Half-Year Financial Report 2026

On August 4, 2026 Bayer reported half-year financial report 2026.

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(Presentation, Bayer, AUG 4, 2026, View Source [SID1234670289])

Arvinas Reports Second Quarter 2026 Financial Results and Provides Corporate Update

On August 4, 2026 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported financial results for the second quarter 2026, and provided a corporate update.

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"Our progress during the quarter has helped position us to fully capitalize on the promise of our platform in oncology and neurology," said Randy Teel, Ph.D., President and Chief Executive Officer at Arvinas. "The approval of VEPPANU, the first ever for a PROTAC degrader, was a significant achievement for the Company, and our subsequent licensing of VEPPANU to Rigel Pharmaceuticals promises to unlock its commercial potential and provide access to patients as efficiently as possible."

"As we move into the second half of the year, enrollment in our ongoing Phase 1 trials is strong and we have important data milestones planned over the next 12 months for ARV-393, ARV-102, and ARV-027," continued Dr. Teel. "In addition, we are initiating our first immuno-oncology Phase 1 trial with ARV-6723 – an HPK1 degrader that has shown meaningful single-agent activity in preclinical models where neither an inhibitor nor an anti-PD1 therapy has shown benefit. Altogether, our pipeline has the potential to address high unmet medical needs and maximize both clinical impact and long-term shareholder value."
Second Quarter 2026 Business Highlights and Recent Developments

Approved Product

VEPPANU (vepdegestrant): Oral PROTAC ER degrader
As part of Arvinas global collaboration with Pfizer, the companies:
•Announced the approval of VEPPANU for the treatment of adults with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.
◦This approval marks the first time the U.S. Food and Drug Administration (FDA) has approved a PROteolysis TArgeting Chimera (PROTAC), a type of heterobifunctional protein degrader therapy.

•Entered into a license agreement with Rigel Pharmaceuticals, Inc. for the exclusive global development, manufacturing, and commercialization rights for VEPPANU.
•Announced that the National Comprehensive Cancer Network (NCCN) added vepdegestrant (VEPPANU) to the latest NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Breast Cancer. Vepdegestrant (VEPPANU) was added as a Category 2A treatment option for patients with hormone receptor (HR)-positive/HER2-negative, ESR1-mutated advanced or metastatic breast cancer after at least one line of endocrine therapy + cyclin-dependent kinase (CDK) 4/6 inhibitor.*

Pipeline

ARV-393: Oral PROTAC BCL6 degrader
•Continued dose escalation in the Phase 1 trial in patients with non-Hodgkin lymphoma (NHL).
▪Preliminary clinical activity has been observed, including responses in B- and T-cell lymphomas, in early cohorts at doses below the predicted effective exposure level.
•Continued enrollment in the Phase 1 combination trial with glofitamab in patients with diffuse large B-cell lymphoma (DLBCL).

ARV-102: Oral PROTAC LRRK2 degrader
•Joined the LRRK2 Investigative Therapeutics Exchange (LITE) program and the Parkinson’s Precision Medicine Initiative (PPMI), both supported by The Michael J. Fox Foundation for Parkinson’s Research (MJFF).

ARV-027: Oral PROTAC polyQ-AR degrader
•Completed the single-ascending dose cohorts of the first-in-human Phase 1 clinical trial in healthy volunteers and initiated enrollment in the multiple dose cohorts in healthy volunteers.

ARV-6723: Oral PROTAC HPK1 degrader
Arvinas’ first immuno-oncology clinical candidate
•Presented preclinical data at the AACR (Free AACR Whitepaper) Annual Meeting demonstrating greater antitumor activity than standard-of-care immune checkpoint inhibitors (ICIs) or an investigational HPK1 inhibitor.
◦Unlike an inhibitor and ICIs, ARV-6723 reversed T-cell exhaustion, reversed the immunosuppressive tumor microenvironment, and boosted innate cell immunity in ICI-(aPD1 and aCTLA4) resistant models.

Novel pan-KRAS degrader
•Presented preclinical data at the AACR (Free AACR Whitepaper) Special Conference in Cancer Research: RAS Oncogenesis and Therapeutics.
◦Robust efficacy observed in CDX models of pancreatic, colorectal, and lung cancer.
◦Greater tumor growth inhibition than a pan-RAS (ON) inhibitor demonstrated in a KRAS G13D model.
◦Enhanced combination efficacy with immune checkpoint blockade compared with a pan-RAS (ON) inhibitor observed in a KRAS G12D syngeneic model.

ARV-806: Novel PROTAC KRAS G12D degrader

•Completed dose escalation enrollment in the Phase 1 clinical trial in patients with solid tumors harboring KRAS G12D mutations.
◦Reiterated plan to share initial data from the Phase 1 monotherapy dose escalation clinical trial in the second half of 2026.
•Announced plans to seek an out-licensing agreement for any additional clinical trials, including dose expansion or combination clinical trials.

Anticipated Upcoming Milestones and Expectations

ARV-393: Oral PROTAC BCL6 degrader
•Share data from early monotherapy cohorts in the ongoing Phase 1 dose escalation clinical trial in patients with relapsed/refractory NHL (ClinicalTrials.gov Identifier: NCT06393738) at a medical congress (2H 2026).
◦Share additional monotherapy data from the ongoing Phase 1 dose escalation trial in B- and T-cell lymphomas (mid-2027).
◦Share data from the combination cohort with glofitamab in patients with DLBCL in the ongoing Phase 1 clinical trial (mid-2027).

ARV-102: Oral PROTAC LRRK2 degrader
•Share additional biomarker data from the Phase 1 clinical trial in patients with Parkinson’s disease at the International Congress on Parkinson’s Disease and Movement Disorders (October 2026).
•Continue discussions with global health authorities on plans to initiate clinical trials in patients with progressive supranuclear palsy (2027).

ARV-027: Oral PROTAC polyQ-AR degrader
•Continue enrollment in the multiple dose cohort of the Phase 1 clinical trial in healthy volunteers and share initial data evaluating androgen receptor (AR)-degradation in muscle (1H 2027).

ARV-6723: Oral PROTAC HPK1 degrader
•Initiate enrollment of the Phase 1 clinical trial in patients with advanced solid tumors (3Q 2026).
Financial Guidance
Based on its current operating plan, Arvinas believes its cash, cash equivalents, and marketable securities as of June 30, 2026, is sufficient to fund planned operating expenses and capital expenditure requirements into the second half of 2028.
Second Quarter 2026 Financial Results
Cash, Cash Equivalents, and Marketable Securities Position: As of June 30, 2026, cash, cash equivalents, and marketable securities were $567.9 million as compared with $685.4 million as of December 31, 2025. The decrease in cash, cash equivalents, and marketable securities of $117.5 million for the six months ended June 30, 2026, was primarily related to cash used in operations of $114.3 million (net of $35.0 million received under the Rigel License Agreement), unrealized losses on marketable securities of $2.0 million, and the purchase of lab equipment and leasehold improvements of $1.5 million.

Research and Development Expenses: Generally Accepted Accounting Principles (GAAP) research and development (R&D) expenses were $52.6 million for the quarter ended June 30, 2026, as compared with $68.6 million for the quarter ended June 30, 2025. The decrease in R&D expenses of $16.0 million for the quarter was primarily due to a decrease in compensation and related personnel expenses of $11.0 million, which are not allocated by program, and a decrease in external expenses of $3.2 million. External expenses include (i) program-specific expenses, which decreased by $0.6 million, primarily driven by a decrease in our vepdegestrant (ARV-471) program of $10.6 million, partially offset by increases in our ARV-806, ARV-027, and ARV-393 programs of $3.9 million, $3.2 million, and $2.3 million, respectively.
Non-GAAP R&D expenses were $51.4 million for the quarter ended June 30, 2026, as compared with $59.5 million for the quarter ended June 30, 2025, excluding $0.3 million and $0.6 million of restructuring expense for the quarters ended June 30, 2026, and 2025, respectively, and $0.9 million and $8.5 million of non-cash stock-based compensation expense for the quarters ended June 30, 2026, and 2025, respectively. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

General and Administrative Expenses: GAAP general and administrative (G&A) expenses were $24.0 million for the quarter ended June 30, 2026, as compared with $25.3 million for the quarter ended June 30, 2025. The decrease in G&A expenses of $1.3 million for the quarter was primarily due to decreases in personnel and infrastructure related costs of $3.9 million, and costs related to developing our commercial operations of $1.4 million, partially offset by an increase in professional fees of $4.2 million, inclusive of an increase in the amortization of costs to obtain a contract related to the Pfizer Letter Agreement supplementing and amending the terms of the Original Vepdegestrant (ARV-471) Collaboration Agreement and professional fees related to the Rigel License Agreement.

Non-GAAP G&A expenses were $18.4 million for the quarter ended June 30, 2026, as compared with $18.1 million for the quarter ended June 30, 2025, excluding $1.3 million and $0.4 million of restructuring expenses for the quarters ended June 30, 2026, and 2025, respectively, and $4.3 million and $6.8 million of non-cash stock-based compensation expense for the quarter ended June 30, 2026, and 2025, respectively. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

Cost of License Revenue: Cost of license revenue was $9.0 million for the quarter ended June 30, 2026, as compared with zero for the quarter ended June 30, 2025. The increase of $9.0 million was due to expenses under the Amended Yale License Agreement related to the FDA’s approval of VEPPANU and the entry into the Rigel License Agreement.
Revenue: Revenue was $249.7 million for the quarter ended June 30, 2026, as compared with $22.4 million for the quarter ended June 30, 2025. Revenue for the quarter is related to the Original Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer, the research collaboration agreement with Pfizer and the Rigel License Agreement. The increase of $227.3 million was primarily due to $112.6 million of revenue from the Original Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer driven by the recognition of the remaining deferred revenue upon entry into the Rigel License Agreement of $126.4 million, partially offset by a decrease in revenue of $13.8 million for the period prior to the Rigel License Agreement. In addition, we recognized $62.5 million of revenue from the Rigel License Agreement, and $50.0 million of revenue from a development milestone payment in connection with the FDA’s approval of VEPPANU.
Investor Call & Webcast Details
Arvinas will host a conference call and webcast today, August 4, 2026, at 8:00 a.m. ET to review its second quarter 2026 financial results and discuss recent corporate updates. Participants are invited to listen by going to the Events and Presentation section under the Investors page on the Arvinas website at www.arvinas.com. A replay of the webcast will be available on the Arvinas website following the completion of the event and will be archived for up to 30 days.

(Press release, Arvinas, AUG 4, 2026, View Source [SID1234669654])

Lisata Therapeutics Provides Update Following Termination of Merger Agreement

On August 4, 2026 Lisata Therapeutics, Inc. (Nasdaq: LSTA) ("Lisata"), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, reported an update following the termination of its merger agreement with Kuva Labs Inc. and its subsidiary Kuva Acquisition Corp. (collectively, "Kuva").

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Lisata has filed suit in the Delaware Court of Chancery against Kuva over Kuva’s breach of the previously-disclosed Agreement and Plan of Merger dated March 6, 2026 (as amended, the "Merger Agreement"), seeking, among other things, damages for the benefit of its stockholders and the $2,000,000 termination fee Lisata is owed under the Merger Agreement.

Lisata’s Board of Directors continues to evaluate strategic alternatives to enhance stockholder value, which will include, but are not limited to, an acquisition, merger, reverse merger, other business combination, sales of assets, liquidation and dissolution, among other strategic transactions. The Company has not set a timetable for completion of this strategic review and does not intend to comment further on the status of this process unless or until its Board of Directors has approved a definitive course of action, or it is determined that another disclosure is warranted.

In order to reduce operating expenses and preserve cash to pursue strategic alternatives, Lisata has implemented a reduction in force, eliminating approximately 72% of its full-time employees, including its Executive Vice President of R&D and Chief Medical Officer position. Certain members of the separated staff may be engaged as external consultants for a period of time, as necessary.

(Press release, Lisata Therapeutics, AUG 4, 2026, View Source [SID1234669686])

Defence Therapeutics Appoints Dr. Amie Phinney As President And Chief Executive Officer

On August 4, 2026 Defence Therapeutics Inc. ("Defence" or the "Company"), (CSE: DTC, OTCQB: DTCFF, FSE: DTC), a publicly traded biotechnology company developing next-generation precision oncology therapeutics using its proprietary Accum technology, reported the appointment of Dr. Amie Phinney, PhD, MBA, as the President and Chief Executive Officer, effective August 1, 2026.

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As part of the leadership transition, Mr. Sébastien Plouffe, Founder and Chief Executive Officer, will now assume the position of Executive Chairman of the Board, where he will continue to play a critical leadership role in guiding the Company’s strategic direction, financing initiatives, corporate partnerships, and long-term growth.

Since joining Defence in 2025, Dr. Phinney has played a key role in supporting Defence’s strategic evolution, strengthening its scientific and commercial positioning, and advancing the Accum technology into the next-generation intracellular drug delivery platform. She joined Defence as Strategy & Business Advisor in July 2025 and was appointed to the Board of Directors in September 2025.

"Over the past year, Amie has demonstrated exceptional leadership, strategic vision, and an unwavering commitment to Defence’s mission," said Sébastien Plouffe, Executive Chairman of Defence Therapeutics. "She has played an instrumental role in refining our corporate strategy, expanding our scientific and commercial vision, building the foundation for new strategic partnerships, and positioning Defence for its next phase of growth. The Board is confident that she is the right leader to guide the Company as we accelerate the development of the Accum platform, expand our therapeutic pipeline, and pursue strategic partnerships."

Dr. Phinney mentioned "I am honoured to be taking on the leadership of Defence Therapeutics at this exciting period of growth for the Company. Defence has built a differentiated technology platform with the potential to transform the delivery of complex biologics and targeted therapeutics. I look forward to working alongside our outstanding scientific team, Board of Directors, partners, and shareholders to accelerate the development of our pipeline, expand the applications of the Accum platform, and position Defence as a global leader in precision intracellular drug delivery."

Dr. Phinney brings more than two decades of international leadership experience spanning pharmaceutical research and development, biotechnology company creation, corporate strategy, business development, and commercialization. She previously held a range of scientific and strategic roles at Abbott and AbbVie (Chicago, USA), supporting strategic planning, alliance management, and business operations across multiple global R&D organizations. She subsequently served as Chief Scientific Officer of Lakeside Discovery, a venture-backed biotechnology company spun-out from Northwestern University in Chicago, advancing academic innovations into therapeutic programs. Most recently, she was the Senior Director of Partnerships and Business Development at adMare BioInnovations, where she helped launch and grow biotechnology companies emerging from Canadian research institutions. She is also the co-founder of Block Biosciences and served as its inaugural Chief Executive Officer, leading the academic biotechnology spinout in the development of first-in-class oncology therapeutics. Dr. Phinney holds a PhD in Biomedical Research from the University of Basel (Switzerland) and an MBA from Lake Forest Graduate School of Management (Chicago, USA). She has also completed executive education in corporate governance (Rotman School of Management, University of Toronto), private capital investment (Ivey Academy, Western University), high-performance negotiation (Kellogg School of Management, Northwestern University), and business leadership (Kenan-Flagler Business School, University of North Carolina at Chapel Hill).

As Executive Chairman, Mr. Plouffe will continue to work closely with Dr. Phinney and the Board, focusing on corporate strategy, capital markets, business development, strategic partnerships, and governance, while supporting the Company’s long-term growth objectives.

"This transition reflects the natural evolution of Defence Therapeutics," added Mr. Plouffe. "I remain deeply committed to the Company and look forward to supporting Amie and the management team as we execute on the tremendous opportunities ahead."

Under Dr. Phinney’s leadership, Defence Therapeutics will continue executing its strategy to expand the clinical and commercial potential of its proprietary Accum platform across antibody-drug conjugates (ADCs), radiotherapeutics, and other targeted biologics, while advancing strategic collaborations with biotechnology and pharmaceutical partners.

The Company wishes to announce that it has granted a total of 600,000 incentive stock options, in accordance with the terms and conditions of Defence’s omnibus incentive plan, including (i) 200,000 options to Dr. Phinney, of which 100,000 are vested immediately and 100,000 will be vested on the 1st anniversary of the date of grant, exercisable at a price of 40 cents per share for a period of five years from the date of grant, (ii) 200,000 options to an employee at the same terms; and (iii) 200,000 to the Executive Chairman vested immediately and exercisable at a price of 40 cents per share for a period of ten years from the date of grant.

(Press release, Defence Therapeutics, AUG 4, 2026, View Source;utm_medium=rss&utm_campaign=defence-therapeutics-appoints-dr-amie-phinney-as-president-and-chief-executive-officer [SID1234669655])

Faeth Therapeutics Reports Second Quarter 2026 Financial Results and Operational Updates

On August 4, 2026 Faeth Therapeutics (Nasdaq: FTH), a clinical-stage oncology company developing PIKTOR, an investigational all-oral, multi-node inhibitor of the PI3K/AKT/mTOR pathway, reported financial results for the quarter ended June 30, 2026, and highlighted recent corporate accomplishments and 2026 milestones.

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"Our combination with Sensei Biotherapeutics marked an important milestone in the history of Faeth Therapeutics," said Anand Parikh, Chief Executive Officer. "With the concurrent $200 million PIPE financing, we now have the capital to interrogate the multi-nodal hypothesis in multiple cancers. We look forward to reading out topline data from our Phase 2 PIK-201 trial in endometrial cancer, which is expected by year-end."

Mr. Parikh continued, "We are also excited to have expanded development of PIKTOR into its second indication with the first patient dosed in our PIK-101 trial in HR+ breast cancer in April. We look forward to reporting initial safety and efficacy data from PIK-101 in 2027."

Recent Corporate Updates:

In April, the Company dosed the first patient in its Phase 1b/2 Trial of PIKTOR in HR+/HER2- Advanced Breast Cancer
In June, stockholders approved the conversion of the Series B preferred stock issued in the February 2026 acquisition of Faeth Therapeutics and concurrent private placement into common stock
In June, the Company changed its name to Faeth Therapeutics, Inc. and began trading under the ticker symbol "FTH"
In June, Anand Parikh, Faeth co-founder, was appointed Chairman, President and Chief Executive Officer, and Brian Stephenson, Ph.D., CFA was appointed Chief Financial Officer. Additionally, the board was strengthened with the addition of former FDA Commissioner Stephen M. Hahn, M.D., and Saira Ramasastry.
Second Quarter 2026 Financial Results

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities were $186.4 million as of June 30, 2026, as compared to $21.2 million as of December 31, 2025.
Research and Development Expenses (R&D): R&D expenses for the quarter ended June 30, 2026 were $9.2 million, compared to $2.5 million for the quarter ended June 30, 2025. The increase in R&D expenses was primarily driven by clinical trial and manufacturing (CMC) costs supporting the development of PIKTOR, together with higher personnel costs, partially offset by lower clinical trial costs for SNS-101.
General and Administrative Expenses (G&A): G&A expenses for the quarter ended June 30, 2026, were $9.2 million, compared to $2.7 million during the quarter ended June 30, 2025. The increase in G&A expense was primarily attributable to increased personnel costs and increased professional fees related to financing and reporting activities.
Net Loss: Net loss was $16.0 million, or $2.84 per basic and diluted share, for the quarter ended June 30, 2026, compared with a net loss of $4.9 million, or $3.91 per basic and diluted share, for the quarter ended June 30, 2025.

Weighted-average common shares outstanding, basic and diluted, were 5,643,222 for the quarter ended June 30, 2026, compared with 1,260,867 for the quarter ended June 30, 2025.

Condensed Statements of Operations
(Unaudited, in thousands except share and per share data)

For the Three Months
Ended June 30,

2026

2025

Operating expenses:
Research and development
$

9,180

$

2,533

General and administrative

9,205

2,673

Total operating expenses

18,385

5,206

Loss from operations

(18,385

)

(5,206

)

Total other income

2,378

270

Net loss

(16,007

)

(4,936

)

Net loss per share, basic and diluted
$

(2.84

)

$

(3.91

)

Weighted-average common shares outstanding, basic and diluted

5,643,222

1,260,867

Selected Condensed Balance Sheet Data
(Unaudited, in thousands)

June 30,
2026 December 31,
2025
Cash and cash equivalents
$

26,903

$

8,668

Marketable securities

159,538

12,516

Total assets

189,306

22,902

Total liabilities

9,581

4,310

Series B redeemable convertible preferred stock

6,767

Total stockholders’ equity

172,958

18,592

About PIKTOR

PIKTOR is an investigational, proprietary, all-oral combination of serabelisib, a selective PI3K-alpha inhibitor, and sapanisertib, an mTORC1/mTORC2 inhibitor, designed to inhibit multiple nodes of the PI3K/AKT/mTOR pathway. According to published literature, this pathway is dysregulated in up to 50% of all solid tumors, making it one of the most prevalent therapeutic targets in oncology. PIKTOR is being evaluated in a Phase 2 trial in second-line advanced endometrial cancer (Study FTH-PIK-201), with topline data anticipated in the second half of 2026. PIKTOR is also being evaluated in a Phase 1b/2 trial in HR+/HER2- advanced breast cancer (Study FTH-PIK-101), in which the first patient was dosed in April 2026 and interim data is anticipated in 2027.

(Press release, Faeth Therapeutics, AUG 4, 2026, View Source [SID1234669671])