ALX Oncology Announces Upcoming Investor Conference Participation

On September 1, 2022 ALX Oncology Holdings Inc., ("ALX Oncology") (Nasdaq: ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, reported that management will participate in two upcoming investor conferences (Press release, ALX Oncology, SEP 1, 2022, View Source [SID1234618891]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Citi’s 17th Annual BioPharma Conference
Format: Investor meetings
Date: Wednesday, September 7
Location: Boston, MA

H.C. Wainwright 24th Annual Global Investment Conference
Format: Fireside chat with analyst, Swayampakula Ramakanth
Date: Monday, September 12
Time: 7:00 AM Eastern Time
Location: Virtual
Webcast link: Available here

A live webcast of the H.C. Wainwright fireside chat is available here and can be accessed by visiting the Investors section of ALX Oncology’s website at www.alxoncology.com and selecting Events under the News and Events tab. A replay of the webcast will be archived for up to 90 days following the fireside chat date.

Sutro Biopharma to Present at the 2022 Wells Fargo Healthcare Conference

On September 1, 2022 Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), reported that Bill Newell, Chief Executive Officer, will present at the 2022 Wells Fargo Healthcare Conference on Friday, September 9, 2022, at 10:25 a.m. ET / 7:25 a.m. PT in Boston (Press release, Sutro Biopharma, SEP 1, 2022, View Source [SID1234618890]).

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The presentation will be accessible through the News & Events page of the Investor Relations section of the company’s website at www.sutrobio.com. An archived replay will be available for at least 30 days after the event.

VBL Therapeutics Receives Nasdaq Notification Regarding Minimum Bid Price Deficiency

On September 1, 2022 VBL Therapeutics (Nasdaq: VBLT) ("VBL"), a biotechnology company developing targeted medicines for immune-inflammatory diseases, reported that VBL received a written notification (the "Notification Letter") from the Nasdaq Stock Market LLC ("Nasdaq") on August 31, 2022, notifying VBL that it is not in compliance with the minimum bid price requirement set forth in the Nasdaq Listing Rules for continued listing on the Nasdaq (Press release, VBL Therapeutics, SEP 1, 2022, View Source [SID1234618889]).

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Nasdaq Listing Rule 5450(a)(1) requires listed securities to maintain a minimum bid price of $1.00 per share, and Nasdaq Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum bid price requirement exists if the deficiency continues for a period of 30 consecutive business days. Based on the closing bid price of the VBL’s ordinary shares for the 30 consecutive business days from July 20, 2022, to August 30, 2022, VBL no longer meets the minimum bid price requirement.

The Notification Letter does not impact the VBL’s listing on the Nasdaq Global Market at this time. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), VBL has been provided 180 calendar days, or until February 27, 2023, to regain compliance with Nasdaq Listing Rule 5450(a)(1). To regain compliance, VBL’s ordinary shares must have a closing bid price of at least $1.00 for a minimum of 10 consecutive business days. In the event VBL does not regain compliance by February 27, 2023, VBL may be eligible for an additional 180 day period to regain compliance or may face delisting.

VBL’s business operations are not affected by the receipt of the Notification Letter. VBL intends to monitor the closing bid price of its ordinary shares and may, if appropriate, consider implementing available options, including, but not limited to, implementing a reverse share split of its outstanding ordinary shares, to regain compliance with the minimum bid price requirement under the Nasdaq Listing Rules.

Veracyte to Participate in the Morgan Stanley 20th Annual Global Healthcare Conference

On September 1, 2022 Veracyte, Inc. (Nasdaq: VCYT) reported that Marc Stapley, chief executive officer, and Rebecca Chambers, chief financial officer, will participate in a fireside chat at the Morgan Stanley 20th Annual Global Healthcare Conference on Tuesday, September 13, at 2:55 p.m. Eastern Time (Press release, Veracyte, SEP 1, 2022, View Source [SID1234618888]).

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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A live audio webcast of the company’s presentation will be available by visiting Veracyte’s website at View Source A replay of the webcast will be available for 90 days following the conclusion of the live presentation broadcast.

Orphan Drug Designation

On September 1, 2022 HEPHAISTOS-Pharma a French Biotech company developing a new class of immunotherapies to address hard-to-treat and metastatic cancers, reported that the European Commission granted Orphan Drug designation (ODD) to ONCO-Boost for the treatment of osteosarcoma (Press release, HEPHAISTOS-Pharma, SEP 1, 2022, View Source [SID1234618887]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"This designation is an important milestone in the development of ONCO-Boost and demonstrate its potential clinical benefits for sarcoma patients who have an urgent need for effective, tolerable, and convenient treatment options" said Frédéric Caroff, CEO and co-founder of HEPHAISTOS-Pharma. "This key milestone was reached thanks to the collaboration of HEPHAISTOS-Pharma with the academic teams from Pr. Charles Dumontet at the Centre de Recherche contre le Cancer de Lyon (CRCL), and Pr. Jean-Yves Blay at the Centre Léon Bérard (CLB). These collaborations have demonstrated the potential clinical benefit of ONCO-Boost against sarcomas such as osteosarcoma and chondrosarcoma, but also against Lymphoma, colorectal and breast cancers. The company is now heading toward regulatory validation and expects a first clinical study by 2023."

In a recent interview on B-SMART TV, Dr. Aurélie Dutour from the CLB estimates that "ONCO-Boost is a great opportunity for patients as there was no therapeutic progress against osteosarcoma for 40 years and even the latest antibodies used in Immunotherapy failed and did not show any efficacy. The results that we obtained with ONCO-Boost were impressive and really encouraging".

In the European Union (EU), Orphan drug designation is granted by the European Commission, based on a positive opinion issued by the EMA Committee for Orphan Medicinal Products, to investigational therapies addressing rare medical diseases or conditions that affect fewer than five in 10,000 persons in the EU, and having sufficient non-clinical or clinical data demonstrating its potential clinical benefit in the indication. Orphan drug status provides benefits to drug developers, including a 10-year period of marketing exclusivity in the EU after product approval, protocol assistance from the EMA at reduced fees during the product development phase and access to centralized marketing authorization.

About Osteosarcoma

Osteosarcoma (OSa) is the most common primary malignancy of bone in children and young adults, but it’s a rare disease with 35.000 cases diagnosed each year in the world. Despite multimodal treatments including mainly surgery and chemotherapies, the 5-year survival rate of OSa patients has not been improved in the last four decades with a rate around 60 % for patients with no clinically detectable metastasis and 30 % for patients with metastatic foci detectable at the time of diagnosis. There is therefore an urgent need to rapidly develop new treatment options for this very aggressive cancer causing the premature death of children.

About ONCO-Boost

ONCO-Boost is the first-in-class natural immunostimulant targeting the Toll Like Receptor 4 (TLR4) compatible with systemic administration enabling to address hard-to-treat and disseminated tumors but also metastatic cancers. ONCO-Boost development has reached preclinical regulatory phases by validating its industrialization, its safety but also its efficacy in various tumor models both as monotherapy and in combination with different therapeutic monoclonal antibodies (mAbs). As monotherapy, ONCO-Boost notably showed impressive anti-tumor efficacy on a relevant orthotopic Osteosarcoma model leading to complete regression of primary tumor and pulmonary metastasis in 78% and 40% of the animals respectively. Unprecedented results were also obtained in combination with a mAb like Rituximab on a Human B lymphoma model (Raise of complete response rates from 17% to 67-100%), and immune checkpoint inhibitors (ICI) on a mouse model of colorectal cancer (Raise of efficacity from 0% to 80%). ONCO-Boost was also found to generate anti-tumor memory immune responses for long-term protections against relapses but also to efficiently address at the same time primary tumors and related metastasis which is unique in this competitive field. The antitumor activity of ONCO-Boost was associated with its capacity to modulate the tumor microenvironment (TME) from a "cold" (immunologically suppressed) to a "hot" (immunologically active) environment.

HEPHAISTOS-Pharma is currently rising private funds to prepare industrialisation of the drug manufacturing and regulatory validation to go to clinical phases. Private investors or Business Angels can contact Frederic CAROFF, the CEO if they wish to participate to our next fundraising.