On February 17, 2022 NexImmune, Inc. (Nasdaq: NEXI), a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells, reported that Kristi Jones has been appointed as the Company’s Chief Executive Officer and a member of its Board of Directors (Press release, NexImmune, FEB 17, 2022, View Source [SID1234608320]). Her appointment follows the departure of Scott Carmer, who submitted his letter of resignation this week.

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"The Board is pleased to appoint Kristi Jones as our new Chief Executive Officer and member of the Board of Directors," said Sol J. Barer, Chairman of NexImmune’s Board of Directors. "Kristi’s decades of experience in the biotechnology and pharmaceutical industries, which includes her playing a pivotal role in NexImmune’s strategic vision as Chief Business Officer and, most recently, Chief Operating Officer, make her the ideal candidate to lead the Company going forward. As we begin this transition, we are fortunate to have such a talented, innovative, and experienced leader to take us into the next phase of growth for the Company. We would also like to thank Scott Carmer for his contributions."

"It has been my privilege to be a part of NexImmune’s leadership team for the past six years, and I am honored to take on these new responsibilities," said Kristi Jones, NexImmune’s Chief Executive Officer. "I want to thank the Board of Directors for an extraordinary opportunity, and I look forward to building upon our groundbreaking efforts to unlock the potential of immunotherapies and revolutionize treatments for patients with high unmet medical need."

Prior to her roles as Chief Business Officer and Chief Operating Officer at NexImmune, Ms. Jones spent more than 25 years in various strategic and operational leadership roles at AstraZeneca (and its biologics R&D subsidiary, MedImmune), Genentech and Eli Lilly. At AstraZeneca, she was Vice President of Portfolio Strategy and Management, where she played an instrumental role in building a scientifically innovative, diverse portfolio creating new value for the Company. Prior to that role, she served as Vice President of Global Strategic Marketing to shape product plans and prepare MedImmune for multiple launches. Previously, Ms. Jones held multiple leadership roles with increasing responsibility at Genentech/Roche, where she worked for 16 years, including Head of Immunology and Ophthalmology in Global Portfolio and Product Strategy at Roche, Head of the Endocrine and Pulmonary franchise at Genentech, and Head of Immunology Business Unit Operations and Pipeline Planning at Genentech. Ms. Jones also served in a consulting role for various companies and organizations and serves on the Life Science Panel for Springboard Enterprises focused on start-up companies led by women. She is also an elected member to the Cell Therapy Committee of the Alliance for Regenerative Medicine. Ms. Jones received her RPh from the University of Texas and a BS in Biology from Texas Tech University.

On February 17, 2022 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported completed Phase 1 and interim Phase 2 ARDENT data for bavdegalutamide (ARV-110), a novel PROTAC degrader targeting the androgen receptor (AR) (Press release, Arvinas, FEB 17, 2022, View Source [SID1234608220]). These data continue to provide evidence of anti-tumor activity and clinical benefit in patients with metastatic castration-resistant prostate cancer (mCRPC). Bavdegalutamide reduced prostate-specific antigen (PSA) levels greater than or equal to 50% (PSA50) in 46% of patients with tumors harboring AR T878X and/ or H875Y (T878X = T878A or T878S) mutations, and two of the seven Response Evaluation Criteria in Solid Tumors (RECIST)-evaluable patients in this group also had confirmed tumor responses. These results also demonstrated PSA declines and tumor regressions in patients without tumors harboring AR T878X/H875Y mutations, suggesting an opportunity to develop bavdegalutamide more broadly in prostate cancer. Data from these trials will be presented in both a rapid abstract session and a poster session on February 17, 2022, at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (ASCO GU) Cancers Symposium.

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"These results reinforce our belief that bavdegalutamide has the potential to provide meaningful clinical benefits to a patient population for which few options exist after progression of their mCRPC," said John Houston, Ph.D., president and chief executive officer of Arvinas. "In addition to a PSA50 response rate of 46% in tumors harboring T875X and/or H878Y mutations, we also saw durable confirmed responses in 2 of the 7 evaluable patients in this group. Overall, these data give us confidence that there is a clear path forward to accelerating the potential development of this novel treatment as a precision medicine option for patients."

Highlights from the Phase 1 and interim Phase 2 ARDENT data (data cut-off date, December 20, 2021):

PSA50 rate of 46% in patients with AR T878X/H875Y tumor mutations (n=28)
Two durable confirmed RECIST (Response Evaluation Criteria in Solid Tumors) partial responses out of seven RECIST-evaluable patients with AR T878X/H875Y tumor mutations
PSA reductions and evidence of anti-tumor activity as measured by RECIST were observed across all subgroups regardless of mutation status, including in patients with tumors not harboring AR T878X/875Y mutations
PSA50 rate of 22% (six of 27) in evaluable patients in the subgroup defined as "less pretreated" (having received only one prior novel hormonal agent and no prior chemotherapy). A majority of patients with PSA50 declines in this group had tumors with the AR T878X/H875Y mutations.
Bavdegalutamide had a manageable tolerability profile at the recommended Phase 2 dose (RP2D) of 420 mg oral, once daily. Most treatment-related adverse events (TRAEs) were Grade 1/2 and there were no Grade ≥4 TRAEs in the 138 patients treated at the RP2D
Arvinas intends to initiate discussions with the U.S. Food and Drug Administration (FDA) about the potential for an accelerated approval pathway with bavdegalutamide in a molecularly defined mCRPC population. The Company also plans to initiate a pivotal trial by year end. Future studies will be planned to explore the potential to treat earlier-line patients who may benefit from bavdegalutamide therapy.

Bavdegalutamide Clinical Update

Enrollment

As of the data cut-off date of December 20, 2021, 195 patients were enrolled across the Phase 1/2 clinical trial (71 in Phase 1; 124 in Phase 2).

The Phase 1 dose escalation trial evaluated bavdegalutamide at doses ranging from 35–700 mg, orally, once-daily (QD), or 210–420 mg twice-daily (BID) in patients with mCRPC and ≥2 prior therapies (including abiraterone and/or enzalutamide or other AR antagonist).

The ARDENT Phase 2 dose expansion trial was administered at a starting dose of 420 mg QD. Patients in the ARDENT trial received a median of four prior lines of therapy with 100% receiving at least one novel hormonal therapy (NHA; 64% abiraterone, 75% enzalutamide or other AR inhibitor, 39% both abiraterone and an AR inhibitor) and 31% receiving at least one chemotherapy regimen.

Patients in ARDENT were enrolled in one of four subgroups:

Tumors with AR T878X and/or H875Y mutations and excluding AR L702H mutations and AR-V7 splice variants
Tumors with wild-type AR or AR alterations other than T878X, H875Y, L702H, AR-V7
Tumors with AR L702H mutations or AR-V7 splice variants, which are variants of AR that bavdegalutamide does not degrade preclinically
Biomarker agnostic tumors with only one prior NHA and no prior chemotherapy
The biomarker-agnostic subgroup is referred to as "less pretreated;" the three biomarker-defined subgroups are referred to collectively as "more pretreated" and received 1-2 prior NHA and no more than two regimens of chemotherapy.

Efficacy Measures

Efficacy measures are presented on a combined basis for patients in both the completed Phase 1 dose escalation trial and the interim analysis from the ongoing ARDENT Phase 2 dose expansion trial.

Biomarker defined ("more pretreated"):
In patients with:

Tumors with AR T878X and/or H875Y mutations but excluding L702H and AR-V7 (n=8)
PSA50=75%; PSA30=75%
Tumors with wild-type AR or AR alterations other than T878X, H875Y, L702H, or AR-V7 (n=44)
PSA50=11%; PSA30=20%
Tumors with AR L702H or AR-V7 (n=25)
PSA50=4%; PSA30=20%
Biomarker agnostic ("less pretreated"):

No more than one prior NHA and no prior chemotherapy (n=27)
PSA50=22%; PSA30=26%
In biomarker-evaluable patients treated at or above the RP2D and with tumors harboring AR T878X/H875Y mutations (across all subgroups and thus regardless of prior therapy regimens or other mutations; n=28), the PSA50 response rate was 46% and the PSA decline of more than 30% (PSA30) response rate was 57%.

Of seven RECIST-evaluable patients across the Phase 1/Phase 2 trial having tumors harboring AR T878X/H875Y mutations, two had confirmed durable confirmed partial responses. These patients were on treatment for approximately nine months (ongoing as of the data cut-off) and 10 months; the duration of treatment ranged from eight weeks to 44 weeks, with three of the seven patients continuing on treatment as of the data cutoff of December 20, 2021.

Twelve (43%) of the 28 patients with AR T878X/H875Y-positive tumors received bavdegalutamide for ≥24 weeks, with nine patients ongoing as of the data cutoff.

One confirmed and three unconfirmed RECIST responses were seen in patients with tumors lacking AR T878X/H875Y mutations. The "less pretreated" subgroup (n=27) had a similar molecular profile – as assessed by circulating tumor DNA analysis – to the more pretreated, biomarker-defined subgroups in the ARDENT trial. These similarities included both AR variations (point mutations and AR-V7 splice variants) and non-AR mutations frequently associated with poor outcomes (e.g., TP53, BRCA1). Six of the 27 patients (22%) had PSA50 reductions, and this PSA50 rate was similar to that observed collectively in the "more pretreated" subgroups (16%; n=77). Four of the six "less pretreated" patients with PSA50 declines had tumors with AR T878X/H875Y mutations.

Safety

Bavdegalutamide had a manageable tolerability profile at the RP2D of 420 mg QD. The majority of treatment-related adverse events (TRAEs) were Grade 1/2 and there were no Grade ≥4 TRAEs in the 138 patients treated at the RP2D.

TRAEs that occurred in ≥10% of patients treated at the RP2D were nausea (Gr 1: 30%; Gr 2: 16%; Gr 3: 1%), fatigue (Gr 1: 23%; Gr 2: 12%; Gr 3: 1%), vomiting (Gr 1: 20%; Gr 2: 5%; Gr 3: 1%), decreased appetite (Gr 1: 14%; Gr 2: 11%; Gr 3: 1%), diarrhea (Gr 1: 14%; Gr 2: 4%; Gr 3: 2%), alopecia (Gr 1: 13%; Gr 2: 1%; Gr 3: N/A), AST increased (Gr 1: 9%; Gr 2: 3%; Gr 3: 1%), weight decreased (Gr 1: 7%; Gr 2: 5%; Gr 3: 0%), and anemia (Gr 1: 4%; Gr 2: 1%; Gr 3: 5%).

TRAEs at the RP2D led to dose reduction in 11 (8%) patients and discontinuation in 12 (9%) patients.

Anticipated 2022 Milestones for Bavdegalutamide

Discuss the potential accelerated approval path with the FDA (1H 2022)
Finalize partnership for companion diagnostic (1H 2022)
Initiate planned pivotal trial for patients with AR T878/H875 tumor mutations (2H 2022)
About Bavdegalutamide (ARV-110)
Bavdegalutamide is an investigational orally bioavailable PROTAC protein degrader designed to selectively target and degrade the androgen receptor (AR). Bavdegalutamide is being developed as a potential treatment for men with metastatic castration-resistant prostate cancer.

Bavdegalutamide has demonstrated activity in preclinical models of AR mutation or overexpression, both common mechanisms of resistance to currently available AR-targeted therapies.

On February 17, 2022 Repertoire Immune Medicines, Inc. reported it has entered a sponsored research agreement with UMass Chan Medical School (UMass Chan) to identify the specific T cell and antigen pairs involved in causing the onset and progression of the autoimmune disease vitiligo (Press release, Repertoire, FEB 17, 2022, View Source [SID1234608253]). The potential discovery of these immunogenic drivers of vitiligo could be used to develop antigen-specific therapeutic candidates for this disease.

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The research team at UMass Chan will be led by John E. Harris, M.D., Ph.D., Chair and Professor of Dermatology and Director of the Vitiligo Clinic and Research Center.

"In autoimmune diseases, the best therapeutic options typically act broadly to suppress the immune system, which can lead to other complications for patients. One of the challenges to discovering new treatment options for vitiligo is the significant complexity of the immune system," said Dr. Harris. "We understand the role of the T cell but have not been able to identify the specific codes directing their function. The opportunity to combine our expertise in vitiligo with Repertoire’s DECODE technology means that, for the first time, we may be able to advance from translational insight to novel, antigen-specific therapies."

Vitiligo is a chronic autoimmune disease in which CD8+ T cells kill melanin-producing cells, leading to the loss of skin pigmentation. In autoimmune diseases like vitiligo, the immune system directs T cells to target and damage healthy cells. It is unknown exactly why this occurs, but it is understood that the immune system activates T cells through codes communicated by antigens that direct T cell activity. If the codes directing the CD8+ T cells can be identified, then it may be possible to develop an immunotherapy that targets these cells and prevents them from killing healthy cells.

"The deep expertise and clinical experience that the UMass Chan team has in the field of vitiligo makes this an ideal partnership for Repertoire. We will be able to apply the proprietary technology in our DECODE platform to assess and potentially identify the key drivers of the dysregulated immune response underlying this autoimmune disease, specifically the T cells and the antigens that activate them," said Anthony Coyle, Ph.D., President, Research and Development, Repertoire Immune Medicines. "Repertoire’s DECODE technology also provides us with the potential to design targeted immunotherapies for vitiligo."

About the DECODE Platform

The DECODE platform is a powerful discovery engine that characterizes essential elements of the immune synapse. In particular, the platform identifies T cell receptor-antigen pairs in the context of other important features of the immune synapse, such as T cell function and how these antigens are presented by molecules on antigen-presenting cells, known as major human leukocyte antigen, or HLA, molecules. Repertoire intends to utilize these insights into key drivers that govern immune function to design and develop novel immune product candidates.

On February 17, 2022 Orion Biotechnology reported that Results from the Phase III ARASENS trial have shown that the use of the oral androgen receptor inhibitor (ARi) darolutamide plus androgen deprivation therapy (ADT) and docetaxel significantly increased overall survival (OS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) compared to ADT plus docetaxel. Darolutamide plus ADT and docetaxel significantly reduced the risk of death by 32.5% compared to ADT plus docetaxel (HR=0.68, 95% CI 0.57-0.80; P<0.001) (Press release, Orion Biotechnology, FEB 17, 2022, View Source [SID1234608321]). At the data cutoff date for the primary analysis (October 25, 2021), the median treatment duration was longer for darolutamide plus ADT and docetaxel (41.0 months) versus ADT plus docetaxel (16.7 months). Darolutamide plus ADT and docetaxel also showed consistent benefits for secondary endpoints and pre-specified subgroups. Adverse event (AE) rates were not increased by the addition of darolutamide. These results were presented at the 2022 ASCO (Free ASCO Whitepaper) GU Cancers Symposium and simultaneously published in The New England Journal of Medicine.

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"Metastatic prostate cancer is a uniformly fatal disease and despite progress in recent years, only 30% of these men will survive beyond five years. ARASENS demonstrated that the addition of darolutamide, an androgen receptor inhibitor, significantly increased overall survival for patients receiving standard androgen deprivation therapy and docetaxel as initial treatment for metastatic hormone-sensitive prostate cancer. Darolutamide also improved time to castration-resistant prostate cancer and other key secondary endpoints," said Matthew Smith, M.D., Ph.D., Director of the Genitourinary Malignancies Program, Massachusetts General Hospital Cancer Center. "These results are an important step forward for the treatment of patients with metastatic hormone-sensitive prostate cancer."

"At Orion, we are excited about the ARASENS trial results showing that darolutamide adds to the benefits of chemotherapy plus ADT for the patients with mHSPC. These results encourage us to further discover and develop new treatments for patients with prostate cancer", said Professor, M.D., Ph.D. Outi Vaarala, Senior Vice President of Research and Development at Orion.

ARASENS is the only randomized, double-blind pivotal study prospectively designed to compare the use of a second-generation ARi plus ADT and docetaxel to ADT plus docetaxel (a guideline recommended standard-of-care) in mHSPC.

Darolutamide is approved in more than 60 markets around the world, including the U.S., the European Union (EU), Japan and China, under the brand name Nubeqa, for the treatment of patients with nmCRPC, who are at high risk of developing metastatic disease. The product is developed jointly by Orion and Bayer. The compound is also being investigated in further studies across various stages of prostate cancer, including another Phase III trial in mHSPC (ARANOTE) as well as an ANZUP-led international co-operative group Phase III trial, evaluating darolutamide as an adjuvant treatment for localized prostate cancer with very high risk of recurrence (DASL-HiCaP, ANZUP1801).

Detailed results from ARASENS

The significant improvement in OS was observed despite substantially higher use of subsequent systemic antineoplastic therapies (such as abiraterone, enzalutamide, cabazitaxel, docetaxel, radium-223 dichloride, sipuleucel-T, lutetium-177 PSMA, or apalutamide) among patients receiving ADT plus docetaxel who entered follow-up (75.6%) compared with the group who received darolutamide plus ADT and docetaxel (56.8%). The ARASENS data also showed consistent improvements in key secondary endpoints including delaying the time to CRPC compared to the placebo arm (HR=0.36, 95% CI 0.30-0.42; P<0.001). Darolutamide plus ADT and docetaxel also significantly delayed time to pain progression versus ADT plus docetaxel (HR=0.79, 95% CI 0.66-0.95; P=0.01), time to first symptomatic skeletal event (SSE) (HR=0.71, 95% CI 0.54-0.94; P=0.02) and time to initiation of subsequent systemic antineoplastic therapy (HR=0.39, 95% CI 0.33-0.46; P<0.001).

Treatment-emergent adverse events (TEAEs) were similar between treatment arms. The most common TEAEs (≥10%) were highest during the overlapping docetaxel treatment period for both arms and decreased progressively thereafter. The most frequently reported AEs in the treatment arms (darolutamide plus ADT and docetaxel versus ADT plus docetaxel) were alopecia (40.5% and 40.6%, respectively), neutropenia (39.3% and 38.8, respectively), fatigue (33.1% and 32.9%, respectively) and anemia (27.8% and 25.1%, respectively). Grade 3 or 4 AEs reported in 66.1% versus 63.5% of patients were mainly due to neutropenia (33.7% versus 34.2%, respectively), which is a well-known effect of docetaxel treatment. Serious AEs occurred in 44.8% versus 42.3% of patients, and TEAEs leading to treatment discontinuation occurred in 13.5% versus 10.6% of patients.

AEs of special interest in patients treated with AR pathway inhibitors for prostate cancer such as fatigue, falls, fractures, mental impairment, and cardiovascular events were similar between study arms.

About the ARASENS trial

The ARASENS trial is a randomized, Phase III, multi-center, double-blind, placebo-controlled trial which was prospectively designed to investigate the efficacy and safety of oral darolutamide, an androgen receptor inhibitor (ARi), plus androgen deprivation therapy (ADT) and the chemotherapy docetaxel in patients with metastatic hormone-sensitive prostate cancer (mHSPC). A total of 1,306 newly diagnosed patients were randomized in a 1:1 ratio to receive 600 mg of darolutamide twice a day or matching placebo, plus ADT and docetaxel.

The primary endpoint of this trial was overall survival (OS). Secondary endpoints included time to castration-resistant prostate cancer (CRPC), time to pain progression, time to first symptomatic skeletal event (SSE), time to initiation of subsequent anticancer therapy, all measured at 12‐week intervals, as well as adverse events (AEs) as a measure of safety and tolerability.

About Metastatic Hormone-Sensitive Prostate Cancer

Prostate cancer is the second most commonly diagnosed malignancy in men worldwide. In 2020, an estimated 1.4 million men were diagnosed with prostate cancer, and about 375,000 died from the disease worldwide.1

At the time of diagnosis, most men have localized prostate cancer, meaning their cancer is confined to the prostate gland and can be treated with curative surgery or radiotherapy. Upon relapse when the disease will metastasize or spread, androgen deprivation therapy (ADT) is the cornerstone of treatment for this hormone-sensitive disease. Approximately 5% of men will already suffer from prostate cancer with distant metastases when first diagnosed. Current treatment options for men with metastatic hormone-sensitive prostate cancer (mHSPC) include hormone therapy, such as ADT, androgen receptor pathway inhibitors plus ADT or a combination of the chemotherapy docetaxel and ADT. Despite these treatments, most men with mHSPC will eventually progress to metastatic castration-resistant prostate cancer (mCRPC), a condition with limited survival.

About darolutamide

Darolutamide is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells. The low potential for blood-brain barrier penetration for darolutamide is supported by preclinical models and neuroimaging data in healthy humans. A low blood-brain barrier penetration would explain the overall low incidence of central nervous system (CNS)-related adverse events (AEs) compared to placebo as seen in the ARAMIS Phase III trial and the improved verbal learning and memory observed in the darolutamide arm of the Phase II ODENZA trial. The product is approved under the brand name Nubeqa in more than 60 markets around the world, including the U.S., EU, Japan, China, for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease. The compound is also being investigated in further studies across various stages of prostate cancer, including another Phase III trial in mHSPC (ARANOTE) as well as an ANZUP-led international co-operative group Phase III trial, evaluating darolutamide as an adjuvant treatment for localized prostate cancer with very high risk of recurrence (DASL-HiCaP, ANZUP1801). Information about these trials can be found at www.clinicaltrials.gov.

On February 17, 2022 Blue Water Vaccines, Inc. ("BWV" or "Blue Water Vaccines" or the "Company"), a biopharmaceutical company developing vaccines, reported the pricing of its initial public offering of 2,222,222 shares of its common stock at a public offering price of $9.00 per share (Press release, Onconetix, FEB 17, 2022, View Source [SID1234641103]). The shares are expected to begin trading on the Nasdaq Capital Market under the ticker symbol "BWV" on February 18, 2022.

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The aggregate gross proceeds to BWV from the initial public offering are expected to be approximately $20 million prior to deducting underwriting discounts, commissions, and other estimated offering expenses. The offering is expected to close on February 23, 2022, subject to the satisfaction of customary closing conditions.

Boustead Securities, LLC is acting as the sole book-running manager for the offering.

The Securities and Exchange Commission ("SEC") declared effective a registration statement on Form S-1 relating to these securities on February 11, 2022. A final prospectus relating to this offering will be filed with the SEC. The offering is being made only by means of a prospectus, copies of which, when available, may be obtained from; Boustead Securities, LLC, Attention: Prospectus Department, 6 Venture, Suite 325, Irvine, CA 92618, or by telephone at 949-502-4408, or by email at [email protected]. Investors may also obtain these documents at no cost by visiting the SEC’s website at View Source

Before you invest, you should read the prospectus and other documents the Company has filed or will file with the SEC for more complete information about the Company and the offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.