On May 7, 2026 Kyowa Hakko Kirin reported Consolidated Financial Summary for Fiscal 2026 First Quarter.

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(Press release, Kyowa Hakko Kirin, MAY 7, 2026, View Source [SID1234669164])

On May 7, 2026 Alector, Inc. (Nasdaq: ALEC), a biotechnology company focused on developing therapies to counteract the devasting progression of neurodegeneration, reported first quarter 2026 financial results and recent portfolio and business updates. As of March 31, 2026, Alector’s cash, cash equivalents, and investments totaled $206.5 million.

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"Over the past seven years, we have built a highly differentiated blood-brain barrier platform with the versatility to deliver antibodies, enzymes, proteins, and siRNA to the brain," said Arnon Rosenthal, Ph.D., Chief Executive Officer of Alector. "We have a rich and growing pipeline of ABC-enabled programs, and we remain deeply committed to developing therapies that can make a meaningful difference for patients living with neurodegenerative diseases."

Recent Program Updates

Alector Brain Carrier (ABC): Preclinical and Research Pipeline

At the core of Alector’s strategy is the Alector Brain Carrier (ABC), the company’s proprietary platform designed to enhance the delivery of therapeutics to the brain. ABC is intended for peripheral dosing and is adaptable across multiple drug modalities, including antibodies, enzymes, and siRNA.

The platform is built on core design principles of versatility, optimized binding properties, and translatability, with the goal of achieving efficient and targeted brain delivery while maintaining a favorable safety profile. Across multiple ABC-enabled programs, preclinical studies have demonstrated robust brain penetration, supporting the advancement of a broad pipeline aimed at addressing the underlying drivers of neurodegenerative diseases.

AL037/AL137

Alector continues to advance AL037/AL137, its ABC-enabled anti-amyloid beta (Aβ) antibody program for the treatment of AD, through investigational new drug (IND)-enabling studies. The company is targeting an IND submission in Q1 2027.
Both of our AL037 and AL137 candidates are engineered for optimal brain uptake, potency, safety, and convenience. Both candidates comprise the same high-affinity, fully human antibody that selectively binds PyroGlu3, a validated epitope on toxic amyloid beta found in plaques and retain an active effector function intended to facilitate myeloid-mediated plaque clearance. AL037 and AL137 each incorporates Alector’s proprietary ABC technology with TfR binding domains that bind the same epitope on TfR, but with different affinities and binding kinetics, to balance brain penetration and plaque removal with minimized hematologic adverse effects.
AL050

Alector continues to progress AL050, its ABC-enabled engineered glucocerebrosidase (GCase) enzyme replacement therapy (ERT) for PD, through preclinical development.
AL050 is designed to address key challenges associated with enzyme delivery to the brain, featuring an engineered GCase with improved activity and stability and a silenced effector function to maximize safety, paired with Alector’s tunable ABC technology. Preclinical studies to date have demonstrated increased GCase activity and reduced toxic substrate accumulation, supporting its continued preclinical development as a potential therapy for PD and Lewy body dementia (LBD) associated with GBA loss-of-function mutations and subsequently for idiopathic PD and LBD. We continue to evaluate our timeline to the clinic.
ABC siRNA Platform

Alector is advancing its ABC-enabled siRNA platform with the goal of making treatment more accessible by enabling peripheral dosing as a potential alternative to traditional intrathecal delivery.
Alector continues to advance AL064/AL164, its ABC-enabled tau siRNA program for the treatment of AD and other tauopathies. AL064 demonstrated robust tau mRNA knockdown and durable reduction of phospho-Tau 217 in non-human primate studies, and it was subsequently modified to further optimize siRNA stability. This modified form is advancing into IND-enabling studies as AL164.
In addition to AL164, the company is advancing early-stage siRNA programs toward lead candidate selection, including ADP062-ABC, an alpha-synuclein siRNA for PD and ADP065-ABC, an NLRP3 siRNA for multiple neurodegenerative conditions, reflecting the broad applicability of the ABC platform across disease mechanisms.
Progranulin Program (nivisnebart (AL101/GSK4527226)

The global, randomized, double-blind, placebo-controlled PROGRESS-AD Phase 2 clinical trial of nivisnebart (AL101/GSK4527226) in early AD has been discontinued following a pre-specified interim futility analysis. An independent data monitoring committee concluded that the trial was unlikely to meet its primary endpoint of slowing disease progression at completion. As the company’s platform and pipeline have continued to evolve, Alector remains focused on the significant opportunities ahead across its ABC-enabled programs.
First Quarter 2026 Financial Results

Revenue. Collaboration revenue for the quarter ended March 31, 2026, was $1.0 million, compared to $3.7 million for the same period in 2025. The decrease in year-over-year collaborative revenue was primarily due to lower manufacturing-related activity to support the Nivisnebart Phase 2 study in early Alzheimer’s disease.

R&D Expenses. Total research and development expenses for the quarter ended March 31, 2026, were $17.9 million, compared to $33.6 million for the quarter ended March 31, 2025. The decrease was mainly due to a decrease in personnel-related costs as a result of the reductions in force as well as a decrease in research and development expenses for the AL002 program.

G&A Expenses. Total general and administrative expenses for the quarter ended March 31, 2026, were $8.1 million, compared to $14.7 million for the quarter ended March 31, 2025. The decrease was mainly driven by a decrease in personnel-related costs as a result of the reductions in force.

Net Loss. For the quarter ended March 31, 2026, Alector reported a net loss of $22.9 million, or $0.21 per share, compared to a net loss of $40.5 million, or $0.41 net loss per share, for the same period in 2025.

Cash Position. Cash, cash equivalents, and investments were $206.5 million as of March 31, 2026. Management anticipates that this will be sufficient to fund Alector’s operations at least through 2027.

(Press release, Alector, MAY 7, 2026, View Source [SID1234665298])

On May 7, 2026 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, reported Q1 2026 financial results and provided a business update.

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"CytomX has continued to gain tremendous momentum in 2026 and we remain highly focused on executing against the multiple layers of potential value creation we see for Varseta-M. Our top priority is to advance this highly differentiated, first in class EpCAM ADC into a registrational study in late-line CRC while also investing to unlock the broader potential of Varseta-M in earlier line CRC and other cancers," said Dr. Sean McCarthy, chairman and CEO of CytomX Therapeutics."

Continued Dr. McCarthy, "Strategically, we view Varseta-M as a company-building asset, uniquely enabled by the CytomX PROBODY therapeutic platform. Varseta-M is the only EpCAM targeted ADC in clinical development and is, we believe, ideally positioned to address the large unmet need in colorectal cancer as well as a broad range of EpCAM-expressing tumors. Based on the highly encouraging clinical results presented to-date and Varseta-M’s pan-tumor potential, we plan to execute with speed and focus to maximize benefit for people with cancer."

Pipeline Program Updates:

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

On March 16th 2026, CytomX announced positive data from the ongoing Phase 1 dose expansion study of Varseta-M in patients with advanced colorectal cancer (CRC).
As of April 2026, enrollment into Varseta-M Dose Optimization cohorts was complete, having reached the goal of 40 total patients across the 8.6 mg/kg Q3W and 10 mg/kg Q3W doses1.
Additional Phase 1 Varseta-M data, including data from ongoing dose optimization, is anticipated to be presented in the second half of 2026. This update is expected to support monotherapy dose selection and a potential registrational trial design in late line CRC.
FDA interactions are planned in 2026 with goal of aligning on the potential first registrational study for Varseta-M monotherapy in advanced CRC starting in 1H 2027.
A Phase 1 Varseta-M combination study with bevacizumab in CRC has commenced with an initial focus on determining combination dose(s) for later phase development, including in earlier lines of therapy. Varseta-M doses to be assessed in combination with bevacizumab will include Q2W and Q4W schedules to align with the approved bevacizumab CRC dose of 5 mg/kg Q2W. Initial clinical data are anticipated by 1H 2027.
Phase 1/2 combination study including Varseta-M administered with bevacizumab, 5-fluorouracil, and leucovorin is planned to start in 2H 2026.
Initiation of initial Phase 1 expansion cohort(s) in non-CRC indications is planned for 2H 2026.
CX-801 (PROBODY Interferon alpha-2b)

The CX-801 Phase 1 study in advanced melanoma is ongoing. The CX-801 monotherapy dose escalation portion of the study has reached the fourth dose level.
CX-801 monotherapy has been generally well tolerated at dose levels exceeding the approved dose of unmasked IFNα2b.2
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 third 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:
Completed an equity follow-on offering in March 2026 with gross proceeds of $250 million.
CytomX ended Q1 2026 with $346.7 million of cash, cash equivalents and investments with expected cash runway to at least the second half of 2028.
Research Pipeline and Collaborations:
CytomX has research collaborations with Amgen, Regeneron, and Moderna. Drug discovery programs continue in our research collaborations with a focus on bispecific immunotherapies, including T-cell engagers.
Q1 2026 Financial Results:

Cash, cash equivalents and investments totaled $346.7 million as of March 31, 2026, compared to $137.1 million as of December 31, 2025. Cash as of March 31, 2026 included $234.2 million of net proceeds from the completion of an underwritten public offering in March 2026.

Total revenue was $10.3 million for the quarter ended March 31, 2026, compared to $50.9 million for the first quarter of 2025. The decrease in revenue was driven primarily by the completion of our performance obligations during 2025 in the collaborations with Bristol Myers Squibb and Amgen.

Total operating expense for quarter ended March 31, 2026 was $29.9 million compared to $28.3 million for the first quarter ended March 31, 2025, an increase of $1.6 million.

Research and development expenses increased by $0.4 million during the quarter ended March 31, 2026, to $19.2 million compared to $18.9 million for the quarter ended March 31, 2025. Research and development expenses increased primarily due to increased manufacturing activities for Varseta-M, partially offset by $1.7 million of restructuring expenses incurred in the first quarter of 2025.

General and administrative expenses increased by $1.3 million during the quarter ended March 31, 2026, to $10.7 million, compared to $9.4 million for the quarter ended March 31, 2025. The general and administrative expenses for the first quarter of 2025 included $1.1 million of one-time restructuring expenses.

(Press release, CytomX Therapeutics, MAY 7, 2026, View Source [SID1234665319])

On May 7, 2026 Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, reported business highlights and financial results for the first quarter ended March 31, 2026.

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"We continue to make excellent progress advancing multiple programs through the clinic, with all three of our clinical-stage programs approaching Phase 2 trial initiations," said Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics. "Building on interim clinical data for our NEK7-directed MGD MRT-8102 demonstrating rapid, deep, and durable reductions in systemic inflammation, we expect to read out the GFORCE-1 study in subjects with elevated cardiovascular disease (CVD) risk this year, and to initiate three Phase 2 studies, starting in H2 2026, in diseases driven by the NLRP3/IL-1/IL-6 pathway. We also expect our collaborator Novartis to initiate multiple Phase 2 studies of our VAV1-directed MGD MRT-6160 in immune-mediated diseases this year. In addition, our oncology programs are also progressing rapidly, in particular with a Phase 2 study initiation of MRT-2359 in metastatic castration-resistant prostate cancer (mCRPC) patients with androgen receptor (AR) mutations planned for Q3 2026, following the encouraging Phase 1/2 data we presented at ASCO (Free ASCO Whitepaper) GU."

RECENT HIGHLIGHTS

MRT-8102, NEK7-directed MGD for inflammatory diseases driven by the NLRP3 inflammasome, IL-1, and IL-6

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In January, Monte Rosa announced positive interim data from an ongoing Phase 1 clinical study evaluating MRT-8102. In subjects with elevated CVD risk, after four weeks of MRT-8102 administration, CRP levels decreased by 85%, and 94% of study participants achieved CRP levels below 2 mg/L, a threshold associated with reduced CVD risk. The Company subsequently announced unblinded safety data from the single ascending dose / multiple ascending dose (SAD/MAD) cohorts and 3-month results from the ongoing long-term toxicology study in cynomolgus monkeys support a broad therapeutic index for MRT-8102.
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The ongoing GFORCE-1 study of MRT-8102 in subjects with elevated CVD risk is evaluating multiple dose levels to accelerate development in atherosclerotic cardiovascular disease (ASCVD) with an anticipated readout in H2 2026.
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Monte Rosa expects to initiate multiple Phase 2 studies of MRT-8102 in indications with high unmet need and strong biologic rationale for targeting the NLRP3/IL-1/IL-6 pathway:
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A study (GFORCE-2) of MRT-8102 in patients with elevated atherosclerotic risk is expected to initiate in H2 2026 to evaluate the effect of MRT-8102 treatment for 12 weeks (plus open-label extension) on CRP levels, as well as effects on liver fat, liver inflammation, and obesity.
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A study of MRT-8102 in patients with gout flares is expected to initiate in Q4 2026 or Q1 2027.
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A study of MRT-8102 in patients with moderate to severe hidradenitis suppurativa is expected to initiate in H1 2027.

MRT-6160, VAV1-directed MGD for immune-mediated conditions

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Advancement of MRT-6160 toward multiple Phase 2 studies in immune-mediated diseases is ongoing, in collaboration with Novartis. Results from the Phase 1, single ascending dose / multiple ascending dose (SAD/MAD) study in healthy volunteers (clinicaltrials.gov identifier NCT06597799) support a clear path into anticipated Phase 2 studies and broad potential applications in multiple immune-mediated diseases.
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Monte Rosa has a global exclusive development and commercialization license agreement with Novartis to advance VAV1-directed MGDs, including MRT-6160. Monte Rosa is eligible to receive up to $2.1 billion in development, regulatory, and sales milestones, beginning upon initiation of Phase 2 studies. Novartis is responsible for conducting and funding Phase 2 studies. Monte Rosa will co-fund any Phase 3 clinical development and will share 30% of any profits and losses associated with the manufacturing and commercialization of MRT-6160 in the U.S., and is also eligible for tiered royalties on ex-U.S. net sales.

MRT-2359, GSPT1-directed MGD for metastatic CRPC

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In February, Monte Rosa presented additional interim data from an ongoing Phase 1/2 clinical study evaluating MRT-2359 in combination with enzalutamide in heavily pretreated patients with mCRPC at the ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU). MRT-2359 is an investigational, orally bioavailable, GSPT1-directed MGD. PSA responses in patients with AR mutations expanded to 5 of 5 patients, with a 100% disease control rate, including 2 patients with RECIST partial responses and 3 with stable disease, all showing reductions in size of target lesions. Across all 15 evaluable patients, the overall RECIST disease control rate was 67%, and 10 of 15 patients showed tumor size reductions of target lesions. The combination of MRT-2359 and enzalutamide was generally well-tolerated with primarily Grade 1-2 AEs. There were no treatment discontinuations due to AEs.

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The Company plans to initiate a Phase 2 study (MODeFIRe-1) in 2026 of up to 25 patients to efficiently assess the efficacy of MRT-2359 in combination with the second-generation AR inhibitor apalutamide in mCRPC patients with AR mutations, with potential to expand the study into additional patient subsets.
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In March, Monte Rosa announced it entered into a supply agreement with Johnson & Johnson to evaluate MRT-2359 in combination with ERLEADA (apalutamide) for the treatment of patients with mCRPC with androgen receptor (AR) mutations in its planned Phase 2 study.

Cyclin E1 (CCNE1)-directed MGD program for CCNE1-amplified solid tumors

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Monte Rosa presented preclinical data on the potential of its potent and highly selective cyclin E1 (CCNE1)-directed molecular glue degrader, MRT-55811, to treat CCNE1-amplified solid tumors at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026. MRT-55811 induced deep tumor regressions in CCNE1-amplified in vivo models of ovarian, breast, and gastric cancers, and demonstrated superior selectivity and reduced off-target activity compared to CDK2 inhibitors.
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Monte Rosa expects to submit an IND application for its CCNE1 MGD program in H2 2026. The Company expects to develop this molecule in ovarian cancer and other cancer types driven by CCNE1 amplification.

CDK2-directed MGD program for ER+ breast cancer

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Monte Rosa continues to advance its CDK2-directed MGD program for the treatment of ER+ breast cancer toward clinical development.

Corporate

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In January, Monte Rosa closed an upsized underwritten public offering. Gross proceeds, before deducting underwriting discounts and commissions and offering expenses, were $345 million.
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Monte Rosa continues to progress its collaboration with Novartis to develop novel degraders for immune-mediated diseases and its collaboration with Roche to discover and develop MGDs against targets in cancer and neurological diseases previously considered impossible to drug.

ANTICIPATED UPCOMING MILESTONES AND DEVELOPMENT PRIORITIES

Immunology and Inflammation programs

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Readout of MRT-8102 GFORCE-1 study in subjects with elevated CVD risk anticipated in H2 2026.
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Initiate multiple Phase 2 studies of MRT-8102, including in elevated atherosclerotic risk patients in H2 2026, in gout flare patients in Q4 2026/Q1 2027, and in hidradenitis suppurativa patients in H1 2027.
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Submit an IND application for a second-generation NEK7-directed MGD in H2 2026.
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Monte Rosa expects its collaborator, Novartis, to initiate multiple Phase 2 studies of VAV1-directed MGD MRT-6160 in immune-mediated diseases in 2026.
Oncology programs

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Initiate the MODeFIRe-1 Phase 2 study of MRT-2359 in combination with apalutamide in mCRPC in Q3 2026.
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Submit an IND application for a cyclin E1-directed MGD in H2 2026.

FIRST QUARTER 2026 FINANCIAL RESULTS

Collaboration Revenue: Collaboration revenue for the first quarter of 2026 was $4.2 million, compared to $84.9 million for the first quarter of 2025. Collaboration revenue represents amounts earned from the Company’s collaboration and license agreements with Roche and Novartis.

Research and Development (R&D) Expenses: R&D expenses for the first quarter of 2026 were $44.1 million, compared to $32.2 million for the first quarter of 2025. These increases were driven by increased spending during the quarter on our MRT-8102 program and on other development and discovery programs.

General and Administrative (G&A) Expenses: G&A expenses for the first quarter of 2026 were $10.2 million, compared to $8.7 million for the first quarter of 2025. These increases, which include non-cash stock-based compensation, were driven by increased headcount and expenses in support of our growth and operations as a public company.

Net Loss: Net loss for the first quarter of 2026 was $44.5 million, compared to $46.9 million net income for the first quarter of 2025.

Cash Position and Financial Guidance:

Cash, cash equivalents, restricted cash, and marketable securities as of March 31, 2026, were $671.2 million, compared to cash, cash equivalents, restricted cash, and marketable securities of $382.1 million as of December 31, 2025. The increase of $289.1 million was primarily due to net proceeds from the underwritten public offering in January, partially offset by operational use of cash.

In January 2026, the Company closed an underwritten public equity offering of

$345.0 million aggregate gross proceeds. Aggregate net proceeds from the offering after deducting underwriting discounts and commissions and offering expenses were $323.8 million.

Based on current cash, cash equivalents, restricted cash, and marketable securities, together with the proceeds from the January 2026 offering, the Company expects its cash and cash equivalents to be sufficient to fund planned operations and capital expenditures into 2029.

(Press release, Monte Rosa Therapeutics, MAY 7, 2026, View Source [SID1234665335])

On May 7, 2026 Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, reported participation at the following investor conferences:

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BofA Securities Health Care Conference 2026
Format: Virtual fireside chat and one-on-one investor meetings
Presentation Date/Time: Wednesday, May 13, 2026 at 10:40 am PT
Location: Las Vegas, NV

TD Cowen’s 7th Annual Oncology Innovation Summit: Insights for ASCO (Free ASCO Whitepaper) & EHA (Free EHA Whitepaper)
Format: Fireside chat with Tyler van Buren
Presentation Date/Time: Tuesday, May 26, 2026 at 2:00 pm ET
Location: Virtual

Jefferies Global Healthcare Conference
Format: Hybrid fireside chat and one-on-one investor meetings
Presentation Date/Time: Wednesday, June 3, 2026 at 3:45 pm ET
Location: New York, NY

A live webcast of the presentations can be accessed by visiting the "For Investors" page on the Tyra Biosciences website and will be available for replay following the event.

(Press release, Tyra Biosciences, MAY 7, 2026, View Source [SID1234665353])