On February 24, 2025 Coherent Biopharma ("Coherent") reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to CBP-1019 for Injection (CBP-1019) for the treatment of recurrent endometrial cancer (EC) after at least one line of platinum-based systemic therapy (Press release, Coherent Biopharma, FEB 24, 2025, View Source [SID1234650463]).

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Dr. Robert Huang, Founder and CEO of Coherent, commented:

"This represents the second FTD granted to Coherent Biopharma, following the designation of CBP-1008, another drug derived from Coherent’s proprietary Bi-XDC technology platform, in October 2024 for the treatment of platinum-resistant ovarian clear cell carcinoma. This further underscores the platform’s therapeutic potential and highlights the company’s robust innovation capabilities in drug development and offering new therapeutic options for patients with advanced/metastatic EC worldwide."

About Fast Track Designation

Fast Track Designation is granted to facilitate the development and expedite the review of drugs to that treat serious conditions and fulfill unmet medical needs, enabling these treatments to reach patients earlier. Clinical programs with Fast Track designation can benefit from early and frequent communication with the FDA throughout the regulatory review process. These clinical programs may also be eligible to apply for Accelerated Approval and Priority Review if relevant criteria are met.

About CBP-1019

CBP-1019 is a Bi-specific ligand drug conjugate developed using Coherent’s proprietary Bi-XDC technology platform. The drug targets Folate Receptor (FRα) and Transient Receptor Potential Vanilloid Subfamily Member 6 receptor (TRPV6) (an Oncochannel), both broadly, and often highly expressed in many cancers. and carries DX-8951 derivative, a topoisomerase I inhibitor (TOPOi). CBP-1019’s innovative dual-targeting mechanism and promising clinical efficacy data demonstrate its therapeutic potential in addressing advanced solid malignancies, particularly recurrent endometrial carcinoma.

The CBP-1019-101 study is a global, multicenter, open-label Phase I/II clinical trial (conducted in the U.S. and China) designed to evaluate the safety, tolerability, and preliminary efficacy of CBP-1019 in patients with advanced solid tumors. As of October 31, 2024, 61 patients with advanced solid tumors were enrolled and treated with CBP-1019 at various dose levels, administered intravenously every two weeks (Q2W) in 4-week cycles. CBP-1019 demonstrated a favorable safety and tolerability profile, with no observed cases of interstitial lung disease (ILD), stomatitis, or ocular toxicity—typical adverse events associated with TOPOIi-based antibody-drug conjugates (ADCs).

Among the 10 advanced/metastatic EC patients enrolled, all had received at least one prior line of platinum-based systemic chemotherapy and presented with visceral metastases. The study results showed that CBP-1019 exhibited superior efficacy regardless of FRα/TRPV6 expression status. At the 3.0 mg/kg dose level (potential recommended Phase II dose, RP2D), 7 out of 9 evaluable advanced/metastatic EC patients achieved an objective response rate (ORR) of 42.9% and a disease control rate (DCR) of 100%. Median duration of response (DoR) and progression-free survival (PFS) were not yet reached, and all patients remained on treatment as of the data cutoff date.

About advanced/metastatic EC

Endometrial cancer is a serious gynecological malignancy threatening women’s health, with approximately 15% of patients who are in the advanced stage of the disease. Limited treatment options and poor prognosis result in a 5-year survival rate of only 17%, highlighting a significant unmet medical need. The development of CBP-1019 offers a breakthrough therapeutic option for these patients.

The FDA’s Fast Track Designation for CBP-1019 represents a major milestone in addressing unmet medical needs and providing new therapeutic options for patients with advanced/metastatic EC on a global scale. Coherent is committed to advancing the clinical development of CBP-1019 and delivering more effective treatment options for patients.

On February 24, 2025 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported financial results for the fourth quarter and full year ended December 31, 2024, and provided a corporate update (Press release, BioCryst Pharmaceuticals, FEB 24, 2025, View Source [SID1234650462]).

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"We ended 2024 with the strongest execution and performance in the company’s history, and this year is off to a fantastic start, with ORLADEYO revenue already exceeding our initial expectations, the first clinical data from both the BCX17725 and avoralstat programs, and our pediatric label expansion for ORLADEYO anticipated later this year," said Jon Stonehouse, president and chief executive officer of BioCryst.

Program Updates and Key Milestones

ORLADEYO (berotralstat): Oral, Once-daily Treatment for Prevention of Hereditary Angioedema (HAE) Attacks

"We are seeing favorable early signs that many more Medicare patients taking ORLADEYO are able to afford therapy because their copayments are lower under the Inflation Reduction Act. New prescription demand also remained strong in the fourth quarter and into the early part of this year and we have increased our guidance for ORLADEYO revenue in 2025," said Charlie Gayer, chief commercial officer of BioCryst.

ORLADEYO net revenue in the fourth quarter of 2024 was $124.2 million (+36.6 percent y-o-y).

73.5 percent of U.S. patients were on paid product at the end of the fourth quarter (up from 71.4 percent at the end of 2023).

Sales from outside the U.S. contributed 13.9 percent of global ORLADEYO net revenues in the fourth quarter and 11.8 percent for full year 2024.

The company has received final reimbursement for ORLADEYO in Portugal. ORLADEYO is now reimbursed in all major countries in Western Europe, except the Netherlands, which is expected in 1H 2025.

A new market tracking survey of 60 HAE treaters showed that 97 percent are considering prescribing ORLADEYO and 59 percent (up from 26 percent 18 months prior) of current prescribers indicate they are extremely likely to prescribe for more of their patients.
Rare Disease Pipeline

"There is a tremendous unmet need for an oral option for children with HAE, so we are excited to bring ORLADEYO to children as young as two years old. In parallel, we look forward to dosing the first patient with DME in our avoralstat clinical program and continuing our ongoing clinical program with BCX17725, the potential first disease-modifying therapy for Netherton syndrome. Both of these programs could produce initial clinical data in 2025," said Dr. Helen Thackray, chief R&D officer of BioCryst.

The goal with our pipeline is to build on our success with ORLADEYO by bringing additional selected, highly differentiated rare disease products to patients.

The company is on track to submit a new drug application (NDA) in 2025 to the U.S. Food and Drug Administration (FDA) to expand the ORLADEYO label to children with HAE aged 2 to 11 using an oral granule formulation. Additional regulatory filings are planned in global territories, including Europe, Japan and Canada. ORLADEYO would be the first targeted oral prophylactic therapy for children with HAE.

Earlier today, the company announced positive results from an interim analysis of the ongoing APeX-P clinical trial evaluating ORLADEYO in children with HAE aged 2 to 11. The results will be presented in a late-breaking abstract at the 2025 American Academy of Allergy, Asthma & Immunology (AAAAI) / World Allergy Organization (WAO) Joint Congress on Sunday, March 2.

The company has advanced BCX17725, its KLK5 inhibitor for the treatment of Netherton syndrome, into clinical trials and expects initial data from the program in 2025.

Netherton syndrome is a serious, rare, lifelong genetic disorder affecting the skin, hair, and immune system, caused by lack of normal function of a natural inhibitor of KLK5. People with Netherton syndrome often have red, scaly, inflamed skin, fragile hair, and are more likely to develop skin infections, severe food allergies, asthma and eczema. Netherton syndrome can be life threatening, especially during infancy when patients are vulnerable to dehydration and recurrent infections. Currently, there are no approved treatments for Netherton syndrome.

In 2025, the company plans to advance avoralstat, a plasma kallikrein inhibitor, into a clinical trial of patients with diabetic macular edema (DME).

DME is an important cause of vision loss in diabetes and is due to leakage of fluid from the blood vessels in the retina. While current treatments focus on vascular endothelial growth factor (VEGF) inhibition, DME can develop from other mechanisms, such as the kallikrein-bradykinin pathway. This is supported by observations that many DME patients have an incomplete response to intravitreal anti-VEGF therapies that are administered every four to eight weeks. Avoralstat targets the kallikrein-bradykinin system on the retinal vascular endothelial cells and may result in less vascular leakage and less edema. Avoralstat, delivered to the suprachoroidal space, is designed to provide high dose levels to the retinal vessels with long-lasting exposure, which could result in less frequent injections and a reduced burden on patients and the healthcare system.
Fourth Quarter 2024 Financial Results

"The strong start to 2025 has enabled us to raise our revenue guidance, further increasing our confidence in achieving our profitability goals. With revenue growth significantly outpacing operating expenses over the next few years, we expect to achieve meaningful and sustainable profitability, adding hundreds of millions in cash to the balance sheet," said Anthony Doyle, chief financial officer of BioCryst.

For the three months ended December 31, 2024, total revenues were $131.5 million, compared to $93.4 million in the fourth quarter of 2023 (+40.8 percent y-o-y). The increase was primarily due to $124.2 million in ORLADEYO net revenue in the fourth quarter of 2024, compared to $90.9 million in the fourth quarter of 2023 (+36.6 percent y-o-y). Revenue in the fourth quarter of 2024 also included $7.3 million of net revenue from RAPIVAB related sales, compared to $2.3 million in the fourth quarter of 2023.

Research and development (R&D) expenses for the fourth quarter of 2024 decreased to $49.4 million from $70.1 million in the fourth quarter of 2023 (-29.5 percent y-o-y), primarily due to decreased expenses driven by the discontinuation and close-out of BCX10013 and BCX9930. These reductions were partially offset by increased investment in BCX17725, avoralstat, and our other early-phase pipeline programs, primarily due to investigational new drug application-enabling activities and the initiation of the Phase 1 trial evaluating BCX17725.

Selling, general and administrative (SG&A) expenses for the fourth quarter of 2024 increased to $80.5 million, compared to $64.4 million in the fourth quarter of 2023 (+25.0 percent y-o-y). The increase was primarily due to increased commercial investment to support our growing ORLADEYO revenue, our newly launched regions, expanded international operations and global commercial support activities. Additionally, there was an increase to general and administrative expenses, and an offsetting reduction to research and development expenses, due to a decrease in the general and administrative expense allocations in 2024.

Interest expense was $24.4 million in the fourth quarter of 2024, compared to $24.6 million in the fourth quarter of 2023.

GAAP operating loss for the fourth quarter of 2024 was $4.5 million, compared to $42.7 million for the fourth quarter of 2023. Non-GAAP operating profit, excluding stock-based compensation expense, was $16.8 million for the fourth quarter of 2024, compared to a non-GAAP operating loss of $26.2 million for the fourth quarter of 2023.

Net loss for the fourth quarter of 2024 was $26.8 million, or $0.13 per share, compared to a net loss of $61.7 million, or $0.31 per share, for the fourth quarter of 2023. In the fourth quarter of 2023, there was a one-time cost associated with the R&D restructuring and the postponement of the expansion at our Discovery Center in Alabama, totaling $5.4 million. Excluding this one-time event, non-GAAP net loss for the fourth quarter of 2023 was $56.4 million, or $0.28 per share. A reconciliation between GAAP and non-GAAP net loss is provided in the table below.

Cash, cash equivalents, restricted cash and investments totaled $342.8 million as of December 31, 2024, compared to $390.8 million as of December 31, 2023. Operating cash use for the fourth quarter of 2024 was $8.4 million.

Full Year 2024 Financial Results

For the full year ended December 31, 2024, total revenues were $450.7 million, compared to $331.4 million in the full year ended December 31, 2023 (+36.0 percent y-o-y). The increase was primarily due to $437.7 million of ORLADEYO net revenue in 2024, compared to $326.0 million in 2023 (+34.3 percent y-o-y). Revenue for the full year 2024 also included $13.0 million of net revenue from RAPIVAB related sales, compared to $5.1 million for the full year 2023.

R&D expenses for the full year 2024 decreased to $174.6 million from $216.6 million for the full year 2023 (-19.4 percent y-o-y), primarily due to decreased expenses driven by the discontinuation and close-out of the Factor D programs, BCX10013 and BCX9930. These reductions were partially offset by increased investment in BCX17725, avoralstat, and our other early-phase pipeline programs, primarily due to investigational new drug application-enabling activities and the initiation of the Phase 1 trial evaluating BCX17725.

SG&A expenses for the full year 2024 increased to $266.1 million, compared to $213.9 million for the full year 2023 (+24.4 percent y-o-y). The increase was primarily due to increased commercial investment to support our growing ORLADEYO revenue, our newly launched regions, expanded international operations, and global commercial support activities. Additionally, there was an increase to general and administrative expenses, and an offsetting reduction to research and development expenses, due to a decrease in the general and administrative expense allocations in 2024.

Interest expense was $98.5 million in full year 2024, compared to $108.2 million in full year 2023. The decrease was primarily due to a decrease in the amortization of interest associated with our royalty financing obligations, partially offset by an increase in interest expense associated with the interest accrued on the Tranche A Loan of $300.0 million under the Pharmakon Loan Agreement.

GAAP operating loss for the full year 2024 was $2.5 million, compared to $103.7 million for the full year 2023. Non-GAAP operating profit, excluding stock-based compensation expense, was $62.9 million for the full year 2024 compared to a non-GAAP operating loss of $48.1 million for the full year 2023.

Net loss for the full year 2024 was $88.9 million, or $0.43 per share, compared to a net loss of $226.5 million, or $1.18 per share, for the full year 2023. Non-GAAP net loss for the full year 2024 was $87.6 million, or $0.42 per share, when excluding one-time costs associated with the R&D restructuring recognized in the first quarter of 2024, totaling $1.3 million. Non-GAAP net loss for full year 2023 was $192.2 million, or $1.00 per share, when excluding the one-time loss on debt extinguishment of $29.0 million on the repayment of the term loans under the Athyrium Credit Agreement recognized in the second quarter of 2023, as well as R&D restructuring and the postponement of previously planned capital expenditures at our Discovery Center in Alabama recognized in the fourth quarter of 2023, totaling $5.4 million. A reconciliation between GAAP and non-GAAP net loss is provided in the table below.

Financial Outlook for 2025

Based on the early signs we are seeing that many more of our Medicare patients are able to afford paid therapy in 2025, and the strong patient demand for ORLADEYO to start the year, the company has increased its full year 2025 outlook for global net ORLADEYO revenue to between $535 million and $550 million (previously $515 million to $535 million). The company now expects full year 2025 total revenue (including RAPIVAB (peramivir injection)) will be between $560 million and $575 million (previously $540 million to $560 million).

The increased guidance for ORLADEYO revenues in 2025 also results in an increase in related operating expenses, primarily related to cost of goods sold, distribution costs and higher incentive compensation. The company reiterates the previously provided 2025 non-GAAP operating expense outlook range of $425 million to $435 million (not including stock-based compensation). The revenue related operating expense increases are captured at the higher end of this range.

Profitability Outlook
In 2024, revenue growth significantly exceeded operating expense growth. The company expects this pattern to continue, and over the next three years the company expects an annual CAGR for revenue of around 20 percent, compared to a projected annual operating expense CAGR of closer to five percent over the same period.

Building on the $62.9 million non-GAAP operating profit the company achieved in 2024 (not including stock-based compensation), the company expects to approach quarterly positive EPS and positive cash flow in the second half of 2025, and to be profitable on an EPS basis, with positive cash flow, for full year 2026.

Conference Call and Webcast

BioCryst management will host a conference call and webcast at 8:30 a.m. ET today to discuss the financial results and provide a corporate update. The live call may be accessed by dialing 1-844-481-2942 for domestic callers and 1-412-317-1866 for international callers. A live webcast and replay of the call will be available online in the investors section of the company website at www.biocryst.com.

On February 24, 2025 Azitra, Inc. (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, reported financial results for the full year ended December 31, 2024, and provided a business update (Press release, Azitra, FEB 24, 2025, View Source [SID1234650461]).

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FY 2024 and Recent Business Highlights

Initiated a Phase 1b clinical trial investigating ATR-12 in adult Netherton syndrome patients; Initial safety data from first set of Netherton syndrome patients expected in the first half of 2025 with topline data from the Phase 1b trial by year-end 2025
Received clearance from the U.S. Food and Drug Administration (FDA) for a first-in-human Phase 1/2 clinical study of ATR-04 for adults with moderate to severe EGFRi-associated dermal toxicity
FDA granted Fast Track designation to ATR-04, demonstrating that the FDA recognizes the unmet need for treatment of EGFRi-associated skin rash
Announced closing of $10.0 million and $5.0 million public offerings
Strengthened intellectual property (IP) portfolio with newly granted and allowed patents
"This is a very exciting time in the growth and evolution of Azitra as we seek to drive shareholder value through development of first-in-class drugs to treat dermatological diseases," said Francisco Salva, CEO of Azitra. "Azitra is currently advancing a therapeutic pipeline with multiple programs developed from our proprietary platform of engineered proteins delivered using topical live biotherapeutic products. Our initial focus is the development of genetically engineered strains of Staphylococcus epidermidis (S. epidermidis) to enable the delivery of critical missing natural proteins and disease-modifying proteins through the stratum corneum of the skin. This advantage could allow Azitra to address several dermatological conditions that are significantly underserved by current standards of care."

Salva continued, "Our lead product, ATR-12, is an engineered strain of S. epidermidis designed to treat Netherton syndrome, a rare, chronic skin disease with no approved treatment options. In August 2024, we initiated a Phase 1b clinical trial investigating ATR-12 in adult Netherton syndrome patients to assess multiple safety, tolerability, and efficacy endpoints. Initial safety data from this trial is expected in the first half of 2025 with topline results by year-end 2025."

Salva continued, "In addition to ATR-12, Azitra has made significant progress with our next most advanced product, ATR-04. ATR-04 is a live biotherapeutic product candidate containing an isolated, naturally derived S. epidermidis strain being developed for the treatment of EGFR inhibitor ("EGFRi") associated rash, which impacts approximately 150,000 patients in the United States annually, representing a market opportunity in excess of $1 billion. Our next milestone in the development of ATR-04 is the first patient dosed in a multicenter, randomized, controlled Phase 1/2 clinical trial in patients undergoing EGFR inhibitors with dermal toxicity, which we expect to occur in the first half of 2025."

Salva concluded, "We look forward to capitalizing on multiple value-building milestones during 2025, including clinical data from our ATR-12 program. These events are expected to provide key inflection points for the company and investors throughout the year as we continue to position Azitra as a leading and innovative company developing transformative drugs for underserved patients with life-altering dermatological diseases."

Pipeline and Upcoming Milestones
ATR-12 – Advancing Phase 1b Clinical Trial in Netherton Syndrome with Multiple Milestones Expected

In August 2024, initiated a Phase 1b clinical trial investigating ATR-12 in adult Netherton syndrome patients. Trial is designed to assess multiple safety, tolerability, and efficacy endpoints, providing a springboard for several potential value creating events during the year
Initial safety data from first set of Netherton syndrome patients in the first half of 2025
Topline data from the Phase 1b trial by year-end 2025
Azitra presented compelling preclinical data for ATR-12 in Netherton syndrome at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 2024 Annual Meeting. Among the findings presented at the conference, ATR-12 significantly reduced protease activity in skin samples compared to a Netherton syndrome model skin (p<0.01). Additionally, ATR-12 produced higher amounts of LEKTI subunit compared to topical application of LEKTI protein alone after 24 hours and resulted in deeper skin penetration of LEKTI.

ATR-04 – Addressing an Unmet Need in a Multi-billion Dollar Market Opportunity

In August, Azitra received clearance from the U.S. Food and Drug Administration (FDA) for a first-in-human Phase 1/2 clinical study of ATR-04 for moderate to severe EGFRi-associated dermal toxicity
In September, the FDA granted Fast Track designation to ATR-04, demonstrating that the FDA recognizes the unmet need for treatment of EGFRi-associated skin rash
Also in 2024, Azitra presented preclinical data at the Society of Investigative Dermatology (SID) and the European Academy of Dermatology and Venereology (EADV) annual meetings showing ATR-04 inhibits IL-36g and S. aureus, both of which are key drivers of the disease
Plan to initiate a multicenter, randomized, controlled Phase 1/2 clinical trial in patients undergoing EGFR inhibitors with dermal toxicity in first half of 2025
Financial Results for the Year Ended December 31, 2024
Service Revenue – Related Party: The Company generated $0.8 thousand of service revenue during the year ended December 31, 2024, compared to $0.7 million for fiscal year 2023.
Research and Development (R&D) expenses: R&D expenses for the year ended December 31, 2024, were $4.7 million compared to $3.6 million for fiscal year 2023.
General and Administrative (G&A) expenses: G&A expenses for the year ended December 31, 2024, were $6.3 million compared to $4.5 million for fiscal year 2023.
Net Loss was $9.0 million for the year ended December 31, 2024, compared to $11.3 million for fiscal year 2023.
Cash and cash equivalents: As of December 31, 2024, the Company had cash and cash equivalents of $4.6 million, which does not include gross proceeds of approximately $2.2 million from follow-on offerings in January and February, 2025.

On February 24, 2025 Ascendis Pharma A/S (Nasdaq: ASND) reported that company executives will participate in a fireside chat at the TD Cowen 45th Annual Health Care Conference on Tuesday, March 4, 2025, at 11:10 a.m. Eastern Time / 8:10 a.m. Pacific Time in Boston, Massachusetts (Press release, Ascendis Pharma, FEB 24, 2025, View Source [SID1234650460]).

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A live webcast of the presentation will be available via the Investors & News section of the Ascendis Pharma website at investors.ascendispharma.com. A webcast replay will also be available on this website shortly after conclusion of the event for 30 days.

On February 24, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that its pioneering CAR-T therapy for ovarian cancer, developed in collaboration with Moffitt Cancer Center ("Moffitt"), was prominently featured in Breaking Cancer News in an article titled "Navigating Uncharted Territory: CAR-T for Ovarian Cancer (Press release, Anixa Biosciences, FEB 24, 2025, View Source [SID1234650459])."

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The article highlights the groundbreaking clinical trial led by Dr. Robert Wenham, Chairman of the Department of Gynecologic Oncology at Moffitt Cancer Center, and Dr. Monica Avila, a leading gynecologic oncologist at Moffitt. The trial explores the use of chimeric antigen receptor-T cell (CAR-T) therapy to treat ovarian cancer, a disease with historically limited treatment options for advanced-stage patients.

The CAR-T therapy being studied in this trial, exclusively licensed to Anixa from The Wistar Institute, and developed through a partnership between Anixa and Moffitt, is designed to target the follicle-stimulating hormone receptor (FSHR), a protein uniquely expressed on ovarian cancer cells. This novel approach has the potential to revolutionize the treatment of ovarian cancer by leveraging the body’s immune system to directly attack tumors.

Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, commented, "We are honored to see our work recognized in Breaking Cancer News and to witness the promising impact this CAR-T therapy is having on patients. Our partnership with Moffitt Cancer Center exemplifies our commitment to developing novel and targeted immunotherapies that could transform the standard of care for some of the most challenging cancers, including ovarian cancer."

The article also highlights the potential expansion of the study to evaluate repeat dosing, given Gallagher’s response, and explores the broader implications of CAR-T therapy for solid tumors—an area of intense research and high unmet medical need.