On March 9, 2026 AN2 Therapeutics, Inc. (Nasdaq: ANTX), a clinical-stage biopharmaceutical company developing novel small molecule therapeutics derived from its boron chemistry platform, reported that it has entered into a securities purchase agreement for a private placement that is expected to result in gross proceeds of approximately $40 million, before deducting placement agent fees and other expenses. The private placement includes participation from Coastlands Capital, Commodore Capital, Vivo Capital and other new and existing institutional investors.

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In the private placement, AN2 Therapeutics is selling 8,245,611 shares of common stock at a price of $2.85 per share and, in lieu of common stock to investors who so choose, pre-funded warrants to purchase up to 5,789,493 shares of common stock at a price of $2.84999 per pre-funded warrant. Each pre-funded warrant will have an exercise price of $0.00001 per share of common stock, will be exercisable immediately and will be exercisable until exercised in full, subject to ownership limitations. The private placement is expected to close on March 10, 2026, subject to the satisfaction of customary closing conditions. The private placement is being conducted in accordance with applicable Nasdaq rules and was priced to satisfy the "Minimum Price" requirement (as defined in the Nasdaq rules).

Leerink Partners is acting as exclusive placement agent for the private placement.

The securities sold in this private placement have not been registered under the Securities Act of 1933, as amended, or applicable state securities laws, and may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. AN2 Therapeutics has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock to be issued in the private placement and the shares of common stock issuable upon exercise of the pre-funded warrants to be issued in the private placement.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities described herein, 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 the registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, AN2 Therapeutics, MAR 9, 2026, View Source [SID1234663349])

On March 9, 2026 Relmada Therapeutics, Inc. (Nasdaq: RLMD, "Relmada" or the "Company"), a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system disorders, reported 12-month interim data from its ongoing Phase 2 trial evaluating NDV-01 in patients with high-risk non-muscle invasive bladder cancer (NMIBC).

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The Phase 2 trial of NDV-01 demonstrated a 12-month complete response (CR) rate of 76% with a favorable safety profile. Notably, a 12-month CR rate of 80% was achieved in the BCG-unresponsive population, one of the most difficult-to-treat segments of NMIBC. Taken together, these findings support the potential best-in-class profile of NDV-01 and support advancement into the Phase 3 RESCUE registrational program evaluating NDV-01 in both 2L BCG-unresponsive and adjuvant intermediate-risk NMIBC.

"These 12-month data show the potential durability of NDV-01’s clinical response profile while continuing to demonstrate a clean safety profile," said Raj S. Pruthi, MD, Chief Medical Officer-Oncology of Relmada Therapeutics. "Importantly, we continue to observe strong responses in patients with BCG-unresponsive disease, with no progression to muscle-invasive disease and no patients requiring radical cystectomy. We believe these interim results provide meaningful clinical validation of the program and support advancing NDV-01 into the registrational Phase 3 RESCUE program with two separate registrational pathways: 2L BCG-unresponsive and adjuvant intermediate-risk, which we expect to initiate in mid-2026."

"I am highly encouraged by NDV-01’s high response rates, 12-month durability and favorable tolerability profile. Building on the clinical community’s familiarity with conventional Gem/Doce, these Phase 2 results provide robust validation of NDV-01’s novel sustained release formulation. In addition, NDV-01’s less than 5-minute administration simplifies dosing for clinical staff, supporting broad adoption in community urology practices where ~80% of NMIBC patients are treated – and potentially offering a significantly more streamlined user experience than currently approved therapies," said Max Kates, MD, Director of Urologic Oncology at Johns Hopkins and Relmada Clinical Advisor.

Highlights of the 12-month follow-up data from the Ongoing Phase 2 study of NDV-01:

Clinical Results (Response Data)
Complete Response
Anytime 95% (36/38)
3 month 87% (33/38)
6 month 86% (25/29)
9 month 85% (22/26)
12 month 76% (19/25)
12-month KM analysis 83%
N=48 patients dosed in overall population; KM: Kaplan-Meier analysis

Efficacy in BCG-Unresponsive Subpopulation**:

Clinical Results (Response Data)
Complete Response
Anytime 94% (16/17)
3 month 82% (14/17)
6 month 86% (12/14)
9 month 91% (10/11)
12 month 80% (8/10)
12-month KM analysis 84%
N=20 patients dosed in BCG-UR subpopulation; ** BCG-UR defined by FDA definition; BCG-UR: Bacillus Calmette-Guérin (BCG) – Unresponsive; KM: Kaplan-Meier analysis
No patient had progression to muscle-invasive disease
No patient underwent a radical cystectomy
No patients had a ≥ Grade 3 treatment related adverse event (TRAE)
No patients discontinued treatment due to AEs
Of the 48 patients who received ≥ 1 dose, 30 (63%) experienced a treatment-related adverse event (AE).
Among treatment-related AEs,
54% were transient uncomfortable urination (dysuria, <24 hours, Grade 1)
8% had an asymptomatic positive urine culture
8% had hematuria
Phase 3 RESCUE Registrational Pathways:

Registrational Pathway 1 – An open label randomized controlled trial in intermediate-risk NMIBC of adjuvant therapy following TURBT (NDV-01 vs. observation). There are no approved treatments for adjuvant intermediate risk NMIBC, which we estimate affects ~75,000 patients/year in the US.

Primary endpoint: Disease Free Survival (DFS)
Key secondary endpoints: High-grade recurrence free survival (HG-RFS), progression free survival (PFS), quality of life (QOL) metrics
Registration Pathway 2 – A single-arm trial in second line (2L) BCG-unresponsive NMIBC with carcinoma in situ (CIS) patients who are currently refractory to approved or developmental therapies. Patients with BCG-unresponsive NMIBC with CIS who fail first line (1L) therapies, which we estimate to affect ~5,000 patients/year in the US, have few, if any, effective treatment alternatives to radical cystectomy.

Primary endpoint: Complete response (CR) rate at any time
Key secondary endpoint: Duration of response (DOR), progression free survival (PFS), recurrence free survival (RFS) amongst responders
Expected Upcoming NDV-01 Milestones:

NDV-01 United States IND clearance – Mid-2026
Phase 3 RESCUE Program Initiation – Mid-2026
Initial 3-month results from Phase 3 2L BCG-unresponsive study expected by YE 2026
About NDV-01

NDV-01 is a sustained-release, intravesical formulation of gemcitabine and docetaxel (Gem/Doce), in development for the treatment of non-muscle invasive bladder cancer. It is designed to enable Gem/Doce bladder retention and gradual drug release over 10 days. The formulation creates a soft matrix that enhances local exposure while minimizing systemic toxicity. The NDV-01 formulation is ready to use, convenient to administer in-office in approximately 5 minutes and does not require anesthesia or specialized equipment. It is protected by patents through 2038.

About the Phase 2 Study

The Phase 2 study (NCT06663137) is an open-label, single-arm, single-center study evaluating the safety and efficacy of NDV-01 in patients with HG-NMIBC. Patients are treated with NDV-01 in a biweekly induction phase, followed by monthly maintenance for up to one year, with regular assessments via cystoscopy, cytology, and biopsy, as indicated. The primary efficacy endpoints are safety and complete response rate (CRR) at 12 months, and secondary efficacy endpoints are duration of response (DOR) and event free survival (EFS).

About NMIBC

NMIBC represents 75-80% of all bladder cancer cases and is associated with high recurrence (50 – 80% over 5 years). With over 744,000 prevalent cases in the U.S. and limited treatment options, the market opportunity is significant. High-grade BCG-unresponsive disease represents one of the most difficult-to-treat NMIBC subtypes, with limited bladder-sparing options. Intermediate-risk NMIBC in the adjuvant setting has no currently approved therapies. NDV-01 has the potential to serve as a frontline or salvage therapy and could be applicable across multiple NMIBC subtypes.

(Press release, Relmada Therapeutics, MAR 9, 2026, View Source [SID1234663371])

On March 9, 2026 Actuate Therapeutics, Inc. (NASDAQ: ACTU) ("Actuate" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers through the inhibition of glycogen synthase kinase-3 beta (GSK-3β), reported the launch of an expanded research initiative evaluating combinations of its clinical-stage GSK-3β inhibitor elraglusib with emerging RAS-targeted therapies.

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Despite recent advances in RAS-targeted therapies, adaptive resistance mechanisms and pathway reactivation remain some of the key barriers to achieving durable responses in patients (Dilly et al., Cancer Discov 2024).

Based on the mechanisms of action, GSK-3 inhibition may represent a critical complementary strategy capable of enhancing RAS-targeted therapies by suppressing downstream survival signaling and resistance pathways, including

NF-κB–mediated survival signaling
MYC-driven transcriptional programs
metabolic adaptation and oxidative stress buffering
tumor microenvironment immune suppression
In addition, RAS-mutant tumors — particularly pancreatic cancer — are widely considered immunologically resistant. Preclinical research suggests that GSK-3β inhibition may enhance antigen presentation, activate T cells and NK cells, and reduce exhausted T-cells. By simultaneously targeting tumor intrinsic survival pathways and modulating the tumor immune microenvironment, the combination of elraglusib and RAS inhibitors has the potential to create a multi-modal therapeutic strategy designed to overcome resistance and expand clinical benefit in RAS-driven cancers.

Expanding the Strategic Opportunity for Elraglusib

Elraglusib is a best-in-class, highly selective GSK-3β inhibitor with broad potential across multiple oncology indications, including pancreatic cancer, melanoma, colorectal cancer, and sarcoma. The investigational product has been administered to more than 500 patients and is currently being evaluated in a Phase 2 trial in metastatic pancreatic cancer (mPDAC).

The combination strategy is designed to simultaneously block proliferative signaling through RAS inhibition and disrupt tumor survival pathways via elraglusib’s GSK-3β inhibition, potentially enhancing apoptotic signaling beyond the threshold achieved with RAS inhibition alone.

The combination program is expected to include in-vitro studies of elraglusib with select RAS inhibitors using tumor models of RAS resistance, in-vivo tumor regression and survival studies, and translational biomarker analysis. Initial data from the program are expected in Q2 2026, with additional results in 2H26.

While next-generation RAS inhibitors are making meaningful progress, the emerging data suggest that combination strategies will be required to maximize clinical benefit (Long et al., Cancer Res 2026). By targeting GSK-3 – a central regulator of tumor survival – the Company believes that elraglusib has the potential to enhance depth and durability of RAS-targeted therapies. Actuate is advancing this work with leading academic collaborators and potential industry partners, further positioning elraglusib as a potential foundational component of next-generation treatment paradigms for RAS-driven cancers.

(Press release, Actuate Therapeutics, MAR 9, 2026, View Source [SID1234663390])

On March 6, 2026 Servier, an independent international pharmaceutical group governed by a foundation, and Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) ("Day One"), a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, reported that they have entered into a definitive agreement for Servier to acquire Day One for $21.50 per share in cash, representing a total equity value of approximately $2.5 billion. The transaction remains subject to customary closing conditions and is expected to close in the second quarter of 2026.

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This acquisition will reinforce Servier’s position in oncology targeted therapies in line with its 2030 ambition to develop innovative treatments for patients with high unmet medical needs. It strengthens Servier’s portfolio and expands its oncology pipeline with programs ranging from early stage to phase 3. The combination of Day One’s scientific expertise with Servier’s established global capabilities advances a shared commitment to delivering innovative solutions for patients worldwide.

"This acquisition of Day One Biopharmaceuticals marks another decisive step in strengthening Servier’s position in rare oncology," said Olivier Laureau, President of Servier. "It reflects our long-term commitment to investing in science that can make a meaningful difference for patients. This announcement is fully aligned with our 2030 ambition, and we believe that combining our expertise will accelerate innovation for people living with a rare cancer."

"Servier’s successful track record in rare cancers and its commitment to advancing targeted therapies makes it the ideal home for our portfolio as part of Day One’s mission to bring medicines to patients of all ages with life threatening diseases" said Jeremy Bender, Ph.D., chief executive officer of Day One. "Joining Servier represents a unique opportunity to extend the reach of our science and our lead program in pediatric low-grade glioma. Importantly, Servier’s dedication to the rare disease community preserves the patient-first mindset that has defined our company since the beginning and has driven our deep commitment to the communities we serve."

Transaction terms

Under the terms of the merger agreement, Servier will commence a cash tender offer to acquire all of the issued and outstanding shares of Day One’s common stock for $21.50 per share in cash, representing a total equity value of approximately of $2.5 billion. The offer price represents a premium of approximately 68% over the closing price of Day One on March 5, 2026, and a premium of approximately 86% over the one-month volume weighted average price (VWAP) of Day One as of March 5, 2026.

Servier expects to fund the transaction through existing cash and investments.

The consummation of the tender offer is subject to certain customary closing conditions, including the tender by Day One shareholders of at least a majority of the issued and outstanding shares of Day One common stock and the receipt of U.S. antitrust clearance. Upon the successful completion of the tender offer, Servier will acquire any shares not acquired in the tender through a second-step merger for the same consideration per share paid in the tender offer. Day One’s Board of Directors recommends that Day One shareholders tender their shares in the tender offer.

Advisors

Goldman Sachs Bank Europe SE is serving as exclusive financial advisor to Servier, and Baker McKenzie is serving as legal counsel. Centerview Partners LLC is serving as the exclusive financial advisor to Day One, with Fenwick & West LLP serving as legal counsel.

(Press release, Day One, MAR 6, 2026, View Source [SID1234663331])

On March 6, 2026 Immuneering Corporation (Nasdaq: IMRX), a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive, reported financial results for the fourth quarter and full year ended December 31, 2025, and provided business updates.

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"2025 was a transformative year for Immuneering. We reported 64% overall survival at 12 months in first-line pancreatic cancer patients treated with atebimetinib + mGnP, well above the benchmark for GnP standard of care. We designed atebimetinib with three mechanisms well-established to improve survival, and we believe these survival gains are driven by atebimetinib shrinking tumors durably with less resistance, preserving body mass by countering cachexia, and minimizing side effects to maximize combinability and performance status," said Ben Zeskind, Ph.D., Chief Executive Officer of Immuneering. "We also made rapid progress in preparation for our pivotal Phase 3 trial in first-line pancreatic cancer patients, MAPKeeper 301, having secured alignment with both the FDA and EMA on our trial design, and we are on track to dose the first patient mid-year. With cash runway expected into 2029, uniquely encouraging clinical data, and a solid pipeline, we are strongly positioned to deliver on our mission to help patients live longer and feel better."

Recent Corporate Highlights

Reported 64% Overall Survival at 12 Months in First-Line Pancreatic Cancer Patients Treated with Atebimetinib + mGnP: In January, the Company announced positive updated survival and safety data from its ongoing Phase 2a trial of atebimetinib in combination with mGnP in first-line pancreatic cancer patients (N=34), with 13.4 months median follow up. Immuneering reported 64% overall survival (OS) observed at 12 months as of the December 15, 2025 data cutoff date. Atebimetinib (320mg dosed once daily) + mGnP was observed to demonstrate a favorable tolerability profile, with only two categories of adverse events observed at or above the grade 3 level in more than 10% of patients (neutropenia and anemia, both of which are categories commonly observed with standard of care chemotherapy), in comparison to toxicity profiles for other combinations in the front line pancreatic cancer setting, which demonstrate significantly more grade 3 and higher adverse events. No head-to-head clinical trial has been conducted evaluating atebimetinib and other candidates or products. Differences exist between trial designs, subject characteristics and other factors, and caution should be exercised when comparing data across studies.
Secured Alignment with FDA and EMA on pivotal Phase 3 Atebimetinib Trial for First-Line Metastatic Pancreatic Cancer Patients: In December, Immuneering announced that it expected to dose the first patient in its planned global pivotal Phase 3 registrational trial, MAPKeeper 301, in first-line pancreatic cancer patients in mid-2026, evaluating atebimetinib (320 mg QD) in combination with modified gemcitabine and nab-paclitaxel (mGnP), compared with gemcitabine and nab-paclitaxel (GnP) alone. The Company remains on track with this guidance. Notably, the Company completed its End-of-Phase 2 (EOP2) interactions with the U.S. Food and Drug Administration (FDA) and received scientific advice from the European Medicines Agency (EMA). Immuneering achieved alignment with both agencies on the key elements of the proposed Phase 3 trial.
Added to the Nasdaq Biotechnology Index (NBI): On December 22, 2025, Immuneering was added to the Nasdaq Biotechnology Index.

Anticipated Near-Term Milestones

Immuneering is planning for several near-term anticipated milestones related to atebimetinib, including:

Q2 2026: Report updated circulating tumor DNA data on acquired alterations at a major scientific meeting.
1H 2026: Report updated survival data from over 50 first-line pancreatic cancer patients treated with atebimetinib + mGnP.
Mid-2026: Dose first patient in pivotal Phase 3 MAPKeeper clinical trial of atebimetinib + mGnP in first-line pancreatic cancer.
2H 2026: Dose first patient in trial of atebimetinib + Libtayo in RAS-mutant first-line non-small cell lung cancer.

Fourth Quarter and Full Year 2025 Financial Highlights

Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2025 were $217.0 million, compared with $36.1 million as of December 31, 2024.
Research and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2025 were $9.3 million compared to $14.9 million for the fourth quarter of 2024. Full year 2025 R&D expenses were $42.0 million compared to $48.0 million for full year 2024. R&D expenses for the fourth quarter and full year 2025 decreased compared to the same respective periods in 2024, primarily driven by reduced spend related to the Company’s product candidate envometinib (IMM-6-415) and certain pre-clinical activities, in addition to decreased personnel related costs. This was partially offset by increased clinical and regulatory consulting resources utilized during the period to support atebimetinib’s ongoing development and regulatory readiness activities.
General and Administrative (G&A) Expenses: G&A expenses for the fourth quarter of 2025 were $4.5 million compared to $3.7 million for the fourth quarter of 2024. Full year 2025 G&A expenses were $17.3 million compared to $16.1 million for full year 2024. G&A expenses for the fourth quarter and full year 2025 increased compared to the same respective periods in 2024, primarily driven by increased employee-related costs and external professional fees, in addition to increased public filing costs associated with the Company’s various financing efforts.
Net Loss: Net loss attributable to common stockholders was $11.6 million, or $0.18 per share, for the quarter ended December 31, 2025, compared to $18.1 million, or $0.58 per share, for the quarter ended December 31, 2024. Net loss attributable to common stockholders for full year 2025 was $56.0 million, or $1.27 per share, compared to $61.0 million, or $2.04 per share, for full year 2024.

2026 Financial Guidance

Based on cash, cash equivalents and marketable securities as of December 31, 2025, and current operating plans, the Company expects its cash runway to be sufficient to fund operations into 2029.

About Atebimetinib

Atebimetinib is the first in a new category of oral drug candidates, Deep Cyclic Inhibitors (DCIs), designed to improve overall survival by three mechanisms: shrinking tumors durably with less resistance, preserving body mass by countering cachexia, and minimizing side effects to maximize performance status and combinability. Each of these mechanisms has been well established to improve survival in published studies. DCIs challenge the conventional model of sustained or continuous inhibition in oncology. Whereas most therapies are designed for sustained inhibition, driving cancer to adapt and develop resistance so tumors shrink quickly but temporarily, DCIs are designed to pulse faster than tumors can adapt, so tumors shrink slowly but durably. Moreover, DCIs aim to restore full transient signaling to healthy cells, with the goal of leading to fewer adverse events. Atebimetinib targets MEK, a key control point in the MAPK pathway (RAS-RAF-MEK-ERK), which is pathologically activated in a majority of cancers, including approximately 97% of pancreatic cancers. Targeting MEK blocks a broader range of MAPK pathway alterations because it is further downstream, creating the potential for more durable benefit.

(Press release, Immuneering, MAR 6, 2026, View Source [SID1234663332])