? our dependence on product candidates, which are still in an early development

our ability to successfully complete research and further development,

? including preclinical and clinical studies, and, if we obtain regulatory

approval, commercialization of our drug candidates and the growth of the

markets for those drug candidates;

? our anticipated timing for preclinical development, regulatory submissions,

commencement and completion of clinical trials and product approvals;

? the impact of the COVID-19 pandemic on our business or on the economy

? whether the COVID-19 pandemic will affect the timing of the completion of our

planned and/or currently ongoing preclinical/clinical trials;

? our ability to negotiate strategic partnerships, where appropriate, for our

? our ability to manage multiple clinical trials for a variety of drug candidates

at different stages of development;

? the cost, timing, scope and results of ongoing preclinical and clinical

? our expectations of the attributes of our product and development candidates,

including pharmaceutical properties, efficacy, safety and dosing regimens;

? the cost, timing and uncertainty of obtaining regulatory approvals for our drug

? the availability, cost, delivery and quality of clinical management services

provided by our clinical research organization partners;

the availability, cost, delivery and quality of clinical and commercial-grade

? materials produced by our own manufacturing facility or supplied by contract

? our ability to develop and commercialize products before competitors that are

our ability to develop technological capabilities, including identification of

? novel and clinically important targets, exploiting our existing technology

platforms to develop new drug candidates and expand our focus to broader

markets for our existing targeted therapeutics;

? the cost of paying the future milestones, if any, under the Settlement

our ability to raise sufficient capital to fund our preclinical and clinical

studies and to meet our long-term liquidity needs, on terms acceptable to us,

or at all. If we are unable to raise the funds necessary to meet our long-term

? liquidity needs, we may have to delay or discontinue the development of one or

more programs, discontinue or delay ongoing or anticipated clinical trials,

license out programs earlier than expected, raise funds at significant discount

or on other unfavorable terms, if at all, or sell all or part of our business;

our ability to protect our intellectual property rights and our ability to

? avoid intellectual property litigation, which can be costly and divert

? our ability to develop and commercialize products without infringing the

intellectual property rights of third parties; and

the risk factors set forth elsewhere in this quarterly report on Form 10-Q and

the factors listed under the headings "Business," "Risk Factors" and

? "Management's Discussion and Analysis of Financial Condition and Results of

Operations" in our annual report on Form 10-K for the year ended December 31,

2021 and other reports that we file with the Securities and Exchange

We are focusing our efforts and resources on the continued research and development of:

Barzolvolimab (also referred to as CDX-0159), a monoclonal antibody that

? specifically binds the KIT receptor and potently inhibits its activity, is

currently being studied across multiple mast cell driven diseases including:

Chronic Urticarias: In June and July 2022 respectively, we announced that

enrollment had opened and the first patients had been dosed in Phase 2 studies

in chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU).

- Positive interim data from the ongoing Phase 1b study in CSU were reported in

July 2022. Positive interim data from the Phase 1b study in CIndU were reported

in July and September 2021 in patients with cold urticaria and symptomatic

- Prurigo Nodularis (PN): In December 2021 we announced that the first patient

had been dosed in a Phase 1b study in PN; and

CDX-527, a bispecific antibody that uses our proprietary highly active

? anti-PD-L1 and CD27 human antibodies to couple CD27 co-stimulation with

blockade of the PD-L1/PD-1 pathway, for which we initiated a Phase 1 study in

advanced solid tumors in August 2020.

? the number of patients that ultimately participate in the trial;

? the duration of patient follow-up that seems appropriate in view of results;

? the number of clinical sites included in the trials;

? the length of time required to enroll suitable patient subjects; and

? the efficacy and safety profile of the drug candidate.

Barzolvolimab (also referred to as CDX-0159)

Mean reduction from baseline in urticaria activity (Urticaria Activity Score

over 7 days or UAS7) of 66.6% in all patients in the 1.5 mg/kg dose group (n=8)

? at week 12 and 75.1% in all patients in the 3.0 mg/kg dose group (n=9) at week

8 (reflects one dose; ongoing), demonstrating clinically meaningful symptom

Complete response (UAS7=0) of 57.1% in the 1.5 mg/kg dose group at week 12 and

? 44.4% at week 8 (reflects one dose; ongoing) in the 3 mg/kg dose group which is

75% well-controlled disease by Urticaria Control Test (UCT) in the 1.5 mg/kg

? dose group at week 12 and 83.3% in the 3 mg/kg dose group at week 8 (reflects

? Patients with prior omalizumab therapy had similar symptom improvement as all

All three doses of barzolvolimab markedly improved urticaria symptoms and

? disease control, with rapid improvement in itch and hives. As predicted, the

lowest dose of 0.5 mg/kg resulted in suboptimal clinical activity compared to

? Rapid onset of responses after initial dosing and sustained durability were

observed; onset as early as 1 week after the first dose.

Tryptase suppression, indicative of mast cell depletion, paralleled symptom

? improvement, demonstrating the impact of mast cell depletion on CSU disease

Barzolvolimab was well tolerated with a favorable safety profile; effects of

multiple dose administration were consistent with observations in single dose

studies. Most AEs were mild or moderate in severity and resolved while on

study, with none leading to treatment discontinuation. The most common

? treatment emergent adverse events were urinary tract infections, headache,

neutropenia and back pain. UTIs, headache and backpain were all reported as

unrelated to treatment. Changes in hematologic parameters were consistent with

observations in single dose studies, with no pattern of further decreases with

multiple doses; hematologic values generally remained within the normal range.

All 19/19 (100)% patients experienced a clinical response as assessed by

provocation threshold testing; 18/19 (95)% experienced a complete response and

1/19 (5)% experienced a partial response.10/10 (100)% patients with cold

? urticaria experienced a complete response. 8/9 (89)% patients with symptomatic

dermographism experienced a complete response and 1/9 (11)% experienced a

partial response. Compete responses were observed in all 3 patients (1 cold

Rapid onset of responses after dosing and sustained durability were observed.

Most patients with cold urticaria and symptomatic dermographism experienced a

? complete response by week 1 and by week 4, respectively. The median duration of

Improvements in disease activity as reported by physician's and patient's

? global assessment of disease severity were consistent with the complete

responses as measured by provocation testing.

A single 3 mg/kg dose of barzolvolimab resulted in rapid, marked and durable

suppression of serum tryptase and depletion of skin mast cells (87% depletion)

as measured through biopsy. The kinetics of serum tryptase and skin mast cell

? depletion mirrored clinical activity. This confirmed that serum tryptase level

is a robust pharmacodynamic biomarker for assessing mast cell burden and

clinical activity in inducible urticaria and potentially in other diseases with

Barzolvolimab was generally well tolerated. The most common adverse events were

hair color changes, mild infusion reactions, and transient changes in taste

perception. Hair color changes (generally small areas of hair color lightening)

and taste disorders (generally partial changes of ability to taste salt) are

consistent with inhibiting KIT signaling in other cell types and are expected

? to be fully reversible. As previously reported in March 2021, a single severe

infusion reaction of brief loss of consciousness was observed in a patient with

a history of fainting. The patient rapidly recovered. Importantly, no evidence

of mast cell activation as measured by serum tryptase monitoring was observed.

One patient with symptomatic dermographism enrolled in the study also had a

? diagnosis of prurigo nodularis (PN). After a single dose of barzolvolimab, this

patient experienced both a complete response of symptomatic dermographism and

notable improvement of the PN.

In September 2021, we reported additional positive data from the study on measurements of symptom control and quality of life. A single dose of barzolvolimab (3 mg/kg) resulted in a rapid and sustained improvement in urticaria control and greatly reduced disease impact on quality of life, as measured by the Urticaria Control Test (UCT) and Dermatology Life Quality Index (DLQI).

We continue to assess potential opportunities for barzolvolimab in other diseases where mast cells play an important role, such as dermatologic, respiratory, allergic, gastrointestinal and ophthalmic conditions.

CRITICAL ACCOUNTING POLICIES AND ESTIMATES

Facility expenses include depreciation, amortization, utilities, rent, maintenance and other related expenses incurred at our facilities. Facility expenses for the three months ended June 30, 2022 was relatively consistent with the three months ended June 30, 2021. We expect facility expenses to remain relatively consistent over the next twelve months, although there may be fluctuations on a quarterly basis.

(Gain) Loss on Fair Value Remeasurement of Contingent Consideration

Investment and Other Income, Net

Six Months Ended June 30, 2022 Compared with Six Months Ended June 30, 2021

Facility expenses include depreciation, amortization, utilities, rent, maintenance and other related expenses incurred at our facilities. Facility expenses for the six months ended June 30, 2022 was relatively consistent with the six months ended June 30, 2021.

(Gain) Loss on Fair Value Remeasurement of Contingent Consideration

We recorded a loss of $15.0 million in the second quarter of 2022 related to the Initial Payment due under the Term Sheet entered with SRS.

Investment and Other Income, Net

The $0.4 million increase in investment and other income, net for the six months ended June 30, 2022, as compared to the six months ended June 30, 2021, was primarily due to higher levels of cash and investment balances and higher interest rates on fixed income investments.

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