On April 22, 2026 PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a hub-and-spoke biotherapeutics company dedicated to giving life to science and transforming innovation into value, reported positive topline data from the completed Phase 1b clinical trial of LYT-200, a first-in-class, fully human anti-galectin-9 monoclonal antibody, in heavily pretreated patients with relapsed/refractory (R/R) high-risk (HR) myelodysplastic syndrome (MDS) and R/R acute myeloid leukemia (AML). Based on the results, PureTech’s Founded Entity, Gallop Oncology, has selected a recommended Phase 2 dose (RP2D) and intends to engage with the U.S. Food and Drug Administration (FDA) to discuss the design of a subsequent trial that could potentially support registration of LYT-200 in R/R HR-MDS.

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"The data from the completed Phase 1b trial highlight the potential for LYT-200 to offer a differentiated treatment approach across a range of myeloid hematological malignancies," said Aleksandra Filipovic, M.D., Ph.D., Head of Oncology at PureTech and Chief Medical Officer of Gallop Oncology. "Across patients with R/R HR-MDS and R/R AML, treatment with LYT-200 resulted in deep responses with an exceptionally favorable safety profile. Importantly, the data in R/R HR-MDS were particularly compelling and support prioritizing this indication, especially given the significant unmet need and lack of successful innovation to help these patients. We intend to engage with the FDA to discuss the design of a subsequent trial in R/R HR-MDS, as our goal is to accelerate delivery of this promising first-in-class therapy to patients while also laying the foundation for broader clinical development, including in AML."

The completed Phase 1b trial (NCT05829226), conducted across nine U.S. sites, evaluated LYT-200 both as a monotherapy and in combination regimens in two heavily pretreated patient populations.

The study included dose escalation of monotherapy LYT-200, followed by dose escalation of LYT-200 in combination with a hypomethylating agent (HMA; azacitidine or decitabine) in patients with R/R HR-MDS and with venetoclax (VEN) and an HMA in R/R AML.

"The safety profile, combinatorial potential, and level of clinical activity observed with LYT-200 in this Phase 1b study across both R/R HR-MDS and R/R AML is very encouraging, particularly given the number of prior lines of treatment and the risk profile in the populations studied," said Amir T. Fathi, M.D., Program Director of the Center for Leukemia at the Mass General Brigham Cancer Institute and Professor of Medicine at Harvard Medical School. "In R/R high-risk MDS, where treatment options are extremely limited and outcomes are poor, the findings are particularly notable. In this context, the potential to achieve clinical responses without added toxicity would represent a meaningful advance in the MDS treatment landscape and warrants continued clinical development."

"The results from this Phase 1b trial provide a strong foundation for the next stage of development of LYT-200," said Eric Elenko, Ph.D., President and Co-founder of PureTech and Acting Chief Executive Officer of Gallop Oncology. "Our decision to prioritize relapsed/refractory high-risk MDS reflects a focused and disciplined approach, grounded in both the data generated to date and the potential to address a tremendous patient need. We intend to engage with the FDA to discuss a subsequent trial design with the potential to support registration, while continuing to evaluate the broader potential of LYT-200."

TOPLINE SAFETY DATA

LYT-200 demonstrated a favorable and consistent safety profile across all cohorts and dose levels studied (N=101), with no dose-limiting toxicities, infusion-related reactions, LYT-200 dose reductions, or LYT-200-related serious adverse events (AEs), discontinuations, or deaths. Importantly, no overlapping or additive toxicities were observed when LYT-200 was combined with an HMA or VEN/HMA.

Six patients at one study site reported experiencing hematology/chemistry-related Grade 3 or 4 AEs attributed as possibly related or related to LYT-200 in the combination arm at the RP2D dose. The reported AEs consisted of decreased levels of platelets, white blood cells, and neutrophils that were below the lower limit of normal physiological levels. The blood count deficits for some of the relevant patients were present at baseline prior to the administration of LYT-200 and are common occurrences in patients due to the underlying advanced MDS/AML, as well as in those receiving VEN/HMA treatment. No other sites reported Grade 3 or greater AEs related to LYT-200 treatment.

TOPLINE EFFICACY DATA

Treatment with LYT-200 in combination with an HMA in R/R HR-MDS patients and VEN/HMA in R/R AML patients demonstrated robust antileukemic activity, including complete responses, bridging to transplant, and durable clinical benefit. The data also provided important insights into the contribution of LYT-200 within combination regimens.

R/R HR-MDS

Across all efficacy-evaluable[1] patients (n=11), the recommended Phase 2 dose (LYT-200 12mg/kg in combination with an HMA) demonstrated:

· 27.3% complete response rate

· 9.1% partial response rate

· 9.1% marrow complete response rate

· 45.5% overall response rate

· 18% conversion to transplant rate

Due to the number of patients alive at the time of study completion (>50%), the upper bound of overall survival could not be calculated; therefore, the median overall survival for this cohort of 6.4 months is not considered fully mature.

Efficacy-evaluable patients had a median of 3 prior lines of therapy (range: 1-5), and all (100%) had previously been treated with an HMA. Additionally, all patients had high-risk cytogenetics, which – coupled with prior exposure to treatment – suggests biologically aggressive, treatment-refractory disease with elevated risk of progression and poor clinical outcomes. Taken together, these attributes underscore the potential mutation-agnostic mechanism of LYT-200 and its potential for broad clinical use.

R/R AML

Across all efficacy-evaluable1 patients (n=26), LYT-200 12mg/kg in combination with VEN/HMA demonstrated:

· 30.8% composite complete response rate[2]; responders included patients with mutations associated with VEN resistance

· 7.7% partial response rate

· 42.3% overall response rate

· 19.2% conversion to transplant rate

Due to the number of patients alive at the time of study completion (50%), the upper bound of overall survival could not be calculated; therefore, the median overall survival for this cohort of 8.2 months is not considered fully mature.

Efficacy-evaluable patients had a median of 2 prior lines of therapy (range: 1-9), and 84.6% had previously been treated with VEN/HMA.

INITIAL PHARMACODYNAMIC FINDINGS

The systemic effects of LYT-200 were evaluated through pharmacodynamic analyses of peripheral blood mononuclear cells, a population of immune cells in the bloodstream that provides insight into how a treatment affects both the immune system and leukemic blast cells. These analyses suggest that LYT-200 engages complementary and potentially synergistic pathways directed at cancer cell killing and anti-cancer immune responses when combined with VEN and HMA-based therapy, which may contribute to the clinical activity observed in patients with relapsed/refractory disease following HMA and VEN/HMA treatment, in MDS and AML, respectively.

About Myelodysplastic Syndromes

Myelodysplastic syndromes (MDS) are a group of serious blood cancers characterized by ineffective blood cell production in the bone marrow, leading to anemia, infections, and bleeding complications. [3], [4] MDS affects approximately 60,000-170,000 people in the United States, with an estimated 30-40% of patients diagnosed with the more aggressive form of the disease known as high-risk (HR) MDS.3, [5] HR-MDS is associated with poor outcomes, with median survival typically less than two years following diagnosis, and approximately 30% of patients progressing to acute myeloid leukemia (AML).

The current standard frontline treatment for HR-MDS are hypomethylating agents (HMAs), such as azacitidine and decitabine; however, most patients do not respond to these therapies or eventually stop benefiting from them.[7] Once the disease becomes relapsed or refractory (R/R), outcomes are especially poor, with survival often limited to only a few months.

Treatment options for patients with R/R HR-MDS remain very limited. Only one therapy has been approved specifically for this setting in the past two decades, and it targets only a small subset of patients (~3-5%) with a specific genetic mutation.7 As a result, there remains a significant need for new treatment approaches for patients with HR-MDS.

About Acute Myeloid Leukemia

Acute myeloid leukemia (AML) is an aggressive blood cancer characterized by the rapid growth of abnormal myeloid blast cells in the bone marrow and blood. It is the most common form of acute leukemia in adults, with a five-year survival rate of less than 30%.[9] Despite available therapies, many patients relapse or fail to respond, and outcomes are especially poor in the relapsed/refractory setting. Around 450,000 people globally are living with AML.9

AML is an area of urgent medical need where new therapies with improved safety, efficacy, and durability or responses are critical. Importantly, the incidence of AML is increasing, and the market is expected to grow to $6 billion annually by 2030,[10] underscoring the scale of the opportunity to bring forward therapies that are not only more effective but also applicable across a broader segment of patients.

About LYT-200

LYT-200 is a fully human IgG4 monoclonal antibody in development for the treatment of hematological malignancies. LYT-200 targets galectin-9, which is an important oncogenic driver and potent immunosuppressor in cancer, positioning it as a novel target for cancer therapy.[11] LYT-200 has been granted Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration (FDA) for the treatment of acute myeloid leukemia.

(Press release, PureTech Health, APR 22, 2026, View Source [SID1234664688])

On April 22, 2026 PharmaMar (MSE:PHM) a global leader in the research, development, and commercialization of marine-derived oncology therapies, reported it will be present at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), that will take place between May 29th and June 2nd in Chicago, U.S.A.

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The Company, along with its partners, will present two oral and four poster presentations reflecting data on advancing treatment approaches in difficult-to-treat cancers through late-stage clinical research, real-world evidence and ongoing pipeline innovation.

Analysis from the Phase 3 IMforte trial evaluating Zepzelca (lurbinectedin) plus atezolizumab (Tecentriq) as first-line maintenance treatment in extensive-stage small cell lung cancer (ES-SCLC) will be presented, including quality-adjusted time without symptoms or toxicity, as well as an oral presentation on outcomes across SCLC molecular subtypes.

Epidemiology of SCLC in Spain will be presented in the poster: Sex Specific Trends and Outcomes in Small Cell Lung Cancer: Insights From the Spanish CLARISSE Study (2019–2024) a retrospective study led by ICAPEM (Association for Research on Lung Cancer in Women) on more than 4,400 patients diagnosed with small cell lung cancer (SCLC) in the last six years.

The ASCO (Free ASCO Whitepaper) abstracts are available at: www.asco.org/annual-meeting/abstracts-presentations

Highlighted studies at ASCO (Free ASCO Whitepaper) 2026

PRODUCT TITLE LEAD AUTHOR ABSTRACT
Zepzelca (lurbinectedin) IMforte: Quality-adjusted time without symptoms or toxicity (Q-TWiST) analysis of first-line maintenance (1Lm) treatment (Tx) with lurbinectedin (lurbi) + atezolizumab (atezo) vs atezo in extensive-stage small cell lung cancer (ES-SCLC) Hossein Borghaei TYPE: Poster SESSION: Lung Cancer— Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers ABSTRACT: 8086 POSTER BOARD: 560 DATE: May 31, 9:00 AM-12:00 PM CDT
Transcriptomic analyses of molecular subsets and correlations with clinical outcomes from the Phase 3 IMforte study of lurbinectedin (lurbi) + atezolizumab (atezo) maintenance treatment (Tx) in extensive-stage small-cell lung cancer (ES-SCLC) Luis Paz-Ares TYPE: rapid oral SESSION: Lung Cancer— Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers ABSTRACT: 8014 DATE: May 31, 4:00 pm-6:00 PM CDT
Safety and pharmacokinetics (PK) of lurbinectedin (lurbi) in pediatric patients (pts) with relapsed/refractory (R/R) solid tumors and preliminary antitumor activity in pediatric and young adult pts with R/R Ewing sarcoma (EwS): Results from a phase 1 study Julia Lynne Glade Bender TYPE: rapid oral SESSION: Sarcoma ABSTRACT: 11518 DATE: May 31, 2026, 4:30PM PM- 6:00 PM CDT
Real-world (RW) effectiveness and safety of lurbinectedin (lurbi) for previously treated extensive-stage small cell lung cancer (ES-SCLC): Final primary and subgroup analysis results of Jazz EMERGE 402 Firas Badin TYPE: Poster SESSION: Lung Cancer— Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers ABSTRACT: 8079 POSTER BOARD: 553 DATE: May 31, 9:00 AM-12:00 PM CDT
Sex Specific Trends and Outcomes in Small Cell Lung Cancer: Insights From the Spanish CLARISSE Study (2019–2024) Pilar Garrido TYPE: Poster SESSION: Lung Cancer— Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers ABSTRACT: 8092 POSTER BOARD: 566 DATE: May 31, 9:00 AM-12:00 PM CDT
Comparison of real-world overall survival between atezolizumab- and durvalumab-containing first-line induction and maintenance regimens in extensive-stage small cell lung cancer. Apar Kishor Ganti TYPE: Poster SESSION: Lung Cancer— Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers ABSTRACT: 8093 POSTER BOARD: 567 DATE: May 31, 9:00 AM-12:00 PM CDT

(Press release, PharmaMar, APR 22, 2026, View Source [SID1234664687])

On April 22, 2026 Oxford Vacmedix (OVM), the UK biotech company developing novel immunotherapies to treat cancer, reported the successful completion of the Phase 1 trial of OVM-200. The primary endpoint for safety has been met as well as the secondary endpoints for immune response and dose selection. In addition, there are early observations of clinical efficacy in NSCLC and in prostate cancer.

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This Phase 1 clinical trial of OVM-200 is a multicentre, open‑label, first‑in‑human evaluation of OVM‑200, an immunotherapy developed using Oxford Vacmedix’s Recombinant Overlapping Peptide (ROP) therapeutic platform. 36 Patients with advanced NSCLC (non‑small cell lung cancer), ovarian cancer, or prostate cancer and with no HLA restrictions, were treated in the trial. The results show:

Excellent Safety Profile (primary endpoint): OVM‑200 is very well tolerated with no serious adverse drug reactions or no dose‑limiting toxicities. The only adverse effects were Grade 1 injection‑site reactions.
Very strong Immunogenicity (secondary endpoint): the immune response for both antibodies and for T cells were very strong even in an advanced Stage IV patient population. The immune responses data conclusively demonstrates the dual mode of action of the ROP technology.
Therapeutic Dose established (secondary endpoint) based on the immune response, the 2mg dose was chosen for Phase 1b with expanded immunisations of up to 11 doses of 2mg being used.
Early observations of clinical efficacy with stable disease in NSCLC and PSA response in prostate cancer.
Professor Shisong Jiang, founder and Chief Scientific Officer of Oxford Vacmedix, said:

We are delighted to be able to confirm these results for this Phase 1 trial of OVM-200 and with this first step toward providing accessible immunotherapy for all patient types. This progress has only been possible through the participation of the patients in the trial and the dedication of the staff in the clinics.

William Finch, Chief Executive Officer of Oxford Vacmedix, said:

This completion of the clinical trial of OVM-200 marks an important milestone for the company and shows the potential of the ROP technology. We are very pleased to have reached this significant inflection point and are already in discussion with Series B investors to fund Phase 2 trials for OVM-200.

(Press release, Oxford Vacmedix, APR 22, 2026, View Source;utm_medium=rss&utm_campaign=successful-ovm-200-phase-1-trial [SID1234664686])

On April 22, 2026 Outlook Therapeutics, Inc. (Nasdaq: OTLK) ("Outlook Therapeutics" or the "Company"), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, reported that it has entered into a definitive agreement for the purchase and sale of an aggregate of 16,129,033 shares of its common stock (or pre-funded warrants in lieu thereof) at an offering price of $0.31 per share of common stock (or per pre-funded warrants in lieu thereof) in a registered direct offering priced at-the-market under Nasdaq rules. Additionally, in a concurrent private placement, the Company will issue unregistered warrants to purchase up to an aggregate of 16,129,033 shares of common stock at an exercise price of $0.31 per share. The unregistered warrants will become exercisable on the later of (i) the date of stockholder approval of the issuance of the shares underlying the warrants and (ii) the effective date of an amendment to the Company’s certificate of incorporation to increase the authorized shares of the Company and will expire five years following the later of (x) the date the unregistered warrants are first exercisable and (y) the effective date of the registration statement registering the resale of the shares of common stock issuable upon exercise of the unregistered warrants. The closing of the offering is expected to occur on or about April 23, 2026, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The aggregate gross proceeds to the Company from the offering are expected to be approximately $5.0 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The potential additional gross proceeds to the Company from the unregistered warrants, if fully exercised on a cash basis, would be approximately $5.0 million. No assurance can be given that any of the unregistered warrants will be exercised for cash. The Company intends to use the net proceeds from this offering primarily for working capital and general corporate purposes.

The shares of common stock (or the pre-funded warrants in lieu thereof and the pre-funded warrant shares issuable thereunder) (but excluding the unregistered warrants and the shares of common stock issuable thereunder) are being offered and sold by the Company in a registered direct offering pursuant to a "shelf" registration statement on Form S-3 (File No. 333-278340) that was originally filed with the Securities and Exchange Commission (the "SEC") on March 28, 2024 and became effective on April 5, 2024. The offering of the shares of common stock (or the pre-funded warrants in lieu thereof and the shares of common stock issuable thereunder) in the registered direct offering is being made only by means of a base prospectus and prospectus supplement that forms a part of the effective registration statement. A final prospectus supplement relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus, when available, may also be obtained from H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

The unregistered warrants described above are being offered and sold by the Company in a transaction not involving a public offering under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder and, along with the shares of common stock issuable thereunder, have not been registered under the Securities Act or applicable state securities laws. Accordingly, the unregistered warrants and the shares of common stock issuable thereunder may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

The Company also has agreed to amend certain outstanding warrants to purchase up to an aggregate of 2,142,854 shares of the Company’s common stock that were previously issued to an investor on January 16, 2025, with an exercise price of $2.26 per share, effective upon the closing of the offering, such that the amended warrants will have a reduced exercise price of $0.31 per share, will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares upon exercise of the amended warrants and will expire five years from the effective date of such stockholder approval.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other 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 other jurisdiction.

(Press release, Outlook Therapeutics, APR 22, 2026, View Source [SID1234664685])

On April 22, 2026 OREGA Biotech reported that interim results from the Phase 2 MATISSE trial evaluating IPH5201, a first-in-class CD39 blocking monoclonal antibody, in combination with durvalumab and platinum-based chemotherapy in patients with resectable early-stage non-small cell lung cancer (NSCLC) were presented on April 21st during a plenary session at AACR (Free AACR Whitepaper) 2026 by Professor Fabrice Barlesi (Gustave Roussy) and discussed by Professor Tina Cascone (MD Anderson).

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Presentation highlights:
Perioperative PD-(L)1 inhibitors combined with chemotherapy are now a standard of care in resectable early-stage NSCLC. However, further improvements in pathological complete response (pCR) and survival outcomes are still needed. IPH5201, a humanized anti-CD39 neutralizing antibody, is designed to enhance antitumor immunity by reducing immunosuppressive adenosine and increasing immuno-activating ATP levels, as demonstrated in preclinical models.

In the ongoing Phase 2 MATISSE study:

40 patients with stage II–IIIA NSCLC were treated
The regimen demonstrated a safety profile comparable to preoperative platinium-based chemo+durvalumab
The observed pathological Complete Response (pCR) rates were:
5% in the overall population
7% in patients with PD-L1 ≥1%
50% in patients with PD-L1 ≥50%
These results compare favorably with historical data from the AEGEAN Phase 3 study.

Biomarker analyses confirmed CD39 target engagement and suggested a correlation between CD39+ tumor cell density and treatment response.

These findings support the continuation of the study, including ongoing recruitment of patients with PD-L1 ≥1%.

About IPH5201 antibody
IPH5201 is a first-in-class-humanized CD39 blocking antibody codeveloped by Innate Pharma and AstraZeneca (AZ).

OREGA Biotech entered into an exclusive and worldwide License Agreement with Innate Pharma in 2016. The lead antibody (IPH5201) has been further partnered with AstraZeneca in 2018. AstraZeneca conducted a multicenter, open-label, dose-escalation Phase 1 trial in advanced solid tumors (NCT04261075) with IPH5201 alone or in combination with durvalumab (anti PD-L1 antibody).

About NCT05742607 clinical trial
MATISSE is a Phase 2 multicenter single-arm study (NCT05742607) evaluating neoadjuvant and adjuvant treatment with IPH5201 in combination with durvalumab (anti-PD-L1, AZ) and chemotherapy in treatment-naïve patients with resectable early-stage non-small cell lung cancer (NSCLC). The primary objectives of the study are to assess antitumor activity of neoadjuvant treatment based on pathological complete response (pCR) and safety.

(Press release, OREGA BIOTECH, APR 22, 2026, View Source [SID1234664684])