Greenwich LifeSciences Announces Use of Commercially Manufactured GP2 in FLAMINGO-01

On March 16, 2026 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, reported the following update on the use of commercially manufactured GP2 in FLAMINGO-01.

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All US Sites Treating Patients with Commercially Manufactured GP2

The Company previously announced that the first three commercial lots of GP2 active ingredient were manufactured in 2023 in an approved commercial facility, which could be used to prepare approximately 200,000 doses of GP2. In 2024, the first of three commercial lots filling GP2 into vials for commercial sale or for clinical use was manufactured in a commercial facility. In addition, drug stability programs were initiated for all four lots. Data on these commercial lots was recently submitted to the FDA, and after review, the first commercial lot of GP2 vials was approved for use in FLAMINGO-01 in the US.

Within weeks following the FDA review, all approximately 40 US sites were supplied with commercially manufactured GP2 vials and these sites began treating patients with these vials immediately. We were able to efficiently distribute the GP2 vials and communicate with the US pharmacists working with our warehouse partners and through our clinical team, which we internalized in Q4 2025.

CEO Snehal Patel commented, "We have started to submit the same manufacturing information to European, UK, and Canadian regulators so that commercially manufactured GP2 can be approved for use by all approximately 160 sites participating in FLAMINGO-01. We are also planning to manufacture additional vials of GP2, seeking a capacity of 500,000 to 1 million vials of GP2 per year, and to make larger lots of GP2 active ingredient to build inventory for a potential commercial launch."

About FLAMINGO-01 Open Label Phase III Data

More than 1,000 patients have been screened with a current screen rate of approximately 800 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.

In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 80% reduction in recurrence rate.
This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products.
The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study.
Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ.

About GLSI-100 Phase IIb Study

In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb results can be summarized as follows:

80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile.
The PIS elicited a potent immune response as measured by local skin tests and immunological assays.
About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of Fast Track designated GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients are planned to be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types are planned to be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.

For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the "Contacts and Locations" section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: [email protected]

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

(Press release, Greenwich LifeSciences, MAR 16, 2026, View Source [SID1234663567])

CytomX Therapeutics Announces 2025 Financial Results and Provides Business Update

On March 16, 2026 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, reported 2025 financial results and provided a business update.

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"Today’s encouraging Varseta-M Phase 1 update underscores the program’s intentional design and broad potential in CRC as well as other EpCAM-expressing indications. CytomX’s top priority in 2026 is to align with the FDA on a registrational path for Varseta-M in late-line CRC. We also plan to accelerate Varseta-M combination studies to benefit CRC patients in earlier lines of treatment," said Sean McCarthy, D.Phil., chief executive officer and chairman of CytomX.

"Our continued and exciting progress with Varseta-M reinforces our leadership in the field of masking and CytomX’s ability to unlock true innovation. Our highly focused portfolio strategy is also illustrated by our second clinical program, CX-801. This masked version of Interferon-alpha-2b is being developed initially in advanced melanoma and, we believe, has the potential to become a new centerpiece of combination immunotherapy across multiple cancers. The CX-801 translational and biomarker data presented to date have been very encouraging, and we expect to share initial proof of concept data for the combination with KEYTRUDA later this year."

Pipeline Program Updates:

Varsetatug masetecan (EpCAM PROBODY Topo-1 ADC, CX-2051)

Announced positive data update from Phase 1 dose expansion study of Varseta-M in patients with advanced colorectal cancer (CRC).
The Company aims to align with the FDA in 2026 on a potential registrational study design for Varseta-M monotherapy in advanced CRC.
Additional Phase 1 follow-up data are also expected to be presented at major medical meeting(s) in 2026.
A Phase 1 Varseta-M combination study with bevacizumab in CRC has been initiated and a Phase 1b/2 study in combination with bevacizumab and chemotherapy is expected to start by the end of 2026.
Initiation of Phase 1 expansion cohort(s) in additional indications is planned for 2H 2026.

CX-801 (PROBODY Interferon alpha-2b)

The CX-801 Phase 1 study is progressing with a focus in advanced melanoma. The CX-801 monotherapy dose escalation portion of the study has reached the fourth dose level.
CX-801 monotherapy has been well tolerated at dose levels exceeding the approved dose of unmasked IFNα2b.1
In May 2025, Phase 1 dose escalation of CX-801 in combination with KEYTRUDA (pembrolizumab) was initiated. Dose escalation of CX-801 in combination with KEYTRUDA is currently enrolling the 2nd dose level.
Biomarker data from the CX‑801 monotherapy study in advanced melanoma were presented at the 2025 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, reinforcing CX‑801’s mechanism of action and supporting the ongoing combination trial with KEYTRUDA.
Initial clinical data for CX-801 in combination with KEYTRUDA in advanced melanoma is projected by the end of 2026.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA

Corporate and Financial:

Financial:
CytomX ended 2025 with $137.1 million of cash, cash equivalents and investments with expected cash runway to the second quarter of 2027.
Research Pipeline and Collaborations:
CytomX has research collaborations with Bristol Myers Squibb, Amgen, Regeneron, and Moderna. Multiple drug discovery programs continue across our research collaborations with a focus on bispecific immunotherapies, including T-cell engagers.
In March 2026, Astellas chose to not advance the remaining preclinical research programs under the alliance resulting in a termination of the collaboration effective in the second quarter of 2026.

Full Year 2025 Financial Results:

Cash, cash equivalents and investments totaled $137.1 million as of December 31, 2025, compared to $100.6 million as of December 31, 2024.

Total revenue was $76.2 million for the year ended December 31, 2025, compared to $138.1 million in 2024. The decrease in revenue was driven primarily by the completion of our performance obligations in our collaboration with Bristol Myers Squibb in April 2025 as well as a lower estimated percentage of performance obligation completion for 2025 compared to 2024 in the Moderna, Astellas, and Regeneron collaborations.

In 2025, CytomX remained focused on controlling costs and efficiently progressing its pipeline programs. Total operating expense for 2025 was $98.6 million compared to $113.1 million for 2024, a decrease of $14.5 million.

Research and development expenses decreased by $14.7 million during the year ended December 31, 2025, to $68.7 million compared to $83.4 million for 2024. Research and development expenses decreased primarily due to lower general research and development expenses as a result of our January 2025 restructuring and reduced expenses for CX-904, partially offset by increased manufacturing and clinical spend on Varseta-M.

General and administrative expenses increased by $0.1 million during the year ended December 31, 2025, to $29.8 million, compared to $29.7 million for 2024. The general and administrative expenses for 2025 included $1.1 million of one-time restructuring expenses partially offset by reduced personnel related expenses and legal and consulting related expenses.

(Press release, CytomX Therapeutics, MAR 16, 2026, View Source [SID1234663566])

CytomX’s Varsetatug Masetecan (EpCAM PROBODY® ADC) Continues to Demonstrate Positive Data Supporting Potential as a New Treatment Option in Late-Line Colorectal Cancer

On March 16, 2026 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, reported positive Phase 1 expansion data for its EpCAM PROBODY ADC, varsetatug masetecan (Varseta-M) in late-line metastatic CRC. The preliminary data are as of a January 16, 2026 data cutoff from the ongoing CTMX-2051-101 Phase 1 study.

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"These latest Phase 1 data reinforce the potential of Varseta-M to meaningfully improve the standard of care in late-line colorectal cancer. We are now planning interactions with the FDA to discuss the initial registrational path for bringing this highly innovative, first-in-class ADC to the market in late-line CRC," said Sean McCarthy, D. Phil, chief executive officer and chairman of CytomX.

McCarthy added, "Our ultimate vision is to reach a broad CRC patient population with Varseta-M, including in earlier lines of treatment, as well as to expand into additional EpCAM-expressing cancers. We aim to aggressively advance this novel therapy towards late-stage development for the benefit of patients as we set our sights on building CytomX into a commercial-stage company."

"Patients with late-stage metastatic CRC face a poor prognosis and have very limited treatment options. These exciting clinical data demonstrate that Varseta-M can drive consistent and durable responses with a manageable tolerability profile in patients with heavily pretreated CRC, supporting its promise as a potential new treatment option for advanced CRC," said Dr. Kimmie Ng, Associate Chief of the Division of Gastrointestinal Oncology at Dana-Farber Cancer Institute.

Varsetatug Masetecan Phase 1 Expansion 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 ranging from 2.4 mg/kg to 12 mg/kg. As of the data cutoff of January 16th 2026, a total of 93 patients with late-line metastatic CRC had been enrolled in the study. 60 patients were enrolled across the Phase 1 expansion dose range of 7.2 mg/kg, 8.6 mg/kg, and 10 mg/kg of which 56 were efficacy evaluable as of the data cutoff.
Starting in October 2025, the expansion doses of 8.6 mg/kg and 10 mg/kg were prioritized for dose optimization utilizing optimized adverse event management guidelines and adjusted ideal body weight (AIBW) dosing. 20 patients had been enrolled in expanded dose optimization as of the January 16th data cutoff towards an enrollment goal of 40 patients.

Patient Characteristics:

Patients enrolled in the study had previously received a median of 3 prior lines of therapy in the metastatic setting and 96% of patients had previously been treated with irinotecan. 76% of patients had liver metastases and 71% had KRAS mutations.
Patients were not preselected based on EpCAM expression levels. All patients with evaluable tumor biopsies had high EpCAM levels as measured by immunohistochemistry.1

Efficacy:

As of the data cutoff, 56 patients were efficacy-evaluable at the expansion doses of 7.2 mg/kg, 8.6 mg/kg, and 10 mg/kg Q3W. Median duration of follow-up across the efficacy-evaluable patient population was approximately 8 months. Efficacy data across the Phase 1 Expansion doses are summarized below in Table 1.

Table 1. Varseta-M Efficacy Summary by Phase 1 Expansion Dose

7.2 mg/kg 8.6 mg/kg 10 mg/kg
Confirmed
Overall Response Rate (ORR)2 6% (1/17) 20% (4/20) 32% (6/19)
Median Progression Free Survival (PFS) 5.5 mo.
(95% CI: 2.5, NE) 6.8 mo.
(95% CI: 2.8, NE) 7.1 mo.
(95% CI: 3.9, NE)
Disease Control Rate (DCR) 88% (15/17) 90% (18/20) 84% (16/19)

At the 8.6 mg/kg dose, the confirmed response rate was 20% with an estimated median PFS of 6.8 months and at the 10 mg/kg dose, the confirmed response rate was 32% with an estimated median PFS of 7.1 months.
The disease control rate was 88% (49/56) across the expansion doses of 7.2 – 10 mg/kg.
The doses of 8.6 mg/kg and 10 mg/kg have been prioritized for further evaluation with the goal of selecting a dose or doses for a registrational study.
Dose optimization at 8.6 mg/kg and 10 mg/kg utilizing AIBW dosing and updated prophylaxis for adverse event management is ongoing.
At the doses of 11 mg/kg Q3W and 12 mg/kg Q3W, which were not expanded for further evaluation, the overall response rate was 30% (3/10).

Safety:

As of the data cutoff, 93 patients were evaluable for safety including 80 patients across the expansion dose range of 7.2 mg/kg to 10 mg/kg. Varseta-M’s safety profile was generally consistent with data presented in Phase 1 dose escalation. Most treatment related adverse events were Grade 1 or Grade 2 in severity.

No interstitial lung disease, febrile neutropenia or pancreatitis were observed.
The most common treatment-related adverse event (TRAE) was diarrhea which was generally manageable and reversible.
In Phase 1 dose expansions starting in Q2 2025, prophylactic strategies for diarrhea management were investigated. In dose optimization starting in Q4 2025, an updated prophylaxis regimen of anti-motility medication (loperamide or diphenoxylate/atropine) plus budesonide was implemented.3
In the 20 patients receiving the updated prophylactic regimen in dose optimization at doses of 8.6 mg/kg and 10 mg/kg, Grade 3 diarrhea was 10%.4,5
Overall, as of the January 16th 2026 data cutoff, in the 80 patients treated at expansion and optimization doses ranging between 7.2 mg/kg to 10 mg/kg, the most common treatment-related adverse events (TRAEs) were diarrhea (68 pts, 19 Gr 3), nausea (44 pts, 4 Gr 3), vomiting (29 pts, 3 Gr 3), fatigue (32 pts, 2 Gr 3), hypokalemia (21 pts, 13 Gr 3+), and anemia (13 pts, 6 Gr 3). Serious treatment related adverse events (SAEs) in > 1 patient included diarrhea (4), vomiting (3), hypokalemia (3), dehydration (3), acute kidney injury (2), and colitis (2).
As previously reported on August 13, 2025, there was one treatment-related grade 5 acute kidney injury (AKI) in a patient treated at the 7.2 mg/kg dose. The patient had a complex medical history including having a solitary kidney, and the AKI was determined to be secondary to Grade 3 nausea and Grade 2 diarrhea. No other Grade 5 TRAEs have been reported as of the January 16th 2026 data cutoff.
At the 11 mg/kg and 12 mg/kg doses, there were no dose limiting toxicities in dose escalation. The most common TRAEs across the patients in the 11 mg/kg dose (n=8) and 12 mg/kg dose (n=3) were diarrhea (9 pts, 6 GR 3), nausea, (8 pts, 0 Gr 3), and vomiting (8 pts, 1 Gr 3). Patients treated at the 11 and 12 mg/kg doses did not receive the optimized prophylactic regimen or adjusted ideal body weight dosing.

Varsetatug Masetecan Next Steps:

Additional efficacy and safety data from the Phase 1 study are expected to be presented at one or more medical meetings in 2026.
The Company aims to align with the FDA in 2026 on a potential registrational study design for Varseta-M monotherapy in advanced CRC.
A Phase 1 Varseta-M combination study with bevacizumab in CRC has been initiated and a Phase 1b/2 study in combination with bevacizumab and chemotherapy is expected to start by the end of 2026.
Initiation of Phase 1 expansion cohort(s) in additional EpCAM-expressing indications is planned for 2H 2026.

(Press release, CytomX Therapeutics, MAR 16, 2026, View Source [SID1234663565])

CytomX Therapeutics Announces Proposed Public Offering of Common Stock and Pre-Funded Warrants

On March 16, 2026 CytomX Therapeutics, Inc. (Nasdaq:CTMX), a leader in the field of masked, conditionally activated biologics, reported that it has commenced an underwritten public offering of $250.0 million of shares of common stock and, in lieu of common stock to certain investors, pre-funded warrants. In addition, CytomX expects to grant the underwriters a 30-day option to purchase up to an additional $37.5 million of shares of common stock at the public offering price, less underwriting discounts and commissions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. All of the shares of common stock and pre-funded warrants are to be offered by CytomX.

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CytomX expects to use the net proceeds from this offering for the continued development of Varseta-M and other pipeline programs. CytomX expects to use any remaining net proceeds from this offering for capital expenditures, working capital and other general corporate purposes.

Jefferies, Piper Sandler, Cantor and Barclays are acting as joint bookrunning managers for the offering. Wedbush PacGrow is acting as co-manager for the offering.

A shelf registration statement relating to these securities was filed with the U.S. Securities and Exchange Commission ("SEC") on March 16, 2026, and automatically became effective upon filing. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, for free from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; Piper Sandler & Co., Attention: Prospectus Department, 350 North 5th Street, Suite 1000, Minneapolis, Minnesota 55401, or by telephone at (800) 747-3924, or by email at [email protected]; Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, NY 10022, or by email at [email protected]; or Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (888) 603-5847, 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, these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification of these securities under the securities laws of any such state or jurisdiction.

(Press release, CytomX Therapeutics, MAR 16, 2026, View Source [SID1234663564])

Cypherpunk Reports Full Year 2025 Financial Results

On March 16, 2026 Cypherpunk Technologies Inc., (Nasdaq: CYPH) ("Cypherpunk"), reported financial results for the year ended December 31, 2025.

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"2025 was a transformational year. Following a $58.88 million private placement led by Winklevoss Capital, we rebranded as Cypherpunk to become a privacy technology company with a digital asset treasury strategy focused on Zcash, while advancing sirexatamab for the treatment of patients with colorectal cancer through our Leap Therapeutics subsidiary," said Douglas E. Onsi, President and CEO of Cypherpunk.

"Since we began operating as Cypherpunk in October, we have purchased 294,743.10 ZEC for our treasury and made a $5 million strategic investment in Zcash Open Development Lab ("ZODL"), the development team behind Zodl, the leading Zcash wallet. In the year ahead, we will remain focused on advancing the adoption of Zcash and expanding our efforts across a broad set of technologies that defend privacy," said Will McEvoy, Chief Investment Officer of Cypherpunk.

Cypherpunk Highlights:

· Closed a $58.88 million private placement in cash led by Winklevoss Capital
o In October 2025, the Company raised $58,888,888 in cash led by Winklevoss Capital to become the leading public company focused on advancing privacy preserving technologies. In the transaction, the Company issued: (i) 15,212,311 shares of common stock, (ii) pre-funded warrants to purchase up to an aggregate of 80,768,504 shares of common stock at an exercise price of $0.001 per share, and (iii) warrants to purchase an additional 71,985,605 shares of common stock at an exercise price of $0.5335 per share.

· Appointed digital asset executives and industry leaders as board members and strategic advisors
o In November 2025, the Company appointed Khing Oei as Chairman of the Board of Directors, and Will McEvoy as Chief Investment Officer and a Board member.
o In December 2025, the Company announced that industry pioneer Zooko Wilcox, the founder of Zcash, former CEO of the Electric Coin Company, and current Chief Product Officer of Shielded Labs, joined the company as a Strategic Advisor.
o In December 2025, the Company announced that Josh Swihart, Chief Executive Officer of ZODL, joined the company as a Strategic Advisor.
o In January 2026, the Company announced that Arjun Khemani, a prominent voice in the Zcash ecosystem and the "philosophy of progress" movement, joined the company as a Strategic Advisor.

· Increased treasury holdings to 294,743.10 ZEC
o As of March 12, 2026, Cypherpunk holds a total of 294,743.10 ZEC, at an average purchase price of $335.89, representing approximately 1.78% of the total circulating supply of the Zcash network.
o The Company believes that privacy-protecting assets and related technologies will be critical in the increasingly digital and AI driven world. The Company intends to acquire and hold ZEC, the native coin of Zcash, as its primary digital asset and to be an active participant in the Zcash community.
o ZEC is a digital currency that can be transmitted over a peer-to-peer payment system. Zcash uses a cryptographic method called "zero-knowledge proofs" to allow users to engage in financial transactions while maintaining greater privacy.

· Invested $5 million into ZODL
o In March 2026, the Company expanded its holdings with a $5 million investment in Zcash company, ZODL, alongside key investors including a16z, Winklevoss Capital, Coinbase, Paradigm, Chapter One, David Friedberg, Balaji Srinivasan, and others. This marks Cypherpunk’s first technology investment outside of ZEC. ZODL, which now houses the top Zcash wallet, Zodl, aims to make Zcash easier to use with continued development of the wallet and support of the Zcash protocol.

Leap Therapeutics Subsidiary Highlights:

· Presented final clinical data from Part B of the DeFianCe study of sirexatamab plus bevacizumab and chemotherapy in colorectal cancer ("CRC") patients
o In a Mini Oral session at the ESMO (Free ESMO Whitepaper) Congress in October 2025, the Company presented the final results from Part B of the DeFianCe study, a Phase 2 study of sirexatamab, an anti-DKK1 monoclonal antibody, in combination with bevacizumab and chemotherapy compared to bevacizumab and chemotherapy in patients with microsatellite stable CRC who have received one prior systemic therapy for advanced disease. Sirexatamab demonstrated a statistically significant benefit on overall response rate ("ORR"), progression-free survival ("PFS"), and Overall Survival ("OS") in patients with high levels of DKK1, along with a positive trend on ORR and PFS in the full intent-to-treat population.
o Across the DKK1-high (upper quartile) patients (n=44):
▪ ORR was 44.0% in the Sirexatamab Arm vs. 15.8% ORR in the Control Arm, p-value = 0.0149
▪ mPFS was 9.36 months in the Sirexatamab Arm vs. 5.88 months in the Control Arm, HR 0.46, p-value = 0.0168.
▪ mOS was not reached in the Sirexatamab Arm vs. 9.66 months in the Control Arm, HR 0.17, p-value < 0.001.

· Advancing DKK1 biomarker diagnostic test and engaging with regulatory authorities
o Leap is engaging with regulatory agencies to discuss the registrational pathway for sirexatamab in DKK1-high CRC patients. Leap is also working with a leading diagnostics research laboratory to optimize the DKK1 biomarker diagnostic test that could be used to identify DKK1-high CRC patients with poor prognosis and to select patients for treatment with sirexatamab. Leap expects to provide an update on the next steps in sirexatamab development and on the registrational pathway in the coming weeks.

Selected Year-End 2025 Financial Results

Net Income was $4.8 million for the year ended December 31, 2025, compared to a Net Loss of $67.8 million for the year ended December 31, 2024. The increase was primarily due to $50.4 million of unrealized gains on the fair value of the Company’s ZEC treasury holdings which are marked to market at the end of each period, as well reductions in research and development expenses and general and administrative expenses due to the completion of the sirexatamab Phase 2 clinical development program and a reduction in force of full-time employees.

Research and development expenses were $25.7 million for the full year 2025, compared to $57.2 million for the same period in 2024. The decrease for the full year 2025 was primarily due to a decrease in clinical trial costs and manufacturing costs during the year ended December 31, 2025. There was also a decrease in payroll and other related expenses due to a decrease in headcount, a decrease in stock based compensation expense, and a decrease in consulting fees.

General and administrative expenses were $10.9 million for the full year 2025, compared to $12.8 million for the same period in 2024. The decrease for the full year 2025 was primarily due to a decrease in payroll and other related expenses due to a decrease in incentive based compensation expense and a decrease in headcount. This decrease was partially offset by an increase in stock based compensation expense due to RSUs granted, and an increase in professional fees during the year ended December 31, 2025.

During the year ended December 31, 2025, the Company recorded a $50.4 million unrealized gain on the change in fair value of the Company’s ZEC treasury holdings.

Cash and cash equivalents totaled $14.0 million on December 31, 2025, and ZEC treasury holdings, categorized as a digital asset receivable, totaled $147.4 million on December 31, 2025.

(Press release, Cypherpunk Technologies, MAR 16, 2026, View Source [SID1234663563])