On June 30, 2025 Nektar Therapeutics (Nasdaq: NKTR), a clinical-stage biotechnology company focused on the development of innovative medicines in the field of immunotherapy, reported that it has commenced an underwritten public offering of shares of its common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase shares of its common stock (Press release, Nektar Therapeutics, JUN 30, 2025, View Source [SID1234654180]). All of the shares of common stock and pre-funded warrants to be sold in this offering are being offered by Nektar. In addition, Nektar intends to grant the underwriters a 30-day option to purchase up to an additional fifteen percent (15%) of shares of its common stock at the public offering price per share, less underwriting discounts and commissions. The proposed 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.

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Nektar intends to use the net proceeds from the offering for general corporate purposes, which may include research and development, clinical development and manufacturing costs to support the advancement of its drug candidates, as well as other general corporate purposes.

Jefferies and Piper Sandler are acting as joint bookrunning managers for the offering.

The securities described above are being offered pursuant to a shelf registration statement on Form S-3 (No. 333-286222) that was filed with the U.S. Securities and Exchange Commission (the "SEC") on March 28, 2025 and declared effective on April 1, 2025. This offering is being made only by means of a prospectus supplement and an accompanying prospectus that form a part of the registration statement.

A preliminary prospectus supplement related to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Copies of the preliminary prospectus supplement and an accompanying prospectus related to the offering may also be obtained, when available, 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]; or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, or by telephone at (800) 747-3924, or by e-mail at [email protected].

This press release shall not constitute an offer to sell or a 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 under the securities laws of that state or jurisdiction.

On June 30, 2025 Intensity Therapeutics, Inc. (Nasdaq: INTS) ("Intensity" or "the Company"), a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, reported that INT230-6 achieved complete responses in a murine models of Malignant Peripheral Nerve Sheath Tumor ("MPNST") (Press release, Intensity Therapeutics, JUN 30, 2025, View Source [SID1234654179]). In a study conducted in the Staedtke-Bai laboratory at Johns Hopkins University, at 21 days, animals tested with INT230-6 (n=5) all achieved a complete response, whereas all animals’ tumors in the control group (N=5) continued to grow.

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"We are excited to see complete responses in a murine model of malignant peripheral nerve sheath tumors, an effect that no small molecule drug before INT230-6 has achieved in our lab before," said Renyuan Bai, PhD, Kennedy Krieger Institute, Associate Professor, Department of Neurosurgery and Oncology Center, Johns Hopkins University School of Medicine, and the coordinating scientist for the study. "We are encouraged that these results can be achieved in this difficult-to-treat neurological model and look forward to continuing to work with Intensity on other preclinical models of neurological tumors."

"MPNST is the first neurological-specific tumor for which INT230-6 has been used. We are pleased to see that INT230-6 achieved meaningful results in MPMNST that are similar to the results we saw in other in vivo models where INT230-6 has been tested," said Lewis H. Bender, President and CEO of Intensity. "We look forward to conducting further preclinical research with the Staedtke-Bai laboratory in other neurological cancer models."

About INT230-6
INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug consists of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a diffusion and cell penetration enhancer molecule ("SHAO") that facilitates the dispersion of potent cytotoxic drugs throughout tumors, allowing the active agents to diffuse into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy.

About Malignant Peripheral Nerve Sheath Tumor
Malignant peripheral nerve sheath tumor (MPNST) is a rare and aggressive type of sarcoma that originates from the peripheral nerves or their surrounding sheath. Few therapies have been proven effective despite extensive efforts, and the five-year survival is 20 to 50%. Current treatment involves surgery, chemotherapy and radiation. The disease is characterized by its tendency to recur after treatment and metastasize to distant sites, making it a challenging cancer to manage. MPNSTs can arise spontaneously or are associated with neurofibromatosis type 1, referred to as NF1. They develop from the cells of the peripheral nerve sheath. One in 3,000 people can carry NF1 gene alternations and are predisposed to tumor formation, which can occur anywhere in the body. MPNSTs are most commonly found in the extremities and trunk. Common sites include the sciatic nerve, brachial plexus, and sacral plexus.

On June 30, 2025 AbbVie (NYSE: ABBV) and Capstan Therapeutics, Inc. ("Capstan"), a clinical-stage biotechnology company dedicated to advancing in vivo engineering of cells through RNA delivery using tLNPs, reported a definitive agreement under which AbbVie will acquire Capstan, including CPTX2309, a potential first-in-class in vivo tLNP anti-CD19 CAR-T therapy candidate, currently in Phase 1, in development for the treatment of B cell-mediated autoimmune diseases (Press release, AbbVie, JUN 30, 2025, View Source [SID1234654178]). Additionally, AbbVie will acquire Capstan’s proprietary tLNP platform technology designed to deliver RNA payloads, such as mRNA, capable of engineering specific cell types in vivo.

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"Scientific innovation is required to address not just the symptoms of autoimmune diseases, but also to resolve and potentially cure the underlying disease," said Roopal Thakkar, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "By advancing CPTX2309 and utilizing Capstan’s novel platform technology, AbbVie and Capstan aim to transform the care of those living with autoimmune diseases by developing treatments that have the potential to reset the immune system."

"In vivo CAR-T represents a potential new treatment modality in medicine – embodying the transformative power of cell therapy with the accessibility and scalability of an off-the-shelf biologic. This technology has the potential to become a first-in-class platform to treat a wide range of autoimmune diseases," said Laura Shawver, Ph.D., president and chief executive officer, Capstan. "Through AbbVie’s world-leading expertise in immunology research, clinical development, and its commercialization capabilities, we believe that this transaction moves us closer to delivering on our shared mission to bring these innovative therapies to patients in need."

B cells contribute to the pathogenesis of autoimmune diseases. CD19 is a cell surface receptor expressed on B cells and is a clinically validated target for B cell depletion using ex vivo CAR-T cell therapy in autoimmune diseases. CPTX2309, a product of Capstan’s proprietary technology platform that includes hepatic de-targeting, delivers an mRNA payload encoding an anti-CD19 CAR preferentially to reprogram CD8-expressing cytotoxic T cells. This process is achieved in vivo, without the need for lymphodepletion preconditioning and complex ex vivo manufacturing. The in vivo-modified CD8-expressing T cells will transiently express the CD19 CAR and deplete B cells in the periphery and tissues. Depletion of autoreactive antibody-producing pathogenic memory B cells and repopulation with naïve B cells, resulting in immune reset, has the potential to prevent disease progression and induce clinical remission.

Under the terms of the agreement, AbbVie will pay up to $2.1 billion in cash at closing to acquire Capstan, subject to certain customary adjustments. The transaction is subject to the satisfaction of customary closing conditions, including expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.

Advisors

Capstan’s exclusive financial advisor was Centerview Partners LLC and Cooley LLP served as legal advisor.

On June 30, 2025 BerGenBio ASA (OSE: BGBIO) ("BerGenBio" or the "Company") and Oncoinvent ASA (OSE: ONCIN) ("Oncoinvent") reported that they have entered into a merger agreement (the "Agreement") to combine the two companies through a statutory merger (the "Merger"), where BerGenBio will be the acquiring entity (Press release, Oncoinvent, JUN 30, 2025, https://www.oncoinvent.com/press-release/bergenbio-and-oncoinvent-a-rising-innovator-in-radiopharmaceutical-cancer-therapies-announce-proposed-merger-and-a-fully-underwritten-rights-issue/?utm_source=mailpoet&utm_medium=email&utm_source_platform=mailpoet [SID1234654177]).

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Following the Merger, the combined company shall carry out a fully underwritten rights issue.

The Merger puts BerGenBio’s capital and listing to productive use by strengthening Oncoinvent’s ability to execute on its clinical strategy and advance potentially life-changing treatments for patients with cancer in the abdominal cavity (peritoneal carcinomatosis).
The exchange ratio in the Merger will be 25% to BerGenBio and 75% to Oncoinvent corresponding to 1.20268049 shares in BerGenBio per share in Oncoinvent and values BerGenBio prior to the Merger at NOK 65 million, which represents a significant premium to what would be available for distribution to BerGenBio’s shareholders in a solvent liquidation scenario, and a premium of 19% compared to the closing price on Monday 30 June 2025. The Merger values Oncoinvent at NOK 195.5 million, which corresponds to its valuation in connection with the listing on Euronext Growth in December 2024 and a premium of 8% compared to the closing price on Monday 30 June 2025.
The Merger will add approximately NOK 45 million in cash to fund Oncoinvent’s clinical development plan. Moreover, the combination will substantially broaden the shareholder base, improving liquidity in the share and enable an uplisting from Euronext Growth Oslo, subject to approval by the Oslo Stock Exchange.
Subject to approval by the extraordinary general meetings of BerGenBio and Oncoinvent, Euronext Oslo Børs’ approval of the continued listing and completion of the Merger, the merged company will carry out a fully underwritten rights issue of NOK 130 million (the "Rights Issue"). The proceeds from the Rights Issue is expected to provide the merged company with a cash runway into 2027, beyond the interim readout from Oncoinvent’s ongoing Phase 2 trial in ovarian cancer, expected H2 2026.
The Merger is supported by BerGenBio’s largest shareholder Meteva AS and Oncoinvent’s largest shareholders Hadean Capital I AS and HVentures Capital I AB (together "Hadean Ventures") and Linc AB, all of whom have entered into voting undertakings to vote in favour of the Merger and lock-up commitments for a period of six months following this announcement.
The Agreement follows from the strategic review that BerGenBio has conducted, in cooperation with DNB Carnegie, to optimise shareholder value following its decision to discontinue the BGBC016 study.

Anders Tullgren, chair of the board of BerGenBio, stated: "I am very pleased to be able to announce our joining forces with Oncoinvent. This Merger, which is backed by the boards of both companies, is the result of an extensive review that explored a range of strategic options for BerGenBio. The Merger gives BerGenBio shareholders a part of an exciting company leveraging Norwegian radiopharmaceutical technology, which has already seen encouraging preliminary efficacy data, without safety concerns. We are confident that this is the best option for current BerGenBio shareholders."

Øystein Soug, CEO of Oncoinvent and forthcoming CEO of the merged company, stated: "We are very excited for the time ahead and to continue the execution of our focused strategy to develop Radspherin in ovarian cancer. We are on track with our randomised phase 2 trial. Going forward with a strengthened balance sheet, we believe the company will be a transformative force in the radiopharmaceutical therapy field, improving the lives of patients with cancer in the peritoneal cavity."

On June 30, 2025 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, reported that updated results from the Phase 1/2 FRAME study conducted by The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust were published online in Nature Medicine (Press release, Verastem, JUN 30, 2025, View Source [SID1234654176]). The full manuscript, titled "Defactinib with avutometinib in patients with solid tumors: the phase 1 FRAME trial," was the first-in-human study to evaluate the safety, tolerability, and efficacy of avutometinib in combination with defactinib in patients with low-grade serous ovarian cancer (LGSOC), non-small cell lung cancer (NSCLC), and other solid tumor types.

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"The FRAME study was the early foundation for the recent FDA approval of avutometinib plus defactinib in KRAS-mutated recurrent low-grade serous ovarian cancer and we are pleased to see that the mature data set continues to show the safety and tolerability of this combination therapy," said Dan Paterson, president and chief executive officer of Verastem Oncology. "This supports our ongoing commitment to advancing our research into the combination for use in other solid tumors, including RAMP 205 in first-line metastatic pancreatic cancer."

The FRAME study enrolled patients, across dose escalation and dose expansion cohorts, with RAS-MAPK-driven solid tumors including LGSOC, NSCLC, colorectal, pancreatic and endometrial cancers. The updated data include an extended follow-up period and more detailed analyses from the FRAME study, featuring efficacy and safety data that demonstrated the novel combination of avutometinib and defactinib continues to be well-tolerated and shows encouraging responses in patients with LGSOC, consistent with previous findings.

"This was the first clinical study to show significant clinical activity of the combination of avutometinib, a RAF/MEK clamp, with defactinib, a FAK inhibitor. The FRAME study demonstrated an important potential advancement in the treatment of solid tumor diseases like low-grade serous ovarian cancer where seventy percent of these tumors are driven by the RAS/MAPK pathway and with thirty percent of these patients carrying a KRAS mutation," said Professor Udai Banerji, co-Director of the Drug Development Unit, The Institute of Cancer Research and The Royal Marsden Hospital NHS Foundation Trust, London. "We are pleased to have contributed to the development of avutometinib and defactinib. With FRAME’s encouraging efficacy signal, the recommended Phase 2 dose was selected and the intermittent dosing schedule evaluated, which is the dose and schedule recently FDA approved in the U.S. and being used in the global confirmatory Phase 3 RAMP 301 trial."

In 26 patients with LGSOC who were evaluable for efficacy, the overall response rate (ORR) was 42.3% (11/26) and median progression-free survival (mPFS) was 20.1 months. In the 24 patients whose samples could be sequenced for KRAS mutations, ORR and mPFS were 58.3% (7/12) and 30.8 months in the 12 patients with KRAS mutations, and 33.3% (4/12) and 8.9 months in the 12 patients without KRAS mutations. In 11 patients who had previously received a MEK inhibitor, the ORR was 27.3% (3/11). Additionally, in two patients with LGSOC who had brain metastases prior to enrolling, MRI imaging at 30 months post-treatment with the combination showed the metastases had shrunk in both patients.

In 27 patients with LGSOC who were evaluable for safety, only one (4%) discontinued treatment due to Grade 3 skin toxicity. The five most common adverse events (AEs) (all grades, grade ≥3) were: rash (90%, 8%), elevated blood levels of creatine phosphokinase (56%, 9%), AST elevation (43%, 1%), hyperbilirubinemia (38%, 2%), and diarrhea (38%, 1%). The tolerability profile of avutometinib plus defactinib was comparable to the tolerability of each agent as monotherapy.

About the Phase 1/2 FRAME Study

The FRAME study is an open-label, investigator-initiated study that is designed to assess safety, dose response, and preliminary efficacy of the VS-6766/defactinib combination in patients with KRAS mutant solid tumors, including low-grade serous ovarian cancer (LGSOC), non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). The FRAME study is being led by Professor Udai Banerji, MBBS, MD, DNB, PhD, FRCP, Deputy Director of the Drug Development Unit at The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust, and is being conducted in the United Kingdom. In this study, VS-6766 was administered using a twice-weekly dose escalation schedule and was administered three out of every four weeks. Defactinib was administered using a twice-daily dose escalation schedule, also three out of every four weeks. Dose levels were assessed in three cohorts: cohort 1 (avutometinib 3.2mg, defactinib 200mg); cohort 2a (avutometinib 4mg, defactinib 200mg); and cohort 2b (avutometinib 3.2mg, defactinib 400mg). The recommended Phase 2 dose was determined to be cohort 1 (avutometinib 3.2mg, defactinib 200mg).

About Low-Grade Serous Ovarian Cancer (LGSOC)

LGSOC is a rare ovarian cancer that is insidious and persistent. LGSOC is distinct and different from high-grade serous ovarian cancer (HGSOC) and requires different treatment. LGSOC is highly recurrent and less sensitive to chemotherapy compared to HGSOC. Approximately 6,000-8,000 women in the U.S. and 80,000 worldwide are living with this disease. LGSOC affects younger women with bimodal peaks of diagnosis at ages between 20-30 and 50-60 and has a median survival of approximately ten years. Approximately 70 percent of LGSOC shows RAS pathway-associated mutations, and 30 percent of people with LGSOC have a KRAS mutation. The majority of patients report a negative impact of LGSOC on their mental and physical health, fertility, and long-term quality of life.

About AVMAPKI and FAKZYNJA Combination Therapy

AVMAPKI (avutometinib) inhibits MEK kinase activity while also blocking the compensatory reactivation of MEK by upstream RAF. RAF and MEK proteins are regulators of the RAS/RAF/MEK/ERK (MAPK) pathway. Blocking RAF and/or MEK activates FAK, a key mediator of drug resistance. FAKZYNJA (defactinib) is a FAK inhibitor and together, the avutometinib and defactinib combination was designed to provide a more complete blockade of the signaling that drives the growth and drug resistance of RAS/MAPK pathway-dependent tumors.

The U.S. Food and Drug Administration (FDA) approved AVMAPKI FAKZYNJA CO-PACK (avutometinib capsules; defactinib tablets) for the treatment of adult patients with KRAS-mutated recurrent LGSOC who have received prior systemic therapy on May 8, 2025. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Verastem is conducting RAMP 301 (GOG-3097/ENGOT-ov81/GTG-UK) (NCT06072781), an international Phase 3 confirmatory trial evaluating the combination of avutometinib and defactinib versus standard chemotherapy or hormonal therapy for the treatment of recurrent low-grade serous ovarian cancer (LGSOC) with and without a KRAS mutation. Verastem is also evaluating avutometinib in combination with defactinib and other agents as a potential treatment for patients with advanced pancreatic cancer (RAMP 205; NCT05669482) and advanced KRAS G12C mutant non-small cell lung cancer (RAMP 203; NCT05074810). Avutometinib and defactinib are not approved by the FDA or any other regulatory authority, either in combination or with other therapies, for any of these investigative uses. Neither avutometinib nor defactinib are approved by the FDA or any other regulatory authority on a stand-alone basis for any use.

AVMAPKI FAKZYNJA CO-PACK U.S. Indication

Indication
AVMAPKI FAKZYNJA CO-PACK is indicated for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy.

This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Important Safety Information

Warnings and Precautions

Ocular Toxicities: Ocular toxicities, including visual impairment and vitreoretinal disorders, occurred. Perform comprehensive ophthalmic evaluation at baseline, prior to cycle 2, every three cycles thereafter, and as clinically indicated. Withhold AVMAPKI FAKZYNJA CO-PACK for ocular toxicities until improvement at the same or reduced dose. Permanently discontinue AVMAPKI FAKZYNJA CO-PACK for any grade 4 toxicity.
Serious Skin Toxicities: Skin toxicities, including photosensitivity and severe cutaneous adverse reactions (SCARSs) occurred. Adhere to concomitant medications. Monitor for skin toxicities and interrupt, reduce or permanently discontinue AVMAPKI FAKZYNJA CO-PACK based on severity, tolerability and duration.
Hepatotoxicity: Monitor liver function tests prior to each cycle, on day 15 of the first 4 cycles, and as clinically indicated. Withhold, reduce or discontinue AVMAPKI FAKZYNJA CO-PACK based on severity and persistence of abnormality.
Rhabdomyolysis: Monitor creatine phosphokinase prior to the start of each cycle, on day 15 of the first four cycles, and as clinically indicated. If increased CPK occurs, evaluate patients for rhabdomyolysis or other causes. Withhold, reduce or permanently discontinue AVMAPKI FAKZYNJA CO-PACK based on severity and duration of the adverse reaction.
Embryo-Fetal Toxicity: AVMAPKI FAKZYNJA CO-PACK can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.
Adverse Reactions
The most common (≥ 25%) adverse reactions, including laboratory abnormalities, were increased creatine phosphokinase, nausea, fatigue, increased aspartate aminotransferase, rash, diarrhea, musculoskeletal pain, edema, decreased hemoglobin, increased alanine aminotransferase, vomiting, increased blood bilirubin, increased triglycerides, decreased lymphocyte count, abdominal pain, dyspepsia, dermatitis acneiform, vitreoretinal disorders, increased alkaline phosphatase, stomatitis, pruritus, visual impairment, decreased platelet count, constipation, dry skin, dyspnea, cough, urinary tract infection, and decreased neutrophil count.

Drug Interactions

Strong and moderate CYP3A4 inhibitors: Avoid concomitant use with AVMAPKI FAKZYNJA CO-PACK.
Strong and moderate CYP3A4 inducers: Avoid concomitant use with AVMAPKI FAKZYNJA CO-PACK.
Warfarin: Avoid concomitant use of AVMAPKI FAKZYNJA CO-PACK with warfarin and use an alternative to warfarin.
Gastric acid reducing agents: Avoid concomitant use of AVMAPKI FAKZYNJA CO-PACK with proton pump inhibitors (PPIs) or H2 receptor antagonists. If use of an acid-reducing agent cannot be avoided, administer FAKZYNJA 2 hours before or 2 hours after the administration of a locally acting antacid.
Use in Specific Populations

Lactation: Advise not to breastfeed.
Fertility: May impair fertility in males and females.