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• Represents First Ever Natural Killer Immunotherapy trial in Metastatic Castration-Resistant Prostate Cancer
• Webinar at 11AM ET on Friday, May 12.

BOCA RATON, Fla., May 08, 2023 (GLOBE NEWSWIRE) —

INmune Bio, Inc. (NASDAQ: INMB) announced today the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for INKmune™, a novel natural killer (NK) cell immunotherapy, for a Phase I/II open-label clinical trial for the treatment of metastatic Castration-Resistant Prostate Cancer (mCRPC).  The Company believes this is the first NK immunotherapy trial in men with mCRPC, which affects more than 80,000 men in the U.S.  The trial is expected to enroll the first of 30 patients in the second half of 2023. It will be opened at 4 more clinical study sites, with a goal to determine short and long-term safety of INKmune™, demonstrate the ability of INKmune™ to control prostate cancer tumor burden, and identify a dose of INKmune™ to be used in a future blinded randomized pivotal trial.

The principal investigator of the clinical trial is Prof. Matt Rettig MD, Professor of Medicine and Urology, Medical Director of the Prostate Cancer Program at the David Geffen School of Medicine at UCLA and member of the Jonsson Comprehensive Cancer.  Prof. Rettig is a consultant to INmune Bio.  According to RJ Tesi, MD, CEO of INmune Bio, “Prostate cancer is one of the few solid tumors that has no immunotherapy options and chemotherapy, the standard-of-care, has suboptimal efficacy with measurable toxicities.  INKmune™ has the potential to provide a safe and effective therapeutic option for men with this difficult disease.”

This will be the second clinical trial using INKmune™ to treat cancer.  The first trial, called Laurel, is an on-going Phase I trial in patients with high risk MDS or AML.  Mark Lowdell PhD, CSO of INmune Bio and inventor of the INKmune™ technology said, “There are compelling clinical evidence demonstrating that men with prostate cancer have lots of NK cells in the blood and their tumor, but often these NK cells are resting or immature NK cells that do not kill cancer.  INKmune therapy can convert these inert NK into therapeutically relevant and effective NK cells.” 

Patients will receive one of three doses of INKmune as an out-patient treatment during the six-month trial.  Two markers of INKmune™ efficacy will be measured – immunologic and therapeutic efficacy.  Immunologic efficacy will measure the increase in memory-like NK cells in the blood and how long those cells are present in the patient’s blood.  Therapeutic efficacy will measure tumor response to INKmune therapy, using traditional biomarkers of prostate cancer tumor burden (progression-free survival, changes in blood PSA level, and tumor burden measured by bone and CT scan). Novel biomarkers of tumor response, PMSA PET scan and circulating tumor DNA, will also be studied.

The Company will host a Webinar entitled: INKmune Primed NK cell Therapy for mCRPC on Friday, 12 May at 11 AM EDT on to discuss why INKmune™ is well suited for the treatment of men with mCRPC and provide details of the clinical trial design.  RJ. Tesi, MD will moderate a discussion between Prof. Matt Rettig, MD and Prof. Mark Lowdell, PhD. 

To register for the webinar, please sign-up by clicking here or the link below:

https://us06web.zoom.us/webinar/register/WN_nFfja42fQQieF4bwCiz4_g

About INKmune™

 

INKmune™ is a product designed to improve the function of the patient’s own NK cells.  INKmune™ is a clinical-grade, replication-incompetent human tumor cell line which conjugates to resting NK cells and delivers multiple, essential priming signals, akin to treatment with at least three cytokines in combination. INKmune™ is stable at -80^oC and is delivered by a simple IV infusion. The INKmune:NK interaction ligates multiple activating and co-stimulatory molecules on the NK cell and enhances its avidity of binding to tumor cells; notably those resistant to normal NK-mediated lysis. Tumor-primed NK (TpNK) cells can lyse a wide variety of NK-resistant tumors including leukemias, lymphomas, myeloma and solid tumors including prostate, renal cell, ovarian, nasopharyngeal, lung and breast cancer. INKmune therapy does not require any type of conditioning, pre-medication or cytokine support. 

About INmune Bio, Inc.

INmune

 

Bio,

 

Inc
. is a publicly traded (NASDAQ: INMB), clinical-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease. INmune Bio has two product platforms that are both in clinical trials: The Dominant-Negative Tumor Necrosis Factor (DN-TNF) product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and a mechanistic driver of many diseases. DN-TNF product candidates are in clinical trials to determine if they can treat cancer (INB03™), Mild Alzheimer’s disease, Mild Cognitive Impairment and treatment-resistant depression (XPro™). The Natural Killer Cell Priming Platform includes INKmune™ developed to prime a patient’s NK cells to eliminate minimal residual disease in patients with cancer. INmune Bio’s product platforms utilize a precision medicine approach for the treatment of a wide variety of hematologic and solid tumor malignancies, and chronic inflammation. To learn more, please visit www.inmunebio.com.

Forward Looking Statements

Clinical trials are in early stages and there is no assurance that any specific outcome will be achieved. Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995.  Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. INB03™, XPro1595, and INKmune™ are still in clinical trials or preparing to start clinical trials and have not been approved by the US Food and Drug Administration (FDA) or any regulatory body and there cannot be any assurance that they will be approved by the FDA or any regulatory body or that any specific results will be achieved. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company’s ability to produce more drug for clinical trials; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company’s filings with the Securities and Exchange Commission, including the Company’s Annual Report on Form 10-K, the Company’s Quarterly Reports on Form 10-Q and the Company’s Current Reports on Form 8-K. The Company assumes no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this release.

INmune Bio
Contact:

David Moss, CFO (858) 964-3720
[email protected]

Investor Contact:

Jason Nelson
Core IR
(516) 842-9614 x-823

BEDFORD, Mass., May 08, 2023 (GLOBE NEWSWIRE) — Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that Antony Mattessich, President and Chief Executive Officer of Ocular Therapeutix, will participate in a fireside chat at the JMP Securities Life Sciences Conference on Monday, May 15, 2023 at 3:00 PM EDT at the New York Hilton Midtown in New York, NY.

In addition to the fireside chat, the management team will host investor meetings at the conference. Investors participating in the conference who are interested in meeting with Ocular Therapeutix management should contact their JMP representative.

A live webcast of the fireside chat can be accessed by visiting the Investors section of the Company’s website at investors.ocutx.com.

About Ocular Therapeutix, Inc.

Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix’s first commercial drug product, DEXTENZA^®, is an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery and ocular itching associated with allergic conjunctivitis. Ocular Therapeutix’s earlier stage development assets include: OTX-TKI (axitinib intravitreal implant), currently in Phase 1 clinical trials for the treatment of wet AMD and diabetic retinopathy; OTX-TIC (travoprost intracameral implant), currently in a Phase 2 clinical trial for the treatment of primary open-angle glaucoma or ocular hypertension; and OTX-DED (dexamethasone intracanalicular insert) for the short-term treatment of the signs and symptoms of dry eye disease; and OTX-CSI (cyclosporine intracanalicular insert) for the chronic treatment of dry eye disease, both of which have completed Phase 2 clinical trials.

Investors

Ocular Therapeutix
Donald Notman
Chief Financial Officer
[email protected]

or

ICR Westwicke
Chris Brinzey
Managing Director
[email protected]

SAN JOSE, Calif., May 08, 2023 (GLOBE NEWSWIRE) — Infinera (NASDAQ: INFN) announced today the successful completion of a simulated intercity network trial for Telstra InfraCo’s intercity fiber project in Australia. The trial delivered a leading-edge 61.3 terabits per second (Tbps) of unregenerated data transmission capacity on a fiber pair over the equivalent of 1,240 route kilometers between Melbourne and Sydney. The network trial was implemented using Infinera’s 800G-capable ICE6 coherent solution and Corning Incorporated’s SMF-28® ULL fiber with advanced bend, demonstrating the high-performance capability of the express network, which is part of the intercity fiber network Telstra InfraCo is building across Australia.

The trial was performed with real-world configurations, including 1,240 kilometers of ultra-low-loss fiber simulating one of Telstra InfraCo’s planned express Melbourne-Sydney routes. Infinera performed an in-service, non-traffic-impacting upgrade from C-band to combined C-band plus L-band as part of the capacity expansion process. With Infinera’s ICE6 and Corning’s optical fiber, Telstra InfraCo achieved 61.3 Tbps total capacity with 6.2 milliseconds latency across the combined C-band and L-band, with wavelengths up to 700 Gbps.

Telstra InfraCo’s express network is designed to be a high-performance national network for customers who need reliable, ultra-high bandwidth between capital cities and international submarine cable landing stations. For hyperscalers, global cloud providers, content companies, and governments, this means access to scalable high capacity and more direct routes, with optional route redundancy.

“Based on these results, Telstra InfraCo’s express network and overall intercity fiber build will lead the world in scale, low latency, and high data transmission performance rate,” said Kathryn Jones, Fiber Executive at Telstra InfraCo. “The simulation exceeds our expectations, offering almost seven times today’s typical capacity of 8.8 Tbps per fibre pair and validates our selection of Corning’s SMF-28 ULL fiber in the cable design. This will enable Telstra to develop market-leading solutions for our customers today and for years to come – a key element of Telstra’s ambitious T25 strategy and transformation goals.”

“To meet the rigorous demands of a vast network over Australia’s unique terrain, Telstra InfraCo needed fiber infrastructure with advanced bend capability and minimal signal loss to deliver ultra-high cable capacity. That’s why they turned to Corning,” said Sharon Bois, Division Vice President, Product Line and Marketing, Corning Optical Fiber and Cable. “Our SMF-28® ULL fiber with advanced bend is designed to meet exactly those needs.”

“Infinera’s 800G-capable ICE6 solution demonstrated industry-leading performance, maximizing fiber capacity and reach on Telstra InfraCo’s express network configuration,” said Nick Walden, Senior Vice President of Worldwide Sales at Infinera. “This achievement underscores the enhanced performance Infinera’s technology can bring to meet Telstra InfraCo’s express network requirements for bandwidth today and into the future.”

Contacts:

Media:

Anna Vue
Tel. +1 (916) 595-8157 
[email protected]

Investors:

Amitabh Passi, Head of Investor Relations
Tel. +1 (669) 295-1489 
[email protected]

About Telstra InfraCo

As Telstra’s specialist infrastructure business, we are committed to partnering with our customers to accelerate business opportunities by accessing our diverse national telecommunications infrastructure.Telstra InfraCo’s growing asset portfolio includes 250,000 kilometres of fiber optic cable, 370,000 kilometres of ducts, 160,000 poles, and thousands of fixed network facilities including data centres, cable landing stations and satellite ground stations. Telstra InfraCo supports Australia’s fixed and mobile networks, and has access to 400,000 kilometres of sub-sea cables enabling greater connectivity and reach for our customers globally. To learn more about Telstra InfraCo, visit infraco.telstra.com.au and LinkedIn.

For more on Telstra InfraCo’s intercity fiber project refer to White Paper, Telstra InfraCo Express Intercity Fibre Network, 08 Nov 2022, which explains the intercity project in more detail, including the express network path.

About Corning Incorporated

Corning (www.corning.com) is one of the world’s leading innovators in materials science, with a 170-year track record of life-changing inventions. Corning applies its unparalleled expertise in glass science, ceramic science, and optical physics along with its deep manufacturing and engineering capabilities to develop category-defining products that transform industries and enhance people’s lives. Corning succeeds through sustained investment in RD&E, a unique combination of material and process innovation, and deep, trust-based relationships with customers who are global leaders in their industries. Corning’s capabilities are versatile and synergistic, which allows the company to evolve to meet changing market needs, while also helping its customers capture new opportunities in dynamic industries. Today, Corning’s markets include optical communications, mobile consumer electronics, display, automotive, solar, semiconductors, and life sciences. 

About Infinera

Infinera is a global supplier of innovative open optical networking solutions and advanced optical semiconductors that enable carriers, cloud operators, governments, and enterprises to scale network bandwidth, accelerate service innovation, and automate network operations. Infinera solutions deliver industry-leading economics and performance in long-haul, submarine, data center interconnect, and metro transport applications. To learn more about Infinera, visit www.infinera.com, follow us on Twitter and LinkedIn, and subscribe for updates.

Infinera and the Infinera logo are registered trademarks of Infinera Corporation.

This press release contains forward-looking statements, including but not limited to the technical and performance capabilities of Infinera’s ICE6 800G coherent optical solution. These statements are not guarantees of results and should not be considered as an indication of future activity or future performance. Actual results may vary materially from these expectations as a result of various risks and uncertainties. Information about these risks and uncertainties, and other risks and uncertainties that affect Infinera’s business, is contained in the risk factors section and other sections of Infinera’s Quarterly Report on Form 10-Q for the Fiscal Quarter ended April 1, 2023 as filed with the SEC on May 4, 2023, as well as any subsequent reports filed with or furnished to the SEC. These reports are available on Infinera’s website at www.infinera.com and the SEC’s website at www.sec.gov. Forward-looking statements include statements regarding our expectations, beliefs, intentions or strategies and can be identified by words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “should,” “will,” and “would” or similar words. Infinera assumes no obligation to, and does not currently intend to, update any such forward-looking statements.

– Partnership to support one of the Company’s preclinical programs outside of thyroid eye disease (TED) –

WALTHAM, Mass., May 08, 2023 (GLOBE NEWSWIRE) — Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biotechnology company focused on discovering and developing potential best-in-class medicines for serious and rare diseases, today announced a new partnership with Enable Injections, a company developing and manufacturing the enFuse^® innovative wearable drug delivery system for volumes of up to 25mL.

“As we expand our pipeline beyond TED and assess the unmet needs of patients living with other serious and rare diseases, it’s clear that convenient drug delivery is an important issue,” said Scott Myers, President and CEO of Viridian. “We believe Enable’s proprietary technology can contribute meaningfully to our goal of delivering therapeutic advances while reducing patient treatment burden as well.”

“Enable Injections is excited to partner with Viridian to utilize the enFuse^® technology to enhance the patient experience,” said Michael D. Hooven, Enable Injections’ Chairman and CEO. “The enFuse^® on-body delivery system was engineered with the patient in mind—the hidden needle and hands-free delivery allows patients to have increased flexibility, improved convenience, and the ability to administer medication discreetly, whether at home via self-administration or in the clinic.”

This partnership, which applies exclusively to areas outside of Viridian’s established TED portfolio, underscores the company’s commitment to patient-centric innovation.

About Viridian Therapeutics

Viridian Therapeutics is a biopharmaceutical company focused on engineering and developing potential best-in-class medicines for patients with serious and rare diseases. Viridian’s expertise in antibody discovery and engineering enables it to develop differentiated therapeutic candidates for previously validated drug targets in commercially established disease areas.

Viridian is advancing multiple candidates in the clinic for the treatment of patients with thyroid eye disease (TED). The Company has initiated its first global Phase 3 trial called ‘THRIVE’ to evaluate the safety and efficacy of VRDN-001 in patients with active TED. Viridian is also evaluating VRDN-001 in a Phase 2 proof-of-concept trial in patients with chronic TED. In addition to its program for intravenously administered VRDN-001, the Company is advancing three candidates for its subcutaneous strategy with the goal of providing a more conveniently administered therapy to patients with TED. Viridian is also developing multiple preclinical assets in autoimmune and rare diseases.

Viridian is based in Waltham, Massachusetts. For more information, please visit www.viridiantherapeutics.com. Follow Viridian on LinkedIn and twitter.

About Enable Injections

Cincinnati-based Enable Injections is a global healthcare innovation company developing and manufacturing drug delivery systems designed to improve the patient experience. Enable’s body-worn enFuse^® delivers high-volume pharmaceutical and biologic therapeutics via subcutaneous administration, with the aim of improving convenience, supporting superior outcomes, and advancing healthcare system economics. The investigational enFuse system has not been approved for use by any regulatory agency and is currently not approved for commercial use. For more information, please visit www.enableinjections.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as, but not limited to, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or other similar terms or expressions that concern the Company’s expectations, plans and intentions. Forward-looking statements include, without limitation, statements regarding the Company’s expectations, strategies, plans and intentions. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on the Company’s current beliefs, expectations, and assumptions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties, including our belief in the potential benefit of the Enable Injections technology and those risks set forth under the caption “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 9, 2023 and other subsequent disclosure documents filed with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither the Company, nor its affiliates, advisors, or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof.

Contacts

Investors:
Louisa Stone, 508-808-2400
Manager, Investor Relations
[email protected]

Todd James, 617-272-4691
Senior Vice President, Corporate Affairs and Investor Relations
[email protected]

Media:
Matt Fearer, 617-272-4605
Vice President, Corporate Communications
[email protected]

Source: Viridian Therapeutics, Inc. 

— Completed enrollment in BROOKLYN Phase 3 clinical trial evaluating obicetrapib in patients with heterozygous familial hypercholesterolemia (“HeFH”) ahead of schedule; topline results expected in 2H 2024 —

— Announced positive topline results in January 2023 and scheduled to present full data from ROSE2 Phase 2 clinical trial evaluating combination of obicetrapib and ezetimibe at the National Lipid Association (“NLA”) Scientific Sessions in June 2023 —

— Expect to report topline results from Phase 2 dose-finding trial of obicetrapib in Japanese patients with dyslipidemia and from Phase 2a trial evaluating obicetrapib in patients with early Alzheimer’s disease in 2H 2023 —

— Topline data from pivotal Phase 3 BROADWAY and PREVAIL trials on-track to be announced in 2H 2024 and 2026, respectively —

NAARDEN, the Netherlands and MIAMI, May 08, 2023 (GLOBE NEWSWIRE) — NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a clinical-stage company focused on the research and development of transformative oral therapies for major cardiometabolic diseases, today provided a corporate update and announced financial highlights for the first quarter ended March 31, 2023.

“We are pleased to report an exceptional start to the year, marked by key accomplishments across our business,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam. “We recently announced the early completion of enrollment in our Phase 3 BROOKLYN trial evaluating obicetrapib in patients with HeFH. Likewise, enrollment in our Phase 3 BROADWAY trial and Phase 3 cardiovascular outcomes (“CVOT”) PREVAIL trial continues to be strong. We have over 1,700 patients randomized in BROADWAY and over 3,400 patients randomized in PREVAIL and expect to complete enrollment in the middle of 2023 and the first quarter of 2024, respectively. We believe that the strong enrollment we have seen in each clinical trial, at a time when patients and investigators have the option of similar clinical trials using injectable drugs, reflects the significant unmet need for a potent oral therapy that can be used as an adjunct to maximally tolerated statin therapy to help patients achieve target low-density lipoprotein cholesterol (“LDL-C”) levels.”

Dr. Davidson continued, “In addition, we plan to announce data from multiple Phase 2 trials in the coming months. We are eager to share full data from the Phase 2 ROSE2 trial at the NLA Scientific Sessions in June, as well as topline results from the Phase 2 dose-finding trial in Japanese patients with dyslipidemia and from the Phase 2a trial in patients with early Alzheimer’s disease, which we expect in the second half of 2023. We believe that, taken together, these datasets can provide important information on the potential of obicetrapib as a next-generation, oral, low-dose CETP inhibitor with the potential to deliver a safe, convenient and effective solution to patients living with some of the world’s most prevalent and debilitating diseases.”

Clinical Development Updates:

NewAmsterdam is developing obicetrapib, an oral, low-dose and once-daily CETP inhibitor, as the preferred LDL-C lowering therapy to be used as an adjunct to maximally tolerated statin therapy for high-risk cardiovascular disease patients. The Company is currently conducting three pivotal Phase 3 clinical trials of obicetrapib: BROOKLYN, evaluating the effect of obicetrapib on LDL-C levels in patients with HeFH as an adjunct to maximally tolerated lipid-lowering therapy; BROADWAY, evaluating the effect of obicetrapib on top of maximally tolerated lipid-lowering therapy in patients with HeFH and/or established atherosclerotic cardiovascular disease (“ASCVD”); and PREVAIL, a CVOT in patients with a history of ASCVD with inadequately controlled LDL-C despite treatment with maximally tolerated lipid-modifying therapies.

In April 2023, NewAmsterdam announced the early completion of enrollment of over 350 patients in the pivotal Phase 3 BROOKLYN trial.

NewAmsterdam is also evaluating obicetrapib in a Phase 2a clinical trial in patients with early Alzheimer’s disease and at least one copy of the apolipoprotein E4 mutation. This study is designed to assess pharmacodynamic and pharmacokinetic effects, safety and tolerability, including whether CETP inhibition results in increased ApoA1 levels in patient cerebrospinal fluid. There is abundant pre-clinical data that suggests patients with the E4 variant of the ApoE protein are worse at transporting amyloid-beta peptides out of the brain, and increasing ApoA1 levels in the brain may rescue this loss-of-function by restoring appropriate cholesterol clearance. Pre-clinical data suggests that cholesterol accumulation in the brain may be a precursor to Alzheimer’s disease; in pre-clinical animal studies, the Company observed a statistically significant reduction in a biomarker of Alzheimer’s disease.

Corporate Updates

• In April 2023, NewAmsterdam appointed Janneke van der Kamp to its Board of Directors.
• In February 2023, NewAmsterdam appointed John W. Smither to its Board of Directors. Mr. Smither also serves as chair of the Company’s Audit Committee.

Upcoming Potential Milestones

NewAmsterdam currently expects to achieve the following upcoming milestones:

• Present full data from the Phase 2 ROSE2 clinical trial testing the combination of obicetrapib and ezetimibe at the NLA Scientific Sessions, June 1-4, 2023 in Atlanta, GA.
• Complete enrollment of the Phase 3 BROADWAY trial for obicetrapib monotherapy in mid-2023 and announce topline data in the second half of 2024.
• Announce topline data from the Phase 2a trial evaluating obicetrapib in ApoE4-carrying patients with early Alzheimer’s disease in the second half of 2023.
• Announce topline results from the Phase 2 obicetrapib monotherapy dose-finding trial in Japanese patients in the second half of 2023.
• Select formulation for Phase 3 fixed-dose combination of obicetrapib and ezetimibe in the second half of 2023.
• Complete enrollment in the Phase 3 PREVAIL trial for obicetrapib monotherapy in the first quarter of 2024 and announce topline data in the second half of 2026.
• Announce topline data from Phase 3 BROOKLYN trial for obicetrapib monotherapy in the second half of 2024.

Financial Highlights

• Cash Position: As of March 31, 2023, NewAmsterdam recorded cash of $441 million, compared to $468 million as of December 31, 2022 (equivalent to €439 million as was reported in the company’s Full Year 2022 Financial Results). The decrease reflects cash used to fund operating activities, partially offset by the receipt of a milestone payment from Menarini pursuant to the Company’s license agreement with Menarini.
• Financial Guidance: Based on its current operating and development plans, NewAmsterdam believes that its existing cash and cash equivalents will be sufficient to fund the Company’s operations through 2026, beyond the anticipated readout of its three ongoing Phase 3 trials, BROADWAY, BROOKLYN and PREVAIL.

About NewAmsterdam

NewAmsterdam Pharma (Nasdaq: NAMS) is a clinical-stage biopharmaceutical company whose mission is to improve patient care in populations with cardiometabolic diseases where currently approved therapies have not been sufficiently successful or well tolerated. NewAmsterdam is investigating obicetrapib, an oral, low-dose and once-daily CETP inhibitor, as the preferred LDL-C lowering therapy to be used as an adjunct to maximally-tolerated statin therapy for high-risk cardiovascular disease (“CVD”) patients. Results from NewAmsterdam Pharma’s ROSE Phase 2b trial (presented at AHA Scientific Sessions in 2021) included observations that patients receiving obicetrapib 10 mg experienced a median reduction in LDL-C of 51% versus baseline in patients on high-intensity statin therapy (vs. a 7% reduction in the placebo arm). In addition, topline results from NewAmsterdam Pharma’s ROSE2 trial evaluating the combination of 10 mg obicetrapib and 10 mg ezetimibe demonstrated a median reduction in LDL-C levels of 59% versus baseline in patients on high-intensity statin therapy (vs. a 6% reduction in the placebo arm). Based in the Netherlands, NewAmsterdam recently completed a business combination with FLAC, a special purpose acquisition company sponsored by an affiliate of Frazier Healthcare Partners. Proceeds from this transaction were approximately $328 million, prior to deducting transaction expenses. In June 2022, NewAmsterdam Pharma entered into an exclusive licensing agreement with the Menarini Group for the commercialization of obicetrapib in Europe, while retaining all rights to commercialize obicetrapib, if approved, in the rest of the world, as well as rights to develop certain forms of obicetrapib for other diseases such as Alzheimer’s disease. For more information, please visit: www.newamsterdampharma.com.

Forward-Looking Statements

Certain statements included in this document that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding the Company’s business and strategic plans, cash runway, the therapeutic and curative potential of the Company’s product candidate, the Company’s clinical trials and the timing for enrolling patients, the timing and forums for announcing data and the achievement and timing of regulatory approvals. These statements are based on various assumptions, whether or not identified in this document, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks relating to the uncertainty of the projected financial information with respect to the Company; risks related to the approval of the Company’s product candidate and the timing of expected regulatory and business milestones; ability to negotiate definitive contractual arrangements with potential customers; the impact of competitive product candidates; ability to obtain sufficient supply of materials; the impact of COVID-19; global economic and political conditions, including the Russia-Ukraine conflict; the effects of competition on the Company’s future business; and those factors described in the Company’s public filings with the U.S. Securities and Exchange Commission. Additional risks related to the Company’s business include, but are not limited to: uncertainty regarding outcomes of the Company’s ongoing clinical trials, particularly as they relate to regulatory review and potential approval for its product candidate; risks associated with the Company’s efforts to commercialize a product candidate; the Company’s ability to negotiate and enter into definitive agreements on favorable terms, if at all; the impact of competing product candidates on the Company’s business; intellectual property related claims; the Company’s ability to attract and retain qualified personnel; ability to continue to source the raw materials for its product candidate. If any of these risks materialize or the Company’s assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that the Company does not presently know or that the Company currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect the Company’s expectations, plans, or forecasts of future events and views as of the date of this document and are qualified in their entirety by reference to the cautionary statements herein. The Company anticipates that subsequent events and developments may cause the Company’s assessments to change. These forward-looking statements should not be relied upon as representing the Company’s assessment as of any date subsequent to the date of this communication. Accordingly, undue reliance should not be placed upon the forward-looking statements. Neither the Company nor any of its affiliates undertakes any obligation to update these forward-looking statements, except as may be required by law.

Company Contact

Matthew Philippe
P: 917-882-7512
[email protected]

Media Contact

Spectrum Science on behalf of NewAmsterdam
Bryan Blatstein
P: 917-714-2609
[email protected]

Investor Contact

Stern Investor Relations on behalf of NewAmsterdam
Hannah Deresiewicz
P: 1 212-362-1200
[email protected] 

Shanghai, China, May 08, 2023 (GLOBE NEWSWIRE) — YanGuFang International Group Co., Ltd. (Nasdaq: YGF) (the “Company”, or YanGuFang”), a health food company primarily engaging in the production, research and development, and sales of oat and grain products, announced today that it has named the “YanGuFang Company Laboratory” (the “Lab”) in partnership with the Rui Hai Liu Research Laboratory at Cornell University’s College of Agriculture and Life Sciences (“Cornell CALS”). The Lab’s mission is to improve human health through better nutrition and diet resulting from advanced food science research on whole grains.

Mr. Junguo He, the Chairman and CEO of the Company, commented, “We are excited to partner with the prestigious Cornell CALS to name the Lab. The Lab’s venture combines YanGuFang’s commitment to enhancing human health through advanced whole grain nutrition and Cornell CALS’ renowned research accomplishments in food science. The partnership between YanGuFang and Cornell CALS is a new and key step towards improving human health through better nutrition and will also facilitate our expansion in international markets. Moving forward, our goal is to leverage the college’s exceptional expertise in the food industry to establish global leadership in whole grain nutritional research, improve the nutrition of natural whole grain products, and enhance human nutritional health.”

About Cornell CALS

Cornell CALS is a premier institution of nutritional research, tackling complex challenges through purpose-driven science. The achievements and leadership of Cornell CALS’s faculty have been recognized globally, including the accomplishments of Dr. Rui Hai Liu. Dr. Liu’s research includes diet and the health benefits of functional foods and bioactive compounds including whole grains, such as oats. Dr. Liu is a Professor in the Department of Food Science within Cornell CALS, in Ithaca, NY., holding a M.D. and a Ph.D. in Toxicology. Dr. Liu has been named as a Highly Cited Researcher for 9 consecutive years.

About YanGuFang International Group Co., Ltd.

YanGuFang International Group Co., Ltd. is an integrated enterprise engaged in the production, research and development, sales and marketing of natural oat and whole grain products. The Company is committed to improving human health through its research to explore the nutritional benefits of its products. The Company has developed over 80 products in its natural oat and whole grain series. For more information, visit the Company’s website at http://ir.ygfang.com/.

Forward-Looking Statements

This press release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. Certain statements in this announcement are forward-looking statements. Investors can identify these forward-looking statements by words or phrases such as “may,” “will,” “expect,” “anticipate,” “aim,” “estimate,” “intend,” “plan,” “believe,” “is/are likely to,” “potential,” “continue” or other similar expressions. These statements are subject to uncertainties and risks including, but not limited to, the following: the Company’s goals and strategies; the Company’s forecast on market trend; the Company’s future business development; the demand for and market acceptance for new products; changes in technology; risks and uncertainties regarding lingering effects of the Covid-19 pandemic on the Company’s businesses, including disruptions to the Company’s supply chain; the Company’s ability to attract and retain skilled professionals; client concentration; and general economic conditions affecting the Company’s industry and assumptions underlying or related to any of the foregoing and other risks contained in reports filed by the Company with the SEC. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct, and the Company cautions investors that actual results may differ materially from the anticipated results and encourages investors to review other factors that may affect its future results in the Company’s filings with the SEC, which are available for review at www.sec.gov. The Company undertakes no obligation to update or revise publicly any forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations that arise after the date hereof, except as may be required by law.

For investor and media inquiries please contact:

YanGuFang International Group Co., Ltd.

Investor Relations Department
Email: [email protected]

Ascent Investor Relations LLC

Tina Xiao
Phone: +1 917-609-0333
Email: [email protected]

Represents the first FDA approved fixed-combination of tropicamide and phenylephrine for mydriasis

Provides critical validation of key technology that is core to Eyenovia’s proprietary development programs as well as current and future partnerships

NEW YORK, May 08, 2023 (GLOBE NEWSWIRE) — Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company developing the Optejet® device for use both in connection with its own drug-device therapeutic product candidates for presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, today announced that the U.S. Food and Drug Administration (FDA) has approved Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% for inducing mydriasis for diagnostic procedures and in conditions where short term pupil dilation is desired. This represents the first approved fixed dose combination of tropicamide and phenylephrine in the United States and also the first product using Eyenovia’s proprietary Optejet device to be approved by any regulatory authority.

Mydcombi is designed to improve the efficiency of the estimated 106 million office-based comprehensive eye exams performed every year in the United States, as well as the estimated 4 million pharmacologic mydriasis applications for cataract surgery. The product is contraindicated and should not be used in patients with known hypersensitivity to any component of the formulation.

“The approval of Mydcombi, our first FDA approved product, represents the culmination of years of tireless effort by the entire Eyenovia team, and I would like to express my sincere gratitude to the associates and technical experts who helped advance this important program through this transformational milestone,” stated Michael Rowe, chief executive officer of Eyenovia. “We look forward to introducing Mydcombi to key offices beginning this summer while we bring our internal manufacturing capabilities on-line for 2024.”

“Perhaps more importantly, FDA approval of Mydcombi provides critical validation of the Optejet as it is the first product approved using the Optejet platform, which is core not only to our internal development programs, including MicroLine for presbyopia, but our partnered programs as well. We see opportunities to unlock significant opportunities in the future treatment of other ophthalmic conditions including glaucoma and dry eye. I am confident in our ability to maintain our current momentum.”

“I am proud of our team for this significant achievement – which represents many ‘firsts’ for eye care,” stated Dr. Sean Ianchulev, Founder and Chairman of Eyenovia’s Board of Directors. “The use of eye dropper bottles has presented challenges for dosing in ophthalmologic settings in millions of patients. We can do better now using sophisticated micro-array print delivery with physiologic dosing that is similar to the natural tear film volume.”

Eyenovia management will provide additional updates on Mydcombi as well as its ongoing development programs and partnerships during its regularly scheduled first quarter 2023 update conference call and webcast on May 11^th, 2023.

IMPORTANT SAFETY INFORMATION for MYDCOMBI
™
 (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5%

INDICATIONS

MYDCOMBI is indicated to induce mydriasis for diagnostic procedures and in conditions where short term pupil dilation is desired

CONTRAINDICATIONS: In patients with known hypersensitivity to any component of the formulation

WARNINGS AND PRECAUTIONS

Not for Injection: Topical ophthalmic use

Significant Elevations in Blood Pressure: Caution in pediatric patients less than 5 years of age, and in patients with cardiovascular disease or hyperthyroidism. In patients at high risk, monitor blood pressure post treatment.

Central Nervous System Disturbances: Caution in pediatric patients where rare incidences of central nervous system disturbances have been reported.

Intraocular Pressure: May produce a transient elevation

Rebound Miosis: Reported 1 day after administration

ADVERSE REACTIONS

• Most common ocular adverse reactions include transient blurred vision, reduced visual acuity, photophobia, superficial punctate keratitis, and mild eye discomfort. Increased intraocular pressure has been reported following the use of mydriatics.
• Systemic adverse reactions including dryness of the mouth, tachycardia, headache, allergic reactions, nausea, vomiting, pallor, central nervous system disturbances and muscle rigidity have been reported with the use of tropicamide.

To report SUSPECTED ADVERSE REACTIONS, contact Eyenovia, Inc. At 1-833-393-6684 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch)

Please go to www.mydcombi.com for FULL PRESCRIBING INFORMATION

About Eyenovia, Inc.
Eyenovia, Inc. (NASDAQ: EYEN) is a commercial stage ophthalmic pharmaceutical technology company developing a pipeline of microdose array print therapeutics. Eyenovia is currently focused on the commercialization of Mydcombi for mydriasis, as well as the ongoing late-stage development of medications in the Optejet device for presbyopia and myopia progression. For more information, visit Eyenovia.com.

The Eyenovia Corporate Information slide deck may be found at ir.eyenovia.com/events-and-presentations.

Forward-Looking Statements
Except for historical information, all the statements, expectations and assumptions contained in this presentation are forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions, including estimated market opportunities for our product candidates and platform technology. These statements are based on current expectations, estimates and projections about our business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may, and in some cases are likely to, differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors discussed from time to time in documents which we file with the U.S. Securities and Exchange Commission.

In addition, such statements could be affected by risks and uncertainties related to, among other things: risks of our clinical trials, including, but not limited to, the costs, design, initiation and enrollment, timing, progress and results of such trials; the timing of, and our ability to submit applications for, obtaining and maintaining regulatory approvals for our product candidates; the potential advantages of our product candidates and platform technology; the rate and degree of market acceptance and clinical utility of our product candidates; our estimates regarding the potential market opportunity for our product candidates; reliance on third parties to develop and commercialize our product candidates; the ability of us and our partners to timely develop, implement and maintain manufacturing, commercialization and marketing capabilities and strategies for our product candidates; intellectual property risks; changes in legal, regulatory, legislative and geopolitical environments in the markets in which we operate and the impact of these changes on our ability to obtain regulatory approval for our products; and our competitive position.

Any forward-looking statements speak only as of the date on which they are made, and except as may be required under applicable securities laws, Eyenovia does not undertake any obligation to update any forward-looking statements.

Eyenovia Contact:

Eyenovia, Inc.
John Gandolfo
Chief Financial Officer
[email protected]

Eyenovia Investor Contact:

Eric Ribner
LifeSci Advisors, LLC
[email protected]
(646) 751-4363

Eyenovia Media Contact:

Eyenovia, Inc.
Norbert Lowe
Vice President, Commercial Operations
[email protected]

SEATTLE, May 08, 2023 (GLOBE NEWSWIRE) — Accolade, Inc. (NASDAQ: ACCD), a healthcare provider that serves millions of members, today announced that it will be presenting at the following upcoming investor events. A webcast and replay of each event will be available at ir.accolade.com.

• Monday, May 8 at 1:00 pm PT. Accolade’s Capital Markets Day at the Wynn Las Vegas
• Tuesday, May 9 at 3:40 pm PT. BofA Securities Health Care Conference 2023 at the Encore Hotel in Las Vegas

About Accolade, Inc.

Accolade (Nasdaq: ACCD) is a Personalized Healthcare company that provides millions of people and their families with exceptional healthcare experiences so they can live their healthiest lives. Accolade’s employer, health plan, and consumer solutions combine virtual primary care and mental health, expert medical opinion, and best-in-class care navigation. These offerings are built on a platform that is engineered to care through predictive engagement of population health needs, proactive care that improves outcomes and cost savings, and by addressing barriers to access and continuity of care. Accolade consistently receives consumer satisfaction ratings of over 90%. For more information, visit accolade.com. Follow us on LinkedIn, Twitter, Instagram and Facebook.

Investor Contact:

Todd Friedman, Investor Relations, [email protected]

Source: Accolade

DOYLESTOWN, Pa., May 08, 2023 (GLOBE NEWSWIRE) — Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical stage biopharmaceutical company focused on developing novel synthetic lethality-based cancer therapeutics targeting DNA damage response (DDR) pathways, today announced the appointment of Gabriela Gruia, M.D. to its Board of Directors, effective as of May 5, 2023. Dr. Gruia joins Aprea with over 25 years of clinical, regulatory and life science leadership experience.

“We are honored to welcome Dr. Gruia to the Aprea Board of Directors, where her deep experience and accomplishments in drug development and regulatory affairs will be of immense importance in advancing and expanding our pipeline of synthetic lethality inhibitors,” said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. “Dr. Gruia’s proven skills in executing successful drug development strategies will provide valuable support to our growing pipeline, as we look ahead to upcoming milestones, including continued advancement of our lead candidate, ATRN-119, currently in a Phase 1/2a monotherapy trial for the treatment of cancers with DDR mutations.”

Dr. Gruia currently serves as Principal at Gabriela Gruia Consulting, LLC, which she founded in January 2021. She also serves as an Independent Board Director at Tessa Therapeutics, TScan Therapeutics, and Molecular Templates. Prior to her time as a consultant, Dr. Gruia served as the Chief Development Officer at Ichnos Sciences Inc. where she led clinical development activities. Prior to that, she was Senior Vice President and Head of Drug Regulatory Affairs for Novartis Oncology, where she led an oncology regulatory affairs organization which oversaw worldwide regulatory submissions and approvals of twelve molecular oncological entities, and over 100 sNDAs and MAAs. Previously, Dr. Gruia held leadership roles in research and development at Novartis, Pfizer, Pharmacia, Aventis and Rhone Poulenc. Dr. Gruia received her M.D. from Bucharest Medical School in Romania and a Masters in Breast Pathology and Mammography from Rene Huguenin/Curie Institute Cancer Center in Paris, France. She received her training in oncology and hematology from Rene Descartes University in Paris, France.

“I am thrilled to join Aprea at this pivotal moment in the company’s growth. I was impressed by Aprea’s approach to cancer therapy using synthetic lethality, and I look forward to applying my expertise in R&D and regulatory affairs to help grow this promising pipeline of synthetic lethality inhibitors, and poise the company for success with regulatory agencies,” said Dr. Gruia. “I share Aprea’s mission and commitment to addressing unmet medical needs for patients suffering from cancers.”

About Aprea Therapeutics, Inc.

Aprea Therapeutics, Inc. is a clinical stage biopharmaceutical company headquartered in Doylestown, Pennsylvania, focused on developing and commercializing novel synthetic lethality-based cancer therapeutics targeting a critical pathway and some of the most central targets in DDR and cancer progression. The Company’s lead program is ATRN-119, a clinical-stage small molecule ATR inhibitor being developed for solid tumor indications. Our WEE1 inhibitor is being advanced to IND submission. For more information, please visit the company website at www.aprea.com.

The Company may use, and intends to use, its investor relations website at https://ir.aprea.com/ as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD.

Forward Looking Statement

Certain information contained in this press release includes “forward-looking statements”, within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, related to our study analyses, clinical trials, regulatory submissions, and projected cash position. We may, in some cases use terms such as “future,” “predicts,” “believes,” “potential,” “continue,” “anticipates,” “estimates,” “expects,” “plans,” “intends,” “targeting,” “confidence,” “may,” “could,” “might,” “likely,” “will,” “should” or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. Our forward-looking statements are based on current beliefs and expectations of our management team and on information currently available to management that involve risks, potential changes in circumstances, assumptions, and uncertainties. All statements contained in this press release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize and achieve market acceptance of our current and planned products and services, our research and development efforts, and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations. Any or all of the forward-looking statements may turn out to be wrong or be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. These forward-looking statements are subject to risks and uncertainties including risks related to the success and timing of our clinical trials or other studies, risks associated with the coronavirus pandemic and the other risks set forth in our filings with the U.S. Securities and Exchange Commission. For all these reasons, actual results and developments could be materially different from those expressed in or implied by our forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which are made only as of the date of this press release. We undertake no obligation to update such forward-looking statements for any reason, except as required by law.

Source: Aprea Therapeutics, Inc.

Investors and Media:

[email protected]
212-600-1902