On May 4, 2023 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported its business update and financial results for the first quarter ended March 31, 2023 (Press release, Curis, MAY 4, 2023, View Source [SID1234631026]).

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"I am pleased with our progress in the TakeAim leukemia study. We enrolled the additional patients requested by FDA ahead of schedule in the first quarter – which is indicative of both the clear unmet need in leukemia and the excitement among the clinical community for this novel agent. We are on track to collect data from these patients in the second quarter and discuss these data with the FDA in the third quarter of this year. I am also pleased to announce the expansion of the Curis Executive Team with the addition of Jonathan Zung, Ph.D. as our Chief Development Officer. Dr. Zung is a well-respected leader in the industry and brings a wealth of experience from senior roles across the industry, most recently at Evelo. We look forward to his contributions toward our mission at Curis," said James Dentzer, President and CEO of Curis.

"I am excited to be joining the Curis team during this critical time, as the company advances its first-in-class IRAK4 inhibitor, emavusertib. In biotech, it is rare to find a novel target with such broad therapeutic potential in that exciting period between the initial demonstration of clear single agent activity and the final stage of clinical development. I look forward to working with the Curis team on the clinical development of emavusertib and helping to establish it as a cornerstone therapy in hematologic malignancies," said Dr. Zung.

First Quarter 2023 and Recent Operational Highlights

Appointed new CDO

Dr. Zung was appointed as Chief Development Officer of Curis on May 1, 2023. Prior to joining Curis, he served as CDO of Evelo Biosciences, where he was responsible for the operational design and execution of Evelo’s clinical programs. Dr. Zung held previous leadership roles at WCG, Covance, UCB, Bristol Myers Squibb, and Pfizer. He also serves on the advisory board of Saama Technologies. He received his Ph.D. in analytical chemistry from Emory University.

Upcoming Milestones

Curis completed the enrollment of 9 additional patients at the 200mg BID dose level requested by FDA, is collecting data on those patients in the second quarter, and expects to discuss those data with FDA in the third quarter of 2023. Discussions with the FDA are expected to determine the recommended Phase 2 dose and resolution of the partial clinical hold on emavusertib development in leukemia.
First Quarter 2023 Financial Results

For the first quarter of 2023, Curis reported a net loss of $11.6 million or $0.12 per share on both a basic and diluted basis as compared to $16.1 million or $0.18 per share on both a basic and diluted basis, for the same period in 2022.

Revenues for the first quarter of 2023 were $2.3 million as compared to $2.1 million for the same period in 2022. Revenues for both periods consist of royalty revenues from Genentech’s and Roche’s sales of Erivedge.

Research and development expenses were $9.1 million for the first quarter of 2023, as compared to $11.4 million for the same period in 2022. The decrease is primarily attributable to the timing of manufacturing costs and lower employee related costs due to a reduction in headcount.

General and administrative expenses were $4.8 million for the first quarter of 2023, as compared to $5.7 million for the same period in 2022. The decrease was mainly attributable to lower employee related costs due to a reduction in headcount.

Other income, net was $0.1 million for the first quarter of 2023, as compared to other expense, net of $1.0 million for the same period in 2022. Other income (expense), net primarily consisted of interest income partially offset by expense related to future royalty payments.

As of March 31, 2023, Curis’s cash, cash equivalents and investments totaled $71.8 million, and the Company had approximately 96.6 million shares of common stock outstanding. Curis expects its existing cash, cash equivalents and investments should enable it to maintain its planned operations into 2025.

Conference Call Information

Curis management will host a conference call today, May 4, 2023, at 4:30 p.m. ET, to discuss the business update and these financial results.

To access the live conference call, please dial 1-888-346-6389 from the United States or 1-412-317-5252 from other locations, shortly before 4:30 p.m. ET. The conference call can also be accessed on the Curis website in the Investors section.

On May 4, 2023 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), (Nasdaq: CRNX) reported financial results for the first quarter ended March 31, 2023 (Press release, Crinetics Pharmaceuticals, MAY 4, 2023, View Source [SID1234631025]).

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"We plan to share topline results from PATHFNDR-1 next quarter, which should provide an important look at the impact that paltusotine may have on patients’ lives," said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. "We designed the two PATHFNDR studies to address both treatment-naïve patients as well as patients who may switch from standard of care, the two patient populations specifically outlined in the recently released draft guidance from the FDA on Developing Drugs for Acromegaly Treatment."

Dr. Struthers continued, "Enrollment in PATHFNDR-2 has benefited from enthusiastic participation of treatment-naïve patients. This enables us to take advantage of a prespecified opportunity to increase the study’s enrollment target while maintaining our estimated timeline of topline data in the first quarter of 2024. We anticipate this will provide an even clearer picture of paltusotine’s potential to treat patients who have been recently diagnosed with acromegaly and could strengthen the competitive position of paltusotine from a market and payer perspective, if approved."

CLINICAL PROGRAM UPDATES:
Paltusotine’s Phase 3 PATHFNDR-1 study: enrollment complete with topline data expected in 3Q 2023. PATHFNDR-1 is a placebo-controlled Phase 3 clinical study of once-daily, oral paltusotine in participants with acromegaly switching from standard-of-care peptide depots. It is designed to support an indication for the maintenance of acromegaly treatment. The study enrolled participants with acromegaly who were biochemically controlled (IGF-1 ≤ 1.0x upper limit of normal) on octreotide or lanreotide depot monotherapy. The primary endpoint of the study is the proportion of participants who maintain biochemical control on paltusotine vs. placebo. Final study enrollment is 58 participants with topline data expected in the third quarter of 2023.
Paltusotine’s Phase 3 PATHFNDR-2 study: enrollment ongoing with enrollment target increased to up to 98; topline data expected in 1Q 2024. PATHFNDR-2 is a placebo-controlled Phase 3 clinical study designed to support an indication for the treatment of acromegaly. The study is enrolling participants with acromegaly with elevated IGF-1 levels who are either treatment-naïve or untreated for at least four months (Stratum 1), or who wash out of prior octreotide or lanreotide therapy (Stratum 2). The current enrollment has included a higher enrollment of participants in Stratum 1 as compared to Stratum 2. Accordingly, Crinetics has elected to adjust PATHFNDR-2’s sample size to enable enrollment of up to 98 participants, which was an option prespecified in the study protocol. In addition to preserving statistical power to detect a difference on the primary endpoint, increasing the study’s sample size may enable a statistical comparison of Stratum 1 participants receiving either paltusotine or placebo. Topline data from the study are expected in the first quarter of 2024, in line with prior guidance.
Paltusotine NDA Submission anticipated in 2024. Pending a successful outcome from the PATHFNDR studies, Crinetics plans to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) seeking regulatory approval for paltusotine in acromegaly with both treatment and maintenance of treatment indications.
Phase 2 open-label study of paltusotine in carcinoid syndrome ongoing. The Phase 2 open-label study of paltusotine in carcinoid syndrome associated with neuroendocrine tumors continues to enroll participants with preliminary data expected in the fourth quarter of 2023.

Advancing CRN04894 studies in Cushing’s disease and congenital adrenal hyperplasia. Based on successful Phase 1 studies demonstrating pharmacologic proof-of-concept, Crinetics is conducting clinical studies of CRN04894 in patients with Cushing’s disease and congenital adrenal hyperplasia. Data from both studies is expected in 2024.

CRN04777 progress. In November 2022, the FDA informed Crinetics that its planned Phase 2 study of CRN04777 in pediatric participants with congenital hyperinsulinism was not yet permitted to proceed. Crinetics plans to submit additional information and data to the FDA to support a release of the clinical hold on the planned Phase 2 study. The planned Phase 2 study is supported by pharmacologic proof-of-concept results from a successful Phase 1 study in healthy adult volunteers conducted under a Clinical Trial Application in Germany.

FIRST QUARTER 2023 FINANCIAL RESULTS

Research and development expenses were $38.5 million for the three months ended March 31, 2023, compared to $28.3 million for the same period in 2022. The increase was primarily attributable to an increase in personnel costs of $7.0 million and increased consulting and outside services of $1.4 million to support paltusotine, CRN04894, CRN04777, and our preclinical programs.

General and administrative expenses were $12.2 million for the three months ended March 31, 2023, compared to $8.7 million for the same period in 2022. The increase was primarily attributable to an increase in personnel costs of $2.7 million and an increase in other corporate expenditures of $0.8 million.
Net loss for the three months ended March 31, 2023 was $46.0 million, compared to a net loss of $34.6 million for the same period in 2022.

Revenues were $2.7 million for the three months ended March 31, 2023, compared to $3.1 million for the same period in 2022. Revenues in both periods were derived from out-licensing arrangements: for CRN01941 in March 2023 and paltusotine in February 2022.

Unrestricted cash, cash equivalents, and investments totaled $296.1 million as of March 31, 2023, compared to $334.4 million as of December 31, 2022. Based on its current projections, the company expects that its cash, cash equivalents and short-term investments will fund its current operating plan through 2024.
The company had 53,994,770 common shares outstanding as of May 1, 2023.

On May 4, 2023 Cerus Corporation (Nasdaq: CERS) reported financial results for the first quarter ended March 31, 2023 (Press release, Cerus, MAY 4, 2023, View Source [SID1234631024]).

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Recent highlights include:

First quarter 2023 total revenue of $38.5 million was comprised of (in thousands, except %):

Three Months Ended

March 31,

Change

2023

2022

$

%

Product Revenue

$

30,974

$

37,444

$

(6,470

)

-17

%

Government Contract Revenue

7,502

5,576

1,926

35

%

Total Revenue

$

38,476

$

43,020

$

(4,544

)

-11

%

The Company is reiterating its full-year 2023 annual product revenue guidance range of $165 million to $170 million.
Completed successful debt refinancing, providing for longer time before principal repayments are required, company options for an additional $20 million and expansion of the revolving line of credit up to $35 million.
Received Medical Device Regulation (MDR) certification for INTERCEPT platelets processing sets.
Submitted INTERCEPT platelets dossier to the Chinese regulatory authority, the National Medical Products Administration (NMPA).
Cash, cash equivalents, and short-term investments were $94.7 million at March 31, 2023.
"With anticipated first-quarter headwinds largely behind us as more normalized customer order patterns resume, we continue to be optimistic about our return to growth for the duration of 2023, supporting our full-year product revenue guidance of $165-170 million," said William "Obi" Greenman, Cerus’ president and chief executive officer. "The INTERCEPT Blood System continues to be the technology of choice in the U.S. for platelet safety, and we expect to see continued adoption in other geographies this year as well."

"We have multiple commercial milestones on tap this year, including ongoing roll-out of INTERCEPT platelets in Canada as well as regulatory progress in China via our joint venture. We remain committed to achieving adjusted EBITDA breakeven this year which, combined with our strong balance sheet and recently completed debt refinancing, would put us in a strategically strong position. Accordingly, this would allow us to reinvest cash flows into continued growth, margin expansion and scale, and new product development," Greenman continued.

Revenue

Product revenue during the first quarter of 2023 was $31.0 million, compared to $37.4 million during the prior year period. The decrease in product revenue was driven primarily by the anticipated short-term U.S. customer inventory drawdown, discussed during the Company’s fourth-quarter 2022 call. The Company expects that this dynamic has largely played out.

First-quarter 2023 government contract revenue was $7.5 million, compared to $5.6 million during the prior year period. Reported government contract revenue in the first quarter 2023 increased versus the prior year period primarily due to funding associated with development of a lyophilized INTERCEPT Fibrinogen Complex. In addition to this funding, 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.

Product Gross Profit & Margin

Product gross profit for the first quarter of 2023 was $17.3 million, down by 11% over the prior year period. Product gross margin for the first quarter of 2023 was 55.8% compared to 51.7% for the first quarter of 2022. The first quarter of 2023 represents the fifth consecutive quarter of gross margin expansion. The Company expects that a number of initiatives aimed at lowering cost of goods sold will contribute to continued margin expansion over time.

Operating Expenses

Total operating expenses for the first quarter of 2023 were $38.9 million compared to $34.8 million for the same period of the prior year, reflecting a year-over-year increase of 12%.

Selling, general, and administrative (SG&A) expenses for the first quarter of 2023 totaled $21.6 million, compared to $20.7 million for the first quarter of 2022. The year-over-year increase in SG&A expenses for the first quarter was tied to investments in field-based personnel in support of commercial growth, costs of attracting and retaining our employees, legal fees, and non-cash stock-based compensation.

R&D expenses for the first quarter of 2023 were $17.4 million, compared to $14.1 million for the first quarter of 2022. The year-over-year increase in R&D expenses in the first quarter was tied to the development of our next-generation illuminator and increased clinical research activities.

Net Loss Attributable to Cerus Corporation

Net loss attributable to Cerus Corporation for the first quarter of 2023 was $15.6 million, or $0.09 per basic and diluted share, compared to a net loss attributable to Cerus Corporation of $12.3 million, or $0.07 per basic and diluted share, for the first quarter of 2022.

Non-GAAP Adjusted EBITDA

Non-GAAP Adjusted EBITDA for the first quarter of 2023 was negative $9.8 million, compared to non-GAAP Adjusted EBITDA of negative $3.7 million for the first quarter of 2022. 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 March 31, 2023, the Company had cash, cash equivalents and short-term investments of $94.7 million, compared to $102.2 million at December 31, 2022.

As of March 31, 2023, the Company had $55.0 million outstanding on its term loan and $18.0 million drawn on its revolving credit facility. The Company has access to $17 million under its revolving line of credit.

For the first quarter of 2023, net cash used in operating activities totaled $8.5 million as compared to $21.5 million during the prior year period, primarily due to the timing of cash collections and payments, offset by continued inventory related purchases.

Reiterating 2023 Product Revenue Guidance

The Company expects full-year 2023 product revenue will be in the range of $165-$170 million, underscoring a return to growth with the short-term customer inventory drawdown largely complete.

Quarterly Conference Call

The Company will host a conference call at 4:30 P.M. EDT 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 May 18, 2023.

On May 4, 2023 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted treatments for cancer, reported financial results for the first quarter ended March 31, 2023 and provided a corporate update (Press release, Cellectar Biosciences, MAY 4, 2023, View Source [SID1234631022]).

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First Quarter and Recent Corporate Highlights

· Presented at both the Roth Capital Partners 35th Annual Conference on March 13, 2023, and the Oppenheimer 33rd Annual Healthcare Conference on March 14, 2023. A replay of the Oppenheimer presentation is available on the Events Page of the Company’s IR website.

"We maintained strong operational momentum in the first quarter, with our primary focus being the execution of our pivotal trial of iopofosine in Waldenstrom’s macroblobulinemia (WM). In parallel with study enrollment and anticipated conclusion, we continue to prepare for the commercial launch of iopofosine." said James Caruso, president and CEO of Cellectar. "At the same time, we are advancing other key programs for iopofosine and are encouraged by the data observed, some of which we presented at recent scientific conferences. We remain pleased with the depth of our clinical program and collectively believe 2023 will be a very meaningful year for us as we look forward to key data announcements including topline data from our WM pivotal study."

First Quarter 2023 Financial Highlights

· Cash and Cash Equivalents: As of March 31, 2023, the company had cash and cash equivalents of $12.7 million, compared to $19.9 million as of December 31, 2023. Net cash used in operating activities during the three months ended March 31, 2023 was approximately $7.2 million. The company believes its cash on hand is adequate to fund budgeted operations into the fourth quarter of 2023.

· Research and Development Expense: R&D expense for the three months ended March 31, 2023 was approximately $6.7 million, compared to approximately $3.9 million for the three months ended March 31, 2022. The overall increase in research and development expense was driven by increased clinical, manufacturing and related costs.

· General and Administrative Expense: G&A expense for the three months ended March 31, 2023 was $2.1 million, compared to $2.3 million for the same period in 2022. The overall decrease in G&A costs was primarily driven by a decrease in professional fees, partially offset by increased personnel costs.

· Net Loss: The net loss attributable to common stockholders for the three months ended March 31, 2023 was ($8.6) million, or ($0.76) per share, compared to ($6.1) million, or ($1.00) per share, for the three months ended March 31, 2023.

On May 4, 2023 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported financial results for the first quarter ended March 31, 2023 and provided a corporate update (Press release, Celldex Therapeutics, MAY 4, 2023, View Source [SID1234631021]).

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"This quarter, we were excited to report additional positive data from our barzolvolimab Phase 1b multi-dose study in chronic spontaneous urticaria. We believe the rapid, durable and profound responses and the favorable safety profile observed in this study continue to position barzolvolimab as a potential best-in-class addition to a historically limited treatment landscape for patients and their physicians," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. "We look forward to presenting additional data from this study and also from the cholinergic cohort in the Phase 1b CIndU study at EAACI next month, where both data sets have been accepted for oral presentations."

"Importantly, our Phase 2 studies in chronic urticaria continue to progress as planned and we are on track to complete enrollment of the Phase 2 CSU study by the end of the third quarter, with topline data expected late this year or in the first quarter of 2024. 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 providing updates on our eosinophilic esophagitis and prurigo nodularis studies throughout the year."

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 had 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. Updated data from this study have been accepted for oral presentation at the EAACI Hybrid Congress 2023, to be held in Hamburg, Germany, June 9 – 11 and on the EAACI Digital Events Platform.

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.

Celldex has completed enrollment in the barzolvolimab Phase 1b open label study in chronic inducible urticaria. Data from the cholinergic cohort in this study have been accepted for oral presentation at the EAACI Hybrid Congress 2023, to be held in Hamburg, Germany, June 9 – 11 and on the EAACI Digital Events Platform.

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. The study remains blinded. Celldex plans to present data from the ongoing study, including 24 weeks of follow-up, in the fourth quarter at a medical meeting and is planning for the initiation of a Phase 2 subcutaneous study in PN in late 2023 or early 2024.

Celldex plans to initiate a Phase 2 international trial of barzolvolimab in eosinophilic esophagitis (EoE), the most common type of eosinophilic gastrointestinal disease, in June of 2023.
Bispecific Antibody Platform

CDX-585 – Bispecific ILT4 & PD-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 mid-2023 in patients with advanced malignancies.
First Quarter 2023 Financial Highlights and 2023 Guidance

Cash Position: Cash, cash equivalents and marketable securities as of March 31, 2023 were $278.4 compared to $305.0 million as of December 31, 2022. The decrease was primarily driven by cash used in operating activities of $28.6 million, partially offset by proceeds from stock issuances under employee benefit plans and unrealized gains due to higher interest rates. At March 31, 2023, Celldex had 47.2 million shares outstanding.

Revenues: Total revenue was $1.0 million in the first quarter of 2023, compared to $0.2 million for the comparable period in 2022. The increase in revenue was primarily due to an increase in services performed under our manufacturing and research and development agreement with Rockefeller University.

R&D Expenses: Research and development (R&D) expenses were $26.8 million in the first quarter of 2023, compared to $17.1 million for the comparable period in 2022. 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 first quarter of 2023, compared to $6.9 million for the comparable period in 2022. The decrease in G&A expenses was primarily due to a decrease in legal expenses, partially offset by an increase in stock-based compensation expense.

Changes in Fair Value Remeasurement of Contingent Consideration: The Company recorded a $0.5 million gain on fair value remeasurement of contingent consideration for the three months ended March 31, 2022, primarily due to changes in discount rates.

Net Loss: Net loss was $29.4 million, or ($0.62) per share, for the first quarter of 2023, compared to a net loss of $23.1 million, or ($0.49) per share, for the comparable period in 2022.

Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at March 31, 2023 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.