On February 28, 2023 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrine, oncologic, metabolic and neurological disorders by modulating the effects of the hormone cortisol, reported its results for the quarter and year ended December 31, 2022 (Press release, Corcept Therapeutics, FEB 28, 2023, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-fourth-quarter-and-full-year-2022 [SID1234627837]).

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Financial Results

Fourth quarter revenue of $103.1 million, compared to $98.8 million in fourth quarter 2021
2022 revenue of $401.9 million, compared to $366.0 million in 2021
2023 revenue guidance of $430 – $450 million
Fourth quarter diluted net income per common share of $0.14, compared to $0.26 in fourth quarter 2021
2022 diluted net income per common share of $0.87, compared to $0.89 in 2021
Cash and investments of $436.6 million, compared to $335.8 million at December 31, 2021
Corcept’s fourth quarter 2022 revenue was $103.1 million, compared to $98.8 million in the fourth quarter of 2021. Revenue for the full year was $401.9 million, compared to $366.0 million in 2021. The company expects 2023 revenue of $430 – $450 million.

Net income was $16.6 million in the fourth quarter of 2022, compared to $32.1 million in the fourth quarter of 2021. For the full year, it was $101.4 million compared to $112.5 million in 2021.

Cash and investments of $436.6 million at December 31, 2022 compared to $335.8 million at December 31, 2021.

"We remain extremely optimistic about the growth potential of our Cushing’s syndrome business. Korlym is an excellent treatment for patients with Cushing’s syndrome and there are many eligible patients who have yet to receive it. We are making substantial investments to improve the screening and treatment of these patients. We are providing 2023 revenue guidance of $430 – $450 million," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer.

Clinical Development

"We significantly advanced our clinical development programs, with three of our proprietary selective cortisol modulators – relacorilant, dazucorilant and miricorilant – now in the clinic," added Dr. Belanoff. "We expect to make further progress in the next twelve months with submission of the NDA for relacorilant in Cushing’s syndrome, enrollment of our confirmatory Phase 3 trial of relacorilant in platinum-resistant ovarian cancer and Phase 2 trial of dazucorilant in ALS, and advancement to Phase 2 of miricorilant as a potential treatment for NASH."

Cushing’s Syndrome

Enrollment to close in the coming weeks in Phase 3 GRACE trial of relacorilant as a treatment for patients with all etiologies of Cushing’s syndrome – new drug application (NDA) submission expected in the first quarter of 2024
Enrollment continues in Phase 3 GRADIENT trial of relacorilant as a treatment for patients with Cushing’s syndrome caused by adrenal adenomas
CATALYST – 1,000-patient randomized, double-blind, placebo-controlled Phase 4 trial to examine the prevalence of hypercortisolism in patients with difficult to control type 2 diabetes and treat the patients determined to have hypercortisolism with Korlym – to begin this quarter
"We are pleased to announce that we believe that we have enough patients in screening in our GRACE trial to complete enrollment in the coming weeks. We expect GRACE to serve as the basis for relacorilant’s NDA in Cushing’s syndrome, which we plan to submit in the first quarter of 2024," said Bill Guyer, PharmD, Corcept’s Chief Development Officer. "The Phase 3 GRADIENT trial will produce valuable data about an etiology of Cushing’s syndrome that affects many patients but has not been subject to rigorous, controlled study."

"Our randomized, double-blind, placebo-controlled, Phase 4 CATALYST study will examine the prevalence of hypercortisolism in patients with difficult to control type 2 diabetes and treat the patients determined to have hypercortisolism with Korlym. Planned enrollment is 1,000 patients, which we expect to complete by the end of this year. The most prominent diabetologists in the country helped design and are participating in this study. We expect CATALYST to produce data that will improve the screening and treatment of these patients," added Dr. Guyer.

Oncology

Enrollment continues in ROSELLA – 360-patient pivotal Phase 3 trial of relacorilant plus nab-paclitaxel in patients with recurrent, platinum-resistant ovarian cancer
Enrollment continues in open-label, Phase 1b trial of relacorilant plus pembrolizumab in patients with adrenal cancer with cortisol excess
Randomized, placebo-controlled Phase 2 trial of relacorilant plus enzalutamide in patients with prostate cancer expected to begin by mid-year in collaboration with the University of Chicago
"We and our investigators are extremely excited to advance relacorilant in platinum-resistant ovarian cancer. The 40,000 women in the United States and Europe with this disease do not have good treatment options and relacorilant plus nab-paclitaxel has the potential to become a new standard of care," said Dr. Guyer.

Amyotrophic Lateral Sclerosis (ALS)

Enrollment continues in DAZALS – 198-patient, randomized, double-blind, placebo-controlled Phase 2 trial of dazucorilant in patients with ALS
"The 55,000 patients in the United States and Europe with ALS have an urgent need for better treatment. Dazucorilant showed great promise in animal models of ALS – improving motor performance and reducing neuroinflammation and muscular atrophy. We are conducting this important study in collaboration with TRICALS, the leading ALS academic consortium in Europe, to investigate dazucorilant’s potential to significantly improve the lives of patients with ALS," said Dr. Guyer.

Non-alcoholic Steatohepatitis (NASH)

Screening closed in Phase 1b dose-finding trial of miricorilant in patients with presumed NASH – data expected by mid-year
"Miricorilant, an oral medication, continues to demonstrate great promise as a treatment for NASH. Our Phase 1b study has identified a range of doses, all substantially lower than our originally tested doses, that significantly reduces liver fat without causing excessive liver irritation," said Dr. Guyer. "We expect to share results from this study by mid-year and plan to start a Phase 2 trial later this year."

Conference Call

We will hold a conference call on February 28, 2023, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). To access the conference call, please dial 877-407-8029 from the United States or +1-201-689-8029 internationally. A replay of the call will be available on the Investors / Events tab of www.corcept.com.

Hypercortisolism

Hypercortisolism, often referred to as Cushing’s syndrome, is caused by excessive activity of the hormone cortisol. Endogenous Cushing’s syndrome is an orphan disease that most often affects adults aged 20-50. In the United States, an estimated 20,000 patients have Cushing’s syndrome, with about 3,000 new patients diagnosed each year. Symptoms vary, but most patients experience one or more of the following manifestations: high blood sugar, diabetes, high blood pressure, upper-body obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety, cognitive disturbances and depression are also common. Hypercortisolism can affect every organ system and can be lethal if not treated effectively. Corcept holds patents directed to the composition of relacorilant and the use of cortisol modulators, including Korlym, in the treatment of patients with hypercortisolism.

On February 28, 2023 Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS) reported that its fourth quarter and full year 2022 financial results will be released after market close on Monday, March 6, 2023 (Press release, Coherus Biosciences, FEB 28, 2023, View Source/news-releases/news-release-details/coherus-biosciences-report-fourth-quarter-and-full-year-2022" target="_blank" title="View Source/news-releases/news-release-details/coherus-biosciences-report-fourth-quarter-and-full-year-2022" rel="nofollow">View Source [SID1234627836]). Starting at 5:00 pm ET on March 6, 2023, Coherus’ management team will host a conference call and webcast to discuss financial results and provide a general business update.

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A replay of the webcast will be available on View Source following the conclusion of the live conference call.

Conference Call Information
When: Monday, March 6th, 2023, starting at 5:00 p.m. Eastern Time
To access the conference call, please pre-register through the following link to receive dial-in information and a personal PIN to access the live call: https://register.vevent.com/register/BI8a3cc318d81c4ebaa9d8f6e635f9731c

Webcast: View Source

The press release with the fourth quarter and full year 2022 financial results and related materials will be available at View Source prior to the start of the conference call.

A live and archived webcast will be available on the "Investors" section of the Coherus website at View Source.

Please dial-in 15 minutes early to ensure a timely connection to the call.

On February 28, 2023 Cerus Corporation (Nasdaq: CERS) reported financial results for the fourth quarter and full year ended December 31, 2022 (Press release, Cerus, FEB 28, 2023, View Source [SID1234627835]).

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Recent highlights include:

Fourth quarter 2022 and full-year 2022 total revenue was comprised of (in thousands, except %):
Three Months Ended

Twelve Months Ended

December 31,

Change

December 31,

Change

2022

2021

$

%

2022

2021

$

%

Product Revenue

$

44,034

$

39,865

$

4,169

10

%

$

162,048

$

130,859

$

31,189

24%

Government Contract Revenue

7,287

10,223

(2,936)

(29%)

26,267

28,659

(2,392)

(8%)

Total Revenue

$

51,321

$

50,088

$

1,233

2

%

$

188,315

$

159,518

$

28,797

18

%

The Company is reiterating its full-year 2023 annual product revenue guidance range of $165 million to $170 million.
Cash, cash equivalents, and short-term investments were $102.2 million at December 31, 2022.
"Throughout 2022, Cerus continued to make significant progress towards its goal of safeguarding the global blood supply and advancing the complete INTERCEPT product portfolio. The Company’s efforts to establish INTERCEPT as the standard of care in various regions, most recently in the U.S., are evident in our financial results," said William "Obi" Greenman, Cerus’ president and chief executive officer. "The success of the INTERCEPT platelet business in the U.S. continued in the fourth quarter, with growth fueled by effective commercial and operational efforts. As the business has grown significantly over the last five years, Cerus has efficiently managed the ongoing expansion of its contracted manufacturing capacity to provide the certainty that our customers demand."

"The successful deployment of the INTERCEPT Blood System for platelets in the U.S. has driven a record-breaking year for the Company. Cerus’ remarkable growth over the past five years has enabled it to lead a transformation in transfusion medicine," Greenman continued. "Cerus remains optimistic about its core business franchise and the potential for future growth. We have multiple opportunities ahead of us, and our improving financial profile and focus on cashflow breakeven will enable Cerus to self-fund these opportunities. We look forward to updating our stakeholders on our progress throughout the year."

Revenue

Product revenue during the fourth quarter of 2022 was $44.0 million, compared to $39.9 million during the prior year period. Product revenue growth during the quarter and full year was driven by increased sales of INTERCEPT platelet kits to blood center customers across the U.S.

Fourth-quarter 2022 government contract revenue was $7.3 million, compared to $10.2 million during the prior year period. Reported government contract revenue in the fourth quarter 2022 decreased versus the prior year period primarily due to the fact that, in Q4 of 2021, we realized a cumulative true up in revenue resulting from reaching mutual resolution on an outstanding item with a government agency partner. Our government contract revenue was comprised of funding associated with research and development (R&D) activities related to the INTERCEPT Blood System for Red Blood Cells as well as efforts related to the development of next-generation pathogen reduction technology to treat whole blood and development of a lyophilized INTERCEPT Fibrinogen Complex.

Product Gross Profit & Margin

Product gross profit for the fourth quarter of 2022 was $24.5 million, the highest in the Company’s history, increasing by 20% over the prior year period. Product gross margin for the fourth quarter of 2022 was 55.7% compared to 51.1% for the fourth quarter of 2021. The fourth quarter of 2022 represents the highest product gross margin achieved.

Full-year 2022 product gross profit was $87.1 million and reflected growth of 29% over the prior year. Product gross margin for the full-year 2022 was 53.7% compared to 51.5% for the prior year. The product gross margins were driven by the distribution of product sales across different regions, with U.S. kit sales showing higher growth compared to other regions, and, to a lesser extent, by the product mix. During the year, the sales of platelet kits accounted for a larger share of overall sales compared to the prior year period.

Operating Expenses

Total operating expenses for the fourth quarter of 2022 were $41.8 million compared to $37.6 million for the same period of the prior year, reflecting a year-over-year increase of 11%. For the full year, 2022 total operating expenses totaled $147.4 million, representing an increase of 2% from 2021 total operating expenses of $145.0 million. On both a quarterly and full-year basis, higher R&D expenses and higher selling, general, and administrative (SG&A) expenses drove operating expenses higher year over year.

SG&A expenses for the fourth quarter of 2022 totaled $23.2 million, compared to $22.0 million for the fourth quarter of 2021. For the full-year 2022, SG&A expenses totaled $83.3 million, compared to $81.3 million for the full-year 2021. The year-over-year increase in SG&A expenses for the fourth quarter and full year was tied to costs associated with non-cash stock-based compensation, increased hiring, legal and commercialization efforts.

R&D expenses for the fourth quarter of 2022 were $18.6 million, compared to $15.6 million for the fourth quarter of 2021. For the full year 2022, R&D expenses totaled $64.1 million, compared to $63.7 million for the full-year 2021. For both the fourth quarter and full year, the Company’s R&D expenses continued to advance key pipeline programs, including development of the LED illuminator and INTERCEPT Red Blood Cell program, both domestically and in EMEA, and increased slightly year over year due to the timing of activities related to new product development.

Net Loss Attributable to Cerus Corporation

Net loss attributable to Cerus Corporation for the fourth quarter of 2022 was $13.6 million, or $0.08 per basic and diluted share, compared to a net loss attributable to Cerus Corporation of $9.1 million, or $0.05 per basic and diluted share, for the fourth quarter of 2021.

For the full-year 2022, net loss attributable to Cerus Corporation was $42.8 million, or $0.24 per basic and diluted share, compared to a net loss attributable to Cerus Corporation of $54.4 million, or $0.32 per basic and diluted share, for the full year 2021.

Non-GAAP Adjusted EBITDA

Non-GAAP Adjusted EBITDA for the fourth quarter of 2022 was negative $3.7 million, compared to non-GAAP Adjusted EBITDA of negative $4.3 million for the fourth quarter of 2021. Full-year 2022 non-GAAP Adjusted EBITDA was negative $12.4 million, compared to non-GAAP Adjusted EBITDA of negative $29.5 million for full year 2021. For additional information, please see definitions and the reconciliation of this non-GAAP measure to net loss attributable to Cerus Corporation accompanying this release.

Balance Sheet & Cash Use

At December 31, 2022, the Company had cash, cash equivalents and short-term investments of $102.2 million, compared to $103.8 million at September 30, 2022, and $129.4 million at December 31, 2021.

As of December 31, 2022, the Company had $54.9 million outstanding on its term loan and $14.9 million drawn on its revolving credit facility. The Company continues to have access to $5 million under its revolving line of credit.

For the fourth quarter of 2022, net cash used in operating activities totaled $1.8 million as compared to $1.2 million during the prior year period, while for the full year 2022, net cash used in operating activities totaled $25.6 million, compared with $33.9 million for the full year 2021. The full-year decrease in net cash used in operating activities was driven by increased product sales and underlying gross profit, as well as by the timing of payments and continued inventory related purchases and payments related to incentive compensation.

Reiterating 2023 Product Revenue Guidance

The Company expects full-year 2023 product revenue will be in the range of $165-$170 million.

Quarterly Conference Call

The Company will host a conference call at 4:30 P.M. EST this afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook. To listen to the live webcast, please visit the Investor Relations page of the Cerus website at View Source

A replay will be available on Cerus’ website approximately three hours after the call through March 14, 2023.

On February 28, 2023 Aligos Therapeutics, Inc. (Nasdaq: ALGS, "Aligos", the "Company"), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in nonalcoholic steatohepatitis (NASH) and viral diseases, reported that it will report the Company’s fourth quarter 2022 financial results on Thursday, March 9, 2023 after the close of the U.S. financial markets (Press release, Aligos Therapeutics, FEB 28, 2023, View Source [SID1234627831]).

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On February 28, 2023 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported financial results for the fourth quarter and year ended December 31, 2022 and provided a corporate update (Press release, Celldex Therapeutics, FEB 28, 2023, View Source [SID1234627827]).

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"Celldex made significant progress over the past year advancing our pipeline. We reported multiple positive data sets from our Phase 1b barzolvolimab program, including updated results from the Phase 1b multi-dose study in chronic spontaneous urticaria this past weekend at AAAAI," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. "Our Phase 2 studies in both inducible and spontaneous urticaria are enrolling as planned and we expect to complete accrual of the Phase 2 CSU study by the end of the third quarter and, importantly, will be in a position to report topline data from this study either late this year or in the first quarter of 2024."

Mr. Marucci continued, "We continue to expand the barzolvolimab program into indications where we believe its unique mechanism could potentially provide new therapeutic options to patients suffering from these difficult diseases and look forward to initiating our Phase 2 study in eosinophilic esophagitis in the first half of 2023 and to presenting Phase 1 data from our prurigo nodularis program later this year. We also made considerable progress on our bispecific platform in 2022, advancing several candidates focused on important targets in inflammatory diseases and are poised to initiate a Phase 1 study of CDX-585, our ILT4 and PD-(L)1 oncology candidate, later this year. Finally, in direct support of our growth, we recently welcomed Dr. Rita Jain to the Celldex Board of Directors and we look forward to her contributions as we continue to advance our programs into later stage development."

Recent Business Highlights

On February 16, 2023, Celldex announced that Rita Jain, M.D. was appointed to the Company’s Board of Directors. Dr. Jain is a rheumatologist and most recently served as Executive Vice President, Chief Medical Officer of ChemoCentryx, Inc. She currently serves as a member of the Board of Directors for Provention Bio, Inc. and serves on the supervisory board of AM Pharma. Celldex believes her deep background in drug development strongly complements the current Board’s skills and experiences.

Recent Program Highlights

Barzolvolimab – KIT Inhibitor Program

Barzolvolimab is a humanized monoclonal antibody developed by Celldex that binds the KIT receptor with high specificity and potently inhibits its activity. The KIT receptor tyrosine kinase is expressed in a variety of cells, including mast cells, which mediate inflammatory responses such as hypersensitivity and allergic reactions. KIT signaling controls the differentiation, tissue recruitment, survival and activity of mast cells.

In June and July 2022, Celldex announced that the first patients have been dosed in the Phase 2 clinical studies of barzolvolimab for the treatment of Chronic Spontaneous Urticaria (CSU) and the two most common forms of chronic inducible urticaria (CIndU) – cold urticaria (ColdU) and symptomatic dermographism (SD). These randomized, double-blind, placebo-controlled, parallel group Phase 2 studies are evaluating the efficacy and safety profile of multiple dose regimens of barzolvolimab in patients who remain symptomatic despite antihistamine therapy, to determine the optimal dosing strategies. Based on current enrollment projections, Celldex anticipates that enrollment to the CSU study will be completed by the end of Q3 2023 and plans to report topline data either late this year or in the first quarter of 2024.

Data from the Phase 1b multiple dose study in patients with antihistamine refractory CSU were presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting on Sunday, February 26, 2023 by Dr. Marcus Maurer, Professor of Dermatology and Allergy at Charité – Universitätsmedizin in Berlin and a lead investigator on the study.

AAAAI 2023 Data Summary:

As of the data cut-off date on November 29, 2022, enrollment was complete with 45 patients with moderate to severe CSU refractory to antihistamines enrolled and treated [35 barzolvolimab (n=9 in 0.5 mg/kg; n=8 in 1.5 mg/kg; n=9 in 3.0 mg/kg; n=9 in 4.5 mg/kg) and 10 placebo]. The 0.5 mg/kg, 1.5 mg/kg and 3.0 mg/kg cohorts had completed study participation through 24 weeks; 6 of 9 patients in the 4.5 mg/kg cohort had completed through the week 20 visit. Complete data were included for all patients in dose levels through 3.0 mg/kg through 24 weeks. All available data for the 4.5 mg/kg and placebo dose levels were presented for adverse events. Activity data for the 4.5 mg/kg dose level were reported through week 20. Activity data for the 0.5 mg/kg and placebo group were only included through week 12 because, as expected, most patients from these groups had significant symptoms ahead of week 24 and discontinued follow up. Two patients did not receive all doses of study treatment [4.5 mg/kg (1), placebo (1)].

— Barzolvolimab resulted in rapid, marked and durable responses in patients with moderate to severe CSU refractory to antihistamines, including patients with prior omalizumab treatment. The 1.5 mg/kg, 3.0 mg/kg and 4.5 mg/kg dose groups showed similar markedly improved urticaria symptoms and disease control with sustained durability up to 24 weeks.

— Mean reduction from baseline in urticaria activity (UAS7) at week 12 of 67% in the 1.5 mg/kg dose group (n=8), 67% in the 3.0 mg/kg dose group (n=9) and 82% in the 4.5 mg/kg dose group (n=9). Complete response (UAS7=0) at week 12 of 57% in the 1.5 mg/kg dose group, 44% in the 3.0 mg/kg dose group and 67% in the 4.5 mg/kg dose group.

— Well-controlled disease (UCT≥ 12) at week 12 of 75% in the 1.5 mg/kg dose group, 63% in the 3.0 mg/kg dose group and 89% in the 4.5 mg/kg dose group.

— Patients with prior omalizumab therapy had similar symptom improvement as all patients.

— 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.
On December 6, 2022, Celldex announced data from the Company’s open label Phase 1b clinical trial of barzolvolimab in patients with antihistamine refractory chronic inducible urticarias, including new data from the Phase 1b 1.5 mg/kg cohort conducted in cold urticaria and long term follow data from the Phase 1b 3.0 mg/kg cohorts conducted in cold urticaria and symptomatic dermographism. The data were presented at the GA²LEN Global Urticaria Forum (GUF) held in Berlin, Germany.

GUF 2022 Data Summary:

Cold Urticaria 1.5 mg/kg intravenous cohort oral presentation: "Cold urticaria patients achieve complete response with 1.5 mg/kg barzolvolimab"

10 patients received a single intravenous infusion of barzolvolimab at 1.5 mg/kg. Patients had high disease activity as assessed by provocation threshold testing. All patients had disease refractory to antihistamines and five patients had disease refractory to omalizumab. Safety results were reported for all 10 patients; activity results were reported for the 9 patients who received a full dose of barzolvolimab, including four patients with omalizumab refractory disease.

— All 9 of 9 (100%) patients evaluable for activity treated at 1.5 mg/kg experienced a complete response as assessed by provocation threshold testing, including 4 patients with disease refractory to omalizumab. Rapid onset of responses after dosing were observed with 6 of 9 patients experiencing complete response within a week of dosing. Responses were durable with a median duration of response of 51+ days (7+ weeks).

— Improvements in disease activity as reported by Urticaria Control Test (UCT) were consistent with the completed responses as measured by provocation testing. All patients entered the cohort with poorly controlled disease. Following barzolvolimab administration, all patients achieved well controlled disease with 7 of 9 achieving complete control.

— A single 1.5 mg/kg dose of barzolvolimab resulted in rapid, marked and durable suppression of serum tryptase. The kinetics of tryptase depletion mirrored changes in provocation threshold and UCT.

— Barzolvolimab was generally well tolerated and the safety profile at 1.5mg/kg was similar to the profile observed with 3.0 mg/kg. No new treatment emergent AEs of concern were noted.

Long-term follow up 3.0 mg/kg intravenous cold urticaria and symptomatic dermographism poster presentation: "Barzolvolimab-induced response and mast cell suppression are durable and linked"

21 patients received a single infusion of barzolvolimab at 3.0 mg/kg, including 11 (10 evaluable for activity) patients with cold urticaria and 10 with symptomatic dermographism. Patients had high disease activity as assessed by provocation threshold testing at baseline and poorly controlled disease by UCT. All patients had disease refractory to antihistamines and three patients had disease refractory to omalizumab. As previously reported, a single 3.0 mg/kg IV dose was generally well tolerated and demonstrated a 95% complete response (negative provocation testing) and 100% well controlled urticaria by Urticaria Control Test (UCT), including in all patients with disease refractory to omalizumab. Profound reduction in serum tryptase and skin mast cells during the 12 week follow up period were observed.

14 patients consented to the optional long term follow up evaluation (6 cold, 8 symptomatic dermographism); 10 of the 14 still had complete control of their disease as assessed by provocation testing at week 12. Data were collected at one or more timepoints beyond week 12 through week 36.

— Most patients had return of symptoms and/or loss of urticaria control between 12 and 36 weeks. Remarkably, two patients remained provocation negative at 36 weeks, and four had well controlled disease (UCT ≥12) 36 weeks post dosing.

— Serum tryptase exhibited a similar rate of recovery as clinical symptoms, while skin mast cells return at a slower rate.

— Drug related adverse events noted during the study all resolved.
Celldex has completed enrollment in the barzolvolimab Phase 1b open label study in chronic inducible urticaria. Patient follow up continues in the cholinergic cohort and is planned for presentation in mid-2023.
Celldex has closed enrollment at 24 patients in the barzolvolimab Phase 1b multi-center, randomized, double-blind, placebo-controlled study in patients with prurigo nodularis (PN), a chronic skin disease characterized by the development of hard, intensely itchy (pruritic) nodules on the skin. Data from this study is planned for presentation in the second half of 2023.
Celldex plans to initiate a Phase 2 international trial of barzolvolimab in eosinophilic esophagitis (EoE), the most common type of eosinophilic gastrointestinal disease, in the first half of 2023.
Bispecific Antibody Platform

CDX-585 – Bispecific ILT4 & PD-(L)1

CDX-585 combines highly active PD-1 blockade with anti-ILT4 blockade to overcome immunosuppressive signals in T cells and myeloid cells. ILT4 is emerging as an important immune checkpoint on myeloid cells.

CDX-585 has successfully completed GMP manufacturing and IND-enabling studies to support clinical development. CDX-585 will initially be developed for the treatment of solid tumors either as monotherapy or in combination with other oncologic treatments and is expected to enter the clinic in 2023 in patients with advanced malignancies.
Fourth Quarter and Twelve Months 2022 Financial Highlights and 2023 Guidance

Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2022 were $305.0 million compared to $323.5 million as of September 30, 2022. The decrease was primarily driven by cash used in operating activities of $21.8 million, partially offset by proceeds from option exercises and unrealized gains due to higher interest rates. At December 31, 2022, Celldex had 47.2 million shares outstanding.

Revenues: Total revenue was $1.6 million in the fourth quarter of 2022 and $2.4 million for the year ended December 31, 2022, compared to $0.3 million and $4.7 million for the comparable periods in 2021. The decrease in revenue for the twelve months ended December 31, 2022 compared to the twelve months ended December 31, 2021 was primarily due to a decrease in services performed under our manufacturing and research and development agreements with Rockefeller University and Gilead Sciences.

R&D Expenses: Research and development (R&D) expenses were $22.9 million in the fourth quarter of 2022 and $82.3 million for the year ended December 31, 2022, compared to $14.7 million and $53.3 million for the comparable periods in 2021. The increase in R&D expenses was primarily due to an increase in barzolvolimab clinical trial, barzolvolimab contract manufacturing, and personnel expenses.

G&A Expenses: General and administrative (G&A) expenses were $6.6 million in the fourth quarter of 2022 and $27.2 million for the year ended December 31, 2022, compared to $6.2 million and $20.5 million for the comparable periods in 2021. The increase in G&A expenses was primarily due to our settlement agreement with SRS, barzolvolimab commercial planning and stock-based compensation expenses.

Changes in Fair Value Remeasurement of Contingent Consideration: The Company recorded a $6.9 million gain on fair value remeasurement of contingent consideration for the twelve months ended December 31, 2022, primarily due to the Company’s decision to deprioritize the CDX-1140 program in the second quarter of 2022.

Litigation Settlement Related Loss: The Company recorded a one-time loss of $15.0 million in the second quarter of 2022 related to the $15.0 million paid to SRS pursuant to our settlement agreement.

Net Loss: Net loss was $26.5 million, or ($0.56) per share, for the fourth quarter of 2022, and $112.3 million, or ($2.40) per share, for the year ended December 31, 2022, compared to a net loss of $20.1 million, or ($0.43) per share, for the fourth quarter of 2021 and $70.5 million, or ($1.64) per share, for the year ended December 31, 2021. The litigation settlement related loss had a ($0.32) impact on net loss per share for the twelve months ended December 31, 2022. The gain on fair value remeasurement of contingent consideration had a $0.15 impact on net loss per share for the twelve months ended December 31, 2022.

Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at December 31, 2022 are sufficient to meet estimated working capital requirements and fund planned operations through 2025, which include our ongoing Phase 1b studies in urticaria and prurigo nodularis and our ongoing and planned Phase 2 studies in CSU, CIndU and EoE.