ELOX

Eloxx Pharmaceuticals, Inc.

NASDAQ · HEALTH CARE · BIOLOGICAL PRODUCTS, (NO DIAGNOSTIC SUBSTANCES)

13.17

+0.37 +2.89%

USD · close Oct 26

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MKT CAP $53.2MP/E —DIV YIELD —FCF YIELD —REV TTM $0 −100.0%NET INCOME −$6MNET CASH $61M52W 10.95 – 20.98SEC XBRL · TTM TO Invalid Date

How ELOX rewrote its risk factors

10-K ITEM 1A · FY2022 → FY2025

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Risk Factors in this Annual Report, including "If our information technology systems or those third parties upon which we rely or our data, are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions, litigation, fines and penalties, disruptions of our business operations, reputational harm, loss of revenue or profits and other adverse consequences.” Governance Our Board addresses our cybersecurity risk management as part of its general oversight function.
The Audit Committee is responsible for overseeing our cybersecurity risk management processes, including oversight and mitigation of risks from cybersecurity threats.
Our cybersecurity risk assessment and management processes are implemented and maintained by our Interim Chief Financial Officer who oversees the work performed by our information security consultant and third-party managed service provider.
Our information security consultant has over 40 years of experience in pharmaceutical information technology, including many years as a chief information officer.
Our Interim Chief Financial Officer is responsible for hiring appropriate personnel, helping to integrate cybersecurity risk considerations into our overall risk management strategy, and communicating key priorities to relevant personnel .
Our Interim Chief Financial Officer, with support from our information security partners, is responsible for approving budgets, helping prepare for cybersecurity incidents, approving cybersecurity processes, and reviewing security assessments and other security-related reports.
Our cybersecurity incident response policy is designed to escalate certain cybersecurity incidents to members of management depending on the circumstances, including our Interim Chief Financial Officer and legal department.
Our Interim Chief Financial Officer works with our incident response team to help mitigate and remediate cybersecurity incidents of which they are notified.
In addition, our incident response policy includes reporting to the Audit Committee for certain cybersecurity incidents.
Pr operties Our principal executive offices were previously located at 480 Arsenal Way, Watertown, Massachusetts.
We also previously leased office space in Ness Ziona, Israel.
We are now a remotely headquartered company.
Legal Proceedings From time to time, we may become involved in various lawsuits and legal proceedings, which arise in the ordinary course of business, which may include, without limitation, actions related to or based on our intellectual property and its use, customer claims, employment practices and employee complaints and other events arising out of our operations.
We are currently unaware of any material pending legal proceedings to which we are party or of which our property is the subject.
However, we may at times in the future become involved in litigation in the ordinary course of business.
When appropriate in management’s estimation, we will record adequate reserves in our financial statements for pending litigation.
Litigation is subject to inherent uncertainties, and an adverse result in any such matters could adversely impact our reputation, operations, and our financial operating results or overall financial condition.
Additionally, any litigation to which we may become subject could also require significant involvement of our senior management and may divert management’s attention from our business and operations.
Market for Registrant’s Common Equity, Related Stoc kholder Matters and Issuer Purchases of Equity Securities Market Information for Common Stock Since October 16, 2023, our common stock has traded on the OTC markets, most recently on the OTC Expert Market, under the symbol “ELOX”.
Any over-the-counter market quotations reflect inter-dealer prices, without retail mark-up, mark-down or commission, and may not necessarily represent actual transactions.
From July 7, 2022 until October 15, 2023, our common stock was traded on The NASDAQ Capital Market under the symbol “ELOX.” From April 26, 2018 to July 6, 2022, our common stock traded on The NASDAQ Global Market under the symbol “ELOX.” Prior to April 26, 2018, our common stock traded on the OTCQB market under the symbol “ELOX”.
Holders As of March 16, 2026 , there were approximately 117 holders of record of our common stock.
This number does not include “street name” or beneficial holders, whose shares are held of record by banks, brokers, financial institutions and other nominees.
Recent Sales of Unregistered Securities On January 9, 2024, the Company entered into a securities purchase agreement (the “Domicilium Securities Purchase Agreement”) with SD MF 4, LLC (“Domicilium”) providing for the issuance by the Company of: (i) 157,138 shares of the Company’s common stock; (ii) a pre-funded warrant (the “January 2024 Pre-Funded Warrant”) to purchase up to 471,508 shares of common stock; and (iii) an additional warrant to purchase up to 150,000 shares of common stock at a price per share of $1.18, as consideration for Domicilium’s assumption of the Tranche 1B Advance under the Company’s outstanding term loan agreement with Hercules.
The Company did not receive any proceeds in connection with the Equity Issuance.
On August 20, 2025, the Company entered into a securities purchase agreement (the “Coastlands Securities Purchase Agreement”), as amended on September 25, 2025, December 11, 2025, and February 20, 2026, with Coastlands Capital Partners LP (“Coastlands”) and Domicilium.
Pursuant to the Coastlands Securities Purchase Agreement, the Company issued and sold prefunded warrants to purchase up to an aggregate of 30,612,243 shares of common stock to Coastlands and prefunded warrants to purchase up to an aggregate of 21,423,618 shares of common stock to Domicilium, at a sale price of $0.49 per underlying share, for an aggregate purchase price of $17.0 million of investment and the conversion of approximately $9.5 million of outstanding indebtedness.
Since January 1, 2024, the registrant has granted (i) stock options to purchase an aggregate of 9,838,008 shares of its common stock with exercise prices ranging from $0.0001 to $0.24 per share, (ii) 1,230,000 shares of Restricted Stock and (iii) Restricted Stock Units exchangeable into up to 106,500 shares of common stock upon vesting, to employees, consultants and directors in connection with services provided to the registrant by such parties.
The issuances of such equity awards and the shares of common stock issuable upon the exercise or vesting of such awards was pursuant to written compensatory plans or arrangements.
Since January 1, 2024, the registrant issued 465,407 shares of common stock in connection with exercise of outstanding options held by executive officers, directors and employees.
All of these unregistered securities were issued pursuant to Section 4(a)(2) under the Securities Act, relative to transactions by an issuer not involving any public offering, to the extent an exemption from such registration was required.
Purchases of Equity Securities by the Issuer or Affiliated Purchaser There were no repurchases of shares of our common stock during the fourth quarter ended December 31, 2025.
Dividend Policy We have not paid dividends on our common stock since inception and we do not intend to pay any dividends in the foreseeable future.
We expect that any earnings which we may realize will be retained to finance the growth of our Company.
The declaration of dividends in the future will be at the election of our board of directors and will depend upon our earnings, capital requirements, financial position, general economic conditions, and other factors the board of directors deems relevant.
MANAGEMENT’S Discussion and analysis o f financial condition and results of operationS You should read the following discussion and analysis of our financial condition and results of operations together with our consolidated financial statements and related notes and other financial information 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.
Please see “Special Note Regarding Forward-Looking Statements.” As a result of many factors, including those factors set forth in the “Part I, Item 1A - Risk Factors” section of this Annual Report, our actual results could differ materially from the results described in, projected or implied by the forward-looking statements contained in the following discussion and analysis.
Our discussion and analysis of our financial condition and results of operations for 2025, 2024, and 2023 are discussed below.
Company Overview We are a clinical-stage biopharmaceutical company developing novel, small-molecule product candidates designed to modulate the ribosome and promote readthrough of premature stop codons induced by nonsense mutations (“NMs”) to enable the production of full-length proteins.

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Item 1A - Risk Factors” section of this Annual Report on Form 10-K, our actual results could differ materially from the results described in, projected or implied by the forward-looking statements contained in the following discussion and analysis.
Our discussion and analysis of our financial condition and results of operations for 2022 as compared to 2021 are discussed below.
For a discussion of our financial condition and results of operations for 2021 as compared to 2020, please refer to Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our 2021 Annual Report on Form 10-K, except as set forth below.
Company Overview We are a clinical-stage biopharmaceutical company engaged in the science of ribosome modulation, leveraging both our innovative TURBO-ZM chemistry technology platform and our library of novel aminoglycosides to develop novel oral small molecule Ribosome Modulating Agents (“RMAs”) and Eukaryotic Ribosome Selective Glycosides (“ERSGs”), for the treatment of rare and ultra-rare genetic diseases where patients have point nonsense genetic mutations that result in premature stop codons and less than full length proteins.
"Nonsense mutations result in premature stop codons in the impacted messenger RNA (“mRNA”) which in turn disrupt protein synthesis from that mRNA leading to less than full length proteins.
Patients with these mutations have significantly worse outcomes than with missense mutations.
We have multiple programs in our pipeline including a clinical program for the treatment of Alport syndrome with ELX-02 (subcutaneous delivery), preclinical programs in investigational new drug ("IND") enabling stages in Recessive Dystrophic (“RDEB”) and Junctional Epidermolysis Bullosa (“JEB”) and Familial Adenomatous Polyposis (“FAP”) with ZKN-013, and IND enabling stage program with inhaled delivery of ELX-02 in Class 1 cystic fibrosis ("CF").
We also have various earlier discovery stage programs in Cystic fibrosis and oncology.
As our programs advance, we plan to actively look to expand our pipeline by seeking new indications in other rare diseases for compounds designed with our platforms.
Food and Drug Administration (“FDA”) has granted Fast Track designation for ELX-02 for the treatment of CF patients with nonsense mutations.
In addition, the FDA granted ELX-02 Orphan Drug Designation for the treatment of CF in July 2020 and based on the European Medicines Agency’s (“EMA”) positive opinion, the European Commission granted ELX-02 orphan medicinal product designation in September 2018.
In March 2022, we announced our decision to advance ELX-02 delivered subcutaneously for the restoration of Collagen IV protein for the treatment of Alport syndrome patients.
Alport syndrome with nonsense mutations is a genetic kidney disorder that occurs in 1 in 50,000 newborns in the United States.
It is caused by the loss of one of three collagen IV subtypes.
This disease is characterized by blood (hematuria) and protein (proteinuria) in the patient's urine, and results in progressive kidney disease, hearing loss, and eye abnormalities.
In November 2022, we began a Phase 2 monotherapy clinical trial for ELX-02 for the potential treatment of Alport syndrome and in January 2023, we announced that the first patients had been enrolled.
ELX-02 treatment has demonstrated restoration of full-length protein in multiple preclinical models, including collagen IV and collagen VII in cells, and also clinical activity in our Phase 2 cystic fibrosis trial.
We believe our results, previously conducted in vivo studies showing improvement of kidney function with collagen IV restoration and the ability to achieve high kidney drug levels at tolerable doses support the clinical development of ELX-02 in Alport syndrome.
This Phase 2 trial is targeting dosing of up to eight Alport syndrome patients with nonsense mutations in the COL4 gene.
Patients will be dosed for two months with a three month follow-up.
In addition to the primary endpoint of safety, the key secondary efficacy endpoint of proteinuria will be measured every two weeks.
For eligible patients, induction of COL IV will also be measured at the end of two months.
Topline results are expected in the first half of 2023.
We are also advancing ZKN-013, as an oral agent for the treatment of RDEB/JEB and FAP patients with nonsense mutations.
RDEB and JEB are rare skin diseases characterized by mutations in Collagen VII (RDEB) and LAMB3(JEB) proteins.
We estimate that there are approximately 4,000 patients with nonsense mutations in these diseases in the major markets of the US, Japan and Western Europe.
Patients suffer from severe skin bruising, wounds and internal lesions resulting in increased risk of skin cancer and severe malnourishment.
FAP patients have mutations in the APC gene that result in a proliferation of polyps in the colon that if untreated can lead to colon and other related cancers.
There are currently no approved disease modifying therapies for these diseases.
ZKN-013 has demonstrated robust collagen VII restoration in patient cells comparable to 5-10% of protein restoration across a range of mutations.
We have also seen in two separate studies, that treatment of APCMin mice, a validated model for evaluating potential treatment effects in FAP patients, with ZKN-013 for eight weeks reduced polyp number, polyp size and meaningfully improved survival.
We submitted an IND for ZKN-013 on March 24, 2023 for the treatment of RDEB.
In September 2022, in consultation with the Cystic Fibrosis Foundation (“CFF”), we terminated the development of ELX-02 delivered subcutaneously, for the treatment of cystic fibrosis (“CF”) patients with at least one nonsense (“Class 1 CF”) mutations.
This decision was made after our Phase 2 trial of ELX-02 in combination with ivacaftor, an approved drug currently marketed for the treatment of certain CF patients under the trade name “Kalydeco”, did not meet the secondary efficacy endpoint of reduction from baseline in sweat chloride concentration (SCC) or improvement from baseline in percent forced expiratory volume (FEV1).
Encouragingly, we continued to see strong evidence of biological activity similar to that in our previously completed Phase 2 study that reported in November 2021 a reduction in sweat chloride concentration from baseline after one week of treatment with ELX-02.
We believe that the lack of statistically significant clinical benefit in Class 1 CF patients was due to drug concentration in the lung tissue being significantly below that required for effect consistent with our preclinical studies.
ELX-02 was well tolerated in the Phase 2 trial with no drug related adverse events even at the clinical dose of 1.5mg/kg.
Going forward, we plan to only develop that ELX-02 as an inhaled therapy for Class 1 CF patients because the achievable drug concentrations are more than one-hundred times higher in the lung tissue than when given subcutaneously.
We have completed the IND enabling studies for inhaled ELX-02 in Class 1 CF but further clinical development is contingent upon funding from the CFF.
Acquisition of Zikani Therapeutics, Inc.

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Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2022 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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