net
proceeds received from the January 2024 underwritten public
offering, will provide cash runway into 2027, funding key TOUR006
data readouts in TED and cardiovascular disease and the opportunity
to expand development efforts into additional indications.
Research and Development
Expenses
- Research and development expenses
were $8.0 million for the fourth quarter of 2023, as compared to
$3.8 million for the fourth quarter of 2022.
- Research and development expenses
were $32.4 million for the full year ended December 31, 2023,
as compared to $17.5 million for the full year ended
December 31, 2022.
- The increase in research and
development expenses for both periods was primarily driven by
employee compensation costs attributable to increased headcount,
costs associated with the manufacture of drug substance and drug
product for Tourmaline’s clinical trials, and clinical trial costs
related to the spiriTED trial.
General and Administrative
Expenses
- General and administrative expenses
were $6.9 million for the fourth quarter of 2023, as compared
to $1.1 million for the fourth quarter of 2022.
- General and administrative expenses
were $13.0 million for the full year ended December 31, 2023,
as compared to $2.2 million for the full year ended
December 31, 2022.
- The increase in general and
administrative expenses for both periods was primarily driven by
employee compensation costs attributable to increased headcount,
increased recruiting and commercial consulting expenses, and
increased professional service fees.
Net Loss
- Net loss was $12.9 million for the
fourth quarter of 2023 and $4.9 million for the fourth quarter of
2022, resulting in basic and diluted net loss per share of $0.81
and $5.51, respectively.
- Net loss was $42.1 million for the
full year ended December 31, 2023 and $19.7 million for the
full year ended December 31, 2022, resulting in basic and
diluted net loss per share of $8.87 and $22.46, respectively.
- The increase in net loss for both
periods was attributable to increased operating expenses and the
overall growth of Tourmaline during 2023 as compared to 2022. The
decrease in net loss per share for both periods was attributable to
the issuance of additional shares of common stock in conjunction
with the reverse merger and private placement that were completed
in October 2023.
About Tourmaline Bio:
Tourmaline is a late-stage clinical
biotechnology company driven by its mission to develop
transformative medicines that dramatically improve the lives of
patients with life-altering immune and inflammatory diseases.
Tourmaline’s lead asset is TOUR006.
About TOUR006:
TOUR006 is a long-acting, fully-human, anti-IL-6
monoclonal antibody with best-in-class potential and differentiated
properties including a naturally long half-life, low
immunogenicity, and high binding affinity to IL-6. To date, TOUR006
has been studied in 448 participants, including patients with
autoimmune disorders, across six clinical trials. Tourmaline is
developing TOUR006 in TED and ASCVD as its first two indications,
with additional diseases under consideration.
Cautionary Note Regarding
Forward-Looking Statements:
Any statements contained in this press release
that do not describe historical facts may constitute
forward-looking statements as that term is defined in the Private
Securities Litigation Reform Act of 1995. These statements may be
identified by words and phrases such as “believe,” “designed to,”
“expect,” “may,” “plan,” “potential,” “will” and similar
expressions, and are based on Tourmaline’s current beliefs and
expectations. These forward-looking statements include expectations
regarding the development and potential therapeutic benefits of
TOUR006; the timing of initiation, progress and results of
Tourmaline’s current and future clinical trials for TOUR006,
including reporting of data therefrom; the timing and potential of
preclinical research and development activities; market
opportunities; and Tourmaline’s anticipated cash runway. These
statements involve risks and uncertainties that could cause actual
results to differ materially from those reflected in such
statements. Risks and uncertainties that may cause actual results
to differ materially include uncertainties inherent in the
development of therapeutic product candidates, such as the risk
that any one or more of Tourmaline’s current or future product
candidates will not be successfully developed or commercialized;
the risk of delay or cessation of any planned clinical trials of
Tourmaline’s current or future product candidates; the risk that
prior results, such as signals of safety, activity or durability of
effect, observed from preclinical trials, will not be replicated or
will not continue in ongoing or future studies or clinical trials
involving Tourmaline’s current or future product candidates; the
risk that Tourmaline’s current or future product candidates or
procedures in connection with the administration thereof will not
have the safety or efficacy profile that Tourmaline anticipates;
risks regarding the accuracy of Tourmaline’s estimates of expenses,
capital requirements and needs for additional financing; changes in
expected or existing competition; changes in the regulatory
environment; the uncertainties and timing of the regulatory
approval process; unexpected litigation or other disputes; the
impacts of macroeconomic conditions Tourmaline’s business, clinical
trials and financial position; and other risks and uncertainties
that are described in Tourmaline’s Annual Report on Form 10-K filed
with the U.S. Securities and Exchange Commission (“SEC”) on or
about March 19, 2024 and other filings that Tourmaline makes with
the SEC from time to time. Any forward-looking statements speak
only as of the date of this press release and are based on
information available to Tourmaline as of the date hereof, and
Tourmaline assumes no obligation to, and does not intend to, update
any forward-looking statements, whether as a result of new
information, future events or otherwise.
Tourmaline Bio, Inc.Consolidated
Statements of Operations (unaudited)(amounts in
thousands, except per share data) |
|
|
|
|
|
Three Months EndedDecember
31, |
|
Year EndedDecember 31, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
8,015 |
|
|
$ |
3,794 |
|
|
$ |
32,368 |
|
|
$ |
17,526 |
|
General and administrative |
|
6,875 |
|
|
|
1,126 |
|
|
|
13,041 |
|
|
|
2,175 |
|
Total operating expenses |
|
14,890 |
|
|
|
4,920 |
|
|
|
45,409 |
|
|
|
19,701 |
|
Loss from operations |
|
(14,890 |
) |
|
|
(4,920 |
) |
|
|
(45,409 |
) |
|
|
(19,701 |
) |
Other income, net |
|
1,988 |
|
|
|
— |
|
|
|
3,285 |
|
|
|
— |
|
Net loss |
$ |
(12,902 |
) |
|
$ |
(4,920 |
) |
|
$ |
(42,124 |
) |
|
$ |
(19,701 |
) |
Net loss per share, basic and
diluted |
$ |
(0.81 |
) |
|
$ |
(5.51 |
) |
|
$ |
(8.87 |
) |
|
$ |
(22.46 |
) |
Weighted-average common shares
outstanding, basic and diluted |
|
16,003 |
|
|
|
893 |
|
|
|
4,747 |
|
|
|
877 |
|
Tourmaline Bio, Inc.Selected Consolidated
Balance Sheet Data (unaudited)(amounts in
thousands) |
|
December 31, |
|
|
2023 |
|
|
2022 |
|
Cash, cash equivalents and
investments |
$ |
202,951 |
|
$ |
8,258 |
|
Working capital |
$ |
203,872 |
|
$ |
6,949 |
|
Total assets |
$ |
210,295 |
|
$ |
9,098 |
|
Total stockholders’ equity
(deficit) |
$ |
205,042 |
|
$ |
(19,732 |
) |
Investor Contact:Meru AdvisorsLee M.
Sternlstern@meruadvisors.com
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