Alligator Bioscience completes Phase 3 GMP manufacturing of mitazalimab, remains on track for trial initiation with partner

On May 9, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported the successful completion of the manufacture of the first GMP drug product batch of its lead asset mitazalimab using a new improved commercial-scale manufacturing process (Press release, Alligator Bioscience, MAY 9, 2025, View Source [SID1234652817]). The material is intended for the planned Phase 3 trial in first line metastatic pancreatic cancer. The batch was produced at Thermo Fisher Scientific, a global leader in pharmaceutical manufacturing. This key milestone underpins the Phase 3 readiness of mitazalimab.

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"The development of an improved commercial-scale process and the successful manufacturing of the Phase 3 GMP drug product batch marks a significant step in advancing mitazalimab toward late-stage development and further reduces the risk in the development program," said Søren Bregenholt, CEO of Alligator Bioscience. "We are proud to have reached this point and remain committed to bringing new treatment options to patients with pancreatic cancer in collaboration with a future partner."

AMGEN TO PRESENT AT THE BANK OF AMERICA MERRILL LYNCH GLOBAL HEALTHCARE CONFERENCE

On May 9, 2025 Amgen (NASDAQ:AMGN) reported it will present at the Bank of America Merrill Lynch Global Healthcare Conference at 9:20 a.m. PT on Wednesday, May 14, 2025. Peter Griffith, executive vice president and chief financial officer at Amgen, and Jay Bradner, executive vice president of Research and Development at Amgen, will present at the conference (Press release, Amgen, MAY 9, 2025, View Source [SID1234652818]). The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

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The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

Boundless Bio Reports First Quarter 2025 Financial Results and Business Highlights

On May 9, 2025 Boundless Bio (Nasdaq: BOLD), a clinical-stage oncology company interrogating extrachromosomal DNA (ecDNA) biology to deliver transformative therapies to patients with previously intractable oncogene amplified cancers, reported financial results and business highlights for the fiscal quarter ended March 31, 2025 (Press release, Boundless Bio, MAY 9, 2025, View Source [SID1234652819]).

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"Boundless remains committed to delivering new therapeutic options to patients with high unmet need oncogene amplified cancers," said Zachary Hornby, President and CEO of Boundless Bio. "We look forward to providing a clinical data update on our BBI-355 program later this year. Additionally, we expect to nominate a development candidate for our novel Kinesin program by mid-year, with plans to submit an IND in the first half of 2026."

Research and Development Highlights and Upcoming Milestones

BBI-355, a novel, oral, potent CHK1 inhibitor designed to target replication stress in oncogene-amplified cancers

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Enrollment is ongoing in the Phase 1/2 POTENTIATE trial. Preliminary clinical proof-of-concept safety and antitumor activity data are expected in the second half of 2025.

Novel Kinesin program targeting ecDNA segregation and inheritance

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Boundless expects to nominate a development candidate for its preclinical program targeting a previously undrugged kinesin by mid-2025, with an investigational new drug (IND) submission planned for the first half of 2026.

Recent Data Presentations

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Preclinical data from studies conducted with Boundless’s ribonucleotide reductase (RNR) inhibitor, BBI-825, were presented in an oral session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. These data suggest that the combination of BBI-825 with mutant-specific, pan, and multi-RAS targeting inhibitors delayed or prevented acquired resistance in colorectal cancer preclinical models. Boundless continues to preclinically evaluate BBI-825 in various treatment settings.

First Quarter 2025 Financial Results

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Cash Position: Cash, cash equivalents, and short-term investments totaled $138.3 million as of March 31, 2025.
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Research and Development (R&D) Expenses: R&D expenses were $12.1 million for the first quarter of 2025, compared to $13.1 million for the same period in 2024.
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General and Administrative (G&A) Expenses: G&A expenses were $5.2 million for the first quarter of 2025, compared to $3.8 million for the same period in 2024.
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Net Loss: Net loss totaled $15.8 million for the first quarter of 2025, compared to $15.4 for the same period in 2024.

Celularity Announces Full Year 2024 Operating and Financial Results

On May 9, 2025 Celularity Inc. (Nasdaq: CELU) ("Celularity" or the "Company"), a regenerative and cellular medicine company, reported operating and financial results for the year ended December 31, 2024 (Press release, Celularity, MAY 9, 2025, View Source [SID1234652821]).

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"We built momentum through 2024 and ended the year with a strong finish, as reflected in higher net revenues from the sale of our commercial-stage advanced biomaterial products," said Dr. Robert Hariri, M.D., Ph.D., CEO and Chairman. "Sales growth was notably strong for our Biovance product line, which we believe will continue to contribute to an improving revenue outlook for the next several quarters. We were also extremely pleased to receive recommendation letters from the U.S. Food and Drug Administration Tissue Reference Group regarding important additions to our portfolio of human placental-derived advanced biomaterial products, which serves as a testament to our commitment to innovate in the wound care sector along with our development of next-generation 510(k) products. At the same time, we continued to act opportunistically and explore opportunities in the rapidly evolving landscape of cellular and regenerative medicine. We believe Celularity will gain additional momentum in 2025 as we leverage our unique business model and world-class technical infrastructure and human capital."

Highlights of Full Year 2024 Operating and Financial Results

Net Revenues

Net revenues for the year ended December 31, 2024, was $54.2 million, an increase of $31.4 million, or 138.1%, compared to the prior year period. This growth was primarily due to a $22.2 million increase in product sales in wound care applications, which increased 168.7% over the prior year.

Operating Expenses

Total operating expenses for the year ended December 31, 2024, were $92.6 million, a decrease of $122.5 million, or 57.0%, compared to 2023. The decrease in operating expenses is attributable to the absence of goodwill and in-process research and development, or IPR&D, impairments in 2024. Loss from operations for the year ending December 31, 2024, was $38.4 million, a decrease of $153.9 million, or 80.1%, compared to the previous year, driven by higher revenue and lower operating expenses which improved our gross margin.

Results of Operations
Comparison of Year Ended December 31, 2024 to December 31, 2023

(in thousands) Year Ended December 31, Percent
2024 2023 Change Change
Revenues:
Product sales, net $ 35,336 $ 13,149 $ 22,187 168.7%
Services 5,140 5,441 (301) (5.5)%
License, royalty and other 13,744 4,181 9,563 228.7%
Total revenues 54,220 22,771 31,449 138.1%
Operating expenses:
Cost of revenues (excluding amortization of acquired
intangible assets)
Product sales 4,924 8,628 (3,704) (42.9)%
Services 1,172 1,650 (478) (29.0)%
License, royalty and other 8,893 5,738 3,155 55.0%
Research and development 17,386 30,465 (13,079) (42.9)%
Selling, general and administrative 58,643 50,576 8,067 16.0%
Change in fair value of contingent consideration liability (193) (104,339) 104,146 (99.8)%
Goodwill impairment — 112,347 (112,347) (100.0)%
IPR&D impairment — 107,800 (107,800) (100.0)%
Amortization of acquired intangible assets 1,753 2,193 (440) (20.1)%
Total operating expenses 92,578 215,058 (122,480) (57.0)%
Loss from operations $ (38,358) $ (192,287) $ 153,929 (80.1)%
CELULARITY INC.
CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)

December 31,
2024 2023
Assets
Current assets:
Cash and cash equivalents $ 738 $ 227
Accounts receivable, net of allowance of $6,294 and $5,837 as of December 31, 2024 and 2023, respectively 13,557 10,046
Notes receivable — 2,072
Inventory 5,409 5,753
Prepaid expenses and other current assets 857 1,695
Total current assets 20,561 19,793
Property and equipment, net 61,600 67,828
Goodwill 7,347 7,347
Intangible assets, net 9,248 11,001
Right-of-use assets – operating leases 10,830 10,990
Restricted cash 10,239 9,936
Inventory, net of current portion 12,587 16,657
Other long-term assets 270 337
Total assets $ 132,682 $ 143,889
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable $ 23,296 $ 14,144
Accrued expenses and other current liabilities 19,842 7,580
Accrued R&D software — 3,500
Acquisition-related contingent consideration 650 —
Short-term debt – unaffiliated (includes debt measured at fair value of $2,485 and $17,223 as of December 31, 2024 and 2023, respectively) 2,485 19,331
Short-term debt – related parties 3,876 19,909
Deferred revenue 3,531 2,834
Total current liabilities 53,680 67,298
Deferred revenue, net of current portion 2,724 3,186
Acquisition-related contingent consideration, net of current portion 1,413 1,606
Long-term debt – related parties 35,927 —
Long-term lease liabilities 26,548 26,177
Warrant liabilities 3,264 4,359
Deferred income tax liabilities 9 9
Other liabilities 280 294
Total liabilities 123,845 102,929
Commitments and Contingencies (Note 12)
Stockholders’ equity:
Preferred stock, $0.0001 par value, 10,000,000 shares authorized, none issued and outstanding as of December 31, 2024 and 2023 — —
Common stock, $0.0001 par value, 730,000,000 shares authorized, 22,546,671 and 19,378,192 issued and outstanding as of December 31, 2024 and 2023, respectively 2 19
Additional paid-in capital 908,523 882,732
Accumulated deficit (899,683) (841,791)
Accumulated other comprehensive loss (5) —
Total stockholders’ equity 8,837 40,960
Total liabilities and stockholders’ equity $ 132,682 $ 143,889

Delcath Systems Reports First Quarter 2025 Results and Business Highlights

On May 8, 2025 Delcath Systems, Inc. (Nasdaq: DCTH) ("Delcath" or the "Company"), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported financial results and business highlights for the first quarter ended March 31, 2025 (Press release, Delcath Systems, MAY 8, 2025, View Source [SID1234652742]).

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First Quarter 2025 Financial Results

Total revenue of $19.8 million, compared with $3.1 million in the first quarter of 2024
HEPZATO KIT revenue of $18.0 million, compared to $2.0 million in the first quarter of 2024
CHEMOSAT revenue of $1.8 million, compared to $1.1 million in the first quarter of 2024
Gross margins of 86%, compared to 71% in the first quarter of 2024
Net income of $1.1 million, compared to a net loss of $11.1 million in the same quarter of 2024
Non-GAAP positive adjusted EBITDA in the first quarter of $7.6 million, compared to a loss of $7.3 million in the first quarter of 2024
Cash and investments of $58.9 million as of March 31, 2025
Cash provided by operations of $2.2 million in the quarter
Business Highlights and Updates

Activated three new U.S. centers in the first quarter and two more so far in the second quarter of 2025, bringing the current total to 19 active centers, with 10 additional centers accepting referrals
Received FDA clearance of an IND application for a phase 2 clinical trial of HEPZATO in liver-dominant metastatic breast cancer
Announced publication of comparative analysis from randomized portion of FOCUS Study in metastatic uveal melanoma
The exercise of 1.62 million Series F warrants resulted in $16.2 million of funding in 2025. The warrants were issued in 2020 as a component of a private placement and had an exercise price of $10.00 per share and expired on May 5, 2025
"Consistent revenue growth and the continued expansion of active treatment centers represent a strong start to 2025," said Gerard Michel, Chief Executive Officer of Delcath. "We achieved our first quarter of net income and positive operating cash flow, underscoring the accelerating clinical adoption of HEPZATO for patients with metastatic uveal melanoma. Ongoing dialogue with oncologists and interventional radiologists reinforces the importance of whole-liver treatment for patients with liver-dominant disease. These insights continue to shape our development strategy as we pursue additional indications for HEPZATO."

First Quarter 2025 Results

Total revenue for the quarter ending March 31, 2025 was $19.8 million compared to $3.1 million for the same period in the prior year. Revenue in the quarter includes sales of $18.0 million of HEPZATO in the U.S. and $1.8 million of CHEMOSAT in Europe.

Research and development expenses for the quarter ended March 31, 2025, were $5.0 million compared to $3.7 million for the same period in the prior year. The increase is primarily due to costs associated with expanding the clinical team and initiation of the Phase 2 clinical trial evaluating HEPZATO in combination with standard of care for mCRC. In 2024, these costs primarily related to medical affairs and regulatory costs associated with the approved products.

Selling, general and administrative expenses for the quarter ending March 31, 2025, were $11.3 million compared to $8.8 million for the same period in the prior year. The increase is primarily due to continued commercial expansion activities including marketing-related expenses and additional personnel in the commercial team.

Net income for the quarter ended March 31, 2025 was $1.1 million compared to net loss of $11.1 million for the same period in the prior year.

Non-GAAP adjusted EBITDA for the quarter ended March 31, 2025 was $7.6 million compared to adjusted EBITDA loss of $7.3 million for the same period in the prior year. A table reconciling non-GAAP measures is included in this press release for reference.

As of March 31, 2025, the Company had $58.9 million in cash and investments, and no debt.

Conference Call Information
To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call.

Event Date: Thursday, May 8, 2025
Time: 8:30 AM Eastern Time

Participant Numbers:
Toll Free: 1-877-407-3982
International: 1-201-493-6780
Webcast: View Source;tp_key=6de250d858
A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website View Source