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• Posters highlight clinically meaningful improvement in HAE symptoms observed in the first hours after treatment with PHVS416 (deucrictibant immediate-release capsules) as compared to placebo

ZUG, Switzerland, June 11, 2023 (GLOBE NEWSWIRE) — Pharvaris (Nasdaq: PHVS), a clinical-stage company developing novel, oral bradykinin-B2-receptor antagonists to treat and prevent hereditary angioedema (HAE) attacks, today announced two presentations highlighting data from RAPIDe-1, a Phase 2 study of PHVS416 (deucrictibant immediate-release capsules) for the on-demand treatment of HAE attacks, included in the “Flash Talks on Angioedema” session at the European Academy of Allergy & Clinical Immunology (EAACI) Hybrid Congress 2023, taking place in Hamburg, Germany, from June 9-11, 2023.

Presentation details:

• Title: 
  Treatment with Oral Administered Bradykinin B2 Receptor Inhibitor PHVS416 Improves Hereditary Angioedema Attack Symptoms
  
  Abstract Number: 001557
  Date/Time: Sunday, June 11, 14:10 CEST (8:10 a.m. EDT)
  Presenter: Emel Aygören-Pürsün, M.D., University Hospital Frankfurt
• Title: 
  Efficacy and Safety of Oral Administered Bradykinin B2 Receptor Inhibitor PHVS416 in Treatment of Hereditary Angioedema Attacks: Topline Results of RAPIDe-1 Phase 2 Trial
  
  Abstract Number: 001510
  Date/Time: Sunday, June 11, 14:30 CEST (8:30 a.m. EDT)
  Presenter: Marcus Maurer, M.D., Charité Universitätsmedizin Berlin

“When asked to identify the most important factor in selecting an on-demand therapy, both people living with HAE and their treating physicians indicated that rapidity to onset of symptom relief and complete symptom relief were essential,” said Wim Souverijns, Ph.D., Chief Community Engagement and Commercial Officer of Pharvaris. “Additionally, our research points to multiple reasons why not all HAE attacks are treated in a timely manner or treated at all, as is recommended by international clinical guidelines, including fear of injection pain, anxiety regarding the ability of a therapy to completely treat an attack with a single dose, and lack of confidence in the speed of symptom relief. An effective oral therapy that provides rapid and complete symptom relief could address some of these barriers.”

“The results from the Phase 2 RAPIDe-1 clinical study show that treatment of an HAE attack with PHVS416 (deucrictibant immediate-release capsules) resulted in rapid and clinically meaningful improvement in symptoms as compared to placebo,” said Peng Lu, M.D., Ph.D., Chief Medical Officer of Pharvaris. “The study met the primary and all key secondary endpoints, providing evidence for the efficacy and tolerability of PHVS416 in treating HAE attacks and supports its further development as a potential on-demand therapy for HAE.”

The posters are available on the Investors section of the Pharvaris website at: https://ir.pharvaris.com/news-events/events-presentations.

About RAPIDe-1

RAPIDe-1 is a Phase 2, double-blind, placebo-controlled, randomized, cross-over, dose-ranging trial of PHVS416 (immediate-release deucrictibant capsules) for the treatment of HAE type 1 and type 2 (HAE-1/2) attacks. The trial enrolled participants in Canada, Europe, Israel, the United Kingdom, and the United States. Eligible participants were between the ages of 18 and 75 years, diagnosed with HAE type I or II and experienced three or more attacks in the last four months or two or more attacks in the last two months prior to screening. Seventy-four participants were enrolled and 62 of them experienced 147 qualifying HAE attacks that were treated with double-blinded study drug (either placebo or PHVS416 10, 20, or 30 mg doses).

About PHVS416 (immediate-release deucrictibant capsules)

PHVS416 (immediate-release deucrictibant capsules) is an investigational medicine intended to treat acute attacks of hereditary angioedema (HAE) containing deucrictibant, a highly potent, specific, and orally bioavailable competitive antagonist of the bradykinin B2 receptor. Pharvaris aims to develop this formulation to provide rapid and reliable symptom relief, through rapid exposure of attack-mitigating therapy in a convenient, small oral dosage form. PHVS416 is currently in Phase 2 clinical development outside the U.S. for the on-demand and proof-of-concept prophylactic treatment of HAE.

About Pharvaris

Building on its deep-seated roots in hereditary angioedema (HAE), Pharvaris is a clinical-stage company developing novel, oral bradykinin-B2-receptor antagonists to treat and prevent HAE attacks. By directly targeting this clinically proven therapeutic target with novel small molecules, the Pharvaris team aspires to offer people with all sub-types of HAE safe, effective, and convenient alternatives to treat attacks, both on-demand and prophylactically. The company brings together the best talent in the industry with deep expertise in rare diseases and HAE. For more information, visit https://pharvaris.com/.

Forward-Looking Statements

This press release contains certain forward-looking statements that involve substantial risks and uncertainties. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements relating to our future plans, studies and trials, and any statements containing the words “believe,” “anticipate,” “expect,” “estimate,” “may,” “could,” “should,” “would,” “will,” “intend” and similar expressions. These forward-looking statements are based on management’s current expectations, are neither promises nor guarantees, and involve known and unknown risks, uncertainties and other important factors that may cause Pharvaris’ actual results, performance or achievements to be materially different from its expectations expressed or implied by the forward-looking statements. Such risks include but are not limited to the following: uncertainty in the outcome of our interactions with regulatory authorities, including the FDA with respect to the clinical holds on deucrictibant clinical trials in the U.S.; the expected timing, progress, or success of our clinical development programs, especially for PHVS416 and PHVS719, which are in mid-stage global clinical trials and are currently on hold in the U.S. as a result of the clinical holds; risks arising from epidemic diseases, such as the COVID-19 pandemic, which may adversely impact our business, nonclinical studies, and clinical trials; the expected timing and results of the rodent toxicology study; the timing of regulatory approvals; the value of our ordinary shares; the timing, costs and other limitations involved in obtaining regulatory approval for our product candidates PHVS416 and PHVS719, or any other product candidate that we may develop in the future; our ability to establish commercial capabilities or enter into agreements with third parties to market, sell, and distribute our product candidates; our ability to compete in the pharmaceutical industry and with competitive generic products; our ability to market, commercialize and achieve market acceptance for our product candidates; our ability to raise capital when needed and on acceptable terms; regulatory developments in the United States, the European Union and other jurisdictions; our ability to protect our intellectual property and know-how and operate our business without infringing the intellectual property rights or regulatory exclusivity of others; our ability to manage negative consequences from changes in applicable laws and regulations, including tax laws, our ability to successfully remediate the material weaknesses in our internal control over financial reporting and to maintain an effective system of internal control over financial reporting; changes and uncertainty in general market, political and economic conditions, including as a result of inflation and the current conflict between Russia and Ukraine; and the other factors described under the headings “Cautionary Statement Regarding Forward-Looking Statements” and “Item 3. Key Information—D. Risk Factors” in our Annual Report on Form 20-F and other periodic filings with the Securities and Exchange Commission.

These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. While Pharvaris may elect to update such forward-looking statements at some point in the future, Pharvaris disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing Pharvaris’ views as of any date subsequent to the date of this press release.

Contact
Maggie Beller
Head of Public Relations and Communications
[email protected]

Finalized Dose Escalation/Dose Exploration Trial in 77 R/R AML Patients


Favorable safety with monotherapy responses across four dose levels with no DLT in mutationally diverse and difficult to treat R/R AML Populations

TP53

^MUT

CR/CRh = 20% │ RAS

^MUT

CR/CRh = 22%

Completed Successful Type B EOP1 Meeting with US FDA


Monotherapy RP2D selected as 80mg daily and single arm accelerated path remains open

Initiated APTIVATE Expansion Trial with R/R AML


Tuspetinib monotherapy and Tuspetinib + Venetoclax (TUS/VEN) doublet show brisk enrollment

TUS/VEN doublet well tolerated, all patients remain on study, preliminary CR activity reported among

first patients treated

SAN DIEGO and TORONTO, June 10, 2023 (GLOBE NEWSWIRE) — Aptose Biosciences Inc. (“Aptose” or the “Company”) (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated oral kinase inhibitors to treat hematologic malignancies, today released highlights from a clinical update event held today, June 10, 2023, in conjunction with EHA 2023 International Congress of the European Hematology Association in Frankfurt, Germany. The event included an up-to-date review of clinical data for Aptose’s two investigational products under development for hematologic malignancies: tuspetinib, an oral, myeloid kinase inhibitor in the Phase 1/2 APTIVATE trial in patients with relapsed or refractory acute myeloid leukemia (AML); and luxeptinib, an oral, dual lymphoid and myeloid kinase inhibitor in Phase 1 a/b stage development for the treatment of patients with relapsed or refractory hematologic malignancies. The webcast of the presentation is available on Aptose’s website here.

Aptose provided updated clinical findings with tuspetinib, a potent suppressor of FLT3, SYK, JAK 1/2, mutant forms of cKIT, and the RSK1/2 kinases operative in AML:

• Completed tuspetinib dose escalation and dose exploration Phase 1/2 trial in 77 R/R AML patients.
  • Tuspetinib demonstrated a favorable safety profile.
  • Tuspetinib delivered monotherapy responses across four dose levels with no DLT in mutationally diverse and difficult to treat R/R AML populations, including TP53-mutated patients with a CR/CRh = 20% and RAS-mutated patients with a CR/CRh = 22%.
• Completed successful End of Phase 1 (EOP1) Meeting with US FDA for tuspetinib, and a monotherapy RP2D was selected as 80mg daily, and all development paths remain open, including the single arm accelerated path.
• Initiated tuspetinib APTIVATE expansion trial with R/R AML patients.
  • Tuspetinib is being administered as a monotherapy and as a combination doublet with tuspetinib + venetoclax (TUS/VEN), and enrollment has been brisk.
  • TUS/VEN doublet has been well tolerated, all patients remain on study, and preliminary CR activity has already been reported in patients previously treated with VEN.

Aptose also reviewed clinical findings with the new G3 formulation of luxeptinib (Lux):

• 50mg G3 formulation with continuous dosing achieves roughly equivalent PK profile as 900mg original G1 formulation.
• Expect to dose escalate G3 formulation with continuous dosing in patients soon.

“We are delighted to have finalized our dose escalation and dose exploration Phase 1/2 trial with tuspetinib (TUS), to have demonstrated single agent responses across four dose levels that had no DLTs and across a range of R/R AML populations with a diversity of adverse mutations,” said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer. “As part of our EOP1 meeting with the FDA, we designated 80mg daily as our monotherapy recommended phase 2 dose (RP2D), and now we focus all attention on our APTIVATE expansion trial to place monotherapy TUS in more patients with highly adverse mutations and to evaluate TUS in combination with venetoclax (VEN) as a doublet in R/R AML patients. Notably, to date, the doublet appears to be well tolerated, with all patients remaining on study, including a preliminary CR in a R/R AML patient who previously failed venetoclax. We look forward to accelerating testing of the doublet, adding MDS patients to our APTIVATE trial, and with the aim of moving into triplet therapy (TUS/VEN/HMA) in 1L AML patients.”

About
Aptose

Aptose Biosciences is a clinical-stage biotechnology company developing precision medicines addressing unmet medical needs in oncology, with an initial focus on hematology. The Company’s small molecule cancer therapeutics pipeline includes products designed to provide single agent efficacy and to enhance the efficacy of other anti-cancer therapies and regimens without overlapping toxicities. The Company has two clinical-stage oral kinase inhibitors under development for hematologic malignancies: tuspetinib (HM43239), an oral, myeloid kinase inhibitor being studied as monotherapy and in combination therapy in the APTIVATE international Phase 1/2 expansion trial in patients with relapsed or refractory acute myeloid leukemia (AML); and luxeptinib (CG-806), an oral, dual lymphoid and myeloid kinase inhibitor in Phase 1 a/b stage development for the treatment of patients with relapsed or refractory hematologic malignancies. For more information, please visit www.aptose.com.

Forward Looking Statements

This press release may contain forward-looking statements within the meaning of Canadian and U.S. securities laws, including, but not limited to, statements relating to the therapeutic potential of tuspetinib, its clinical development and safety profile, as well as statements relating to the Company’s plans, objectives, expectations and intentions and other statements including words such as “continue”, “expect”, “intend”, “will”, “should”, “would”, “may”, and other similar expressions. Such statements reflect our current views with respect to future events and are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by us are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies. Many factors could cause our actual results, performance or achievements to be materially different from any future results, performance or achievements described in this press release. Such factors could include, among others: our ability to obtain the capital required for research and operations and to continue as a going concern; the inherent risks in early stage drug development including demonstrating efficacy; development time/cost and the regulatory approval process; the progress of our clinical trials; our ability to find and enter into agreements with potential partners; our ability to attract and retain key personnel; changing market conditions; inability of new manufacturers to produce acceptable batches of GMP in sufficient quantities; unexpected manufacturing defects; and other risks detailed from time-to-time in our ongoing quarterly filings, annual information forms, annual reports and annual filings with Canadian securities regulators and the United States Securities and Exchange Commission.

Should one or more of these risks or uncertainties materialize, or should the assumptions set out in the section entitled “Risk Factors” in our filings with Canadian securities regulators and the United States Securities and Exchange Commission underlying those forward-looking statements prove incorrect, actual results may vary materially from those described herein. These forward-looking statements are made as of the date of this press release and we do not intend, and do not assume any obligation, to update these forward-looking statements, except as required by law. We cannot assure you that such statements will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. Investors are cautioned that forward-looking statements are not guarantees of future performance and accordingly investors are cautioned not to put undue reliance on forward-looking statements due to the inherent uncertainty therein.

For further information, please contact:

Aptose Biosciences Inc. Susan Pietropaolo Investor Relations 201-923-2049 [email protected]

LifeSci Advisors, LLC Dan Ferry, Managing Director 617-430-7576 [email protected]

• 7 of 10 r/r NHL patients achieved complete response (70% CR rate) following treatment with NKX019 monotherapy at 1 billion and 1.5 billion CAR NK cells per dose in the Phase 1 dose escalation study
• Data demonstrate potential for redosing of allogeneic CD19 CAR NK to deepen response or restore response post-relapse
  • Majority of patients achieved CR after a single cycle of NKX019
• Early safety data support potential of allogeneic CD19 CAR NK to be administered on outpatient basis
  • No neurotoxicity / ICANS, graft versus host disease (GvHD), or > Gr3 cytokine release syndrome (CRS)
  • 40% of eligible patients received NKX019 in the outpatient setting after first cycle

SOUTH SAN FRANCISCO, Calif., June 10, 2023 (GLOBE NEWSWIRE) — Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies, today announced presentations highlighting preliminary data based on a November 2022 data cut-off from its Phase 1 dose escalation clinical trial of NKX019 at two scientific conferences: the European Hematology Association (EHA) 2023 Hybrid Congress and the 17^th International Conference on Malignant Lymphoma (17-ICML). NKX019 is an allogeneic, off-the-shelf NK cell therapy candidate derived from healthy donors and engineered to target CD19.

Seven of ten patients with relapsed/ refractory non-Hodgkin lymphoma (NHL) treated at the higher dose levels showed a complete response (70% CR), including two patients with aggressive large B cell lymphoma (LBCL) as well as other difficult histologies, including mantle cell lymphoma (MCL), high-risk follicular lymphoma (FL) and marginal zone lymphoma (MZL). No dose limiting toxicity, neurotoxicity / ICANS, graft versus host disease (GvHD), or >Grade 3 cytokine release syndrome (CRS) were observed in the study.

“Autologous CAR-T cell therapies set a standard for responses in patients with relapsed/ refractory B-cell malignancies. However, potential for toxicity and logistic challenges have limited access to these therapies, and many patients could still benefit from a safe, on-demand treatment,” said Michael Dickinson, M.D., Lead, Aggressive Lymphoma disease group, Clinical Haematology, Peter MacCallum Cancer Centre and Royal Melbourne Hospital, and investigator in the NKX019 trial. “In this early evaluation of an allogeneic CAR-NK cell therapy candidate, NKX019 had a manageable safety profile with encouraging anti-tumor activity as well as the option for retreatment after relapse. Based on these early data, NKX019 merits further study as a potential outpatient cell therapy approach.”

“These data highlight the encouraging safety profile and clinical activity across different histologies in the dose escalation portion of the NKX019 study,” said David R. Shook, M.D., Nkarta’s Chief Medical Officer. “We continue to explore the potential of allogeneic CAR NK cells, leveraging their biology to create a differentiated cellular therapy, and we look forward to the next update on the NKX019 program later this year.”

Nkarta’s presentation materials from EHA and ICML will be available for download on the Nkarta website (https://www.nkartatx.com/publications/). The presentations will ensure that the broader clinical and academic community has the opportunity to assess the NKX019 clinical data in a peer-reviewed format. All data were previously disclosed at a company event in December 2022. Nkarta plans to provide an update from the NKX019 program, including data from dose expansion cohorts, in 2023.

About NKX019

NKX019 is an allogeneic, cryopreserved, off-the-shelf cancer immunotherapy candidate that uses natural killer (NK) cells derived from the peripheral blood of healthy adult donors. It is engineered with a humanized CD19-directed CAR for enhanced tumor cell targeting and a proprietary, membrane-bound form of interleukin-15 (IL-15) for greater persistence and activity without exogenous cytokine support. CD19 is a biomarker for normal and malignant B cells, and it is a validated target for B cell cancer therapies. To learn more about the NKX019 clinical trial in adults with advanced B cell malignancies, please visit ClinicalTrials.gov.

About Nkarta

Nkarta is a clinical-stage biotechnology company advancing the development of allogeneic, off-the-shelf natural killer (NK) cell therapies. By combining its cell expansion and cryopreservation platform with proprietary cell engineering technologies and CRISPR-based genome engineering capabilities, Nkarta is building a pipeline of future cell therapies engineered for deep anti-tumor activity and intended for broad access in the outpatient treatment setting. For more information, please visit the company’s website at www.nkartatx.com.

Cautionary Note on Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as “anticipates,” “believes,” “expects,” “intends,” “plans,” “potential,” “projects,” “would” and “future” or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include, but are not limited to, statements concerning Nkarta’s expectations regarding any or all of the following: the timing of release of additional NKX019 clinical trial data and the nature of the data to be released; the anti-tumor activity and safety profile of NKX019; the potential for NKX019 to be a differentiated, outpatient cellular therapy; and the ability of redosing with NKX019 to restore responses post-relapse. Clinical data referenced in this press release are as of the November 28, 2022 data cut-off date and are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more data on existing patients become available. 

Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Nkarta’s limited operating history and historical losses; Nkarta’s lack of any products approved for sale and its ability to achieve profitability; the risk that the results of preclinical studies and early-stage clinical trials may not be predictive of future results; Nkarta’s ability to raise additional funding to complete the development and any commercialization of its product candidates; Nkarta’s dependence on the clinical success of its two lead product candidates, NKX101 and NKX019; that Nkarta may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; Nkarta’s ability to obtain, maintain and protect its intellectual property; Nkarta’s dependence on third parties in connection with manufacturing, clinical trials and pre-clinical studies; the complexity of the manufacturing process for CAR NK cell therapies; the availability of components and supplies necessary for the conduct of our clinical trials; and risks relating to the impact on our business of the COVID-19 pandemic or similar public health crises. 

Interim data from clinical trials are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more data on existing patients become available. The clinical trial program is ongoing, and the final results may be materially different from those reflected in any interim data we report. Further, others, including regulatory agencies, may not accept or agree with Nkarta’s assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization of the particular product candidate or product and the value of the company in general. In addition, the information Nkarta chooses to publicly disclose regarding a particular study or clinical trial is typically a summary of extensive information, and you or others may not agree with what Nkarta determines is the material or otherwise appropriate information to include in Nkarta’s disclosure, and any information Nkarta determines not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding a particular product, product candidate or business. 

These and other risks are described more fully in Nkarta’s filings with the Securities and Exchange Commission (“SEC”), including the “Risk Factors” section of Nkarta’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, filed with the SEC on May 11, 2023, and Nkarta’s other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Nkarta undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Nkarta Media/Investor Contact:

Greg Mann
Nkarta, Inc.
[email protected]

– Data updates at EAACI 2023 continue to position barzolvolimab as a potential best-in-class addition to a historically limited treatment landscape –

– At week 24, 55% of all patients with CSU in the 1.5 mg/kg, 3.0 mg/kg and 4.5 mg/kg dose groups had complete response (UAS7) and 69% had well-controlled disease (UCT) –

– Patients in the CSU study with angioedema treated at these doses had profound and durable angioedema symptom improvement –

– Single 3.0 mg/kg dose of barzolvolimab was well tolerated and demonstrated impressive clinical activity in difficult to treat cholinergic urticaria with a 56% complete response rate and patients reporting clinically significant improvement in quality of life –

– Phase 2 CSU study nearing enrollment completion with topline data by year-end; Phase 2 CindU study enrolling as planned –

HAMPTON, N.J., June 10, 2023 (GLOBE NEWSWIRE) — Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today that updated data from the Company’s Phase 1b multi-dose clinical trial in chronic spontaneous urticaria (CSU) and new data from the Phase 1b single-dose cholinergic cohort included in the chronic inducible urticaria (CIndU) trial were presented at the European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress 2023. Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity, which is required for the function and survival of mast cells. Data continue to support that mast cell depletion by barzolvolimab, as demonstrated by tryptase suppression, parallels symptom improvement.

The CSU data were presented by Dr. Marcus Maurer, Professor of Dermatology and Allergy at Charité – Universitätsmedizin in Berlin, in a late breaking oral presentation (#000401) and the cholingeric data were presented by Dr. Eva Grekowitz, Clinical Investigator, Department of Dermatology, Venerology and Allergy at Charité – Universitätsmedizin in Berlin in an oral presentation (#000393).

“As we expand development into more patients and new disease settings, the data repeatedly support that barzolvolimab’s mast cell depleting mechanism holds great potential to offer patients a much needed rapid, profound and durable treatment option for chronic urticarias— including patients who are not seeing meaningful benefits from the current standard of care,” said Marcus Maurer, M.D. “In the CSU study, we also observed very significant improvements in angioedema which can be a devastating manifestation of urticaria for many patients. In cholinergic urticaria, barzolvolimab again demonstrated remarkable response rates and impressive improvements in quality of life in this tough to treat form of inducible urticaria.”

“We are extremely pleased with these further results which once again demonstrated strong clinical activity, rapid onset and sustained durability with a well-tolerated safety profile, including in patients who had previously taken omalizumab,” commented Anthony S. Marucci, President and Chief Executive Officer of Celldex Therapeutics. “These strong results support our ongoing Phase 2 studies in urticaria. We look forward completing accrual ahead of schedule in the Phase 2 CSU study later this month and reporting topline data by the end of this year.”

Summary of Barzolvolimab Phase 1b Chronic Spontaneous Urticaria (CSU) Data Update

CSU is characterized by the occurrence of hives or wheals for 6 weeks or longer without identifiable specific triggers or causes. Treatment options for patients with CSU are limited and there are no approved therapies for patients who do not respond to omalizumab. Celldex’s Phase 1b study is a randomized, double-blind, placebo-controlled clinical trial designed to assess the safety of multiple ascending doses of barzolvolimab in patients with moderate to severe CSU who remain symptomatic despite treatment with antihistamines. Approximately 40% of patients with CSU report accompanying episodes of angioedema, which typically presents as swelling in the lips, cheeks, around the eyes, arms, legs, or genitals¹; patients with CSU and angioedema typically experience significant negative impacts on health-related quality of life, daily activities and productivity in work compared to patients with CSU who do not have angioedema².

Clinical Activity Data

Celldex previously presented interim Phase 1b CSU data at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting 2023. The 0.5 mg/kg, 1.5 mg/kg and 3.0 mg/kg cohorts had completed study participation through 24 weeks; 6 of 9 patients in the 4.5 mg/kg cohort had completed through the week 20 visit (last barzolvolimab dose administered at 8 weeks). The study is now complete. At EAACI 2023, Celldex presented data on the complete 24 week experience for the 4.5 mg/kg cohort and data on angioedema impact across all study cohorts. 45 patients with moderate to severe CSU refractory to antihistamines were enrolled and treated [35 barzolvolimab (n=9 in 0.5 mg/kg; n=8 in 1.5 mg/kg; n=9 in 3.0 mg/kg; n=9 in 4.5 mg/kg) and 10 placebo]. Data for the 0.5 mg/kg and placebo group are only outlined below through week 12 because, as expected, most patients from these groups had significant symptoms ahead of week 24 and discontinued follow up. Two patients did not receive all doses of study treatment [4.5 mg/kg (1), placebo (1)].

• These data show that multiple doses of barzolvolimab resulted in rapid dose-dependent decreases in itch and hives with durable and prolonged symptom control in patients with moderate to severe CSU refractory to antihistamines, including patients with prior omalizumab treatment.
• Mean reduction from baseline in urticaria activity (UAS7) at week 24 was 80% in the 1.5 mg/kg dose group (n=7), 70% in the 3.0 mg/kg dose group (n=6) and 77% in the 4.5 mg/kg dose group (n=7).
• Complete response (UAS7=0) at week 24 was 57% in the 1.5 mg/kg dose group, 67% in the 3.0 mg/kg dose group and 43% in the 4.5 mg/kg dose group.
• Well-controlled disease (UCT≥ 12) at week 24 was 75% in the 1.5 mg/kg dose group, 67% in the 3.0 mg/kg dose group and 67% in the 4.5 mg/kg dose group.
• During post-treatment follow up, 71% (10 of 14) of patients who had been treated with doses greater than or equal to 1.5 mg/kg and had a complete response (UAS7=0) at week 12, remained urticaria free at week 24.
• Profound and durable improvement in angioedema symptoms as measured through the angioedema activity score over 7 days (AAS7) was achieved across all dose levels evaluated with sustained activity observed with the 1.5 mg/kg and greater dose levels.
  • 31 patients on study (n=26 barzolvolimab; 5=placebo) reported angioedema activity at baseline when enrolling in the study. 86% of the barzolvolimab treated patients at 1.5 mg/kg or greater were angioedema free at week 12 and 83% were angioedema free at week 24.

Summary of Clinical Activity Assessments

All Patients	0.5 mg/kg Q4W at Week 12		1.5 mg/kg Q4W at Week 12/24	3.0 mg/kg Q8W at Week 12/24	4.5 mg/kg Q8W at Week 12/24	Placebo at Week 12
Baseline UAS7 (mean, range)	31 (20 -39)		30 (20 – 41)	29 (16 – 42)	28 (22 – 38)	36 (19 – 42)
UAS7 Changes
Mean Score Change in UAS7 From Baseline	-11		-18 / -23	-21 / -23	-24 / -24	-14
Mean % Change in UAS7 From Baseline	-40	%	-67% / -80%	-67% / -70%	-82% / -77%	-37	%
Clinical Responses**
UAS7=0 (Complete Response)	11	%	57% / 57%	44% / 67%	67% / 43%	13	%
UAS7 ≤ 6 (Well-controlled)	22	%	57% / 57%	67% / 67%	67% / 57%	13	%
UCT ≥ 12 (Well-controlled)	11	%	75% / 75%	63% / 67%	89% / 67%	33	%

*24 week data not shown for 0.5 mg/kg and placebo dose levels as most patients had significant symptoms ahead of week 24 and discontinued follow up.



The UAS7 score is calculated as the sum over 7 days of the daily intensity of itch (ISS7 itch severity score) and number of hives (HSS7 hives severity score). UAS7 values range from 0 to 42, with higher values reflecting higher disease activity. UCT has 4 items with 5 answer options (scored with 0-4 points); recall period of 4 weeks. Low points indicate high disease activity and low disease control. The minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control and ≥12 indicating well controlled disease.

** Clinical responses shown are the proportion of patients with the defined response at the specific timepoint. Patients with missing data at the timepont are excluded.

Safety Data

Barzolvolimab was well tolerated with a favorable safety profile; effects of multiple dose administration were consistent with observations in single dose studies. Most AEs were mild or moderate in severity and resolved while on study.

Summary of Barzolvolimab Phase 1b Cholinergic (CIndU) Data Results

Chronic inducible urticarias are forms of urticaria that have an attributable trigger associated with them, typically resulting in wheals (hives) or angioedema. Cholinergic urticaria, a form of CindU, is triggered by physical exercise or passive warming and characterized by itchy hives/wheals that appear upon sweating. There are currently no approved therapies for chronic inducible urticarias other than antihistamines and patients attempt to manage symptoms associated with their disease through avoidance of triggers.

Clinical Activity Data

In this open-label, Phase 1 trial, a cohort of patients with antihistamine refractory cholinergic urticaria (n=9) received a single intravenous 3.0 mg/kg barzolvolimab dose with a 12-week follow-up. Assessments included provocation testing using pulse-controlled ergometry (PCE; complete response, CR=no whealing within 40 min of test initiation), urticaria control test (UCT), quality of life assessments, and measurement of circulating tryptase and stem cell factor and skin mast cell numbers. Safety assessments included adverse events and clinical laboratory monitoring. Data reported at EAACI 2023 include treatment and safety data through 12 weeks.

• 56% (5/9) patients achieved a complete response (negative test) with PCE provocation testing with just one dose of barzolvolimab and most responses remained durable through to week 12. PCE testing included controlled exercise on a stationary bicycle with monitoring for development of itch and wheals.
• 63% (5/8) patients reported well controlled disease (UCT ≥12) at week 8 and 50% (4/8) at week 12, respectively.
• 100% (6/6) patients who reported on quality of life (QoL) measurements at week 8 had clinically significant improvements in QoL. These improvements in QoL were sustained through week 12 for the majority (5/7, 71%) of patients.
• The kinetics of tryptase and mast cell reduction mirrored clinical activity

Safety Data

Barzolvolimab was generally well tolerated in patients with CholU, with a similar safety profile to that reported previously. The most common AEs were mainly mild; hair color changes (78%), nasopharyngitis (67%), taste disorders (44%), and infusion related reactions (33%). Hematology parameters were consistent with previous observation and generally remained within the normal ranges. Mild, transient, and asymptomatic decreases in hemoglobin and WBC parameters were noted.

¹JAllergy Clin Immunol Pract. 2018 Jul-Aug; 6(4): 1097–1106; ²Allergy 2018 Aug;73(8):1724-1734. doi: 10.1111/all.13430.

About Barzolvolimab

Barzolvolimab is a humanized monoclonal antibody that binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity. KIT is expressed in a variety of cells, including mast cells, which mediate inflammatory responses such as hypersensitivity and allergic reactions. KIT signaling controls the differentiation, tissue recruitment, survival and activity of mast cells. In certain inflammatory diseases, such as chronic urticaria, mast cell activation plays a central role in the onset and progression of the disease.

About the Phase 1b CSU Study Design

The Phase 1b study is a randomized, double-blind, placebo-controlled clinical trial designed to assess the safety of multiple ascending doses of barzolvolimab in patients with moderate to severe CSU who remain symptomatic despite treatment with antihistamines. Secondary and exploratory objectives include pharmacokinetic and pharmacodynamic assessments, including measurement of tryptase and stem cell factor levels and clinical activity outcomes (impact on urticaria symptoms, disease control, clinical response) as well as quality of life assessments. The study enrolled 45 patients with CSU across four cohorts. Barzolvolimab was administered intravenously at 0.5 mg/kg every 4 weeks (3 doses), 1.5 mg/kg every 4 weeks (3 doses), 3 mg/kg every 8 weeks (2 doses), 4.5 mg/kg every 8 weeks (2 doses), as add-on treatment to H1-antihistamines, either alone or in combination with H2-antihistamines and/or leukotriene receptor agonists. Following completion of the 12 week treatment period, patients were followed for an additional 12 weeks or until resumption of symptoms, whichever was sooner. For additional information on this trial (NCT04538794), please visit www.clinicaltrials.gov.

About the Phase 1b CindU Study Design

The Phase 1b study is an open label clinical trial designed to evaluate the safety of a single dose of barzolvolimab in patients with cold urticaria, symptomatic dermographism and cholinergic urticaria who are refractory to antihistamines. Patients’ symptoms are induced via provocation testing that resembles real life triggering situations. Secondary and exploratory objectives include pharmacokinetic and pharmacodynamic assessments, including changes from baseline provocation thresholds, measurement of tryptase and stem cell factor levels, clinical activity outcomes (impact on urticaria symptoms, disease control, clinical response), quality of life assessments and measurement of tissue mast cells through skin biopsies. The study enrolled 40 patients with inducible urticaria across four cohorts (cold urticaria, symptomatic dermagraphism and cholinergic urticaria at 3.0 mg/kg each and cold urticaria at 1.5 mg/kg). Barzolvolimab was administered intravenously as add on treatment to H1-antihistamines and patients were followed for 12 weeks after dosing, with an optional longer term follow up period. For additional information on this trial (NCT04548869), please visit www.clinicaltrials.gov.

About Celldex Therapeutics, Inc.

Celldex is a clinical stage biotechnology company dedicated to developing monoclonal and bispecific antibodies that address devastating diseases for which available treatments are inadequate. Our pipeline includes antibody-based therapeutics which have the ability to engage the human immune system and/or directly affect critical pathways to improve the lives of patients with inflammatory diseases and many forms of cancer. Visit www.celldex.com.

Forward Looking Statement

This release contains “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as “believes,” “expects,” “anticipates,” “intends,” “will,” “may,” “should,” or similar expressions. These forward-looking statements reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct or that those goals will be achieved, and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to successfully complete research and further development and commercialization of Company drug candidates, including barzolvolimab (also referred to as CDX-0159), in current or future indications; the uncertainties inherent in clinical testing and accruing patients for clinical trials; our limited experience in bringing programs through Phase 3 clinical trials; our ability to manage and successfully complete multiple clinical trials and the research and development efforts for our multiple products at varying stages of development; the effects of the outbreak of COVID-19 on our business and results of operations; the availability, cost, delivery and quality of clinical materials produced by our own manufacturing facility or supplied by contract manufacturers, who may be our sole source of supply; the timing, cost and uncertainty of obtaining regulatory approvals; the failure of the market for the Company’s programs to continue to develop; our ability to protect the Company’s intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company’s products; our ability to continue to obtain capital to meet our long-term liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that we have initiated or plan to initiate; and other factors listed under “Risk Factors” in our annual report on Form 10-K and quarterly reports on Form 10-Q.

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.

Company Contact

Sarah Cavanaugh
Senior Vice President, Corporate Affairs & Administration
(508) 864-8337
[email protected]

Patrick Till
Meru Advisors
(484) 788-8560
[email protected]

 

Data on CD19/BCMA dual-targeting FasTCAR-T GC012F showed 100% overall response rate (ORR) and 66.7% 6-month complete response (CR) rate among treated patients, all with diffuse large B-cell lymphoma (DLBCL) subtype

Data on GC012F for treatment of relapsed/refractory multiple myeloma (RRMM) and donor-derived CAR-T GC007g for treatment of relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) have been presented as posters on June 9 at EHA2023

SAN DIEGO, Calif., and SUZHOU and SHANGHAI, China, June 10, 2023 (GLOBE NEWSWIRE) — Gracell Biotechnologies Inc. (“Gracell” or the “Company”, NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing innovative and highly efficacious cell therapies for the treatment of cancer and autoimmune disease, today presented longer-term follow-up data from a first-in-human study evaluating GC012F, a CD19 and B-cell maturation antigen (BCMA) dual-targeted autologous CAR-T therapeutic candidate, in patients with relapsed/refractory B-cell non-Hodgkin’s Lymphoma (r/r B-NHL) as an oralpresentation (abstract #S234) at the European Hematology Association (EHA2023) Congress.

While CD19-directed CAR-T cell therapy has been demonstrated to be a valuable treatment option for r/r B-NHL, other studies have identified that 39% to 97% of clinical B-NHL samples express BCMA as well.^1,2,3 To further improve safety and efficacy of NHL treatment, Gracell is exploring the clinical potential of GC012F, a CD19 and BCMA dual-targeting CAR-T cell therapy, for treatment of r/r B-NHL. GC012F is manufactured through a novel next-day FasTCAR process and demonstrated a younger phenotype of CAR-T cells and highly effective tumor killing activity in preclinical animal models.

In the single-arm, open label investigator-initiated trial (IIT), nine r/r B-NHL patients were enrolled and treated with GC012F, and completed at least three months of follow-up. Doses range between 3.7×10⁴ to 3×10⁵ CAR-T cells/kg. All nine patients are classified as relapsed/refractory DLBCL. All patients’ lymphoma samples expressed CD19, and samples from seven out of eight tested patients expressed BCMA.

As of the April 12, 2023 data cutoff date, with a median follow-up of 293 days (range: 131-546 days), patients treated with GC012F achieved a high response rate and outstanding durability of response:

• 100% (9/9) overall response rate (ORR) at 3 months among nine patients with r/r DLBCL;
• 77.8% (7/9) complete response (CR) rate at 3 months;
• 66.7% (6/9) CR rate at 6 months;
• GC012F CAR-T cells were detectable in tumor biopsies from all tested patients, indicating the infiltration of CAR-T cells into the tumor lesions.

GC012F also continued to show a favorable safety profile:

• Cytokine release syndrome (CRS) was mostly Grade 1 (56%; 5/9). Grade 3 CRS was observed in one patient (duration of 2 days) with quick recovery after standard of care treatment. No Grade 4/5 CRS events occurred;
• No neurotoxicity or immune effector cell-associated toxicity (ICANS) of any grade were observed.

“One year after we reported initial data from the IIT evaluating FasTCAR-T GC012F in B-NHL at EHA2022, we are proud to be back at EHA presenting longer-term results from more patients as an oral presentation,” said Dr. Wendy Li, Chief Medical Officer of Gracell. “Durable responses, enhanced safety, and timely access to cell therapy remain significant unmet needs for NHL patients. With a 100% ORR at 3 months and CR rates of 78% at 3 months and 67% at 6 months, particularly among DLBCL patients, the updated data further support the clinical potential and wide applicability of GC012F, and the benefits of a CD19/BCMA dual-targeting approach combined with FasTCAR next-day manufacturing.”

Gracell is also evaluating GC012F in RRMM, newly-diagnosed multiple myeloma (NDMM), and systemic lupus erythematosus (SLE).

On June 9, Gracell also presented the following during poster sessions:

• First results from a Phase 1 study of the donor-derived allogeneic CAR-T GC007g (abstract #P369), showing 100% ORR and a favorable safety profile for treatment of r/r B-ALL;
• Updated results from the IIT evaluating GC012F for the treatment of RRMM (abstract #P869), which were also presented as an oral presentation at the 2023 ASCO Annual Meeting. The data demonstrated 100% minimal residual disease (MRD) negativity and 82.8% MRD negative stringent complete response (sCR) in a predominantly high-risk RRMM population.

Additional information about the presentations and the EHA2023 Hybrid Congress is available on the EHA website.

[1] Blood Cancer Journal (2020); 10:73.
[2] Blood (2017); 130:2755.
[3] Hum Gene Ther (2018); 29(5): 585.

About GC012F

GC012F is Gracell’s FasTCAR-enabled BCMA/CD19 dual-targeting autologous CAR-T cell therapy, which aims to transform cancer and autoimmune disease treatment by driving fast, deep and durable responses with improved safety profile. GC102F is currently being evaluated in investigator-initiated trials in multiple hematological cancers as well as autoimmune disease, and has demonstrated a consistently strong efficacy and safety profile. In February 2023, Gracell announced regulatory clearance of Investigational New Drug applications in the United States and China to commence clinical trials evaluating GC012F for the treatment of relapsed/refractory multiple myeloma. Gracell has also initiated an investigator-initiated trial evaluating GC012F for the treatment of SLE.

About FasTCAR

Introduced in 2017, FasTCAR is Gracell’s revolutionary next-day autologous CAR-T cell manufacturing platform. FasTCAR is designed to lead the next generation of therapy for cancer and autoimmune diseases, and improve outcomes for patients by enhancing effect, reducing costs, and enabling more patients to access critical CAR-T treatment. FasTCAR drastically shortens cell production from weeks to overnight, potentially reducing patient wait times and probability for their disease to progress. Furthermore, FasTCAR T-cells appear younger than traditional CAR-T cells, making them more proliferative and effective at killing cancer cells. In November 2022, FasTCAR was named the winner of the Biotech Innovation category of the 2022 Fierce Life Sciences Innovation Awards for its ability to address major industry obstacles.

About Gracell

Gracell Biotechnologies Inc. (“Gracell”) is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies. Leveraging its pioneering FasTCAR and TruUCAR technology platforms and SMART CAR™ technology module, Gracell is developing a rich clinical-stage pipeline of multiple autologous and allogeneic product candidates with the potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal cell quality, high therapy cost, and lack of effective CAR-T therapies for solid tumors and autoimmune disease. For more information on Gracell, please visit www.gracellbio.com. Follow @GracellBio on LinkedIn.

Cautionary Noted Regarding Forward-Looking Statements

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the expected trading commencement and closing date of the offering. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including factors discussed in the section entitled “Risk Factors” in Gracell’s most recent annual report on Form 20-F as well as discussions of potential risks, uncertainties, and other important factors in Gracell’s subsequent filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Gracell specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Readers should not rely upon the information on this page as current or accurate after its publication date.

Media contacts
Marvin Tang
[email protected]
Jessica Laub
[email protected]

Investor contacts
Gracie Tong
[email protected]
Stephanie Carrington
[email protected]

GARAMBA NATIONAL PARK, Democratic Republic of Congo, June 10, 2023 (GLOBE NEWSWIRE) — An initiative begun by Barrick president and chief executive Mark Bristow almost 13 years ago has come to fruition with the successful reintroduction of 16 white rhinos to the Garamba National Park in the northeast of the DRC, where the species was last seen in 2006.

Following more than a decade of dedicated action and support, an environment has been created where they can exist safely. The rhino arrived by aircraft from South Africa this week and have now been released in the park where professional staff and qualified veterinarians will regularly monitor their acclimatization.

Barrick Gold Corporation (NYSE:GOLD)(TSX:ABX) was the lead donor in the translocation as part of its long-standing partnership with African Parks and Garamba National Park, Africa’s oldest wildlife park and a UNESCO World Heritage Site. To date, Barrick has provided more than $2.5 million for tracking collars, fuel for observation planes, rescue and rehabilitation programs as well as improvements to critical infrastructure such as roads and bridges.

The rhinos were sourced from the &Beyond Phinda Private Game Reserve in Kwazulu-Natal, South Africa, and their translocation was achieved in collaboration with the Institut Congolais pour la Conservation de la Nature (ICCN), the Congolese government and African Parks.

Garamba was one of the last strongholds of the now extinct in the wild northern white rhino. The introduction of the near-threatened southern sub-species not only promotes the long-term conservation of rhino in Africa by extending their range, but also creates another breeding node for the species in a safe environment. Since African Parks assumed management of Garamba in 2005, there has been a significant decrease in poaching and most wildlife species found there are showing positive population increases, thanks largely to the development of alternative socio-economic initiatives in and around the park. Additionally, rhino have historically played an important role in regulating the structure and functioning of the park’s ecosystem, creating and maintaining grazing lawns that support other fauna and flora and provides important ecosystem services.

Bristow says Barrick’s continued support for Garamba is based on the company’s holistic approach to sustainability.

“Conserving biodiversity is fundamental to planetary survival, essential to tackling climate change and has an important role to play in the war on poverty. We strive not only to preserve and maintain biodiversity within our permits but to partner with NGOs and other organizations, such as African Parks and Garamba, to protect and restore critical biodiversity in some of the world’s most precious places,” he says.

Barrick’s successful group-wide biodiversity strategy places importance on protecting areas with high conservation value.

It is very important to understand the relationship between the natural environment and the communities that depend on it. Garamba is one of the largest employers in the region, with over 500 full-time staff and hundreds more employees on contract, including law enforcement teams and dedicated community personnel. The park also supports more than 9,000 community members in entrepreneurial enterprises including beekeeping, fish and poultry farming as well as four hospitals with a capacity of 12,000 patients.

Enquiries:

Investor and Media Relations

Kathy du Plessis
+44 20 7557 7738
Email: [email protected] 

Website:
www.barrick.com

Cautionary Statement on Forward-Looking Information

Certain information contained or incorporated by reference in this press release, including any information as to our strategy, projects, plans or future performance, constitutes “forward-looking statements”. All statements, other than statements of historical fact, are forward-looking statements. The words “continue”, “support”, “strive”, “strategy”, “protect”, “will”, “can” and similar expressions identify forward-looking statements. In particular, this press release contains forward-looking statements including, without limitation, with respect to: Barrick’s support of the Garamba National Park including anti-poaching initiatives and other measures to support the white rhino and other wildlife species; Barrick’s biodiversity strategy including protection of areas with high conversation value and the development of alternative socio-economic initiatives in and around the Garamba National Park; and Barrick’s holistic approach to sustainability and its environmental, health and safety, corporate social responsibility and human rights programs, policies and performance, including regarding local community relations, economic contributions and education and employment initiatives.

Forward-looking statements are necessarily based upon a number of estimates and assumptions including material estimates and assumptions related to the factors set forth below that, while considered reasonable by the Company as at the date of this press release in light of management’s experience and perception of current conditions and expected developments, are inherently subject to significant business, economic and competitive uncertainties and contingencies. Known and unknown factors could cause actual results to differ materially from those projected in the forward-looking statements and undue reliance should not be placed on such statements and information. Such factors include, but are not limited to: failure to comply with environmental and health and safety laws and regulations; increased costs and physical and transition risks related to climate change, including extreme weather events, resource shortages, emerging policies and increased regulations relating to related to greenhouse gas emission levels, energy efficiency and reporting of risks; non-renewal of key licences by governmental authorities; changes in national and local government legislation, taxation, controls or regulations and/or changes in the administration of laws, policies and practices; expropriation or nationalization of property and political or economic developments in the Democratic Republic of the Congo and other jurisdictions in which the Company or its affiliates do or may carry on business in the future; timing of receipt of, or failure to comply with, necessary permits and approvals; lack of certainty with respect to foreign legal systems, corruption and other factors that are inconsistent with the rule of law; risks associated with illegal and artisanal mining; risks associated with new diseases, epidemics and pandemics, including the effects and potential effects of the global Covid-19 pandemic; damage to the Company’s reputation due to the actual or perceived occurrence of any number of events, including negative publicity with respect to the Company’s handling of environmental matters or dealings with community groups, whether true or not; risk of loss due to acts of war, terrorism, sabotage and civil disturbances; the impact of inflation, including global energy cost increases following the invasion of Ukraine by Russia; litigation and administrative proceedings; contests over title to properties, particularly title to undeveloped properties, or over access to water, power and other required infrastructure; risks associated with working with partners in jointly controlled assets; and employee relations including loss of key employees. In addition, there are risks and hazards associated with the business of mineral exploration, development and mining, including environmental hazards, industrial accidents, unusual or unexpected formations, pressures, cave-ins, flooding and gold bullion, copper cathode or gold or copper concentrate losses (and the risk of inadequate insurance, or inability to obtain insurance, to cover these risks).

Many of these uncertainties and contingencies can affect our actual results and could cause actual results to differ materially from those expressed or implied in any forward-looking statements made by, or on behalf of, us. Readers are cautioned that forward-looking statements are not guarantees of future performance. All of the forward-looking statements made in this press release are qualified by these cautionary statements. Specific reference is made to the most recent Form 40-F/Annual Information Form on file with the SEC and Canadian provincial securities regulatory authorities for a more detailed discussion of some of the factors underlying forward-looking statements and the risks that may affect Barrick’s ability to achieve the expectations set forth in the forward-looking statements contained in this press release.

We disclaim any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise, except as required by applicable law. 

NEW YORK and VIENNA, Austria, June 10, 2023 (GLOBE NEWSWIRE) — HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced that the Compensation Committee of the Company’s Board of Directors approved the grant of non-statutory options to new employees to purchase an aggregate of 80,000 shares of the Company’s Common Stock under HOOKIPA’s 2023 Inducement Plan. The award was granted as an inducement material to the employees’s acceptance of employment with HOOKIPA in accordance with Nasdaq Listing Rule 5635(c)(4). The options have an exercise price equal to $ 1.01 per share. The options have a ten year term and vest over four years, with 25% vesting on the one-year anniversary of the grant date and the remainder vesting in equal quarterly installments for three years thereafter, subject to the employee’s continued service with HOOKIPA on each such vesting date. The options are subject to the terms and conditions of HOOKIPA’s 2023 Inducement Plan approved by the Board of Directors in April 2023 and the terms and conditions of award agreements covering the grants.

About HOOKIPA

HOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies, based on its proprietary arenavirus platform, which are designed to mobilize and amplify targeted T cells and thereby fight or prevent serious disease. HOOKIPA’s replicating and non-replicating technologies are engineered to induce robust and durable antigen-specific CD8+ T cell responses and pathogen-neutralizing antibodies. HOOKIPA’s pipeline includes its wholly owned investigational arenaviral immunotherapies targeting Human Papillomavirus 16-positive cancers, prostate cancers, and other undisclosed programs. HOOKIPA is collaborating with Roche on an arenaviral immunotherapeutic for KRAS-mutated cancers. In addition, HOOKIPA aims to develop functional cures of HBV and HIV in collaboration with Gilead.

Find out more about HOOKIPA online at www.hookipapharma.com

Forward Looking Statements

Certain statements set forth in this press release constitute “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements can be identified by terms such as “believes,” “expects,” “plans,” “potential,” “would” or similar expressions and the negative of those terms. Such forward-looking statements involve substantial risks and uncertainties that could cause HOOKIPA’s research and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including HOOKIPA’s programs’ early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, HOOKIPA’s ability to successfully establish, protect and defend its intellectual property, risks relating to business interruptions resulting from the coronavirus (COVID-19) disease outbreak or similar public health crises, the impact of COVID-19 on the enrollment of patients and timing of clinical results, and other matters that could affect the sufficiency of existing cash to fund operations. HOOKIPA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see HOOKIPA’s quarterly report on Form 10-Q for the quarter ended March 31, 2023, which is available on the Security and Exchange Commission’s website at www.sec.gov and HOOKIPA’s website at www.hookipapharma.com.

Investors and others should note that we announce material financial information to our investors using our investor relations website (https://ir.hookipapharma.com/), SEC filings, press releases, public conference calls and webcasts. We use these channels, as well as social media, to communicate with our members and the public about our company, our services and other issues. It is possible that the information we post on social media could be deemed to be material information. Therefore, we encourage investors, the media, and others interested in our company to review the information we post on the U.S. social media channels listed on our investor relations website.

For further information, please contact:

Media	Investors
Instinctif Partners	Reinhard Kandera
[email protected]	Chief Financial Officer
+44 (0) 7457 2020	[email protected]

NEW YORK, June 09, 2023 (GLOBE NEWSWIRE) — Keefe, Bruyette & Woods, Inc., a leading specialist investment bank to the financial services and fintech sectors, and a wholly owned subsidiary of Stifel Financial Corp. (NYSE: SF), announces the upcoming index rebalancing for the second quarter of 2023.

This quarter, there are constituent changes within one of our indexes: the KBW Nasdaq Bank Index (Index Ticker: BKX; ETF Ticker: KBWB).

These changes will be effective prior to the opening of business on Tuesday, June 20, 2023.

As part of this rebalancing, below are the component-level changes across impacted indices:

KBW Nasdaq Bank Index (Index Ticker: BKX; ETF Ticker: KBWB)

Add (3):

First Horizon Corporation (NYSE: FHN)

The Goldman Sachs Group, Inc. (NYSE: GS)

Morgan Stanley (NYSE: MS)

Several of the KBW Nasdaq indexes have tradable exchange‐traded funds licensed: KBW Nasdaq Bank Index (Index Ticker: BKX^SM, ETF Ticker: KBWB^SM); KBW Nasdaq Capital Markets Index (Index Ticker: KSX^SM); KBW Nasdaq Insurance Index (Index Ticker: KIX^SM); KBW Nasdaq Regional Banking Index (Index Ticker: KRX^SM, ETF Ticker: KBWR^SM); KBW Nasdaq Financial Sector Dividend Yield Index (Index Ticker: KDX^SM, ETF Ticker: KBWD^SM); KBW Nasdaq Premium Yield Equity REIT Index (Index Ticker: KYX^SM, ETF Ticker: KBWY^SM); KBW Nasdaq Property and Casualty Insurance Index (Index Ticker: KPX^SM, ETF Ticker: KBWP^SM); KBW Nasdaq Global Bank Index (Index Ticker: GBKX^SM); KBW Nasdaq Financial Technology Index (Index Ticker: KFTX^SM, ETF Ticker: FTEK.LN^SM).

Not all of the listed securities may be suitable for retail investors; in addition, not all of the listed securities may be available to U.S. investors. European investors interested in FTEK.LN can contact Invesco at https://etf.invesco.com/gb/private/en/product/invesco-kbw-nasdaq-fintech-ucits-etf-acc/trading-information. U.S. investors cannot buy or hold FTEK LN. An investor cannot invest directly in an index.

About KBW

KBW (Keefe, Bruyette & Woods, Inc., operating in the U.S., and Stifel Nicolaus Europe Limited, also trading as Keefe, Bruyette & Woods Europe, operating in Europe) is a Stifel company. Over the years, KBW has established itself as a leading independent authority in the banking, insurance, brokerage, asset management, mortgage banking and specialty finance sectors. Founded in 1962, the firm maintains industry‐leading positions in the areas of research, corporate finance, mergers and acquisitions as well as sales and trading in equities securities of financial services companies.

Media Contact

Neil Shapiro, (212) 271-3447
[email protected]