On November 12, 2026 BlossomHill Therapeutics, Inc. (Nasdaq: BLSM), a clinical-stage biopharmaceutical company applying an intentional, chemistry-based approach to design and develop innovative small molecule medicines for the treatment of cancer, reported financial results for the third quarter 2026 and highlighted recent progress.

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"We are pleased to have aligned with the FDA on a recommended Phase 2 dose of 50 mg BID based on favorable PK, safety and efficacy data in the Phase 1 portion of the SOLARA trial. We are now preparing to initiate SOLARA-2, a single arm, pivotal Phase 2 trial designed to evaluate BH-30643 in both chemotherapy-naive and chemotherapy-pretreated patients with C797S-positive NSCLC after progression on a third-generation EGFR TKI," said J. Jean Cui, Ph.D., Founder, President and Chief Executive Officer of BlossomHill Therapeutics. "In parallel, we continue to advance the development of novel, small molecule medicines in our portfolio. We recently presented preclinical data on BH-501284, our novel, pseudo-irreversible, Switch-II pan-KRAS inhibitor, that demonstrated sustained KRAS pathway suppression and deep and durable antitumor activity across multiple KRAS-mutant tumor models. An IND filing is planned for the first quarter next year. We also plan to present translational data with clinical validation of BH-30236’s mechanism of action at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December, reinforcing our belief in its potential to address a significant unmet need in patients with myeloid malignancies."

Recent Business Highlights and Corporate Updates:

Alignment with the FDA on 50 mg twice daily as the recommended Phase 2 dose based on favorable pharmacokinetic (PK), safety and efficacy data from the SOLARA Phase 1 trial
Announced SOLARA-2, the single-arm Phase 2 portion of the SOLARA trial, in patients with EGFR C797S-positive NSCLC to potentially support an accelerated approval application
Collaboration with Foundation Medicine to develop a companion diagnostic assay (CDx) for the EGFR C797S resistance mutation
Preclinical data on BH-501284, a novel, orally bioavailable, non-covalent, pseudo-irreversible pan-KRAS inhibitor designed to overcome limitations of current KRAS-targeted therapies, presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Conference on Pancreatic Cancer: New Frontiers in Biology and Therapeutic Development
Abstract highlighting the upcoming presentation of translational data providing further clinical validation of BH-30236’s mechanism of action at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December

Anticipated Upcoming Milestones:
BH-30643

Q1 2027: First patient dosed in pivotal SOLARA-2 trial
1H 2027: Updated Phase 1 data, including C797S durability
2H 2027: Phase 1 data on TKI-naive durability and initial chemo combo cohort data

BH-501284

Q1 2027: Investigational new drug application (IND) submission

BH-30236

1H 2027: Updated Phase 1 data on safety and anti-leukemic effect

Third Quarter 2026 Financial Results

Research and development (R&D) expenses for the third quarter of 2026 were $21.9 million, compared with $14.7 million for the same period in 2025. The increase of $7.3 million was primarily due to greater clinical development expenses related to BH-30643, increased personnel-related expenses driven by R&D headcount growth, and greater expenses related to IND-enabling work for BH-501284.

General and administrative (G&A) expenses for the third quarter of 2026 were $3.6 million, compared with $2.1 million for the same period in 2025. The increase of $1.5 million was primarily due to increased personnel-related expenses, greater general overhead and outside services expenses, and an increase in legal expenses.

Net loss for the third quarter of 2026 was $24.0 million, or ($1.29) per basic and diluted share, compared with $16.0 million, or ($6.54) per basic and diluted share for the same period in 2025. The increase in net loss was primarily attributable to increased operating expenses, partially offset by an increase in other income.

Cash and cash equivalents totaled $224.9 million as of September 30, 2026. BlossomHill completed its IPO in August 2026 in which it sold 10,516,240 shares of its common stock, including partial exercise of the over-allotment option, for gross proceeds of $168.3 million. BlossomHill believes that its cash and cash equivalents as of September 30, 2026, will be sufficient to fund its operations into the second quarter of 2028.

About BH-30643
BH-30643 is an investigational, novel, orally bioavailable, non-covalent, macrocyclic, brain active, mutant-selective, OMNI-EGFR inhibitor for the treatment of EGFR-mutant NSCLC. BH-30643 was designed to overcome the limitations of currently approved EGFR inhibitors, which were discovered over a decade ago without the current, modern understanding of the structure and protein dynamics of mutant EGFRs. In preclinical studies, BH-30643 demonstrated potent inhibitory activity across diverse EGFR mutation categories — classical mutations, on-target resistance mutations such as C797S with or without T790M, atypical mutations and exon 20 insertions — while maintaining marked selectivity over wild-type EGFR. BH-30643 has received Fast Track designation and is being evaluated in SOLARA, a global Phase 1/2, first-in-human clinical trial with ongoing Phase 1 dose expansion cohorts enrolling in both TKI-pretreated and TKI-naive settings, including a C797S resistance cohort. SOLARA-2, a global Phase 2 pivotal study in C797S-Positive NSCLC is scheduled to dose the first patient in the first quarter of 2027. For additional information on SOLARA, including a list of study sites and how to enroll, please visit clinicaltrials.gov (NCT06706076).

About BH-30236
BH-30236 is an investigational orally bioavailable, macrocyclic inhibitor of the CDC-like kinase (CLK) family. BH-30236 was intentionally designed to potently inhibit CLK, leading to modulation of aberrant alternative splicing in cancerous tissue, targeting the same aberrant splicing machinery that drives relapsed or refractory (R/R) acute myeloid leukemia (AML) and higher-risk myelodysplastic syndromes (HR-MDS) disease biology and that cancer cells exploit to develop resistance to venetoclax, FLT3 inhibitors and cytarabine. BH-30236 is being evaluated in a Phase 1/1b multicenter, open-label, first-in-human dose escalation and expansion trial in adults with R/R AML and HR-MDS. The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to BH-30236 for the treatment of AML. For additional information on this trial, including a list of study sites and how to enroll, please visit clinicaltrials.gov (NCT06501196).

About BH-501284
BH-501284 is an investigational, orally bioavailable, pan-KRAS inhibitor, which utilizes a novel Switch-II chemical scaffold to achieve prolonged, potent and selective inhibition of KRAS mutations. We believe this molecule, which uses a non-covalent scaffold, is unique in its potential to achieve tight and durable binding, a feature described as "pseudo-irreversible" binding. In preclinical studies, BH-501284 demonstrated sustained blocking of KRAS signaling leading to deeper and more durable antitumor activities in KRAS mutant cells and tumor models at low dose levels.

(Press release, BlossomHill Therapeutics, NOV 12, 2026, View Source [SID1234674722])

On November 12, 2026 Electra Therapeutics, Inc. (Nasdaq: ETRA), a late clinical-stage biopharmaceutical company focused on pioneering a new class of precision medicines for the treatment of immune-mediated diseases and cancer, reported financial results for the third quarter ended September 30, 2026 and provided an overview of its portfolio and recent business highlights.

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"Our recent IPO positions Electra to build on our first-mover advantage in SIRP-targeted precision immune cell depletion," said Kathy Dong, PharmD, MBA, President and Chief Executive Officer of Electra Therapeutics. "Our deep expertise in SIRP biology and proprietary library of SIRP-targeting antibodies enable us to selectively address distinct pathogenic immune cell populations, creating therapeutic optionality across immune-mediated diseases and cancer. Building on compelling clinical data in sHLH, we are advancing ipsoprubart through a global registrational program and evaluating its potential in T/NK cell malignancies. With ELA822 now in Phase 1, we are advancing multiple programs with the potential to benefit patients and create value for our stakeholders. We anticipate several important milestones in 2027, including ELA822 healthy volunteer data expected in the first half of the year, followed by ipsoprubart data in T/NK cell malignancies and completion of enrollment in the sHLH registrational program in the second half."

Electra’s novel approach targets signal regulatory proteins (SIRP), a family of cell surface receptors whose expression increases upon activation in specific immune cell populations. This approach is designed to selectively deplete disease-driving immune cells while preserving normal immune function. By offering a more targeted alternative to broad immunosuppression, this approach has the potential to bring greater precision to the treatment for immune-mediated diseases, much as precision oncology has transformed cancer care.

Portfolio Overview

Ipsoprubart Global Registrational Development for sHLH: The company’s lead product candidate, ipsoprubart, is a novel pan-SIRP monoclonal antibody in development for secondary hemophagocytic lymphohistiocytosis (sHLH), designed to selectively deplete the pathogenic SIRPα/b1-positive myeloid cells and SIRPg-positive T cells characteristic of sHLH.
In a Phase 1b trial, ipsoprubart was generally well tolerated and demonstrated 100% overall survival at eight weeks and a 100% overall response rate at the week four assessment in 12 frontline patients with malignancy-associated HLH, the largest subset of sHLH and the population with the poorest outcomes.
The company’s global registrational program comprises SURPASS, a Phase 2/3 trial in newly diagnosed, treatment-naïve sHLH patients, and COMPASS, a retrospective natural history study designed to provide an external control comparator, with enrollment completion expected in the second half of 2027.

ASH Abstract Acceptances: Two abstracts, including an analysis of healthcare claims data and preclinical data on SIRPα/β1/γ expression in pathogenic immune cells, have been accepted for poster presentations at the 2026 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (ASH) (Free ASH Whitepaper) on December 13, 2026, from 6:00–8:00 p.m. CT. Presentation details are as follows:
Title: Increasing burden of secondary hemophagocytic lymphohistiocytosis in the United States: A national-claims analysis of associated conditions, treatments, and care patterns, 2016-2025
Abstract number: 4454
Session: 905. Outcomes Research: Non-Malignant Conditions Excluding Hemoglobinopathies: Poster II
Title: SIRPα/β1/γ expression is enriched on pathogenic immune cell populations in adults with secondary hemophagocytic lymphohistiocytosis
Abstract number: 2965
Session: 201. Granulocytes, Monocytes, and Macrophages: Poster II

Ipsoprubart for T Cell Malignancies: Ipsoprubart is also being evaluated as single-agent therapy in patients with relapsed/refractory T/NK cell malignancies.
Among eight sHLH patients with underlying T- or B-cell lymphomas and available objective tumor response assessments across the Phase 1b trial and Expanded Access Program, all eight patients had an objective tumor response and seven had complete responses.
Based on this anti-tumor activity, the company is conducting an ongoing Phase 1 trial in patients with relapsed/refractory T/NK malignancies, with initial data expected in the second half of 2027.

ELA822 for Chronic Immune and Inflammatory Diseases: ELA822 is a novel SIRPγ-specific antibody in development for chronic T cell-mediated immune and inflammatory diseases, designed to selectively deplete activated, pathogenic T cells while sparing naïve and regulatory T cells.
In nonclinical models of giant cell arteritis and graft-versus-host disease, ELA822 reduced cytotoxic T cell infiltration into tissues and inflammatory cytokine production, with improvements in disease activity and survival.
In September 2026, Electra initiated a randomized, placebo-controlled Phase 1 trial of ELA822 in healthy volunteers, with data expected in the first half of 2027. The company plans to initiate a first-in-disease trial in patients with T cell-mediated immune disorders in mid-2027, subject to regulatory approval.

Third Quarter 2026 Financial Results

Cash Position: Cash, cash equivalents, and marketable securities totaled $402.5 million as of September 30, 2026, including $320.0 million in net proceeds from the company’s September 2026 IPO, after deducting underwriting discounts, commissions and other offering expenses paid or payable. Electra expects its current cash position to support planned operations into 2029.
R&D Expenses: Research and development (R&D) expenses were $17.3 million for the third quarter of 2026.
G&A Expenses: General and administrative (G&A) expenses were $7.8 million for the third quarter of 2026.
Net Loss: Net loss totaled $23.9 million for the third quarter of 2026.

(Press release, Electra Therapeutics, NOV 12, 2026, View Source [SID1234674721])

On November 12, 2026 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, reported that senior leadership plans to present at the following upcoming conference:

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2026 Jefferies Global Healthcare Conference in London
Fireside Chat: November 16, 2026, at 11:00 a.m. GMT / 6:00 a.m. EST
London, UK
The live and archived webcast will be available at View Source

(Press release, Iovance Biotherapeutics, NOV 12, 2026, View Source [SID1234674720])

On November 12, 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 financial results for the third quarter ended September 30, 2026, and provided a business update, including 18-month results from the NDV-01 Phase 2 study, the registrational Phase 3 SPECTRUM program, and continued progress toward the planned year-end 2026 Investigational New Drug (IND) submission for NDV-01 and sepranolone.

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"Relmada has made significant progress in advancing the NDV-01 CMC program and remains on track to submit the NDV-01 IND by year-end 2026. Furthermore, we have established a manufacturing plan to provide uninterrupted clinical supply through the completion of the Phase 3 SPECTRUM program," said Sergio Traversa, Chief Executive Officer of Relmada Therapeutics.

"Initial 18-month results from the ongoing NDV-01 Phase 2 study demonstrate extended durability of complete response and continued favorable tolerability," added Bipin Dalmia, Chief Business Officer of Relmada Therapeutics. "Our Phase 3 program remains unchanged, with two independent registrational pathways in NMIBC, and we have renamed it SPECTRUM to reflect the potential breadth of NDV-01 across the NMIBC disease spectrum. We expect to begin the SPECTRUM program upon IND clearance."

CMC and Manufacturing Update

NDV-01: NDV-01 CMC program is on track for IND submission by year-end 2026, with initiation of the registrational Phase 3 SPECTRUM program upon IND clearance. Furthermore, we have established a manufacturing plan to provide uninterrupted clinical supply through completion of the Phase 3 SPECTRUM program.

Sepranolone: The Company is finalizing the stability testing of the pre-filled syringe (PFS) delivery system to enable sepranolone IND submission, which is on track for year-end 2026. We expect to start the Phase 2b trial in Prader-Willi Syndrome upon IND clearance.

NDV-01 Clinical Update

Phase 2 Study: Initial 18-month results from the ongoing Phase 2 TRGC-011 study of NDV-01 in high-risk NMIBC continue to support extended durability of NDV-01 complete responses and continued favorable tolerability profile.

Initial 18-month durability results: 23 patients in complete response (CR) at 12 months continued into the long-term extension (LTE). 86% (12/14) of evaluable patients who reached 18 months remained in CR. In the BCG-unresponsive subgroup, 11 patients continued into the LTE, and 88% (7/8) of evaluable patients who reached 18 months remained in CR. Two BCG-naïve patients (T1 at study entry) progressed to muscle-invasive disease (T2a) at the Month 15 assessment.
Updated 12-month efficacy results: Among 51 evaluable patients, the anytime CR rate was 94% (48/51) and the 12-month CR rate was 77% (24/31). In the BCG-unresponsive subgroup, the anytime CR rate was 96% (22/23) and 12-month CR rate was 73% (11/15). Through 12-months, both progression-free and cystectomy-free survival was 100%.
Safety and tolerability: To date, there were no Grade ≥3 treatment-related adverse events (TRAEs), no treatment-related serious adverse events, and no treatment-related discontinuations.

Phase 3 SPECTRUM Program: The NDV-01 Phase 3 program remains unchanged and is designed to pursue two independent registrational pathways in NMIBC:

A single-arm study in second-line (2L) high-risk BCG-unresponsive carcinoma in situ (CIS) ± Ta/T1 (Cohort 2UC), together with a separate single-arm 2L high-risk BCG-unresponsive Ta/T1 w/o CIS exploratory cohort (Cohort 2UP).
A randomized study evaluating NDV-01 as adjuvant therapy following transurethral resection of bladder tumor (TURBT) versus observation in low-grade intermediate-risk NMIBC (Cohort IRA).

The Company has changed the name of its Phase 3 program from RESCUE to SPECTRUM to better reflect the potential breadth of NDV-01 across the entire NMIBC disease spectrum. Clinical trial sites are engaged and preparing to initiate patient enrollment upon IND clearance.

Anticipated Upcoming Milestones

NDV-01:

NDV-01 United States IND submission – By year-end 2026
NDV-01 Phase 3 SPECTRUM program initiation – Upon IND clearance

Sepranolone:

Sepranolone United States IND submission – By year-end 2026
Sepranolone Phase 2b initiation in Prader-Willi Syndrome – Upon IND clearance

Financial Results

Third Quarter 2026 Financial Results

Research and development expense for the three months ended September 30, 2026, totaled $9.2 million, compared to $4.0 million for the three months ended September 30, 2025, an increase of $5.2 million. The increase was primarily attributable to higher NDV-01 and sepranolone study preparation costs, increased manufacturing and drug storage costs and higher employee compensation, partially offset by lower stock-based compensation.
General and administrative expense for the three months ended September 30, 2026, totaled $3.9 million compared to $6.3 million for the three months ended September 30, 2025, a decrease of approximately $2.4 million. The decrease was primarily driven by lower stock-based compensation and lower stock appreciation rights expense, partially offset by higher employee compensation and consulting services.
Net cash used in operating activities for the three months ended September 30, 2026, totaled $12.6 million compared to $6.7 million for the three months ended September 30, 2025.
The net loss for the three months ended September 30, 2026, was $13.9 million, or $0.12 per basic and diluted share, compared with a net loss of $10.1 million, or $0.30 per basic and diluted share, for the three months ended September 30, 2025.
As of September 30, 2026, the Company’s cash, cash equivalents, and short-term investments totaled $202.1 million, compared to cash, cash equivalents, and short-term investments of approximately $93.0 million at December 31, 2025.
The Company’s current cash, cash equivalents, and short-term investments as of September 30, 2026, are expected to provide sufficient resources to fund Company operations through 2029, including completion of the two registrational cohorts of the NDV-01 Phase 3 SPECTRUM program.
The Company had 106,694,846 shares outstanding, as of November 10, 2026.

Nine Months Ended September 30, 2026 Financial Results

Research and development expense for the nine months ended September 30, 2026, totaled $25.7 million, compared to $18.8 million for the nine months ended September 30, 2025, an increase of $6.9 million. The increase was primarily attributable to increased manufacturing and drug storage costs, higher employee compensation and higher stock appreciation rights expense, partially offset by lower study costs and lower stock-based compensation.
General and administrative expense for the nine months ended September 30, 2026, totaled $21.9 million compared to $20.0 million for the nine months ended September 30, 2025, an increase of approximately $1.9 million. The increase was primarily driven by higher employee compensation, stock appreciation rights expense and consulting services, partially offset by lower stock-based compensation.
Net cash used in operating activities for the nine months ended September 30, 2026, totaled $37.3 million compared to $31.2 million for the nine months ended September 30, 2025.
The net loss for the nine months ended September 30, 2026, was $45.8 million, or $0.44 per basic and diluted share, compared with a net loss of $37.5 million, or $1.16 per basic and diluted share, for the nine months ended September 30, 2025.

Conference Call and Webcast Information

Relmada will host a conference call and webcast today at 4:30 PM ET to discuss recent business progress and financial results.

Date: Thursday, November 12, 2026 at 4:30 PM ET
Participant Dial-in (US): 1-800-717-1738
Participant Dial-in (International): 1-646-307-1865
Webcast Access: Click Here

A replay of the webcast will be available in the Investors section of the Relmada website at View Source

About NDV-01

NDV-01 is a novel, sustained-release, intravesical co-formulation of gemcitabine and docetaxel (Gem/Doce) being developed for the treatment of non-muscle invasive bladder cancer (NMIBC). The formulation is engineered to provide prolonged bladder retention and sustained drug release for up to 10 days. By forming a soft intravesical matrix, NDV-01 is designed to increase local drug exposure while limiting systemic toxicity. The treatment can be administered conveniently in an office setting in under 5 minutes without the need for anesthesia or specialized equipment. NDV-01 is encompassed by multiple patent applications that if issued, could provide protection until 2047.

About the NDV-01 Phase 3 SPECTRUM Registrational Pathways:

Relmada has received written FDA feedback confirming alignment on two registrational pathways for NDV-01, including study design, patient populations, and primary endpoints. The Company expects to submit an IND by year-end 2026 and initiate the Phase 3 SPECTRUM program upon IND clearance.

About NMIBC

NMIBC represents 75-80% of all bladder cancer cases and is associated with high recurrence rates (50–80% over 5 years) and disease progression in a subset of these patients. With 63,000 incident NMIBC cases per year in the U.S. and limited treatment options, the market opportunity is significant. High-risk BCG-unresponsive disease represents the biggest unmet need in NMIBC, with limited and suboptimal bladder-sparing treatment options. While four therapies are FDA-approved for first line BCG-unresponsive disease, there are no approved therapies in the second line or later. Intermediate-risk NMIBC in the adjuvant setting has no currently approved therapies and patients with recurrence must undergo repeated surgical resections. NDV-01 has the potential to serve as a foundational intravesical therapy across the NMIBC disease spectrum.

About Sepranolone and GABA Modulation

Sepranolone, a synthetic isoallopregnanolone, selectively modulates GABAA receptors by antagonizing allopregnanolone (ALLO), without disrupting GABA signaling. It targets disorders linked to excess GABAergic activity such as Prader-Willi syndrome (PWS), Tourette syndrome, and obsessive-compulsive disorder (OCD). More than 335 patients have been treated with sepranolone in clinical trials to date, with a favorable safety profile. The Company is on track to submit the sepranolone IND by year-end 2026 and expects to initiate the Phase 2 study in Prader-Willi syndrome upon IND clearance.

About Prader-Willi Syndrome (PWS)

PWS is a rare genetic disorder caused by chromosomal deletions on chromosome 15, leading to neurodevelopmental and behavioral complications. Global prevalence is estimated to be 350,000-400,000 patients. Current treatments address symptoms but do not modify the underlying neurobehavioral pathology.

(Press release, Relmada Therapeutics, NOV 12, 2026, View Source [SID1234674719])

On November 12, 2026 Prime Medicine, Inc. (Nasdaq: PRME), a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies, reported the closing of its underwritten public offering of 41,071,428 shares of its common stock, which includes the full exercise of the underwriters’ option to purchase 5,357,142 additional shares of its common stock, at a public offering price of $3.50 per share. All of the shares of common stock in the offering were sold by Prime Medicine. The gross proceeds to Prime Medicine from the offering, before deducting underwriting discounts and commissions and offering expenses, were approximately $143.7 million.

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Jefferies, TD Cowen and Goldman Sachs & Co. LLC acted as joint book-running managers for the offering. Oppenheimer & Co. and LifeSci Capital acted as passive book-running managers for the offering.

The shares of common stock were offered by Prime Medicine pursuant to a shelf registration statement on Form S-3ASR (File No. 333-291348) filed with the U.S. Securities and Exchange Commission (SEC) on November 7, 2025, as amended by that certain Post-Effective Amendment No. 1 to Form S-3 (No. 333-291348) and that certain Post-Effective Amendment No. 2 to Form S-3 (No. 333-291348), each filed with the SEC on March 3, 2026, and declared effective by the SEC on March 4, 2026. The offering was made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement relating to and describing the terms of the offering was filed with the SEC and is available on the SEC’s website at www.sec.gov.

Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, New York 10022, by telephone at (877) 821-7388, or by email at [email protected]; TD Securities (USA) LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at [email protected] or Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, by telephone at (866) 471-2526, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, 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, Prime Medicine, NOV 12, 2026, View Source [SID1234674718])