Rakovina Therapeutics Presents New Preclinical Data at AACR 2026 Annual Meeting

On April 22, 2026 Rakovina Therapeutics Inc. (TSX-V: RKV; FSE: 7JO0), a biopharmaceutical company advancing innovative cancer therapies through artificial intelligence (AI)-powered drug discovery, reported the presentation of new preclinical data from two of its lead programs at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, held April 17–22 in San Diego, California.

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The data, presented across two poster sessions at the world’s premier cancer research forum, advance Rakovina’s AI-driven pipeline targeting DNA damage response (DDR) vulnerabilities in hard-to-treat solid tumors. Both programs leverage generative AI platforms to address longstanding limitations of existing cancer therapies, including poor central nervous system (CNS) penetrance and the toxicity burden of drug combination regimens.

Novel Brain-Penetrant Dual ATR-mTOR Inhibitor Demonstrates In Vivo Efficacy in PTEN-Deficient Cancers

The first poster, titled A Novel Brain-Penetrant Dual ATR-mTOR Inhibitor for PTEN-Deficient Cancers (Presentation #1743, DNA Damage and Repair 2 session, April 20), presented preclinical data from Rakovina’s program to develop first-in-class CNS-penetrating molecules that simultaneously inhibit ATR and mTOR, two key drivers of survival in PTEN-deficient cancer cells. The program was developed in collaboration with Variational AI (Vancouver, BC) using the Enki generative AI platform.

PTEN deficiency is found in up to 40% of gliomas and 63% of breast cancers, which frequently metastasize to the brain. Simultaneous inhibition of ATR and mTOR is a rational therapeutic strategy in PTEN-deficient tumors, as PTEN loss activates both ATR-dependent DNA damage signaling and mTOR-driven cell survival pathways. However, no approved therapy directly addresses this dual vulnerability with effective CNS penetrance.

Using the Enki latent diffusion model to simultaneously optimize potency, selectivity, CNS penetrance, and ADMET properties, Rakovina generated and synthesized a curated set of novel small-molecule dual ATR-mTOR inhibitor candidates. Key findings presented at AACR (Free AACR Whitepaper) 2026 include:

Enzymatic potency: Candidate compounds demonstrated equal or greater inhibition of recombinant ATR and mTOR enzymes compared to reference compounds ceralasertib and tuvusertib.
Selectivity: Candidates are equally or more selective against PIKK family enzymes than the reference compounds ceralasertib and tuvusertib.
Cell viability inhibition: Candidates inhibit cell viability of D283 medulloblastoma cells equally or more than reference compounds. A prototype lead candidate inhibited cell viability of both PTEN wild-type and PTEN-deficient cancer cell lines.
Metabolic stability: After 45 minutes of incubation with human liver microsomes, candidate compounds demonstrated strong metabolic stability.
CNS penetrance: Pharmacokinetic profiling following intraperitoneal administration in mice confirmed varying but measurable levels of CNS penetrance across candidates, with brain-to-plasma ratios broadly consistent with Enki AI predictions.
In vivo efficacy: In a subcutaneous LNCaP prostate tumor model, a prototype lead candidate significantly prolonged tumor doubling time compared to vehicle control, with equal potency to reference compound ceralasertib. Critically, the Rakovina candidate was better tolerated than ceralasertib, demonstrating less weight loss with daily dosing and no signs of hematological toxicity at terminal complete blood count analysis.
Optimization of candidate inhibitors is ongoing.

Novel AI-Designed Lipid Nanoparticle Formulation of kt-3283 Successfully Characterized

The second poster, titled Development of a Lipid Nanoparticle Formulation of the Bifunctional PARP and HDAC Inhibitor Kt-3283 (Presentation #6373, Drug Delivery session, April 21), presented preclinical formulation data on pLNP/kt-3283, developed in collaboration with NanoPalm (Riyadh, Saudi Arabia) using the EnsaliX AI platform.

kt-3283 integrates PARP inhibition and HDAC-mediated chromatin remodeling into a single compound, thereby improving the PARP efficacy, and eliminating the need for combination drug regimens and their associated toxicity risks. While kt-3283 has demonstrated potent anti-tumor activity across multiple tumor types in prior in vitro studies, its clinical viability has been limited by bioavailability and metabolic stability challenges. The pLNP formulation has been specifically designed to address these limitations.

Data presented confirm the successful assembly of the EnsaliX-designed patterned lipid nanoparticles. Physicochemical characterization confirmed uniform particle size, stable colloidal behavior, and a structured surface texture predicted to enhance cellular uptake. The pLNP/kt-3283 formulation demonstrated structure and particle size consistency supporting further biological evaluation.

Next steps include in vitro and in vivo characterization to confirm activity against PARP and HDAC enzymes, determine ADME properties, and evaluate efficacy in tumor models.

"Presenting at AACR (Free AACR Whitepaper) is a meaningful milestone for our team, and these results represent a genuine step forward for both programs," said Kim Oishi, Chief Executive Officer of Rakovina Therapeutics. "The in vivo efficacy data for our ATR-mTOR inhibitor are particularly encouraging. The compound demonstrated potency comparable to an established reference compound while exhibiting a meaningfully improved tolerability profile. That is exactly the differentiation we are building toward. Combined with the initial characterization of our LNP formulation for kt-3283, we believe these results reinforce the potential of our AI-driven pipeline and support a path toward IND-enabling studies."

Rakovina’s AI-powered discovery approach leverages generative AI platforms to evaluate billions of potential drug candidates at a pace not achievable through traditional methods. These capabilities are supported by the company’s access to the University of British Columbia’s lab infrastructure, enabling rapid in-house testing of lead compounds.

"These results demonstrate that our strategy of integrating AI-guided design with biological validation, is working as intended," said Dr. Mads Daugaard, President and Chief Scientific Officer of Rakovina Therapeutics. "For the ATR-mTOR program, our candidate inhibitors are tracking closely with the AI predictions for potency, selectivity, and CNS penetrance and our in vivo results give confidence in the direction of this program. For kt-3283, we have demonstrated that the EnsaliX-designed LNP formulation produces a well-characterized nanoparticle. The structured surface and organized phospholipid assembly we observed are precisely the properties expected to enhance nanoparticle stability and cellular uptake of kt-3283. Both programs have clear next steps, and we are moving forward with purpose."

The data presented at AACR (Free AACR Whitepaper) 2026 reinforce the progress of Rakovina’s AI-enabled DDR inhibitor pipeline and inform the next phase of preclinical development for both programs. For the ATR-mTOR program, further optimization of candidate inhibitors is ongoing. For the kt-3283 LNP program, the company will advance in vitro and in vivo studies to further characterize biological activity prior to evaluating efficacy in tumor models.

Rakovina intends to use these findings to advance best-in-class lead candidates toward IND-enabling studies in collaboration with pharmaceutical partners.

(Press release, Rakovina Therapeutics, APR 22, 2026, View Source;utm_medium=rss&utm_campaign=rakovina-therapeutics-presents-new-preclinical-data-at-aacr-2026-annual-meeting [SID1234664689])

PureTech Reports Positive Topline Data from Phase 1b Trial of LYT-200 in Relapsed/Refractory (R/R) High-Risk (HR) Myelodysplastic Syndrome (MDS) and R/R Acute Myeloid Leukemia (AML)

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])

PharmaMar to Present Data at ASCO 2026 Highlighting Advancements for Zepzelca® (lurbinectedin)

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])

Oxford Vacmedix announce results of successful Phase 1 trial of OVM-200

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])

Outlook Therapeutics Announces $5.0 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

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])