Medicus Pharma Ltd.
For the period ended Sep 30, 2026. Filed Nov 6, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 6, 2026
MDCX$1.87+2.2%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-12.
0001062993-26-004230
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-06.
0001062993-26-005803
Item 2. 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 95 previous paragraphs and 86 current paragraphs.
34 unchanged; 34 reworded; 18 added; 26 removed; 1 previous and 0 current paragraphs rearranged.
Tables are not compared: 6 previous and 6 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 (18)
Current report
In support of this program, the Company submitted a protocol for a registrational Phase 2b study ("SKNJCT-005"), and in July 2026, the FDA issued a "Study May Proceed" letter authorizing the initiation of SKNJCT-005. The Company has also filed applications for Orphan Drug Designation ("ODD") and Rare Pediatric Disease Designation ("RPDD"), the review of which the FDA has held in abeyance pending receipt of additional information from the Company. In September 2026, the Company also announced that it has concluded any further development in sporadic nBCC, following a comprehensive assessment incorporating findings from an independent third party commercial assessment commissioned by the Company, clinical input from Babar K. Rao, MD, FAAD, Clinical Associate Professor of Dermatology at Weill Cornell Medical College and Principal Investigator of the SkinJect Program, findings from the final Phase 2 SkinJect clinical study report and feedback from the FDA's Office of Orphan Products Development.
Current report
In September 2026, the Company, through Medicus Oncology, entered into a co-development and license agreement (the "Pfizer Agreement") with Pfizer Inc. ("Pfizer"), under which Pfizer granted the Company, subject to certain rights retained by Pfizer and other qualifications contained therein, an exclusive, worldwide license to develop, manufacture and commercialize PF-08046031 ("CD228V"), an early clinical-stage antibody-drug conjugate targeting melanotransferrin (CD228). The Pfizer Agreement is structured as a co-development arrangement, under which Pfizer is expected to remain involved in the CD228V program. The Company, however, has sole authority over and control of the development, manufacture, regulatory approval and commercialization of CD228V and products incorporating it.
Current report
On September 8, 2026, the Company announced a strategic update to its development portfolio under which CD228V has become the Company's principal development priority. The Company intends to focus initial development of CD228V on establishing clinical proof-of-concept in melanoma, particularly in patients with relapsed or refractory disease, supported by the existing U.S. investigational new drug application for CD228V and a first-in-human Phase 1 clinical study (NCT06799533). In connection with this update, the Company announced that it intends to concentrate development of SkinJect on Gorlin Syndrome and, with respect to Teverelix, to prioritize its approximately 126-patient Phase 2 AUR study and the PRECISION-E2 study, while seeking to advance Teverelix in APC through potential strategic partnerships.
Current report
On September 11, 2026, the Company and Yorkville (as defined below) mutually agreed to terminate the SEPA (as defined below), effective as of such date. At the time of termination, there were no outstanding borrowings, advance notices or common shares to be issued under the SEPA, and no fees were payable by the Company or Yorkville in connection with the termination.
Current report
On September 29, 2026, the Company announced that it had submitted to the FDA a protocol for a Phase 2b/3 registration-intent study of Teverelix in patients with APC at increased cardiovascular risk. As proposed, the study would begin with an initial stage of approximately 80 randomized patients, which would replace the previously FDA-cleared 40-patient open-label Phase 2b dose-optimization study, and, if predefined continuation criteria are satisfied, would enroll approximately 528 additional patients, for a total of approximately 608 patients. Following receipt of FDA feedback, the Company intends to seek to out-license or otherwise strategically partner the Teverelix APC program rather than independently fund the proposed study. There can be no assurance that the FDA will agree with the proposed protocol or that the Company will enter into any such transaction.
Current report
On October 7, 2026, the Company announced that it would effect the 2026 Share Consolidation (as defined below) to be effective on October 12, 2026, with the goal of the 2026 Share Consolidation to increase the bid price of the common shares and to enable the Company to regain compliance with the minimum bid price requirement for continued listing on Nasdaq. The common shares commenced trading on Nasdaq on a consolidated basis at the commencement of trading on October 12, 2026. On October 23, 2026, the Company announced that Nasdaq had informed the Company that it had regained compliance with Nasdaq's minimum bid price requirement.
Current report
On October 8, 2026, the Company provided a shareholder update celebrating its third anniversary, highlighting three years of progress, focused on execution and capital efficient drug development. The Company has advanced its transformation into a precision oncology-led biotechnology company, with a portfolio of select novel assets, anchored by CD228V, an investigational antibody-drug conjugate molecule utilizing Pfizer's established vedotin linker-payload platform, SkinJect for basal cell carcinomas in patients with Gorlin Syndrome and Teverelix for development opportunities in urology and women's health.
Current report
Share Consolidations
Current report
After the completion of the 2026 Share Consolidation, the number of the Company's issued and outstanding common shares decreased from 93,770,921 to 1,850,418. The Company's common shares continue to have no par value following the 2026 Share Consolidation. The 2026 Share Consolidation was completed to regain compliance with the minimum bid price requirement for continued listing on the Nasdaq as set forth in Nasdaq Listing Rule 5550(a)(2). No fractional common shares were issued in connection with the 2026 Share Consolidation, and any fractional common share resulting from the 2026 Share Consolidation was rounded down to the nearest whole common share and cash was paid in lieu of such fractional share. Proportionate adjustments were made to the per share exercise price and the number of common shares issuable upon the exercise or conversion of outstanding equity awards, convertible securities and warrants, as well as to the number of common shares issued and issuable under the Company's equity incentive plans.
Current report
On September 1, 2026, the Company entered into a note exchange agreement with Streeterville (the "Note Exchange Agreement") whereby the Company exchanged $2,000,000 of Note B borrowings to a separate Secured Promissory Note A-2 ("Note A-2" and, together with Note A and Note B, the "Secured Promissory Notes"). As a result of the exchange, $2,000,000 of the $10,000,000 previously subject to restriction under Note B was no longer restricted. Upon execution of the Note Exchange Agreement, Note A-2 was issued at a face value of $2,139,037 and a purchase price of $2,000,000, resulting in an issuance discount of $139,037. Note A-2 bears interest of 8.75% per annum compounded daily. The Secured Promissory Notes will mature on November 27, 2027.
Current report
R&D expenses increased by $267,997 or 15.91% for the three months ended September 30, 2026, compared to the three months ended September 30, 2025. R&D expenses increased by $4,434,304 or 86.43% for the nine months ended September 30, 2026, compared to the nine months ended September 30, 2025. The increase for the three months ended September 30, 2026, was primarily due to increases of approximately $2.2 million in R&D salaries and benefits, and $0.1 million in external costs attributable to CD228V, partially offset by a decrease of approximately $0.6 million in external costs attributable to SkinJect and $1.4 million in external costs attributable to Teverelix. The increase for the nine months ended September 30, 2026 was primarily due to increases of approximately $2.6 million in external costs attributable to Teverelix, reflecting a full period of development activities following the acquisition of Antev in August 2025, $2.8 million in R&D salaries and benefits, primarily related to Antev personnel, and $0.1 million in external costs attributable to CD228V, partially offset by a decrease of approximately $1.1 million in external costs attributable to SkinJect following the completion of SKNJCT-003.
Current report
In-process research and development ("IPR&D")
Current report
IPR&D expense was $10,000,000 for each of the three and nine months ended September 30, 2026, compared to $8,717,475 for each of the three and nine months ended September 30, 2025. IPR&D expense for the 2026 periods related to the license of CD228V under the Pfizer Agreement, and represents the $12.0 million upfront payment paid to Pfizer, net of the $2.0 million development funding payment received from Pfizer. IPR&D expense for the 2025 periods related to the in-process research and development acquired in connection with the acquisition of Antev.
Current report
None of the outstanding Regulation A Warrants were exercised during the three and nine months ended September 30, 2026 and as of September 30, 2026, no June 2030 Warrants were exercised.
Current report
Cash flows provided by financing activities for the nine months ended September 30, 2026, were $36,245,297 compared to cash flows provided by financing activities of $25,286,315 for the nine months ended September 30, 2025. The increase is primarily due to gross proceeds of $22,000,000 from the issuance of the Secured Promissory Notes, net proceeds of $17,154,819 from the issuance of common shares under the ATM and net proceeds of $4,102,740 from the issuance of common shares under the SEPA during the nine months ended September 30, 2026, partially offset by the repayment of debentures and other loans of $6,397,262. Financing activities for the nine months ended September 30, 2025, primarily consisted of net proceeds from the issuance of common shares and warrants of $9,790,015, proceeds from the issuance of debentures of $11,866,293, proceeds from the exercise of warrants of $4,729,398 and proceeds from the issuance of common shares under the SEPA of $5,097,005, partially offset by the repayment of debentures and other loan of $5,637,709.
Current report
On October 12, 2026, the Company effected the 2026 Share Consolidation, with the goal of the 2026 Share Consolidation to increase the bid price of the common shares and to enable the Company to regain compliance with the minimum bid price requirement for continued listing on Nasdaq. On October 23, 2026, the Company announced that Nasdaq had informed the Company that it had regained compliance with Nasdaq's minimum bid price requirement as set forth in Nasdaq Listing Rule 5550(a)(2).
Current report
On November 4, 2026, the Company announced that SkinJect entered into a non-binding letter of intent with an undisclosed special purpose acquisition company for a proposed business combination involving SkinJect (the “Business Combination”) and concurrent equity financing. There can be no assurance that definitive agreements relating to the Business Combination will be signed, that the equity financing will be secured or that the transaction will be completed.
Current report
As previously disclosed, the Company received a notice from Nasdaq's Listing Qualifications Department on May 20, 2026, notifying the Company that its market value of listed securities for its common shares had been below $35 million for the previous 30 consecutive business days under Nasdaq Listing Rule 5550(b)(2), that the Company also did not meet the equity standard requirements under Nasdaq Listing Rule 5550(b)(1) or the net income standard requirements under Nasdaq Listing Rule 5550(b)(3) and therefore that the Company was not in compliance with the continued listing standards on the Nasdaq as set forth in Nasdaq Listing Rule 5550(b) (the "MVLS Requirement"). The Company has until November 16, 2026, to regain compliance with the MVLS Requirement.
Removed paragraphs (26)
Previous report
The Company is separately pursuing SkinJect as a treatment for Gorlin Syndrome (Nevoid Basal Cell Carcinoma Syndrome), a rare inherited genetic disorder associated with lifelong development of multiple basal cell carcinomas and recurrent skin cancers. In support of this program, the Company is pursuing a registrational Phase 2b study design ("SKNJCT-005") and filed applications for Orphan Drug Designation and Rare Pediatric Disease Designation.
Previous report
On April 6, 2026, the Company announced its submission of an optimized Phase 2 clinical study design to the FDA for Teverelix, for the prevention of recurrent AUR in men with benign prostatic hyperplasia as part of the Company's existing open investigational new drug for Teverelix.
Previous report
On April 17, 2026, the Company announced its submission of an orphan drug designation application to the FDA for SkinJect for the treatment of BCC in patients with Gorlin Syndrome, a rare genetic disorder characterized by the development of multiple, recurrent skin cancers.
Previous report
On April 21, 2026, the Company received written notice from the Listing Qualifications Department of Nasdaq, notifying the Company that the closing bid price for the common shares had been below $1.00 per share for the previous 30 consecutive business days, and that the Company is therefore not in compliance with the minimum bid price requirement for continued listing on the Nasdaq Capital Market as set forth in Nasdaq Listing Rule 5550(a)(2). In accordance with the Nasdaq Listing Rule 5810(c)(3)(A), the Company has a period of 180 calendar days, or until October 19, 2026, to regain compliance with the minimum bid price requirement. To regain compliance, the closing bid price of the common shares must meet or exceed $1.00 per share for a minimum of ten consecutive business days during this 180-day period. The notice has no immediate effect on the listing or trading of the common shares on the Nasdaq Capital Market.
Previous report
On May 6, 2026, the Company announced results from a pre-specified expanded dataset analysis demonstrating positive dose response from its Phase 2 SKNJCT-003 study evaluating safety and efficacy of D-MNA to treat nBCC of the skin, the most common type of skin cancer. This additional pre-specified analysis, builds upon the previously reported positive topline results, provides expanded biological, histologic, and safety insights that further strengthen SkinJect's therapeutic profile and future registrational discussions with the FDA. The expanded analysis showed clear and consistent dose response relationship across endpoints, demonstrating stronger separation between the 200ug cohort and control, particularly at Day 57. These additional findings are also consistent with prior Phase 1 clinical observations in the SKNJCT-001 study in March 2021, and interim analysis of SKNJCT-003 in March 2025, reinforcing reproducibility across studies.
Previous report
On June 3, 2026, the Company announced its submission of Protocol SKNJCT-005 to the FDA under the Company's existing Investigational New Drug ("IND") application, for SkinJect into registrational development for patients with Gorlin Syndrome, also called Nevoid Basal Cell Carcinoma Syndrome, a rare inherited genetic disorder associated with lifelong development of multiple basal cell carcinomas and recurrent skin cancers, often resulting in repeated surgical procedures. The submitted protocol outlines a Phase 2b, open-label study designed to generate efficacy and safety data intended to support a future new drug application for SkinJect in Gorlin Syndrome.
Previous report
On June 8, 2026, the Company announced its submission of a substantial modification application through the European Union Clinical Trials Information System supporting the planned Phase 2b study of Teverelix in APC. The planned Phase 2b study is designed to optimize dose selection and further characterize the pharmacokinetic, pharmacodynamic, efficacy and safety profile of Teverelix ahead of planned registrational development. Medicus has previously engaged extensively with the FDA regarding its APC development strategy, including future studies focused on patients with elevated cardiovascular risk.
Previous report
On June 11, 2026, the Company announced its submission of an IND application to the DOH for PRECISION-E2, a first-of-its-kind, Phase 2a genomics-enabled clinical trial evaluating Teverelix in women with symptomatic endometriosis in the UAE. The PRECISION-E2 study is designed to combine clinical outcomes, hormonal biomarkers, pharmacokinetic and pharmacodynamic measurements, and genomic analyses to better understand treatment response variability in women suffering from endometriosis.
Previous report
On June 15, 2026, the Company announced its submission of Rare Pediatric Disease Designation ("RPDD") request to the FDA for SkinJect, the Company's investigational D-MNA patch, for the treatment of BCC in patients with Gorlin Syndrome, also known as Nevoid Basal Cell Carcinoma Syndrome. The RPDD submission was made pursuant to Section 529 of the Federal Food, Drug, and Cosmetic Act and follows the Company's previously announced Orphan Drug Designation ("ODD") application (DRU-2026-11578), and Registrational study design (SKNJCT-005) which remains under FDA review. The design of the Company's Gorlin Syndrome development program has been informed through engagement with clinical experts and the Gorlin Syndrome Alliance, a patient advocacy group focused on the needs and priorities of this unique patient population.
Previous report
On June 24, 2026, the Company participated in the 2026 Bio International Conference in San Diego, California, where Dr. Faisal Mehmud, Chief Medical Officer of Medicus, delivered a company presentation highlighting clinical, regulatory and strategic advancements across the Company's development portfolio. The presentation included, among other updates, the updated positive decision-grade dataset from the Phase 2 SKNJCT-003 study, which demonstrated a clear dose-response relationship and clinically meaningful complete response rates (55% histological clearance and 64% clinical clearance) in patients in the 200 ug cohort that were treated with SkinJect.
Previous report
On July 16, 2026, the Company announced it received written feedback from the FDA and central Institutional Review Board approval, with modifications, for its optimized Phase 2 clinical study of Teverelix in men following a first episode of AUR. The Company submitted the optimized protocol to the FDA on April 2, 2026, under its existing IND application for Teverelix. The redesigned study is expected to enroll approximately 126 patients across the United States and Europe, compared with approximately 390 patients contemplated under the Company's previously disclosed development plan, and is intended to generate an early pharmacodynamic signal while supporting dose optimization, route selection and future clinical development.
Previous report
On July 27, 2026, the Company announced that the FDA completed its safety review of the Company's IND application for SKNJCT-005 and issued a "Study May Proceed" letter authorizing the initiation of the Company's NDA-enabling registrational Phase 2b clinical study evaluating SkinJect 200 mcg in patients with Gorlin Syndrome presenting with multiple BCCs.
Previous report
On July 31, 2026, the Company announced that the UAE DOH has granted IND authorization for the Company's PRECISION-E2 Phase 2a clinical study evaluating Teverelix in women with moderate-to-severe symptomatic endometriosis.
Previous report
On August 3, 2026, the Company announced the appointment of Faisal Mehmud, MD, MRCP, as chief executive officer of Antev, effective August 30, 2026. Dr. Mehmud will continue to serve as Chief Medical Officer of Medicus and Co-Chairman of Antev.
Previous report
Share Consolidation
Previous report
After the completion of the Share Consolidation, the number of the Company's issued and outstanding common shares decreased from 21,693,560 to 10,846,721. The par value of the Company's common shares remains unchanged at $0 per share after the Share Consolidation. The Share Consolidation was completed in preparation for a U.S. listing.
Previous report
R&D expenses increased by $4,166,307 or 120.9% for the six months ended June 30, 2026, compared to the six months ended June 30, 2025. This increase is primarily due to the development of Teverelix, offset with a reduction in costs relating to SkinJect as we come to the end of its Phase 2 trials. We expect our R&D expenses to increase going forward with the costs of two separate Phase 2 trials associated with Teverelix advancing.
Previous report
On March 10, 2025, the Company completed the Regulation A Offering of 1,490,000 units at $2.80 per unit. None of the 1,490,000 Regulation A Warrants have been exercised during the three and six months ended June 30, 2026.
Previous report
Yorkville's obligation to purchase the common shares is subject to a number of conditions, including that the Company file a registration statement with the SEC registering the resale of the common shares issuable thereunder, and that the registration statement is declared effective by the SEC. Such current registration statement, as amended, was originally filed with the SEC on September 29, 2025 and declared effective by the SEC on November 14, 2025.
Previous report
The issuance of common shares under the SEPA is subject to further limitations, including that the common shares beneficially owned by Yorkville and its affiliates at any one time will not exceed 4.99% of the then-outstanding common shares.
Previous report
Common shares issued and sold to Yorkville under the SEPA will be priced at 97% of the market price (as defined in the SEPA) of the common shares during a specified three-day pricing period. The Company reserves the right to set a minimum acceptable price for the common share issuances.
Previous report
Cash flows provided by financing activities for the six months ended June 30, 2026, were $32,354,942 compared to cash flows provided by financing activities of $14,915,048 for the six months ended June 30, 2025. The increase is primarily due to increased proceeds from the issuance of common shares in equity offerings and under the SEPA, during the six months ended June 30, 2026, compared to proceeds from the issuance of common shares and warrants, net of offering costs from the Regulation A Offering, during the six months ended June 30, 2025.
Previous report
On July 16, 2026, the Company announced it received written feedback from the FDA and central Institutional Review Board approval, with modifications, for its optimized Phase 2 clinical study of Teverelix in men following a first episode of AUR. The Company submitted the optimized protocol to the FDA on April 2, 2026, under its existing IND application for Teverelix. The redesigned study is expected to enroll approximately 126 patients across the United States and Europe, compared with approximately 390 patients contemplated under the Company's previously disclosed development plan, and is intended to generate an early pharmacodynamic signal while supporting dose optimization, route selection and future clinical development.
Previous report
On July 27, 2026, the Company announced that the FDA completed its safety review of the Company's IND application for SKNJCT-005 and issued a "Study May Proceed" letter authorizing the initiation of the Company's NDA-enabling registrational Phase 2b clinical study evaluating SkinJect 200 mcg in patients with Gorlin Syndrome presenting with multiple BCCs.
Previous report
On July 31, 2026, the Company announced that the UAE DOH has granted IND authorization for the Company's PRECISION-E2 Phase 2a clinical study evaluating Teverelix in women with moderate-to-severe symptomatic endometriosis.
Previous report
On August 3, 2026, the Company announced the appointment of Faisal Mehmud, MD, MRCP, as chief executive officer of Antev, effective August 30, 2026. Dr. Mehmud will continue to serve as Chief Medical Officer of Medicus and Co-Chairman of Antev.
Reworded paragraphs (34)
Previous wording
This Item and other sections of this Quarterly Report contain forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that involve risks and uncertainties. When reviewing the discussion below, you should keep in mind the substantial risks and uncertainties that impact our business. In particular, we encourage you to review the risks and uncertainties described in "Risk Factors" in Part I, Item 1A in the 2025 Annual Report and Part II, Item 1A of this Quarterly Report. These risks and uncertainties could cause actual results to differ materially from those projected or implied by our forward-looking statements contained in this Quarterly Report. These forward-looking statements are made as of the date of this Quarterly Report, and we do not intend, and do not assume any obligation, to update these forward-looking statements, except as required by law. All amounts are expressed in United States dollars unless otherwise stated. This discussion should be read in conjunction with the Company's interim unaudited condensed consolidated financial statements for the three and six months ended June 30, 2026 and 2025.
Current wording
This Item and other sections of this Quarterly Report contain forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that involve risks and uncertainties. When reviewing the discussion below, you should keep in mind the substantial risks and uncertainties that impact our business. In particular, we encourage you to review the risks and uncertainties described in "Risk Factors" in Part I, Item 1A in the 2025 Annual Report and Part II, Item 1A of this Quarterly Report. These risks and uncertainties could cause actual results to differ materially from those projected or implied by our forward-looking statements contained in this Quarterly Report. These forward-looking statements are made as of the date of this Quarterly Report, and we do not intend, and do not assume any obligation, to update these forward-looking statements, except as required by law. All amounts are expressed in United States dollars unless otherwise stated. Unless otherwise stated, all information in this MD&A is presented giving retroactive effect to the 2026 Share Consolidation (as defined below under "Share Consolidations"). Pursuant to the anti-dilution provisions of the Company's option and warrant agreements, the 2026 Share Consolidation proportionally adjusted the terms of all outstanding options and warrants, so that 50 options or warrants are now required to purchase one common share. Accordingly, the number of options and warrants outstanding remain unchanged under the original agreements. However, the number of common shares that the options and warrants can be exercised for were adjusted to reflect the share consolidation. All share, option, warrant and per share amounts in the accompanying unaudited condensed consolidated financial statements and related notes have been retroactively adjusted to reflect the share consolidation for all periods presented. This discussion should be read in conjunction with the Company's interim unaudited condensed consolidated financial statements for the three and nine months ended September 30, 2026 and 2025.
Previous wording
Medicus Pharma Ltd. (the "Company") is a clinical stage, multi-strategy, biotech/life sciences company focused on investing in and accelerating clinical development programs of novel and potentially disruptive therapeutic assets. The Company looks into opportunities across all therapeutic areas where an unmet need exists for improved patient safety and efficacy. The Company is opportunistically exploring to expand its drug development pipeline through qualified and accretive acquisitions and partnerships.
Current wording
Medicus Pharma Ltd. (the "Company") is a precision guided, biotech/life sciences company focused on advancing novel and potentially disruptive therapeutic assets. The Company looks into opportunities across all therapeutic areas where an unmet need exists for improved patient safety and efficacy. The Company is opportunistically exploring to expand its drug development pipeline through qualified and accretive acquisitions and partnerships.
Previous wording
The Company has three wholly owned subsidiaries, Medicus Pharma Inc., a company incorporated in the state of Delaware on October 12, 2023, SkinJect, Inc. ("SkinJect"), a company incorporated in the state of Pennsylvania on March 3, 2015 and, for purposes of engaging in the Secured Promissory Notes (as defined below) transactions, MDCX Holdings, LLC, a limited liability company organized in the state of Utah on May 19, 2026.
Current wording
The Company has three wholly owned subsidiaries, Medicus Pharma Inc. (doing business as Medicus Oncology), a company incorporated in the state of Delaware on October 12, 2023, SkinJect, Inc. ("SkinJect"), a company incorporated in the state of Pennsylvania on March 3, 2015 and, for purposes of engaging in the Secured Promissory Notes (as defined below) transactions, MDCX Holdings, LLC, a limited liability company organized in the state of Utah on May 19, 2026.
Previous wording
The Company has advanced SkinJect through a multi-stage clinical program. An initial Phase 1 dose-escalation study ("SKNJCT-001") established that the D-MNA patch was well tolerated with no dose-limiting toxicity in patients with basal cell carcinoma ("BCC"). The Company also initiated a study ("SKNJCT-002") to evaluate device penetration in healthy volunteers, but paused the study after enrolling seven of a planned 15 subjects due to variability in array application and ultimately closed the study without further enrollment - no adverse events were reported. The Company also conducted a Phase 2 study ("SKNJCT-003") which was a randomized, double-blinded, three arm study evaluating two dose levels of D-MNA compared with a device-only control (C-MNA or P-MNA) in patients with nodular type basal cell carcinoma ("nBCC"). The SKNJCT-003 study, conducted across sites in the United States and in Europe, reported topline results in March 2026 showing 73% clinical clearance and 40% histological clearance in the D-MNA arm compared to 38% clinical clearance in the device-only P-MNA arm in the 200-µg patient cohort at Day 57 of the study. The Company provided further updates on the results of the SKNJCT-003 study in June 2026, showing 55% histological clearance and 64% clinical clearance in patients in the 200 ug cohort that were treated with SkinJect. The Company is conducting a separate Phase 2 study in the United Arab Emirates ("SKNJCT-004") and, in September 2025, gained FDA alignment to pursue the 505(b)(2) regulatory pathway to treat BCC using D-MNA.
Current wording
The Company has advanced SkinJect through a multi-stage clinical program. An initial Phase 1 dose-escalation study ("SKNJCT-001") established that the D-MNA patch was well tolerated with no dose-limiting toxicity in patients with basal cell carcinoma ("BCC"). The Company also initiated a study ("SKNJCT-002") to evaluate device penetration in healthy volunteers, but paused the study after enrolling seven of a planned 15 subjects due to variability in array application and ultimately closed the study without further enrollment; no adverse events were reported. The Company also conducted a Phase 2 study ("SKNJCT-003") which was a randomized, double-blinded, three-arm study evaluating two dose levels of D-MNA compared with a device-only control (C-MNA or P-MNA) in patients with nodular type basal cell carcinoma ("nBCC"). The SKNJCT-003 study, conducted across ten sites in the United States, reported topline results in March 2026 showing 73% clinical clearance and 40% histological clearance in the D-MNA arm compared to 38% clinical clearance in the device-only P-MNA arm in the 200 µg patient cohort at Day 57 of the study. The Company provided further updates on the results of the SKNJCT-003 study in June 2026, showing 55% histological clearance and 64% clinical clearance in patients in the 200 µg cohort that were treated with SkinJect. In September 2026, the clinical study report was finalized and an abridged clinical study report for SKNJCT-003 is available on ClinicalTrials.gov (NCT06608238). In September 2026, the Company also announced exclusive development focus for SkinJect in Gorlin Syndrome patients, a rare-autosomal dominant disease, presenting with multiple basal cell carcinoma lesions.
Previous wording
In August 2025, the Company completed its acquisition of Antev, a UK-based clinical biotech company developing Teverelix, a next-generation gonadotropin-releasing hormone ("GnRH") antagonist, as a first in market product for cardiovascular high-risk prostate cancer patients and patients with first acute urinary retention ("AUR") episodes due to enlarged prostate. The Company has received FDA clearance to proceed with a Phase 2b dose-optimization study of Teverelix in men with advanced prostate cancer ("APC") and has submitted an optimized Phase 2 study design for the prevention of recurrent AUR in men with benign prostatic hyperplasia. The Company has also submitted an investigational new drug application to the United Arab Emirates ("UAE") Department of Health, Abu Dhabi ("DOH") for its planned PRECISION-E2 study, a first-of-its-kind, Phase 2a genomics-enabled clinical trial, that will evaluate Teverelix in women with symptomatic endometriosis in the UAE.
Current wording
In August 2025, the Company completed its acquisition of Antev, a UK-based clinical biotech company developing Teverelix, a next-generation gonadotropin-releasing hormone ("GnRH") antagonist, as a first-in-market product for cardiovascular high-risk prostate cancer patients and patients with first acute urinary retention ("AUR") episodes due to enlarged prostate. The Company has received FDA clearance to proceed with a Phase 2b dose-optimization study of Teverelix in men with advanced prostate cancer ("APC"). The Company has since submitted to the FDA a proposed seamless Phase 2b/3 registration-intent protocol that would incorporate the dose-optimization study into its initial stage and, subject to FDA feedback, intends to seek to out-license or otherwise strategically partner the APC program rather than independently fund the proposed study. The Company has also received written feedback from the FDA and central Institutional Review Board approval, with modifications, for an optimized Phase 2 study for the prevention of recurrent AUR in men with benign prostatic hyperplasia. The Company also received investigational new drug authorization from the United Arab Emirates ("UAE") Department of Health, Abu Dhabi ("DOH") for its planned PRECISION-E2 study, a first-of-its-kind, Phase 2a genomics-enabled clinical trial that will evaluate Teverelix in women with symptomatic endometriosis in the UAE.
Previous wording
On June 25, 2024, the Company's shareholders approved an amendment to the Company's articles of incorporation to provide for a share consolidation (the "Share Consolidation"), or reverse stock split, of the Company's issued and outstanding common shares at such a consolidation ratio to be determined by the Company's board of directors in its sole discretion, to permit the Company to satisfy all conditions and necessary regulatory approvals to list the common shares on a U.S. national securities exchange as the Company's board of directors may determine in its sole discretion. Our board of directors approved the Share Consolidation on October 15, 2024, and the Share Consolidation was completed by the Company on October 28, 2024, at the ratio of 1-for-2.
Current wording
On June 25, 2024, the Company's shareholders approved an amendment to the Company's articles of incorporation to provide for a share consolidation (the "2024 Share Consolidation"), or reverse stock split, of the Company's issued and outstanding common shares at such a consolidation ratio to be determined by the Company's board of directors (the "Board") in its sole discretion, to permit the Company to satisfy all conditions and necessary regulatory approvals to list the common shares on a U.S. national securities exchange as the Board may determine in its sole discretion. The Board approved the 2024 Share Consolidation on October 15, 2024, and the 2024 Share Consolidation was completed by the Company on October 28, 2024, at the ratio of 1-for-2. The 2024 Share Consolidation was completed in preparation for a U.S. listing, which was successfully completed in November 2024.
Previous wording
On June 3, 2026, at the Company's 2026 Annual General and Special Meeting of shareholders, the Company's shareholders approved a special resolution authorizing the Board, in its discretion, to effect a consolidation of the Company's common shares on the basis of a consolidation ratio to be determined by the Board, up to a maximum ratio of 50 pre-consolidation common shares for every one post-consolidation Common Share, if the Board determines such a consolidation is necessary or desirable, including, without limitation, for the purpose of meeting any applicable stock exchange or regulatory requirements. As of the date hereof, the Board has neither effected such share consolidation nor announced an intention to do so.
Current wording
On June 3, 2026, at the Company's 2026 Annual General and Special Meeting of shareholders, the Company's shareholders approved a special resolution authorizing the Board, in its discretion, to effect a consolidation of the Company's common shares on the basis of a consolidation ratio to be determined by the Board, up to a maximum ratio of 50 pre-consolidation common shares for every one post-consolidation common share, if the Board determines such a consolidation is necessary or desirable, including, without limitation, for the purpose of meeting any applicable stock exchange or regulatory requirements (the "2026 Share Consolidation"). The Board subsequently approved the 2026 Share Consolidation, which became effective on October 12, 2026, at the ratio of 50-to-1.
Previous wording
On November 14, 2024, the Company completed its initial public offering with the sale of 970,000 Units at the price of $4.125 per Unit, with each Unit (the "Unit") consisting of one common share and one warrant (the "Public Warrants" and with the Regulation A Warrants and the June 2030 Warrants, each as defined below, the "Warrants"). The Public Warrants expire five years from their date of issuance on November 15, 2029. In addition, the underwriters exercised an option to purchase 145,500 Public Warrants (the "Overallotment Warrants") at a price of $0.01 per warrant.
Current wording
On November 14, 2024, the Company completed its initial public offering with the sale of 19,400 Units at the price of $206.25 per Unit, with each Unit (the "Unit") consisting of one common share and one warrant (the "Public Warrants" and with the Regulation A Warrants and the June 2030 Warrants, each as defined below, the "Warrants"). The Public Warrants are each exercisable at $232 per common share, and expire five years from their date of issuance on November 15, 2029. In addition, the underwriters exercised an option to purchase 2,910 Public Warrants (the "Overallotment Warrants") at a price of $0.50 per warrant.
Previous wording
Total gross proceeds from our initial public offering were $4.0 million, including the proceeds from the Overallotment Warrants. The Company incurred total issuance costs of $2.1 million, including underwriter fees, and legal and other professional fees incurred directly related to the issuance. No Public Warrants issued as part of our initial public offering were exercised during the three and six months ended June 30, 2026.
Current wording
Total gross proceeds from our initial public offering were $4.0 million, including the proceeds from the Overallotment Warrants. The Company incurred total issuance costs of $2.1 million, including underwriter fees, and legal and other professional fees incurred directly related to the issuance. No Public Warrants issued as part of our initial public offering were exercised during the three and nine months ended September 30, 2026.
Previous wording
On March 10, 2025, the Company completed an offering (the "Regulation A Offering") of 1,490,000 units at $2.80 per unit pursuant to Tier II of Regulation A under the Securities Act, with each unit consisting of one common share and one warrant (each, a "Regulation A Warrant"). The Regulation A Warrants have an exercise price of $2.80 and expire on March 10, 2030. The aggregate gross proceeds to the Company from the Regulation A Offering were $4.2 million. No Regulation A Warrants were exercised during the three and six months ended June 30, 2026.
Current wording
On March 10, 2025, the Company completed an offering (the "Regulation A Offering") of 29,800 units at $140 per unit pursuant to Tier II of Regulation A under the Securities Act, with each unit consisting of one common share and one warrant (each, a "Regulation A Warrant"). The Regulation A Warrants have an exercise price of $140 per common share, and expire on March 10, 2030. The aggregate gross proceeds to the Company from the Regulation A Offering were $4.2 million. No Regulation A Warrants were exercised during the three and nine months ended September 30, 2026.
Previous wording
On May 2, 2025, the Company entered into a securities purchase agreement with YA II PN, Ltd. ("Yorkville"), under which the Company has issued and sold three debentures (the "Initial Debentures") to Yorkville in an aggregate principal amount totaling $5,000,000. The Initial Debentures were issued at a discounted price of 90% for proceeds to the Company of $4,500,000. Interest accrued on the outstanding principal amount of each Initial Debenture at an annual rate of 8%, subject to a potential increase to 18% per annum upon the occurrence of certain events of default. The Initial Debentures had a maturity date of February 2, 2026.
Current wording
On May 2, 2025, the Company entered into a securities purchase agreement with YA II PN, Ltd. ("Yorkville"), under which the Company issued and sold three debentures (the "Initial Debentures") to Yorkville in an aggregate principal amount totaling $5,000,000. The Initial Debentures were issued at a discounted price of 90% for proceeds to the Company of $4,500,000. Interest accrued on the outstanding principal amount of each Initial Debenture at an annual rate of 8%, subject to a potential increase to 18% per annum upon the occurrence of certain events of default. The Initial Debentures had a maturity date of February 2, 2026.
Previous wording
On June 2, 2025, the Company closed a public offering with gross proceeds of $7.0 million (the "June 2025 Public Offering"). The Company issued 2,260,000 units at a price of $3.10 per unit. Each unit consisted of one common share of the Company and one warrant to purchase one common share (the "June 2030 Warrants"). The June 2030 Warrants have an exercise price of $3.10 per share and will expire on June 2, 2030. No June 2030 Warrants were exercised during the three and six months ended June 30, 2026.
Current wording
On June 2, 2025, the Company closed a public offering with gross proceeds of $7.0 million (the "June 2025 Public Offering"). The Company issued 45,200 units at a price of $155 per unit. Each unit consisted of one common share of the Company and one warrant to purchase one common share (the "June 2030 Warrants"). The June 2030 Warrants have an exercise price of $155 per share, and will expire on June 2, 2030. No June 2030 Warrants were exercised during the three and nine months ended September 30, 2026.
Previous wording
On July 14, 2025, the Company entered into a warrant inducement agreement (the "Warrant Inducement Agreement") with an institutional investor, pursuant to which the investor agreed to exercise existing Regulation A Warrants to purchase up to 1,340,000 of the Company's common shares issued on March 10, 2025 and with an exercise price of $2.80 per common share, in consideration for receiving the 2,680,000 warrants (the "Series A and B Warrants") with an exercise price of $3.75. In accordance with the Warrant Inducement Agreement, the investor exercised its existing warrants for cash, for gross proceeds of $3.8 million to the Company.
Current wording
On July 14, 2025, the Company entered into a warrant inducement agreement (the "Warrant Inducement Agreement") with an institutional investor, pursuant to which the investor agreed to exercise 26,800 existing Regulation A Warrants issued on March 10, 2025, in order to purchase 26,800 of the Company's common shares, in consideration for receiving the 53,600 warrants (the "Series A and B Warrants") with an exercise price of $187.50. In accordance with the Warrant Inducement Agreement, the investor exercised its existing warrants for cash, for gross proceeds of $3.8 million to the Company.
Previous wording
On December 5, 2025, the Company entered into a warrant inducement agreement with an institutional investor (the "Second Warrant Inducement Agreement"), pursuant to which the investor agreed to exercise existing Series A and B Warrants to purchase up to 2,680,000 of the Company's common shares issued on July 14, 2025 with an amended exercise price of $1.92 per common share, in consideration for receiving 4,020,000 warrants (the "Series C and D Warrants") with an exercise price of $2.00. In accordance with the Second Warrant Inducement Agreement, the investor exercised its existing warrants for cash, for gross proceeds of approximately $5.1 million to the Company.
Current wording
On December 5, 2025, the Company entered into a warrant inducement agreement with an institutional investor (the "Second Warrant Inducement Agreement"), pursuant to which the investor agreed to exercise 53,600 existing Series A and B Warrants, issued on July 14, 2025 with an amended exercise price of $96 per warrant, in order to purchase 53,600 of the Company's common shares, in consideration for receiving 80,400 warrants (the "Series C and D Warrants") with an exercise price of $100 per share. In accordance with the Second Warrant Inducement Agreement, the investor exercised its existing warrants for cash, for gross proceeds of approximately $5.1 million to the Company.
Previous wording
On December 29, 2025, we entered into an equity distribution agreement (the "Equity Distribution Agreement") with Maxim Group LLC and Yorkville Securities, LLC, an affiliate of Yorkville as agents (together, the "Agents"), whereby the Agents may sell up to $15.3 million of our common shares as part of an at-the-market program (the "ATM"). On April 23, 2026, the Company and the Agents entered into an amendment to the Equity Distribution Agreement, up-sizing the ATM program from $15.3 million to up to $50 million.
Current wording
On December 29, 2025, we entered into an equity distribution agreement (the "Equity Distribution Agreement") with Maxim Group LLC and Yorkville Securities, LLC, an affiliate of Yorkville, as agents (together, the "Agents"), whereby the Agents may sell up to $15.3 million of the Company's common shares as part of an at-the-market program (the "ATM"). On April 23, 2026, the Company and the Agents entered into an amendment to the Equity Distribution Agreement, upsizing the ATM program from $15.3 million to up to $50 million. As of September 30, 2026, the Company sold approximately $17.8 million of its common shares in the ATM program.
Previous wording
On May 27, 2026, the Company entered into and closed on a note purchase agreement with Streeterville Capital, LLC, providing for the issuance of two secured promissory notes: (i) a Secured Promissory Note A in the original principal amount of $12,864,225 carrying an 8.75% interest rate and a 6.7% original issue discount (the “Note A”) and (ii) a Secured Promissory Note B in the original principal amount of $10,000,000 carrying a 5% interest rate with no original issue discount (the “Note B” and together with the Note A, the “Secured Promissory Notes”). The Secured Promissory Notes will mature on November 27, 2027.
Current wording
On May 27, 2026, the Company entered into and closed on a note purchase agreement with Streeterville Capital, LLC ("Streeterville"), providing for the issuance of two secured promissory notes: (i) a Secured Promissory Note A in the original principal amount of $12,864,225 carrying an 8.75% interest rate and a 6.7% original issue discount ("Note A") and (ii) a Secured Promissory Note B in the original principal amount of $10,000,000 carrying a 5% interest rate with no original issue discount ("Note B").
Previous wording
The following table outlines our statements of loss and comprehensive loss for the three and six months ended June 30, 2026 and 2025:
Current wording
The following table outlines our statements of loss and comprehensive loss for the three and nine months ended September 30, 2026 and 2025:
Previous wording
General and administrative expenses increased by $1,994,573 or 43.6% for the three months ended June 30, 2026, compared to the three months ended June 30, 2025, and increased by $4,767,197 or 61.9% for the six months ended June 30, 2026, compared to the six months ended June 30, 2025. This increase was primarily due to an increase in consulting fees, salaries and wages with increased headcount at board and management level and fees, expenses related to business development and investor relations and stock-based compensation. General and administrative expenses primarily include professional fees, consulting fees, salaries, wages and benefits, general office, insurance, administration expenditures, costs related to business development and investor relations, public relations, market awareness, advocacy and stock-based compensation associated with maintaining investor relations, public relations, market awareness, advocacy, director and officer insurance and compliance with applicable securities law requirements. In addition, there are additional costs, recurring and non-recurring, associated with increased regulatory requirements following the Company's initial public offering, transition to U.S. domestic issuer status, multiple financing transactions and the Antev acquisition.
Current wording
General and administrative expenses decreased by $2,516,606 or 50.1% for the three months ended September 30, 2026, compared to the three months ended September 30, 2025, and increased by $2,250,591 or 17.7% for the nine months ended September 30, 2026, compared to the nine months ended September 30, 2025. The decrease in general and administrative expenses for the three months ended September 30, 2026, was primarily due to the decrease in the allocation of certain personnel costs to general and administrative expenses as a result of increased research and development activities in 2026. The increase for the nine months ended September 30, 2026 was primarily due to higher stock-based compensation expense, which was $2,136,908, for the nine months ended September 30, 2026 compared to $1,082,482 for the nine months ended September 30, 2025. General and administrative expenses primarily include professional fees, consulting fees, salaries, wages and benefits, general office, insurance, administration expenditures, costs related to business development and investor relations, public relations, market awareness, advocacy and stock-based compensation associated with maintaining investor relations, public relations, market awareness, advocacy, director and officer insurance and compliance with applicable securities law requirements. In addition, there are additional costs, recurring and non-recurring, associated with the Antev acquisition and the Pfizer Agreement.
Previous wording
Research and development expenses consist of costs incurred to research and develop our product candidates and are expensed as incurred. We do not track total R&D expense by program, therapeutic indication or product candidate, as our internal resources are shared across programs and our development priorities shift over time. We separately identify external costs that are directly attributable to the SkinJect and Teverelix programs, which primarily include costs related to clinical, manufacturing, and regulatory activities, as well as certain professional services and intellectual property costs. Internal personnel costs (salaries and benefits, including share-based compensation) are shared across programs, are not attributable to a single product candidate, and are presented as unallocated. Of the total research and development expense noted in the table below, the external, third-party costs that were directly attributable to our product candidates were as follows:
Current wording
Research and development expenses consist of costs incurred to research and develop our product candidates and are expensed as incurred. We do not track total R&D expense by program, therapeutic indication or product candidate, as our internal resources are shared across programs and our development priorities shift over time. We separately identify external costs that are directly attributable to the SkinJect, Teverelix and CD228V programs, which primarily include costs related to clinical, manufacturing, and regulatory activities, as well as certain professional services and intellectual property costs. Internal personnel costs (salaries and benefits, including bonuses) are shared across programs, are not attributable to a single product candidate, and are presented as unallocated. Of the total research and development expense noted in the table below, the external, third-party costs that were directly attributable to our product candidates were as follows:
Previous wording
The principal risks related to the Company's future performance are that the trials are unsuccessful, the Company does not receive FDA approval to proceed with the next stages of its multiple research and development tracks, or the Company is unsuccessful in obtaining future funding needed to continue its research and development tracks. These are customary risks for a development stage pharmaceutical Company and are less acute than for a Company with a less advanced product. Nevertheless, there can be no assurance that the Company will be able to complete its trials, that the trials will be successful, or that the product will ultimately reach commercialization.
Current wording
The principal risks related to the Company's future performance are that the trials are unsuccessful, the Company does not receive FDA approval to proceed with the next stages of its multiple research and development tracks, the Company is unsuccessful in obtaining future funding needed to continue its research and development tracks or the Company is unable to maintain its listing on the Nasdaq. These are customary risks for a development stage pharmaceutical Company and are less acute than for a Company with a less advanced product. Nevertheless, there can be no assurance that the Company will be able to complete its trials, that the trials will be successful, or that the product will ultimately reach commercialization.
Previous wording
Other income (expense) for the three and six months ended June 30, 2026, was an expense of $205,638 and $650,872, respectively, compared to an expense of $159,996 and $136,130 for the three and six months ended June 30, 2025, respectively. Other income (expense) for the three and six months ended June 30, 2026 is primarily related to interest expense of $205,638 and $523,789, respectively, a loss on SEPA settlements of $nil and $127,083, respectively. Other income (expense) for the three and six months ended June 30, 2025 consisted primarily of finance income of $40,004 and $63,870, respectively, more than offset by a $200,000 change in the fair value of debentures recognized in each period.
Current wording
Other income (expense) for the three and nine months ended September 30, 2026 was an expense of $712,652 and $1,363,524, respectively, compared to an expense of $554,972 and $691,102 for the three and nine months ended September 30, 2025, respectively. Other income (expense) for the three and nine months ended September 30, 2026 primarily consisted of net interest expense of $712,652 and $1,236,441, respectively, which primarily reflects interest on, and accretion of, the Secured Promissory Notes and, for the nine-month period, the Debenture, as well as a loss on SEPA settlements of $127,083 for the nine months ended September 30, 2026. Other income (expense) for the three and nine months ended September 30, 2025 consisted primarily of interest income of $11,572 and $75,442, respectively, more than offset by changes in the fair value of debentures of $383,823 and $583,823, respectively, losses on SEPA settlements of $157,721 in each period and a loss on extinguishment of debentures of $25,000 in each period*.*
Previous wording
The Company expects to continue to incur significant operating losses for the foreseeable future and may never become profitable. In addition to the ATM, SEPA and Secured Promissory Notes (as defined herein), management believes that the Company has access to additional capital resources through public and/or private equity offerings, debt financings or other capital sources, including potential collaborations, licenses and other similar arrangements. However, it is possible that the Company may not be able to obtain financing on acceptable terms, or at all, and the Company may not be able to enter into strategic alliances or other arrangements on favorable terms, or at all. Further, the terms of any financing may adversely affect the holdings or the rights of the Company's shareholders. If the Company is unable to secure additional capital, it may be required to take additional measures to reduce costs in order to conserve its cash in amounts sufficient to sustain operations and meet its obligations. These measures could cause significant delays or entirely prevent the Company's continued efforts to progress its research and development program, pursue product portfolio expansion or commercialize its current or future products, each of which is critical to the realization of the Company's business plan and its future operations. This uncertainty, along with the Company's history of losses, indicates that substantial doubt exists about the Company's ability to continue as a going concern within one year after the date that the financial statements are issued. The financial statements and this MD&A do not include any adjustments that may be necessary should the Company be unable to continue as a going concern.
Current wording
The Company expects to continue to incur significant operating losses for the foreseeable future and may never become profitable. In addition to the ATM and Secured Promissory Notes (as defined herein), management believes that the Company has access to additional capital resources through public and/or private equity offerings, debt financings or other capital sources, including potential collaborations, licenses and other similar arrangements. However, it is possible that the Company may not be able to obtain financing on acceptable terms, or at all, and the Company may not be able to enter into strategic alliances or other arrangements on favorable terms, or at all. Further, the terms of any financing may adversely affect the holdings or the rights of the Company's shareholders. If the Company is unable to secure additional capital, it may be required to take additional measures to reduce costs in order to conserve its cash in amounts sufficient to sustain operations and meet its obligations. These measures could cause significant delays or entirely prevent the Company's continued efforts to progress its research and development program, pursue product portfolio expansion or commercialize its current or future products, each of which is critical to the realization of the Company's business plan and its future operations. This uncertainty, together with the Company's history of losses and its outstanding debt obligations, including debt that will become current by year-end 2026, indicates that substantial doubt exists about the Company's ability to continue as a going concern within one year after the date that the financial statements are issued. The financial statements and this MD&A do not include any adjustments that may be necessary should the Company be unable to continue as a going concern.
Previous wording
The Company is subject to risks associated with any specialty biotechnology company that has substantial expenditures for research and development. There can be no assurance that the Company's research and development projects will be successful, that products developed will obtain necessary regulatory approval, or that any approved product will be commercially viable.
Current wording
The Company is subject to risks associated with any specialty biotechnology company that has substantial expenditures for research and development. In addition, the Company has made significant cash investments for certain of its products, most recently with its acquisition of the CD228V license. There can be no assurance that the Company's research and development projects will be successful, that products developed will obtain necessary regulatory approval, or that any approved product will be commercially viable, requiring the Company to be dependent on additional fundraising activities.
Previous wording
As of June 30, 2026, the Company had cash and cash equivalents of $15,174,128 and restricted cash of $10,017,412 compared to cash and cash equivalents of $8,705,218 and restricted cash of $nil as of December 31, 2025. During the six months ended June 30, 2026, the Company received $21,385,000 of net proceeds from the issuance of the Secured Promissory Notes, $12,399,815 of net proceeds from the issuance of common shares under the ATM and $4,102,740 of proceeds from the issuance of common shares under the SEPA. For the six months ended June 30, 2026, cash used in operating activities was $15,953,129 compared to $9,409,825 for the six months ended June 30, 2025. As of June 30, 2026, the Company had an accumulated deficit of $85,007,966 (December 31, 2025 – $64,348,118) and net loss of $11,684,427 and $20,726,738 for the three and six months ended June 30, 2026, respectively (June 30, 2025 - $6,176,084 and $11,278,492, respectively). The Company has a working capital of $6,140,096 as of June 30, 2026.
Current wording
As of September 30, 2026, the Company had cash and cash equivalents of $5,019,755 and restricted cash of $8,075,075 compared to cash and cash equivalents of $8,705,218 and restricted cash of $nil as of December 31, 2025. During the nine months ended September 30, 2026, the Company received $21,377,589 of net proceeds from the issuance of the Secured Promissory Notes, $17,154,819 of net proceeds from the issuance of common shares under the ATM and $4,102,740 of proceeds from the issuance of common shares under the SEPA. For the nine months ended September 30, 2026, cash used in operating activities was $31,893,868 compared to $16,167,654 for the nine months ended September 30, 2025. As of September 30, 2026, the Company had an accumulated deficit of $100,189,301 (December 31, 2025 - $64,348,118) and net loss of $15,172,908 and $35,899,646 for the three and nine months ended September 30, 2026, respectively (September 30, 2025 - $15,981,312 and $27,259,804, respectively). The Company had a working capital deficit of $3,370,880 as of September 30, 2026.
Previous wording
As of June 30, 2026, no Public Warrants issued as part of the initial public offering have been exercised for cash for nil proceeds to the Company.
Current wording
During the nine months ended September 30, 2026, no Public Warrants issued as part of the initial public offering were exercised for cash for nil proceeds to the Company.
Previous wording
On July 14, 2025, the Company entered into the Warrant Inducement Agreement with an institutional investor, pursuant to which the investor agreed to exercise existing Regulation A Warrants to purchase up to 1,340,000 of the Company's common shares issued on March 10, 2025 and with an exercise price of $2.80 per common share, in consideration for receiving the 2,680,000 Series A and B Warrants with an exercise price of $3.75. In accordance with the Warrant Inducement Agreement, the investor exercised its existing warrants for cash, for gross proceeds of $3.8 million to the Company.
Current wording
On July 14, 2025, the Company entered into the Warrant Inducement Agreement with an institutional investor, pursuant to which the investor exercised its existing Regulation A Warrants for cash, for gross proceeds of $3.8 million to the Company.
Previous wording
On December 5, 2025, the Company entered into The Second Warrant Inducement Agreement with an institutional investor, pursuant to which the investor agreed to exercise existing Series A and B Warrants to purchase up to 2,680,000 of the Company's common shares issued on July 14, 2025 with an amended exercise price of $1.92 per common share, in consideration for receiving 4,020,000 Series C and D Warrants with an exercise price of $2.00. In accordance with the Second Warrant Inducement Agreement, the investor exercised its existing warrants for cash, for gross proceeds of approximately $5.1 million to the Company.
Current wording
On December 5, 2025, the Company entered into the Second Warrant Inducement Agreement with an institutional investor, pursuant to which the investor exercised its existing Series A and B Warrants for cash, for gross proceeds of approximately $5.1 million to the Company.
Previous wording
On December 29, 2025, the Company entered into the Equity Distribution Agreement with Maxim Group LLC and Yorkville Securities, LLC, an affiliate of Yorkville as agents, whereby the Agents may sell up to $15.3 million of our common shares as part of an at-the-market program. On April 23, 2026, the Company and the Agents entered into an amendment to the Equity Distribution Agreement, up-sizing the ATM program from $15.3 million to up to $50 million. As of June 30, 2026, the Company has issued 28,248,981 common shares as part of the program. The gross proceeds from the issuances were $12,868,181.
Current wording
On December 29, 2025, the Company entered into the Equity Distribution Agreement with Maxim Group LLC and Yorkville Securities, LLC, an affiliate of Yorkville, as agents, whereby the Agents may sell up to $15.3 million of our common shares as part of an at-the-market program. On April 23, 2026, the Company and the Agents entered into an amendment to the Equity Distribution Agreement, upsizing the ATM program from $15.3 million to up to $50 million. As of September 30, 2026, the Company had issued 1,035,449 common shares as part of the program. The gross proceeds from the issuances were approximately $17.8 million.
Previous wording
As of June 30, 2026, the Company had issued 5,336,780 common shares at an aggregate market price of $4,229,823 for net proceeds of $4,102,740 under the SEPA.
Current wording
During the nine months ended September 30, 2026, and prior to the termination of the SEPA on September 11, 2026, the Company issued 106,735 common shares at an aggregate market price of $4,229,823 for net proceeds of $4,102,740 under the SEPA.
Previous wording
The Company entered into a standby equity purchase agreement dated February 10, 2025 (the "SEPA") with Yorkville, an investment fund managed by Yorkville Advisors Global, LP. Pursuant to the SEPA, the Company has the option, at its sole discretion, to sell up to $15,000,000 of the Company's common shares to Yorkville at any time during the 36-months following the date of the SEPA.
Current wording
The Company entered into a standby equity purchase agreement dated February 10, 2025 (the "SEPA") with Yorkville, an investment fund managed by Yorkville Advisors Global, LP. Pursuant to the SEPA, the Company had the option, at its sole discretion, to sell up to $15,000,000 of the Company's common shares to Yorkville at any time during the 36 months following the date of the SEPA.
Previous wording
As of June 30, 2026, the Company issued 5,336,780 common shares at market price of $4,229,823 for proceeds of $4,102,740. During the six months ended June 30, 2026, $3,223,980 of the gross proceeds were held back to partially repay the Company's outstanding debenture and interest to Yorkville, which was fully repaid and extinguished on May 27, 2026. As of June 30, 2026, the Company has capacity to issue up to approximately $2.5 million worth of common shares under the SEPA.
Current wording
During the nine months ended September 30, 2026, $3,223,980 of the gross proceeds were held back to partially repay the Company's outstanding debenture and interest to Yorkville, which was fully repaid and extinguished on May 27, 2026. On September 11, 2026, the Company and Yorkville mutually agreed to terminate the SEPA, effective as of such date. At the time of termination, there were no outstanding borrowings, advance notices or common shares to be issued under the SEPA, and no fees were payable by the Company or Yorkville in connection with the termination.
Previous wording
Cash flows used in operating activities for the six months ended June 30, 2026, were $15,953,129 compared to cash flows used in operating activities of $9,409,825 for the six months ended June 30, 2025. The increase is primarily due to increased spending on research and development and general and administrative expenses.
Current wording
Cash flows used in operating activities for the nine months ended September 30, 2026, were $31,893,868 compared to cash flows used in operating activities of $16,167,654 for the nine months ended September 30, 2025. The increase is primarily due to the $10.0 million IPR&D cash payment in connection with the Pfizer Agreement and increased spending on research and development and general and administrative expenses, partially offset by non-cash expenses, including stock-based compensation, the issuance of restricted common shares in lieu of cash bonuses and non-cash interest expense, and a decrease in accounts payable.
Previous wording
There have been no material changes to our critical accounting policies and estimates from the information provided in the MD&A section in our Annual Report.
Current wording
There have been no material changes to our critical accounting policies and estimates from the information provided in the MD&A section in the 2025 Annual Report.
Previous wording
As of June 30, 2026, we had 60,168,044 common shares issued and outstanding. In addition, there were 5,510,000 common shares issuable upon the exercise of outstanding stock options and 7,281,795 common shares issuable upon the exercise of warrants.
Current wording
As of September 30, 2026, we had 1,850,418 common shares issued and outstanding. In addition, there were 140,200 common shares issuable upon the exercise of outstanding stock options and 145,636 common shares issuable upon the exercise of warrants.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
On June 2, 2025, the Company closed its public offering with gross proceeds of $7.0 million. The Company issued 2,260,000 units at a price of $3.10 per unit. Each unit consisted of one common share of the Company and one June 2030 Warrant. The June 2030 Warrants have an exercise price of $3.10 per share and will expire June 2, 2030. As of June 30, 2026, no June 2030 Warrants have been exercised.