Transcode Therapeutics, Inc.
For the period ended Dec 31, 2025. Filed Apr 15, 2026.
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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2025 · Filed Apr 15, 2026
RNAZ$1.49-1.3%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-K
Period ended 2024-12-31; filed 2025-04-15.
0001558370-25-004843
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-K
Period ended 2025-12-31; filed 2026-04-15.
0001104659-26-043810
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 177 previous paragraphs and 190 current paragraphs.
76 unchanged; 54 reworded; 55 added; 42 removed; 5 previous and 5 current paragraphs rearranged.
Tables are not compared: 60 previous and 64 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (55)
Current report
TransCode is an immuno-oncology and targeted cancer therapy company with a focus on treating advanced malignancy. Our lead therapeutic candidate, TTX-MC138, is focused on treating metastatic tumors that overexpress microRNA-10b, a unique, well-documented biomarker of metastasis.
Current report
Polynoma Acquisition. On October 8, 2025, we entered into a Membership Interest Purchase Agreement (the “Purchase Agreement”) with DEFJ, LLC, a Delaware limited liability company, (“DEFJ”) pursuant to which we acquired 100% of the issued and outstanding membership interests of ABCJ, LLC, a Delaware limited liability company, (“ABCJ”) (such transaction, the “Acquisition”). Prior to the Acquisition, ABCJ was a wholly owned subsidiary of DEFJ and an indirect wholly owned subsidiary of CK Life Sciences Int’l., (Holdings) Inc., a listed entity on the Main Board of the Hong Kong Stock Exchange (“CKLS”). In the Acquisition, we issued 1,242.0717 shares of Series A Non-Voting Convertible Preferred Stock, par value $0.0001 per share, (the “Series A Preferred Stock”) to DEFJ. Each share of Series A Preferred Stock is convertible into 10,000 shares of Common Stock.
Current report
ABCJ owns 100% of the issued and outstanding membership interests of Polynoma, LLC, a Delaware limited liability company, (“Polynoma”) previously headquartered in San Diego, California. Polynoma is an immuno-oncology focused biopharmaceutical company developing Seviprotimut-L, an investigational polyvalent antigen vaccine intended to reduce the risk of recurrence of cancer in patients with stage IIB and IIC melanoma who have limited options. Seviprotimut-L has been safely administered in clinical trials to more than 1,000 patients.
Current report
We intend to work on developing both TTX-MC138 and Seviprotimut-L, with the initial focus on advancing TTX-MC138 in a planned Phase 2a clinical trial. We believe there is potential to augment Seviprotimut-L's focus with TTX-MC138 by addressing micrometastases in stage IIB and IIC melanoma patients.
Current report
Concurrent with the Acquisition, we entered into an Investment Agreement (the “Investment Agreement”) with DEFJ. Pursuant to the Investment Agreement, DEFJ agreed to purchase, and we agreed to issue and sell, in a private placement an aggregate of 223.7337 shares of Series B Non-Voting Convertible Preferred Stock, par value $0.0001 per share, (the “Series B Preferred Stock” and, together with the Series A Preferred Stock, the “Preferred Stock”) for a price per share of $111,740, for an aggregate purchase price of approximately $25 million. The aggregate purchase price consisted of a cash subscription of $20 million paid on October 8, 2025, and a promissory note (the “Promissory Note”) in the aggregate principal amount of approximately $5 million (together, the “Investment”). The Promissory Note accrued interest at a rate of 4% per annum, calculated as simple interest on a 365-day year. The principal and accrued interest were paid on December 30, 2025. Each share of Series B Preferred Stock is convertible into 10,000 shares of Common Stock.
Current report
**Contingent Value Rights.**Concurrent with the closing of the Acquisition, we entered into a contingent value rights agreement (the “CVR Agreement”) with a rights agent (the “Rights Agent”), pursuant to which each holder of our Common Stock as of October 20, 2025, (the “Record Date”) including those holders who received shares of Common Stock in connection with the Acquisition, is entitled to one contractual contingent value right (each, a “CVR”) issued by us, subject to and in accordance with the terms and conditions of the CVR Agreement, for each share of Common Stock held by such holder as of 5:00 p.m. Eastern Daylight Time on the Record Date. The CVR Agreement has a term of seven years (the “Term”).
Current report
Each CVR entitles the holders thereof (each a “Holder”), in the aggregate, to 50% of the Net Proceeds (as defined in the CVR Agreement) from any Upfront Payment (as defined in the CVR Agreement) or Milestone Payment (as defined in the CVR Agreement) we receive in a given calendar quarter during the Term. Distributions in respect of CVRs that become payable will be made on a quarterly basis and will be subject to a number of deductions, subject to certain exceptions or limitations, including but not limited to for certain taxes and certain out-of-pocket expenses we incur.
Current report
Under the CVR Agreement, the Rights Agent has, and Holders of at least 30% of the CVRs then-outstanding have, certain rights to audit and enforcement on behalf of all Holders. The CVRs may not be sold, assigned, transferred, pledged, encumbered or in any other manner transferred or disposed of, in whole or in part, other than as permitted pursuant to the CVR Agreement. Holders do not have the rights of stockholders by virtue of their CVR holdings and do not have the ability to vote, rights to dividends, or other interests. The CVRs also establish certain restrictions of mergers and change in control activities, as defined in the CVR Agreement.
Current report
**Unleash Licensing Agreement.**In March 2026, we entered into the Unleash Licensing Agreement with Unleash pursuant to which the we acquired a pre-clinical candidate program involving genetically-engineered adenoviruses to harness the immune system to fight cancer, as well as an exclusive, perpetual, irrevocable, worldwide, fully-paid up, royalty-free, sublicensable right and license to related technology.
Current report
As consideration for the Unleash Licensing Agreement, pursuant to an Equity Issuance and Registration Rights Agreement with Unleash (the “Unleash Registration Rights Agreement”), we agreed to issue 1,136,364 shares of our Series C Non-Voting Convertible Preferred Stock to Unleash. The Series C Preferred Stock is not convertible until our stockholders approve its conversion into Common Stock in accordance with the listing rules of Nasdaq (the “Unleash Stockholder Approval”). Following the Unleash Stockholder Approval, each share of Series C Preferred Stock is convertible into one share of our Common Stock.
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Drug Candidates
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In addition to TTX-MC138, we have a portfolio of other first-in-class therapeutic candidates designed to mobilize the immune system to recognize and destroy cancer cells. TTX-siPDL1 is an siRNA-based modulator of programmed death-ligand 1, or PD-L1. TTX-RIGA is an RNA-based agonist of the retinoic acid-inducible gene I, or RIG-I, targeting activation of innate immunity in the tumor microenvironment. TTX-siMYC is a siRNA-based inhibitor of c-MYC, a widely expressed but currently undruggable oncogene. Seviprotimut-L is a novel allogeneic, polyvalent partially purified shed antigens vaccine (alum adjuvanted) for the adjuvant treatment of Stage IIB and IIC melanoma patients 60 years and younger. Seviprotimut-L is derived from three proprietary human melanoma cell lines. Seviprotimut-L works by stimulating both humoral and cellular immune responses. It has completed Phase 2 clinical development and has been administered to approximately 1,000 patients in prior clinical trials.
Current report
In 2023, we conducted a Phase 0 clinical trial in one patient with advanced solid tumors. The intent of the Phase 0 trial was to demonstrate quantitative delivery of radiolabeled TTX-MC138 to metastatic lesions. In September 2024, we commenced a Phase I/II clinical trial with TTX-MC138 which was substantially completed by the end of 2025. Analysis of the Phase I/II clinical trial results is ongoing. We expect to commence a Phase 2a clinical trial in the first half of 2026.
Current report
Phase I/II Clinical Trial
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Yorkville Finan cing
Current report
On April 7, 2026, we entered into a Standby Equity Purchase Agreement (the “SEPA”) with YA II PN, LTD, a Cayman Islands exempt limited partnership, (“Yorkville”) pursuant to which the Company has the right to sell to Yorkville up to $14 million of shares of Common Stock, subject to certain limitations and conditions set forth in the SEPA, from time to time during the term of the SEPA (the “Commitment Amount”). Sales of Common Stock to Yorkville under the SEPA, and the timing of any such sales, are at the Company’s option, and the Company is under no obligation to sell any shares of Common Stock to Yorkville under the SEPA.
Current report
Upon satisfaction of the conditions to Yorkville’s purchase obligations set forth in the SEPA, the Company can, at its sole discretion, direct Yorkville to purchase specified amounts of Common Stock. The purchase price per share for each Advance is set at 97% of the lowest daily VWAP during the three consecutive trading days beginning on the date upon which the Advance Notice is delivered. Actual sales of Common Stock to Yorkville under the SEPA will depend on a variety of factors including some to be determined by the Company, in its sole discretion, from time to time, which may include, among other things, market conditions, the trading price of the Common Stock and determinations by the Company as to appropriate sources of funding for the Company’s business and operations.
Current report
In connection with the SEPA, and subject to the conditions set forth therein, Yorkville has also agreed to advance to the Company up to $6.0 million, less certain amounts as described below, to be paid in two tranches (each, a “Pre-Paid Advance” and, together, the “Pre-Paid Advances”), in exchange for the Company’s issuance to Yorkville of convertible promissory notes (each, a “Convertible Note” and, together, the “Convertible Notes”). Pursuant to the Convertible Notes and the SEPA, Yorkville may convert all or any portion of the outstanding principal amount, accrued but unpaid interest, and other amounts outstanding under the Convertible Notes into shares of Common Stock, at any time and from time to time during the term of the Convertible Notes.
Current report
The first Pre-Paid Advance is expected to be disbursed to us the day after we file this Annual Report on Form 10-K. In exchange for the first Pre-Paid Advance, we shall issue to Yorkville a Convertible Note in the principal amount of $1.0 million (the “First
Current report
Convertible Note”), which will be sold with a purchase price discount of 5.0% (or $50,000). The First Convertible Note will be convertible into Common Stock at the lower of (i) a fixed conversion price equal to 115% of the VWAP on the day prior to the issuance of the Note and (ii) 95% of the lowest daily VWAP during the seven consecutive trading days immediately preceding the conversion date, but in no event lower than 20% of last reported trading price of our Common Stock on Nasdaq as quoted by Bloomberg (the “First Convertible Note Conversion Price”) as of the trading day immediately prior to the date of the SEPA (the “Floor Price”). After accounting for the purchase price discount, we expect to receive gross proceeds of $950,000 for the First Convertible Note.
Current report
The second tranche of the Pre-Paid Advance shall be disbursed to the Company in exchange for the issuance to Yorkville of a Convertible Note in the principal amount of $5.0 million (the “Second Convertible Note”). The Second Convertible Note will be issued with a purchase price discount of 5.0% (or $250,000) and will be convertible into Common Stock at the lower of (i) a price equal to 115% of the VWAP on the day prior to the issuance of the Second Convertible Note and (ii) 95% of the lowest daily VWAP during the seven consecutive trading days immediately preceding the conversion date, but in no event lower than the Floor Price (the “Second Convertible Note Conversion Price,” and together with the First Convertible Note Conversion Price, the “Conversion Price”). The Second Convertible Note will be issued on the second trading day after the later of (i) the registration statement filed pursuant to the SEPA, including any prospectus, amendments and supplements thereto, (the “Yorkville Registration Statement”) first becoming effective under the Securities Act, (ii) the Company’s receipt of stockholder approval to issue shares of Common Stock to Yorkville under the SEPA in excess of the Exchange Cap (defined below) and (iii) the approval by Nasdaq of the initial listing application required under Nasdaq Listing Rules 5110 and 5635(b). After accounting for the purchase price discount, the Company expects to receive gross proceeds of $4,750,000 pursuant to the Second Convertible Note.
Current report
Interest on the outstanding balances of the Convertible Notes will accrue at an annual rate of 5.0%, subject to an increase to 18% upon an event of default as described in the Convertible Notes. The maturity date of each Convertible Note will be 18 months from the date upon which the Convertible Note is issued. The applicable maturity date of each Convertible Note may be extended by the Company, at its option, for a period of six months on two occasions by providing written notice to Yorkville. On the applicable maturity date, any portion of the outstanding principal amount and accrued but unpaid interest that remains outstanding on such Convertible Note will automatically be converted at the then applicable Conversion Price, provided that if any Equity Condition (as defined in the Form of Promissory Note ) is not satisfied, the applicable maturity date will be automatically extended until all Equity Conditions have been satisfied.
Current report
The sale and issuance of shares under the SEPA, including conversion of the Convertible Notes at Yorkville’s option and the sale of shares of Common Stock at the option of the Company, is subject to an exchange cap limiting the total number of shares issuable to Yorkville to 183,301 (19.99% of outstanding shares of Common Stock before the effective date of the SEPA) (the “Exchange Cap”), unless the Company obtains stockholder approval to exceed the Exchange Cap (the “Yorkville Issuance Approval”). Additionally, Yorkville may not own more than 9.99% of the Company’s outstanding Common Stock at any time, unless it provides written notice of its intention to increase this limit, effective after 65 days.
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MGH License Amendment
Current report
Effective August 15, 2025, we and The General Hospital Corporation, d/b/a Massachusetts General Hospital, (“Licensor”) further amended our 2018 License (the “Second Amendment”) to revise diligence requirements and milestone payments. Pursuant to the 2018 License (the License”), we licensed the exclusive rights to certain intellectual property to support development of our therapeutic candidates. In connection with the Second Amendment, we paid the Licensor a license amendment fee of $75,000. The Second Amendment revised certain one-time milestone payments to be made by us to the Licensor for Products and Processes covered by the License as follows:
Current report
In addition, upon the occurrence of a Change of Control Liquidity Event (as defined in the Second Amendment), we shall pay Licensor up to a certain dollar amount.
Current report
On June 2, 2025, we received a letter from the Nasdaq Stock Market (“Nasdaq”) notifying us that we were deemed in compliance with Nasdaq Listing Rule 5550(a)(2), requiring that a company maintain a minimum closing bid price of $1.00 per share. As a result, and subject to our remaining in compliance with Nasdaq listing requirements, our stock will continue to be listed on the Nasdaq.
Current report
Reverse Stock Split
Current report
On May 15, 2025, we effected a Reverse Stock Split pursuant to which every 28 shares of our issued and outstanding Common Stock was converted automatically into one issued and outstanding share of Common Stock. The Reverse Stock Split affected all stockholders uniformly and did not by itself alter any stockholder’s percentage interest in our equity except to the extent that the Reverse Stock Split would result in a stockholder owning a fractional share. No fractional shares were issued in connection with the Reverse Stock Split; any stockholder who would have received fractional shares instead had their shares rounded up to the nearest whole number of shares.
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Operating expense**s
Current report
Research and development, or R&D, expenses increased $3,716 thousand in 2025 compared to 2024. The increase reflects primarily increases in clinical trial spending, costs of production of drug used in the clinical trial, and intellectual property expenses offset in part by reductions in certain preclinical testing and reduced lab facilities costs.
Current report
General and administrative expenses increased $8,604 thousand in 2025 compared to 2024. The increase reflects primarily increased fees for professional services, primarily financial advisory, legal and accounting services related to the Acquisition, and increased compensation costs, offset in part by decreased share-based compensation expense, spending for directors and officers liability insurance, investor relations services, and facilities expenses. Our transaction costs in connection with the Acquisition were approximately $8.8 million. These costs include direct expenses as well as integration-related professional fees and other incremental costs directly associated with the Acquisition. Transaction costs were expensed as incurred and are included in General and Administration expenses in our consolidated statement of operations.
Current report
The change in fair value of warrant liability expense was $8,338 thousand greater in 2025 compared to 2024, resulting primarily from a higher share price at December 31, 2025, and exercises of Series D warrants in the first quarter of 2025.
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Change in fair value of contingent consideration
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The change in fair value of contingent consideration was a $1,584 thousand gain. Contingent consideration arose in connection with the Acquisition; there was no contingent consideration in 2024.
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Warrant issuance costs
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Issuance costs for warrants issued in connection with our December 2, 2024, Private Investment in Public Equity, or PIPE, were $597 thousand in 2024. There was no corresponding expense in 2025.
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Currency exchange gain (loss)
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Loss on currency exchange was $55 thousand greater in 2025 than in 2024, reflecting changes in exchange rates on billings in Euros from certain vendors.
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Interest income was $79 thousand in 2025 compared to $1 thousand in 2024 reflecting earnings on higher cash balances from equity financings in 2025.
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Removed paragraphs (42)
Previous report
TransCode is a platform delivery company focused on oncology, created on the belief that cancer can be defeated through the intelligent design and effective delivery of targeted therapeutics. Our lead therapeutic candidate, TTX-MC138, targets microRNA-10b, or miRNA-10b, generally believed to be a master regulator of metastatic cell viability in a range of cancers, including breast, pancreatic, ovarian, colon cancer, glioblastomas, and several others. In 2023, we conducted a Phase 0 clinical trial intended to demonstrate quantitative delivery of radiolabeled TTX-MC138 to metastatic lesions in subjects with advanced solid tumors. We treated one patient in the Phase 0 trial. In April 2024, we received an IND Study May Proceed notification from FDA to conduct a Phase I/II clinical trial with TTX-MC138 which trial commenced in the third quarter 2024.
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In addition to TTX-MC138, we have other solid tumor programs in the preclinical stage. One, TTX-siPDL1, is an siRNA-based modulator of programmed death-ligand 1. A second, TTX-RIGA, is an RNA-based agonist of the retinoic acid-inducible gene I, or RIG-I, targeting activation of innate immunity in the tumor microenvironment. In addition, two of our pipeline candidates are TTX-CRISPR, a CRISPR/Cas9-based therapy platform for the repair or elimination of cancer-causing genes inside tumor cells; and TTX-mRNA, an mRNA-based platform for the development of cancer vaccines that activate cytotoxic immune responses against tumor cells, which we may seek to develop subject to available funding.
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All our therapeutic candidates are designed to utilize our proprietary TTX delivery mechanism with the goal of significantly improving outcomes for cancer patients.
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In January 2025, we submitted an STTR to the NCI in support of clinical development of TTX-siPDL1. If awarded, the SBIR award is expected to provide up to $2.3 million of non-dilutive funding over three years beginning in the second half of 2025.
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Phase 1 Clinical Trial
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January 2024 Financing
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On January 22, 2024, we entered into securities purchase agreements pursuant to which we issued and sold approximately 180,079 shares of common stock and PFWs at a purchase price of $40.26 per share (or $39.93 per PFW), and approximately 360,159 warrants to purchase common stock at an exercise price of $40.26 per share (or $0.33 per PFW), in a public offering (the “January Offering”). As of April 30, 2025, all PFWs from the January Offering had been exercised. Net proceeds from the January Offering, after deducting underwriting discounts, commissions and fees paid to the underwriter and other offering expenses, were approximately $6.2 million.
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In connection with the January Offering, we also issued warrants to the placement agent to purchase up to approximately 10,805 shares of common stock, or the January Placement Agent Warrants. The January Placement Agent Warrants became exercisable on the date of issuance, expire three and one-half years following the date of sale and have an exercise price of $50.325 per share.
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July 2024 Financing
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On July 22, 2024, we entered into a Placement Agency Agreement (the “Agreement”) with ThinkEquity LLC, pursuant to which the we agreed to issue and sell directly to various investors, in a best efforts public offering (the “July Offering”), an aggregate of approximately 303,030 shares of the Company’s common stock, par value $0.0001 per share, at an offering price of $9.90 per share of common stock. We received gross proceeds of $3.0 million in connection with the July Offering, before deducting placement agent fees and other offering expenses payable by us. The July Offering closed on July 24, 2024. The shares of common stock sold in the July Offering were offered and sold pursuant to a registration statement on Form S-3 (File No. 333-268764), which was filed with the Securities and Exchange Commission (the “Commission”) on December 13, 2022, and was declared effective by the Commission on December 16, 2022.
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As part of its compensation for acting as placement agent for the July Offering, we also agreed to issue to the placement agent, warrants to purchase approximately 15,152 shares of common stock (the “July Placement Agent Warrants”). The July Placement Agent Warrants became exercisable commencing on January 18, 2025, expire July 22, 2029, and have an exercise price of $12.375 per share. The July Placement Agent Warrants, and the shares of common stock issuable upon exercise thereof, will be issued in reliance on the exemption from registration provided in Section 4(a)(2) under the Securities Act of 1933, as amended. The representations, warranties and covenants contained in the Agreement were made solely for the benefit of the parties to the Agreement. In addition, such representations, warranties and covenants (i) are intended as a way of allocating the risk between the
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parties to the Agreement and not as statements of fact, and (ii) may apply standards of materiality in a way that is different from what may be viewed as material by stockholders of, or other investors in, us. Moreover, information concerning the subject matter of the representations and warranties may change after the date of the Agreement, which subsequent information may or may not be fully reflected in public disclosures.
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This Annual Report on Form 10-K shall not constitute an offer to sell or the solicitation of an offer to buy securities, nor shall there be any sale of securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.
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The foregoing descriptions of the Agreement and July Placement Agent Warrants are not complete and are qualified in their entirety by references to the full text of the Form of Agreement and Form of Placement Agent Warrant which are filed as exhibits to this Annual Report on Form 10-K and are incorporated by reference herein.
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November 2024 Private Placement
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On November 26, 2024, we entered into a securities purchase agreement (the “Purchase Agreement”) with certain accredited investors, pursuant to which we agreed to sell and issue in a private placement (the “November Private Placement”) an aggregate of (i) approximately 173,033 shares (the “Shares”) of our common stock, par value $0.0001 per share, (ii) approximately 470,007 pre-funded warrants to purchase shares of common stock (the “Pre-Funded Warrants”) (iii) approximately 643,039 Series C Warrants to purchase shares of common stock (the “Series C Warrants”) and (iv) approximately 643,039 Series D Warrants to purchase shares of common stock (the “Series D Warrants” and together with the Series C Warrants, the “Common Warrants”; the Common Warrants together with the Pre-Funded Warrants, the “Warrants”; the Warrants together with Shares, the “Purchased Securities”). Each Share or Pre-Funded Warrant, as applicable, was sold together with one Series C Warrant to purchase one share of common stock and one Series D Warrant to purchase one share of common stock. The price for each Share and accompanying Common Warrants was $12.4409, and the price for each Pre-Funded Warrant and accompanying Common Warrants was $12.4377 (the “Offering Price”).
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The Pre-Funded Warrants have an exercise price of $0.0033 per share, are exercisable immediately and expire when exercised in full. Each Series C Warrant has an initial exercise price per share of $15.675 and will be exercisable beginning on the date on which Stockholder Approval (as defined below) is received and deemed effective (the “Initial Exercise Date” or the “Stockholder Approval Date”). The Series C Warrants will expire on the five-year anniversary of the Initial Exercise Date. Additionally, the Series C Warrants provide for an adjustment to the exercise price and number of shares underlying such Series C Warrants upon the Company’s issuance of common shares or common share equivalents at a price per share that is less than the exercise price of the Series C Warrants, subject to a floor price of $2.4882 per share (the “Floor Price”). The Series D Warrants have an initial exercise price per share of $15.675 and will be exercisable beginning on the Initial Exercise Date. The Series D Warrants will expire two and one-half years after the Initial Exercise Date. Under an alternate cashless exchange provision in the Series D Warrants, holders thereof have the right to receive an aggregate number of shares equal to the product of (i) the aggregate number of common shares that would be issuable upon a cash exercise of the Series D Warrants and (ii) 3.0. In addition, on the 11th trading day following each of (i) the later of (A) the Stockholder Approval Date and (B) the Effective Date (as that term is defined in the Purchase Agreement) and (ii) each subsequent date that a Registration Statement (as that term is defined in the Purchase Agreement) is declared effective by the Securities and Exchange Commission, if any (each such trading day, a “Reset Date”), the Series C Warrants and the Series D Warrants contain a reset of the exercise price to a price equal to the lesser of (i) the then applicable exercise price and (ii) the greater of the Floor Price and the lowest volume weighted average price for the ten trading days immediately preceding the Reset Date. Upon such reset of the exercise price, the number of shares issuable under the Common Warrant shall be increased such that the aggregate exercise price of the Common Warrant shall remain unchanged following such reset.
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The issuance of shares of common stock upon exercise of the Common Warrants was subject to stockholder approval under applicable rules and regulations of The Nasdaq Stock Market LLC (“Nasdaq”) (“Stockholder Approval” and the date on which Stockholder Approval was received and deemed effective, the “Stockholder Approval Date”). We obtained Stockholder Approval at a shareholder meeting on February 25, 2025.
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A holder of Purchased Securities will not have the right to exercise any portion of the Common Warrants or Pre-Funded Warrants if the holder (together with its affiliates) would beneficially own in excess of 4.99% or 9.99%, as applicable, of the number of shares of common stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the Common Warrants or the Pre-Funded Warrants, respectively. The Purchase Agreement also contains
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representations, warranties, indemnification and other provisions customary for transactions of this nature. The November Private Placement closed on December 2, 2024.
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In connection with the November Private Placement, subsequent to the closing of the November Private Placement until the later of Shareholder Approval or April 1, 2025, we agreed not to issue, enter into any agreement to issue or announce the issuance or proposed issuance of any common stock or Common Stock Equivalents (as defined in the Purchase Agreement), or (ii) file any registration statement or amendment or supplement thereto, other than with respect to the registration statement filed in connection with the November Private Placement. We also agreed that for the 12 month period following the date of the Purchase Agreement, we are not to effect or enter into an agreement to effect any issuance of common stock or any securities convertible into or exercisable or exchangeable for Common Shares involving a Variable Rate Transaction (as defined in the Purchase Agreement), subject to certain exceptions.
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The Benchmark Company LLC acted as the exclusive placement agent (the “Placement Agent”) for the November Private Placement. Pursuant to an engagement agreement with the Placement Agent, we agreed to pay the Placement Agent in connection with the November Private Placement a cash fee equal to $50,000. Additionally, we engaged A.G.P./Alliance Global Partners (“A.G.P.”) as Financial Advisor for which we agreed to pay A.G.P. (i) a cash fee for financial services rendered in connection with the November Private Placement equal to 4.0% of the aggregate gross proceeds received in the November Private Placement, less $50,000; (ii) up to $75,000 for fees and expenses, and (iii) a nonaccountable expense allowance of one percent of the gross proceeds. The aggregate gross proceeds for the November Private Placement were approximately $8 million, before deducting fees and expenses payable by us, excluding the proceeds, if any, from the exercise in cash of the Pre-Funded Warrants and Common Warrants. All of the Pre-Funded Warrants were exercised prior to January 31, 2025. No assurance can be given that any of the Common Warrants will be exercised.
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We intend to use the net proceeds from the November Private Placement for working capital and general corporate purposes.
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Pursuant to the Purchase Agreement, we agreed to prepare and file a registration statement with the Securities and Exchange Commission no later than 10 days after November 27, 2024, to register the resale of the Shares (including Shares issuable upon exercise of the Warrants) purchased pursuant to the Purchase Agreement. We filed this registration statement with the Securities and Exchange Commission on December 6, 2024, and it was declared effective on December 17, 2024 (Registration Number 333-283666).
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The offer and sale of the securities pursuant to the Purchase Agreement have not been registered under the Securities Act or any state securities laws. The securities issued to the purchasers under the Purchase Agreement were offered and sold in reliance on an exemption from registration provided by Rule 506 of Regulation D promulgated under the Securities Act of 1933, as amended (the “Securities Act”). The Company relied on this exemption from registration based in part on representations made by the purchasers, including that each purchaser is an “accredited investor”, as defined in Rule 501(a) promulgated under the Securities Act.
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The Purchased Securities may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. Neither this Annual Report on Form 10-K, nor the exhibits attached hereto, is an offer to sell or the solicitation of an offer to buy the securities described herein or therein.
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The foregoing summary of the terms of the Purchase Agreement, the Pre-Funded Warrants, the Series C Warrants, the Series D Warrants and the Registration Rights Agreement are subject to, and qualified in their entirety by, the full text of such agreement which forms are filed as exhibits, to this Annual Report on Form 10-K and are incorporated by reference herein.
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In the third quarter 2024, the Company received three letters from the Nasdaq Stock Market (“Nasdaq”) Staff notifying the Company that it was not in compliance with Nasdaq Listing Rules 5550(a)(2) (the “Bid Price Rule”), 5550(b)(1) (the “Equity Rule”) or any of the alternative requirements in Listing Rule 5550(b), and 5635(d) (the “Shareholder Approval Rule”). As a result, the shares of the Company’s common stock were subject to delisting from The Nasdaq Capital Market. On October 1, 2024, the Company appealed the Staff’s determination to a Nasdaq Hearings Panel (the “Panel”). On November 4, 2024, the Company was informed that the Panel granted the Company a formal extension to regain compliance with the Nasdaq Listing Rules.
Previous report
In the event of a delisting from the Nasdaq Capital Market, we may seek to have our stock traded in the over-the-counter inter-dealer quotation system, more commonly known as the OTC. OTC transactions involve risks in addition to those associated with transactions in securities traded on the securities exchanges, such as the Nasdaq Capital Market, or, together, Exchange-listed stocks. Many OTC stocks trade less frequently and in smaller volumes than Exchange-listed stocks. Accordingly, our stock would be less liquid than it would be otherwise. Also, the prices of OTC stocks are often more volatile than Exchange-listed stocks. Additionally, institutional investors are usually prohibited from investing in OTC stocks, and it might be more challenging to raise capital.
Previous report
Upon being delisted from the Nasdaq Capital Market, our stock would likely be traded in the over-the-counter inter-dealer quotation system, more commonly known as the OTC. OTC transactions involve risks in addition to those associated with transactions in securities traded on the securities exchanges, such as the Nasdaq Capital Market, or, together, Exchange-listed stocks. Many OTC stocks trade less frequently and in smaller volumes than Exchange-listed stocks. Accordingly, our stock would be less liquid than it would be otherwise. Also, prices of OTC stocks are often more volatile than Exchange-listed stocks. Additionally, institutional investors are usually prohibited from investing in OTC stocks, and it would likely be more challenging to raise capital when needed.
Previous report
With respect to the Equity Rule, we believe that as of the date of the filing of this Annual Report on Form 10-K, we are in compliance with such Rule with stockholders’ equity above $2.5 million.
Previous report
Operating expenses
Previous report
Comparison of years ended December 31, 2024 and 2023
Previous report
Research and development, or R&D, expenses decreased $2,558 thousand in the year ended December 31, 2024, compared to the same period in 2023. The decrease was primarily due to reduced science-related research activities, consulting costs, purchases of materials, facilities-related costs, and compensation costs as a result of staff reductions, one-time severance payments and related benefits costs. These decreases were offset in part by increased clinical trial and related costs and non-cash share-based compensation, offset in part by purchased services and regulatory expenses.
Previous report
General and administrative expenses decreased $1,201 thousand in the year ended December 31, 2024, compared to the same period in 2023. Decreases primarily related to staff reduction costs (compensation, benefits and one-time severance payments), directors and officers liability insurance expenses, and professional services, including legal, accounting, and consulting, facilities-related costs and technology-related costs, offset in part by increased non-cash share-based compensation and costs related to being a public company.
Previous report
The charge in connection with a change in the fair value of the warrant liability between the December 2, 2024, issuance of the underlying warrants and December 31, 2024, was $1,536 thousand for the year ended December 31, 2024. There was no charge in the year ended December 31, 2023. The warrants were issued in the November 2024 financing.
Previous report
Interest expense was $27 thousand for the year ended December 31, 2024, compared to $56 thousand in the same period in 2023. The decrease reflects primarily reduced imputed interest expense charged in connection with our right-of-use asset and reduced finance charges on our D&O insurance policy.
Previous report
Interest income was $1 thousand for the year ended December 31, 2024, compared to $5 thousand in the same period in 2023. Interest income declined primarily as a result of our lower cash balances held in interest bearing accounts.
Previous report
During the year ended December 31, 2024, we used cash of $13,336 thousand in operating activities compared to $18,075 thousand in the year ended December 31, 2023. Cash used in operating activities in 2024 primarily reflected our net loss of $16,755 thousand and a decrease of $343 thousand in accounts payable and accrued expenses, offset in part by increased share-based compensation expense of $1,700 thousand and other non-cash items (including those related to our leased facility), a fair value reset of warrants issued during 2024, and an increase in prepaid expenses and other current assets of $406 thousand.
Previous report
During the years ended December 31, 2024, and 2023, we obtained cash (net) of $16,432 thousand and $15,909 thousand, respectively, from equity offerings.
Showing the first 40 of 42 passages. Open the source sections for the rest.
Reworded paragraphs (54)
Previous wording
You should read the following discussion and analysis of our financial condition and results of operations together with the “Financial Statements” section of this Annual Report on Form 10-K including the related notes appearing elsewhere in this Annual Report. Some of the information contained in this discussion and analysis or set forth elsewhere in this Annual Report, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those set forth in the “Cautionary Note Regarding Forward Looking Statements” and “Risk Factors” sections of this Annual Report, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.
Current wording
You should read the following discussion and analysis of ourconsolidatedfinancial condition andconsolidatedresults of operations together with the “Consolidated Financial Statements” section of this Annual Report on Form 10-K including the related notes appearing elsewhere in this Annual Report. Some of the information contained in this discussion and analysis or set forth elsewhere in this Annual Report, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those set forth in the “Cautionary Note Regarding Forward Looking Statements” and “Risk Factors” sections of this Annual Report, our actual results could differ materially from the consolidated results described in or implied by the forward-looking statements contained in the following discussion and analysis.
Previous wording
To customize the development of targeted therapeutics, we have developed a design engine that is modular at both the levels of the core nanoparticle and the therapeutic loading. The size, charge, and surface chemistry of the core iron oxide nanoparticle are designed so that it can be tuned to optimize the particles for the intended target and therapeutic load. The therapeutic load is designed to consist of synthetic oligonucleotides and other molecular moieties such as proteins, peptides, radionuclides, and small molecules that can be adapted to the specific approach being developed. The approach can range from RNA interference, or RNAi, including small interfering RNAs, antisense oligonucleotides, and non-coding RNA mimics to Pattern Recognition Receptors such as RIG-I. We believe the TTX platform can further be used for developing targeted radiolabeled therapeutics and diagnostics and other custom products targeting known and novel biomarkers and other genetic elements as they are discovered and validated.
Current wording
To customize the development of RNA therapeutics, we have developed a design engine that is modular at both the levels of the core nanoparticle and the therapeutic loading. The size, charge, and surface chemistry of the core iron oxide nanoparticle are designed so that it can be tuned to optimize the particles for the intended target and therapeutic load. The therapeutic load is designed to consist of synthetic oligonucleotides and other molecular moieties such as proteins, peptides, radionuclides, and small molecules that can be adapted to the specific approach being developed. The approach can range from RNA interference, or RNAi, including small interfering RNAs, antisense oligonucleotides, and non-coding RNA mimics to Pattern Recognition Receptors such as RIG-I. We believe the TTX platform can further be used for developing targeted radiolabeled therapeutics and diagnostics and other custom products targeting known and novel biomarkers and other genetic elements as they are discovered and validated.
Previous wording
Our TTX technology has gone through approximately 20 years of research and development, or R&D, and optimization, including 12 years at Harvard Medical School and the Massachusetts General Hospital, by our scientific co-founders prior to company formation.
Current wording
Our TTX technology has gone through more than 20 years of research and development, or R&D, and optimization, including 12 years at Harvard Medical School and the Massachusetts General Hospital, by our scientific co-founders prior to company formation.
Previous wording
Nanoparticles similar in formulation to ours have an excellent clinical safety record of low toxicity and immunogenicity. Because their iron core is magnetic and visible with magnetic resonance imaging, or MRI, they have the additional benefit of enabling quantification of the particles’ delivery to target organs. Our nanoparticles carry functional groups to provide stable links to the therapeutic oligonucleotides of interest through covalent bonds.
Current wording
Nanoparticles similar in formulation to ours have an excellent clinical safety record of low toxicity and immunogenicity. Because their iron core is magnetic and visible with magnetic resonance imaging, or MRI, they have the additional benefit of enabling quantification of the delivery of the particles to target organs. Our nanoparticles carry functional groups to provide stable links to the therapeutic oligonucleotides of interest through covalent bonds.
Previous wording
In September 2021, research conducted by MGH was published inCancer Nanotechnology, entitled “Radiolabeling and PET-MRI microdosing of the experimental cancer therapeutic, MN-anti-miR10b, demonstrates delivery to metastatic lesions in a murine model of metastatic breast cancer.” This paper reported on an MGH study using a radiolabeled derivative of TTX-MC138 (referred to in the paper as MN-anti-miR10b). In this study, TTX-MC138 was tagged with copper-64, or Cu-64. As a result, highly sensitive and specific quantitative determination of pharmacokinetics and biodistribution, as well as observation of delivery of the radiolabeled TTX-MC138 to metastases, was made in laboratory tests using noninvasive PET-MRI. The key results of the study suggest that when injected intravenously, TTX-MC138 accumulates in metastatic lesions. These results suggest that our TTX platform delivers its therapeutic candidate as intended and support clinical evaluation of TTX-MC138. In addition, the MGH investigation describes a microdosing PET-MRI approach to measure TTX-MC138 biodistribution in cancer patients and its delivery to clinical metastases. (Microdoses are minute, subpharmacologic doses of a test compound, not greater than 100 micrograms.) The capacity to carry out microdosing PET-MRI studies in patients under an exploratory IND, or eIND, application could be important because they have the potential to support additional clinical trials we may propose for FDA consideration. The research described in this paper, published by Dr. Zdravka Medarova, our Chief Scientific Officer and scientific co-founder, and others, describes what we believe is an effective approach to assessing delivery of TTX-MC138 in metastatic cancer patients. Since the PET-MRI technique is sensitive enough to determine the concentration of radiolabeled drug candidate in the sub-picomolar range, microgram quantities of the radiolabeled drug candidate are believed to be sufficient to perform such a study in humans. We believe this capability has significant advantages in the initial phases of drug development. Because the low mass of radiolabeled TTX-MC138 is subtherapeutic, it may inform future clinical trials with this candidate.
Current wording
microdosing PET-MRI approach to measure TTX-MC138 biodistribution in cancer patients and its delivery to clinical metastases. (Microdoses are minute, subpharmacologic doses of a test compound, not greater than 100 micrograms.) The capacity to carry out microdosing PET-MRI studies in patients under an exploratory IND, or eIND, application could be important because they have the potential to support additional clinical trials we may propose for FDA consideration. The research described in this paper, published by Dr. Zdravka Medarova, our Chief Scientific Officer and scientific co-founder, and others, describes what we believe is an effective approach to assessing delivery of TTX-MC138 in metastatic cancer patients. Since the PET-MRI technique is sensitive enough to determine the concentration of radiolabeled drug candidate in the sub-picomolar range, microgram quantities of the radiolabeled drug candidate are believed to be sufficient to perform such a study in humans. We believe this capability has significant advantages in the initial phases of drug development.
Previous wording
Because of the potential benefits from a microdose Phase 0 clinical trial, and reflecting the studies described inCancer Nanotechnology, our First-in-Human Phase 0 trial was designed to deliver a microdose of our therapeutic candidate. Preliminary results from the Phase 0 microdose trial suggest the validity of our TTX pipeline for drug delivery generally, potentially opening-up additional relevant RNA targets that have been previously undruggable.
Current wording
Because of the potential benefits from a microdose Phase 0 clinical trial, and reflecting the studies described inCancer Nanotechnology, our First-in-Human Phase 0 trial was designed to deliver a microdose of our therapeutic candidate. Results from the trial suggest the validity of our TTX pipeline for drug delivery generally, potentially opening-up additional relevant RNA targets that have been previously undruggable.
Previous wording
In April 2021, we received a Fast-Track Small Business Innovation Research award, or SBIR Award, from the National Cancer Institute that provided approximately $2.4 million to fund a two-phased research partnership between us and Massachusetts General Hospital. The program commenced in April 2021 and ended in March 2024. We received SBIR Award funds of $308,861 in May 2021, $1,129,316 in the second year of the award and $870,597 in April 2023 for the third year of the Award. In the SBIR Award application, we proposed performing key translational experiments including IND-enabling and supporting imaging studies using MRI to assess delivery and target engagement of TTX-MC138 in metastatic lesions of breast cancer patients. The experiments were designed to achieve the following aims:
Current wording
In April 2021, we received a Fast-Track Small Business Innovation Research award, or SBIR Award, from the National Cancer Institute that provided approximately $2.4 million to fund a two-phased research partnership between us and Massachusetts General Hospital. The program commenced in April 2021 and ended in March 2024. In the SBIR Award application, we proposed performing key translational experiments including IND-enabling and supporting imaging studies using MRI to assess delivery and target engagement of TTX-MC138 in metastatic lesions of breast cancer patients. The experiments were designed to achieve the following aims:
Previous wording
We believe that we have achieved all three aims under this SBIR.
Current wording
We believe that we achieved all three aims under this SBIR.
Previous wording
In September 2024, the Company received its second NIH Award (the “2024 Award”), a Direct to Phase II SBIR Award, from the National Cancer Institute of the NIH. The 2024 Award is to support IND-enabling and clinical trial activities in the Company’s Phase 1a clinical trial with its lead candidate, TTX-MC138, over two years. The total 2024 Award is for $1,999,972 of which $1,011,207 applies to the first year and $988,765 applies to the second year.
Current wording
In September 2024, we received our second NIH Award (the “2024 Award”) from the National Cancer Institute of the NIH. The 2024 Award is a Direct to Phase II SBIR Award to support IND-enabling and clinical trial activities in our clinical trial with TTX-MC138 over two years. The total 2024 Award is for $1,999,972 of which $1,011,207 applies to the first year and $988,765 applies to the second year.
Previous wording
On April 15, 2024, we announced that FDA had completed its review of our IND application to conduct a Phase I/II clinical trial with our lead therapeutic candidate, TTX-MC138, and concluded that we may proceed with this clinical trial. The trial is a multicenter, open-label, dose-escalation and dose-expansion study of in patients with advanced solid tumors. We commenced the trial in the third quarter 2024 at MD Anderson and three other clinical trial sites. The first stage of this trial, the Phase 1a, calls for administration of escalating therapeutic dose levels of our drug candidate to as many as six cohorts of approximately three patients per cohort. The first cohort received the lowest therapeutic dose level. In October 2024, the trial’s Safety Review Committee (the “SRC”), approved commencing dosing of patients in the second cohort. Patients in the second and third cohorts have received dosing that is approximately double the level received by patients in each prior cohort. After three patients in each cohort received their initial dose of our drug candidate, the SRC assessed the data and determined that there were no drug-related serious adverse effects or dose limiting toxicities. The SRC approved commencement of dosing in the fourth cohort at a dosage that is approximately fifty percent higher than that administered in the third cohort. The SRC also approved enrollment of additional patients in Cohort 3 to build upon the safety profile of TTX-MC138. Preliminary data indicate no significant safety or dose limiting toxicities reported in Cohorts 1, 2, or 3 and PK and PD data from patients in Cohort 1 and Cohort 2 is consistent with preclinical results and results from our Phase 0 clinical trial. Key assessments in the clinical trial characterize the safety, pharmacokinetic, pharmacodynamic and anti-tumor activity thus identifying a maximum tolerated dose (MTD) and ensuring the mechanism of action is on target. The study also is exploring the effect of TTX-MC138 on biomarker expression, which may include miR-10b expression, and miR-10b downstream targets (RNA sequencing). Clinical assessments to further evaluate TTX=MC138 include clinical laboratory exams, CT scan assessments, and response assessments per RECIST.
Current wording
We commenced a Phase I/II clinical trial with TTX-MC138 in September 2024 at MD Anderson and three other clinical trial sites. This trial has been designed as a multicenter, open-label, dose-escalation and dose-expansion study in patients with advanced solid tumors. The Phase 1a stage of this trial involved administration of escalating therapeutic dose levels of our drug candidate in up to six cohorts of three patients or more per cohort. Preliminary data indicate no significant safety or dose limiting toxicities have been reported in the trial. To date, 77 doses of TTX-MC138 have been administered to 16 patients with advanced solid tumors. Three patients remain on trial. The median treatment duration of treatment is four months. Importantly, the duration of treatment for all patients ranged from two to twelve cycles indicative of tolerability and disease control. Sixteen patients showed positive pharmacodynamic effects over a wide dose range, consistent with preclinical results and TransCode’s Phase 0 clinical trial. Key assessments in the clinical trial characterize the safety, pharmacokinetic, pharmacodynamic and anti-tumor activity of TTX-MC138 from which we have estimated a maximum tolerated dose, or MTD, and which suggest that the mechanism of action of TTX-MC138 is on target. The trial also is exploring the effect of TTX-MC138 on biomarker expression, which may include miR-10b expression, and miR-10b downstream targets (RNA sequencing). Clinical assessments to further evaluate TTX-MC138 include clinical laboratory exams, CT scan assessments, and response assessments per RECIST criteria. The Phase 2a stage of the trial is expected to commence in the first half of 2026.
Previous wording
On March 23, 2025, we entered into a Placement Agency Agreement, or the March Agreement, with ThinkEquity LLC, or the Placement Agent, pursuant to which we agreed to issue and sell, directly to various investors, in a registered direct offering (the “March Offering”) an aggregate of 10,250,000 shares, or the Shares of our common stock, or the Common Stock, and 10,250,000 Common Warrants, or the Common Warrants, to purchase 10,250,000 shares of Common Stock, at an aggregate offering price of $0.98 per share of Common Stock and accompanying Common Warrant. Additionally, as part of its compensation for acting as placement agent for the March Offering, the Company also agreed to issue to the Placement Agent warrants to purchase 512,500 shares of Common Stock, or the Placement Agent Warrants, and together with the Shares and the Common Warrants, the Securities. We received gross proceeds of
Current wording
On March 23, 2025, we entered into a Placement Agency Agreement, or the March Agreement, with ThinkEquity LLC, or the Placement Agent, pursuant to which we agreed to issue and sell, directly to various investors, in a registered direct offering (the “March Offering”) an aggregate of approximately 366,072 shares, or the March Shares, of our Common Stock and approximately 366,072 Common Stock Purchase Warrants, or the March Warrants, to purchase approximately 366,072 shares of Common Stock at an aggregate offering price of $27.44 per share of Common Stock and accompanying March Warrant. As part of its compensation for acting as placement agent for the March Offering, we also agreed to issue to the Placement Agent warrants to purchase approximately 18,304 shares of Common Stock, or the Placement Agent Warrants, and together with the March Shares and the March Warrants, the March Securities. We received gross proceeds of approximately $10 million in connection with the March Offering before deducting placement agent fees and other offering expenses payable by us. The March Offering closed on March 25, 2025. The March Warrants are exercisable commencing March 25, 2025, expire on March 25, 2030, and have an exercise price equal to $24.08 per share. The Placement Agent Warrants are exercisable commencing March 25, 2025, expire on March 25, 2030, and have an exercise price equal to $29.96 per share.
Previous wording
In an effort to continue to manage our costs, in connection with the January 31, 2025, termination of our sublease of laboratory and office space in Newton, Massachusetts, we (i) relocated our R&D activities to space at Michigan State University with which we are negotiating a sponsored research agreement and (ii) relocated our business activities to short-term office rental space in Woburn, Massachusetts. In connection with our R&D activities, we terminated one scientist that we employed and one consulting scientist that we had engaged.
Current wording
In an effort to continue to manage our costs, in connection with the January 31, 2025, termination of our sublease of laboratory and office space in Newton, Massachusetts, we (i) determined to conduct our R&D activities primarily in conjunction with Michigan State University under a sponsored research agreement, (ii) terminated an additional research scientist, and (iii) relocated our business activities to short-term office rental space in Woburn, Massachusetts. In connection with our R&D activities, we also terminated one consulting scientist that we had engaged. In connection with integrating Polynoma’s operations into our own, we terminated three former Polynoma employees and did not extend the lease on Polynoma’s office in San Diego.
Previous wording
From inception in January 2016 through approximately mid-2021, we devoted substantially all of our efforts and financial resources to organizing and staffing our company, business planning, raising capital, securing intellectual property rights, conducting limited research and development activities, and preparing to manufacture drug substance and drug product for our clinical development program. Following our IPO, we expanded our R&D activities and company operations. We do not have any products approved for sale and have not generated any revenue from product sales. We may never be able to develop or commercialize a marketable product. We have limited experience with clinical trials, have not obtained any regulatory approvals to sell any products,
Current wording
Following our IPO in July 2021, we expanded our R&D activities and company operations. We do not have any products approved for sale and have not generated any revenue from product sales. We may never be able to develop or commercialize a marketable product. We have limited experience with clinical trials, have not obtained any regulatory approvals to sell any products, have not manufactured a commercial-scale drug, or conducted sales and marketing activities. Through December 31, 2025, we received approximately $95.8 million of net proceeds, primarily from our IPO, other equity financings including the Investment Agreement, our SBIR Awards and from borrowings under convertible promissory notes between 2018 and 2020.
Previous wording
We have incurred significant operating losses since inception. Our net losses were approximately $16.8 million and $18.5 million for the years ended December 31, 2024 and 2023, respectively. At December 31, 2024, we had an accumulated deficit of approximately $63.2 million. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our current or future product candidates for which there is no assurance of occurrence. We expect that our expenses and capital requirements will increase substantially in connection with our ongoing activities, particularly if and as we:
Current wording
approximately $97.9 million. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our current or future product candidates for which there is no assurance of occurrence. We expect that our expenses and capital requirements will increase substantially in connection with our ongoing activities, particularly if and as we:
Previous wording
As a result, we will need substantial additional funding to support our continuing operations and pursue our business strategy. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through sales of equity, debt financings or other capital sources, which may include collaborations with other companies or other strategic transactions. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. If we fail to raise capital or enter into such agreements as and when needed, we will likely need to consider additional cost reduction strategies, which may include, among others, amending, delaying, limiting, reducing, or terminating our development programs, and we may need to seek an in-court or out-of-court restructuring of our liabilities. In the event of such future restructuring activities, holders of our common stock and other securities will likely suffer a total loss of their investment.
Current wording
As a result, we will need substantial additional funding to support our continuing operations and pursue our business strategy. Until we can generate significant revenue from product sales, if ever, we expect to finance our operations through sales of equity, debt financings or other capital sources, which may include collaborations with other companies or other strategic transactions. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. If we fail to raise capital or enter into such agreements as and when needed, we will likely need to consider additional cost reduction strategies, which may include, among others, amending, delaying, limiting, reducing, or terminating our development programs, and we may need to seek an in-court or out-of-court restructuring of our liabilities. In the event of such future restructuring activities, holders of our common stock and other securities would likely suffer a total loss of their investment.
Previous wording
At December 31, 2024, we had cash of approximately $5.8 million. We believe that these funds together with the approximately $8.8 million we obtained in the March Offering, will be sufficient to support our operating expenses and capital expenditure requirements into the fourth quarter 2025. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect.
Current wording
At December 31, 2025, we had cash of approximately $17.8 million. We believe that these funds will be sufficient to support our operating expenses and capital expenditure requirements through approximately year end 2026. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect.
Previous wording
Impact of Global Economic and Political Developments and the Novel Coronavirus (COVID-19) Pandemic
Current wording
Impact of global economic and political developments and global pandemics
Previous wording
The development of our product candidates or our operations could be disrupted and materially adversely affected by global economic or political developments. In addition, economic uncertainty in global markets caused by political instability and conflict, such as the ongoing conflicts in Ukraine and the Middle East, and economic challenges caused by global pandemics or other public health events, may lead to market disruptions, including significant volatility in commodity prices, credit and capital market instability and supply chain interruptions. Our business, financial condition and results of operations could be materially and adversely affected by negative impacts on the global economy and capital markets resulting from these global economic conditions and circumstances, particularly if such conditions and circumstances are prolonged or worsen.
Current wording
The development of our product candidates or our operations could be disrupted and materially adversely affected by global economic or political developments. In addition, economic uncertainty in global markets caused by political instability and conflict, such as the ongoing conflicts in Ukraine and the Middle East, and economic challenges caused by global pandemics or other public health events, may lead to market disruptions, including significant volatility in commodity prices, credit and capital market instability and supply chain interruptions. Our business, consolidated financial condition and consolidated results of operations could be materially and adversely affected by adverse events in the global economy and capital markets resulting from these global economic conditions and circumstances, particularly if such conditions and circumstances are prolonged or worsen.
Previous wording
Although our business has not been materially impacted by these global economic and political developments to date, it is impossible to predict the extent to which we may be impacted in the short and long term, or the ways in which our business, financial condition and results of operations could be affected by any of the foregoing or by other events which may occur in the future. Any such disruptions may also magnify the impact of other risks described herein or in our other filings with the Securities and Exchange Commission.
Current wording
Although our business has not been materially impacted by these global economic and political developments to date, it is impossible to predict the extent to which we may be impacted in the short and long term, or the ways in which our business, consolidated financial condition and consolidated results of operations could be affected by any of the foregoing or by other events which may occur in the future. Any such disruptions may also magnify the impact of other risks described herein or in our other filings with the SEC.
Previous wording
We recognize external development costs based on an evaluation of the progress toward completion of specific tasks using information provided to us by our employees, consultants and service providers, including CROs and CMOs. This process involves reviewing open contracts and purchase orders, communicating with our personnel to identify services that have been performed on our behalf, the estimated level of service performed and the associated costs incurred for the service when we have not yet been invoiced or otherwise notified of actual costs. Nonrefundable advance payments that we make for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. Such amounts are subsequently expensed as the related goods are delivered or the related services are performed, or until it is no longer expected that the goods will be delivered or the services rendered.
Current wording
We recognize external development costs based on an evaluation of the progress toward completion of specific tasks using information provided to us by our employees, consultants and service providers, including CROs and CMOs. This process involves reviewing open contracts and purchase orders, communicating with our personnel to identify services that have been performed on our behalf, the estimated level of service performed, and the associated costs incurred for the service when we have not yet been invoiced or otherwise notified of actual costs. Nonrefundable advance payments that we make for goods or services to be received or performed in the future in research and development activities are recorded as prepaid expenses. Such amounts are subsequently expensed as the related goods are delivered or the related services are performed, or until it is no longer expected that the goods will be delivered or the services rendered.
Previous wording
We seek to track our research and development expenses on a program-by-program basis. Our direct external research and development expenses comprise primarily payments to outside consultants, CROs, CMOs, research laboratories, and suppliers in connection with our preclinical development, process development, manufacturing and clinical development activities. Our direct external research and development expenses also includes fees incurred under license and option agreements. We do not intend generally to allocate costs of management personnel, certain costs associated with our discovery efforts, certain supplies used in the laboratory, and certain facilities costs, including depreciation or other indirect costs, to specific programs when these costs are incurred across multiple programs and where it may not be practical to track them by program. We use internal resources along with outside parties primarily to conduct our research and discovery as well as for managing our preclinical development, process development, manufacturing and clinical development activities.
Current wording
We seek to track our research and development expenses on a program-by-program basis. Our direct external research and development expenses comprise primarily payments to outside consultants, CROs, CMOs, research laboratories, and suppliers. Our direct external research and development expenses also include fees incurred under license and option agreements. We do not intend generally to allocate costs of management personnel, certain costs associated with our discovery efforts, certain supplies used in the laboratory, and certain facilities costs, including depreciation or other indirect costs, to specific programs when these costs are incurred across multiple programs and where it may not be practical to track them by program. We use internal resources along with outside parties primarily to conduct our research and discovery as well as for managing our preclinical development, process development, manufacturing and clinical development activities.
Previous wording
In September 2021, we signed a statement of work with a European CMO to manufacture TTX-MC138 in accordance with current good manufacturing practices, or cGMP. Separately, we engaged a consulting toxicologist to assist us in designing and conducting IND-enabling studies including toxicology, pharmacokinetic, or PK, studies. These studies are designed to examine multiple parameters with a range of analytical assessments in support of regulatory submissions using radiolabeled or non-radiolabeled test substances. Toxicokinetic assessments can be conducted in parallel or concurrent with ongoing toxicology programs and in compliance with good laboratory practice, or GLP, requirements. We also engaged an analytical testing laboratory to provide testing and other services, as well as documentation and reporting that meet regulatory requirements.
Current wording
In September 2021, we signed a statement of work with a European CMO to manufacture TTX-MC138 in accordance with current good manufacturing practices, or cGMP. Separately, we engaged a consulting toxicologist to assist us in designing and conducting IND-enabling studies including toxicology and pharmacokinetic, or PK, studies. These studies are designed to examine multiple parameters with a range of analytical assessments in support of regulatory submissions using radiolabeled or non-radiolabeled test substances. Toxicokinetic assessments can be conducted in parallel or concurrent with ongoing toxicology programs and in compliance with good laboratory practice, or GLP, requirements. We also engaged an analytical testing laboratory to provide testing and other services, as well as documentation and reporting that meet regulatory requirements.
Previous wording
In late 2024, we and The University of Texas M. D. Anderson Cancer Center (“MD Anderson”) agreed to amend our five-year strategic collaboration agreement in favor of MD Anderson focusing solely on participation in our Phase I/II clinical trial. This amendment relieves us from the obligation to make up to $10 million of collaboration payments. We are obligated to pay charges incurred by MD Anderson in connection with the clinical trial. In January 2023, the Company made an initial payment of $250,000 to MD Anderson recorded as a Prepaid Expense pending such time as payments under the collaboration became due. Initial expenses of the clinical trial will be charged against the initial payment made to MD Anderson and for the years ended December 31, 2024 and 2023, were $279,768 and $0, respectively.
Current wording
In late 2024, we and The University of Texas M. D. Anderson Cancer Center (“MD Anderson”) agreed to amend our five-year strategic collaboration agreement in favor of MD Anderson focusing solely on participation in our Phase I/II clinical trial. This amendment relieved us from the obligation to make up to $10 million of collaboration payments. We are obligated to pay charges incurred by MD Anderson in connection with clinical trial services. In January 2023, we made an initial payment of $250,000 to MD Anderson recorded as a Prepaid Expense pending such time as payments under the collaboration became due. Initial expenses of the clinical trial have been charged against the initial payment and for the years ended December 31, 2025 and 2024, were $154,306 and $279,768, respectively.
Previous wording
At this time, we cannot reasonably estimate or know the nature, timing and costs of the efforts that will be necessary to complete the manufacturing, preclinical and clinical development of any of our product candidates or when, if ever, material net cash inflows might commence from or related to any of our product candidates. The successful development and commercialization of our product
Current wording
At this time, we cannot reasonably estimate or know the nature, timing and costs of the efforts that will be necessary to complete the manufacturing, preclinical and clinical development of any of our product candidates or when, if ever, material net cash inflows might commence from or related to any of our product candidates. The successful development and commercialization of our product candidates is highly uncertain due to the numerous risks and uncertainties associated with product development and commercialization, including:
Previous wording
General and administrative expenses consist primarily of staffing costs comprising mainly salaries, benefits, and share-based compensation expense for personnel serving in executive, finance, and other business functions; insurance costs, especially directors and officers liability insurance; professional fees for legal, patent, consulting, investor and public relations, accounting, tax and audit services; corporate and office expenses, including facilities costs; and information technology costs.
Current wording
General and administrative expenses consist primarily of staffing costs comprising mainly salaries, benefits, and share-based compensation expense for personnel serving in executive, finance, and other business functions; professional fees for legal, patent, consulting, investor and public relations, accounting, tax and audit services; insurance costs, especially directors and officers liability insurance; corporate and office expenses, including facilities costs; and information technology costs.
Previous wording
We anticipate that our general and administrative expenses will increase in the future as we increase our headcount to support our R&D activities, prepare for potential commercial activities including possible partnerships for the development or marketing of approved product candidates, if any, and the increased requirements of a larger and publicly-traded company. We also anticipate that we will incur significantly increased accounting, audit, tax, legal, regulatory, compliance and director and officer liability insurance costs as well as investor and public relations expenses associated with operating as a public company. Additionally, if and when we believe regulatory approval of a product candidate appears likely, we anticipate an increase in payroll and other personnel-related expenses as we prepare for commercial operations, especially as it relates to the sales and marketing of that product candidate. There is a risk that we could incur the foregoing expenses but not receive the anticipated regulatory approval.
Current wording
We anticipate that our general and administrative expenses will increase in the future as we increase our headcount to support our R&D activities, prepare for potential commercial activities including possible partnerships for the development or marketing of approved product candidates, if any, and the increased requirements of a larger and publicly-traded company. We also anticipate that we will incur significantly increased accounting, audit, tax, legal, regulatory, compliance and director and officer liability insurance costs as well as investor and public relations expenses associated with operating as a public company. Additionally, if and when we believe regulatory approval of a product candidate appears likely, we anticipate an increase in payroll and other personnel-related expenses involved in preparing for commercial operations, especially as it relates to the sales and marketing of that product candidate. There is a risk that we could incur the foregoing expenses but not receive the anticipated regulatory approval.
Previous wording
In September 2021, we engaged an independent executive compensation advisory firm to support the continued development of our compensation programs and governance model for officers, directors and employees. Our goal is to ensure that our culture, values, and strategic priorities are effectively represented in our compensation philosophy and strategy.
Current wording
In September 2021, we engaged an independent compensation advisory firm to support the continued development of our compensation programs and governance model for officers, directors and employees. Our goal is to ensure that our culture, values, and strategic priorities are effectively represented in our compensation philosophy and strategy.
Previous wording
Interest expense previously consisted primarily of accrued interest on convertible promissory notes and other charges related to the notes. Since the notes converted into shares of common stock concurrent with our IPO, we no longer incur interest expense on these notes. Under our payment program for directors and officers liability insurance, we incur certain financing charges and we incur imputed interest expense in connection with our right-of-use asset.
Current wording
Interest expense previously consisted primarily of accrued interest on convertible promissory notes and other charges related to the notes. Since the notes converted into shares of common stock concurrent with our IPO, we no longer incur interest expense on these notes. Under our payment program for directors and officers liability insurance, we incur certain financing charges, and we incurred imputed interest expense in connection with our previous right-of-use asset.
Previous wording
The following table summarizes the approximate amounts of our results of operations for the periods indicated:
Current wording
The following table summarizes the approximate amounts of our consolidated results of operations for the periods indicated:
Previous wording
Grant income decreased $399 thousand in the year ended December 31, 2024, compared to the same period in 2023. Grant income was recognized under two NIH grants, one awarded in April 2021 and one in September 2024, to fund certain costs to advance our lead therapeutic candidate into clinical trials.
Current wording
Grant income increased $754 thousand in 2025 compared to 2024. Prior to September 2024, grant income was recognized under an NIH grant awarded in April 2021 to fund certain costs to advance our lead therapeutic candidate into clinical trials. The April 2021 award ended in March 2024. We were awarded a second NIH grant in September 2024. Grant income in 2025 is related to the 2024 Award.
Previous wording
The following table summarizes the approximate amounts of our cash flows for the periods indicated:
Current wording
The following table summarizes the approximate amounts of consolidated our cash flows for the periods indicated:
Previous wording
During the year ended December 31, 2024, we used cash of $22 thousand in investing activities, primarily for purchases of laboratory and computer equipment, compared to $36 thousand used for such purchases in the year ended December 31, 2023.
Current wording
During 2025, we used cash of $4 thousand in investing activities compared to $22 thousand used in 2024, reflecting primarily purchases of laboratory and computer equipment.
Previous wording
Since inception, we have not generated any revenue from product sales or any other sources, and we have incurred significant operating losses and negative cash flows from our operations. We have not yet commercialized any of our product candidates and we do not expect to generate revenue from sales of any product candidates for several years, if ever. We have funded our operations to date primarily with proceeds from borrowings under convertible promissory notes, funds from our IPO and other equity financings,
Current wording
Since inception, we have not generated any revenue from product sales or any other sources, and we have incurred significant consolidated operating losses and negative consolidated cash flows from operations. We have not yet commercialized any of our product candidates and we do not expect to generate revenue from sales of any product candidates for several years, if ever. We have funded our operations to date primarily with proceeds from our IPO and other equity financings, SBIR Awards, and funds from borrowings under convertible promissory notes. Through December 31, 2025, we had received net cash proceeds of approximately $95.8 million from these sources.
Previous wording
We expect our expenses to increase substantially in connection with our ongoing and planned activities, particularly as we advance preclinical activities and pursue additional clinical trials of TTX-MC138. We expect to incur additional costs associated with operating as a public company, including significant legal, accounting, tax, investor relations and other expenses that we did not incur as a private company.
Current wording
We expect our expenses to increase substantially in connection with our ongoing and planned activities, particularly as we advance preclinical activities and pursue additional clinical trials of TTX-MC138. We expect to incur additional costs associated with operating as a public company, including significant legal, accounting, tax, investor relations and other expenses.
Previous wording
At December 31, 2024, we had cash of approximately $5.8 million. We believe that these funds together with the approximately $8.8 million we obtained in the March Offering, will be sufficient to support our operating expenses and capital expenditure requirements into the fourth quarter 2025. We have based this estimate on assumptions that may prove wrong, and we could utilize our available capital resources sooner than we expect. We do not believe that our existing cash will be sufficient to fund our planned operating and capital expenditures for at least the next 12 months from the date of our financial statements included elsewhere herein. Changed circumstances may also result in the depletion of our capital resources more rapidly than we currently anticipate. These factors raise substantial doubt about our ability to continue as a going concern. We anticipate that we will require additional capital for additional research, development, and clinical trials, as we seek regulatory approval of our product candidates, for operations, and for licenses or acquisitions of other product candidates we may choose to pursue. If we receive regulatory approval for TTX-MC138 or other product candidates we may develop, we expect to incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution, all of which will vary depending on where and how we choose to commercialize approved product candidates.
Current wording
We believe that our cash of approximately $17.8 million at December 31, 2025, will be sufficient to fund our operating expense and capital expenditure requirements through approximately year end 2026. We have based this estimate on assumptions that may prove wrong, and we could utilize our available capital resources sooner than we expect. Changed circumstances may also result in the depletion of our capital resources more rapidly than we currently anticipate. We anticipate that we will require additional capital for additional research, development, and clinical trial costs as we seek regulatory approval of our product candidates, for operations, and for licenses or acquisitions of other product candidates we may choose to pursue. If we receive regulatory approval for TTX-MC138 or other product candidates we may develop, we expect to incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution, all of which will vary depending on where and how we choose to commercialize approved product candidates.
Previous wording
Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations through a combination of public or private equity offerings, debt financings, governmental funding, collaborations, strategic partnerships and alliances or marketing, distribution or licensing arrangements with third parties. There is no assurance that funding from any of the foregoing sources or otherwise will be available on acceptable terms, if at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities, ownership interests in our common stock may be materially diluted, and the terms of such securities could include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include restrictive covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. In addition, we could incur fixed payment obligations as a result of any debt or preferred equity financing.
Current wording
Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations through a combination of public or private equity offerings, debt financings, governmental funding, collaborations, strategic partnerships and alliances, and marketing, distribution or licensing arrangements with third parties. There is no assurance that funding from any of the foregoing sources or otherwise will be available on acceptable terms, if at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities, ownership interests in our common stock may be materially diluted, and the terms of such securities could include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include restrictive covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. In addition, we could incur fixed payment obligations as a result of any debt or preferred equity financing.
Previous wording
As further described below, in light of our financial position and our need to raise additional capital, delisting of our common stock from the Nasdaq Capital Market would materially limit our ability to obtain additional equity capital. We may need to seek an in-court or out-of-court restructuring of our liabilities. In the event of such restructuring activities, holders of our common stock and other securities will likely suffer a total loss of their investment.
Current wording
If we are unable to raise additional funds when needed, we will likely need to consider additional cost reduction strategies, which may include, among others, amending, delaying, limiting, reducing, or terminating our development programs, and we may need to seek an in-court or out-of-court restructuring of our liabilities. In the event of such future restructuring activities, holders of our common stock and other securities will likely suffer a total loss of their investment.
Previous wording
At December 31, 2024, we had future minimum lease payments under one non-cancelable operating lease commitment of $38 thousand. We enter into contracts in the normal course of business with CROs, collaborators, CMOs and other third-parties for the manufacture of our product candidates, to support clinical trials and preclinical research studies and testing, and for other purposes. Any payments due upon completion or cancellation of these contracts generally consist only of payments for services provided or expenses incurred, including noncancelable obligations of our service providers, up to the date of cancellation although some agreements provide for termination fees or payments for the balance of the term of the agreement.
Current wording
At December 31, 2025, we had no future minimum lease payments under non-cancelable operating lease commitments. From time to time, we enter into contracts in the normal course of business with CROs, collaborators, CMOs and other third-parties for the manufacture of our product candidates, to support clinical trials and preclinical research studies and testing, and for other purposes. Any payments due upon completion or cancellation of these contracts generally consist only of payments for services provided or expenses incurred, including noncancelable obligations of our service providers, up to the date of cancellation although some agreements provide for termination fees or payments for the balance of the term of the agreement.
Previous wording
In late 2024, we and The University of Texas M. D. Anderson Cancer Center (“MD Anderson”) agreed to amend our five-year strategic collaboration agreement in favor of MD Anderson focusing solely on participation in our Phase 1/II clinical trial. This amendment relieves us from the obligation to make up to $10 million of collaboration payments. We are obligated to pay charges incurred by MD Anderson in connection with the clinical trial. In January 2023, the Company made an initial payment of $250,000 to MD Anderson recorded as a Prepaid Expense pending such time as payments under the collaboration became due. Initial expenses of the clinical trial will be charged against the initial payment made to MD Anderson and for the years ended December 31, 2024 and 2023, were $279,768 and $0, respectively.
Current wording
On July 29, 2022, we signed a five-year strategic collaboration agreement with The University of Texas M. D. Anderson Cancer Center (“MD Anderson”). Under the collaboration, we anticipated making certain expenditures with respect to Phase I and Phase II clinical trials in part through MD Anderson as a clinical site. MD Anderson was also expected to provide preclinical work under the collaboration. The details of clinical and preclinical work were to be mutually agreed by the parties prior to commencing work. We had agreed to fund up to $10 million over the term of the collaboration. In January 2023, we made an initial payment of $250,000 to MD Anderson recorded as a Prepaid Expense pending such time as payments under the collaboration became due. As a result of changes at MD Anderson and the Company, we and MD Anderson agreed to amend the collaboration to continue our Phase 1a clinical trial at MD Anderson. Initial expenses of the clinical trial were charged against the initial payment made to MD Anderson. For the years 2025 and 2024, MD Anderson expenses were $154,306 and $279,768, respectively.
Previous wording
We have based our management’s discussion and analysis of financial condition and results of operations on our financial statements. Our financial statements are prepared in accordance with United States GAAP. The preparation of our financial statements and related disclosures requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, costs and expenses and the disclosure of contingent assets and liabilities at the date of the financial statements. We base our estimates on historical experience, known trends and events, and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for our judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate estimates and assumptions on an ongoing basis. Our actual results may differ from amounts derived from these estimates or from amounts obtained under different assumptions or conditions.
Current wording
We have based our management’s discussion and analysis of consolidated financial condition and consolidated results of operations on our consolidated financial statements. Our consolidated financial statements are prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). The preparation of our consolidated financial statements and related disclosures requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, costs and expenses and the disclosure of contingent assets and liabilities at the dates of the consolidated financial statements. We base our estimates on historical experience, known trends and events, and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for our judgments about the carrying values of assets and liabilities that are not readily apparent from other sources including contingent consideration. We evaluate estimates and assumptions on an ongoing basis. Our actual consolidated results may differ from amounts derived from these estimates or from amounts obtained under different assumptions or conditions.
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Current report — wording carried from elsewhere
In September 2021, research conducted by MGH was published inCancer Nanotechnology, entitled “Radiolabeling and PET-MRI microdosing of the experimental cancer therapeutic, MN-anti-miR10b, demonstrates delivery to metastatic lesions in a murine model of metastatic breast cancer.” This paper reported on an MGH study using a radiolabeled derivative of TTX-MC138 (referred to in the paper as MN-anti-miR10b). In this study, TTX-MC138 was tagged with copper-64, or Cu-64. As a result, highly sensitive and specific quantitative determination of pharmacokinetics and biodistribution, as well as observation of delivery of the radiolabeled TTX-MC138 to metastases, was made in laboratory tests using noninvasive PET-MRI. The key results of the study suggest that when injected intravenously, TTX-MC138 accumulates in metastatic lesions. These results suggest that our TTX platform delivers its therapeutic candidate as intended and support clinical evaluation of TTX-MC138. In addition, the MGH investigation describes a
Current report — wording carried from elsewhere
We have incurred significant operating losses since inception. Our net losses were approximately $34.7 million and $16.8 million for the years ended December 31, 2025 and 2024, respectively. At December 31, 2025, we had an accumulated deficit of
Current report — wording carried from elsewhere
Comparison of the years ended December 31, 2025 and 2024
Current report — wording carried from elsewhere
We rely to a significant extent on third-parties to conduct preclinical studies, manufacture drug substance and drug products, provide materials, conduct analytical testing and to provide clinical trial services, including trial conduct, data management, statistical analysis, medical and safety monitoring, and electronic compilation. At the end of each reporting period, we compare payments made to each service provider and clinical trial site to the estimated progress towards completion of the related project. Factors that we
Current report — wording carried from elsewhere
holders could potentially require “net cash settlement” in a circumstance outside of our control, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent quarterly period end-date while the warrants are outstanding.
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Previous report — wording carried elsewhere
approximately $10 million in connection with the March Offering, before deducting placement agent fees and other offering expenses payable by us. The March Offering closed on March 25, 2025.
Previous report — wording carried elsewhere
The Common Warrants are exercisable commencing March 25, 2025, expire on March 25, 2030, and have an exercise price equal to $0.86 per share. The Placement Agent Warrants are exercisable commencing March 25, 2025, expire on March 25, 2030, and have an exercise price equal to $1.07 per share.
Previous report — wording carried elsewhere
have not manufactured a commercial-scale drug, or conducted sales and marketing activities. Through December 31, 2024, we received approximately $62.5 million of net proceeds, primarily from our IPO, other equity financings, our SBIR Awards and from borrowings between 2018 and 2020 under convertible promissory notes.
Previous report — wording carried elsewhere
candidates is highly uncertain due to the numerous risks and uncertainties associated with product development and commercialization, including:
Previous report — wording carried elsewhere
and our SBIR Awards. Through December 31, 2024, we had received net cash proceeds of approximately $62.5 million from these sources.