On May 12, 2025 FibroGen, Inc. (NASDAQ: FGEN) reported financial results for the first quarter 2025 and provided an update on the company’s recent developments (Press release, FibroGen, MAY 12, 2025, View Source [SID1234652879]).

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"We continue to focus on our most important strategic priority of advancing our lead asset, FG-3246, with the initiation of the Phase 2 monotherapy dose optimization study in mCRPC, expected to start in the third quarter of 2025," said Thane Wettig, Chief Executive Officer, FibroGen. "In addition, we have filed a Type C meeting request with the FDA to discuss the potential Phase 3 development program for roxadustat in the treatment of anemia associated with LR-MDS, an indication with significant unmet medical need. As we look to finalize the sale of FibroGen China in the third quarter of 2025, we remain highly focused on driving significant shareholder value by supporting our US development initiatives with our strong balance sheet and extended cash runway into the second half of 2027."

Recent Developments and Key Highlights of First Quarter 2025:

Sale of FibroGen China to AstraZeneca now expected to be for a total consideration of approximately $185 million, representing an enterprise value of $85 million plus estimated net cash held in China at closing of approximately $100 million. The transaction is expected to close in the third quarter of 2025.
Upon closing, FibroGen will repay its term loan to Morgan Stanley Tactical Value, further simplifying the Company’s capital structure.
FibroGen maintains its rights to roxadustat in the U.S. and in all markets outside of China, South Korea, and those licensed to Astellas.
Publication of results from Phase 1 Monotherapy Study of FG-3246 titled, "A Phase 1, First-in-Human Study of FOR46 (FG-3246), an Immune-Modulating Antibody-Drug Conjugate Targeting CD46, in Patients with Metastatic Castration Resistant Prostate Cancer", in the peer-reviewed Journal of Clinical Oncology (JCO). The trial results provide key insights into the clinical impact of targeting CD46 and its potential to become the next generation target in the prostate cancer treatment paradigm.
Upcoming Milestones:

FG-3246 (CD46 Targeting ADC) and FG-3180 (CD46 Targeting PET Imaging Agent)

Anticipate initiation of Phase 2 monotherapy dose optimization study of FG-3246 in mCRPC in the third quarter of 2025.
Phase 2 trial will include FG-3180 to enable assessment of its diagnostic performance and the potential correlation between CD46 expression and response to FG-3246.
Topline results from the Phase 2 portion of the investigator-sponsored Phase 1b/2 study conducted by UCSF of FG-3246 in combination with enzalutamide in patients with mCRPC expected in the fourth quarter of 2025.
Phase 2 portion of the study will include data on FG-3180.
Roxadustat

Filed a Type-C meeting request with the FDA for roxadustat in anemia associated with LR-MDS. The Company expects feedback on a potential path forward in the third quarter of 2025.
Financial:

Total revenue from continuing operations for the first quarter of 2025 was $2.7 million, as compared to $25.4 million for the first quarter of 2024.
Net loss from continuing operations for the first quarter of 2025 was $16.8 million, or $0.16 net loss per basic and diluted share, compared to a net loss of $49.0 million, or $0.49 net loss per basic and diluted share, one year ago.
At March 31, 2025, FibroGen reported $33.8 million in cash, cash equivalents and accounts receivable in the U.S. and $128.4 million in total consolidated cash, cash equivalents and accounts receivable.
Upon closing of the announced sale of FibroGen China, the Company expects its cash, cash equivalents and accounts receivable to be sufficient to fund our operating plans into the second half of 2027.
Conference Call and Webcast Presentation
The FibroGen management team will host a conference call and webcast presentation to discuss the financial results and provide a business update. A live Q&A session will follow the brief presentation. Interested parties may access a live audio webcast of the conference call here. To access the call by phone, please register here, and you will be provided with dial in details. A replay of the webcast will also be available for a limited time on the Events & Presentations page on FibroGen’s website.

About FG-3246
FG-3246 (FOR46) is a potential first-in-class fully human antibody-drug conjugate (ADC), exclusively in-licensed from Fortis Therapeutics, and is being developed by FibroGen for metastatic castration-resistant prostate cancer and potentially other tumor types. FG-3246 binds to an epitope of CD46, a cell receptor target, that induces internalization upon antibody binding, is present at high levels in prostate cancer and other tumor types and demonstrates very limited expression in most normal tissues. FG-3246 is comprised of an anti-CD46 antibody, YS5, linked to the anti-mitotic agent, MMAE, which is a clinically and commercially validated ADC payload. FG-3246 has demonstrated anti-tumor activity in both preclinical and clinical studies.

FG-3246 is currently in an ongoing Phase 1b/2 study being conducted at UCSF as an investigator-sponsored trial to evaluate FG-3246 in combination with enzalutamide. An additional investigator-sponsored radiopharmaceutical marker trial using a zirconium-89 positron emission tomography (PET) tracer for CD46 that utilizes the YS5 antibody is also underway at UCSF. The initiation of the Phase 2 monotherapy dose optimization trial for FG-3246 in metastatic castration-resistant prostate cancer is anticipated in the third quarter of 2025. FG-3246 is an investigational drug and not approved for marketing by any regulatory authority.

About Roxadustat
Roxadustat, an oral medication, is the first in a new class of medicines comprising HIF-PH inhibitors that promote erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin, improved iron absorption and mobilization, and downregulation of hepcidin. Roxadustat is in clinical development for chemotherapy-induced anemia (CIA) and a Supplemental New Drug Application (sNDA) has been accepted by the China Health Authority.

Roxadustat is approved in China, Europe, Japan, and numerous other countries for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). FibroGen has the sole rights to roxadustat in the United States, Canada, Mexico, and in all markets not held by AstraZeneca or licensed to Astellas. Astellas and FibroGen are collaborating on the commercialization of roxadustat for the treatment of anemia in territories including Japan, Europe, Turkey, Russia, and the Commonwealth of Independent States, the Middle East, and South Africa.

On May 12, 2025 CytomX Therapeutics, Inc. (NASDAQ:CTMX), a leader in the field of masked, conditionally activated biologic therapeutics, reported the pricing of an underwritten offering of 76,923,076 shares of its common stock at an offering price of $1.30 per share, before underwriting discounts and commissions (Press release, CytomX Therapeutics, MAY 12, 2025, View Source [SID1234652878]). All of the shares are being offered by the Company. The gross proceeds from the offering are expected to be approximately $100 million before deducting underwriting discounts and commissions and other offering expenses. The offering is expected to close on May 13, 2025, subject to customary closing conditions.

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The Company intends to use the net proceeds from this offering for research and development, general corporate purposes and working capital needs.

The offering was led by Longitude Capital and also included participation from OrbiMed, Venrock Healthcare Capital Partners, Vivo Capital, RTW Investments, and a large investment management firm, among other funds. Jefferies and Piper Sandler are acting as joint book-running managers for the offering.

The securities described above are being offered pursuant to an effective shelf registration statement that was filed with the U.S. Securities and Exchange Commission (SEC) on August 9, 2024. This offering is being made only by means of a prospectus supplement and the accompanying prospectus which forms a part of the effective shelf registration statement.

A prospectus supplement related to the offering (including the accompanying prospectus) will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Copies of the prospectus supplement related to the offering and the accompanying prospectus may be obtained, when available, by visiting the SEC’s website or by contacting: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by telephone at (800) 747-3924, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, the securities in this offering in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state or jurisdiction.

On May 12, 2025 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, reported positive interim Phase 1 data for its EpCAM PROBODY ADC candidate, CX-2051, in advanced, late-line CRC (Press release, CytomX Therapeutics, MAY 12, 2025, View Source [SID1234652877]). The data are as of an April 7th 2025 data cutoff from the ongoing CTMX-2051-101 Phase 1 study.

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"EpCAM is a high potential and broadly expressed cancer target that has been challenging to drug historically due to expression on normal tissues. We believe we have broken important new ground with our data announced today, which show potential for markedly improved outcomes for CRC patients," said Sean McCarthy, D. Phil, chief executive officer and chairman of CytomX. "CX-2051 is showing impressive, durable anti-tumor activity in late line metastatic CRC, an area of high unmet need and a very difficult tumor to treat. Furthermore, CX-2051 has been generally well tolerated, highlighting the power of CytomX PROBODY masking technology."

Dr. McCarthy added, "Importantly, we believe these results validate EpCAM as an oncology target and unlock a broad development opportunity for CX-2051 in CRC and potentially many other cancer types where EpCAM is expressed. We are excited to rapidly advance CX-2051 for the benefit of CRC patients and to explore the full potential of this novel ADC."

CX-2051 Phase 1a Interim Data Summary in Advanced, Late-line Colorectal Cancer

The CTMX-2051-101 study was initiated in April 2024 with dose escalation proceeding through seven dose levels as of April 2025.
25 advanced metastatic CRC patients were treated with CX-2051 across dose levels 1 through 5 as of the April 7, 2025 data cutoff. CX-2051 was administered on a once every three week schedule (Q3W).
The 2.4 mg/kg and 4.8 mg/kg doses were single patient dose escalation cohorts not anticipated to be therapeutically active.
At the 7.2 mg/kg, 8.6 mg/kg, and 10 mg/kg doses, 23 patients were treated in total, 18 of whom were efficacy evaluable, having had at least one post-baseline tumor assessment as of the data cutoff.
Patient Characteristics:

The 25 patients enrolled in the study across dose levels 1 through 5 had previously received a median of 4 prior lines of therapy and all patients had previously been treated with irinotecan. 64% of patients had liver metastases, 64% had KRAS mutations, and 96% were microsatellite stable.
Patients were not preselected based on EpCAM expression levels.
Efficacy Results:
As of the data cutoff, 18 patients were efficacy-evaluable at the expansion doses of 7.2 mg/kg, 8.6 mg/kg, and 10 mg/kg Q3W.

Overall response rate (ORR):
28% of patients (5/18) achieved confirmed partial RECIST v. 1.1 responses. Overall response rates for currently approved therapies in 3rd line or later CRC are in the low to mid-single digit percentages1.
At the 10 mg/kg dose, 3 of 7 evaluable patients (43%) achieved confirmed partial responses.
The Disease Control Rate2 was 94% across the three dose groups (17/18).
Durability:
Median progression free survival was 5.8 months as of the data cutoff.
10 of 18 patients remained on study treatment as of the data of cutoff.
Safety Results:
As of the data cutoff, 25 patients were evaluable for safety.

CX-2051 was generally well-tolerated with manageable adverse events, with no observed dose limiting toxicities. Most treatment related adverse events (TRAEs) were Grade 1 or Grade 2 in severity.
The most common reported TRAEs were diarrhea (18 patients, 5 Grade 3), nausea (11 patients, 1 Grade 3), vomiting (8 patients, No Grade 3), fatigue (8 patients, 1 Grade 3), anemia (5 patients, 3 Grade 3), hypokalemia (3 patients, 1 Grade 3), neutrophil count decrease (2 patients, 2 Grade 3) and neutropenia (2 patients, 1 Grade 3). TRAEs included serious adverse events in 5 patients (1 Grade 2, 4 Grade 3). No Grade 4 or 5 TRAEs were observed.
No events of pancreatitis, interstitial lung disease or febrile neutropenia were reported at time of data cutoff.
CX-2051 Phase 1 Dose Expansions Initiated:

Dose expansions have been initiated at doses of 7.2 mg/kg, 8.6 mg/kg and 10 mg/kg Q3W.
A total of 20 patients are expected to be enrolled at each dose level to inform the selection of recommended phase 2 dose.
CX-2051 Anticipated Milestones:

CX-2051 Monotherapy for Advanced Late-Line CRC:
Additional Phase 1 data update by Q1 2026
Planning Phase 2 study initiation in 1H 2026
CX-2051 CRC Combinations:
Potential to initiate CX-2051 combination studies in earlier lines of CRC in 2026
CX-2051 Pan-tumor Potential:
Evaluate non-CRC, EpCAM-expressing tumor indications for potential Phase 1b study initiation in 2026
CytomX Investor Event Information
Additional details will be provided on the Company’s Investor Call on May 12, 2025 at 8 a.m. EST. Participants may access the live webcast of the conference call from the Events and Presentations page of CytomX’s website at View Source Participants may register for the conference call here and are advised to do so at least 10 minutes prior to joining the call. An archived replay of the webcast will be available on the company’s website for at least 30 days.

About CTMX-2051-101 Study
Additional information about the CTMX-2051-101 study can be found here on clinicaltrials.gov.

About CX-2051 (EpCAM PROBODY ADC)
CX-2051 is an investigational masked, conditionally activated ADC directed toward epithelial cell adhesion molecule (EpCAM) and armed with a topoisomerase-1 inhibitor payload. CX-2051 has potential applicability across multiple EpCAM-expressing epithelial cancers, including CRC, and was discovered in collaboration with ImmunoGen, now part of AbbVie. EpCAM (Epithelial Cell Adhesion Molecule) is a highly expressed but previously undruggable tumor antigen due to expression on normal tissues. CX-2051 is designed to open a therapeutic window for this high potential target and to deliver meaningful anti-cancer activity in solid tumors, including CRC.

On May 12, 2025 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, reported first quarter 2025 financial results and provided a business update (Press release, CytomX Therapeutics, MAY 12, 2025, View Source [SID1234652876]).

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"Our positive interim clinical results announced today for CX-2051 in advanced colorectal cancer are highly encouraging and provide a significant opportunity for CytomX. As an EpCAM-directed ADC, CX-2051 was intentionally designed to address the high unmet need in CRC. CX-2051 remains the Company’s top strategic priority and is positioned to rapidly advance towards later stage development. Just one year into the clinic, CX-2051 dose expansions are already in progress with a goal to initiate a Phase 2 study in advanced CRC in the first half of 2026. This excellent progress underscores the intense focus of the CytomX team on diligent execution for the benefit of the patients we serve," said Sean McCarthy, D.Phil., chief executive officer and chairman of CytomX.

Pipeline Program Updates:

CX-2051 (EpCAM PROBODY Topo-1 ADC)

Announced positive interim data from ongoing Phase 1 dose escalation study of EpCAM Antibody Drug Conjugate (CX-2051) candidate in patients with advanced colorectal cancer (CRC).
Initiated CX-2051 dose expansions at the 7.2 mg/kg, 8.6 mg/kg, and 10 mg/kg doses, administered every three weeks (Q3W).
Phase 1 data update in advanced CRC in at least 70 patients is expected to be presented by Q1 2026.
Planning Phase 2 study initiation in 1H 2026
CX-801 (PROBODY Interferon alpha-2b)

Phase 1 dose escalation continues with a focused early development strategy in metastatic melanoma and with the goal of initiating combination therapy with CX-801 and KEYTRUDA in 2025.
The Phase 1 study is currently in the fourth monotherapy dose escalation cohort where the dose of CX-801 exceeds the approved dose of the unmasked peginterferon alfa-2b (SYLATRON)1.
Initial Phase 1a translational and biomarker data in advanced melanoma is expected in the second half of 2025.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA

Corporate and Financial:

Financial:
Focused clinical development priorities and cost reductions implemented in Q1 2025 have extended the Company’s cash runway into the second quarter of 2026. CytomX ended the first quarter of 2025 with $79.9 million of cash, cash equivalents and investments.
Research collaborations:
Milestone achieved in Astellas T-cell engager collaboration: In February 2025, Astellas advanced the second program to GLP toxicology studies, triggering a $5.0 million milestone payment to CytomX.
Presented preclinical data for mRNA encoded masked IL-12 molecule in collaboration with Moderna at AACR (Free AACR Whitepaper) Annual Meeting showing potent anti-tumor activity with significantly enhanced tolerability vs. unmasked IL-12 molecule.
Multiple drug discovery programs continue across our research collaborations with a focus on T-cell engagers. CytomX has research collaborations with Bristol Myers Squibb, Amgen, Astellas, Regeneron, and Moderna.
First Quarter 2025 Financial Results:

Cash, cash equivalents and investments totaled $79.9 million as of March 31, 2025, compared to $100.6 million as of December 31, 2024.

Total revenue was $50.9 million for the quarter ended March 31, 2025, compared to $41.5 million for the quarter ended March 31, 2024. The increase in revenue was driven primarily by a higher percentage of completion for research programs in the Bristol Myers Squibb collaboration and the acceleration of revenue recognition in the Amgen collaboration due to the decision to not further develop the CX-904 program, partially offset by lower Astellas milestones and Moderna revenue.

Total operating expense in the first quarter of 2025 was $28.3 million compared to $29.8 million in the first quarter of 2024, a decrease of $1.5 million. Operating expenses in the first quarter of 2025 included $2.9 million of one-time expenses related to the Company’s January 2025 restructuring.

Research and development expenses were $18.9 million for the three months ended March 31, 2025, a decrease of $3.2 million compared to the corresponding period of 2024. Reduced research and development expenses were primarily due to reduced pre-clinical activities in wholly owned and partnered programs and decreased manufacturing activities for CX-801, partially offset by increased clinical trial activities related to CX-2051 and CX-801, and $1.8 million of restructuring expenses.

General and administrative expenses were $9.4 million for the three months ended March 31, 2025, an increase of $1.7 million compared to the corresponding period of 2024. The increase in general and administrative expenses was primarily driven by $1.1 million of restructuring expenses as well as other personnel-related expenses.

On May 12, 2025 Curium reported that it has marketing authorization in Switzerland for the distribution of PYLCLARI (INN: Piflufolastat (18F) formerly known as (18F)-DCFPyL) (Press release, Curium Pharma, MAY 12, 2025, View Source [SID1234652875]). PYLCLARI is indicated for the detection of prostate-specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in adults with prostate cancer in the following clinical settings:

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Primary staging of patients with high-risk prostate cancer prior to initial curative therapy
To localize recurrence of prostate cancer in patients with a suspected recurrence based on increasing serum prostate-specific antigen (PSA) levels after primary treatment with curative intent
Today’s announcement follows the decision in July 2023 by the European Commission granting marketing authorization for PYLCLARI in the European Union. b.e. Imaging currently distributes Curium’s entire suite of SPECT radiopharmaceuticals across Switzerland and following an exclusive distribution rights agreement in September 2023, will now also distribute PYLCLARI.

Dr. Michel Wuillemin, Managing Director at b.e. Imaging commented, "b.e. Imaging has proven to be a crucial supplier for the whole range of Curium’s SPECT radiopharmaceuticals for Switzerland. The extension of the partnership with Curium to PSMA PET imaging with PYLCLARI underscores b.e. Imaging’s focus in the field of prostate cancer. Curium’s PYLCLARI is in line with b.e. Imaging’s experience in the field of radioligand therapy for patients with prostate cancer."

Benoit Woessmer, PET Europe CEO at Curium commented, "We are pleased with the growing availability of PYLCLARI to reach more nuclear medicine physicians and their patients across Europe. With today’s announcement, we are extremely proud to be improving the choice of diagnostic radiopharmaceuticals available to our customers in Switzerland – ultimately for the benefit of patients with prostate cancer."

In Switzerland, prostate cancer is the most common cancer among men with around 7,800 new cases diagnosed nationwide every year. Today’s announcement is part of the continued roll-out of PYLCLARI across the European Union, which with the addition of Switzerland, is now available for patients with prostate cancer in 12 countries. In the U.S., Lantheus received approval for PYLARIFY (Piflufolastat (18F) Injection) from the Food and Drug Administration (FDA) in May 2021. It is the #1 utilized PSMA PET agent in the U.S. market. The European rights were licensed to Curium from Progenics, a Lantheus company, in 2018.