TransCode Therapeutics Reports Business Progress and Second Quarter 2021 Financial Results
August 23 2021 - 4:01PM
Business Wire
Completed initial public offering of common
stock, raising $28.8 million in gross proceeds
Awarded $2.3 million in funding from NIH to
support clinical evaluation of TTX-MC138
On track to submit eIND application for
TTX-MC138 in Q1 2022
TransCode Therapeutics, Inc. (Nasdaq: RNAZ), an emerging RNA
oncology company, created on the belief that cancer can be defeated
through the intelligent design and effective delivery of RNA
therapeutics, today reported recent business progress and second
quarter 2021 financial results.
“2021 has so far been foundational for TransCode, highlighted by
our recent initial public offering and listing on Nasdaq. With
resources from the IPO and additional support from the NIH, we are
driving progress across our organization, including key staff
additions who bring valued expertise to our team and advancement of
our preclinical work,” said Michael Dudley, co-founder, president
and CEO of TransCode Therapeutics. “Looking forward, we are
positioning to move our pipeline into clinical development, as we
seek to demonstrate the power and versatility of our TTX platform
in solving the challenges of RNA delivery in oncology. We remain on
track to submit an exploratory Investigational New Drug Application
(eIND) in the first quarter of 2022 to test our lead therapeutic
candidate, TTX-MC138, in a Phase 0 study in metastatic solid
tumors. We believe this study has the potential to establish
proof-of-mechanism for our platform, upon which we hope to build a
broad and diverse pipeline of therapeutics and diagnostics with the
potential to reach previously undruggable genetic targets.”
Second Quarter 2021 and Recent Highlights
- Completed an initial public offering of 7,187,500 shares of
common stock, including full exercise of the underwriters’ option
to purchase additional shares, resulting in aggregate gross
proceeds of $28.8 million, before deducting underwriting discounts
and commissions and other offering expenses.
- Awarded a Fast-Track Small Business Innovation Research (SBIR)
grant from National Institutes of Health (NIH), totaling $2.3
million expected over three years to support the clinical
evaluation of TTX-MC138. The Company expects to use these funds for
translational experiments to identify and optimize a method for
measuring miR-10b expression in breast cancer clinical samples, as
well as IND-enabling activities and measurement of delivery and
target engagement of TTX-MC138.
- Strengthened the Company’s leadership team with several key
appointments, including:
- Judy Carmody, Ph.D., as SVP of Operations, Susan Duggan as VP
of Clinical Operations, Dustan Bonnin as VP of Corporate Strategy
and Subrata Ghosh, Ph.D., as Principal Scientist; and
- Dejan Juric, M.D., appointed to its Scientific Advisory Board.
Dr. Juric, a renowned expert in personalized cancer medicine and
breast cancer specialist, is currently serving as director of the
Henri and Belinda Termeer Center for Targeted Therapies and
Investigational Cancer Therapeutics Program at Massachusetts
General Hospital.
- Advanced preclinical work for TTX-MC138, the Company’s lead
program, targeting miR-10b for treatment of metastatic solid
tumors. The Company has completed development of a diagnostic assay
validating a method for measuring miR-10b expression in patient
blood and tissue samples. This new assay should support future
TTX-MC138 clinical trials including the initial Phase 0 study.
- Initiated IND-enabling activities to support its planned eIND
filing for TTX-MC138.
Planned Upcoming Milestones
TransCode continues to advance its portfolio and has set the
following goals:
- TTX-MC138
- Submission to FDA of an eIND application in the first quarter
of 2022.
- Initiation of Phase 0 clinical study evaluating TTX-MC138 for
treatment of metastatic solid tumors later in 2022.
- Concurrent completion of IND-enabling studies to support second
half of 2022 filing an IND application for a Phase I clinical trial
of TTX-MC138.
- Publication of preclinical results supporting its TTX delivery
platform in the second half of 2021.
Second Quarter Financial Highlights
- Cash and Cash Equivalents: As of June 30, 2021, cash and
cash equivalents totaled approximately $80 thousand, excluding
approximately $25.4 million in net proceeds from the Company’s July
IPO.
- R&D Expenses: Research and development expenses were
approximately $212 thousand in the second quarter of 2021, compared
to approximately $75 thousand in the second quarter of 2020. The
increase was primarily due to purchases of materials, license fees,
lab facility expenses, costs related to development of intellectual
property, and share-based compensation expenses.
- G&A Expenses: General and administrative expenses
were approximately $144 thousand in the second quarter of 2021,
compared to approximately $177 thousand in the second quarter of
2020. The increase was primarily due to increased legal,
accounting, insurance, and investor relations costs associated with
the Company’s IPO and to share-based compensation expenses.
- Operating Income (Loss): Operating loss was
approximately $356 thousand in the second quarter of 2021, compared
to approximately $92 thousand in the second quarter of 2020. Net
income was approximately $2.8 million, or $0.60 per basic share and
$0.51 per diluted share, for the second quarter of 2021, compared
to a net loss of approximately $127 thousand, or $0.03 per basic
and diluted share, for the second quarter of 2020. The results in
the second quarter of 2021 primarily reflect a change in fair value
of derivative liabilities related to convertible promissory notes.
The convertible promissory notes automatically converted into
common stock upon completion of the IPO. In the foreseeable future,
the Company expects that operating losses will increase
substantially and does not expect net profits.
Financial Guidance
TransCode expects that its cash and cash equivalents as of June
30, 2021, together with net proceeds from its initial public
offering and the SBIR award, are sufficient to fund planned
operations through year-end 2022.
About TransCode Therapeutics
TransCode is an emerging RNA oncology company created on the
belief that cancer can be defeated through the intelligent design
and effective delivery of RNA therapeutics. The Company has created
a platform of drug candidates designed to target a variety of tumor
types with the objective of significantly improving patient
outcomes. The Company’s lead therapeutic candidate, TTX-MC138, is
focused on treating metastatic cancer, which causes approximately
90% of all cancer deaths representing over nine million deaths per
year worldwide. The Company believes that TTX-MC138 has the
potential to produce regression without recurrence in a range of
cancers, including breast, pancreatic, ovarian and colon cancer,
glioblastomas and others. The Company’s other drug candidates,
TTX-siPDL1 and TTX-siLIN28b, focus on the treatment of tumors by
targeting PD-L1 and Lin28b, respectively. The Company is also
developing diagnostic products related to its planned therapeutics
business.
Forward-Looking Statements
This release contains “forward-looking statements” within the
meaning of the Private Securities Litigation Reform Act of 1995,
including, without limitation, statements concerning the timing and
outcome of expected regulatory filings, including the filing of an
eIND for the planned first-in-human study of TTX-MC138, and
statements concerning the timing and outcome of this study,
including whether this study will demonstrate proof-of-concept, and
statements concerning TransCode’s development programs and TTX
technology platform generally. Any forward-looking statements in
this press release are based on management’s current expectations
of future events and are subject to a number of risks and
uncertainties that could cause actual results to differ materially
and adversely from those set forth in or implied by such
forward-looking statements. These risks and uncertainties include,
but are not limited to: the risk associated with drug discovery and
development; the risk that the results of our planned clinical
trials will not be consistent with our pre-clinical studies or
expectations; risks associated with the timing and outcome of
TransCode s planned regulatory submissions; risks associated with
TransCode’s planned clinical trials for its product candidates;
risks associated with obtaining, maintaining and protecting
intellectual property; risks associated with TransCode’s ability to
enforce its patents against infringers and defend its patent
portfolio against challenges from third parties; the risk of
competition from other companies developing products for similar
uses; risks associated with TransCode’s financial condition and its
need to obtain additional funding to support its business
activities, including TransCode’s ability to continue as a going
concern; risks associated with TransCode’s dependence on third
parties; and risks associated with the COVID-19 coronavirus. For a
discussion of these and other risks and uncertainties, and other
important factors, any of which could cause TransCode’s actual
results to differ from those contained in or implied by the
forward-looking statements, see the section entitled “Risk Factors”
in TransCode’s Quarterly Report on Form 10-Q for the period ended
June 30, 2021, as well as discussions of potential risks,
uncertainties and other important factors in TransCode’s subsequent
filings with the Securities and Exchange Commission. All
information in this press release is as of the date of the release;
TransCode undertakes no duty to update this information unless
required by law.
Balance Sheet Data
(unaudited)
June 30, 2021
December 31, 2020
Cash and cash equivalents
$
79,567
$
828,016
Prepaid expenses and other current
assets
460,652
3,199
Deferred offering costs
890,452
224,153
Total assets
1,522,265
1,055,368
Accounts payable and accrued expenses
1,216,501
369,177
Deferred grant income
251,810
--
Convertible promissory notes, net of debt
issuance costs and debt discount
2,125,813
2,086,675
Accrued interest – convertible promissory
notes
247,285
191,687
Derivative liabilities
2,618,000
1,751,000
Total stockholders’ equity (deficit)
(5,036,081)
(3,408,232)
Statement of Operations
Data
(unaudited)
Three Months Ended June
30,
2021
2020
Operating expenses:
Research and development
$
211,752
$
75,000
General and administrative
143,776
16,605
Total operating expenses
355,528
91,605
Loss from operations
(355,528)
(91,605)
Other income (expenses), net
3,126,432
(35,593)
Income (loss) before income taxes
2,770,904
(127,198)
Net income (loss)
$
2,770,904
$
(127,198)
Basic earnings (loss) per share
$
0.60
$
(0.03)
Diluted earnings (loss) per share
$
0.51
$
(0.03)
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version on businesswire.com: https://www.businesswire.com/news/home/20210823005510/en/
Investor Contact: Josh Rappaport Stern Investor Relations
josh.rappaport@sternir.com
Company Contact: Tom Fitzgerald, CFO
tom.fitzgerald@transcodetherapeutics.com
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