Full Press Release Details
TransCode Therapeutics Reports Business Progress
and Third Quarter 2021 Financial Results
eIND application submission for TTX-MC138 anticipated
Boston, MA, Nov 15, 2021 - TransCode Therapeutics, Inc.
(Nasdaq: RNAZ), an 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 third quarter 2021 financial results.
"TransCode has made further progress across our corporate infrastructure
and bourgeoning portfolio, advancing our mission to design RNA therapeutics that can effectively treat cancer. Reflecting the results
of an important microdosing study recently reported in Cancer Nanotechnology, TransCode believes it has an opportunity in its planned
First-in-Human (FIH) Phase 0 clinical trial of its lead therapeutic candidate, TTM-MC138, to obtain results that will better inform designs
of planned follow-on trials than the original FIH trial design. The reported study was conducted by Dr. Zdravka Medarova, a scientific
co-founder of TransCode Therapeutics who was appointed Chief Technology Officer effective October 1." said Michael Dudley,
co-founder, president and CEO of TransCode Therapeutics. Dr. Medarova noted, "We believe a microdosing study offers the potential
to more definitively establish proof-of-mechanism for our delivery 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."
Dudley added, "We are striving to file our exploratory
Investigational New Drug Application (eIND) required for the FIH trial by the end of the first quarter 2022, although because of
COVID-19-related backlogs at contract research organizations, the filing may be later in the first half. Regardless, we believe the
proposed microdosing study should, if successful, demonstrate the power and versatility of our TTX platform in solving the
challenges of RNA delivery in oncology. In addition, we have continued IND-enabling work for TTX-MC138 and remain on track to file
an IND for a Phase I clinical trial for treatment of metastatic disease by year end 2022."
Third Quarter 2021 and Recent Highlights
Key Planned Upcoming Milestones
TransCode's goals to continue to advance its portfolio include:
Third Quarter Financial Highlights
TransCode expects that its cash and cash equivalents as of September 30,
2021, together with additional funding expected from an April 2021 SBIR award, are sufficient to fund planned operations through
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 is believed to cause 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. Two of 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 other therapeutic candidates and 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, statements concerning
TransCode's development programs and TTX technology platform generally, and statements about TransCode's cash burn and ability
to fund operations through year-end 2022. 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 September 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.
| September 30, 2021 | December 31, 2020 | |||||||
| Cash and cash equivalents | $ | 22,499,856 | $ | 828,016 | ||||
| Prepaid expenses and other current assets | 2,704,386 | 3,199 | ||||||
| Deferred offering costs | -- | 224,153 | ||||||
| Total assets | 25,359,852 | 1,055,368 | ||||||
| Accounts payable and accrued expenses | 1,984,657 | 369,177 | ||||||
| Deferred grant income | 220,075 | -- | ||||||
| Convertible promissory notes, net of debt issuance costs and debt discount | -- | 2,086,675 | ||||||
| Accrued interest - convertible promissory notes | -- | 191,687 | ||||||
| Derivative liabilities | -- | 1,751,000 | ||||||
| Total stockholders' equity (deficit) | 23,155,120 | (3,408,232 | ) |
Statement of Operations Data
| Three Months Ended September 30, | ||||||||
| 2021 | 2020 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 992,946 | $ | 53,936 | ||||
| General and administrative | 1,366,963 | 185,555 | ||||||
| Total operating expenses | 2,359,909 | 239,491 | ||||||
| Loss from operations | (2,359,909 | ) | (239,491 | ) | ||||
| Other income (expenses), net | 30,203 | (1,134,413 | ) | |||||
| Loss before income taxes | (2,329,706 | ) | (1,373,904 | ) | ||||
| Net loss | $ | (2,329,706 | ) | $ | (1,373,904 | ) | ||
| Weighted average common shares outstanding | 11,526,514 | 4,636,216 | ||||||
| Basic and diluted loss per share | $ | (0.20 | ) | $ | (0.30 | ) |