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Item 1. Business

2025-03-19 compared with 2024-03-28 · 285 added, 487 removed, 427 unchanged (64% of the section changed)

We are a biopharmaceutical company focused on the development of targeted oncology therapies.

We believe that the pursuit of novel or underexplored targets will be central to the next generation of transformative therapies.

For that reason, we pursue therapeutics that we believe have best-in-class or first-in-class potential.

Our goal is to establish a broad pipeline of preclinical and clinical assets which we can efficiently develop through successive value inflection points.

To support that goal, we pair business development activity with significant investment in our internal discovery programs.

Our named pipeline comprises one clinical and three preclinical assets.

Our clinical asset is AL102, an investigational gamma secretase inhibitor, or GSI, currently under evaluation in a Phase 3 trial for the treatment of desmoid tumors.

We acquired AL102 and related assets pursuant to an Asset Purchase Agreement, or the Ayala Purchase Agreement, with Ayala Pharmaceuticals, Inc., or Ayala, that we entered into on February 5, 2024, and the

transaction closed on March 25, 2024.

Based on our evaluation of Phase 2 data, we believe that AL102 has the potential, if approved, to establish a new standard of care for patients with desmoid tumors.

Our preclinical pipeline is centered on IM-1021, a receptor tyrosine kinase-like orphan receptor 1, or ROR1, antibody-drug conjugate, or ADC;

IM-3050, a fibroblast activation protein, or FAP, targeted radioligand therapy, or RLT, candidate;

and IM-4320, an anti-IL-38 immunotherapy candidate.

We anticipate submitting investigational new drug applications, or INDs, for IM-3050 and IM-1021 in the first quarter of 2025 and for IM-4320 at a later date.

We believe that each of these drugs has the potential to improve outcomes for patients across multiple indications.

Our business model is built upon our expertise in discovering and developing targeted therapies as well as our ability to evaluate and acquire high- potential assets.

We believe that the successful track record of our leadership team will make us more attractive to companies selling assets, especially early-stage biotechnology companies that lack resources to efficiently develop their assets.

Our perspective is that the most important considerations when acquiring an asset are the quality of its preclinical or clinical data and the economic terms on which it can be acquired.

Accordingly, we are willing to consider assets across multiple modalities, including ADCs, RLTs, naked antibodies, small molecules and more.

We believe that effectively pursuing a novel target requires selecting a modality that is appropriate to the target biology.

At present, our internal discovery efforts are centered on ADCs and RLTs.

We believe that a broad toolbox of linkers and payloads is necessary to design and develop a broad pipeline of ADCs, as different targets may require different payloads to achieve optimal efficacy and therapeutic index.

The novel linker-payload unit we exclusively licensed from Zentalis Pharmaceuticals, Inc., or Zentalis, is an important component of this toolbox, and we have efforts underway to develop additional linkers and payloads.

We also believe that the incorporation of albumin binders into radioligand therapies provides a differentiated approach that can increase the dose of radiation absorbed by patient tumors.

Our discovery platform provides us with a proprietary hybridoma technology to immortalize memory B cells isolated from oncology patient samples.

This enables the production of sufficient quantities of antibodies to perform high-throughput functional screening, allowing for the recognition of antibodies and targets whose role in cancer was not previously appreciated.

In January 2023, we announced an agreement with AbbVie under which AbbVie paid us $30 million upfront for access to up to 10 targets identified through our discovery platform.

On October 2, 2023, we completed a merger with Morphimmune Inc, or the Merger.

As a result of the Merger, our corporate strategy has shifted significantly.

At the close of the Merger, Clay Siegall, Ph.D.

became our President and Chief Executive Officer.

Three additional Morphimmune Inc, or Morphimmune, executives joined our leadership at the time of the Merger and, since that time, we have continued to expand our executive management team.

We believe that these new hires, in combination with our existing management, have the experience and skills necessary to execute our post-Merger strategy.

We are a clinical-stage targeted oncology company committed to developing targeted therapies designed to improve outcomes for cancer patients.

We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge targeted cancer therapies, including antibody-drug conjugate therapies, or ADCs.

We believe that the pursuit of novel or underexplored targets will be central to the next generation of transformative therapies, and we are dedicated to developing targeted cancer therapies with first-in-class and best-in-class potential.

Our goal is to establish a broad pipeline of preclinical and clinical assets and develop these assets into approved products for commercialization.

We are advancing a pipeline comprising two clinical assets and four preclinical assets.

Varegacestat, formerly AL102, is an investigational gamma secretase inhibitor, or GSI, currently under evaluation in a Phase 3 clinical trial for the treatment of desmoid tumors.

Our investigational new drug application, or IND, for IM-1021, a receptor tyrosine kinase-like orphan receptor 1, or ROR1, antibody-drug conjugate, received FDA clearance in December 2024, and the Phase 1 trial is ongoing with the first patient dosed in February 2025.

Our other preclinical assets include IM-3050, a fibroblast activation protein, or FAP, targeted radioligand therapy, or RLT, for which we submitted an IND in March 2025, and three solid tumor ADC drug candidates:

IM-1617, IM-1340, and IM-1335, all of which are in IND-enabling activities.

We have six additional ADCs currently undergoing lead optimization in advance of future development decisions.

At present, our internal discovery efforts center on designing ADCs against novel or underexplored targets.

We believe that pursuing differentiated targets provides a path to significant clinical benefit and meaningful market opportunities.

This strategy is supported by HC74, the differentiated, novel topoisomerase 1, or TOP1, inhibitor payload we exclusively licensed from Zentalis Pharmaceuticals, Inc., or Zentalis, in January 2024 and subsequently purchased from Zentalis in October 2024.

We have efforts underway to develop additional linkers and payloads and believe that a broad toolbox of linkers and payloads supports our mission to design and develop a diverse pipeline of ADCs.

To expand and advance our innovative portfolio of therapeutics, we draw on leadership that previously played key roles in the design, development, and commercialization of cutting-edge targeted cancer therapies, including the first ADCs commercialized for Hodgkin and T-cell lymphoma, urothelial cancer and cervical cancer.

Immunome Pipeline

AL102 (Gamma Secretase Inhibitor)

On February 5, 2024, we entered into the Ayala Purchase Agreement with Ayala, pursuant to which we acquired assets including the rights to AL102, a GSI, currently under evaluation in a Phase 3 trial for the treatment of desmoid tumors.

We closed the transaction contemplated by the Ayala Purchase Agreement, including the purchase of AL102, on March 25, 2024.

Our interest in AL102 was largely a response to Phase 2 data, a preliminary version of which was shared by Ayala at European Society for Medical Oncology congress, or ESMO, in October 2023.

Ayala’s data showed an objective response rate, or ORR, of 64% in the intent-to-treat population and 75% among evaluable patients.

Other measures of response, including tumor volume as measured by MRI and cellularity as estimated via T2 imaging, also showed deep responses.

Varegacestat (formerly AL102)

Varegacestat is an oral, once daily GSI therapy that is being evaluated for the treatment of desmoid tumors.

In the Phase 2 RINGSIDE study Part A, varegacestat demonstrated objective response rates, or ORR, of 75% of evaluable patients and 64% in the intent-to-treat population;

median reduction in tumor volume of 88%;

and an 85% reduction in T2 imaging, which is suggestive of a reduction in cellularity.

The Phase 2 data also show that varegacestat has a safety profile consistent with other GSI therapies.

Enrollment in a Phase 3 registrational trial was completed in February 2024, and we expect to report topline data from this trial in the second half of 2025.

We acquired varegacestat from Ayala Pharmaceuticals, Inc., or Ayala, in March 2024.

Disease background

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These tumors are rare, with approximately 1,000-1,650 patients diagnosed each year and approximately 5,500-7,500 actively managed patients in the United States.

They typically occur in people between the ages of 15 and 60 and are most common in early adolescence, with a peak around 30 years of age, and they are more common in women than men.

They typically occur in people between the ages of 15 and 60 and are most common in adults, with a peak around 30 years of age, and they are more common in women than men.

Desmoid tumors arise in connective tissue and can occur anywhere in the body where connective tissue is found.

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Symptoms largely depend on the location of the tumor and the extent of invasion or compression of surrounding tissue.

The pain and physical limitations associated with desmoid tumors lead to high clinical burdens and reduced quality of life.

Additionally, a study conducted in Denmark found that patients with desmoid tumors have substantially higher healthcare resource utilization compared with matched patients at 1- and 3- years post-diagnosis, including increases in both in-patient and out-patient visits as well as days of hospitalization.

The vast majority (85-90%) of desmoid tumors are sporadic and result from somatic mutations in the CTNNB1 gene, which encodes β-catenin protein.

The pain and physical limitations associated with desmoid tumors can lead to high clinical burdens and reduced quality of life.

Additionally, a study conducted in Denmark found that patients with desmoid tumors have substantially higher healthcare resource utilization compared with matched patients at one and three years post-diagnosis, including increases in both in-patient and out-patient visits as well as days of hospitalization.

The vast majority (85-90%) of desmoid tumors are sporadic and of these, 85% result from somatic mutations in the CTNNB1 gene, which encodes β-catenin protein.

Desmoid tumors may also result from germline mutation of the APC gene, which is also associated with familial adenomatous polyposis, that leads to accumulation of β-catenin in the nucleus and drives overexpression of its target genes.

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Risk factors for the initial development of desmoid tumors can also increase the risk of recurrence.

Prior to the November 2023 U.S.

Food & Drug Administration, or FDA, approval of the GSI nirogacestat for the treatment of adult patients with progressing desmoid tumors who require systemic treatment, the treatment landscape for desmoid tumors included watchful waiting, surgery, radiation therapy, low-dose or conventional chemotherapy, or tyrosine kinase inhibitors.

Prior to the November 2023 FDA approval of the GSI OGSIVEO ® (nirogacestat) for the treatment of adult patients with progressing desmoid tumors who require systemic treatment, the treatment landscape for desmoid tumors included active surveillance, surgery, radiation therapy, low-dose or conventional chemotherapy, or tyrosine kinase inhibitors.

Treatment considerations include tumor progression, symptoms, risk of morbidity, surgical risk, and the need for a fast response.

Active surveillance is now the preferred management approach for patients whose tumors are in non-critical anatomic locations.

We believe GSIs may ultimately capture much of the market for first-line desmoid tumor therapy.

Mechanism of action

AL102 is an investigational, oral, once-daily GSI.

The uptake of OGSIVEO ® in the United States in the treatment of desmoid tumors demonstrates the potential for GSIs to address unmet need, and we believe that GSIs may ultimately capture much of the market for desmoid tumor therapy.

Proposed mechanism of action

Varegacestat is an investigational, oral, once-daily GSI.

GSIs alter signaling through the Notch pathway, which is involved in embryonic development and the renewal and maintenance of adult tissues.

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Gamma secretase-mediated cleavage of Notch releases the Notch intracellular domain which travels to the nucleus and activates the genes that mediate oncologic behavior.

Inhibition of gamma secretase by AL102 blocks this cleavage and inhibits Notch pathway activation.

Inhibition of gamma secretase by varegacestat may block this cleavage and inhibits Notch pathway activation.

Clinical development

Prior to the initiation of the Phase 3 trial of AL102 in desmoid tumors (RINGSIDE Part B), AL102 clinical activity was observed in two clinical trials that enrolled adult desmoid tumor patients.

Prior to the initiation of the Phase 3 clinical trial of varegacestat in desmoid tumors (RINGSIDE Part B), varegacestat clinical activity was observed in two clinical trials that enrolled adult desmoid tumor patients.

A Phase 1 dose-escalation clinical trial was conducted by Bristol-Myers Squibb, or BMS, in patients with solid tumors.

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This patient demonstrated tumor shrinkage of 16.5% while on study.

Based on these data and responses demonstrated with other GSIs, Ayala designed a seamless Phase 2/3 study called RINGSIDE to specifically evaluate the activity of AL102 in patients with progressing desmoid tumors who required therapy.

RINGSIDE Part A enrolled 42 patients at three different dosing regimens of AL102:

2 mg once a day for two days every week, 4 mg once a day for two days every week or 1.2 mg once a day daily.

Based on these data and responses demonstrated with other GSIs, Ayala designed a seamless Phase 2/3 study called RINGSIDE to specifically evaluate the activity of varegacestat in patients with progressing desmoid tumors who required therapy.

RINGSIDE Part A enrolled 42 patients at three different dosing regimens of varegacestat:

2 mg once a day for two days every week, 4 mg once a day for two days every week and 1.2 mg once a day daily.

Overall, the ORR in evaluable patients as measured by RECIST v1.1 by an independent radiologist was 64% for all doses tested.

The 1.2 mg daily dosing cohort had an ORR of 75% in

the evaluable population.

AL102 was well tolerated overall with a safety profile consistent with that reported with other GSIs.

These data were reported at ESMO in 2023.

Overview of Treatment-Emergent Adverse Events for AL102 and Nirogacestat

Study Population, n

AL102, 1.2mg QD

RINGSIDE Part A

Nirogacestat 150mg BID

Adverse Event

Dermatitis acneiform

Hypophosphatemia

Rash maculo-papular

Aspartate aminotransferase increased

Months on the study, mean (range), months

16.6 (1-21.6)

20.6 (0.3 - 33.6)

The 1.2 mg daily dosing cohort had an ORR of 75% in the evaluable population.

Among patients in the intention-to-treat population, the overall response rate was 55% across all doses tested and the response rate was 64% for patients in the 1.2 mg daily dosing cohort.

In this study, more rapid and deeper responses were achieved with 1.2 mg once-daily dosing compared with the other dosing schedules, as evaluated based on RECIST by blinded independent central review, or BICR, tumor volume, and T2W signal intensity.

These data were reported in a poster presentation at ESMO in 2024.

Safety results from the Phase 2 portion of RINGSIDE show that varegacestat was well tolerated and has an overall safety profile consistent with that reported with other GSIs.

A lower rate of ovarian dysfunction in premenopausal women was observed for varegacestat (55.6%) compared with published data for an approved GSI (75.0%).

Additionally, responses observed in the 1.2mg once-daily cohort in the Phase 2 portion of RINGSIDE compared favorably to nirogacestat across all measures assessed.

Phase 3 RINGSIDE Part B trial in desmoid tumors

Based upon the clinical activity observed in RINGSIDE Part A at the dose of 1.2 mg given once daily, and following consultation with the FDA, the phase 3 randomized registration trial, RINGSIDE Part B (NCT04871282) was initiated by Ayala in November 2022.

Enrollment was completed in February of 2024.

Based upon the clinical activity observed in RINGSIDE Part A at the dose of 1.2 mg given once daily, and following consultation with the FDA, RINGSIDE Part B (NCT04871282) was initiated in November 2022.

RINGSIDE Part B is a registrational Phase 3, global, double-blind, randomized, placebo-controlled clinical trial, conducted at clinical sites in North America, Europe, Asia and Australia.

It will evaluate the efficacy, safety and tolerability of AL102 compared to placebo in patients with progressing desmoid tumors.

It is designed to evaluate the efficacy, safety and tolerability of varegacestat compared to placebo in patients with progressing desmoid tumors.

One hundred fifty-six patients with histologically confirmed desmoid tumors with progressive disease (defined as tumor growth of at least 20% within the past 12 months as measured by RECIST v1.1) were enrolled.

Patients were either treatment-naïve with desmoid tumors not amenable to surgery or had refractory or recurrent disease after at least one line of therapy.

Patients in the study were randomized to receive either AL102 at a dose of 1.2 mg given once daily or placebo and evaluated for tumor progression using RECIST v1.1.

Patients who progress while on study are eligible to enter an open-label extension whereby they may receive AL102 at a dose of 1.2 mg once daily until disease progression or unacceptable toxicity.

Enrollment was completed in February 2024 and the study is ongoing.

Enrolled patients were either treatment-naïve with desmoid tumors not amenable to surgery or had refractory or recurrent disease after at least one line of therapy.

Patients in the study were randomized 1:1 to receive either varegacestat at a dose of 1.2 mg given once daily or placebo and evaluated for tumor progression using RECIST v1.1.

Patients who progress while on study are eligible to enter an open-label extension whereby they may receive varegacestat at a dose of 1.2 mg once daily until disease progression or unacceptable toxicity.

The primary endpoint of RINGSIDE Part B is progression-free survival with secondary endpoints of ORR, duration of response and specific patient-reported outcomes.

We expect to publish topline data for RINGSIDE Part B in the first quarter of 2025.

In parallel, we are evaluating and performing the additional manufacturing and pharmacology work required to support an NDA submission.

IM-1021 (ROR1 ADC)

On January 8, 2024, we announced that we had entered into an exclusive, worldwide license agreement with Zentalis, or the Zentalis License Agreement, under which we licensed from Zentalis ZPC-21 (now IM-1021), a preclinical-stage ADC targeting ROR1.

ROR1 has an oncofetal expression pattern, with little or no expression in healthy tissue, and it is expressed on solid and liquid tumors.

We believe ROR1 has been validated as an ADC target through clinical trials of a competitor ADC in multiple B-cell malignancies.

ROR1 as a therapeutic target in multiple oncology indications

ROR1 is expressed during normal embryonic and fetal development but is largely absent in most mature tissues.

While low ROR1 expression is seen in some adult tissues (adipose, pancreas, lung, and a subset of intermediate B cells), high expression has been observed in a variety of blood malignancies and solid tumors.

High expression of ROR1 was initially detected in B-cell chronic lymphocytic leukemia, or CLL, and subsequently identified in acute lymphocytic leukemia, non-Hodgkin lymphomas, and myeloid malignancies.

Strong expression of ROR1 has also been reported in >30% of primary colon, lung, and pancreatic tumor samples, with more moderate expression seen in the majority of ovarian, lymphoma, skin, testicular, uterine, prostate, and adrenal cancers.

Given this pattern of expression, ROR1 may have clinical utility as a therapeutic target in multiple solid and liquid tumor indications, including diseases with large patient populations and high unmet need.

ROR1 is an ADC target with demonstrated clinical activity.

Clinical data from two competitor programs support the potential of ROR1-targeted ADCs.

MK-2140 (formerly known as VLS-101) is a ROR1-targeted ADC which is currently being evaluated in four phase 2 trials for B-cell malignancies.

In a Phase 1 dose escalation study of MK-2140 in heavily pre-treated patients (median prior lines of therapy = 4, range 1-9), objective tumor responses were observed in patients with mantle cell lymphoma, or MCL, or diffuse large B-cell lymphoma, or DLBCL, but not in patients with CLL,

follicular lymphoma, Richter’s transformation lymphoma, or RTL, or marginal zone lymphoma.

Fourteen-month follow-up data from this trial in patients with DLBCL, MCL, or RTL showed an ORR of 29%, 53%, and 57%, respectively.

Six-month efficacy data from 20 patients with relapsed/refractory DLBCL in a Phase 2 trial of MK-2140 demonstrate an ORR by investigator review of 30%, including two patients with complete responses, or CR, four patients with partial responses, or PR, and 5 patients with stable disease, or SD.

IM-1021 is designed to overcome the challenges to developing a successful ADC for ROR1

Although ROR1 is expressed in diverse malignancies, its expression levels are relatively low compared with the targets of other ADC therapies.

This moderate-to-low expression and slow internalization of ROR1 present challenges to developing a successful ADC for the treatment of ROR1-positive solid tumors.

We expect to share topline data for RINGSIDE Part B in the second half of 2025.

In parallel, we are completing the manufacturing, toxicology and pharmacology work required to support an NDA submission.

IM-1021 (Solid Tumor and B-Cell Lymphoma ADC)

IM-1021 is a ROR1 ADC that incorporates HC74, our proprietary TOP1i payload.

ROR1 is expressed in both hematologic malignancies and solid tumors with limited normal tissue expression, and previous ADCs targeting ROR1 have demonstrated clinical activity.

In preclinical studies, IM-1021 showed sustained tumor regression in preclinical models, including a mouse model of triple-negative breast cancer, or TNBC, and a mouse model of mantle cell lymphoma, or MCL.

We believe that IM-1021 may provide improved therapeutic index as compared to other ROR1-targeted ADCs in development.

IM-1021 received IND clearance in December 2024, and the phase 1 clinical trial is ongoing with a starting dose of 2 mg/kg of adjusted ideal body weight.

We expect dose escalation to include patients both with solid tumors and with B-cell lymphoma.

ROR1 is a clinically validated target in B-cell lymphoma

High or moderate expression of ROR1 has been demonstrated in a variety of hematopoietic malignancies, particularly in B-cell lymphomas, and clinical results have validated it as a target in these tumors.

Preliminary Phase 1 data from zilovertamab vedotin (also known as MK-2140 or VLS-101), a ROR1-targeted ADC with a vedotin payload, in heavily pre-treated patients (median prior lines of therapy = 4, range 1-9), showed objective tumor responses in participants with mantle cell lymphoma, or MCL, and diffuse large B-cell lymphoma, or DLBCL.

Subsequent evaluation in a Phase 2 study by Merck in DLBCL showed that of 103 patients treated at 2.5 mg/kg, 15 participants had complete responses, or CRs, 14 had partial responses, or PRs, and 17 had stable disease, or SDs.

Of 37 participants treated at 2.25 mg/kg, there were 7 CRs, 2 PRs, and 7 SDs.

Both of these dose levels were associated with a high degree of toxicity.

In February 2025, Merck announced the initiation of waveLINE-010 (ClinicalTrials.gov, NCT06717347), a pivotal Phase 3 clinical trial evaluating zilovertamab vedotin in combination with rituximab plus cyclophosphamide, doxorubicin and prednisone, or R-CHP, compared to rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone, or R-CHOP, alone, for the treatment of patients with previously untreated DLBCL.

In addition, CStone Phamaceuticals has shared Phase 1 data demonstrating activity in both Hodgkin and non-Hodgkin lymphoma for CS5001, their ROR1-targeted ADC.

ROR1 is an attractive target for select solid tumors

While ROR1 expression is more variable in solid tumors than in B-cell lymphomas, it is known to be expressed in a variety of malignancies including NSCLC, TNBC, ovarian cancer, mesothelioma, liposarcoma and pancreatic cancer, and responses have been observed in NSCLC and pancreatic cancer with CS5001.

We believe that developing a successful ADC for ROR1 in solid tumors requires overcoming challenges like moderate-to-low expression and slow internalization.

IM-1021 embodies our approach to overcoming these challenges:

it incorporates a ROR1 antibody that is designed to promote internalization;

a cleavable, undisclosed linker is used to conjugate the payload to the ROR1 antibody via cysteine conjugation;

and a proprietary camptothecin derivative (a topoisomerase I inhibitor) that is designed to maximize the potential bystander effect and supports a drug-antibody ratio, or DAR, of 8.

We believe that this combination of attributes may potentially provide IM-1021 with an improved therapeutic index compared with other ROR1-targeted ADCs in development.

In preclinical studies, IM-1021 showed sustained tumor regression in a mouse model triple-negative breast cancer, or TNBC.

In this model, IM-1021 dosed weekly for three weeks at 2.5 mg/kg or 5.0 mg/kg demonstrated superior reductions in tumor volume compared with the same respective dose of a competitor, vedotin payload ROR1 ADC, with no meaningful weight loss observed.

Subject to obtaining an IND, our IM-1021 clinical strategy is designed to efficiently evaluate dose escalation in patients with solid tumors or lymphoma, followed by potential expansion of the solid tumor clinical program into targeted indications, potentially including non-small cell lung cancer, breast prostate, pancreatic, and gastric cancer, and expansion of the lymphoma program into diffuse large B-cell lymphoma and mantle cell lymphoma.

Concurrent with the dose escalation and expansion studies, we plan to conduct non-clinical studies evaluating IM-1021 in combination with other therapies, particularly in B-cell malignancies, and to evaluate and develop potential companion diagnostics that could help identify patients most likely to respond to IM-1021.

Our strategy is to pursue pivotal clinical studies in indications that have shown compelling clinical outcomes in earlier-stage trials, present significant commercial opportunities, have the potential for enhanced outcomes using a companion diagnostic, and offer potential for accelerated approval.

We expect to submit an IND for the IM-1021 program to the FDA in the first quarter of 2025.

it utilizes a cleavable, undisclosed linker to conjugate the payload to the ROR1 antibody via cysteine conjugation;

and it includes a proprietary camptothecin derivative, HC74, a TOP1 inhibitor, that is designed to maximize the potential bystander effect and that supports a drug-antibody ratio, or DAR, of 8.

We believe that this combination of attributes could provide IM-1021 with an improved therapeutic index compared with other ROR1-targeted ADCs in development.

In October 2024, we presented preclinical data demonstrating robust anti-tumor activity for IM-1021 at the 36th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics.

IM-1021 showed superior activity compared to zilovertamab vedotin 1 at both dose levels in both the Jeko-1 mantle cell lymphoma model and the MDA-MB-468 TNBC model.

In the MDA-MB-468 study, five out of eight animals achieved complete responses after three 5 mg/kg doses.

1 The head-to-head data is based on our synthesized version of MK-2140, which we believe is structurally equivalent to MK-2140.

In a patient-derived NSCLC xenograft model, eight out of eight animals achieved complete responses after three 2.5 mg/kg doses IM-1021.

We received IND clearance for IM-1021 in December 2024 and began dosing patients in our Phase 1 clinical trial in February 2025 with a starting dose of 2 mg/kg of adjusted ideal body weight.

Our clinical strategy is designed to efficiently evaluate dose escalation in patients with solid tumors and lymphoma, followed by potential expansion into specific indications.

Dose escalation will evaluate B-cell lymphomas, including diffuse large B-cell lymphoma, mantle cell lymphoma, follicular lymphoma and small lymphocytic lymphoma, as well as solid tumor indications like non-small cell lung cancer triple-negative breast cancer, ovarian cancer, liposarcoma, mesothelioma, and pancreatic cancer.

Expansion cohorts may include any of the above-mentioned tumor types.

We are also evaluating the need and benefit of developing a potential companion diagnostic(s) that could help identify patients most likely to respond to IM-1021.

Our strategy is to pursue pivotal clinical studies in indications that have shown compelling clinical outcomes in early-stage trials, present significant commercial opportunities, and offer a potential accelerated path to approval.

IM-3050 (FAP Radioligand Therapy)

Through our merger with Morphimmune, we acquired IM-3050, a FAP-targeted Lu-177 RLT development candidate for the treatment of solid tumors.

FAP, or fibroblast activation protein, serves as a tumor-specific marker due to its broad expression on cancer associated fibroblasts.

Cancer-associated fibroblasts are the most common tumor stromal cell, with expression in 75% of solid tumors.

IM-3050 is a FAP-targeted lutetium-177, Lu-177 or 177Lu, RLT product candidate for the treatment of solid tumors.

FAP, or fibroblast activation protein, is a cell surface protease that serves as a tumor-specific marker due to its broad expression on cancer associated fibroblasts, the most common tumor stromal cell.

FAP is expressed in 75% of solid tumors.

IM-3050 is designed to deliver radioactive 177Lu directly to FAP- expressing cells, where the “bystander” effect of the radiation may damage or kill nearby tumor cells.

We believe this RLT approach could overcome the limitations, such as poor internalization and low expression on tumor cells, that make FAP an unsuitable target for ADCs.

In vivo data show single dose antitumor activity and tolerability.

FAP is expressed in a wide variety of solid tumors

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Many CAFs differ from normal fibroblasts by their expression of FAP.

A retrospective analysis of images obtained from PET/CT imaging using 68Ga-FAPI, a FAP-targeted radiodiagnostic, found tumor-specific uptake across fifteen types of solid tumors with the highest uptake in lung, breast and esophageal cancers, cholangiocellular carcinoma and sarcoma.

FAP is a membrane-bound serine protease that promotes tumor development and metastasis by influencing extracellular matrix remodeling, intracellular signaling, angiogenesis, epithelial-to-mesenchymal transition, and immunosuppression.

The broad distribution of FAP across tumor types and the specificity of its expression in tumors make it an attractive target for the development of therapeutics and diagnostics.

A retrospective analysis of images obtained from PET/CT imaging using 68Ga-FAPI, a FAP-targeted radiodiagnostic, found tumor-specific uptake across fifteen types of solid tumors.

FAP-specific inhibitors, such as talabostat, also known as BXCL701, have been investigated in clinical trials since at least 2005;

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Two targeted radiotherapies have been approved by the FDA in the past few years:

Luthera® for gastroenteropancreatic neuroendocrine tumors, or GEP-NETs, that express the somatostatin receptor;

and Pluvicto® for metastatic castration-resistant prostate cancer, or mCRPC.

Lu ta thera® for gastroenteropancreatic neuroendocrine tumors, or GEP-NETs, that express the somatostatin receptor;

and Pluvicto® for metastatic castration-resistant prostate cancer, or mCRPC that expresses PSMA .

There has also been strong interest from pharmaceutical companies in acquiring radiotherapies, exemplified by the $4.1 billion dollar acquisition of RayzeBio , Inc.

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by Novartis AG in 2018;

a $260 million upfront payment from Lantheus Holdings, Inc.

to license two radiotherapeutics from Point Biopharma, Inc.

the $1.4 billion dollar acquisition of Point Biopharma Global, Inc.

by Eli Lilly and Company ;

and a $50 million upfront payment from Novartis AG to license FAP-2286, a FAP-targeted radiotherapy Phase 1 clinical candidate originally developed by Clovis Oncology , Inc.

Published clinical results from IM-3050 competitor product candidates have demonstrated both the potential therapeutic benefits of this class of therapeutics and the limitations of current candidates.

Published clinical results from FAP-targeted RLT product candidates have demonstrated both the potential therapeutic benefits of this class of therapeutics and the limitations of current candidates.

Among eleven patients with advanced or metastatic solid tumors treated with 177 Lu-FAP-2286, one patient achieved a PR after six treatments, and that patient’s disease did not progress for more than 12 months after their first dose.

However, most patients did not achieve a PR , highlighting the potential for FAP-targeted therapies with improved activity.

IM-3050, our lead FAP-targeted RLT, has four functional domains:

● A small molecule FAP-specific ligand

● A linker tuned to drive tumor-specific uptake

● An albumin-binding domain to improve tumor retention

● A chelator to deliver the radionuclide

Over the last two years, we have evaluated over 80 FAP-targeted RLTs that use different combinations of ligands, linkers, and albumin binders while still maintaining the four-domain structure.

An example of the impact that a change in a single domain can impart on the therapeutic potential of the product candidate is the effect of specific albumin-binding domains.

However, most patients did not achieve a response, highlighting the need for FAP-target ed therapies with improved activity.

IM-3050 is a FAP-targeted RLT with best-in-class potential

IM-3050, our lead FAP-targeted RLT is an optimized molecule with best-in-class potential.

It has four functional domains:

a small molecule FAP-specific ligand, a linker tuned to drive tumor-specific uptake, an albumin-binding domain to improve tumor retention, and a chelator to deliver the radionuclide.

Over the last three years, we have evaluated over 80 FAP-targeted RLTs that use different combinations of ligands, linkers, and albumin binders while still maintaining the four-domain structure.

An example of the impact that a change in a single domain can impart on the therapeutic potential of a product candidate is the effect of specific albumin-binding domains.

The inclusion of albumin-binding domains has previously been used to improve the pharmacokinetics of biologics and small molecules that bind to albumin and have been shown to extend their half-life in circulation.

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The increase in circulating half-life is correlated with an increase in tumor-specific uptake and retention.

We selected IM-3050 as a lead candidate following evaluation of factors like binding affinity, specificity for FAP, radiostability, in vivo tumor retention, preclinical activity and preclinical tolerability.

We selected IM-3050 as a lead candidate following an evaluation of factors like binding affinity, specificity for FAP, radiostability, in vivo tumor retention, preclinical activity, biodistribution and preclinical tolerability.

Use of 177Lu- IM- 3050 in a mouse model of glioblastoma demonstrated substantial tumor regression with no meaningful weight loss observed.

We expect to submit an IND for this program to the FDA in the first quarter of 2025.

IM-4320 (Anti-IL-38 Immunotherapy)

We initiated our anti-IL-38 immunotherapy program on the basis of data generated by our proprietary memory B cell hybridoma screening technology.

IL-38 was identified as the target of an antibody isolated from a hybridoma library generated from the memory B cells of a patient with squamous head and neck cancer.

Our query of public and proprietary databases of cancer gene expression revealed over-expression of IL-38 in multiple solid tumors.

Furthermore, in some tumor types, we observed a correlation between high IL-38 expression and low levels of tumor-infiltrating immune effector cells, a hallmark of immune suppression, suggesting a role for IL-38 as an immune modulator.

IL-38 is an immunosuppressive cytokine and is a novel potential immuno-oncology target

IL-38 is one of the eleven members of the IL-1 family of cytokines.

IL-38 functions as an antagonist for IL-36R and IL-1 receptor accessory protein-like 1, or IL1RAPL1, limiting the activation of innate immune cells, and inhibiting the secretion of chemotactic and stimulatory factors that are critical for the induction of adaptive immunity.

In the context of cancer, overexpression of IL-38 results in the acceleration of tumor growth in the Lewis Lung model of lung cancer in vivo and reduced intra-tumoral T cell infiltrates.

In lung adenocarcinoma patients, high IL-38 expression is associated with poor prognosis, correlates with PD-L1, and negatively correlates with CD8+ T cell density by histology.

While the cellular source of IL-38 is unclear, the release of IL-38 is observed in vitro following apoptosis of tumor cells, suggesting that IL-38 may function as a negative feedback loop to suppress intra-tumoral immunity.

IL-38 mRNA expression data from The Cancer Genome Atlas, or TCGA, show that IL-38 expression is significantly higher in head and neck squamous carcinoma, or HNSC, compared to normal tissues.

IL-38 transcripts were also detectable in multiple squamous tumor types among the 30 types tested.

Notably, carcinomas with squamous cell morphology have exhibited the highest IL-38 expression and highest frequency of IL-38 positive patient samples.

Results of the mRNA expression analysis were further confirmed by screening primary tumor samples from patients with HNSC, lung cancer (adenocarcinoma and squamous cell carcinoma), and cervical squamous cell carcinoma for the presence of IL-38 protein, which was found to be present in the majority of samples.

In addition to the studies noted above demonstrating that overexpression of IL-38 is associated with reduced intra-tumoral immunity, the potential for IL-38 as an immuno-oncology, or I/O, target is supported by data showing that down-regulation of IL-38 promotes activation of the innate immune system.

For example, IL-38 knockout mice exhibited increased pro-inflammatory cytokine levels and delayed tumor growth.

Moreover, the IL-38 pathway has been validated as a therapeutic target for treating psoriasis, a disease in which low levels of IL-38 promote a pro-inflammatory immune state.

Spesolimab-sbzo, an antibody therapy that received FDA approval in 2022 for the treatment of adults with generalized pustular psoriasis, binds to IL36R and prevents the binding of other ligands that can induce downstream immune activation.

We believe these findings provide compelling evidence that IL-38 inhibition has potential as a novel I/O strategy.

While immune checkpoint inhibitors that target T-cells, such as anti-CTLA-4, anti-PD-1 and anti-PD-L1, show great promise in diverse cancer indications, most patients receiving these therapies do not experience meaningful or sustained clinical responses.

This is believed to be due to limited infiltration of immune cells, low tumor mutational burden, or the absence of a sustained immune response to the tumor.

IL-38 inhibition may reverse the inhibitory mechanisms that regulate innate immune cells, providing a novel approach to leveraging the immune system to treat cancer.

Development of IM-4320 as a potential I/O therapy

To pursue IL-38, we generated anti-IL-38 antibodies and evaluated them for therapeutic potential.

Through these evaluations, we found that:

● An anti-IL-38 antibody demonstrated a favorable pharmacokinetic profile and was well-tolerated in non-tumor-bearing mice.

● An anti-IL-38 antibody induced complete tumor regression in a subset of EMT6 tumor-bearing mice (a breast tumor model) and protects against tumor rechallenge.

● An anti-IL-38 antibody inhibited tumor growth in the B16.F10 syngeneic mouse model of melanoma and induced immunostimulatory chemokine expression in the tumor microenvironment.

We believe that IM-4320, our lead anti-IL-38 antibody, shows in vivo anti-tumor activity consistent with an active I/O agent.

Our data indicate that IM-4320 selectively binds to IL-38, inhibiting its binding ILRAPL1 and IL-36R.

Furthermore, it inhibited tumor growth in an immune cold melanoma model.

We intend to submit an IND for this program to the FDA subsequent to our anticipated IND submissions for IM-3050 and IM-1021.

We are pursuing a target-driven development strategy intended to establish a broad pipeline of next-generation ADCs focused on oncology indications with high unmet need.

We are working to identify novel or under-explored targets that we believe will enable the development of first-in-class ADCs.

We also are working to identify clinically validated ADC targets for which competitor programs have shown suboptimal efficacy and/or safety, with the goal of advancing best-in-class ADCs against these targets that overcome these limitations.

Our ability to achieve these goals is predicated on our deep understanding of ADC target biology and our ability to deploy a broad toolbox of antibodies, linkers, and payloads in combinations that best match this biology.

Our development process is intended to efficiently advance ADC pipeline candidates through clinical proof-of-concept.

We believe that key steps in this process include:

● Optimize the antibody portion of the ADC for binding and internalization

● Incorporate proven or novel linkers

● Select payloads that provide consistent cytotoxic effects

● Optimize ADC pharmacology for clinical activity

● Enable early go/no-go decisions via well-designed clinical trials

We believe that identifying appropriate targets is a key challenge of ADC development.

One piece of evidence for this is the concentration of current ADC development activity, with 54% of active ADC clinical programs focused on the same ten targets as of November 2023.

We believe there are several downsides to pursuing these targets, including:

● Potential difficulty in overcoming limitations of existing ADCs against these targets due to heterogeneity of target expression on tumor cells and/or the likelihood that changes in payload and/or linker technology will yield only incremental gains in efficacy.

● Challenging development and commercialization pathways

● Lower unmet patient need

Given these downsides, we are systematically evaluating novel targets that we believe will have first-in-class potential using multiple target and antibody sources.

We have already identified more than 30 novel targets through our discovery platform and, subject to satisfaction of the closing terms of the definitive asset purchase agreement with Atreca, Inc., or Atreca, announced December 26, 2023, we will have access to more than 25 additional antibodies that may support the development of ADCs against novel or underexplored targets.

We also screen public and proprietary expression databases to identify other potential targets for ADC development.

Potential targets identified through this systematic approach are evaluated for differential expression on tumor cells compared with normal cells and additional factors.

We believe that our proprietary camptothecin derivative/topoisomerase I inhibitor payload provides a significant opportunity to develop ADCs.

We have exclusively licensed this payload, which is in the same class as another camptothecin derivative (deruxtecan) used in an FDA-approved ADC targeting HER2, from Zentalis.

This proprietary payload is designed to have enhanced ADME properties, including the potential for greater in vivo potency, increased permeability that may lead to superior bystander effects, and faster clearance that may improve tolerability after cleavage.

We have conducted studies in the JIMT-1 breast cancer model demonstrating that a HER2 ADC constructed

with our proprietary payload provided improved activity compared with a deruxtecan-containing HER2 ADC when dosed intravenously weekly for three weeks.

We believe that camptothecin derivatives are well-suited for ADCs targeting solid tumor because they achieve a higher DAR and higher clinical doses.

Additionally, a third-party comparison of two FDA-approved HER2 ADCs that contain the same antibody (trastuzumab) but different payloads showed that percentage of patients with progression-free survival was significantly higher for the ADC containing the camptothecin derivative.

In addition to our portfolio of targets, antibodies, and payloads, we also have access to novel linker technologies under our exclusive worldwide license agreement with Zentalis.

Immunome Discovery Platform

Immunome’s discovery platform provides a proprietary approach to identifying cancer-associated targets.

Although many of these targets are known in scientific literature, many of them were not previously known to be associated with cancer.

The workflow for our discovery platform is as follows:

Patient Sampling :

Our discovery process begins with obtaining a patient’s lymph node, tumor or blood sample and then purifying and expanding the memory B cell population.

In oncology, patients sampled include those who are treatment naïve, treated with standard regimens, or have been treated with immunotherapies.

Patient Response :

We fuse and immortalize thousands of these patient-derived memory B cells using proprietary methods, capturing them as hybridomas, each of which typically express an individual antibody in quantities sufficient for extensive functional screening.

Antibody Screening :

For oncology, we screen individual antibodies by assessing their binding to intact cancer cells or normal cells, or by assessing their binding to a large number of different extracts of authentic tumor samples and cancer cell lines.

Using our proprietary approach, we can screen up to 18,400 antibodies on a single array.

Hybridomas producing antibodies that show both high-affinity binding, by typically binding at single digit nanomolar concentrations, and specific binding, by showing much higher binding to a subset of tumor cells compared to normal cells, are designated as screening “hits.” Hybridomas producing those hits can be sequenced, their immunoglobulin genes can be cloned into expression vectors, and the individual antibodies can then be produced recombinantly.

Antibody Validation:

The next step in our process is to identify the specific antigen to which the antibody appears to bind with high affinity and specificity.

We use one of two complementary approaches for this activity:

method involves an assessment of antibody binding to known human proteins spotted on a protein microarray with high selectivity.

If the target is not represented on the array or no specific binding is seen, we attempt to use the antibody to “pull out” the antigen from its source using immunoprecipitation, and then identify the antigen sequence using mass spectrometry.

Using these two approaches we are largely successful in identifying the antigen to which newly identified antibodies are binding.

We then conduct experiments to assess whether the binding of the antibody to the specific antigen can produce a change in the biology of a cancer cell expressing the target, which we refer to as target validation.

Additional tests, such as measurements of changes in cell growth, cell survival, cell migration, or internalization of the antigen after it has been bound by the antibody, are used to further assess the potential that the antibody could be of therapeutic interest.

Our Management Team

We submitted an IND for this program to the FDA in March 2025, and expect to initiate a Phase 1 clinical trial in the second half of 2025.

We believe that our team’s ADC expertise positions us to develop the next generation of transformative ADCs.

This expertise comprises executive leadership with a proven record of success, an ADC-focused discovery team with deep experience in ADC design, and a seasoned development team whose members spearheaded the development of multiple FDA-approved ADCs.

We pair our portfolio of antibodies to potential first-in-class ADC targets with rigorous target selection based on a deep understanding of target biology.

That target-driven approach is complemented by HC74, our differentiated, proprietary TOP1 inhibitor payload and our optimized, proprietary linkers.

A key challenge to realizing the full potential of ADCs in the treatment of cancer is the disproportionate focus on a small number of targets, with 10 targets accounting for 55% of active clinical ADC programs.

We believe there are several downsides to pursuing these targets.

One downside is the potential difficulty in overcoming limitations of existing ADCs against these targets due to considerations like the heterogeneity of target expression on tumor cells and the likelihood that changes in payload or linker technology will yield only incremental gains in efficacy.

Another is their challenging development and commercialization pathways.

Additionally, with multiple therapies in development against them, these highly prevalent targets provide reduced opportunity to address unmet need — which is an essential component of our mission.

Instead, we are focusing on targets with no approved therapeutics.

A critical challenge in the pursuit of novel or underexplored targets is optimizing the design of the molecule to match target biology.

HC74, our proprietary camptothecin-derived TOP1 inhibitor payload, is designed to address this challenge by supporting development of ADCs for novel targets.

TOP1 inhibitors are DNA-damaging agents and are validated ADC payloads.

ADCs with these payloads generally show greater tolerability and achieve higher doses than earlier ADCs.

For example, a third-party randomized controlled clinical trial found that a HER2-targeted ADC with a TOP1 inhibitor payload, Enhertu, showed a significant progression-free survival benefit compared with a HER2-targeted ADC with an emtansine payload.

Additionally, ADCs containing TOP1 inhibitors have achieved higher DARs and have the ability to achieve higher clinical doses compared to ADCs with microtubule payloads, allowing for potential increased payload delivery.

These attributes may allow for a higher clinical dose of TOP1 inhibitor-containing ADCs, enabling an increased therapeutic index.

In October 2024, we presented preclinical data at the 36th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics demonstrating that, compared to deruxtecan, or DXd, HC74 demonstrated superior potency measured across 89 cell lines while retaining potency in chemotherapy-resistant cell lines.

HC74 also shows increased permeability that may lead to superior bystander effect, reduced efflux that may lead to avoiding certain mechanisms of resistance, and rapid hepatocyte clearance that may improve tolerability.

Our unique combination of ADC expertise, novel targets, proprietary payload, and novel linkers enables us to pursue a differentiated ADC development strategy, which is focused on targets that have no approved ADCs and on indications with substantial unmet need.

We perform extensive expression analyses to understand where and at what levels these targets are expressed and optimize our antibodies for enhanced internalization and tumor localization.

We also prioritize definitive preclinical experiments that enable rapid and financially efficient development.

Executing on this strategy, we have screened more than 1,000 targets, and this effort has to-date yielded more than 40 targets evaluated in vitro and more than 15 targets evaluated in vivo.

This has yielded three novel solid tumor ADCs for which IND-enabling studies are ongoing and six additional ADCs currently undergoing lead optimization.

Continued execution of this ADC development strategy is anticipated to yield multiple new and highly differentiated ADC candidates each year.

IM-1617 (Solid Tumor ADCs)

IM-1617 is a potential first-in-class ADC that targets an undisclosed receptor that is preferentially expressed in a broad array of solid tumors, including colorectal cancer, or CRC, non-small cell lung cancer, or NSCLC, and breast and ovarian cancers.

The target is a receptor tyrosine kinase that promotes tumor cell survival and mediates immune cell exclusion, providing potential for a secondary mechanism of action.

IM-1617 incorporates a proprietary antibody that was selected for attributes that may drive tumor binding while minimizing normal tissue binding;

a cleavable, undisclosed linker;

An initial study in non-human primates, or NHPs, found a highest non-severely toxic dose of 40 mg/kg, indicating a potentially robust therapeutic window.

Preclinical in vivo efficacy studies have shown tumor regression after a single, clinically relevant dose of IM-1617 in tumor models derived from melanoma, esophageal cancer, CRC, NSCLC, and other carcinomas.

IND-enabling work for IM-1617 was initiated in the fourth quarter of 2024.

IM-1340 (Solid Tumor ADCs)

IM-1340 is a potential first-in-class ADC for the treatment of multiple solid tumors.

The target of IM-1340 is underexplored and non-obvious in cancer and, to our knowledge, there are no ADCs or other therapeutic modalities in development against it.

It has a unique expression profile that spans neuroendocrine tumors, or NETs, and other carcinomas, including lung and prostate tumors, with limited expression in normal tissue.

This target is known to promote tumor growth by accelerating proliferation, cell cycle progression, and migration of cancer cells.

Additionally, it is a transport receptor for an endolysomal protease, leading to potential favorable ADC internalization dynamics.

IM-1340 incorporates a proprietary antibody selected for attributes that drive tumor binding while minimizing normal tissue binding;

a cleavable, undisclosed linker;

IM-1340 has shown robust preclinical activity, with evidence of regressions following a single 1 mg/kg dose in in vivo tumor models representing NETs and carcinomas including NSCLC, SCLC, pancreatic cancer, and prostate cancer.

An initial study in NHPs found a highest non-severely toxic dose of 40 mg/kg, indicating potential for a robust therapeutic window.

IND-enabling work for IM-1340 was initiated in the fourth quarter of 2024.

IM-1335 (Solid Tumor ADCs)

IM-1335 is being developed for the treatment of solid tumor indications.

It shares a target with a competitor’s now-discontinued investigational ADC that showed clinical activity prior to discontinuation.

Our goal in designing IM-1335 was to optimize the safety and efficacy through a deep understanding of target biology and ADC optimization.

We identified limitations that we expect contributed to the failure of the prior ADC against this target, and we believe that IM-1335 overcomes these limitations.

Toward this end, the antibody portion of IM-1335 has been designed for improved pharmacokinetic and tumor biodistribution profiles.

IM-1335 also incorporates a linker designed to enhance stability for on-target activity as well as our proprietary HC74 to match drug sensitivity in top indications.

As shown below, IM-1335 shows in vivo preclinical efficacy in a solid tumor indication.

IND-enabling work for IM-1335 was initiated in the fourth quarter of 2024.

Management Team

We are led by Clay Siegall, Ph.D., President and Chief Executive Officer.

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Pfizer purchased Seagen in December 2023.

Siegall joined us in connection with our acquisition of Morphimmune, a preclinical biotechnology company led by Dr.

Siegall joined us in connection with our merger with Morphimmune, a preclinical biotechnology company led by Dr.

Siegall, in October 2023.

In addition to Dr.

Siegall, three members of our current management team joined us from Morphimmune in October 2023.

Jack Higgins, Ph.D., our Chief Scientific Officer, held the same role at Morphimmune.

He was previously the Chief Development Sciences Officer at Molecular Templates, Inc., where he led discovery and development efforts for multiple clinical candidates and co-invented the company’s Engineered Toxin Body platform.

Bruce Turner, MD, Ph.D., our Chief Strategy Officer, held the same role at Morphimmune and previously founded several biotechnology companies including Xanadu Bio, Inc.

and Gennao Bio, Inc.

Max Rosett, our Executive Vice President, Operations, and Interim Chief Financial Officer, served as Acting Chief Operating Officer at Morphimmune.

Rosett previously served as a Principal at Research Bridge Partners, where he led Research Bridge Partners’ investment in Morphimmune’s Series A financing.

Bob Lechleider, M.D.

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Siegall at Seagen, where he was responsible for directing the development of early and late-stage portfolios.

Phil Roberts serves as our Chief Technical Officer.

Roberts previously served as SVP, Technical Operations at Mirati Therapeutics, Inc., where he led the CMC development of Krazati, Mirati’s first approved product.

Jack Higgins, Ph.D., is our Chief Scientific Officer.

Most recently, he was Chief Scientific Officer at Morphimmune.

Previously, he was the Chief Development Sciences Officer at Molecular Templates, Inc., where he led discovery and development efforts for multiple clinical candidates and co-invented the company’s Engineered Toxin Body platform.

Phil Tsai, Ph.D., serves as our Chief Technical Officer.

Prior to joining Immunome, Dr.

Tsai spent 21 years at Seagen and then Pfizer (following the acquisition of Seagen in December 2023) in positions of increasing responsibility.

Most recently, he was the SVP of Technical Development, responsible for end-to-end development of biologics and drug-linker manufacturing processes, analytics, and drug products.

Max Rosett, our Chief Financial Officer, most recently served as Acting Chief Operating Officer at Morphimmune and joined Immunome as Senior Vice President, Operations.

Rosett previously served as a Principal at Research Bridge Partners, where he led Research Bridge Partners’ investment in Morphimmune’s Series A financing.

Sandra Stoneman, J.D., serves as our Chief Legal Officer.

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and spent more than 15 years at Genentech, Inc.

Roee Shahar is our Executive Vice President, Commercial.

Shahar served as Vice President and Franchise Lead for Pfizer, where he managed the combined hematology portfolio resulting from the December 2023 acquisition of Seagen.

Before the acquisition, he served as Vice President and Franchise Lead for Seagen overseeing all commercial activities for hematology.

Strategic Transactions

Acquisition of Assets from Ayala Pharmaceuticals, Inc.

On February 5, 2024, we entered into the Ayala Purchase Agreement with Ayala, pursuant to which we acquired Ayala’s AL101 and AL102 programs and assumed certain of Ayala’s liabilities associated with the acquired assets, or the Ayala Asset Purchase.

The Ayala Asset Purchase closed on March 25, 2024, or the Ayala Closing.

At the Ayala Closing we (i) paid Ayala $20,000,000, less certain adjustments, (ii) issued Ayala 2,175,489 shares of Company common stock, or the Ayala Shares, with the shares valued at the trailing 30-day volume-weighted average price and (iii) assumed specified liabilities.

Pursuant to the Ayala Purchase Agreement, we are obligated to pay Ayala up to $37,500,000 in development and commercial milestones.

No legal entities or employees were acquired from Ayala.

The Ayala Purchase Agreement also provides that until the six-month anniversary of the Ayala Closing, Ayala will hold and not sell 50% of the Ayala Shares, subject to certain exceptions.

Further, Ayala has agreed, subject to certain exceptions, that until the one-year anniversary of the Ayala Closing, any transfer of the Ayala Shares by Ayala that exceed 15% of the average daily trading volume of our stock over the five-trading day period ending on the trading day immediately prior to such trading date shall be made pursuant to a block trade or other disposition through a market participant designated by us.

We have agreed to use our commercially reasonable efforts to (x) file a resale registration statement with the SEC registering the Ayala Shares for resale on or before the date seven days following the earlier of (i) April 1, 2024 and (ii) the date of this Annual Report and (y) cause such resale registration statement to be declared effective as soon as practicable after the filing thereof but no later than 90 calendar days after the filing thereof or by five trading days from when we are notified that the SEC will not review the resale registration statement or that it will not be subject to further review.

In March 2024, we completed an asset purchase, or the Ayala Closing, pursuant to an asset purchase agreement, or the Ayala Purchase Agreement, initially entered into with Ayala in February 2024, pursuant to which we acquired Ayala’s AL101 and varegacestat programs and assumed certain liabilities associated with the acquired assets.

Under the Ayala Purchase Agreement, we paid Ayala approximately $20.0 million in cash and issued 2,175,489 shares of our common stock with an aggregate fair value of $50.6 million on the date of issuance.

We are also obligated to pay Ayala up to $37.5 million in the aggregate upon the achievement of certain development, regulatory and commercial milestones.

Acquisition of Assets from Zentalis Pharmaceuticals, Inc.

In January 2024, we entered into a license agreement with Zentalis, or the Zentalis License Agreement, pursuant to which we received an exclusive, worldwide, royalty-bearing, sublicensable license under certain intellectual property relating to Zentalis’ proprietary ADC platform technology, ROR1 antibodies and ADCs targeting ROR1 to exploit products covered by or incorporating the licensed intellectual property rights, or, collectively, the Zentalis Licensed Assets.

Under the Zentalis License Agreement, we paid Zentalis $15.0 million in cash and issued Zentalis 2,298,586 shares of our common stock with an aggregate fair value of $23.4 million on the date of issuance.

In October 2024, we completed an asset purchase agreement with Zentalis, or the Zentalis Purchase Agreement, pursuant to which we purchased the Zentalis Licensed Assets and the Zentalis License Agreement was terminated.

Under the Zentalis Purchase Agreement, we issued Zentalis 1,805,502 shares of our common stock with an aggregate fair value of $21.0 million on the date of issuance.

We are also obligated to pay Zentalis a one-time payment of $5.0 million in cash upon the achievement of a developmental milestone that was previously a milestone under the Zentalis License Agreement.

The $5.0 million developmental milestone was achieved in the fourth quarter of 2024 and paid in the first quarter of 2025.

Merger with Morphimmune

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In connection with the Merger, on October 2, 2023, we issued and sold 21,690,871 shares of our common stock pursuant to the subscription agreements in a private investment in public equity, or PIPE, transaction which provided us with gross proceeds of $125.0 million.

Acquisition of Assets from Atreca, Inc.

On December 22, 2023, we entered into an asset purchase agreement with Atreca, pursuant to which we will acquire certain antibody-related assets and materials for an upfront payment of $5.5 million and up to $7.0 million in clinical development milestones.

The closing of the transaction is subject to customary conditions, including the approval of Atreca’s stockholders.

We expect the closing to occur in the second quarter of 2024.

Strategic Collaborations, License Agreements and Other Material Agreements

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In connection with the Ayala Closing, we assumed the License Agreement dated as of November 29, 2017, with BMS, as amended by that certain First Amendment to License Agreement dated as of May 4, 2020, or the BMS License.

Under the BMS License, BMS has granted us a worldwide, non-transferable, exclusive, sublicensable license under certain patent rights and know-how controlled by BMS to research, discover, develop, make, have made, use, sell, offer to sell, export, import and commercialize AL101 and AL102, or the BMS Licensed Compounds, and products containing AL101 or AL102, or the BMS Licensed Products, for all uses including the prevention, treatment or control of any human or animal disease, disorder or condition.

Following the closing of the Ayala Purchase Agreement on August 7, 2024, we entered into Amendment No.

2 to the BMS License Agreement, or the BMS License Agreement Amendment.

As consideration to BMS for entering into the BMS License Agreement Amendment, we issued BMS 230,415 unregistered shares of our common stock at an aggregate fair value of $2.7 million on the date of issuance.

Under the BMS License, BMS granted us a worldwide, non-transferable, exclusive, sublicensable license under certain patent rights and know-how controlled by BMS to research, discover, develop, make, have made, use, sell, offer to sell, export, import and commercialize AL101 and varegacestat, or the BMS Licensed Compounds, and products containing AL101 or varegacestat, or the BMS Licensed Products, for all uses including the prevention, treatment or control of any human or animal disease, disorder or condition.

Under the BMS License, we are obligated to use commercially reasonable efforts to develop at least one BMS Licensed Product.

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We are obligated to pay BMS up to approximately $142 million in the aggregate upon the achievement of certain clinical development and regulatory milestones by products containing the BMS Compounds.

Furthermore, we are obligated to pay up to $50 million per BSM Licensed Product containing a BMS Compound upon the achievement of certain commercial milestones for that product.

Furthermore, we are obligated to pay up to $50 million per BMS Licensed Product containing a BMS Compound upon the achievement of certain commercial milestones for that product.

In addition, we are obligated to pay BMS tiered royalties ranging from a high single-digit to a low teen percentage on worldwide net sales of all BMS Licensed Products.

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In exchange for such license, BMS must pay us a low single-digit percentage royalty on net sales of the BMS Licensed Compounds and/or BMS Licensed Products by it or its affiliates, licensees or sublicensees, provided that the termination occurred after a specified developmental milestone for such BMS Licensed Compounds and/or BMS Licensed Products.

Zentalis License Agreement

In January 2024, we entered into the Zentalis License Agreement with Zentalis, pursuant to which we received an exclusive, worldwide, royalty-bearing, sublicensable license under certain intellectual property relating to Zentalis’ proprietary ADC platform technology, ROR1 antibodies and ADCs targeting ROR1 to exploit products covered by or incorporating the licensed intellectual property rights.

Under the Zentalis License Agreement, we are required to use commercially reasonable efforts to develop an ADC targeting ROR1, two additional ADCs, and commercialize any product that receives regulatory approval.

Under the Zentalis License Agreement, we paid to Zentalis upfront consideration totaling $15 million in cash and $20 million in shares of our common stock, with the shares valued at the trailing 30-day volume-weighted average price.

We are obligated to pay Zentalis an aggregate of up to $150 million in development and regulatory milestones on the first product containing an ADC targeting ROR1, or a ROR1 ADC Product, to achieve such milestones and commercial milestones on ROR1 ADC Products.

We are also obligated to pay to Zentalis mid-to-high single digit royalties on ROR1 ADC Products.

In addition, we are obligated to pay Zentalis $25 million in development and regulatory milestones for the first product from each of the first five additional development programs using the licensed platform technology to generate products, and mid-single digit royalties on products from each such program.

Our royalty payment obligation will commence, on a product-by-product and country-by-country basis, on the first commercial sale of such product in such country and will expire on the latest of (a) the ten (10)-year anniversary of such first commercial sale for such product in such country, (b) the expiration of regulatory exclusivity for such product in such country, and (c) the expiration of the last-to-expire valid claim of a licensed patent covering such product in such country.

The Zentalis License Agreement will continue until the expiration of all royalty payment obligations.

The Zentalis License Agreement may be terminated early by (a) either party in its entirety upon (i) the other party’s uncured material breach, subject to a notice and cure period, (ii) any insolvency event of the other party or (iii) prolonged force majeure, (b) us, either in its entirety or in part, for convenience upon a specified period prior written notice, or (c) Zentalis (i) in its entirety if we challenge one of the licensed patents or (ii) fail to meet certain development activity benchmarks within specified time periods.

Collaboration with AbbVie

On January 4, 2023, we entered into a collaboration and option agreement, or the Collaboration Agreement, with AbbVie Global Enterprises Ltd., or AbbVie, pursuant to which we will use our discovery platform to discover and

validate targets derived from patients with three specified tumor types, and antibodies that bind to such targets, which may be the subject of further development and commercialization by AbbVie.

The research term is at least 66 months, subject to extension in certain circumstances by specified extension periods.

Pursuant to the terms of the Collaboration Agreement, with respect to each novel target-antibody pair that we generate that meets certain mutually agreed criteria (each, a Validated Target Pair or VTP), we granted to AbbVie an exclusive option (up to a maximum of 10 in total) to purchase all rights in and to such Validated Target Pair, for all human and non-human diagnostic, prophylactic and therapeutic uses throughout the world, including without limitation the development and commercialization of certain products derived from the assigned Validated Target Pair and directed to the target comprising such VTP (Products).

No rights are granted by us to AbbVie under any of our technology covering our discovery platforms.

Until the expiration of the research term, we are not permitted to conduct any activities in connection with targets or antibodies derived from patients with the specified tumor types, whether independently or with other third parties, except in limited circumstances with respect to certain target-antibody pairs that are no longer subject to the collaboration with AbbVie.

In addition, during the term of the Collaboration Agreement, we are not permitted to develop products directed to targets that are included in VTPs purchased by AbbVie, or to which AbbVie still has rights under the Collaboration Agreement, whether independently or with other third parties.

Under the Collaboration Agreement, AbbVie paid us an upfront payment of $30.0 million, and will make certain additional platform access payments in the aggregate amount of up to $70.0 million based on our use of our discovery platform in connection with activities under each stage of the research plan, and delivery of VTPs to AbbVie.

AbbVie will also pay an option exercise fee in the low single digit millions for each of the up to 10 VTPs for which it exercises an option.

If AbbVie progresses development and commercialization of a Product, AbbVie will pay us development and first commercial sale milestones of up to $120.0 million per target, and sales milestones based on achievement of specified levels of net sales of Products of up to $150.0 million in the aggregate per target, in each case, subject to specified deductions in certain circumstances.

On a Product-by-Product basis, AbbVie will pay us tiered royalties on net sales of Products at a percentage in the low single digits, subject to specified reductions and offsets in certain circumstances.

AbbVie’s royalty payment obligation will commence, on a Product-by-Product and country-by-country basis, on the first commercial sale of such Product in such country and will expire on the earlier of (a) (i) the ten (10)-year anniversary of such first commercial sale for such Product in such country, or (ii) solely with respect to a Product that incorporates an antibody comprising a VTP (or certain other antibodies derived from such delivered antibody), the expiration of all valid claims of patent rights covering the composition of matter of any such antibody (whichever out of (i) or (ii) is later), and (b) the expiration of regulatory exclusivity for such Product in such country.

We are potentially eligible to receive up to $2.8 billion from AbbVie under the Collaboration Agreement from the sources described above.

The Collaboration Agreement will expire upon the expiration of the last to expire royalty payment obligation with respect to all Products in all countries, subject to earlier expiration if all option exercise periods for all Validated Target Pairs expire without AbbVie exercising any option.

In addition, the research term will terminate if AbbVie does not elect to make certain platform access payments at specified points during the research term, in order for the Company to continue the target discovery activities under the collaboration.

The Collaboration Agreement may be terminated by (a) either party upon the other party’s uncured material breach, or upon any insolvency event of the other party, (b) AbbVie for convenience upon a specified period prior written notice, or (c) AbbVie for the Company’s breach of representations and warranties with respect to debarment or compliance with anti-bribery and anti-corruption laws.

If AbbVie has the right to terminate the Collaboration Agreement for our uncured material breach or a breach of representations and warranties with respect to debarment or compliance with anti-bribery and anti-corruption laws, AbbVie may elect to continue the Collaboration Agreement, subject to certain specified reductions applicable to certain of AbbVie’s payment obligations (with a specified floor on such reductions).

Whitehead Patent License Agreement

In June 2009, we entered into an exclusive patent license agreement, or the Whitehead Agreement, with the Whitehead Institute for Biomedical Research, or Whitehead, and the Massachusetts Institute of Technology, or MIT, as licensing agent for Whitehead, pursuant to which we obtained from MIT and Whitehead a royalty-bearing exclusive license under certain patent rights of Whitehead and a royalty-bearing non-exclusive license under certain biological and chemical material of Whitehead that relate to our discovery platform.

The foregoing license recently expired in accordance with its terms.

On November 17, 2022, we entered into a Letter Agreement, or Letter Agreement, with Whitehead, which became effective on January 4, 2023, upon the satisfaction of the conditions described therein.

The Letter Agreement supplements the Whitehead Agreement.

Pursuant to the Letter Agreement, certain payments received by us from the Collaborator (as defined in the Letter Agreement) (i.e., a corporate partner, as defined in the License Agreement) would be excluded from our payment obligations to Whitehead.

Further, we will make certain payments to Whitehead (i) as Net Sales (as defined in the License Agreement) as long as we receive those payments from the Collaborator on a specified number of products purchased by the Collaborator and (ii) upon the achievement of certain milestones whether by us or the Collaborator.

License Agreement with Purdue Research Foundation

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Under the Purdue License Agreement, Morphimmune paid PRF a one-time upfront payment of $200,000 upon execution and $100,000 on each of the first and second anniversary of the effective date of the Purdue License Agreement.

During the period commencing on the date of first commercial sale of a licensed product and ending upon the date of expiration of the last valid claim of the licensed patents covering such licensed product in a country, referred to as the royalty term, Morphimmune will pay PRF an earned unit royalty of a low single-digit percentage on gross receipts from sale of the licensed product, and beginning with the first sale of a licensed product, a tiered minimum annual royalty from the low to mid six-digit figure range less the unit royalties due for the annual period.

Upon the achievement of specified development and commercialization milestones, Morphimmune will pay PRF the milestone payments as specified in the Purdue License Agreement, which may be up to $3.75 million in the aggregate.

Morphimmune is also required to pay PRF an annual maintenance fee ranging from a low five-digit figure to a low six-digit figure prior to first sale of a licensed product and a low double-digit percentage of sublicense income received for sublicenses of licensed intellectual property, with such percentage depending upon the timing of execution of the sublicense.

During the period commencing on the date of first commercial sale of a licensed product and ending upon the date of expiration of the last valid claim of the licensed patents covering such licensed product in a country, referred to as the royalty term, we will pay PRF an earned unit royalty of a low single-digit percentage on gross receipts from sale of the licensed product, and beginning with the first sale of a licensed product, a tiered minimum annual royalty from the low to mid six-digit figure range less the unit royalties due for the annual period.

Upon the achievement of specified development and commercialization milestones, we will pay PRF the milestone payments as specified in the Purdue License Agreement, which may be up to $3.75 million in the aggregate.

We are also required to pay PRF an annual maintenance fee ranging from a low five-digit figure to a low six-digit figure prior to first sale of a licensed product and a low double-digit percentage of sublicense income received for sublicenses of licensed intellectual property, with such percentage depending upon the timing of execution of the sublicense.

The Purdue License Agreement expires on a licensed product-by-licensed product and country-by-country basis, upon expiration of the royalty term for such licensed product for the applicable country.

Morphimmune may terminate the Purdue License Agreement upon at least one month’s prior written notice to PRF.

PRF may terminate the Purdue License Agreement and the licenses granted thereunder if Morphimmune fails to cure a payment default or other material breach of the Purdue License Agreement after written notice from PRF, or if Morphimmune becomes insolvent.

We may terminate the Purdue License Agreement upon at least one month’s prior written notice to PRF.

PRF may terminate the Purdue License Agreement and the licenses granted thereunder if we fail to cure a payment default or other material breach of the Purdue License Agreement after written notice from PRF, or if we become insolvent.

Manufacturing

For certain early research and development activities, we may produce materials at the laboratory scale necessary to support those activities.

For other early-stage activities and for all later stage work, such as IND-enabling studies and safety assessment and clinical assessment, we use third-party manufacturers to produce necessary antibodies, linkers, payloads, ADCs, small molecules, and, in the case of radioligand therapies, cold and chelated forms of the compound.

We use third-party manufacturers to produce all materials (including intermediates or reagents) necessary to advance our four named programs.

We do not have, and we do not currently plan to acquire or develop the infrastructure, facilities or capabilities to conduct these manufacturing activities ourselves.

We intend to continue to utilize third-party

manufacturers to produce, package, label, test and release product for clinical and non-clinical testing and for future commercial use, as needed.

For other early-stage activities and for all later stage work, such as IND-enabling studies and safety assessment and clinical assessment, we use third-party manufacturers to produce antibodies, linkers, payloads, ADCs, small molecules, and, in the case of radioligand therapies, cold and chelated forms of the compound.

We use third-party manufacturers to produce all materials (including intermediates or reagents) necessary to advance our six named programs.

We do not have facilities or capabilities to conduct these manufacturing activities ourselves.

We intend to continue to utilize third-party manufacturers to produce, package, label, test and release product for clinical and non-clinical testing and for future commercial use, as needed.

We expect to continue to rely on such third parties to manufacture our products for the foreseeable future.

Our expected future contractual manufacturing organizations will each have successful track records of producing products for other companies under applicable compliance regulations, such as cGMP compliance in the case of the FDA.

We expect our future contractual manufacturing organizations to have successful track records of producing products for other companies under applicable compliance regulations, such as cGMP compliance in the case of the FDA.

The development and commercialization of new product candidates is highly competitive.

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We expect to compete with oncology companies advancing antibodies, ADCs, small molecules, targeted radiotherapies, and other therapeutic modalities.

We are aware of competitors who are pursuing antibody-based discovery approaches, including, but not limited to, AbCellera Biologics, Inc.;

Adaptive Biotechnologies Corporation, or Adaptive;

AIMM Therapeutics B.V.;

IGM Biosciences, Inc.;

and OncoReponse, Inc.

We also expect to compete with companies pursuing targeted radiotherapies, including, but not limited to, RayzeBio, Fusion Pharmaceuticals, POINT Biopharma, Aktis Oncology, Actinium Pharmaceuticals, and Yantai LNC Biotechnology.

In addition, we expect to compete with large, multinational pharmaceutical companies that discover, develop and commercialize antibodies, ADCs, small molecules, targeted radiotherapies, and other therapeutics for use in treating cancer such as Immunogen (acquired by AbbVie Inc.), AstraZeneca;

Bayer AG, BMS;

We are aware of competitors who are developing ADCs, including, but not limited to, ADC Therapeutics SA, Ipsen SA, Exelexis, Inc., and Zymeworks Inc.

and competitors based overseas, including, but not limited to, Hansoh Pharmaceutical Group, Ltd., Jiangsu Hengrui Pharmaceuticals Company Ltd.

and LaNova Medicines.

We also expect to compete with companies pursuing targeted radiotherapies, including, but not limited to, RayzeBio, (acquired by BMS), Fusion Pharmaceuticals (acquired by AstraZeneca), Point Biopharma (acquired by Eli Lilly and Company), Aktis Oncology, Actinium Pharmaceuticals, and Yantai LNC Biotechnology.

Daiichi Sankyo;

Eli Lilly and Company;

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If any future product candidates identified through our current lead programs are eventually approved for sale, they will likely compete with a range of treatments that are either in development or currently marketed for use in those same disease indications.

With respect to AL102, we expect to compete with companies advancing treatment of desmoid tumors, including but not limited to, SpringWorks Therapeutics, Inc.

In November 2023, Springworks received FDA approval for its oral gamma secretase inhibitor, OGSIVEO ® (nirogacestat), for the treatment of adult patients with progressing tumors who require systemic treatment.

With respect to varegacestat, we expect to compete with companies advancing treatments for desmoid tumors, including, but not limited to, SpringWorks Therapeutics, Inc.

In November 2023, Springworks received FDA approval for its oral gamma secretase inhibitor, OGSIVEO ® (nirogacestat), for the treatment of adult patients with progressing desmoid tumors who require systemic treatment.

Desmoid tumors treatments also include surgery, hormonal therapy, targeted therapy and chemotherapy.

There are several other companies developing FAP-targeted radioligand therapies which may represent the most direct competition to our IM-3050 program.

Novartis is advancing a FAP-targeted radioligand therapy (177Lu-FAP-2286) that was acquired from Clovis Oncology and is currently in Phase 1/2.

In December 2023, Eli Lilly and Company acquired POINT Biopharma, which is developing a FAP-targeted radioligand therapy (PNT2004) that is currently in Phase 1.

Yantai LNC Biotechnology has also initiated a Phase 1 trial for another FAP-targeted radioligand therapy (LNC1004.) Additionally, our IM-3050 program faces competition from competitors who may have superior access to a consistent supply of radioactive isotopes.

In January 2023, we exclusively licensed a preclinical ROR1 ADC program from Zentalis with the potential to address hematologic and solid tumor indications.

There are several other companies developing antibodies, ADCs, and CAR-T therapies targeting ROR1, and they may represent the most direct competition to our ROR1 ADC program.

We believe that IM-1021, our preclinical ROR1 ADC program, has the potential to address hematologic and solid tumor indications.

There are several other companies developing antibodies, ADCs, and targeting ROR1, and they may represent the most direct competition to our ROR1 ADC program.

Merck has an ADC program (zilovertamab vedotin) in a Phase 3 clinical trial for B-cell lymphoma.

CStone Pharaceuticals, Inc.

CStone Pharmaceuticals , Inc.

has an ADC program in a Phase I trial.

Companies advancing clinical ROR1-CAR T therapy programs include Octernal Therapeutics (ONCT-808) in a Phase 1/2 in B-cell malignancies, and Lyell Immunopharma (LYL797) in a Phase 1 trial.

Many of our competitors have significantly greater financial resources and expertise in research and development, manufacturing, preclinical studies, conducting clinical studies, obtaining regulatory approvals and marketing approved

products than we have.

CSPC Pharmaceutical Group Limited and Radiance Biopharma have received clearance from Chinese regulatory authority clearance to initiate clinical trials for SYS6005, a ROR1 ADC.

There are several other companies developing FAP-targeted radioligand therapies which may represent the most direct competition to our IM-3050 program.

Novartis is advancing a FAP-targeted radioligand therapy (177Lu-FAP-2286) that was acquired from Clovis Oncology and is currently in Phase 2.

Yantai LNC Biotechnology has also initiated a Phase 1 trial for another FAP-targeted radioligand therapy (LNC1004).

Additionally, our IM-3050 program faces competition from competitors who may have superior access to a consistent supply of radioactive isotopes.

These competitors also compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical study sites and patient registration for clinical studies, as well as in acquiring technologies complementary to, or necessary for, our programs.

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Intellectual property is of vital importance in our field and in biotechnology generally.

We seek to protect and enhance proprietary technology, inventions, and improvements that are commercially important to the development of our business by seeking, maintaining, and defending patent rights, whether developed internally, acquired or licensed from third parties.

We seek to protect and enhance proprietary technology, inventions, and improvements that are important to the advancement of our pipeline and growth of our business by seeking, maintaining, and defending patent rights, whether developed internally, or acquired or licensed from third parties.

We will also seek to rely on regulatory protection afforded through orphan drug designations, inclusion in expedited development and review, data exclusivity, market exclusivity and patent term extensions where available.

We utilize various types of intellectual property assets to provide multiple layers of protection.

For example, we seek a variety of patents to protect our inventions including, for example, compositions of matter and uses in treatment and diagnostic and methods for novel antibodies, including methods of treatment for diseases expressing novel targets.

For example, we seek a variety of patents to protect our inventions including coverage areas such as compositions of matter and uses in treatment and diagnostic and methods for novel antibodies, including methods of treatment for diseases expressing novel targets.

We believe our current layered patent estate, together with our efforts to develop and patent next generation technologies, provides us with substantial intellectual property protection.

As of March 28, 2024, we own or exclusively in-license (a) 139 issued or granted patents, including 6 issued U.S.

patents, 74 EP validations, 2 Australian patents, 2 Canadian patents, 2 Chinese patents, 3 Indian patents, 2 Japanese patents, and 2 Korean patents;

(b) 3 pending U.S.

provisional patent applications;

(d) 19 pending U.S.

non-provisional patent applications;

and (e) 148 pending foreign patent applications, including 10 in Australia, 12 in Canada, 12 in China, 15 in Europe, 7 in India, 11 in Japan and 10 in Korea, all across 24 patent families, covering our IM-4320 (IL-38), IM-1021 (ROR1), IM-3050 (FAP), AL102 and AL101 product candidates.

Our portfolio includes issued and/or pending claims directed to the composition of matter and methods of use for IM-4320, IM-1021, IM-3050, AL102 and AL101.

Patent applications covering IM-4320, if issued, are expected to expire between 2040 and 2042, absent any patent term extensions or adjustments and without accounting for terminal disclaimers.

Patent applications covering IM-1021, if issued, are expected to expire in 2042, absent any patent term extensions or adjustments and without accounting for terminal disclaimers.

As of December 31, 2024, we own or exclusively in-license 141 issued or granted patents and 117 pending applications on a world-wide basis (including major commercial and manufacturing jurisdictions of the United States, Europe, Japan and China) covering our varegacestat, IM-1021, IM-3050, IM-1617, IM-1340 and IM-1335 product candidates.

The US composition of matter patent covering varegacestat will expire in 2038, which includes 5 years of expected patent term extension.

Patent applications covering varegacestat and various derivatives, if issued, are expected to expire between 2033-2045, absent any patent term extensions or adjustments and without accounting for terminal disclaimers.

Patent or Patent applications covering IM-1021, if issued, are expected to expire in 2045, absent any patent term extensions or adjustments and without accounting for terminal disclaimers.

Patent applications covering IM-3050, if issued, are expected to expire in 2045, absent any patent term extensions or adjustments and without accounting for terminal disclaimers.

The US composition of matter patent covering AL102 will expire in 2038, which includes 5 years of expected patent term extension.

Patent applications covering AL102 and various derivatives, if issued, are expected to expire between 2033-2043, absent any patent term extensions or adjustments and without accounting for terminal

The US composition of matter patent covering AL-101 will expire in 2037, which includes 5 years of expected patent term extension;

patent applications covering AL-101, if issued, are expected to expire between 2032-2042, absent any patent term extensions or adjustments and without accounting for terminal disclaimers.

Patent applications covering IM-1617, IM-1340 and IM-1335 will expire in 2045 absent any patent term extensions or adjustments and without accounting for terminal disclaimers.

We recognize that the area of patent and other intellectual property rights in biotechnology is an evolving one with many risks and uncertainties, which may affect the validity, enforceability and expiration of the aforementioned patents and patent applications.

Our commercial success will depend in significant part upon obtaining and maintaining patent protection and trade secret protection for our targeted therapeutics and the methods used to develop and manufacture them, as well as successfully defending these patents against third-party challenges and operating without infringing on the proprietary rights of others.

Our ability to obtain and maintain patent protection and/or trade secret protection for our targeted therapeutics and the methods used to develop and manufacture them, as well as successfully defending these patents against third-party challenges and operating without infringing on the proprietary rights of others.

Our ability to stop third parties from making, using, selling, offering to sell or importing our products depends on the extent to which we have rights under valid and enforceable patents or trade secrets that cover these activities.

We cannot be sure that patents will be granted with respect to any of our pending patent applications or with respect to any patent applications filed by us in the future, nor can we be sure that any of our existing patents, or any patents granted to us in the future will be commercially useful in protecting our targeted therapeutics, current programs and processes.

For this and more comprehensive risks related to our intellectual property, please see the section titled “Risk Factors — Risks Related to Our Intellectual Property.”

We cannot be sure that patents will be granted with respect to the subject matter of our pending patent applications or with respect to any patent applications filed by us in the future, nor can we be sure that any of our existing patents, or any patents granted to us in the future, will be commercially useful in protecting our targeted therapeutics, current programs and processes.

The term of individual patents depends upon the legal term of the patents in the countries in which they are obtained.

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provisional or non-provisional application, and to designate all of the 157 PCT contracting states in which national phase patent applications can later be pursued based on the PCT application.

The PCT International Searching Authority performs a patentability search and issues a non-binding

patentability opinion which can be used to evaluate the chances of success for the national applications in foreign countries prior to having to incur the filing fees.

The PCT International Searching Authority performs a patentability search and issues a non-binding patentability opinion which can be used to evaluate the chances of success for the national applications in foreign countries prior to having to incur the filing fees.

Although a PCT application does not issue as a patent, it allows the applicant to establish a patent application filing date in any of the member states and then seek patents through later-filed national-phase applications.

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Any patents that we hold may be challenged, circumvented or invalidated by third parties.

When available to expand market exclusivity, we may also obtain, or license additional patented intellectual property related to current or future technology and/or programs.

In addition to patent protection, we also rely on trademark registration, trade secrets, know-how, other proprietary information and/or continuing technological innovation to develop and maintain our competitive position.

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Our breach of any license agreements or our failure to obtain a license to proprietary rights required to develop or commercialize our future products may have a material adverse impact on us.

If third parties prepare and file patent

applications in the United States that also claim technology to which we have rights, we may have to participate in interference or derivation proceedings in the USPTO to determine priority of invention.

When available to expand market exclusivity, our strategy is to obtain, or license additional intellectual property related to current or contemplated development platforms, core elements of technology and/or programs and targeted therapeutics.

For more information regarding the risks related to our intellectual property, see the section titled “Risk Factors — Risks Related to Our Intellectual Property.”

If third parties prepare and file patent applications in the United States that also claim technology to which we have rights, we may have to participate in interference or derivation proceedings in the USPTO to determine priority of invention.

Government Regulation

The FDA and other regulatory authorities at federal, state, and local levels, as well as in foreign countries, extensively regulate, among other things, the research, development, testing, manufacture, quality control, import, export, safety, effectiveness, labeling, packaging, storage, distribution, record keeping, approval, advertising, promotion, marketing, post-approval monitoring, and post-approval reporting of drugs and biologics.

We, along with our third-party contractors, will be required to navigate the various preclinical, clinical and commercial approval requirements of the governing regulatory agencies of the countries in which we wish to conduct studies or seek approval or licensure of our programs and development candidates.

Government Regulation of Biological Products

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Failure to comply with the applicable U.S.

requirements may subject an applicant to administrative or judicial sanctions, such as FDA refusal to approve pending new drug applications, or NDAs, or biologics license applications, or BLAs, or the agency's issuance of warning letters, or the imposition of fines, civil penalties, product recalls, product seizures, total or partial suspension of production or distribution, injunctions and/or criminal prosecution brought by the FDA and the U.S.

requirements may subject an applicant to administrative or judicial sanctions, such as FDA refusal to approve pending NDAs or BLAs, or the agency's issuance of warning letters, or the imposition of fines, civil penalties, product recalls, product seizures, total or partial suspension of production or distribution, injunctions and/or criminal prosecution brought by the FDA and the U.S.

Department of Justice or other governmental entities.

Nonclinical and Clinical Development

Nonclinical studies include laboratory evaluation of product chemistry and formulation and may involve in vitro testing or in vivo animal studies to assess the potential for toxicity, adverse events, and other safety characteristics of the program or development candidate, and in some cases to establish a rationale for therapeutic use.

Nonclinical studies include laboratory evaluation of product chemistry and formulation and may involve in vitro testing or in vivo animal studies to assess the potential for toxicity, adverse events, and other safety characteristics of the program or product candidate, and in some cases to establish a rationale for therapeutic use.

The conduct of nonclinical studies is subject to federal regulations and requirements, including good laboratory practice regulations for safety/toxicology studies.

The sponsor must submit the results of the preclinical studies, together with manufacturing information, analytical data, any available clinical data or literature and a proposed clinical protocol, as well as other information, to the FDA as part of the IND application.

The sponsor must submit the results of the nonclinical studies, together with manufacturing information, analytical data, any available clinical data or literature and a proposed clinical protocol, as well as other information, to the FDA as part of the IND application.

Some long-term nonclinical testing as well as manufacturing process development and product quality evaluation, continues after the IND is submitted.

Human clinical trials in support of an NDA or BLA

Prior to beginning the first clinical trial with a program or development candidate, the sponsor must submit an IND to the FDA.

The central focus of an IND submission is on the general investigational plan and the protocol(s) for clinical trials.

Prior to beginning the first clinical trial with a product candidate, the sponsor must submit an IND to the FDA.

An IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises concerns or questions related to the proposed clinical trial and places the IND on a clinical hold.

In such a case, the IND sponsor must resolve all outstanding concerns or questions posed by the FDA before the clinical trial can begin.

Submission of an IND therefore may not result in FDA authorization to begin a clinical trial.

Clinical trials involve the administration of the investigational product to human subjects under the supervision of qualified investigators in accordance with Good Clinical Practices, or GCPs, which include the requirement that all research subjects provide their informed consent for their participation in any clinical study.

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Sponsors of clinical trials of certain FDA-regulated products must register and disclose certain clinical trial information to a public registry maintained by the National Institutes of Health, or NIH.

In particular, information related to the investigational product, patient population, phase of investigation, trial sites and investigators and other aspects of the clinical trial is made public as part of the registration of the clinical trial.

Although sponsors are also obligated to disclose the results of their clinical trials after completion, disclosure of the results can be delayed in some cases for up to two years after the date of completion of the trial.

Failure to timely register a covered clinical study or to submit study results as provided for in the law can give rise to civil monetary penalties and also prevent the non-compliant party from receiving future grant funds from the federal government.

Failure to timely register an applicable clinical trial or to submit study results as provided for in the law can give rise to civil monetary penalties and also prevent the non-compliant party from receiving future grant funds from the federal government as well as prevent publication of the results in a scholarly journal.

For purposes of NDA or BLA approval, human clinical trials are typically conducted in three sequential phases that may overlap.

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Additionally, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the candidate does not undergo unacceptable deterioration over its shelf life.

BLA Submission and Review

BLA and NDA Submission and Review

Assuming successful completion of all required testing in accordance with all applicable regulatory requirements, the results of product development, nonclinical studies and clinical trials, along with information relating to the product’s chemistry, manufacturing, and controls and proposed labeling, are submitted to the FDA as part of an NDA or BLA requesting approval to market the product for one or more indications.

An NDA or BLA must contain sufficient evidence of the candidate’s safety, purity, potency and efficacy for its proposed indication or indications.

Data may come from company-sponsored clinical trials or from a number of alternative sources, including studies initiated by investigators.

To support marketing approval, the data submitted must be sufficient in quality and quantity to establish the safety and efficacy of the investigational product to the satisfaction of the FDA.

The testing and approval processes require substantial time and effort and there can be no assurance that the FDA will accept the NDA or BLA for filing and, even if filed, that any approval will be granted on a timely basis, if at all.

To support marketing approval, the data submitted must be sufficient in quality and quantity to establish the safety and efficacy of the investigational drug (or safety, purity and potency of the investigational biologic product) to the satisfaction of the FDA.

Under the Prescription Drug User Fee Act, as amended, or PDUFA, each NDA or BLA must be accompanied by a significant user fee, and the sponsor of an approved application is also subject to an annual program fee.

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Once the submission is accepted for filing, the FDA begins an in-depth substantive review.

The FDA reviews BLA to determine, among other things, whether the proposed product is safe, pure, and potent for its intended use, and whether the facility (or facilities) in which it is manufactured, processed, packed, or held meets standards designed to assure the product’s continued safety, purity and potency.

The FDA reviews an NDA to determine, among other things, whether a product is safe and effective for its intended use and whether its manufacturing is current good manufacturing practice, or cGMP-compliant to assure and preserve the product's identity, strength, quality and purity.

Most such applications are meant to be reviewed within ten months from the date they are accepted for filing, and most applications for “priority review” products are meant to be reviewed within six months from the date the application is accepted for filing.

The review process may be extended by the FDA for three additional months to consider new information or in the case of a clarification provided by the applicant deemed a major amendment to the application.

The FDA likely will re-analyze the clinical trial data, which could result in extensive discussions between the FDA and the applicant during the review process.

The FDA may refer applications for novel products or products that present difficult questions of safety or efficacy to an advisory committee, typically a panel that includes clinicians and other experts, for review, evaluation and a recommendation as to whether the application should be approved and under what conditions.

The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making final decisions on approval.

Before approving an NDA or BLA, the FDA will typically inspect the facility or facilities where the product is manufactured.

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Additionally, the FDA will typically inspect one or more clinical trial sites to assure that the clinical trials were conducted in compliance with good clinical practices, or GCP.

To assure cGMP and GCP compliance, an applicant must incur significant expenditure of time, money and effort in the areas of training, record keeping, production, and quality control.

After the FDA evaluates an NDA or BLA and conducts inspections of manufacturing facilities where the investigational product and/or its drug substance will be produced, the FDA may issue an approval letter or a Complete Response Letter, or CRL.

To assure cGMP and cGCP compliance, an applicant must incur significant expenditure of time, money and effort in the areas of training, record keeping, production, and quality control.

The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making final decisions on approval.

After the FDA evaluates an NDA or BLA and conducts inspections of manufacturing facilities where the investigational product and/or its drug substance will be produced and/or clinical trial sites where appropriate, the FDA may issue an approval letter or a Complete Response Letter, or CRL.

An approval letter authorizes commercial marketing of the product with specific prescribing information for specific indications.

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For example, the FDA may approve the product with a risk evaluation and mitigation strategy, or REMS, to ensure the benefits of the product outweigh its risks and to assure the safe use of the drug or biological product.

A REMS is a safety strategy to manage a known or potential serious risk associated with a product and to enable patients to have continued access to such medicines by managing their safe use, and could include medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools.

The FDA determines the requirement for a REMS, as well as the specific REMS provisions, on a case-by-case basis.

If the FDA concludes a REMS is needed, the sponsor of the NDA or BLA must submit a proposed REMS.

The FDA will not approve the application without a REMS, if required.

The FDA also may condition approval on, among other things, changes to proposed labeling (e.g., the addition of specific contraindications, warnings or precautions) or the development of adequate controls and specifications.

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Fast Track, Breakthrough Therapy and Priority Review Designations

The FDA is authorized to designate certain products for expedited development or review if they are intended to address an unmet medical need in the treatment of a serious or life-threatening disease or condition.

These programs include fast track designation, breakthrough therapy designation and priority review designation.

To be eligible for a fast track designation, the FDA must determine, based on the request of a sponsor, that a product is intended to treat a serious or life-threatening disease or condition and demonstrates the potential to address an unmet medical need for such diseases or condition.

Fast track designation provides opportunities for more frequent interactions with the FDA review team to expedite development and review of the product.

The FDA may also review

sections of the NDA or BLA for a fast track product on a rolling basis before the complete application is submitted, if the sponsor and the FDA agree on a schedule for the submission of the application sections and the sponsor pays any required user fees upon submission of the first section of the application.

In addition, fast track designation may be withdrawn by the sponsor or rescinded by the FDA if the designation is no longer supported by data emerging from the clinical trial process.

The FDA may also review sections of the NDA or BLA for a fast track product on a rolling basis before the complete application is submitted, if the sponsor and the FDA agree on a schedule for the submission of the application sections and the sponsor pays any required user fees upon submission of the first section of the application.

In addition, fast track designation may be withdrawn by the sponsor or rescinded by the FDA if the product no longer meets the qualifying criteria of fast track designation.

In addition, the FDA may designate a drug or biologic as a “breakthrough therapy” upon a request made by the IND sponsor.

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The FDA may also grant accelerated approval for such a drug or biologic when the product has an effect on an intermediate clinical endpoint that can be measured earlier than an effect on irreversible morbidity or mortality, or IMM, and that is reasonably likely to predict an effect on IMM or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments.

As a condition of approval, the FDA will require that a sponsor of a drug receiving accelerated approval perform post-marketing clinical trials to verify and describe the predicted effect on IMM or other clinical endpoint, and the product may be subject to expedited withdrawal procedures.

As a condition of approval, the FDA will require that a sponsor of a drug receiving accelerated approval perform post-marketing clinical trial(s) to verify and describe the predicted effect on IMM or other clinical endpoint, and the product may be subject to expedited withdrawal procedures.

Drugs and biologics granted accelerated approval must meet the same statutory standards for safety and effectiveness as those granted traditional approval.

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The accelerated approval pathway is usually contingent on a sponsor’s agreement to conduct, in a diligent manner, additional post-approval confirmatory studies to verify and describe the drug’s clinical benefit.

As a result, a program or

development candidate approved on this basis is typically subject to rigorous post-marketing compliance requirements, including the completion of Phase 4 or post-approval clinical trials to establish the effect on the clinical endpoint.

As a result, a program or product candidate approved on this basis is typically subject to rigorous post-marketing compliance requirements, including the completion of Phase 4 or post-approval clinical trials to establish the effect on the clinical endpoint.

Failure to conduct required post-approval studies, or to confirm the predicted clinical benefit of the product during post-marketing studies, may allow the FDA to withdraw approval of the drug.

The FDA may require the sponsor of a product granted accelerated approval to have a confirmatory trial underway prior to approval.

The FDA may require the sponsor of a product granted accelerated approval to have a confirmatory trial underway and substantially completed prior to approval.

The sponsor must also submit progress reports on a confirmatory trial every six months until the trial is complete, and such reports are published on FDA’s website.

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Pediatric Trials

Under the Pediatric Research Equity Act, or PREA, an NDA or BLA or supplement thereto must contain data to assess the safety and efficacy of the product for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective.

Under the Pediatric Research Equity Act, or PREA, certain NDAs or BLAs or supplements thereto must contain data to assess the safety and efficacy of the drug candidate (or safety, purity and potency of the biologic candidate) for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective.

The FDA may grant deferrals for submission of such data or full or partial waivers.

The FDCA requires that a sponsor who is planning to submit a marketing application for a drug or biologic product that includes a new active ingredient, new indication, new dosage form, new dosing regimen or new route of administration submit an initial Pediatric Study Plan, or PSP, within sixty days of an end-of-Phase 2 meeting or as may be agreed between the sponsor and FDA, if there is no such meeting, as early as practicable before the initiation of Phase 3 or Phase 2/3 clinical trials.

The initial PSP must include an outline of the pediatric study or studies that the sponsor plans to conduct, including study objectives and design, age groups, relevant endpoints and statistical approach, or a justification for not including such detailed information, and any request for a deferral of pediatric assessments or a full or partial waiver of the requirement to provide data from pediatric studies along with supporting information.

The FDA and the sponsor must reach agreement on the PSP.

A sponsor can submit amendments to an agreed-upon initial PSP at any time if changes to the pediatric plan need to be considered based on data collected from nonclinical studies, early phase clinical trials, and/or other clinical development programs.

Unless otherwise required by regulation, the PREA does not apply to any product for an indication for which orphan designation has been granted.

However, if only one indication for a product has orphan designation, a pediatric assessment may still be required for any applications to market that same product for the non-orphan indication(s).

Orphan Drug Designation and Exclusivity

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the posting will also indicate whether the drug or biologic is no longer designated as an orphan drug.

More than one program or development candidate may receive an orphan drug designation for the same indication.

More than one program or product candidate may receive an orphan drug designation for the same indication.

Orphan drug designation does not convey any advantage in or shorten the duration of the regulatory review and approval process.

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A product is clinically superior if it is safer, more effective or makes a major contribution to patient care.

Thus, orphan drug exclusivity could block the approval of one of our potential products for seven years if a competitor obtains approval of the same product as defined by the FDA and we are not able to show the clinical superiority of our program or development candidate or if our program or development candidate’s indication is determined to be contained within the competitor’s product orphan indication.

In addition, the FDA will not recognize

orphan drug exclusivity if a sponsor fails to demonstrate upon approval that the product is clinically superior to a previously approved product containing the same active moiety for the same orphan condition, regardless of whether or not the previously approved product was designated an orphan drug or had orphan drug exclusivity.

Thus, orphan drug exclusivity could block the approval of one of our potential products for seven years if a competitor obtains approval of the same product as defined by the FDA and we are not able to show the clinical superiority of our program or product candidate or if our program or product candidate’s indication is determined to be contained within the competitor’s product orphan indication.

In addition, the FDA will not recognize orphan drug exclusivity if a sponsor fails to demonstrate upon approval that the product is clinically superior to a previously approved product containing the same active moiety for the same orphan condition, regardless of whether or not the previously approved product was designated an orphan drug or had orphan drug exclusivity.

A product that has received orphan drug designation may not receive orphan exclusivity if it is approved for a use that is broader than the indication for which it received the designation.

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The cGMP regulations include requirements relating to organization of personnel, buildings and facilities, equipment, control of components and drug product containers and closures, production and process controls, packaging and labeling controls, holding and distribution, laboratory controls, records and reports and returned or salvaged products.

The manufacturing facilities for our programs and development candidates must meet cGMP requirements and satisfy the FDA or comparable foreign regulatory authorities before any product is approved and our commercial products can be manufactured.

The manufacturing facilities for our programs and product candidates must meet cGMP requirements and satisfy the FDA or comparable foreign regulatory authorities before any product is approved and our commercial products can be manufactured.

Third-party manufacturers must comply with cGMP regulations that require, among other things, quality control and quality assurance, the maintenance of records and documentation and the obligation to investigate and correct any deviations from cGMP.

Manufacturers, including third-party manufacturers, and other entities involved in the manufacture and distribution of approved biologics are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP and other laws.

Manufacturers, including third-party manufacturers, and other entities involved in the manufacture and distribution of approved products are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP and other laws.

Accordingly, manufacturers must continue to expend time, money, and effort in the area of production and quality control to maintain cGMP compliance.

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The FDA does, however, restrict manufacturer’s communications on the subject of off-label use of their products.

Pediatric exclusivity

Pediatric exclusivity is a type of non-patent marketing exclusivity available in the United States and, if granted, it provides for the attachment of an additional six months of marketing protection to the term of any existing regulatory exclusivity or listed patents.

This six-month exclusivity may be granted if a sponsor submits pediatric data that fairly responds to a Written Request from the FDA for such data.

The data do not need to show the product to be effective in the pediatric population studied;

rather, if the clinical trial is deemed to fairly respond to the FDA’s request, the additional protection is granted.

If reports of requested pediatric studies are submitted to and accepted by the FDA within the statutory time limits, whatever statutory or regulatory periods of exclusivity or patent protection cover the product are extended by six months.

The issuance of a Written Request does not require the sponsor to undertake the described studies.

Biosimilars and Reference Product Exclusivity

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The FDCA provides a five-year period of non-patent data exclusivity within the United States to the first applicant to obtain approval of an NDA for a new chemical entity.

A drug is a new chemical entity if the FDA has not

previously approved any other new drug containing the same active moiety, which is the molecule or ion responsible for the action of the drug substance.

A drug is a new chemical entity if the FDA has not previously approved any other new drug containing the same active moiety, which is the molecule or ion responsible for the action of the drug substance.

During the exclusivity period, the FDA may not accept for review an abbreviated new drug application, or ANDA, or an NDA submitted under Section 505(b)(2) (505(b)(2) NDA) submitted by another company for another drug based on the same active moiety, regardless of whether the drug is intended for the same indication as the original innovative drug or for another indication, where the applicant does not own or have a legal right of reference to all the data required for approval.

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Most companion diagnostics for oncology product candidates utilize the PMA pathway.

If use of companion diagnostic is deemed essential to the safe and effective use of a drug product, then the FDA generally will require approval or clearance of the diagnostic contemporaneously with the approval of the therapeutic product.

On August 6, 2014, the FDA issued a final guidance document addressing the development and approval process for “In Vitro Companion Diagnostic Devices.” According to the guidance, for novel product candidates, a companion diagnostic device and its corresponding drug candidate should be approved or cleared contemporaneously by FDA for the use indicated in the therapeutic product labeling.

The guidance also explains that a companion diagnostic device used to make treatment decisions in clinical trials of a drug generally will be considered an investigational device, unless it is employed for an intended use for which the device is already approved or cleared.

If used to make critical treatment decisions, such as patient selection, the diagnostic device may be considered a significant risk device under the FDA's Investigational Device Exemption, or IDE, regulations.

In which case, the sponsor of the diagnostic device will be required to submit and obtain approval of an IDE application, and subsequently comply with the IDE regulations.

However, according to the guidance, if a diagnostic device and a drug are to be studied together to support their respective approvals, both products can be studied in the same investigational study, if the study meets both the requirements of applicable IDE regulations and the IND regulations.

The guidance provides that, depending on the details of the study plan and degree of risk posed to subjects, a sponsor may seek to submit an IND alone, or both an IND and an IDE.

The FDA has generally required companion diagnostics intended to select the patients who will respond to cancer treatment to obtain approval of a PMA for that diagnostic simultaneously with approval of the therapeutic.

The PMA process, including the gathering of clinical and preclinical data and the submission to and review by the FDA, can take several years or longer.

It involves a rigorous premarket review during which the applicant must prepare and provide the FDA with reasonable assurance of the device's safety and effectiveness and information about the device and its

components regarding, among other things, device design, manufacturing and labeling.

In addition, PMAs for certain devices must generally include the results from extensive preclinical and adequate and well-controlled clinical trials to establish the safety and effectiveness of the device for each indication for which FDA approval is sought.

In particular, for a diagnostic, the applicant must demonstrate that the diagnostic produces reproducible results when the same sample is tested multiple times by multiple users at multiple laboratories.

As part of the PMA review, the FDA will typically inspect the manufacturer's facilities for compliance with the Quality System Regulation, or QSR, which imposes elaborate testing, control, documentation and other quality assurance requirements.

If the FDA's evaluation of the PMA application is favorable, the FDA may issue an approvable letter requiring the applicant's agreement to specific conditions, such as changes in labeling, or specific additional information, such as submission of final labeling, in order to secure final approval of the PMA.

If the FDA's evaluation of the PMA or manufacturing facilities is not favorable, the FDA will deny approval of the PMA or issue a not approvable letter.

A not approvable letter will outline the deficiencies in the application and, where practical, will identify what is necessary to make the PMA approvable.

The FDA may also determine that additional clinical trials are necessary, in which case the PMA approval may be delayed for several months or years while the trials are conducted and then the data submitted in an amendment to the PMA.

If and when the FDA concludes that the applicable criteria have been met, the FDA will issue a PMA for the approved indications, which can be more limited than those originally sought by the applicant.

The PMA can include post-approval conditions that the FDA believes necessary to ensure the safety and effectiveness of the device, including, among other things, restrictions on labeling, promotion, sale and distribution.

Once granted, PMA approval may be withdrawn by the FDA if compliance with post approval requirements, conditions of approval or other regulatory standards are not maintained or problems are identified following initial marketing.

After a device is commercialized, it remains subject to significant regulatory requirements.

Medical devices may be marketed only for the uses and indications for which they are cleared or approved.

Device manufacturers must also establish registration and device listings with the FDA.

A medical device manufacturer's manufacturing processes and those of its suppliers are required to comply with the applicable portions of the QSR, which cover the methods and documentation of the design, testing, production, processes, controls, quality assurance, labeling, packaging and shipping of medical devices.

Domestic facility records and manufacturing processes are subject to periodic unscheduled inspections by the FDA.

The FDA also may inspect foreign facilities that export products to the United States.

Health Care Laws and Compliance Requirements

Although we currently do not have any products on the market, our business operations and current and future arrangements with investigators, health care professionals, consultants, third-party payors and customers may be subject to regulation and enforcement by various federal, state and local authorities in addition to the FDA, including but not limited to, the Centers for Medicare and Medicaid Services, or CMS, other divisions of the U.S.

Department of Health and Human Services, or HHS, (such as the Office of Inspector General and the Health Resources and Service Administration), the Department of Justice, or the DOJ, and individual U.S.

Attorney offices within the DOJ, and state and local governments.

For example, sales, marketing and scientific/educational grant programs may have to comply with the anti-fraud and abuse provisions of the Social Security Act, the false claims laws, the privacy and security provisions of the Health Insurance Portability and Accountability Act, or HIPAA, and similar state laws, each as amended, as applicable.

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Further, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.

The federal Anti-Kickback Statute has been interpreted to apply to arrangements between therapeutic product manufacturers on one hand and prescribers and purchasers on the other.

There are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution.

The exceptions and safe harbors are drawn narrowly and practices that involve remuneration that may be alleged to be intended to induce prescribing, purchasing or recommending may be subject to scrutiny if they do not qualify for an exception or safe harbor.

Further, courts have found that if “one purpose”

of remuneration is to induce referrals, the federal Anti-Kickback statute is violated.

Failure to meet all of the requirements of a particular applicable statutory exception or regulatory safe harbor does not make the conduct per se illegal under the federal Anti-Kickback Statute.

Instead, the legality of the arrangement will be evaluated on a case-by-case basis based on a cumulative review of all of its facts and circumstances.

Our practices, including our arrangements with physicians, may not in all cases meet all of the criteria for protection under a statutory exception or regulatory safe harbor.

The federal false claims and civil monetary penalty laws, including the False Claims Act, or FCA, which can be enforced by private citizens through civil qui tam actions, prohibit any person or entity from, among other things, knowingly presenting, or causing to be presented, a false or fraudulent claim for payment to, or approval by, the federal health care programs, including Medicare and Medicaid, or knowingly making, using, or causing to be made or used a false record or statement material to a false or fraudulent claim to the federal government.

A claim includes “any request or demand” for money or property presented to the U.S.

For instance, historically, pharmaceutical and other health care companies have been, and continue to be, prosecuted under these laws for allegedly providing free product to customers with the expectation that the customers would bill federal programs for the product.

A violation of the Anti-Kickback Statute makes any claim submitted as a result of the violation of the Anti-Kickback Statute a false claim under the FCA.

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Among other things, the passage of HITECH made HIPAA’s privacy and security standards directly applicable to business associates and their covered subcontractors.

HITECH also created four new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce HIPAA and seek attorneys’ fees and costs associated with pursuing federal civil actions.

In addition, many state laws govern the privacy and security of health information in specified circumstances, many of which differ from each other in significant ways, are often not pre-empted by HIPAA, and may have a more prohibitive effect than HIPAA, thus complicating compliance efforts.

Additionally, the federal Physician Payments Sunshine Act, or the Sunshine Act, within the Patient Protection and Affordable Care Act, or ACA, and its implementing regulations, require that certain manufacturers of drugs, devices, biological and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) report annually to CMS information related to certain payments or other transfers of value made or distributed to physicians, as broadly defined by such law, certain advanced non-physician health care practitioners, and teaching hospitals, or to entities or individuals at the request of, or designated on behalf of,

such individuals or entities, and to report annually certain ownership and investment interests held by physicians and their immediate family members.

In addition, many states also govern the reporting of payments or other transfers of value, many of which differ from each other in significant ways, are often not pre-empted, and may have a more prohibitive effect than the Sunshine Act, thus further complicating compliance efforts.

In order to distribute products commercially, we must comply with state laws that require the registration of manufacturers and wholesale distributors of drug and biological products in a state, including, in certain states, manufacturers and distributors who ship products into the state even if such manufacturers or distributors have no place of business within the state.

Some states also impose requirements on manufacturers and distributors to establish the pedigree of product in the chain of distribution, including some states that require manufacturers and others to adopt new technology capable of tracking and tracing product as it moves through the distribution chain.

Several states have enacted legislation requiring pharmaceutical and biotechnology companies to establish marketing compliance programs, file periodic reports with the state, make periodic public disclosures on sales, marketing, pricing, clinical trials and other activities, and/or register their sales representatives, as well as to prohibit pharmacies and other health care entities from providing certain physician prescribing data to pharmaceutical and biotechnology companies for use in sales and marketing, and to prohibit certain other sales and marketing practices.

Some states also require pharmaceutical and biotechnology companies to:

establish the pedigree of product in the chain of distribution, including new technology capable of tracking and tracing product;

establish marketing compliance programs;

file periodic reports with the state, make periodic public disclosures on sales, marketing, pricing, clinical trials and other activities;

and/or register their sales representatives, Further, certain states prohibit certain pharmacies and other health care entities from sharing certain physician prescribing data for use in sales and marketing, and other sales and marketing practices by pharmaceutical and biotechnology companies.

All of our activities are potentially subject to federal and state consumer protection and unfair competition laws.

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Coverage, Pricing and Reimbursement

Significant uncertainty exists as to the coverage and reimbursement status of any programs or development candidates for which we may obtain regulatory approval.

Significant uncertainty exists as to the coverage and reimbursement status of any programs or product candidates for which we may obtain regulatory approval.

In the United States and in foreign markets, sales of any products for which we receive regulatory approval for commercial sale will depend, in part, on the extent to which third-party payors provide coverage and establish adequate reimbursement levels for such products.

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We cannot be sure that reimbursement will be available for any product that we commercialize and, if coverage and reimbursement are available, we cannot be sure that the level of reimbursement will be adequate.

Coverage may also be

more limited than the purposes for which the product is approved by the FDA or comparable foreign regulatory authorities.

Coverage may also be more limited than the purposes for which the product is approved by the FDA or comparable foreign regulatory authorities.

Limited coverage and less than adequate reimbursement may reduce the demand for, or the price of, any product for which we obtain regulatory approval.

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We may need to conduct expensive pharmacoeconomic studies in order to demonstrate the medical necessity and cost-effectiveness of our products, in addition to the costs required to obtain FDA approvals.

Our programs and development candidates may not be considered medically necessary or cost-effective.

Obtaining coverage and reimbursement approval of a product from a third-party payor is a time-consuming and costly process that could require us to provide to each payor supporting scientific, clinical and cost-effectiveness data for the use of our product on a payor-by-payor basis, with no assurance that coverage and adequate reimbursement will be obtained.

A third-party payor’s decision to provide coverage for a product does not imply that an adequate reimbursement rate will be approved.

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Adequate third-party payor reimbursement may not be available to enable us to maintain price levels sufficient to realize an appropriate return on our investment in product development.

If reimbursement is not available or is available only at limited levels, we may not be able to successfully commercialize any program or development candidate that we successfully develop.

Many pharmaceutical manufacturers must calculate and report certain price reporting metrics, such as average sales price and best price, to the government, such as average sales price and best price.

These prices for drugs or biologics may be reduced by mandatory discounts or rebates required by government health care programs or private payors and by any future relaxation of laws that presently restrict imports of drugs or biologics from countries where drugs may be sold at lower prices than in the United States.

Further, certain of our products, if approved, may be administered by a physician.

Under currently applicable U.S.

law, certain products that are not self-administered by the patient (including injectable drugs) may be eligible for coverage under Medicare through Medicare Part B.

Medicare Part B is part of original Medicare, the federal health care program that provides health care benefits to the aged and disabled, and covers outpatient services and supplies, including certain drug and biological products, that are medically necessary to treat a beneficiary’s health condition.

As a condition of receiving Medicare Part B reimbursement for a manufacturer’s eligible drugs or biologicals, the manufacturer is required to participate in other government health care programs, including the Medicaid Drug Rebate Program and the 340B Drug Pricing Program.

The Medicaid Drug Rebate Program requires biopharmaceutical manufacturers to enter into and have in effect a national rebate agreement with the Secretary of HHS as a condition for states to receive federal matching funds for the manufacturer’s outpatient therapeutic products furnished to Medicaid patients.

Under the 340B Drug Pricing Program, the manufacturer must extend discounts to entities that participate in the program.

If reimbursement is not available or is available only at limited levels, we may not be able to successfully commercialize any program or product candidate that we successfully develop.

Different pricing and reimbursement schemes exist in other countries.

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Some jurisdictions operate positive and negative list systems under which products may only be marketed once a reimbursement price has been agreed.

To obtain reimbursement or pricing approval, some of these countries may require the completion of clinical trials that compare the cost effectiveness of a particular program or development candidate to currently available therapies.

To obtain reimbursement or pricing approval, some of these countries may require the completion of clinical trials that compare the cost effectiveness of a particular program or product candidate to currently available therapies.

Other member states allow companies to fix their own prices for medicines but monitor and control company profits.

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In addition, in some countries, cross-border imports from low-priced markets exert a commercial pressure on pricing within a country.

The marketability of any programs or development candidates for which we receive regulatory approval for commercial sale may suffer if the government and third-party payors fail to provide coverage and adequate reimbursement.

In addition, emphasis on managed care, the increasing influence of health maintenance organizations,

and additional legislative changes in the United States has increased, and we expect will continue to increase, the pressure on health care pricing.

The marketability of any programs or product candidates for which we receive regulatory approval for commercial sale may suffer if the government and third-party payors fail to provide coverage and adequate reimbursement.

In addition, emphasis on managed care, the increasing influence of health maintenance organizations, and additional legislative changes in the United States has increased, and we expect will continue to increase, the pressure on health care pricing.

The downward pressure on the rise in health care costs has become very intense.

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Health Care Reform

In the United States and some jurisdictions outside the United States, there have been, and continue to be, proposed legislative and regulatory changes to the current health care systems that could prevent or delay marketing approval of programs and development candidates, restrict or regulate post-approval activities, and affect the ability to profitably sell programs and development candidates for which marketing approval is obtained.

The FDA’s and other regulatory authorities’ policies may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product and therapeutic candidates.

If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we otherwise may have obtained and we may not achieve or sustain profitability, which would adversely affect our business, prospects, financial condition and results of operations.

Moreover, among policy makers and payors in the United States and elsewhere, there is significant interest in promoting changes in health care systems with the stated goals of containing health care costs, improving quality and/or expanding access.

In the United States and some jurisdictions outside the United States, there have been, and continue to be, proposed legislative and regulatory changes to the current health care systems that could prevent or delay marketing approval of programs and product candidates, restrict or regulate post-approval activities, and affect the ability to profitably sell programs and product candidates for which marketing approval is obtained.

For example, the ACA was enacted in March 2010 and has had a significant impact on the health care industry in the United States.

The ACA expanded coverage for the uninsured while at the same time containing overall health care costs.

With regard to biopharmaceutical products, the ACA, among other things, addressed a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected, increased the minimum Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program and extended the rebate program to individuals enrolled in Medicaid managed care organizations, established annual fees on manufacturers of certain branded prescription drugs, and created a new Medicare Part D coverage gap discount program.

Additionally, the Creating and Restoring Equal Access to Equivalent Samples Act, or CREATES Act, was enacted on December 20, 2019 to address the concern articulated by both the FDA and others in the industry that some brand manufacturers have improperly restricted the distribution of their products, including by invoking the existence of a REMS for certain products, to deny generic product developers access to samples of brand products.

Because generic product developers need samples to conduct certain comparative testing required by the FDA, some have attributed the inability to timely obtain samples as a cause of delay in the entry of generic products.

To remedy this concern, the CREATES Act establishes a private cause of action that permits a generic product developer to sue the brand manufacturer to compel it to furnish the necessary samples on “commercially reasonable, market-based terms.” Whether and how generic product developments will use this new pathway, as well as the likely outcome of any legal challenges to provisions of the CREATES Act, remain highly uncertain and its potential effects on any of our future commercial products are unknown.

Following several years of litigation in the federal courts, in June 2021, the U.S.

Supreme Court dismissed a challenge on procedural groups that argued the ACA is unconstitutional in its entirety because the individual mandate was repealed by Congress.

In addition, on August 16, 2022, President Biden signed the Inflation Reduction Act of 2022, or the IRA, into law, which among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025.

There have been judicial and Congressional challenges and amendments to certain aspects of the ACA.

For example, on August 16, 2022, the Inflation Reduction Act of 2022, or the IRA, was signed into law, which among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025.

The IRA also eliminates the “donut hole” under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and creating a new manufacturer discount program.

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Moreover, there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products.

In addition, the IRA has multiple provisions that may impact the prices of drug products that are both sold into the Medicare program and throughout the United States.

For example, the IRA has multiple provisions that may impact the prices of drug products that are both sold into the Medicare program and throughout the United States.

Starting in 2023, a manufacturer of a drug or biological product covered by Medicare Parts B or D must pay a rebate to the federal government if the drug product’s price increases faster than the rate of inflation.

This calculation is made on a drug product by drug product basis and the amount of the rebate owed to the federal government is directly dependent on the volume of a drug product that is paid for by Medicare Parts B or D.

Additionally, starting in payment year 2026, CMS will negotiate drug prices annually for a select number of single source Part D drugs without generic or biosimilar competition.

On August 29, 2023, the list of the first ten drugs that will be subject to price negotiations was published, although the Medicare drug price negotiation program is currently subject to legal challenges.

CMS will also negotiate drug prices for a select number of Part B drugs starting for payment year 2028.

If a drug product is selected by CMS for negotiation, it is expected that the revenue generated from such drug will decrease.

The IRA permits HHS to implement many of these provisions through guidance, as opposed to regulation, for the initial years.

HHS has and will continue to issue and update guidance as these programs as implemented.

These provisions take effect progressively starting in fiscal year 2023.

It is unclear how the IRA will be implemented but is likely to have a significant impact on the pharmaceutical industry.

Further, on February 14, 2023, HHS released a report outlining three new models for testing by the Centers for Medicare & Medicaid Services Innovation Center which will be evaluated on their ability to lower the cost of drugs, promote accessibility, and improve quality of care.

It is unclear whether the models will be utilized in any health reform measures in the future.

Additionally, on December 7, 2023, the Biden administration announced an initiative to control the price of prescription drugs through the use of march-in rights under the Bayh-Dole Act.

On December 8, 2023, the National Institute of Standards and Technology published for comment a Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights which for the first time includes the price of a product as one factor an agency can use when deciding to exercise march-in rights.

Additionally, starting in payment year 2026, CMS will negotiate drug prices annually for a select number of single source Part D drugs and biologics that have been on the market for at least 7 years for drugs and 11 years for biologics without generic or biosimilar competition.

On August 15, 2024, the agreed-upon prices for the first ten drugs that were subject to price negotiations was published, although the Medicare drug price negotiation program is currently subject to legal challenges.

On January 17, 2025, CMS selected fifteen additional products covered under Part D for price negotiation in 2025.

Each year thereafter more Part B and Part D products will become subject to the Medicare drug price negotiation program If a drug product is selected by CMS for negotiation, it is expected that the revenue generated from such drug will decrease.

Additionally, on December 8, 2023, the National Institute of Standards and Technology published for comment a Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights which for the first time includes the price of a product as one factor an agency can use when deciding to exercise march-in rights.

While march-in rights have not previously been exercised, it is uncertain if that will continue under the new framework.

The current Trump administration is pursuing policies to reduce regulations and expenditures across government including at HHS, the FDA, CMS and related agencies.

These actions presently directed by executive orders or memoranda from the Office of Management and Budget, may propose policy changes that create additional uncertainty for our business.

These actions may, for example, include directives to reduce agency workforce, rescinding a Biden administration executive order tasking the Center for Medicare and Medicaid Innovation (“CMMI”) to consider new payment and healthcare models to limit drug spending and eliminating the Biden administration’s executive order that directed HHS to establishing an AI task force and developing a strategic plan.

Additionally, in its June 2024 decision in Loper Bright Enterprises v.

Raimondo (“Loper Bright”), the U.S.

Supreme Court overturned the longstanding Chevron doctrine, under which courts were required to give deference to regulatory agencies’ reasonable interpretations of ambiguous federal statutes.

The Loper Bright decision could result in additional legal challenges to current regulations and guidance issued by federal agencies applicable to our operations, including those issued by the FDA.

Congress may introduce and ultimately pass health care related legislation that could impact the drug approval process and make changes to the Medicare Drug Price Negotiation Program created under the IRA.

Individual states in the United States have also increasingly passed legislation and implemented regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

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Any such approved importation plans, when implemented, may result in lower drug prices for products covered by those programs.

We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative or executive action, either in the United States or abroad.

We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative or executive action, either in the United States or abroad, particularly in light of the recent U.S.

Presidential and Congressional elections.

We expect that additional state and federal health care reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for health care products and services, including any future drug products for which we secure marketing approval.

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We incentivize high performers through an annual bonus program based on our company and individual performance for which all employees are eligible.

We also offer equity incentive plans, the purpose of which are to attract, retain and reward employees through the granting of share-based compensation awards, with the intention of increasing stockholder value and the success of our company by motivating team members.

We currently lease approximately 11,000 square feet of office and laboratory space in Exton, Pennsylvania under a lease that expires on March 31, 2025.

We currently lease approximately 14,000 square feet of office and laboratory space in Bothell, Washington under a lease that expires on October 31, 2028.

We believe the leased spaces are sufficient to meet our immediate facility needs, and that any additional space we may require will be available on commercially reasonable terms.

We also offer equity incentives, the purpose of which are to attract, retain and reward employees through the granting of share-based compensation awards, with the intention of increasing stockholder value and the success of our company by motivating team members.

Corporate and Other Information

We were incorporated in the state of Pennsylvania on March 2, 2006, and converted to a Delaware corporation on December 2, 2015.

Our principal executive offices are located at 18702 North Creek Parkway, Suite 100, Bothell WA 98011, and our telephone number is (610) 321 3700.

We were incorporated in the Commonwealth of Pennsylvania on March 2, 2006, and converted to a Delaware corporation on December 2, 2015.

Our principal executive offices are located at 18702 North Creek Parkway, Suite 100, Bothell, Washington 98011, and our telephone number is (425) 939 7410.

Our corporate website is www.immunome.com and we regularly post copies of our press releases as well as additional information about us on our website.

We intend to announce material information to the public through filings with the SEC, the investor relations page on our website, press releases, public conference calls and public webcasts.

Information contained on, or accessible through, our website shall not be deemed incorporated into, and is not a part of, this Annual Report.

We have included our website in this Annual Report solely as an inactive textual reference.

We have included a reference to our website in this Annual Report solely as an inactive textual reference.

All brand names or trademarks appearing in this Annual Report are the property of their respective holders.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business