On July 31, 2025 Sumitomo Dainippon Pharma reported first quarter financial results.

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(Presentation, Sumitomo Dainippon Pharma, JUL 31, 2025, View Source [SID1234661682])

On July 31, 2025 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), a company developing new approaches for the treatment for cancer and fibrosis, reported further progress across its small molecule, focal adhesion kinase (FAK) inhibitor program and the release of its Appendix 4C Cash Flow Report (attached) for the quarter ending 30 June 2025 (Press release, Amplia Therapeutics, JUL 31, 2025, View Source [SID1234654649]).

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Key Highlights

• The ACCENT trial achieved a key activity threshold with 17 confirmed partial responses (PRs), showing a 31% response rate for narmafotinib combined with chemotherapy, which is superior to chemotherapy alone (23%).
• Two patients achieved complete responses, including one patient with undetectable cancer lesions for over two months and another with a rare pathological complete response in metastatic pancreatic cancer, garnering significant media attention.
• Progress has been made in initiating a second trial of narmafotinib, combining it with FOLFIRINOX chemotherapy in the USA and Australia, with ethics approvals now secured for both regions.
• Dr Jason Lickliter was appointed Chief Medical Officer in May, bringing extensive experience as a medical oncologist and clinical triallist, having advised Amplia since 2021.
• ACCENT trial data was presented for the initial 26-patient cohort at the prestigious American Association of Cancer Research annual meeting in April. • $27.5m capital raise announced in July 2025, funding the company into 2027

Operations Update

Significant developments in the ACCENT trial were achieved over this quarter. In May we reported that we had achieved the key activity threshold of 15 confirmed partial responses (PRs), demonstrating that the combination of our best-in-class FAK inhibitor narmafotinib with chemotherapy was superior to chemotherapy alone. At the time of writing we now have reported 17 confirmed PR’s, which equates to a response rate of 31%, superior to the 23% response rate observed for chemotherapy alone.

In June we announced that two (2) patients from the trial had achieved complete responses. In one patient, the cancer lesions had decreased in size over the course of treatment to become no longer detectable for over a 2-month period. In the second patient, surgical removal of tissue that appeared to be residual tumour was shown by pathology to be non-malignant tissue, meaning that the patient had achieved a pathological complete response. This latter finding is extremely rare in metastatic pancreatic cancer and resulted in significant media attention for the patient and the hospital where the treatment was delivered.

Further progress has been made towards initiation of the second trial of narmafotinib in pancreatic cancer, this time combining the drug with a different chemotherapy called FOLFIRINOX. This trial, to will be conducted in the USA and Australia, is designed to demonstrate that narmafotinib can also improve the response to FOLFIRINOX. In June we announced that ethics approval had been received from the central US Institutional Review Board (IRB), a critical approval required before sites can initiate patient recruitment. We have now also received similar ethics approval for the Australian sites. The first stage of the trial, where different doses of narmafotinib will be trialled in combination with FOLFIRINOX, is due to start imminently.

In May, the Company announced the appointment of Dr Jason Lickliter as Chief Medical Officer. Dr Lickliter is a highly experienced medical oncologist and clinical triallist and joins the Company in a part- time capacity, whilst retaining a CMO role at clinical trials organisation Nucleus Network. Dr Lickliter has been acting in the role of clinical adviser to Amplia since 2021 and has a deep knowledge of our clinical program and data.

In April, the Company presented ACCENT trial data for the initial cohort of 26 patients at the American Association of Cancer Research annual meeting, a highly prestigious cancer meeting that attracts scientists, clinicians and representatives from pharma and biotech from across the globe.

Outlook and future activities

The Company will continue to collect, analyse and report data from the ongoing ACCENT trial over the coming months. Initiation and progression of the FOLFIRINOX and narmafotinib combination trial, being conducted in the USA and Australia, will also be a major focus of the Amplia team. Interactions with regulatory agencies, in particular the US FDA, is also planned in the coming months.

Capital Raise

On 23 July the Company announced a capital raise of $27.5 million (before costs) to support the ongoing clinical activities and additional planned activities, funding the Company into 2027. The capital raise comprises a successful institutional placement raising $25.0 million (before costs) and a Share Purchase Plan seeking to raise an additional $2.5 million. The Placement was strongly supported by existing and new institutional and sophisticated investors in Australia and offshore.

Financial update

Amplia finished the June 2025 quarter with a cash position of $7.0 million (March 2025: $10.9 million).

During the quarter, the Company had net operating cash outflows of $3.8 million in relation to operating activities (March 2025: $2.7 million). Operating cashflows included:

• Outflows of $0.9 million for staff and administration/corporate costs; and • Outflows of $3.0 million for research and development costs, which primarily related to trial costs, Contract Research Organisation (CRO), manufacturing and other CMC related costs incurred in relation to the ACCENT Phase 2 clinical trial for narmafotinib (AMP945) with gemcitabine and Abraxane and initiation costs with its AMPLICITY Phase 2 study clinical trial for narmafotinib (AMP945) with FOLFIRINOX.

The Company is also expecting to receive its Research and Development Tax Incentive refund for the year ended 31 March 2025 of $3.8m in the September 2025 quarter.

On July 31, 2025 Immunophotonics, Inc., a clinical-stage biotech company developing novel immunostimulatory drugs to improve efficacy of routine tumor destruction techniques, reported the completion of treatment of the last patient in its INJECTABL-1 multicenter Phase 1b/2a clinical trial of IP-001 for advanced solid tumors (Press release, Immunophotonics, JUL 31, 2025, View Source [SID1234654693]). The 41-patient trial, which focused on three distinct cancer types — colorectal cancer, non-small cell lung cancer, and soft tissue sarcoma— was conducted in France, Germany, Switzerland, the UK, and the US.

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The INJECTABL-1 trial was designed to evaluate the systemic immune-mediated anti-cancer effects of IP-001 following tumor ablation, which aims to destroy all cells in targeted tumor lesions in patients with advanced solid tumors but fails to induce robust anti-tumor immunity. Tumor ablation is an approved and well-established procedure that is readily available at most hospitals and clinics. IP-001 is a novel immunotherapy administered by injection into the ablation zone. It works by retaining tumor debris, including tumor antigens, and by activating the patient’s own immune system to allow systemic tumor surveillance. Such immune surveillance enables the patient’s own defense mechanisms to recognize and destroy tumor cells that had escaped the destroyed metastatic lesion.

Prof. Dr. Markus Jörger, Principal Investigator for the trial at the Cantonal Hospital St. Gallen Clinic for Medical Oncology and Hematology, commented: "We are proud to announce the completion of treatment of the last patient in our INJECTABL-1 Phase 1b/2a clinical trial. This significant milestone brings us closer to potentially providing a new treatment option for patients with advanced solid tumors."

"Immunophotonics is committed to leading the field of Interventional Immuno-Oncology through a therapeutic approach intended to reduce tumor recurrence after standard-of-care local ablation therapy, which remains a significant unmet medical need. With the completion of our INJECTABL-1 trial, we will evaluate data to assess IP-001’s ability to transform ablation into something more powerful as we continue to advance the clinical development of our proprietary novel asset. Early signals are positive, and the company has expanded clinical collaborations to further assess the efficacy of this novel therapy," stated Lu Alleruzzo, Immunophotonics co-founder and CEO.

About IP-001
IP-001 is a proprietary glycan polymer that generates tumor antigen depots and acts as a potent, multimodal immune stimulant intended to induce immunological responses to eradicate cancer. IP-001 is designed to (1) prolong the availability of the targeted tumor antigens, (2) facilitate the recruitment and activation of innate immune cells such as antigen-presenting cells (APCs), (3) increase the uptake of the tumor antigens into the APCs, and (4) lead to a downstream adaptive immune response against the tumor cells. Activation of a systemic, adaptive immune response allows immune effector cells to seek out and eliminate tumor cells throughout the body.

On July 31, 2025 Biogen Inc. (NASDAQ: BIIB) reported second quarter 2025 financial results (Press release, Biogen, JUL 31, 2025, View Source [SID1234654669]). Commenting on the results, President and Chief Executive Officer Christopher A. Viehbacher said:

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"We delivered another quarter of strong execution against our strategy to transform our portfolio and build the new Biogen. Our performance reflects robust financial results, ongoing cost discipline, continued growth of our launch products, and meaningful strides expanding and advancing our late-stage pipeline. We are now progressing salanersen to registrational studies in SMA following exciting interim Phase 1b results, and have initiated all three Phase 3 studies for felzartamab in rare kidney disease. These achievements reinforce our commitment to building a stronger company, with the potential for sustainable growth and long-term value for our shareholders."

Financial Highlights
Q2 ’25 Q2 ’24 △
r (CC*)
Total Revenue (in millions) $2,646 $2,465 7% 8%
GAAP diluted EPS $4.33 $4.00 8% N/A
Non-GAAP diluted EPS $5.47 $5.28 4% N/A

Note: Percent changes represented as favorable/(unfavorable) versus the prior year period.
N/A = not applicable.
* Percentage changes in revenue growth at constant currency (CC) are presented excluding the impact of changes in foreign currency exchange rates and hedging gains or losses. Foreign currency revenue values are converted into U.S. Dollars using the exchange rates from the end of the previous calendar year.

Second quarter 2025 GAAP and Non-GAAP diluted EPS reflects the approximately ($0.26) impact from $47 million of acquired IPR&D, upfront and milestone expense.

A reconciliation of GAAP to Non-GAAP financial measures can be found in Table 4 at the end of this news release.
Revenue Summary
(in millions) Q2 ’25 Q2 ’24 △
r (CC*)
Multiple sclerosis (MS) product revenue(1)
$1,107 $1,150 (4)% (4)%
Rare disease revenue(2)
$543 $534 2% 3%
Biosimilars revenue $182 $198 (8)% (8)%
Other product revenue(3)
$47 $18 169% 170%
Total product revenue $1,879 $1,900 (1)% (1)%
Revenue from anti-CD20 therapeutic programs $467 $445 5% 5%
Alzheimer’s collaboration revenue(4)
$55 $12 NMF NMF
Contract manufacturing, royalty and other revenue $245 $109 124% 119%
Total revenue $2,646 $2,465 7% 8%

Note: Percent changes represented as favorable/(unfavorable) versus the prior year period. Numbers may not foot or recalculate due to rounding.
NMF = no meaningful figure.
(1) Multiple sclerosis includes TECFIDERA, VUMERITY, AVONEX, PLEGRIDY, TYSABRI and FAMPYRA. Effective
January 1, 2025, our collaboration and license agreement for FAMPYRA global commercialization rights was terminated.
(2) Rare disease includes SPINRAZA, SKYCLARYS and QALSODY.
(3) Other includes ADUHELM, FUMADERM and ZURZUVAE.
(4) Includes Biogen’s 50% share of net revenue and cost of sales, including royalties, from the LEQEMBI Collaboration.
Expense Summary
(in millions) Q2 ’25 Q2 ’24 △
GAAP cost of sales*
$605 $546 (11)%
% of Total Revenue 23% 22%
Non-GAAP cost of sales*
$554 $504 (10)%
% of Total Revenue 21% 20%
GAAP R&D expense $399 $505 21%
Non-GAAP R&D expense $394 $455 13%
GAAP SG&A expense $584 $554 (5)%
Non-GAAP SG&A expense $579 $542 (7)%
GAAP acquired IPR&D, upfront and milestone expense $47 $9 NMF
Non-GAAP acquired IPR&D, upfront and milestone expense $47 $9 NMF

Note: Percent changes represented as favorable/(unfavorable) versus the prior year period
IPR&D = in-process R&D; NMF = no meaningful figure.
* Excluding amortization and impairment of acquired intangible assets

2

•The increase in second quarter 2025 GAAP and Non-GAAP cost of sales as a percentage of total revenue was driven primarily by product mix, particularly the year-over-year increase in contract manufacturing revenue driven in-part by accelerated batch production in preparation for expected plant maintenance shutdowns in the fourth quarter of 2025, partially offset by an increase in launch product revenue.

•The decrease in second quarter 2025 GAAP and Non-GAAP R&D expense was driven primarily by savings from the Company’s R&D prioritization, Fit for Growth initiatives and R&D funding received.

•The increase in second quarter 2025 GAAP and Non-GAAP SG&A was driven primarily by sales and marketing spend to support product launches, partially offset by savings from the Company’s Fit for Growth initiative.

•Second quarter 2025 GAAP and Non-GAAP acquired IPR&D, upfront and milestone expense was approximately $47 million and includes a $30 million milestone to MorphoSys AG as part of the initiation of the Phase 3 trial of felzartamab in IgA nephropathy and a $16 million upfront payment as part of a strategic research agreement with City Therapeutics, Inc.
Other Financial Highlights

•Second quarter 2025 GAAP and Non-GAAP collaboration profit sharing was a net expense of approximately $75 million, which includes approximately $57 million related to Biogen’s collaboration with Samsung Bioepis, and approximately $18 million related to Biogen’s collaboration with Sage Therapeutics, Inc. and the commercialization of ZURZUVAE in the U.S.

•Second quarter 2025 GAAP other expense was approximately $49 million, primarily driven by net interest expense and impacts from foreign currency. Second quarter 2025 Non-GAAP other expense was approximately $57 million, primarily driven by net interest expense.

•Second quarter 2025 GAAP and Non-GAAP effective tax rates were 14.7% and 13.5%, respectively. Second quarter 2024 GAAP and Non-GAAP effective tax rates were 16.5% and 15.9%, respectively.
Financial Position

•Second quarter 2025 net cash flow from operations was approximately $161 million and includes the impact of cash tax payments of approximately $745 million. Capital expenditures were approximately $27 million, and free cash flow, defined as net cash flow from operations less capital expenditures, was approximately $134 million.

•As of June 30, 2025, Biogen had cash and cash equivalents totaling approximately $2.8 billion and approximately $6.3 billion in total debt, resulting in net debt of approximately $3.5 billion.

•For the second quarter of 2025 the Company’s weighted average diluted shares were approximately 147 million.

On July 31, 2025 Shenzhen Chipscreen Biosciences Co., Ltd. ("Chipscreen Biosciences") reported that its wholly owned subsidiary, Chipscreen Biosciences (USA) Ltd., has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) for its innovative drug CS231295 tablet for the treatment of advanced solid tumors (Press release, Shenzhen Chipscreen Biosciences, JUL 31, 2025, View Source [SID1234654694]). This significant milestone marks a key step forward in the global development strategy for CS231295.

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Malignant tumors remain one of the leading causes of death worldwide. Despite continuous advancements in clinical treatments and efficacy, most cancers remain incurable. Drug resistance, recurrence, and metastasis pose significant threats to long-term patient survival. In particular, due to the presence of the blood-brain barrier, primary brain tumors and brain metastases not only pose a severe danger to life but also serve as natural barriers to effective drug therapy. Thus, developing novel brain-penetrant anti-cancer drugs has become a pressing challenge and a key research focus.

CS231295 is a next-generation brain-penetrant Aurora B selective inhibitor discovered through years of mechanism-based research by Chipscreen Biosciences. On one hand, it precisely inhibits tumor-specifically overexpressed Aurora B kinase to induce synthetic lethality, directly targeting the genetic vulnerability of hard-to-treat cancers such as those with RB1 deletion. On the other hand, due to its strong blood-brain barrier permeability, it shows significant therapeutic potential for both primary and metastatic brain tumors. Furthermore, this molecule also exhibits broad-spectrum anti-tumor activity, which improves the tumor microenvironment. It is expected to provide a novel solution for tumors with similar genetic defects and the global challenge of brain metastases. Currently, there is no similar compound with this design that has entered clinical trials globally.

With its unique mechanism and chemical structure, CS231295 demonstrates synergistic effects when combined with chemotherapy, targeted therapy, and cancer immunotherapy. In preclinical studies, CS231295 has shown remarkable pharmacodynamic activity, ideal pharmacokinetic properties, and a favorable safety profile.

Notably, CS231295 completed the first patient enrollment in its Phase I first-in-human clinical trial in China in May 2025, providing preliminary evidence to support the scientific rationale and feasibility of global multicenter clinical development. The FDA’s IND approval will further accelerate the initiation and implementation of its clinical research in the United States.