IMMUNIC, INC.

Previous wording

Immunic, Inc. (“Immunic," “we,” “us,” “our” or the "Company") is a biotechnology company developing a clinical pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases. We are headquartered in New York City with our main operations in Gräfelfing near Munich, Germany. We had approximately 90 employees as of July 31, 2025.

Current wording

Immunic, Inc. (“Immunic," “we,” “us,” “our” or the "Company") is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic and gastrointestinal diseases. We are headquartered in New York City with our main operations in Gräfelfing near Munich, Germany. We had approximately 90 employees as of November 3, 2025.

Previous wording

We are pursuing clinical development of orally administered, small molecule programs, each of which has unique features intended to directly address the unmet needs of patients with serious chronic inflammatory and autoimmune diseases. These include the vidofludimus calcium (IMU-838) program, which is in Phase 3 clinical development for patients with relapsing multiple sclerosis (“RMS”), and which has shown therapeutic activity in Phase 2 clinical trials in patients suffering from relapsing-remitting MS ("RRMS"), progressive MS (”PMS”) and moderate-to-severe ulcerative colitis (“UC”); the IMU-856 program, which is targeted to regenerate bowel epithelium and restore intestinal barrier function, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease, inflammatory bowel disease (“IBD”), Graft-versus-Host-Disease ("GvHD") and possibly weight management; and the IMU-381 program, which is a next generation molecule being developed to specifically address the needs of gastrointestinal diseases.

Current wording

We are pursuing clinical development of orally administered, small molecule programs, each of which has unique features intended to directly address the unmet needs of patients with serious chronic inflammatory and autoimmune diseases. These include the vidofludimus calcium (IMU-838) program, which is in Phase 3 clinical development for patients with relapsing multiple sclerosis (“RMS”), and which has shown therapeutic activity in Phase 2 clinical trials in patients suffering from relapsing-remitting MS ("RRMS"), progressive MS (”PMS”) and moderate-to-severe ulcerative colitis (“UC”); the IMU-856 program, which is targeted to regenerate bowel epithelium and restore intestinal barrier function, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease, inflammatory bowel disease (“IBD”), Graft-versus-Host-Disease ("GvHD") and possibly weight management; and the IMU-381 program, which is a next generation molecule being developed to specifically address gastrointestinal diseases.

Previous wording

Our most advanced drug candidate, vidofludimus calcium (IMU-838), is being tested in ongoing MS trials as part of its overall clinical program in order to support potential approvals for patients with MS in major markets.

Current wording

Our most advanced drug candidate, vidofludimus calcium (IMU-838), is being tested in ongoing MS trials as part of its overall clinical development program in order to support potential regulatory approvals for patients with MS in major markets.

Previous wording

Our Phase 2 CALLIPER trial of vidofludimus calcium in PMS was designed to corroborate vidofludimus calcium’s neuroprotective potential and to evaluate the clinical efficacy, safety and tolerability of vidofludimus calcium in a broad set of PMS patients to determine the suitability of advancing to a confirmatory Phase 3 program. On October 9, 2023, we announced positive interim data from the CALLIPER trial, showing biomarker evidence that vidofludimus calcium’s activity extends beyond the previously observed anti-inflammatory effects, thereby further reinforcing its neuroprotective potential. In April and June 2025, we announced positive clinical data from the CALLIPER trial, showing substantial and medically relevant reductions in 24-week confirmed disability progression as well as in the annualized rate of thalamic brain volume loss and volume of new or enlarging T2 lesions. The top-line data also confirmed the favorable safety and tolerability profile of vidofludimus calcium already observed in previous clinical trials.

Current wording

Our Phase 2 CALLIPER trial of vidofludimus calcium in PMS was designed to corroborate vidofludimus calcium’s neuroprotective potential and to evaluate the clinical efficacy, safety and tolerability of vidofludimus calcium in a broad set of PMS patients to determine the suitability of advancing to a confirmatory Phase 3 program. On October 9, 2023, we announced positive interim data from the CALLIPER trial, showing biomarker evidence that vidofludimus calcium’s activity extends beyond the previously observed anti-inflammatory effects, thereby further reinforcing its neuroprotective potential. In 2025, we announced positive clinical data from the CALLIPER trial, showing substantial and medically relevant reductions in 24-week confirmed disability progression across disability endpoints, patient populations and subgroups without evidence of focal inflammation; substantial and statistically significant data regarding confirmed disability improvement; and reductions in the annualized rate of thalamic brain volume loss and volume of new or enlarging T2 lesions. The data also confirmed the favorable safety and tolerability profile of vidofludimus calcium already observed in previous clinical trials.

Previous wording

Immunic has selected IMU-381 as a development candidate to specifically address the needs of gastrointestinal diseases. IMU-381 is a next generation molecule with improved overall properties, supported by a series of chemical derivatives. IMU-381 is currently in preclinical testing.

Current wording

Immunic has selected IMU-381 as a development candidate to specifically address gastrointestinal diseases. IMU-381 is a next generation molecule with improved overall properties, supported by a series of chemical derivatives. IMU-381 is currently in preclinical testing.

Previous wording

•Completing the analysis of the full data set of the Phase 2 CALLIPER clinical trial and discussing the results with healthcare authorities to determine appropriate next steps for vidofludimus calcium in PMS.

Current wording

•Completing the analysis of the full data set of the Phase 2 CALLIPER clinical trial and continuing to discuss the results with healthcare authorities to determine appropriate next steps for vidofludimus calcium in PMS.

Previous wording

We have no products approved for commercial sale and have not generated any revenue from product sales. We have never been profitable and have incurred operating losses in each year since inception in 2016. We have an accumulated deficit of approximately $563.7 million as of June 30, 2025 and $511.4 million as of December 31, 2024. Substantially all of our operating losses resulted from expenses incurred in connection with our research and development programs and from general and administrative costs associated with our operations.

Current wording

We have no products approved for commercial sale and have not generated any revenue from product sales. We have never been profitable and have incurred operating losses in each year since inception in 2016. We have an accumulated deficit of approximately $589.3 million as of September 30, 2025 and $511.4 million as of December 31, 2024. Substantially all of our operating losses resulted from expenses incurred in connection with our research and development programs and from general and administrative costs associated with our operations.

Previous wording

We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future as we initiate and continue the development of our product candidates and add personnel necessary to advance our pipeline of product candidates. We expect that our operating losses will fluctuate significantly from quarter-to-quarter and year-to-year due to timing of development programs.

Current wording

We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future as we initiate and continue the development of our product candidates and add personnel necessary to advance our pipeline of product candidates. We expect that our operating losses will fluctuate significantly from quarter-to-quarter and year-to-year due to the timing of development programs.

Previous wording

From inception through June 30, 2025, we have raised net cash of approximately $496.3 million from private and public offerings of common stock, pre-funded warrants, common stock purchase warrants and tranche rights. As of June 30, 2025, we had cash and cash equivalents of approximately $55.3 million. With these funds, the Company does not have adequate liquidity to fund its operations for at least twelve months from the issuance of these consolidated financial statements included in this Quarterly Report without raising additional capital and such actions are not solely within the control of the Company. If the Company is unable to obtain additional capital, it would have a material adverse effect on the operations of the Company, its clinical development program, and the Company may have to cease operations altogether. These factors raise substantial doubt about the Company’s ability to continue as a going concern.

Current wording

From inception through September 30, 2025, we have raised net cash of approximately $496.3 million from private and public offerings of common stock, pre-funded warrants, common stock purchase warrants and tranche rights. As of September 30, 2025, we had cash and cash equivalents of approximately $35.1 million. With these funds, the Company does not have adequate liquidity to fund its operations for at least twelve months from the issuance of these consolidated financial statements included in this Quarterly Report without raising additional capital and such actions are not solely within the control of the Company. If the Company is unable to obtain additional capital, it would have a material adverse effect on the operations of the Company, its clinical development program, and the Company may have to cease operations altogether. These factors raise substantial doubt about the Company’s ability to continue as a going concern.

Previous wording

On June 24, 2025, we announced new long-term open-label extension (“OLE”) data from our Phase 2 EMPhASIS trial in patients with RRMS. The data at week 144 showed that 92.3% of patients remained free of 12-week CDW, and 92.7% free of 24-week CDW. A total of 29 CDW events were confirmed at 12 weeks following the trigger event through week 144. Of these, 44.8% were associated with relapse-associated worsening (“RAW”), while only 13.8% were associated with progression independent of relapse activity (“PIRA”). Additionally, the cumulative data available from the EMPhASIS OLE period, thus far, further reinforces the favorable safety and tolerability profile of vidofludimus calcium, showing low discontinuation rates and low rates of treatment-emergent and serious adverse events. Importantly, no new safety signals have emerged during treatment durations up to 5.5 years.

Current wording

On June 24, 2025, we announced new long-term OLE data from our Phase 2 EMPhASIS trial in patients with RRMS. The data at week 144 showed that 92.3% of patients remained free of 12-week CDW, and 92.7% free of 24-week CDW. A total of 29 CDW events were confirmed at 12 weeks following the trigger event through week 144. Of these, 44.8% were associated with relapse-associated worsening (“RAW”), while only 13.8% were associated with progression independent of relapse activity (“PIRA”). Additionally, the cumulative data available from the EMPhASIS OLE period, thus far, further reinforces the favorable safety and tolerability profile of vidofludimus calcium, showing low discontinuation rates and low rates of treatment-emergent and serious adverse events. Importantly, no new safety signals have emerged during treatment durations up to 5.5 years.

Previous wording

On June 5, 2025, we also announced completion of enrollment for both Phase 3 ENSURE trials. The ENSURE program comprises two identical multicenter, randomized, double-blind Phase 3 trials designed to evaluate the efficacy, safety and tolerability of vidofludimus calcium versus placebo in RMS patients. Each of the trials, titled ENSURE-1 and ENSURE-2, enrolled adult patients with active RMS at more than 100 sites in 15 countries, including the United States, India and countries in the Middle East and North Africa (“MENA”) region, Latin America, and Central and Eastern Europe. In total, 1,121 patients in ENSURE-1 and 1,100 patients in ENSURE-2 have been randomized in a double-blinded fashion to either 30 mg daily doses of vidofludimus calcium or placebo. The primary endpoint for both trials is time to first relapse up to 72 weeks. Secondary endpoints include time to confirmed disability worsening based on the EDSS, volume of new T2-lesions, time to sustained clinically relevant changes in cognition, and MRI-based endpoints. The top-line data from both ENSURE trials is expected by the end of 2026, which should allow for a synchronized readout and a pooled assessment of the confirmed disability worsening secondary endpoint.

Current wording

On June 5, 2025, we also announced completion of enrollment for both Phase 3 ENSURE trials. The ENSURE program comprises two identical multicenter, randomized, double-blind Phase 3 trials designed to evaluate the efficacy, safety and tolerability of vidofludimus calcium versus placebo in RMS patients. Each of the trials, titled ENSURE-1 and ENSURE-2, enrolled adult patients with active RMS at more than 100 sites in 15 countries, including the United States, India and countries in the Middle East and North Africa (“MENA”) region, Latin America, and Central and Eastern Europe. In total, 1,121 patients in ENSURE-1 and 1,100 patients in ENSURE-2 have been randomized in a double-blinded fashion to either 30 mg daily doses of vidofludimus calcium or placebo. The primary endpoint for both trials is time to first relapse up to 72 weeks. Secondary endpoints include time to confirmed disability worsening based on the expanded disability status scale ("EDSS"), volume of new T2-lesions, time to sustained clinically relevant changes in cognition, and MRI-based endpoints. The top-line data from both ENSURE trials is expected by the end of 2026, which should allow for a synchronized readout and a pooled assessment of the confirmed disability worsening secondary endpoint.

Previous wording

On June 5, 2025, we announced additional data from our Phase 2 CALLIPER trial in PMS, further supporting the positive top-line results announced on April 30, 2025, and underlining vidofludimus calcium's neuroprotective potential. Building on the top-line data showing reductions in the relative risk of 24wCDW events based on the EDSS at the end of the main treatment period, newly available data for the secondary endpoint of time to 24wCDW based on the EDSS further reinforces the neuroprotective potential of vidofludimus calcium. In the overall PMS patient population (n=467), vidofludimus calcium demonstrated a clinically meaningful reduction of the hazard ratio (“HR”) for 24wCDW by 24% compared to placebo (HR 0.76). Further analyses by disease subtype showed that vidofludimus calcium was associated with a 33% reduction in 24wCDW in the PPMS study population (n=152) compared to placebo (HR 0.67), a 19% reduction in the naSPMS study population (n=268) compared to placebo (HR 0.81), and a 34% reduction in the active secondary progressive multiple sclerosis (“aSPMS”) study population (n=47) compared to placebo (HR 0.66).)

Current wording

On June 5, 2025, we announced additional data from our Phase 2 CALLIPER trial in PMS, further supporting the positive top-line results announced on April 30, 2025. Building on the top-line data showing reductions in the relative risk of 24wCDW events based on the EDSS at the end of the main treatment period, newly available data for the secondary endpoint of time to 24wCDW based on the EDSS further reinforces the neuroprotective potential of vidofludimus calcium in the overall PMS patient population and in the PPMS, naSPMS and active secondary progressive multiple sclerosis (“aSPMS”) subtypes. Similarly, consistent with the top-line data, further analyses of subpopulations – both with and without inflammatory gadolinium-enhanced lesion activity at baseline, who are largely shown to not benefit from current anti-inflammatory therapies – continued to demonstrate promising results for the overall study population as well as the PPMS and naSPMS subtypes.

Previous wording

Vidofludimus Calcium Reduced Risk of Disability Worsening by 30% in Primary Progressive Multiple Sclerosis Patients from Phase 2 CALLIPER Trial

Current wording

Vidofludimus Calcium Reduced Risk of Disability Worsening in Progressive Multiple Sclerosis Patients from Phase 2 CALLIPER Trial

Previous wording

On April 30, 2025, we announced positive data from our Phase 2 CALLIPER trial of vidofludimus calcium in patients with PMS. In the overall PMS patient population, vidofludimus calcium reduced the relative risk of 24-week confirmed disability worsening (“24wCDW”) events based on changes in the expanded disability status scale (“EDSS”) by 20% compared to placebo. Further analyses by disease subtype demonstrated that vidofludimus calcium was associated with a 30% reduction in the relative risk of 24wCDW events in the primary progressive multiple sclerosis ("PPMS") study population compared to placebo and a respective 15% reduction in the non-active secondary progressive multiple sclerosis (“naSPMS”) study population. A consistent reduction of disability worsening was observed in the different subpopulations with or without inflammatory gadolinium-enhanced lesion activity at baseline and during the study. Vidofludimus calcium reduced the relative risk of 24wCDW events in patients without gadolinium-enhancing lesions at baseline by 29% compared to placebo.

Current wording

On April 30, 2025, we announced positive data from our Phase 2 CALLIPER trial of vidofludimus calcium in patients with PMS. In the overall PMS patient population, vidofludimus calcium reduced the relative risk of 24wCDW events based on changes in the EDSS compared to placebo. Further analyses by disease subtype demonstrated that vidofludimus calcium was associated with similar reductions in the relative risk of 24wCDW events in the PPMS and the naSPMS study populations compared to placebo. A consistent reduction of disability worsening was observed in the different subpopulations with or without inflammatory gadolinium-enhanced lesion activity at baseline and during the study. Vidofludimus calcium reduced the relative risk of 24wCDW events in patients without gadolinium-enhancing lesions at baseline compared to placebo.

Previous wording

While vidofludimus calcium had a modest benefit on the exploratory primary magnetic resonance imaging (“MRI”) endpoint (annualized rate of percent brain volume change: 5% improvement compared to placebo), vidofludimus calcium substantially reduced the annualized rate of thalamic brain volume loss by 20% in patients with PMS compared to placebo. The total volume of new or enlarging T2 lesions showed a substantial difference between vidofludimus calcium and placebo over time, with vidofludimus calcium decreasing and placebo increasing (mean percent change, 3.19% benefit for vidofludimus calcium (-0.22%) over placebo (+2.97%) at month 24).

Current wording

While vidofludimus calcium had a modest benefit on the exploratory primary MRI endpoint, vidofludimus calcium substantially reduced the annualized rate of thalamic brain volume loss in patients with PMS compared to placebo. The total volume of new or enlarging T2 lesions showed a substantial difference between vidofludimus calcium and placebo over time, with vidofludimus calcium decreasing and placebo increasing.

Previous wording

The Company intends to actively monitor the closing bid price of its common stock and is evaluating available options to regain compliance with the minimum bid price requirement. There can be no assurance that the Company will be able to regain compliance with the minimum bid price requirement or that the Company will otherwise remain in compliance with the other listing standards for the Nasdaq.

Current wording

The Company has been actively monitoring the closing bid price of its common stock and has been evaluating available options to regain compliance with the minimum bid price requirement and remain listed on the Nasdaq Global Select Market. However, the closing bid price of our common stock remains well below the minimum $1.00 per share requirement and the Company may not be able to regain compliance with the minimum bid price requirement before expiration of the Initial Compliance Period on December 24, 2025. Therefore, the Company is currently considering whether to apply for initial listing on the Nasdaq Capital Market to seek an additional 180-day compliance period to regain compliance with the minimum $1.00 closing bid price requirement. If we pursue that course, Nasdaq’s determination of whether we qualify for an additional compliance period will depend on whether we will meet the continued listing requirement for market value of publicly held shares and all other applicable requirements for initial listing on the Nasdaq Capital Market (with the exception of the minimum bid price requirement). Even if we are able to list on the Nasdaq Capital Market, we might not remain in compliance with the other listing standards for the Nasdaq. A switch in the trading market of the Company’s common stock from the Nasdaq Global Select Market to the Nasdaq Capital Market could be expected to have a material adverse effect on the trading price and liquidity of the common stock.

Previous wording

Since our inception in March 2016, we have spent a total of approximately $421.2 million in research and development expenses through June 30, 2025.

Current wording

Since our inception in March 2016, we have spent a total of approximately $441.2 million in research and development expenses through September 30, 2025.

Previous wording

Research and development expenses increased by $5.8 million during the six months ended June 30, 2025, as compared to the six months ended June 30, 2024. The increase reflects a $7.3 million increase in external development costs related to the vidofludimus calcium programs. The increase was offset by (i) a $1.5 million decrease in external development costs related to IMU-856 due to the completion of the Phase 1b clinical trial in celiac disease patients in 2024.

Current wording

Research and development expenses decreased by $1.4 million during the three months ended September 30, 2025, as compared to the three months ended September 30, 2024. The decrease reflects (i) a $1.3 million decrease in external development costs related to IMU-856, (ii) a $1.1 million decrease in external development costs related to the completion of the Phase 2 Caliper trial in the prior year and (iii) a $0.2 million decrease related to costs across numerous categories. The decrease was offset by a $1.2 million increase in personnel expenses for research and development, of which $0.8 million were related to non-cash share-based compensation.

Previous wording

General and administrative expenses increased by $1.2 million during the three months ended June 30, 2025, as compared to the three months ended June 30, 2024. The increase was due to (i) a $0.8 million increase in personnel expenses and (ii) a $0.4 million increase in legal and consultancy expenses.

Current wording

General and administrative expenses increased by $1.6 million during the three months ended September 30, 2025, as compared to the three months ended September 30, 2024. The increase was due to (i) a $1.2 million increase in personnel expenses, of which $1.0 million is related to non-cash share-based compensation and (ii) a $0.4 million increase related to costs across numerous categories.

Previous wording

Interest income decreased by $0.8 million during the three months ended June 30, 2025, as compared to the three months ended June 30, 2024, due primarily to a lower average cash balance.

Current wording

Interest income decreased by $0.4 million during the three months ended September 30, 2025, as compared to the three months ended September 30, 2024, primarily due to a lower average cash balance.

Previous wording

Other income decreased by $0.4 million during the three months ended June 30, 2025, as compared to the three months ended June 30, 2024. The decrease was attributable to activity across numerous categories.

Current wording

Other income decreased by $0.6 million during the three months ended September 30, 2025, as compared to the three months ended September 30, 2024. The decrease was primarily attributable to a decrease in research and development tax incentives for clinical trials in Australia due to lower clinical trial spend in Australia.

Previous wording

The following table summarizes our operating expenses for the six months ended June 30, 2025 and 2024:

Current wording

The following table summarizes our operating expenses for the nine months ended September 30, 2025 and 2024:

Previous wording

Research and development expenses increased by $3.0 million during the three months ended June 30, 2025, as compared to the three months ended June 30, 2024. The increase reflects (i) a $2.6 million increase in external development costs related to the vidofludimus calcium programs and (ii) a $0.6 million increase in personnel expenses. The increase was offset by a $0.2 million decrease related costs across numerous categories.

Current wording

Research and development expenses increased by $4.5 million during the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024. The increase reflects (i) a $6.2 million increase in external development costs related to the Phase 3 ENSURE trials and (ii) a $1.6 million increase in personnel expenses for research and development of which $0.4 million was related to non-cash stock compensation. The increase was offset by (i) a $2.7 million decrease in external development costs related to IMU-856 primarily due to the timing of the purchase of drug supply for this program and (ii) a $0.6 million decrease across numerous categories.

Previous wording

General and administrative expenses increased by $1.4 million during the six months ended June 30, 2025, as compared to the six months ended June 30, 2024. The increase was due to (i) a $0.7 million increase related to personnel expenses, (ii) a $0.5 million increase in legal and consultancy expenses and (iii) a $0.2 million increase related costs across numerous categories.

Current wording

General and administrative expenses increased by $3.0 million during the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024. The increase was due to (i) a $1.8 million increase related to personnel expenses, of which $0.8 million was related to non-cash stock compensation, (ii) a $0.6 million increase in legal and consultancy expenses and (iii) a $0.6 million increase related to costs across numerous categories.

Previous wording

Interest income decreased by $1.8 million during the six months ended June 30, 2025, as compared to the six months ended June 30, 2024, due to a lower average cash balance.

Current wording

Interest income decreased by $2.1 million during the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024, due to a lower average cash balance.

Previous wording

In the six months ended June 30, 2024, there was a non-cash charge related to the change in value of the tranche rights associated with the January 2024 Financing from January 8, 2024 until March 4, 2024. These tranches were initially classified as a liability, but were reclassified to equity on March 4, 2024, when stockholders approved the increase in our authorized shares from 130 million to 500 million shares of common stock and therefore the tranche 2 and tranche 3 rights needed to be revalued to fair value upon the reclassification to equity. There was no change in fair value of the tranche rights recognized in the six months ended June 30, 2025.

Current wording

In the nine months ended September 30, 2024, there was a non-cash charge related to the change in value of the tranche rights associated with the January 2024 Financing from January 8, 2024 until March 4, 2024. These tranches were initially classified as a liability, but were reclassified to equity on March 4, 2024, when stockholders approved the increase in our authorized shares from 130 million to 500 million shares of common stock and therefore the tranche 2 and tranche 3 rights needed to be revalued to fair value upon the reclassification to equity. There was no change in fair value of the tranche rights recognized in the nine months ended September 30, 2025.

Previous wording

Other income (expense) increased by $2.8 million during the six months ended June 30, 2025, as compared to the six months ended June 30, 2024. The increase was primarily attributable to (i) a $1.7 million expense related to the portion of deal costs from the January 2024 Financing related to the tranche rights that were established at the time of the deal closing in 2024, (ii) $1.0 million of grant income from the German Federal Ministry of Finance recognized in the first quarter 2025 and (iii) a $0.1 million increase across numerous categories.

Current wording

Other income (expense) increased by $2.3 million during the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024. The increase was primarily attributable to (i) a $1.7 million expense related to the portion of deal costs from the January 2024 Financing related to the tranche rights that were established at the time of the deal closing in 2024, (ii) $1.0 million of grant income from the German Federal Ministry of Finance recognized in the first quarter 2025 and (iii) a $0.3 million increase across numerous categories. The increase was offset by a $0.7 million decrease in research and development tax incentives for clinical trials in Australia due to lower clinical trial spend in Australia.

Previous wording

We have no products approved for commercial sale and have not generated any revenue from product sales. We have never been profitable and have incurred operating losses in each year since inception in 2016. We have an accumulated deficit of approximately $563.7 million as of June 30, 2025 and $511.4 million as of December 31, 2024. Substantially all of our operating losses resulted from expenses incurred in connection with our research and development programs and from general and administrative costs associated with our operations.

Current wording

We have no products approved for commercial sale and have not generated any revenue from product sales. We have never been profitable and have incurred operating losses in each year since inception in 2016. We have an accumulated deficit of approximately $589.3 million as of September 30, 2025 and $511.4 million as of December 31, 2024. Substantially all of our operating losses resulted from expenses incurred in connection with our research and development programs and from general and administrative costs associated with our operations.

Previous wording

From inception through June 30, 2025, we have raised net cash of approximately $496.3 million from private and public offerings of common stock, prefunded warrants, common stock purchase warrants and tranche rights. As of June 30, 2025, we had cash and cash equivalents of approximately $55.3 million. With these funds, the Company does not have adequate liquidity to fund its operations for at least twelve months from the issuance of these consolidated financial statements without raising additional capital and such actions are not solely within the control of the Company. If the Company is unable to obtain additional capital, it would have a material adverse effect on the operations of the Company, its clinical development program, and the Company may have to cease operations altogether. These factors raise substantial doubt about the Company’s ability to continue as a going concern.

Current wording

From inception through September 30, 2025, we have raised net cash of approximately $496.3 million from private and public offerings of common stock, prefunded warrants, common stock purchase warrants and tranche rights. As of September 30, 2025, we had cash and cash equivalents of approximately $35.1 million. With these funds, the Company does not have adequate liquidity to fund its operations for at least twelve months from the issuance of these consolidated financial statements without raising additional capital and such actions are not solely within the control of the Company. If the Company is unable to obtain additional capital, it would have a material adverse effect on the operations of the Company, its clinical development program, and the Company may have to cease operations altogether. These factors raise substantial doubt about the Company’s ability to continue as a going concern.

Previous wording

We did not have any ATM activity during the six months ended June 30, 2025.

Current wording

We did not have any ATM activity during the three or nine months ended September 30, 2025.

Previous wording

For the six months ended June 30, 2024, we raised gross proceeds of $0.2 million pursuant to the December 2020 ATM through the sale of 150,000 shares of common stock at a weighted average price of $1.31 per share. The net proceeds from the December 2020 ATM were $0.2 million after deducting sales agent commissions of $6,000. We did not have any ATM activity for the three months ended June 30, 2024.

Current wording

For the nine months ended September 30, 2024, the Company raised gross proceeds of $0.2 million pursuant to the December 2020 ATM through the sale of 150,000 shares of common stock at a weighted average price of $1.31 per share. The net proceeds from the December 2020 ATM were $0.2 million after deducting sales agent commissions of $6,000. The Company did not have any ATM activity for the three months ended September 30, 2024.

Previous wording

In addition, on April 9, 2025, the Company entered into a placement agency agreement with Titan Partners Group LLC, a division of American Capital Partners, LLC (the “Placement Agent”), relating to the April 2025 Offering. Pursuant to the Placement Agency Agreement, the Company agreed to pay the Placement Agent a cash fee of 6.0% of the gross proceeds from the April 2025 Offering raised from investors and to reimburse the Placement Agent for certain costs incurred in connection therewith. Additionally, upon the closing of the April 2025 Offering, the Company agreed to issue to the Placement Agent, or its designees, warrants to purchase up to an aggregate of 283,334 shares of common stock, representing 5.0% of the shares sold in the April 2025 Offering (the “Placement Agent Warrants”). The Placement Agent Warrants will be exercisable, in whole or in part, commencing 180 days from the date of the Placement Agency Agreement and expiring on the five year anniversary of the Placement Agency Agreement, at an initial exercise price per share of common stock of $1.125, which is equal to 125% of the price per share to investors in the April 2025 Offering. The Placement Agent Warrants and the shares of common stock underlying the Placement Agent Warrants were offered pursuant to the exemptions from registration provided in Section 4(a)(2) under the Securities Act and Regulation D promulgated thereunder.

Current wording

In addition, on April 9, 2025, the Company entered into a placement agency agreement with Titan Partners Group LLC, a division of American Capital Partners, LLC (the “Placement Agent”), relating to the April 2025 Offering. Pursuant to the Placement Agency Agreement, the Company agreed to pay the Placement Agent a cash fee of 6.0% of the gross proceeds from the April 2025 Offering raised from investors and to reimburse the Placement Agent for certain costs incurred in connection therewith. Additionally, upon the closing of the April 2025 Offering, the Company agreed to issue to the Placement Agent, or its designees, warrants to purchase up to an aggregate of 283,334 shares of common stock, representing 5.0% of the shares sold in the April 2025 Offering (the “Placement Agent Warrants”). The Placement Agent Warrants became exercisable, in whole or in part, commencing 180 days from the date of the Placement Agency Agreement and will expire on the five year anniversary of the Placement Agency Agreement, at an initial exercise price per share of common stock of $1.125, which is equal to 125% of the price per share to investors in the April 2025 Offering. The Placement Agent Warrants and the shares of common stock underlying the Placement Agent Warrants were offered pursuant to the exemptions from registration provided in Section 4(a)(2) under the Securities Act and Regulation D promulgated thereunder.

Previous wording

The April 2025 Shares were registered under the Securities Act of 1933, as amended (the “Securities Act”), on the Company’s Registration Statement on Form S-3 (Registration No. 333-275717), previously filed with the SEC, and declared effective on May 31, 2024.

Current wording

The shares issued in the April 2025 Offering were registered under the Securities Act of 1933, as amended (the “Securities Act”), on the Company’s Registration Statement on Form S-3 (Registration No. 333-275717), previously filed with the SEC, and declared effective on May 31, 2024.

Previous wording

On May 28, 2025, Immunic entered into an underwriting agreement (the “Underwriting Agreement”) with Leerink Partners LLC, issuance and sale of (i) pre-funded warrants to purchase an aggregate of 86,666,667 shares of common stock, par value $0.0001 (“Common Stock”) of the Company (the “Pre-Funded Warrants”), (ii) accompanying series A warrants to purchase an aggregate of 86,666,667 shares of Common Stock of the Company (or Pre-Funded Warrants) (the “Series A Warrants”), and (iii) accompanying series B warrants to purchase an aggregate of 86,666,667 shares of Common Stock of the

Current wording

On May 28, 2025, Immunic entered into an underwriting agreement (the “Underwriting Agreement”) with Leerink Partners LLC, issuance and sale of (i) pre-funded warrants to purchase an aggregate of 86,666,667 shares of common stock, par value $0.0001 (“Common Stock”) of the Company (the “Pre-Funded Warrants”), (ii) accompanying series A warrants to purchase an aggregate of 86,666,667 shares of Common Stock of the Company (or Pre-Funded Warrants) (the “Series A Warrants”), and (iii) accompanying series B warrants to purchase an aggregate of 86,666,667 shares of Common Stock of the Company (or Pre-Funded Warrants) (the “Series B Warrants”) (the “May 2025 Offering”). The price per Pre-Funded Warrant and accompanying Series A Warrant and Series B Warrant was $0.7499.

Previous wording

The May 2025 Offering was made pursuant to an effective registration statement on Form S-3 (Registration Statement No. 333-275717), as amended, previously filed with the Securities and Exchange Commission (the “SEC”) on November 22, 2023, and declared effective by the SEC on May 31, 2024, as supplemented by the preliminary prospectus supplement, dated May 28, 2025, and a final prospectus supplement (the “Prospectus Supplement”) filed with the SEC pursuant to Rule 424(b) under the Securities Act of 1933, as amended (the “Securities Act”), on May 30, 2025. The closing of the May 2025 Offering took place on June 3, 2025.

Current wording

The May 2025 Offering was made pursuant to an effective registration statement on Form S-3 (Registration Statement No. 333-275717), as amended, previously filed with the Securities and Exchange Commission (the “SEC”) on November 22, 2023, and declared effective by the SEC on May 31, 2024, as supplemented by the preliminary prospectus supplement, dated May 28, 2025, and a final prospectus supplement (the “Prospectus Supplement”) filed with the SEC pursuant to Rule 424(b) under the Securities Act on May 30, 2025. The closing of the May 2025 Offering took place on June 3, 2025.

Previous wording

The first tranche, which closed on January 8, 2024, resulted in the purchase by the Investors of an aggregate of $80 million of Common Stock (or pre-funded warrants) from the Company at a price of $1.43 per share; The second tranche is a conditional mandatory purchase by the Investors of an additional $80 million of Common Stock (or pre-funded warrants) from the Company at a price of $1.716 per share, equal to 120% of the price paid in the first tranche and is subject to the satisfaction of three conditions:

Current wording

The first tranche, which closed on January 8, 2024, resulted in the purchase by the Investors of an aggregate of $80 million of Common Stock (or pre-funded warrants) from the Company at a price of $1.43 per share; the second and third tranches of this financing were not exercised and expired on October 31, 2025.

Previous wording

relatively low trading price of our common stock. Debt financing, if available, may involve covenants restricting our operations or our ability to incur additional debt or other terms that are not favorable to us or our stockholders. Also, the cost of debt financing has increased due to the rise in interest rates over the past few years. If we raise additional funds through collaborations and licensing arrangements with third parties, we would expect to relinquish substantial rights to our technologies or our future products, or grant licenses on terms that may not be favorable to us. If we were to complete a merger, or other business combination, we may relinquish all control over the organization and could experience detrimental tax effects. If we are unable to raise adequate funds, we may have to curtail our product development programs and liquidate some or all of our assets. Any of these factors could harm our operating results and could result in substantial declines in the trading price of our common stock.

Current wording

Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through a combination of stock offerings, debt financings, strategic alliances, collaborations and licensing arrangements. We do not expect to achieve revenue from product sales prior to the use of all the net proceeds from our public and private offerings to date. We do not have any committed external source of funds. Additional funds may not be available on acceptable terms, if at all. To the extent that we raise additional capital through the sale of equity securities, the ownership interest of our stockholders will be diluted and it may be on terms that are not favorable to us or our stockholders. Sales of equity securities will also be more difficult for at least the foreseeable future because of general volatility in the equity markets for companies like us. Debt financing, if available, may involve covenants restricting our operations or our ability to incur additional debt or other terms that are not favorable to us or our stockholders. Also, the cost of debt financing has increased due to the rise in interest rates over the past few years. If we raise additional funds through collaborations and licensing arrangements with third parties, we would expect to relinquish substantial rights to our technologies or our future products, or grant licenses on terms that may not be favorable to us. If we were to complete a merger, or other business combination, we may relinquish all control over the organization and could experience detrimental tax effects. If we are unable to raise adequate funds, we may have to curtail our product development programs and liquidate some or all of our assets. Any of these factors could harm our operating results and could result in substantial declines in the trading price of our common stock.

Previous wording

The following table shows a summary of our cash flows for the six months ended June 30, 2025 and 2024:

Current wording

The following table shows a summary of our cash flows for the nine months ended September 30, 2025 and 2024:

Previous wording

During the six months ended June 30, 2025, operating activities used $46.4 million of cash. The use of cash primarily resulted from (i) our net loss of $52.3 million adjusted for non-cash charges of $4.1 million related to $3.9 million for stock-based compensation, $0.1 million related to non-cash lease expense and $0.1 million related to depreciation (ii) a $1.8 million net decrease in our operating assets and liabilities. Changes in our operating assets and liabilities during the six months ended June 30, 2025 consisted primarily of a $2.3 million increase in our other current liabilities partially offset by a decrease in other current assets and prepaid expenses of $0.4 million.

Current wording

During the nine months ended September 30, 2025, operating activities used $66.5 million of cash. The use of cash primarily resulted from (i) our net loss of $77.9 million adjusted for non-cash charges of $7.8 million related to $7.6 million for stock-based compensation, $0.1 million related to non-cash lease expense and $0.1 million related to depreciation and (ii) a net increase in operating assets and liabilities of $3.5 million. Changes in our operating assets and liabilities during the nine months ended September 30, 2025 consisted primarily of (i) a $3.6 million increase in our other current liabilities partially offset by a (ii) a decrease of $0.1 million in our other current assets and prepaid expenses.

Previous wording

During the six months ended June 30, 2024, operating activities used $41.0 million of cash. The use of cash primarily resulted from (i) our net loss of $51.0 million adjusted for non-cash charges of $11.4 million related to a $4.8 million change in the fair value of the tranche rights, $4.6 million for stock-based compensation, $0.3 million related to non-cash lease expense and $0.1 million for depreciation expense as well as $1.7 million in fees expensed as part of the January 2024 Financing, partially offset by a $0.1 million foreign currency gain and (ii) a $1.4 million net decrease in our operating assets and liabilities. Changes in our operating assets and liabilities during the six months ended June 30, 2024 consisted primarily of a $1.8 million decrease in our other current liabilities partially offset by an increase in other current assets and prepaid expenses of $0.4 million.

Current wording

During the nine months ended September 30, 2024, operating activities used $61.8 million of cash. The use of cash primarily resulted from (i) our net loss of $75.3 million adjusted for non-cash charges of $7.0 million related to stock-based compensation, non-cash lease expense, unrealized foreign currency gains and depreciation and amortization, $4.8 million related to a change in the fair value of the tranche rights, $1.7 million for fees expensed as part of the January 2024 financing and (ii) a net increase in operating assets and liabilities of $0.1 million. Changes in our operating assets and liabilities during the nine months ended September 30, 2024 consisted primarily of (i) a $1.5 million increase in our other current assets and prepaid expenses and (ii) a decrease of $1.4 million in our other current liabilities.