Pliant Therapeutics Provides Corporate Update and Reports Third Quarter 2025 Financial Results

On November 6, 2025 Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical-stage biotechnology company focused on the discovery and development of integrin-based therapeutics, reported a corporate update and announced third quarter 2025 financial results.

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"During the third quarter, our team continued to advance our portfolio while winding down activities surrounding the BEACON-IPF trial," said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer of Pliant. "Looking ahead, we continue to evaluate a range of opportunities to create shareholder value."

Third Quarter and Recent Developments

Oncology Program

•Phase 1 open-label trial of PLN-101095 in solid tumors has completed enrollment. PLN-101095 is an oral, small molecule, dual selective inhibitor of αvβ8 and αvβ1 integrins designed to overcome checkpoint resistance by blocking TGF-β activation in the tumor microenvironment. The Phase 1 open-label, dose-escalation trial of PLN-101095 as monotherapy and in combination with pembrolizumab is in patients with solid tumors that are resistant to immune checkpoint inhibitors. In March of 2025 we announced interim data from this trial showing PLN-101095 was well tolerated and displayed an objective response rate of 50% in the third of five ascending dose cohorts. The trial has now completed enrollment of all five dose cohorts. Data from the trial, including the two highest dose cohorts, is expected by the end of 2025.

Bexotegrast
•BEACON-IPF close out activities to be completed in fourth quarter. Close out activities from the BEACON-IPF Phase 2b/3 clinical trial are expected to be completed in the fourth quarter of 2025 with full results from the trial to be submitted for future publication.

Corporate Highlights
•In October, the Company announced that it completed a voluntary prepayment of all outstanding principal, accrued and unpaid interest, fees, costs and expenses under the March 11, 2024 Loan Agreement with Oxford Finance LLC.

Third Quarter 2025 Financial Results

•Research and development expenses were $17.9 million as compared to $47.8 million for the prior-year quarter. The decrease was primarily driven by the discontinuation of BEACON-IPF.
•General and administrative expenses were $10.3 million as compared to $14.3 million for the prior-year quarter. The decrease was primarily due to lower personnel-related costs resulting from the strategic restructuring of our workforce.
•Net loss was $26.3 million as compared to $57.8 million for the prior-year quarter. The decrease was primarily attributable to the discontinuation of BEACON-IPF coupled with the decrease in personnel-related costs resulting from the strategic restructuring of our workforce.
•As of September 30, 2025, the Company had cash, cash equivalents and short-term investments of $243.3 million.

(Press release, Pliant Therapeutics, NOV 6, 2025, View Source [SID1234659585])

Atossa Therapeutics Announces Acceptance of Four Abstracts Highlighting (Z)-Endoxifen Research for Presentation at the 2025 San Antonio Breast Cancer Symposium

On November 6, 2025 Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing innovative medicines in oncology, reported that four abstracts featuring data on (Z)-endoxifen have been accepted for presentation at the San Antonio Breast Cancer Symposium (SABCS), being held on December 9-12, 2025, in San Antonio, TX.

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"We continue to add to our body of clinical evidence. At SABCS 2025, we look forward to four poster presentations highlighting findings from studies evaluating the use of (Z)-endoxifen to advance breast cancer treatment and prevention," said Dr. Steven Quay, Atossa Therapeutics President and Chief Executive Officer.

Poster Presentation Details:

Title:

Initial results from RECAST DCIS: Multicenter platform trial testing active
surveillance and novel endocrine therapy agents for DCIS management

Date/Time:

Thursday, December 11, 2025, 12:30pm – 2:00pm CT

Title:

Low dose (Z)-endoxifen in the I-SPY2 Endocrine Optimization Pilot

Date/Time:

Thursday, December 11, 2025, 12:30pm – 2:00pm CT

Title:

(Z)-Endoxifen Maintains ERα Antagonist Function Against ESR1 Mutants via
Inactive Conformation Stabilization and Reversal of Mutant ESR1-Associated
Transcriptional Signatures

Date/Time:

Friday, December 12, 2025, 7:00am – 8:30am CT

Title:

A Randomized Phase 2 Non-Inferiority Trial of (Z)-Endoxifen + Goserelin vs Exemestane + Goserelin as Neoadjuvant Treatment for
Premenopausal Women with ER+/HER2- Breast Cancer (EVANGELINE)

Date/Time:

Friday, December 12, 2025, 12:30pm – 2:00pm CT

(Press release, Atossa Therapeutics, NOV 6, 2025, View Source [SID1234659613])

9M and Q3 2025 results announcement

On November 6, 2025 AstraZeneca reported nine months and third quarter financial results (Press release, AstraZeneca, NOV 6, 2025, View Source [SID1234660872]).

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Black Diamond Therapeutics to Participate in Upcoming Investor Conferences

On November 6, 2025 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, reported its participation in upcoming investor conferences. Presentation details with President and Chief Executive Officer, Mark Velleca, M.D., Ph.D., are as follows:

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Stifel Healthcare Conference fireside chat at 9:20am ET on Tuesday, November 11, 2025
Guggenheim 2nd Annual Healthcare Innovation Conference fireside chat at 9:00am ET on Wednesday, November 12, 2025
Piper Sandler 37th Annual Healthcare Conference fireside chat at 1:00pm ET on Thursday, December 4, 2025
Raymond James CEO Strategy Series at 10:00am ET on Friday, December 5, 2025. Investors who are interested in attending should reach out to their Raymond James representative
Webcasts will be available at the start of the presentations on the investor relations section of the Company’s website, www.blackdiamondtherapeutics.com. Replays of the presentations will also be available and archived on the site for 90 days.

(Press release, Black Diamond Therapeutics, NOV 6, 2025, View Source [SID1234659554])

Galapagos Reports Nine Months 2025 Financial Results and Provides Business Update

On November 6, 2025 Galapagos NV (Euronext & Nasdaq: GLPG) reported its financial results for the first nine months of 2025, and provided a third quarter and recent business update.

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"We successfully delivered on our commitment to define a clear path forward for Galapagos following the completion of the strategic review of our cell therapy business," said Henry Gosebruch, CEO of Galapagos. "We have built a team with world-class strategy and business development capabilities as we focus on disciplined capital stewardship and transformative business development, supporting a stronger and sustainable future for Galapagos."

Gosebruch added, "Looking ahead, we will seek to strategically deploy our capital in a disciplined manner by pursuing value-accretive transactions. Our business development team is actively evaluating a broader array of opportunities with priority given to promising small molecule and biologics programs with proof-of-concept in immunology and oncology and potential to deliver meaningful patient impact. We believe our partnership with Gilead can be a strategic advantage as we pursue these opportunities. We expect to focus on transactions that can deliver meaningful value to patients and shareholders while ensuring effective risk diversification."

"We ended the third quarter with a strong balance sheet that provides us with the flexibility to allocate capital strategically and invest in future business development opportunities," said Aaron Cox, CFO of Galapagos. "We expect to end the year with approximately €2.975 billion to €3.025 billion in cash and financial investments, excluding any business development activities and currency fluctuations. If the intention to wind down the cell therapy business is implemented and the process is completed, we would expect to be cash flow neutral to positive by the end of 2026, excluding any business development activities and currency fluctuations."

Third quarter 2025 and recent business update

Outcome of the Strategic Alternatives Process for Galapagos’ Cell Therapy Business

On October 21, 2025, Galapagos announced its intention to wind down its cell therapy business as part of the Company’s ongoing transformation. This intention is subject to the conclusion of consultations with works councils in Belgium and the Netherlands, during which Galapagos will continue to operate the business. Galapagos would consider any viable proposal to acquire all, or part of the cell therapy business, if such a proposal were to emerge during the wind down process.
If ultimately implemented, the wind down would impact approximately 365 employees across Europe, the U.S., and China, and would include the closure of sites in Leiden (the Netherlands), Basel (Switzerland), Princeton and Pittsburgh (U.S.), and Shanghai (China).
The remaining Galapagos organization is expected to be a lean organization of approximately 35-40 employees by the end of 2026, repositioned for long-term growth through transformational business development, while maintaining a dedicated presence at its headquarters in Mechelen, Belgium and its hub in Chicago, IL (U.S.).
Corporate

Senior leadership has been further strengthened with the appointment of Fred Blakeslee as Executive Vice President and General Counsel on October 16, and Sooin Kwon as Chief Business Officer and Dan Grossman as Chief Strategy Officer, effective August 4. These appointments have added strong corporate, business development and strategic assessment capabilities to the leadership team.
As part of the Company’s ongoing commitment to long-term governance and strategic continuity, several changes to the Board of Directors were announced:
Dawn Svoronos and Jane Griffiths were appointed by way of co-optation as Non-Executive Independent Directors, replacing Peter Guenter and Simon Sturge, effective July 28.
Dr. Neil Johnston has been appointed to the Board of Directors by way of co-optation as Non-Executive Independent Director, effective November 1. In addition, Devang Bhuva, current Senior Vice President of Corporate Development and Alliance Management at Gilead, has been appointed by way of co-optation as Non-Executive Non-Independent Director, effective November 1. In connection with these co-optations, Non-Executive Independent Directors Dr. Elisabeth Svanberg and Dr. Susanne Schaffert, and Non-Executive Non-Independent Director and current CFO of Gilead, Andrew Dickinson, stepped down, effective November 1. An additional Non-Executive Independent Director is expected to be appointed in the near future as part of the Board’s commitment to maintain a balanced, diversified Board composition with appropriate capabilities and profiles.
Clinical Pipeline
GLPG5101, a CD19 CAR-T candidate in Phase 1/2 across eight hematological malignancies

Two abstracts have been accepted for an oral and poster presentation at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, to be held in Orlando, from December 6-9.
In August, the FDA granted RMAT designation to GLPG5101 for the treatment of relapsed/refractory mantle cell lymphoma.
GLPG3667, a small molecule TYK2 inhibitor in two Phase 3-enabling studies in systemic lupus erythematosus (SLE) and dermatomyositis (DM)

Both the SLE and DM studies have progressed well, and topline data from both studies are expected in early 2026.
On October 26, Galapagos presented in vitro pharmacology data at the American College of Rheumatology (ACR) Convergence 2025, suggesting differentiation of GLPG3667 from other TYK2 inhibitors at their clinical dose regimens.
Financial performance

Key figures for the first nine months of 2025 (consolidated)
(€ millions, except basic & diluted earnings/loss (-) per share)

September 30, 2025 September 30, 2024 % Change
Supply revenues 29.3 19.1 +53%
Collaboration revenues 182.1 181.0 +1%
Total net revenues 211.4 200.1 +6%
Cost of sales (29.3) (19.1) +53%
R&D expenses (351.9) (238.2) +48%
G&Aiand S&Miiexpenses (109.0) (93.2) +17%
Impairment of the cell therapy business (204.8) -
Other operating result 21.4 24.8 -14%
Operatingloss (462.2) (125.6) +368%
Fair value adjustments and net exchange differences (50.5) 31.8
Net other financial result 30.4 71.7
Income taxes 19.3 1.7
Net loss from continuing operations (463.0) (20.4)
Net profit from discontinued operations, net of tax 1.7 69.2
Net profit/loss (-) of the period (461.3) 48.8
Basic and diluted earnings/loss (-) per share (€) (7.0) 0.7
Financial investments, cash & cash equivalents 3,050.1 3,338.8
Details of the financial results for the first nine months of 2025
Total operating loss from continuing operations for the first nine months of 2025, amounted to €462.2 million, compared to an operating loss of €125.6 million for the first nine months of 2024. This operating loss was negatively impacted by an impairment on the cell therapy business of €204.8 million as a result of the Company’s previously announced strategic alternatives process for the cell therapy business, and the executed strategic reorganization announced in January 2025, for €135.5 million. The latter is reflected in severance costs of €47.5 million, costs for early termination of collaborations of €45.5 million, impairment on fixed assets related to small molecules activities of €9.5 million, deal costs of €21.4 million, €9.8 million accelerated non-cash cost recognition for subscription right plans related to good leavers and €1.8 million other operating expenses.

Total net revenues amounted to €211.4 million for the first nine months of 2025, compared to €200.1 million for the first nine months of 2024. The revenue recognition related to the exclusive access rights granted to Gilead for Galapagos’ drug discovery platform amounted to €172.6 million for the first nine months, for both 2025 and 2024. The deferred income balance at September 30, 2025, includes €896.4 million allocated to the Company’s drug discovery platform. Royalties on Jyseleca from Gilead amounted to €8.3 million for the first nine months of 2025 (€8.4 million for the same period last year).
Cost of sales amounted to €29.3 million for the first nine months of 2025, compared to €19.1 million for the first nine months of 2024, and related to the supply of Jyseleca to Alfasigma under the transition agreement. The related revenues are reported in total net revenues.
R&D expenses amounted to €351.9 million for the first nine months of 2025, compared to €238.2 million for the first nine months of 2024. Increased personnel expenses (mainly related to severance costs), impairment on fixed assets (related to small molecules programs) and costs for early termination of collaboration agreements lead to this increase in R&D expenses.
S&M and G&A expenses amounted to €109.0 million for the first nine months of 2025, compared to €93.2 million for the first nine months of 2024. This increase was mainly due to higher personnel costs (primarily severance costs) and higher legal and professional fees (deal costs).
Impairment of cell therapy business is a result of the Company’s previously announced strategic alternatives process for the cell therapy business whereby the Company assessed the cell therapy business associated assets’ recoverable amount in accordance with IAS 36. The recoverable amount was estimated lower than the assets’ carrying value. As a result, the Company recognized an impairment loss of €204.8 million, thereby aligning the cell therapy assets’ book value with the Company’s strategic intention to wind down the cell therapy business, which resulted in a full impairment of both the associated goodwill and intangible assets and a partial impairment of property, plant and equipment.
Other operating result amounted to €21.4 million for the first nine months of 2025, compared to €24.8 million for the first nine months of 2024, mainly driven by lower grant and R&D incentives income and no recharges to Alfasigma.
Net financial loss amounted to €20.1 million for the first nine months of 2025, compared to net financial income of €103.5 million for the first nine months of 2024.

Fair value adjustments and net currency exchange results amounted to a negative amount of €50.5 million for the first nine months of 2025, compared to positive fair value adjustments and net currency exchange gains of €31.8 million for the first nine months of 2024, and were primarily attributable to €29.1 million of negative changes in fair value of financial investments, €44.0 million of unrealized currency exchange losses on our cash and cash equivalents and financial investments at amortized cost in U.S. dollars, partly offset by a positive effect of €22.7 million as consequence of the settlement of a hedging instrument.
Net other financial income amounted to €30.4 million for the first nine months of 2025, compared to net other financial income of €71.7 million for the first nine months of 2024. Interest income amounted to €31.4 million for the first nine months of 2025, compared to €70.6 million of interest income for the first nine months of 2024, due to a decrease in the interest rates and a shift from investments in term deposits generating financial income to investments in money market funds generating fair value changes. Fair value gains and interest income derived from cash, cash equivalents and financial investments excluding any currency exchange results amounted to €77.2 million for the first nine months of 2025 (compared to €108.9 million for the same period last year).
Income taxes amounted to €19.3 million for the first nine months of 2025. The increase is mainly explained by the reversal of the deferred tax liabilities linked to capitalized intangible assets related to the cell therapy business, as the Company recorded an impairment on these intangible assets.

The Company reported a net loss from continuing operations of €463.0 million for the first nine months of 2025, compared to a net loss from its continuing operations of €20.4 million for the first nine months of 2024.

Net profit from discontinued operations related to Jyseleca amounted to €1.7 million for the first nine months of 2025, compared to net profit amounting to €69.2 million for the first nine months of 2024. The net result for discontinued operations included €10.4 million of R&D expenses primarily related to the final settlement of disputed expenses with Alfasigma, and €11.4 million of other operating income related to a fair value adjustment of the contingent consideration receivable from Alfasigma as a consequence of an adjusted sales forecast. The operating profit from discontinued operations for the first nine months of 2024, was mainly related to the gain on the sale of the Jyseleca business to Alfasigma of €52.3 million.

Galapagos reported a net loss of €461.3 million for the first nine months of 2025, compared to a net profit of €48.8 million for the first nine months of 2024.

Cash position

Financial investments and cash and cash equivalents totaled €3,050.1 million on September 30, 2025, as compared to €3,317.8 million on December 31, 2024. The cash and cash equivalents and financial investments included $2,161.1 million held in U.S. dollars ($726.9 million on December 31, 2024) which could generate foreign exchange gains or losses in the financial results in accordance with the fluctuation of the EUR/U.S. dollar exchange rate as the Company’s functional currency is EUR (translated at a rate of 1.1741 €/$ at September 30, 2025).

Total net decrease in cash and cash equivalents and financial investments amounted to €267.7 million during the first nine months of 2025, compared to a net decrease of €345.7 million during the first nine months of 2024. This net decrease was composed of (i) €145.1 million of operational cash burn, which includes cash in of €77.7 million related to the return on financial investments) (ii) €118.6 million of negative exchange rate differences, positive changes in fair value of current financial investments, variation in accrued interest income, (iii) €20.0 million convertible loan issued to a third party, and (iv) €16.0 million of net cash is related to the sale of subsidiaries.

Financial guidance

Galapagos anticipates ending 2025 with approximately €2.975 billion to €3.025 billion in cash, cash equivalents and financial investments, excluding any business development activities and currency fluctuations. In the event that the Board would effectively proceed with a full wind down decision of the cell therapy business (i.e., if the intention is confirmed after works council processes), the Company would expect to incur the following spend related to the cell therapy business: €100 million to €125 million of operating cash impact from Q4 2025 through 2026 and €150 million to €200 million of one-time restructuring cash impact in 2026. If the intention to wind down is implemented and the process is completed, the Company would expect to be cash flow neutral to positive by the end of 2026, excluding any business development activities and currency fluctuations.

Conference call for investors and analysts

Galapagos will host a conference call on November 6, 2025, at 14:00 CET / 08:00 AM ET, during which the company will also share further details on its business development strategy. To participate, please register using this link. Dial-in details will be provided upon registration. Participants can join the call 10 minutes before the start time using the access information received by email or via the "call me" feature. The live call and presentation will be available on glpg.com or via the following link. A replay and related materials will be available shortly after the call in the investors section of the website.

(Press release, Galapagos, NOV 6, 2025, View Source [SID1234659570])