On March 5, 2024 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported financial results for the fourth quarter and full year 2023 and provided a corporate update (Press release, Compugen, MAR 5, 2024, View Source [SID1234640774]).

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"Our accomplishments in 2023 position us well for an exciting future," said Anat Cohen-Dayag, Ph.D., President, and CEO of Compugen. "We advance into an expected catalyst rich 2024, with a solid balance sheet, an expected extended cash runway into 2027 and validating partnerships. We believe we have the tools in place to accelerate value creation through advancement of our diversified pipeline portfolio along with our computational discovery platform which is the engine powering our competitive advantage."

Dr. Cohen-Dayag added, "Compugen made significant progress in 2023, including a license agreement with Gilead Sciences for our preclinical potential first-in-class, antibody program against IL-18 binding protein, COM503. The deal, including an upfront payment of $60 million and an additional $30 million near term milestone payment, reflects on our computational discovery, research, and development capabilities. Compugen is expected to lead the Phase 1 development of COM503 and is on track for IND submission in the second half of 2024 with subsequent initiation of the Phase 1 study following IND clearance. In 2023 we also progressed our novel COM701 triple combination strategy with the initiation of two proof-of concept studies, in MSS CRC including patients with liver metastases, and in platinum resistant ovarian cancer and we expect to report data from these studies in the first half of 2024 and the fourth quarter of 2024, respectively. While these are particularly challenging indications to treat having historically failed to respond to immunotherapy, representing a high bar for success, we previously presented encouraging clinical data, supported by immune activation suggesting that the unique biology of PVRIG enables anti-PD-1 activity in these challenging indications. The goal of these studies is to further substantiate our clinical findings including our initial biomarker results, to potentially enable us to move forward with a biomarker enriched development strategy."

Dr. Cohen-Dayag continued, "In 2023, our partner AstraZeneca continued to make progress advancing rilvegostomig, a PD-1/TIGIT bispecific antibody, the TIGIT component of which is derived from our COM902, into Phase 3 development in biliary tract cancer. AstraZeneca is also advancing rilvegostomig across multiple other indications and combinations and expects data from two of these Phase 2 trials, in the second half of 2024. This partnership provides further validation to our potential best-in-class anti-TIGIT, COM902, and the extensive clinical program being run by AstraZeneca increases our opportunity for obtaining additional non-dilutive financing through expected future milestone payments and royalties."

Upcoming Expected Milestones:
COM701 +COM902 + pembrolizumab proof-of-concept studies
•
Microsatellite stable colorectal cancer – data in the first half of 2024
•
Platinum resistant ovarian cancer – on track to complete enrolment of at least 20 patients in the first quarter of 2024, and data in the fourth quarter of 2024
COM503 (Licenced to Gilead, Compugen responsible through Phase 1 development)
•
IND submission in the second half of 2024 with subsequent initiation of the Phase 1 study following IND clearance
Rilvegostomig (AstraZeneca’s PD-1/TIGIT bispecific, TIGIT component derived from COM902)
•
Data in the second half of 2024 from Phase 1/2 ARTEMIDE-01 trial in advanced/metastatic NSCLC and Phase 2b GEMINI-HBP trial in hepatobiliary cancer

Fourth Quarter and Full Year 2023 Financial Highlights
Cash: As of December 31, 2023, Compugen had approximately $51.1 million in cash, cash equivalents, restricted cash, and cash investments, compared with approximately $83.7 million as of December 31, 2022. The cash balance at the end of 2023 does not include the receipt of the upfront payment of $60 million from Gilead for the licensing of COM503 and the $10 million milestone payment from AstraZeneca on dosing of the first patient in the rilvegostomig Phase 3 trial in biliary tract cancer. Compugen expects to receive from Gilead an additional $30 million milestone payment on COM503 IND clearance in 2024. All payments from Gilead are subject to a 15% withholding tax. During the three months ended December 31, 2023, the Company sold approximately 0.9 million ordinary shares under it’s at the market offering (ATM) facility pursuant to a sales agreement entered into with Leerink Partners on January 31, 2023, for aggregate gross proceeds of approximately $1.9 million. Subsequent to the financial results for the year ended December 31, 2023, a total of approximately 0.3 million shares were sold through the Company’s ATM facility contributing gross proceeds of approximately $0.6 million. Compugen expects that its cash and cash-related balances will be sufficient to fund its operating plans into 2027. The Company has no debt.

Revenues: Compugen reported approximately $33.5 million in revenues for the fourth quarter and for the year ended December 31, 2023, compared to $7.5 million revenues for each of the comparable periods in 2022. The 2023 recognized revenues include the portion of the upfront payment from the license agreement with Gilead allocated to the license and the $10 million clinical milestone payment from AstraZeneca.

R&D expenses for the fourth quarter and year ended December 31, 2023, increased to approximately $10.9 million, and $34.5 million, respectively, compared with $7.3 million and $30.6 million for the comparable periods in 2022, respectively. The increase in 2023 is mainly due to lower amortization of the deferred participation in R&D expenses following the termination of the agreement with Bristol Myers Squibb, offset by decrease in headcount related expenses. Research and development expenses, as a percentage of total operating expenses, were 78% in 2023 compared to 73% in 2022.

G&A expenses for the fourth quarter and year ended December 31, 2023, were $2.5 million and $9.7 million, respectively, compared with approximately $2.5 million and approximately $10.3 million for the comparable periods in 2022, respectively.

Net Income / Loss: During the fourth quarter of 2023, Compugen reported a net profit of $9.7 million, or 11 cents per basic and diluted share, compared to a net loss of $3.1 million, or 4 cents per basic and diluted share in the comparable period of 2022. Net loss for the year ended December 31, 2023, was $18.8 million, or 21 cents per basic and diluted share, compared with a net loss of $33.7 million, or 39 cents per basic and diluted share in the comparable period in 2022.

Full financial tables are included below.

Conference Call and Webcast Information
The Company will hold a conference call today, March 5, 2024, at 8:30 AM ET to review its fourth quarter and full year 2023 results. To access the conference call by telephone, please dial 1-866-744-5399 from the United States, or +972-3-918-0644 internationally. The call will also be available via live webcast through Compugen’s website, located at the following link. Following the live audio webcast, a replay will be available on the Company’s website.

On March 5, 2024 Chemomab Therapeutics Ltd. (Nasdaq: CMMB) (Chemomab), a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need, reported that CEO Dr. Adi Mor will deliver a corporate presentation and participate in investor meetings at the Leerink Partners Global Biopharma Conference, March 11-13, 2024 in Miami, Florida (Press release, Chemomab, MAR 5, 2024, View Source [SID1234640773]). Dr. Mor’s presentation will be webcast live and will be available at the investor relations section of the Chemomab website for 90 days.

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Leerink Partners Global BioPharma Conference

Date:

March 12, 2024

Time:

10:40am ET

Venue:

Fontainebleau Hotel

Format:

Live presentation and webcast

Webcast Link:

View Source

Information:

[email protected]

On March 5, 2024 Cerus Corporation (Nasdaq: CERS) reported financial results for the fourth quarter and full year ended December 31, 2023 (Press release, Cerus, MAR 5, 2024, View Source [SID1234640772]).

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Recent highlights include:

Fourth-quarter 2023 and full-year 2023 total revenue was comprised of (in thousands, except %):

Three Months Ended

Twelve Months Ended

December 31,

Change

December 31,

Change

2023

2022

$

%

2023

2022

$

%

Product Revenue

$

46,768

$

44,034

$

2,734

6

%

$

156,367

$

162,048

$

(5,681

)

-4

%

Government Contract Revenue

6,574

7,287

(713

)

-10

%

30,430

26,267

4,163

16

%

Total Revenue

$

53,342

$

51,321

$

2,021

4

%

$

186,797

$

188,315

$

(1,518

)

-1

%

The Company is reiterating its full-year 2024 annual product revenue guidance range of $172 million to $175 million. Included in this range is full-year 2024 guidance for INTERCEPT Fibrinogen Complex, which is expected to be between $8 million to $10 million.
Cash and cash equivalents and short-term investments were $65.9 million at December 31, 2023.
"Our fourth quarter performance sets the stage well for what we expect will be sustainable growth, beginning in 2024. On the commercial side, we continue to expect double-digit product revenue growth in 2024, rooted in both the expansion of our INTERCEPT platelet and plasma systems in both the U.S. and internationally, as well as the growth of INTERCEPT Fibrinogen Complex through large national blood center partnerships," stated William "Obi" Greenman, Cerus’ president and chief executive officer. "It is encouraging to see that pathogen inactivation has secured its position as a foundational technology for blood safety and availability across the globe, and we are excited about the opportunities ahead of us for expanding its reach."

"For the fourth quarter, reported net loss attributable to Cerus Corporation narrowed to $1.3 million. In addition, our fourth quarter achievement of reaching and surpassing adjusted EBITDA breakeven is a meaningful milestone for Cerus, and one that we are committed to sustaining and improving upon going forward. We also remain on track to announce the top-line readout soon from ReCePI, the first of our two U.S. Phase 3 studies for INTERCEPT Red Blood Cells," continued Greenman.

Revenue

Product revenue during the fourth quarter of 2023 was $46.8 million, compared to $44.0 million during the prior year period, driven by growth of INTERCEPT platelets across North America, including in both the U.S. and Canada. Product revenue for the full year 2023 was $156.4 million, in line with the Company’s 2023 product revenue guidance range of $155-$158 million, compared to $162.1 million for the full year 2022 driven by previously detailed customer ordering patterns, market dynamics, and timing of national sales agreements for INTERCEPT Fibrinogen Complex.

Fourth-quarter 2023 government contract revenue was $6.6 million, compared to $7.3 million during the prior year period. 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 (RBCs) 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. Reported government contract revenue during the fourth quarter 2023 decreased versus the prior year period primarily due to completion of enrollment across sites in our U.S. Phase 3 ReCePI study for the INTERCEPT Blood System for RBCs.

Product Gross Profit & Margin

Product gross profit for the fourth quarter of 2023 was $26.0 million, increasing by 6% over the prior year period. Product gross margin for the fourth quarter of 2023 was relatively stable year over year at 55.5% compared to 55.7% for the fourth quarter of 2022.

Full-year 2023 product gross profit was $86.4 million, comparable to the prior year. Product gross margin for the full year 2023 was 55.3% compared to 53.7% for the prior year. The improvement in product gross margins was driven by a relatively higher percentage of U.S. sales and increased platelet sales as a relative percentage of total product revenue.

Operating Expenses

Total operating expenses for the fourth quarter of 2023 were $31.6 million compared to $41.8 million for the same period of the prior year, reflecting a year-over-year decrease of 24%. For the full year, 2023 total operating expenses totaled $146.9 million, comparable to 2022 total operating expenses of $147.4 million.

R&D expenses for the fourth quarter of 2023 were $14.3 million, compared to $18.6 million for the fourth quarter of 2022. For the full year 2023, R&D expenses totaled $67.6 million, compared to $64.1 million for the full year 2022. The year-over-year increase in R&D expenses for the full year relate to increased costs associated with development of our next generation illuminator and increased clinical activities which, combined, were partially offset by the impact of our June 2023 restructuring initiatives and lower non-cash stock-based compensation expense.

Selling, general, and administrative (SG&A) expenses narrowed for the fourth quarter of 2023 and totaled $17.3 million, compared to $23.2 million for the fourth quarter of 2022. For the full year 2023, SG&A expenses totaled $75.5 million, compared to $83.3 million for the full year 2022. The year-over-year decrease in SG&A expenses for the fourth quarter and full year was tied to the impact of our June 2023 restructuring initiative and lower non-cash stock-based compensation.

Net Loss Attributable to Cerus Corporation

Net loss attributable to Cerus Corporation for the fourth quarter of 2023 was $1.3 million, or $0.01 per basic and diluted share, compared to a net loss attributable to Cerus Corporation of $13.6 million, or $0.08 per basic and diluted share, for the fourth quarter of 2022.

For the full year 2023, net loss attributable to Cerus Corporation was $37.5 million, or $0.21 per basic and diluted share, compared to a net loss attributable to Cerus Corporation of $42.8 million, or $0.24 per basic and diluted share, for the full year 2022.

Non-GAAP Adjusted EBITDA

Non-GAAP Adjusted EBITDA for the fourth quarter of 2023 was positive $4.7 million, compared to non-GAAP Adjusted EBITDA of negative $3.7 million for the fourth quarter of 2022. Full-year 2023 non-GAAP Adjusted EBITDA was negative $10.7 million, compared to non-GAAP Adjusted EBITDA of negative $12.4 million for full year 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 December 31, 2023, the Company had cash and cash equivalents and short-term investments of $65.9 million, compared to $79.0 million at September 30, 2023, and $102.2 million at December 31, 2022.

As of December 31, 2023, the Company had $60.0 million outstanding on its term loan and $20.0 million drawn on its revolving credit facility. The Company’s revolving line of credit allows for an additional $15.0 million.

For the fourth quarter of 2023, net cash used in operating activities totaled $15.2 million as compared to $1.8 million during the prior year period, while for the full year 2023, net cash used in operating activities totaled $43.2 million, compared with $25.6 million for the full year 2022. Throughout 2023, the Company invested in working capital, namely increased inventory and a significant paydown of its accounts payable and accrued liabilities. The Company plans to bring down reported December 31, 2023 inventory levels and manage other working capital items closely, in order to move closer to generating operating cash flows based on its stated product revenue guidance.

Reiterating 2024 Product Revenue Guidance

The Company expects full-year 2024 product revenue will be in the range of $172 million to $175 million. Included in this range is full-year 2024 INTERCEPT Fibrinogen Complex revenue guidance between $8 million to $10 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 19, 2024.

On March 5, 2024 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, reported an upcoming oral presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024, taking place April 5-10 in San Diego, California (Press release, Black Diamond Therapeutics, MAR 5, 2024, View Source [SID1234640771]). The presentation will describe real world data of the evolving EGFR mutation landscape in patients with NSCLC, highlighting the increasing relevance of "non-classical" EGFR mutations, which can be found in up to 30% of EGFRm NSCLC. The presentation will also describe the profile of BDTX-1535, an oral, brain-penetrant MasterKey inhibitor that selectively targets more than 50 oncogenic EGFR mutations.

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Abstract Number: 1229
Title: BDTX-1535 – A MasterKey EGFR Inhibitor Targeting Classical, Non-Classical and the C797S Resistance Mutation to Address the Evolved Landscape of EGFR Mutant NSCLC
Session Title: Minisymposia
Session Date and Time: Sunday, April 7, 2024, 3:00-5:00pm PDT
Location: San Diego Convention Center

About BDTX-1535
BDTX-1535 is an oral, brain-penetrant MasterKey inhibitor of oncogenic epidermal growth factor receptor (EGFR) mutation in non-small cell lung cancer (NSCLC), including classical driver mutations, families of non-classical driver mutations (e.g., L747P, L718Q), acquired resistance C797S mutation, and complex mutations. BDTX-1535 is a fourth-generation tyrosine kinase inhibitor (TKI) that potently inhibits, based on preclinical data, more than 50 oncogenic EGFR mutations expressed across a diverse group of patients with NSCLC in multiple lines of therapy. Based on preclinical data, BDTX-1535 also inhibits EGFR extracellular domain mutations and alterations commonly expressed in glioblastoma (GBM) and avoids paradoxical activation observed with earlier generation reversible TKIs. A "window of opportunity" trial of BDTX-1535 in patients with GBM is ongoing (NCT06072586) and a Phase 2 trial is currently ongoing in patients with NSCLC (NCT05256290).

On March 5, 2024 Bicycle Therapeutics plc (NASDAQ: BCYC), a biopharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported the acceptance of three abstracts for poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024, taking place in San Diego on April 5-10 (Press release, Bicycle Therapeutics, MAR 5, 2024, View Source [SID1234640770]).

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Poster Presentation Details:

Title: Bicycle Toxin Conjugates for the treatment of solid tumors
Session Title: Cancer Treatment: New Technologies
Date and Time: Tuesday, April 9, at 1:30 p.m. PT/4:30 p.m. ET
Abstract Number: 5807
Speaker/Lead Author: Stephen Walsh, Ph.D., Bicycle Therapeutics

Title: Modulation of the natural killer cell immune response to tumor with a synthetic tumor-immune cell agonist, NK-TICA
Session Title: CAR-NK, NK Engagers and NK Modulators
Date and Time: Monday, April 8, at 9 a.m. PT/12 p.m. ET
Abstract Number: 1340
Speaker/Lead Author: Fay Dufort, Ph.D., Bicycle Therapeutics

Title: Tumor-targeted activation of CD137 using Bicycles: New insights into mechanism of action and discovery of BT7455, a clinical candidate for the treatment of EphA2-expressing cancers
Session Title: Immune Modulation Employing Agonist or Co-Stimulatory Approaches
Date and Time: Tuesday, April 9, at 1:30 p.m. PT/4:30 p.m. ET
Abstract Number: 5301
Speaker/Lead Author: Johanna Lahdenranta, Ph.D., Bicycle Therapeutics

The posters will be made available in the Publications section of bicycletherapeutics.com following the presentations.