At MorphoSys, we are committed to improving patient lives by changing the trajectory of blood cancer.

In 2022, we built momentum toward this commitment through our pivotal studies, in particular the Phase 3 trial of pelabresib in myelofibrosis. This momentum continues into 2023, when we will continue to focus on progressing our Phase 3 studies and nearing potential value inflection points.

Pelabresib – Striving to Enhance the Standard of Care in Myelofibrosis

Pelabresib, our investigational, late-stage BET inhibitor, is being explored in the Phase 3 MANIFEST-2 study in combination with ruxolitinib as a first-line treatment for patients with myelofibrosis. The latest Phase 2 data suggest that pelabresib has great potential to enhance the standard of care for this debilitating disease.

Myelofibrosis is a difficult-to-treat form of blood cancer that is characterized by a buildup of scar tissue in the bone marrow, an enlarged spleen, and severe anemia, which often requires a blood transfusion. Patients with myelofibrosis can also suffer from a range of physical symptoms, including fatigue, increased bleeding risk, and significant pain caused by an enlarged spleen – severely impacting their quality of life. Sadly, available therapies offer adequate symptom control for only about half of patients with myelofibrosis, and for many that relief fades with time. Patients deserve more.

In 2022, we presented clinical data from a subset of myelofibrosis patients in our ongoing Phase 2 MANIFEST study who had never received JAK inhibitor therapy. The results suggest that pelabresib plus ruxolitinib may provide prolonged improvement in both spleen size and symptom severity at and beyond 24 weeks. We also presented preliminary research indicating the association of biomarkers with potential disease-modifying activity of pelabresib. These new data from the MANIFEST trial have generated a lot of excitement about pelabresib’s potential within the physician community.

Based on the body of data we have presented thus far, our confidence in pelabresib and the Phase 3 MANIFEST-2 study is high. We will continue to prioritize uncovering the potential of pelabresib through the MANIFEST-2 study in 2023, and we look forward to sharing the topline data from this trial in early 2024.

Monjuvi® (tafasitamab-cxix) – Expanding into New Areas of Patient Need

We continue to educate the medical community on the efficacy and safety profile of Monjuvi (tafasitamab-cxix) as a treatment for appropriate patients with second-line relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Monjuvi addresses an important patient need in this setting and has achieved significant market share despite increasing competition. In March 2022, the U.S. National Comprehensive Cancer Network updated its guidelines, designating Monjuvi as a “preferred regimen” for second-line therapy in patients with DLBCL who are not candidates for transplant. Last year, we also presented new long-term data from patients in the L-MIND trial who were treated for at least two years, including six patients on treatment for five years or more. These data suggest durable responses and reinforce the critical patient need Monjuvi serves as the only in-practice, outpatient targeted immunotherapy in second-line DLBCL.

We believe the major opportunities for tafasitamab are yet to come. Beyond the currently approved indication, we are exploring tafasitamab in two Phase 3 studies for patients with newly diagnosed DLBCL (frontMIND) and for patients with indolent lymphomas (inMIND).

For about 50% of patients with high-intermediate and high-risk DLBCL, the standard of care first-line therapy, R-CHOP, is ineffective. And the prognosis for patients with relapsed or refractory disease is very poor. By adding tafasitamab and lenalidomide to R-CHOP, we are investigating the combination therapy’s potential to increase the DLBCL cure rate in the first line of treatment and help more patients avoid relapse.

Tulmimetostat (CPI-0209) – Establishing Proof of Concept

Abnormal EZH2 function is implicated in several ways in cancer and may make tumors more resistant to anti-cancer treatment. Tulmimetostat is a next-generation investigational selective dual inhibitor of EZH2 and EZH1 designed to improve on first-generation EZH2 inhibitors through increased potency, longer residence time on target, and a longer half-life. Our excitement about this mid-stage program increased in 2022 with the release of early data. Initial data from a Phase 1/2 basket study showed encouraging patient response rates to monotherapy treatment with tulmimetostat, despite having received many prior therapies. These preliminary results are promising, and we look forward to learning more as the trial progresses.

Strong Financial Position Combined with Strategic Focus on Oncology Pipeline

In 2022, we further strengthened our financial position through active cost management and funds from a previously negotiated development funding bond from Royalty Pharma, giving us additional flexibility as we advance our clinical programs. We also out-licensed felzartamab and MOR210, highly promising product candidates that are outside our focus, to HI-Bio. This decision will enable us to exclusively concentrate on our mid- to late-stage oncology pipeline.

Also in 2022, three partnered programs with ianalumab, abelacimab and setrusumab entered pivotal trials. By contrast, two of our licensing partners stopped development of otilimab in rheumatoid arthritis and of gantenerumab in early Alzheimer’s disease following negative late-stage clinical trial results. Please recall that MorphoSys monetized the majority of the future royalty interests in these two compounds, consistent with our strategy to reduce our dependence on partnered programs.

Thank You for Your Support as We Focus on Our Bright Future

It has been a difficult year with geopolitical tensions, rising inflation and interest rates, and increased market volatility. As a result, investors were more cautious than ever.

MorphoSys was not immune to the global situation, and we experienced our own challenges. We at MorphoSys have aligned on a clear strategic focus and have established a highly experienced team to execute that focus. We remain steadfast in our commitment to develop and deliver novel therapies that are safer and more effective for cancer patients.

The important work we do would not be possible without our employees, and I am deeply grateful for their dedication and hard work. I would like to thank Malte Peters, M.D., who retired as our Chief Research and Development (R&D) Officer in the fall of 2022, for his contributions to MorphoSys. I am very pleased that Tim Demuth, M.D., Ph.D., has taken over the R&D reins from Malte. He is a seasoned executive with broad leadership experience in drug development and scientific expertise in oncology.

I would also like to express my immense gratitude to our shareholders as well as to the clinicians, patients, and their loved ones who put their trust in us and our medicines.

We are on this journey together, and I am excited about what lies ahead.

Sincerely,

Jean-Paul Kress, M.D.
Chief Executive Officer