On February 20, 2025 Cerus Corporation (Nasdaq: CERS) reported financial results for its full year and fourth quarter ended December 31, 2024 (Press release, Cerus, FEB 20, 2025, View Source [SID1234650411]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Recent highlights include:

•
Total revenue for full-year 2024 and fourth quarter 2024 was comprised of (in thousands, except %):

Three Months Ended

Twelve Months Ended

December 31,

Change

December 31,

Change

Unaudited

Unaudited

2024

2023

$

%

2024

2023

$

%

Product Revenue

$ 50,809

$ 46,768

$ 4,041

9%

$ 180,270

$ 156,367

$23,903

15%

Government Contract Revenue

5,942

6,574

(632)

-10%

21,051

30,430

(9,379)

-31%

Total Revenue

$ 56,751

$ 53,342

$ 3,409

6%

$ 201,321

$ 186,797

$14,524

8%

•
The Company is reiterating its full-year 2025 annual product revenue guidance range of $194 million to $200 million, which includes $12 million to $15 million for INTERCEPT Fibrinogen Complex (IFC).

•
Continued financial execution for full year and Q4 2024:

o
Over 40% improvement in 2024 GAAP net loss attributable to Cerus Corporation to $20.9 million from $37.5 million for the previous year.
o
Achieved positive non-GAAP adjusted EBITDA of $5.7 million for 2024, outperforming against the stated objective of break-even adjusted EBITDA.
o
Generated positive operating cash flows for the fourth straight quarter of 2024 bringing year-to-date positive operating cash flows to $11.4 million, an improvement of almost $55.0 million from 2023.

"Our exceptional fourth quarter performance capped a year of significant growth for Cerus, positioning us well for 2025 and beyond. INTERCEPT double-digit product revenue growth in 2024 reflects the continued momentum of our platelets business and rising clinical demand for our IFC product, underscoring the expanding impact of our pathogen inactivation technology in transfusion medicine," stated William "Obi" Greenman, Cerus’ president and chief executive officer.

"Beyond our top-line growth, we delivered robust financial results, narrowing our GAAP net loss and achieving our communicated target of positive non-GAAP adjusted EBITDA for 2024 – key metrics we remain committed to improving. After achieving positive adjusted EBITDA in 2024 and projecting growth based on our 2025 product revenue guidance, we anticipate leveraging the inherent strengths of our business for continued financial improvement. With a multi-billion dollar total addressable market for existing approved products, enduring customer trust and a first-mover advantage, we believe we are setting new standards in blood safety and are well-positioned for continued success."

Revenue

Product revenue for the full year 2024 was $180.3 million, up $23.9 million from the prior year, representing 15% growth. IFC product revenue for full-year 2024 was $9.2 million, up from $6.5 million from the prior year, representing 42% growth. Product revenue for the fourth quarter of 2024 was $50.8 million, compared to $46.8 million for the prior year period. This year-over-year increase of 9% was driven primarily by growth in the Company’s platelets business, in both EMEA and North America. Fourth quarter product revenue included sales of IFC, which were $3.0 million, up from $2.3 million during the prior year period.

Government contract revenue for the full year 2024 was $21.1 million, compared to $30.4 million for the prior year. Fourth quarter 2024 government contract revenue was $5.9 million, compared to $6.6 million during the prior year period. The Company’s government contract revenue was comprised of funding associated with research and development (R&D) activities related to the INTERCEPT Blood System for RBCs as well as efforts related to the development of next-generation pathogen reduction technology to treat whole blood and development of a lyophilized IFC. Reported government contract revenue during the fourth quarter of 2024 decreased versus the prior year period, primarily due to completion of the U.S. Phase 3 ReCePI clinical trial for INTERCEPT RBCs.

Product Gross Profit & Margin

Full-year 2024 product gross profit was $99.5 million, compared to $86.4 million for the prior year. Product gross margin for the full year 2024 was relatively stable year-over-year at 55.2% compared to 55.3% for the prior year.

Product gross profit for the fourth quarter of 2024 was $27.4 million, increasing by over 5% over the prior year period. Product gross margin for the fourth quarter of 2024 was 53.9%, compared to 55.5% for the prior year period. Product gross margin for the fourth quarter of 2024 decreased versus the prior period, primarily driven by the strengthening U.S. dollar and elevated freight costs driven by measures taken to serve the growing demand for our products in the U.S.

Operating Expenses

Total operating expenses for the year declined over 8% from 2023 levels and were $134.8 million in 2024 compared to $146.9 million in the prior year. The decrease in operating expenses for the year are attributable to the impact of the Company’s 2023 restructuring program, the successful completion and outcome of the ReCePI Phase 3 clinical trial for the red blood cell program offset by higher costs for the company’s next generation illumination device and the increase in enrollment at sites supporting the RedeS Phase 3 clinical trial for red blood cells. For the fourth quarter of 2024, total operating expenses were $34.8 million, compared to $31.6 million for the same period of the prior year, reflecting an increase of 10%.

R&D expenses for the full year 2024 were down 13% to $58.9 million from $67.6 million in the prior year. For the fourth quarter of 2024, R&D expenses were $15.4 million, compared to $14.3 million for the prior year period. The increase in R&D expenses was related to RedeS site ramp enrollment, activities covered under the new U.S. Biomedical Advanced Research and Development Authority (BARDA) contract and submission for CE Mark approval for the Company’s next generation illuminator.

Full-year 2024 SG&A expenses were $75.9 million compared to $75.5 million for the prior year. SG&A expenses for the fourth quarter of 2024 were $19.3 million, compared to $17.3 million for the prior year period. The primary reason for the increase in SG&A expenses was non-cash stock-based compensation, offset by the impact of the Company’s 2023 restructuring. The Company expects to continue seeing significant leverage in SG&A expenses with costs rising modestly relative to the expected revenue growth.

Net Loss Attributable to Cerus Corporation

Net loss attributable to Cerus Corporation for full-year 2024 was $20.9 million, compared to a net loss attributable to Cerus Corporation of $37.5 million for full-year 2023. Net loss attributable to Cerus Corporation for the fourth quarter of 2024 was $2.5 million, or $0.01 per basic and diluted share, compared to a net loss attributable to Cerus Corporation of $1.3 million, or $0.01 per basic and diluted share, for the fourth quarter of 2023.

Non-GAAP Adjusted EBITDA

Importantly, the Company not only outperformed on the top-line but also achieved its other stated 2024 goal of reaching positive non-GAAP adjusted EBITDA, which was a positive $5.7 million for the full-year 2024, compared to a loss of $10.7 million for the full-year 2023. Non-GAAP adjusted EBITDA for the fourth quarter of 2024 was $3.3 million, compared to $4.7 million for the fourth quarter of 2023. The Company expects improvements to GAAP net loss attributable to Cerus Corporation for the full-year 2025 and to maintain a positive non-GAAP adjusted EBITDA for the full-year 2025. 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 Flows

At December 31, 2024, the Company had cash and cash equivalents and short-term investments of $80.5 million, compared to $75.6 million at September 30, 2024, and $65.9 million at December 31, 2023.

As of December 31, 2024, the Company had $65.0 million outstanding on its term loan and $19.3 million drawn on its revolving credit facility. The Company’s revolving line of credit allows for an additional $15.7 million as of December 31, 2024, which is dependent on eligible assets supporting the borrowing base.

For full-year 2024, the Company generated positive operating cash flows of $11.4 million compared to cash used from operations during 2023 of $43.2 million, an improvement of almost $55.0 million. Similarly, for the fourth quarter of 2024, the Company generated positive cash flows of $4.9 million from operations compared to cash used in operations of $15.2 million during the prior year period.

Reiterating 2025 Product Revenue Guidance

The Company expects full-year 2025 product revenue will be in the range of $194 million to $200 million, reflecting 8% to 11% growth from 2024. Included in this range is full-year 2025 IFC revenue guidance between $12 million to $15 million. Product revenue growth is expected to be fueled by continued penetration with U.S. platelet customers, geographic expansion of the INTERCEPT platelet business as well as increasing uptake of IFC in the U.S.

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 6, 2025.

On February 20, 2025 Bantam Pharmaceutical, a drug discovery and development company targeting selective modulation of mitochondrial dynamics in cancer, reported the activation of its first clinical trial site at The University of Texas MD Anderson Cancer Center for its Phase 1 study evaluating BTM-3566 in relapsed/refractory mature B-cell lymphomas (Press release, Bantam Pharmaceutical, FEB 20, 2025, View Source [SID1234650429]). BTM-3566 is a first-in-class, small molecule cancer therapeutic which targets mitochondrial homeostasis via the ATF4-Integrated Stress Response (ISR) pathway to treat aggressive tumors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are pleased to activate our first clinical site at MD Anderson Cancer Center, a world-renowned institution known for its leadership in cancer research and treatment," said Michael Stocum, President & CEO of Bantam Pharmaceutical. "This represents a major milestone for our company as we transition from discovery into clinical development. Through its novel mechanism of action, BTM-3566 has the potential to deliver the tumor-killing potency of chemotherapy with the precision and selectivity of targeted therapies. We are excited to partner with MD Anderson and believe this collaboration reflects our shared commitment to advancing medical research and improving patient outcomes."

The Phase 1 clinical trial is a multicenter, open-label, dose-escalation and -expansion study. The study will evaluate the safety, tolerability, pharmacokinetics, anti-tumor, and pharmacodynamic effects of BTM-3566. Initial clinical data from the trial are expected in the second half of 2025.

Bantam remains dedicated to addressing the need for new treatments targeting aggressive tumors and looks forward to expanding the clinical trial to additional North American sites in the coming months.

For more information about the trial, visit ClinicalTrials.gov and search NCT number NCT06792734.

About BTM-3566

BTM-3566 is a novel, orally available small molecule designed to target a wide range of cancers, including both hematologic and solid tumors. Its initial clinical focus is on mature B-cell lymphomas, such as mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), and follicular lymphoma (FL). In preclinical studies, BTM-3566 demonstrated potent anti-cancer activity, driving significant tumor regression – and in many cases, complete tumor elimination – in tumor models resistant to standard treatments, including CAR-T cell therapy. BTM-3566 works by disrupting the mitochondrial function in tumor cells, triggering their natural cell death process (apoptosis). With its unique mechanism of action and strong preclinical data, Bantam also plans to expand clinical development into solid tumors, broadening its potential impact for patients with limited treatment options.

On February 20, 2025 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), reported that company management will participate in two upcoming investment bank conferences (Press release, Crinetics Pharmaceuticals, FEB 20, 2025, View Source [SID1234650412]). The TD Cowen 45th Annual Healthcare Conference is being held in Boston, MA, and the Leerink Global Healthcare Conference is taking place in Miami, FL.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

TD Cowen 45th Annual Healthcare Conference
Fireside chat on Monday, March 3, 2025 at 11:10 a.m. Eastern Time
Webcast link HERE

Leerink Global Healthcare Conference
Fireside chat on Monday, March 10, 2025 at 4:20 p.m. Eastern Time
Webcast link HERE

The live and archived webcasts will be accessible on the Events & Presentations page in the Investors section of the Crinetics’ website at www.crinetics.com/events.

If you are interested in arranging a 1×1 meeting with management, please contact your conference representative.

On February 20, 2025 TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) , a clinical-stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, reported that its CEO will join the Cancer Progress Panel discussion on February 27th at 1:10 pm CET at the 18th Annual European Life Sciences CEO Forum, which will include HealthTech topics such as AI, convergence, and diagnostics (Press release, TC Biopharm, FEB 20, 2025, View Source [SID1234650431]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The forum will take place on the 26th – 27th of February 2025 at the Hilton Zurich Airport Hotel. The main programme for the 18th Annual ELSF will feature more than 12 hours of high-level keynotes and panel discussions.

Additionally, there will be a global company showcase of 50+ presentations by established public, private, emerging, and seed companies, offering innovative solutions and seeking investment and partnering opportunities. For more information about the 18th Annual European Life Sciences CEO Forum.

On February 20, 2025 Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, reported financial results for the fourth quarter and full year ended December 31, 2024 (Press release, Dynavax Technologies, FEB 20, 2025, View Source [SID1234650413]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In 2024, we successfully executed on our strategic growth initiatives, achieving record HEPLISAV-B product revenue, advancing our pipeline programs, and maintaining a disciplined approach to capital allocation," said Ryan Spencer, Chief Executive Officer of Dynavax. "Looking ahead to 2025, we plan to drive significant top-line growth as we continue to establish HEPLISAV-B as the market share leader in the expanding hepatitis B vaccine market in the U.S. We also expect to advance our pipeline programs to key milestones this year, including providing top-line results from our shingles vaccine Phase 1/2 program in the third quarter, as well as completing our $200 million share capital return and pursuing external opportunities to generate sustainable long-term value for our shareholders and other stakeholders."

BUSINESS UPDATES
HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted]
HEPLISAV-B vaccine is the first and only adult hepatitis B vaccine approved in the U.S., the European Union and the United Kingdom that enables series completion with only two doses in one month. Hepatitis B vaccination is universally recommended for adults aged 19-59 in the U.S.

HEPLISAV-B achieved record net product revenue of $268.4 million for the full year 2024, an increase of 26% compared to $213.3 million for the full year 2023.
HEPLISAV-B achieved quarterly net product revenue of $71.1 million for the fourth quarter of 2024, an increase of 39% compared to $51.1 million for the fourth quarter of 2023.
HEPLISAV-B total estimated market share in the U.S. increased to approximately 44% at the end of 2024, compared to approximately 42% at the end of 2023.
Dynavax continues to expect the hepatitis B adult vaccine market in the U.S. to expand to a peak of over $900 million in annual sales by 2030, with HEPLISAV-B expected to achieve at least 60% total market share. Additionally, Dynavax believes the HEPLISAV-B U.S. market opportunity will remain substantial beyond 2030 due to the ongoing penetration of the unvaccinated eligible adult population, observed revaccination practices by healthcare providers, and continued gains in market share.
Clinical Pipeline
Dynavax is advancing a pipeline of differentiated product candidates that leverage its CpG 1018 adjuvant, which has demonstrated its ability to enhance the immune response with a favorable tolerability profile in a wide range of clinical trials and real-world commercial use.

Shingles Vaccine Program:
Z-1018 is an investigational vaccine candidate being developed for the prevention of shingles in adults aged 50 years and older.

Dynavax is currently conducting a randomized, active-controlled, dose escalation, multicenter Phase 1/2 trial to evaluate the safety, tolerability, and immunogenicity of Z-1018 compared to Shingrix in 441 healthy adults aged 50 to 69.
In the fourth quarter of 2024, the Company completed enrollment in the trial, and Dynavax anticipates reporting top-line immunogenicity and safety data in the third quarter of 2025.
Plague Vaccine Program:
Dynavax is developing a plague (rF1V) vaccine candidate adjuvanted with CpG 1018 in collaboration with, and fully funded by, the U.S. Department of Defense (DoD).

Based on the results from a randomized, active-controlled Phase 2 clinical trial of the plague vaccine adjuvanted with CpG 1018, Dynavax and the DoD executed a new agreement for approximately $30 million through the first half of 2027 to support additional clinical and manufacturing activities, including a Phase 2 clinical trial expected to initiate in the third quarter of 2025.
HEPLISAV-B for Adults on Hemodialysis:
Dynavax is developing a four-dose HEPLISAV-B vaccine regimen for adults on hemodialysis.

In the fourth quarter of 2024, Dynavax received feedback from the FDA regarding the potential to conduct an observational retrospective cohort study to support its sBLA filing for adults on hemodialysis.
FOURTH QUARTER 2024 FINANCIAL HIGHLIGHTS

Total revenues were $72.0 million for the fourth quarter of 2024, a 30% increase compared to $55.6 million for the fourth quarter of 2023.
HEPLISAV-B net product revenue was $71.1 million for the fourth quarter of 2024, a 39% increase compared to $51.1 million for the fourth quarter of 2023.
Cost of sales – product for HEPLISAV-B were $13.4 million for the fourth quarter of 2024, compared to $8.7 million for the fourth quarter of 2023.
Research and development expenses (R&D) were $18.7 million for the fourth quarter of 2024, compared to $14.1 million for the fourth quarter of 2023.
Selling, general, and administrative expenses (SG&A) were $41.6 million for the fourth quarter of 2024, compared to $41.3 million for the fourth quarter of 2023.
GAAP net income was $7.1 million, or $0.06 per share (basic) and $0.05 per share (diluted) for the fourth quarter of 2024, compared to GAAP net income of $0.2 million, or $0.00 per share (basic and diluted) for the fourth quarter of 2023.
Adjusted EBITDA* (excluding stock-based compensation) was $13.4 million for the fourth quarter of 2024, compared to $4.1 million for the fourth quarter of 2023, representing a 225% increase year-over-year.
Cash, cash equivalents and marketable securities were $713.8 million as of December 31, 2024, compared to $742.3 million as of December 31, 2023.
Share Repurchase Program: In November 2024, Dynavax announced a $200 million share repurchase program authorized by its Board of Directors, including $100 million repurchased through an Accelerated Share Repurchase program, which was completed in the first quarter of 2025. The Company expects to complete the remainder of the $200 million share repurchase program by the end of 2025.
FULL YEAR 2024 FINANCIAL HIGHLIGHTS

Total revenues were $277.2 million for the full year 2024, a 19% increase compared to $232.3 million for the full year 2023.
HEPLISAV-B net product revenue was $268.4 million for the full year 2024, a 26% increase compared to $213.3 million for the full year 2023.
Cost of sales – product for HEPLISAV-B were $49.4 million for the full year 2024, compared to $50.2 million for the full year 2023.
Research and development expenses (R&D) were $61.6 million for the full year 2024, compared to $54.9 million for the for the full year 2023.
Selling, general, and administrative expenses (SG&A) were $170.4 million for the full year 2024, compared to $152.9 million for the for the full year 2023.
GAAP net income was $27.3 million, or $0.21 per share (basic) and $0.20 per share (diluted) for the full year 2024, compared to GAAP net loss of $6.4 million, or ($0.05) per share (basic and diluted) for the full year 2023.
Adjusted EBITDA* (excluding stock-based compensation) was $51.9 million for the full year 2024, compared to $12.1 million for the full year 2023, representing a 329% increase year-over-year.
FULL YEAR 2025 FINANCIAL GUIDANCE
Dynavax is providing its full year 2025 financial guidance, based on the Company’s current operating plan:

HEPLISAV-B net product revenue is expected in the range of $305 to $325 million.
Adjusted EBITDA* (excluding stock-based compensation) is expected to be at least $75 million.
* Non-GAAP financial measure. Please refer to the "Non-GAAP Financial Measures" section for details regarding this measure.

Conference Call and Webcast Information
Dynavax will host a conference call and live audio webcast on Thursday, February 20, 2025, at 4:30 p.m. ET/1:30 p.m. PT. The live audio webcast may be accessed through the "Events & Presentations" page on the "Investors" section of the Company’s website at View Source A replay of the webcast will be available for 30 days following the live event.

To dial into the call, participants will need to register for the call using the participant call link. It is recommended that participants dial into the conference call or log into the webcast approximately 10 minutes prior to the call.

WHAT IS HEPLISAV-B?
HEPLISAV-B is a shot given to adults 18 years of age and older to help prevent infection caused by the hepatitis B virus. HEPLISAV-B is usually given in the arm muscle. HEPLISAV-B is given in 2 doses, 1 month apart, by a healthcare provider.

IMPORTANT SAFETY INFORMATION
Do not administer HEPLISAV-B to individuals with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast.

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B.

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B.

Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.

The most common patient-reported adverse reactions reported within 7 days of vaccination were injection site pain (23%-39%), fatigue (11%-17%), and headache (8%-17%).

There are no adequate and well-controlled studies of HEPLISAV-B in pregnant individuals. Available data, primarily in individuals who received one dose of HEPLISAV-B in the 28 days prior to or during pregnancy, do not suggest an increased risk of major birth defects and miscarriage.

It is not known whether HEPLISAV-B is excreted in human milk.

Data are not available to assess the effects of HEPLISAV-B on the breastfed infant or on milk production/excretion.

Vaccination with HEPLISAV-B may not result in protection of all vaccine recipients.

Talk to your healthcare provider to determine if HEPLISAV-B is right for you.