On September 24, 2025 ESSA Pharma Inc. ("ESSA," or the "Company") (NASDAQ: EPIX) reported that it has reached an agreement to amend its previously announced Business Combination Agreement (the "Amended Agreement") with XenoTherapeutics Inc. ("Xeno"), a non-profit biotechnology company (Press release, ESSA, SEP 24, 2025, View Source [SID1234656208]). XOMA Royalty Corporation ("XOMA Royalty") (NASDAQ: XOMA) continues to act as structuring agent and intends to provide financing for the transaction (the "Transaction").

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Under the Amended Agreement, ESSA shareholders are now expected to receive approximately US$0.12, exclusive of future non-transferable contingent value right ("CVR") payments and exclusive of the approximately US$1.69 of cash previously distributed to ESSA shareholders, per Common Share at closing (as compared to the approximately US$1.91 that was originally estimated as the aggregate distribution, as described in greater detail below), plus one CVR per Common Share, which CVR now represents the right to receive up to approximately US$0.14 per CVR and payable within specified periods following the close of the Transaction. The potential CVR payments of US$0.14 per Common Share represents up to US$6.7 million in the aggregate that may be distributed to CVR holders depending on the outcome of certain contingent liabilities. ESSA and Xeno are making this change in light of potential liabilities, associated expenses and the latest estimates of the Company’s expected cash balance at closing. ESSA will be filing the Amended Agreement on a Current Report on Form 8-K.

As previously disclosed on July 14, 2025, ESSA shareholders were expected to receive a cash payment per Common Share determined based on ESSA’s cash balance at closing, plus one CVR per Common Share. At that time, ESSA estimated that shareholders would receive approximately US$1.91 per Common Share, exclusive of any CVR payments. On August 22, 2025, ESSA distributed approximately US$1.69 per Common Share to its shareholders as an initial cash distribution.

ESSA intends to apply to the Supreme Court of British Columbia (the "Court") to amend the interim order obtained from the Court on August 5, 2025 (the "Interim Order") following the adjournment of the Meeting. The amended Interim Order would provide for a new Meeting date of October 3, 2025, a new deadline to deliver notices of dissent of October 1, 2025, a new Court hearing date for approval of the Arrangement of October 7, 2025 and a deadline of October 3, 2025 for responses for persons intending to attend the October 7th hearing.

Special Meeting to Reconvene on October 3, 2025

In connection with the Amended Agreement, ESSA also announced today that it has further adjourned its special meeting of the holders of common shares of the Company ("Common Shares" and the holders of such Common Shares, the "Shareholders"), optionholders and warrantholders (the "Special Meeting") scheduled to occur on September 29, 2025.

The Special Meeting will now reconvene at 2:00 p.m. (Pacific Time) on October 3, 2025. The Special Meeting will still be held online via a live interactive webcast on the internet at View Source

The additional adjournment will allow time for shareholders to consider and approve the Amended Agreement. Shareholders who have already voted on the transaction and do not wish to change their vote do not need to take any further action.

ESSA will file supplemental proxy materials reflecting the revised terms in due course.

Advisors

Leerink Partners is serving as the exclusive financial advisor to ESSA and Blake, Cassels & Graydon LLP and Skadden, Arps, Slate, Meagher & Flom LLP are serving as ESSA’s Canadian legal counsel and U.S. legal counsel, respectively.

Stikeman Elliott LLP and Gibson, Dunn & Crutcher LLP are serving as XOMA Royalty’s Canadian legal counsel and U.S. legal counsel, respectively.

On September 24, 2025 SystImmune, Inc. (SystImmune), a clinical-stage biotechnology company, reported the presentation of data on iza-bren (izalontamab brengitecan) and BL-M07D1, two distinct clinical programs from its antibody drug conjugate (ADC) pipeline, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, taking place October 17-21 in Berlin, Germany (Press release, SystImmune, SEP 24, 2025, View Source [SID1234656207]). Iza-bren, a potentially first-in-class EGFRxHER3 bispecific ADC, is jointly developed by SystImmune and Bristol Myers Squibb under a collaboration and exclusive license agreement in territories outside of China.

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"The breadth of data we are presenting at ESMO (Free ESMO Whitepaper) this year reflects not only the strength of our ADC platform but also the speed and depth with which we are advancing our clinical pipeline across tumor types," said Dr. Jie D’Elia, Ph.D., Chief Executive Officer of SystImmune. "From our late-stage pivotal trials to our earlier proof-of-concept studies, these achievements demonstrate SystImmune’s ability to translate our differentiated ADC platform into potential medicines that have the power to change treatment paradigms for cancer patients worldwide."

Key data to be presented at ESMO (Free ESMO Whitepaper) include:

Highlighting the continued clinical advancement of iza-bren:

Late-breaking data from the first randomized, open-label, multicenter, Phase III study evaluating iza-bren versus physician’s choice of chemotherapy in heavily pretreated recurrent/metastatic nasopharyngeal carcinoma in China
Results from the first Phase 1 study of iza-bren in a global patient population (BL-B01D1-LUNG-101) with metastatic or unresectable non-small cell lung cancer (NSCLC) and other solid tumors
Safety and efficacy results of iza-bren as a monotherapy in patients with advanced stages of ovarian cancer in China
Safety and efficacy results of iza-bren in combination with serplulimab, an anti-PD-1 monoclonal antibody, in patients with extensive-stage small cell lung cancer in China
Demonstrating strength of ADC platform with a second novel ADC program BL-M07D1

Safety and efficacy data of BL-M07D1 in patients with metastatic breast cancer and HER2-positive advance gastric or gastroesophageal junction adenocarcinoma (GC/GEJ) will be presented.
"We are excited to present the first randomized data of iza-bren compared to systemic chemotherapy in advanced nasopharyngeal carcinoma demonstrating the clinical benefit of iza-bren for these patients. In addition, the breadth of data being presented at ESMO (Free ESMO Whitepaper) underscores the potential versatility of iza-bren across multiple tumor types," said Jonathan Cheng, M.D., Chief Medical Officer of SystImmune. "We are strongly encouraged by the single-agent activity seen in ovarian cancer and EGFR-mutated NSCLC, as well as the potential for rational combinations observed in small cell lung cancer. These results reinforce our commitment to advancing iza-bren as a therapy that could meaningfully expand treatment options for patients with difficult-to-treat cancers."

Details of the presentations at ESMO (Free ESMO Whitepaper) are below:

Iza-Bren (BL-B01D1), an EGFR×HER3 Bispecific Antibody-drug Conjugate, versus Physician’s Choice of Chemotherapy in Heavily Pretreated Recurrent/Metastatic Nasopharyngeal Carcinoma: A Randomized, Open-Label, Multicenter, Phase III, Pivotal study
Trial Reference: BL-B01D1-303 (NCT06118333), China
Session Title: Proffered paper session: Development therapeutics
Presentation Number: LBA35
Speaker: Huaqiang Zhou (Guangzhou, China)
Session Date & Time: Sunday, October 19th, 2025, 2:45 PM-4:15 PM CEST

Phase 1 Global Study of Iza-Bren (BL-B01D1), an EGFR x HER3 Bispecific Antibody-drug Conjugate (ADC), in Patients with Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors
Trial Reference: BL-B01D1-LUNG-101 (NCT05983432), Global
Session Title: Mini oral session: Developmental therapeutics
Presentation Number: 921MO
Speaker: Helena A. Yu (New York, USA)
Session Date & Time: Friday, October 17th, 2025, 4:00 PM-5:30 PM CEST

Phase II Study of iza-bren (BL-B01D1) in Combination with Serplulimab in Patients with Small Cell Lung Cancer (SCLC)
Trial Reference: BL-B01D1-204-01 (NCT06437509), China
Session Title: Developmental therapeutics
Presentation Number: 934P
Speaker: Fei Zhou (Shanghai, China)
Onsite Poster Display Date: Sunday, October 19th, 2025, 12:00 PM-12:45 PM CEST

Phase Ib/II Study of iza-bren (BL-B01D1), an EGFR x HER3 Bispecific Antibody-drug Conjugate (ADC), in Patients with Recurrent Metastatic Ovarian Cancer (OC)
Trial Reference: BL-B01D1-202 (NCT05803018, NCT05990803), China
Session Title: Developmental therapeutics
Presentation Number: 933P
Speaker: Wu Yong (Shanghai, China)
Onsite Poster Display Date: Sunday, October 19th, 2025, 12:00 PM-12:45 PM CEST

A phase 1/2a, open-label, dose-finding study of the safety, pharmacokinetics, and preliminary efficacy of iza-bren (BL-B01D1) combinations in patients with advanced solid tumors
Trial Reference: CA244-0001 (NCT06618287), Global
Session Title: NSCLC, metastatic
Presentation Number: 2080eTIP
Speaker: Marie Florescu (Montreal, Canada)

BL-M07D1, a novel HER2 antibody-drug conjugate, in subjects with locally advanced or metastatic breast cancer and other solid tumors: Results from a phase 1 study
Trial Reference: BL-M07D1-101 (NCT05461768), China
Session Title: Developmental therapeutics
Presentation Number: 935P
Speaker: Hong Zong (Zhengzhou, China, Henan)
Onsite Poster Display Date: Sunday, October 19th, 2025, 12:00 PM-12:45 PM CEST

Primary efficacy and safety of BL-M07D1 in patients with previously treated HER2-positive advanced gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJ)
Trial Reference: BL-M07D1-101, 102, 202 (NCT05461768, NCT05631964, NCT06031584), China
Session Title: Developmental therapeutics
Presentation Number: 937P
Speaker: Shuqin Ni (Jinan, China)
Onsite Poster Display Date: Sunday, October 19th, 2025, 12:00 PM-12:45 PM CEST

About iza-bren
SystImmune, in collaboration with BMS outside of China, is developing iza-bren (BL-B01D1), a bispecific antibody-drug conjugate (ADC) that targets both EGFR and HER3, which are highly expressed in various epithelial cancers and are known to be associated with cancer cell proliferation and survival. Iza-bren’s dual mechanism of action blocks EGFR and HER3 signals to cancer cells, reducing proliferation and survival signals. In addition, upon antibody mediated internalization, iza-bren’s therapeutic novel Topo1i payload is released causing cytotoxic stress that leads to cancer cell death.

About BL-M07D1
SystImmune is developing BL-M07D1, an ADC comprising a monoclonal antibody component binding HER2 and a linker-payload component composed of a topoisomerase I inhibitor payload and a stable enzyme-cleavable linker. HER2 is highly expressed in multiple solid tumors. BL-M07D1 works by triggering antibody-dependent cellular cytotoxicity (ADCC) when it binds to HER2 on cancer cells. In addition, the binding to HER2 causes its internalization followed by the release of the payload, which then kills the tumor cell.

On September 24, 2025 Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering novel approaches for precision immunotherapy in oncology and inflammation and immunology (I&I), reported it will present a late-breaking mini oral presentation on initial Phase 2 clinical results for invikafusp alfa monotherapy in tissue-agnostic, TMB-H/MSI-H solid tumors at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting taking place October 17-21, 2025, in Berlin, Germany (Press release, Marengo Therapeutics, SEP 24, 2025, View Source [SID1234656206]).

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Presentation details:

Title: STARt-001: Initial Phase 2 clinical activity of invikafusp alfa, a first-in-class T cell receptor (TCR) β-chain-targeted bispecific antibody as monotherapy in patients with antigen-rich solid tumors resistant to immune checkpoint blockade (ICB)
Conference: ESMO (Free ESMO Whitepaper) Annual Meeting 2025
Abstract Number: LBA55
Session Title: Mini oral session: Investigational immunotherapy
Session Date and Time: Friday, October 17, 2025, 14:00 – 15:30
Session Room: Nuremberg Auditorium
Presenter: Antione Italiano, M.D., Ph.D. (Institut Bergonié, France)

On September 24, 2025 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company developing next-generation treatments for dermatological and inflammatory conditions, reported the expansion of its intellectual property portfolio for HT-001, its lead topical therapeutic candidate (Press release, Hoth Therapeutics, SEP 24, 2025, View Source [SID1234656205]). The Company has filed multiple U.S. Provisional Patent Applications covering novel dermatological indications, broadening the commercial and clinical potential of HT-001.

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The filings include:

Treatment of Drug-Induced Hypersensitivity Syndrome

Treatment of Radiotherapy-Induced Rash

Treatment of Dermatological Conditions Associated with MENIN Inhibitor Therapy
"These additional patent applications demonstrate our commitment to unlocking the full therapeutic potential of HT-001 across multiple high-value indications," said Robb Knie, Chief Executive Officer of Hoth Therapeutics. "Drug-induced hypersensitivity, radiotherapy-related rash, and MENIN inhibitor-associated dermatological conditions represent areas of significant unmet need. Expanding our IP protection into these indications strategically positions Hoth to address major markets in oncology supportive care and beyond."

MENIN Inhibitor Therapy and the Role of HT-001

MENIN inhibitors are an emerging class of targeted oncology drugs designed to block the interaction between the menin protein and MLL1/KMT2A fusion proteins — genetic drivers implicated in acute leukemias and other cancers. Early clinical data from leading oncology companies have shown that MENIN inhibitors can induce strong antitumor activity, making them one of the most closely watched new therapeutic classes in cancer drug development.

However, patients receiving MENIN inhibitors frequently experience significant dermatological side effects, including painful or disfiguring rashes that can lead to dose reductions or treatment discontinuation. These adverse events may limit the full therapeutic potential of MENIN inhibitor therapy.

HT-001’s novel topical formulation is designed to address these dermatological toxicities directly, offering patients relief from rash and skin irritation without interrupting or reducing their cancer treatment. By improving tolerability, HT-001 could help patients stay on therapy longer and maximize the clinical benefit of MENIN inhibitors.

Expanding the Potential of HT-001

HT-001 is currently being advanced as a topical therapeutic for chemotherapy-induced rash, a dose-limiting side effect affecting patients receiving EGFR inhibitors and other targeted therapies. The patent filings broaden the potential utility of HT-001 to additional drug-induced and treatment-related skin disorders, further establishing the program as a versatile platform candidate.

"With this expanded IP portfolio, HT-001 is positioned not only as a targeted solution for oncology-related rash but also as a potential cornerstone therapy for a range of dermatological conditions driven by emerging cancer treatments," added Knie. "This expansion underscores our strategy to build durable value through innovation, intellectual property, and pipeline diversification."

On September 24, 2025 SciTech Development, Inc., a clinical-stage oncology company advancing its innovative nanotechnology-enabled cancer drug, reported the successful close of its Convertible Note Round #3 (CNR 3) at $5.5 million (Press release, SciTech Development, SEP 24, 2025, View Source [SID1234656204]). The round, which officially closed on September 5, 2025, surpassed its original $3.0 million target by $2.5 million.

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The strong investor response is driven by extraordinary interim results from SciTech’s lead drug candidate, ST-001 nanoFenretinide (ST-001), which is currently being evaluated in clinical trials for T-cell Non-Hodgkin Lymphoma (T-cell NHL) across nine prestigious cancer centers.

"This has truly been a breakout year for SciTech," said Earle Holsapple, CEO of SciTech Development. "The oversubscription of our CNR 3 underscores the confidence investors place in our science, our market position, and the transformative potential of ST-001. We are deeply grateful to both new and returning investors for their belief in our mission and support as we advance into the next phase of our trials."

Recent Clinical Highlights

ST-001 has achieved an unprecedented 100% Disease Control Rate at the highest dose levels to date, with all patients demonstrating either stable disease, partial responses, or showing a clear trajectory toward complete responses.
Several patients have already experienced confirmed partial responses, marking a critical step on the path toward potential complete responses.
ST-001 nanoFenretinide has demonstrated efficacy in both early- and late-stage cancer patients, reinforcing its broad therapeutic potential.
Along with this documented clinical activity at therapeutic doses, the trial has confirmed ST-001 safety, validating the strength of the underlying science behind the drug.
Importantly, most patients report minimal side effects and have chosen to remain in the trial because of the positive impact on their health and quality of life.
"Our new and returning investors are motivated by the exceptional interim trial results we’ve delivered and the proven strength of our team," said Andrew Stumpf, CFO of SciTech Development. "This investment enables us to continue to advance clinical development in both T-cell NHL and Small Cell Lung Cancer, while building a strong foundation for our future pipeline."