Immunic, Inc. is a biotechnology company that has been steadfastly developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases. The company's lead asset, vidofludimus calcium (IMU-838), has the potential to redefine the oral multiple sclerosis (MS) treatment landscape and elevate the standard of care for patients.
Business Overview and History
Immunic, Inc. was founded in March 2016 and is headquartered in New York City with its main operations in Gräfelfing near Munich, Germany. The company has focused on developing innovative therapies to address the unmet needs of patients suffering from chronic inflammatory and autoimmune conditions, with a particular emphasis on multiple sclerosis.
In July 2019, Immunic's stockholders approved the 2019 Omnibus Equity Incentive Plan, which allowed for the grant of equity awards to employees, consultants, and non-employee directors. This plan included an evergreen provision that allowed for the annual addition of up to 4% of the company's fully-diluted outstanding stock, with a maximum allowable increase of 4.9 million shares over the term of the plan.
In April 2019, Immunic completed a transaction with Vital Therapies, assuming Vital's 2012 Stock Option Plan, 2014 Equity Incentive Plan, and 2017 Inducement Equity Incentive Plan. All awards granted under these plans were eventually forfeited or expired, and there are no longer any shares available for grant under the 2014 Plan as of September 30, 2024.
In August 2019, Immunic AG received a grant of up to approximately $726,000 from the German Federal Ministry of Education and Research to support a three-year research project relating to autoimmune diseases. The company has recorded $726,000 of income in total from this grant, classified as Other Income, and the funding of this grant is now completed.
In December 2020, Immunic filed a Prospectus Supplement to the shelf registration statement on Form S-3 for the offering, issuance, and sale of up to a maximum aggregate offering price of $50 million of common stock under an at-the-market sales agreement with SVB Leerink LLC. The company used the net proceeds from this to fund the ongoing clinical development of its product candidates and for other general corporate purposes.
Immunic's lead product candidate, vidofludimus calcium, is a first-in-class molecule that combines neuroprotective effects through its mechanism as a nuclear receptor related 1 (Nurr1) activator, with anti-inflammatory and antiviral properties via inhibition of the enzyme dihydroorotate dehydrogenase (DHODH). This unique dual mode of action positions vidofludimus calcium to potentially address the full spectrum of multiple sclerosis, from the relapsing-remitting stage to the progressive forms of the disease.
The company's pipeline also includes IMU-856, an orally available and systemically acting small molecule modulator that targets Sirtuin 6 (SIRT6). This compound is being developed as a potential treatment for a broad range of gastrointestinal disorders, such as celiac disease, inflammatory bowel disease, and graft-versus-host disease, by targeting the restoration of intestinal barrier function and bowel wall architecture.
Vidofludimus Calcium: Advancing Towards Potential Regulatory Approval in Relapsing and Progressive MS
Immunic's lead program, vidofludimus calcium, is currently in late-stage clinical development for the treatment of both relapsing and progressive multiple sclerosis. The compound has demonstrated a consistent safety and tolerability profile, having been exposed to more than 1,800 human subjects and patients in previous clinical trials.
The company's Phase 3 ENSURE program, which consists of twin studies evaluating the efficacy, safety, and tolerability of vidofludimus calcium versus placebo in relapsing multiple sclerosis (RMS), is progressing as planned. In October 2024, Immunic announced a positive outcome from the interim analysis of this program, with an independent data monitoring committee (IDMC) confirming that the predetermined futility criteria had not been met and recommending that both ENSURE trials continue without changes, including no need for a potential upsizing of the sample size. Completion of the first of the ENSURE trials is currently anticipated in the second quarter of 2026, with the second trial expected to be completed in the second half of 2026.
Immunic is also advancing the Phase 2 CALLIPER trial of vidofludimus calcium in progressive multiple sclerosis (PMS). The company is eagerly anticipating the topline data from this trial, which is expected to be available in April 2025. The CALLIPER trial is designed to corroborate vidofludimus calcium's neuroprotective potential, with a focus on evaluating its impact on confirmed disability worsening, neurofilament light chain (NfL) levels, and other important biomarkers and clinical endpoints. The data from this trial could position vidofludimus calcium as a potential first-in-class oral treatment option for non-relapsing secondary progressive MS, a subtype with significant unmet medical need.
Strengthening the Leadership Team and Board of Directors
Immunic has strategically bolstered its management team and board of directors to support the advancement of its clinical programs and potential commercialization of its lead asset, vidofludimus calcium.
In July 2024, the company appointed Jason Tardio as President and Chief Operating Officer. Tardio brings a wealth of experience in launching and commercializing multiple sclerosis drugs for major biotechnology and pharmaceutical companies. He has been instrumental in leading internal efforts to prepare for the potential launch of vidofludimus calcium and collaborating with Chief Business Officer Patrick Walsh to explore partnership opportunities.
Additionally, in July 2024, Immunic promoted Werner Gladdines to the role of Chief Development Officer. Gladdines, who joined the company in 2021 as Head of the IMU-838 (vidofludimus calcium) program, has taken on additional strategic and operational responsibilities for Immunic's overall clinical operations functions.
The company also strengthened its board of directors in July 2024 with the appointment of Simona Skerjanec, a thought-leader in brain health with decades of experience in drug development and commercialization. Skerjanec's success in leading business and global corporate strategy for Roche's portfolio of neurological and rare diseases, including the highly successful Ocrevus (ocrelizumab) for the treatment of multiple sclerosis, enhances Immunic's board as the company works towards the potential commercial launch of vidofludimus calcium.
Financials
As of September 30, 2024, Immunic reported cash and cash equivalents of $59.1 million, which the company expects to be able to fund its operations into the third quarter of 2025. This cash position was bolstered by a three-tranche private placement totaling up to $240 million that the company announced in January 2024. The first tranche of this financing, which closed in January 2024, resulted in gross proceeds of approximately $80 million to Immunic.
For the nine months ended September 30, 2024, Immunic reported research and development expenses of $58.4 million, a decrease from $63.9 million in the same period of the prior year. This decrease was primarily driven by the deprioritization of the izumerogant program in psoriasis and castration-resistant prostate cancer, as well as the completion of the Phase 1 clinical trial of IMU-856 in celiac disease. These savings were partially offset by an increase in external development costs related to the vidofludimus calcium program and an increase in personnel expenses.
General and administrative expenses for the nine months ended September 30, 2024, were $14.0 million, compared to $11.9 million in the same period of the prior year. The increase was primarily related to higher personnel expenses, legal and consultancy expenses, and other costs across numerous categories.
Immunic reported a net loss of $75.3 million, or $0.75 per basic and diluted share, for the nine months ended September 30, 2024, compared to a net loss of $72.0 million, or $1.63 per basic and diluted share, for the same period in 2023.
For the fiscal year ended December 31, 2023, Immunic reported $0 in annual revenue, $93.6 million in annual net loss, $70.8 million in annual operating cash flow, and $71.2 million in annual free cash flow. For the quarter ended September 30, 2024, the company reported $0 in quarterly revenue and $24.4 million in quarterly net loss.
Immunic has never been profitable and has incurred operating losses in each year since its inception in 2016, with an accumulated deficit of approximately $486.2 million as of September 30, 2024. The company expects to continue incurring significant expenses and increasing operating losses for the foreseeable future as it advances its product candidates through clinical development.
Liquidity
Immunic's liquidity position has been strengthened by the recent private placement and careful management of expenses. The company's cash and cash equivalents of $59.1 million, combined with the proceeds from the first tranche of the private placement, provide a runway into the third quarter of 2025. This financial position allows Immunic to continue advancing its clinical programs, particularly the development of vidofludimus calcium in multiple sclerosis.
The company's ability to secure additional funding through private placements and potential partnerships demonstrates investor confidence in Immunic's pipeline and strategy. As the company progresses towards key clinical milestones, maintaining a strong liquidity position will be crucial for supporting ongoing research and development efforts and preparing for potential commercialization activities.
Immunic had a debt-to-equity ratio of 0.021 as of September 30, 2024. The company's current ratio and quick ratio were both 2.71 as of the same date, indicating a strong short-term liquidity position. Immunic does not have any available credit lines or credit facilities disclosed.
Upcoming Milestones and Catalysts
Immunic's key upcoming milestones and catalysts include:
1. Topline data from the Phase 2 CALLIPER trial of vidofludimus calcium in progressive multiple sclerosis expected in April 2025. 2. Completion of the first of the twin Phase 3 ENSURE trials of vidofludimus calcium in relapsing multiple sclerosis expected in the second quarter of 2026, with the second trial expected to be completed in the second half of 2026. 3. Potential partnership discussions for vidofludimus calcium and other pipeline assets, leveraging the company's strengthened management team and board of directors. 4. Advancement of the IMU-856 program, including the initiation of a Phase 2 clinical trial in celiac disease and exploration of other gastrointestinal indications.
Risks and Challenges
As with any biotechnology company, Immunic faces several risks and challenges that investors should be aware of:
1. Clinical trial success: The company's ability to obtain regulatory approval for its product candidates, including vidofludimus calcium and IMU-856, is dependent on the successful completion of its clinical trials and demonstrating the safety and efficacy of its compounds. 2. Competitive landscape: Immunic's products, if approved, will face competition from other approved or investigational therapies in the multiple sclerosis and gastrointestinal disease markets. 3. Regulatory approval and commercialization: Even if Immunic's product candidates are successful in clinical trials, there is no guarantee that they will receive regulatory approval or be successfully commercialized. 4. Funding and capital requirements: As a clinical-stage biotechnology company, Immunic will require significant additional funding to complete the development and potential commercialization of its product candidates.
Market Opportunity and Guidance
The multiple sclerosis market, which is Immunic's primary focus, is expected to grow at a CAGR of approximately 4-6% over the next several years, driven by the continued uptake of oral disease-modifying therapies. Immunic is positioning vidofludimus calcium to potentially disrupt this market if its unique dual mechanism of action and safety profile are confirmed in late-stage trials.
Immunic has provided a peak sales estimate for vidofludimus calcium ranging from $2 billion to $6 billion, if approved across the various MS indications. This estimate underscores the significant market potential for the company's lead asset.
Conclusion
Immunic, Inc. is a biotechnology company that has made significant strides in advancing its clinical pipeline, particularly with its lead asset, vidofludimus calcium. The compound's unique dual mode of action, combining neuroprotective, anti-inflammatory, and antiviral properties, positions it to potentially address the full spectrum of multiple sclerosis, from the relapsing-remitting stage to the progressive forms of the disease.
With the positive interim analysis of the Phase 3 ENSURE program in relapsing multiple sclerosis, the anticipated topline data from the Phase 2 CALLIPER trial in progressive multiple sclerosis, and the strengthening of the company's management team and board of directors, Immunic is well-positioned to transform the oral multiple sclerosis treatment landscape and address the significant unmet needs of patients.
As the company continues to execute on its clinical development strategy and explore partnership opportunities, investors should closely monitor Immunic's progress and the potential impact of its innovative therapies on the treatment of chronic inflammatory and autoimmune diseases. The company's strong liquidity position, coupled with its promising clinical pipeline and potential market opportunity, make Immunic an intriguing prospect in the biotechnology sector.