On August 1, 2024 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 inhibitor, reported its financial and operating results for the second quarter ended June 30, 2024 (Press release, Curis, AUG 1, 2024, View Source [SID1234645258]).

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Operational Highlights

TakeAim Lymphoma

In July 2024, emavusertib was granted Orphan Drug Designation (ODD) by the European Commission (EC) for the treatment of patients with primary central nervous system lymphoma (PCNSL). To qualify for ODD in the European Union, among several requirements, emavusertib must be intended for the treatment, prevention or diagnosis of a disease that is life-threatening or chronically debilitating and the prevalence of the condition must be fewer than 5 in 10,000 across the EU.

"We are extremely pleased that emavusertib has been granted ODD in the EU for the treatment of PCNSL. The designation is significant for the development of emavusertib in the EU and shows the high unmet need for this patient population," said Jonathan Zung, Chief Development Officer.

In addition to the EC ODD designation, Curis continues to progress the clinical development of emavusertib and expects to have initial data for 15-20 patients with R/R PCNSL by late 2024.

"We are pleased with our progress in the TakeAim Lymphoma study and look forward to providing updated data at the ASH (Free ASH Whitepaper) conference in December. As we continue the expansion of clinical sites in our PCNSL study, we have initiated discussions with health authorities to align on a registrational development path for emavusertib in PCNSL. We are excited to take this next step in advancing a novel treatment for patients with PCNSL," said James Dentzer, President and Chief Executive Officer.

TakeAim Leukemia

In May 2024, Curis released data for 25 new patients in the Relapsed/Refractory (R/R) FLT3 mutation (FLT3m) and U2AF1/SF3B1 Splicing Factor mutation (SFm) cohorts who had received fewer than 3 lines of prior therapy and were treated with emavusertib as monotherapy at the Recommended Phase 2 Dose (RP2D) of 300 mg BID. 12 R/R AML patients with FLT3m were treated with emavusertib. Preliminary data show 6 objective responses in 11 response-evaluable patients: 3 complete remission (CR), 1 CR with partial hematologic recovery (CRh) and 2 morphologic leukemia-free state (MLFS) with on-treatment duration range of 46-324 days. 4 patients were ongoing at the data-cutoff, including 1 CRh and 1 MLFS. 20 R/R AML patients with SFm were treated with emavusertib. Preliminary data show 4 of 18 response-evaluable patients in this population have achieved objective response (CR/CRh/MLFS). 8 of 20 patients were ongoing at the data-cutoff, including 1 MLFS. 2 patients were not response-evaluable.

Upcoming Presentations

On September 26, 2024, Curis will be hosting the 3rd Annual Symposium on IRAK-4 in cancer. The symposium will be hosted by Dr. Eric S. Winer and Dr. Grzegorz S. Nowakowski and will focus on IRAK-4 and the promise of IRAK-4 inhibition in both hematologic malignancies and solid tumors.

Upcoming Milestones

TakeAim Lymphoma – updated clinical data from the on-going combination study of emavusertib with ibrutinib in patients with R/R PCNSL in late 2024.
TakeAim Leukemia – updated clinical data from the on-going monotherapy study of emavusertib in patients with R/R AML with a FLT3 or SFm in late 2024.
Initial safety data from the frontline triplet combination study of emavusertib with azacitidine and venetoclax in patients with AML in late 2024.
Second Quarter 2024 Financial Results

For the second quarter of 2024, Curis reported a net loss of $11.8 million or $2.03 per share on both a basic and diluted basis as compared to $12.0 million or $2.47 per share on both a basic and diluted basis, for the same period in 2023. Curis reported a net loss of $23.7 million or $4.08 per share on both a basic and diluted basis, for the six months ended June 30, 2024 as compared to a net loss of $23.5 million or $4.87 per share on both a basic and diluted basis for the same period in 2023.

Revenues for the second quarter of 2024 were $2.5 million as compared to $2.2 million for the same period in 2023. Revenues were $4.6 million for the six months ended June 30, 2024 as compared to $4.5 million for the same period in 2023. Revenues consist of royalty revenues from Genentech/Roche’s sales of Erivedge.

Research and development expenses were $10.3 million for the second quarter of 2024, as compared to $10.0 million for the same period in 2023. The increase was primarily attributable to higher employee related costs, partially offset by a decrease in consulting costs. Research and development expenses were $19.9 million for the six months ended June 30, 2024, as compared to $19.2 million for the same period in 2023.

General and administrative expenses were $4.8 million for the second quarter of 2024, as compared to $4.2 million for the same period in 2023. The increase was primarily attributable to higher employee related costs. General and administrative expenses were $9.7 million for the six months ended June 30, 2024, as compared to $9.0 million for the same period in 2023.

Other income was $0.7 million for the second quarter of 2024, as compared to $0.2 million for the same period in 2023. The increase was primarily attributable to a decrease in the non-cash expense related to the sale of future royalties. Other income, net was $1.3 million for the six months ended June 30, 2024 compared to $0.2 million for the same period in 2023.

Curis’s cash, cash equivalents and investments totaled $28.4 million as of June 30, 2024, and the Company had approximately 5.9 million shares of common stock outstanding. Curis expects its existing cash, cash equivalents and investments will enable its planned operations into the first quarter of 2025.

Conference Call and Webcast Information

Curis management will host a conference call and webcast today, August 1, 2024, at 8:30 a.m. ET, to discuss the business update and these financial results.

To access the live conference call, please dial 800-836-8184 from the United States or 1-646-357-8785 from other locations, to access the webcast login to View Source shortly before 8:30 a.m. ET. The webcast can also be accessed via the Curis website in the ‘Investors’ section.

On August 1, 2024 Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS) (GLOBAL NEWSWIRE), a clinical-stage biopharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to soquelitinib for the treatment of adult patients with relapsed or refractory peripheral T cell lymphoma (PTCL) after at least two lines of systemic therapy (Press release, Corvus Pharmaceuticals, AUG 1, 2024, View Source [SID1234645257]).

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"The granting of Fast Track Designation by the FDA highlights the significant unmet need for patients with relapsed or refractory PTCL," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "The current treatment options for these patients provide limited efficacy and are associated with significant toxicity, and there are no FDA fully approved agents. There continues to be strong interest in soquelitinib from investigators at sites with deep experience treating T cell lymphomas and we are on track to initiate patient enrollment in our registrational Phase 3 trial in PTCL in the third quarter 2024."

The Fast Track program is designed to facilitate the development and expedite the review of new drugs or biologics that are intended to: 1) treat serious or life-threatening conditions and 2) demonstrate the potential to address unmet medical needs. Fast Track designation can accelerate development and review of new drug and biological products by increasing the level of communication between FDA and drug developers and by enabling the FDA to review portions of a drug application on a rolling basis. In addition to Fast Track Designation, soquelitinib has also been granted FDA Orphan Drug Designation for the treatment of T cell lymphoma, which provides benefits to drug developers, including assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees and seven years of post-approval marketing exclusivity.

On August 1, 2024 Cerus Corporation (Nasdaq: CERS) reported financial results for its second quarter and six months ended June 30, 2024 (Press release, Cerus, AUG 1, 2024, View Source [SID1234645254]).

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Total revenue for the three and six months ended June 30, 2024 was comprised of ( in thousands, except %) :

Three Months Ended

Six Months Ended

June 30,

Change

June 30,

Change

2024

2023

$

%

2024

2023

$

%

Product Revenue

$

45,079

$

38,853

$

6,226

16

%

$

83,444

$

69,827

$

13,617

20

%

Government Contract Revenue

5,440

8,875

(3,435

)

-39

%

10,470

16,377

(5,907

)

-36

%

Total Revenue

$

50,519

$

47,728

$

2,791

6

%

$

93,914

$

86,204

$

7,710

9

%

Recent highlights include:

Advanced efforts to expand the U.S. manufacturing capacity for INTERCEPT Fibrinogen Complex (IFC).
Achievement of 100% adoption of INTERCEPT platelets by Canadian Blood Services, resulting in the pathogen inactivation of the majority of platelets in Canada.
Narrowed GAAP net loss attributable to Cerus Corporation to $5.8 million and generated non-GAAP adjusted EBITDA of $0.8 million for the second quarter.
Generated positive operating cash flows for the second straight quarter of 2024 bringing year-to-date positive operating cash flows to $2.4 million.
Cash and cash equivalents and short-term investments were $71.2 million at June 30, 2024.
The Company is increasing its full-year 2024 annual product revenue guidance range from $172-175 million to $175-178 million which includes $8-10 million for IFC.
The Company continues to expect future improvements to GAAP net loss attributable to Cerus Corporation for the full-year 2024 and remains committed to adjusted EBITDA breakeven for the full-year 2024.
"We are very pleased to post another strong quarter to continue our growth trajectory in 2024. North American sales in our platelet business led the way, including both organic U.S. sales growth and 100% adoption by Canadian Blood Services. Given our expectations for continued momentum in the business, we are raising our full-year 2024 product revenue guidance today," stated William "Obi" Greenman, Cerus’ president and chief executive officer. "Our IFC business is accelerating with respect to the increasing recognition of its pivotal early role in the care of bleeding patients and its improved operational ease of use for hospital transfusion services. Two recent publications spotlighting the hospital experience with IFC document these benefits well, and there are expanding numbers of hospital case studies being presented at upcoming conferences, including the AABB Annual Meeting in the fall."

"We are also extremely pleased with our execution to date on key financial measures that we discussed at the beginning of the year, namely adjusted EBITDA and operating cash flows," continued Greenman. "We will continue our efforts to improve on these metrics during the back half of 2024, which is expected to help further strengthen our financial position."

Revenue

Product revenue during the second quarter of 2024 was $45.1 million, compared to $38.9 million during the prior year period. This year-over-year increase of 16% was driven primarily by growth in our platelets business, particularly in North America. Second-quarter product revenue included sales of IFC, which were $2.0 million, up from $1.4 million during the prior year period.

Second-quarter 2024 government contract revenue was $5.4 million, compared to $8.9 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 IFC. Reported government contract revenue during the second 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

Product gross profit for the second quarter of 2024 was $24.7 million, increasing by 16% over the prior year period. Product gross margin for the second quarter of 2024 was relatively stable year over year at 54.7% compared to 54.9% for the second quarter of 2023. Absent any unanticipated factor, we expect product gross margin levels will remain relatively consistent with second-quarter 2024 levels for the duration of 2024.

Operating Expenses

Total operating expenses for the second quarter of 2024 were $33.9 million, compared to $41.9 million for the same period of the prior year, reflecting a year-over-year decrease of 19%. This decline resulted from year-over-year decreases in both R&D and selling, general and administrative (SG&A) expenses, driven by the restructuring implemented in the second quarter of 2023, as well as completion of key initiatives by the Company.

R&D expenses for the second quarter of 2024 were $15.0 million, compared to $19.2 million for the second quarter of 2023. The primary drivers for the decrease in R&D expenses were the restructuring implemented in the second quarter of last year and the completion of the Company’s ReCePI trial in the first quarter of 2024.

SG&A expenses narrowed for the second quarter of 2024 and totaled $19.0 million, compared to $20.5 million for the second quarter of 2023. The primary driver for the decrease in SG&A expenses was again the restructuring implemented in the second quarter of last year.

Net Loss Attributable to Cerus Corporation

Net loss attributable to Cerus Corporation for the second quarter of 2024 was $5.8 million, or $0.03 per basic and diluted share, compared to a net loss attributable to Cerus Corporation of $13.3 million, or $0.07 per basic and diluted share, for the second quarter of 2023. Net loss attributable to Cerus Corporation for the first half of 2024 was $15.5 million, compared to a net loss attributable to Cerus Corporation of $28.9 million for the first half of 2023.

Non-GAAP Adjusted EBITDA

Non-GAAP adjusted EBITDA for the second quarter of 2024 was $0.8 million, compared to a loss of $4.7 million for the second quarter of 2023. Non-GAAP adjusted EBITDA narrowed to a loss of $1.9 million for the first half of 2024, compared to a loss of $14.5 million for the first half of 2023. The Company continues to focus on achieving non-GAAP adjusted EBITDA breakeven for the full-year 2024 period as a whole. 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 June 30, 2024, the Company had cash and cash equivalents and short-term investments of $71.2 million, compared to $65.9 at December 31, 2023.

As of June 30, 2024, the Company had $65.0 million outstanding on its term loan and $18.8 million drawn on its revolving credit facility which represents a payback of $1.2 million for the quarter. The Company’s revolving line of credit allows for an additional $16.2 million.

For the second quarter of 2024, the Company generated positive cash flows of $0.4 million from operations compared to cash used in operations of $7.6 million during the prior year period. These improvements were in line with the Company’s expectations and will continue to be a focus area going forward.

Increasing 2024 Product Revenue Guidance

Given the strong performance in the first half and continued growing conviction around IFC demand, the Company expects full-year 2024 product revenue will be in the range of $175 million to $178 million, representing increased growth expectations of approximately 12-14% over full-year 2023 results. Previously, the Company’s 2024 product revenue guidance range was $172 million to $175 million. The Company is reiterating full-year 2024 IFC revenue guidance of $8 million to $10 million.

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 August 22, 2024.

On August 1, 2024 Cellectis (the "Company") (Euronext Growth: ALCLS – NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Cellectis’ CLLS52 (alemtuzumab), an Investigational Medicinal Product (IMP) used as part of the lymphodepletion regimen associated with UCART22, evaluated in the BALLI-01 clinical trial in relapsed/refractory B-cell acute lymphoblastic leukemia (ALL) (Press release, Cellectis, AUG 1, 2024, View Source [SID1234645253]).

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"We are excited that the FDA granted CLLS52 (alemtuzumab) ODD designation status. The importance of adding alemtuzumab to the lymphodepletion regimen has been demonstrated in Cellectis’ BALLI-01 study, where the addition of this lymphodepletion agent to the fludarabine and cyclophosphamide regimen was associated with sustained lymphodepletion and significantly higher UCART22 cell expansion allowing for greater clinical activity", said Mark Frattini, M.D., Ph.D. Chief Medical Officer at Cellectis.

Cellectis is the inventor of the combination of CD52 knockout UCART cells with a lymphodepleting regimen containing an anti-CD52 antibody such as alemtuzumab. The CD52 knockout aims to render the UCART product candidates resistant to alemtuzumab as part of the lymphodepleting regimen. Cellectis’ UCART22 product candidate has the CD52 gene inactivated by TALEN gene editing technology.

The FDA grants ODD status to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US. Receiving ODD may help to expedite and reduce the cost of development, approval, and commercialization of a therapeutic agent.

On August 1, 2024 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, reported financial results for the second quarter ended June 30, 2024, as well as recent business highlights (Press release, C4 Therapeutics, AUG 1, 2024, View Source [SID1234645252]).

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"Our strong execution during the first half of the year has built momentum across our clinical, discovery and partnered programs, each of which has the potential to advance targeted protein degradation science and transform patients’ lives," said Andrew Hirsch, president and chief executive officer of C4 Therapeutics. "Our two lead programs continue to advance in the clinic, and we are on track to share multiple Phase 1 datasets during the second half of the year. At the upcoming ESMO (Free ESMO Whitepaper) Congress, we will present initial CFT1946 Phase 1 data, marking the first clinical presentation for a BRAF V600X degrader, which has the potential to address many of the liabilities that occur with inhibitors. Additionally, we expect to share updated cemsidomide Phase 1 data in relapsed refractory multiple myeloma and relapsed refractory non-Hodgkin’s lymphoma in the fourth quarter."

SECOND QUARTER 2024 AND RECENT ACHIEVEMENTS

Cemsidomide: Cemsidomide is an oral degrader of IKZF1/3 for the potential treatment of relapsed/refractory (R/R) multiple myeloma (MM) and R/R non-Hodgkin’s lymphoma (NHL).

Advanced the Phase 1/2 Clinical Trial. The cemsidomide Phase 1/2 trial in combination with dexamethasone for R/R MM and as a monotherapy for R/R NHL continues to enroll patients. For the combination with dexamethasone MM arm, dose level 4 (75 µg QD) has been declared safe and additional patients are enrolling in this expansion cohort. Dose escalation continues as the maximum tolerated dose has not yet been reached. For the monotherapy NHL arm, patients are enrolling at dose level 5 (100 µg QD).
CFT1946: CFT1946 is an oral degrader targeting BRAF V600X mutations for the potential treatment of solid tumors including colorectal cancer (CRC), melanoma and non-small cell lung cancer (NSCLC).

Advanced the Phase 1/2 Clinical Trial. The CFT1946 Phase 1/2 trial for BRAF V600X mutant solid tumors continues to enroll patients. Enrollment is complete at dose level 5 (640 mg BID), with patients currently in the dose limiting toxicity evaluation period for this dose level. Simultaneously, patients continue to be evaluated for pharmacokinetic, pharmacodynamic and anti-tumor activity at the 160 mg BID and 320 mg BID dose levels. Additionally, patients are now enrolling in a monotherapy exploratory expansion cohort for BRAF inhibitor refractory melanoma at the 320 mg BID dose level.

The Phase 1b portion of the trial evaluating CFT1946 in combination with cetuximab for CRC has also been opened and patients are enrolling at the 160 mg BID dose level.
Preliminary CFT1946 Monotherapy Data Accepted as a Mini Oral Presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024. Monotherapy data from the ongoing CFT1946 Phase 1 trial will be presented on Saturday, September 14, 2024 from 2:45 – 2:50 CEST at the ESMO (Free ESMO Whitepaper) Congress 2024 in Barcelona, Spain.
CORPORATE UPDATES:

In June 2024, Ron Cooper was appointed as chairman of C4T’s Board of Directors as a part of C4T’s commitment to strategically transform the Board to lead the company into its next phase of growth. Mr. Cooper brings decades of deep biopharmaceutical executive leadership across discovery, development and commercialization.
KEY UPCOMING MILESTONES

Cemsidomide:

Present updated data from at least three dose levels from the dose escalation and expansion cohorts of the ongoing Phase 1/2 clinical trial in R/R MM in Q4 2024.
Present data from at least four dose levels from the dose escalation portion of the ongoing Phase 1/2 clinical trial in R/R NHL in Q4 2024.
Complete Phase 1 dose exploration in R/R MM and R/R NHL by year-end 2024.
CFT1946:

Present data from at least five dose levels from the ongoing Phase 1 monotherapy dose escalation trial in BRAF V600X solid tumors as a mini oral presentation on Saturday, September 14, 2024 from 2:45 – 2:50 CEST at the ESMO (Free ESMO Whitepaper) Congress 2024 in Barcelona, Spain.
UPCOMING INVESTOR EVENTS:

September 5, 2024 at 9:30 AM ET: Management will participate in a fireside chat at the Wells Fargo Healthcare Conference taking place in Boston, MA.
September 16, 2024: Management will host a webcast to discuss the CFT1946 data presented at the ESMO (Free ESMO Whitepaper) Congress 2024.
September 17 – 19, 2024: Management will participate in the Cantor Global Healthcare Conference taking place in New York, NY.
SECOND QUARTER 2024 FINANCIAL RESULTS

Revenue: Total revenue for the second quarter of 2024 was $12.0 million, compared to $2.7 million for the second quarter of 2023. The increase in revenue was primarily due to the receipt of an $8.0 million milestone payment from Biogen after the company accepted delivery of a development candidate. Total revenue for the second quarter of 2024 reflects revenue recognized under our collaborations with Merck KGaA, Darmstadt, Germany (MKDG), Merck, Roche and Biogen, and total revenue recognized in the second quarter of 2023 reflects revenue recognized under collaboration agreements with Roche and Biogen.

Research and Development (R&D) Expense: R&D expense for the second quarter of 2024 was $23.8 million, compared to $29.9 million for the second quarter of 2023. The reduction in R&D expense was primarily due to the prioritization of our internal discovery efforts and stopping clinical development for CFT8634, partially offset by increased clinical trial expense as cemsidomide and CFT1946 continue to advance.

General and Administrative (G&A) Expense: G&A expense was $9.7 million for the second quarter of 2024, compared to $10.3 million for the second quarter of 2023. The decrease in G&A expense was primarily attributable to a reduction in external consulting spend.

Net Loss and Net Loss per Share: Net loss for the second quarter of 2024 was $17.7 million, compared to $35.9 million for the second quarter of 2023. Net loss per share for the second quarter of 2024 was $0.26 compared to $0.73 for the second quarter of 2023.

Cash Position and Financial Guidance: Cash, cash equivalents and marketable securities as of June 30, 2024 were $295.7 million, compared to $299.2 million as of March 31, 2024, and $281.7 million as of December 31, 2023. The reduction in cash, cash equivalents and marketable securities during the second quarter was primarily the result of operating expenses offset by receipt of the upfront payment from our collaborator MKDG and a milestone payment from Biogen. C4T expects that its cash, cash equivalents and marketable securities as of June 30, 2024 will be sufficient to fund planned operating expenses and capital expenditures into 2027.