On September 9, 2021 Avalo Therapeutics presented a Corporate presentation(Presentation, Avalo Therapeutics, SEP 9, 2021, View Source [SID1234587479]).

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On September 9, 2021 ImmunoPrecise Antibodies, a leader in full-service therapeutic antibody discovery and development, reported financial results for first quarter fiscal year 2022, which ended July 31, 2021 (Press release, ImmunoPrecise Antibodies, SEP 9, 2021, View Source [SID1234587475]).

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First Quarter Fiscal Year 2022 Financial Summary*
• Revenues of $4.6 million, up 22%
• Research and development costs increased to $1.1 million from $309,213 in 2021
• The Company recorded a net loss of $3.2 million in the quarter
• Adjusted EBITDA** loss of $1.3M
• As of July 31, 2021, the Company held cash of $40.7M
*Expressed in Canadian dollars, unless otherwise indicated.
**For additional information on Adjusted

Dr. Jennifer Bath, CEO of ImmunoPrecise, stated, "This quarter marks an exciting leap into IPA’s major strategic initiatives to support our vision shared by the board of directors and management alike: Formidable and unabashed goals as we invest to recognize new heights of potential in our contract research, our internally-owned therapeutic assets, and new research and manufacturing services. In the previous quarters, our operational sites focused on the development of complementary revenue-generating service offerings, each of which is now resulting in new revenue streams. Under the guidance of our recently appointed CSO, Ilse Roodink, this quarter saw unprecedented investments driving later-stage pre-clinical asset development toward clinical manufacturing (PolytopeTM) and functional validation, as well as a ramp in earlier stage discovery. Our excitement around these programs is palpable yet does not overshadow our ongoing dedication to the Company’s contract research, as we celebrate numerous milestones such as our recent commercial partnership with Eurofins Discovery and ongoing push to open new doors to opportunities such as the French R&D tax credit, CIR (Crédit d’Impôt de Recherche). Our fiscal year is off to an energetic start as we continue to execute on growth strategies and focus in on initiatives around R&D investments, aggressive sales and partnering agendas, and potential acquisitions."

Recent and Fiscal 2021 Operational Highlights
• Appointed Dr. Ilse Roodink to the Role of Chief Scientific Officer and Dr. Dion Neame to the Strategic Advisory Board.
• Successfully demonstrated pre-clinical in vivo results for TATX-03 PolyTope Therapy, a four monoclonal antibody cocktail developed for the potential prevention and treatment of SARS-CoV-2. The preclinical study demonstrated potent pseudovirus, neutralizing activity against the SARS-CoV-2 Delta (B.1.617.2) variant.
• Histopathology preclinical data from TATX-03a Polytope Program confirms treatment substantially reduced bronchitis and tracheitis severity in preclinical studies.
• Completed preclinical efficacy studies for newly optimized 4-antibody cocktail (TATX-03b), showing strong in vivo therapeutic efficacy and synergy for the treatment and protection against SARS-CoV-2 infection
 o IPA’s optimized, 4-Ab cocktail (TATX-03b) shows high levels of efficacy in treating SARS-CoV-2 in the preclinical study
 o Updated mutant binding data demonstrates continued in vitro resistance against novel variants of concern, including the recently described Californian and New York variants.
• Release of publication entitled "Cornering an Ever-Evolving Coronavirus: TATX-03, a Fully Human, Synergistic, Multi-Antibody Cocktail Targeting the SARS-CoV-2 Spike Protein with in vivo Efficacy" on bioRxiv.
• Expanded partnership providing Eurofins Discovery’s global clients greater access to ImmunoPrecise’s end-to-end antibody discovery capabilities using wild type and best-in-class in vivo and in vitro antibody discovery technologies that are optimized to deeply mine antibody repertoires.
• Presented results from in vitro characterizations investigating TATX-21, a novel potential first-in-class antibody for Atherosclerosis Cardiovascular Disease (ACVD) at 2021 BIO International Convention partnering sessions.

Financial Results

Revenue
The Company achieved revenues of $4.6 million during the three months ended July 31, 2021, compared to $3.8 million in 2020, a 22% increase in its core CRO business. The Company’s strong organic revenue growth of its CRO business continues as a result of increases in both volume and financial values of client contracts as well as continued focus on the development and expansion of revenue-generating services.

Research & Development
Research and development increased to $1.1 million from $309,213 in 2020, due to the extensive R&D work the Company is undertaking, the majority attributed to the development of potential therapeutic assets in the Company’s subsidiary, Talem.

Net Loss

The Company recorded a net loss of $3.2 million during the three months ended July 31, 2021, compared to net loss of $549,318 for the three months ended July 31, 2020.

Financing Activities / Liquidity and Capital Resources
As of July 31, 2021, the Company held cash of $40.7 million and had working capital of $40.2 million.

On September 09, 2021 Heat Biologics, Inc., a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, reported that Jeff Wolf, Chief Executive Officer of Heat Biologics, will be presenting at the H.C. Wainwright 23rd Annual Global Investment Conference being held virtually between September 13-15, 2021 (Press release, Heat Biologics, SEP 9, 2021, https://ir.heatbio.com/news/detail/701/heat-biologics-to-present-at-the-h-c-wainwright-23rd-annual-global-investment-conference [SID1234587474]).

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Heat Biologics’ presentation will be available on-demand to registered attendees via the conference platform beginning Monday, September 13, 2021 at 7:00 AM Eastern Time.

The webcast can be accessed here and on the investor relations section of Heat Biologics’ website at View Source Management will also be participating in one-on-one meetings with qualified members of the investor community throughout the conference.

On September 9, 2021 Greenwich LifeSciences, Inc., a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, provided updates on recent and upcoming developments (Press release, Greenwich LifeSciences, SEP 9, 2021, View Source [SID1234587472]).

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As of the close of markets on September 8, 2021, Greenwich LifeSciences has the highest listed share price return of all 307 biotech IPOs tracked since February 2019 based on the Company’s share price increase of approximately 763% from its IPO offering price (Source: BioPharmCatalyst with data from IPOScoop).

CEO Snehal Patel commented, "We look forward to celebrating the upcoming first year anniversary of our IPO. In addition, we are pleased that H. C. Wainwright initiated analyst coverage of the Company on September 1, 2021 with a price target of $78 per share, consistent with the $75 price target from our first covering analyst. Another important milestone is our addition to the Russell 2000, which placed more of our public float in the hands of long-term investors."

"The analyst coverage, participation in investor conferences, and addition to the Russell 2000 will continue to support our outreach to institutional investors and our transition to investment banking partners that focus on M&A, licensing, and long-term biotech institutional investors. We want to thank Aegis Capital and their investors for their support during our first year as a public company and for their continued support as we expand our investment banking team and investor base."

Mr. Patel added, "We are grateful to our loyal shareholders and breast cancer patients who continue to reach out to us offering encouragement and support. In the near future, the Company plans to announce updates on the manufacturing of GP2 and initiation of the upcoming Phase III clinical trial, as well as the publication of additional data from the Phase IIb clinical trial."

About Breast Cancer and HER2/neu Positivity
One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 282,000 new breast cancer patients and 3.8 million breast cancer survivors in 2021. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

On September 9, 2021 Xenetic Biosciences, Inc., a biopharmaceutical company focused on advancing XCART, a personalized CAR T platform technology engineered to target patient- and tumor-specific neoantigens, reported the United States Patent and Trademark Office (USPTO) has issued Xenetic a Notice of Allowance for U.S. patent application number 16/983,491 entitled, "Articles and Methods Directed to Personalized Therapy of Cancer," covering the co-administration of XCART-derived CAR T cells together with a personalized vaccine designed to enhance the effectiveness of the CAR T therapy (Press release, Xenetic Biosciences, SEP 9, 2021, View Source [SID1234587470]).

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"We believe our XCART platform technology has the potential to offer cancer patients substantial benefits over the existing standard of care and currently approved CAR T therapies. This is the first patent allowance of many that we expect to receive that will protect our XCART technology platform. We have pending patent applications that we expect will result in additional allowed claims for this important technology, and we expect to file additional applications as we generate data during our development program," commented Jeffrey Eisenberg, Chief Executive Officer of Xenetic. "This notice of allowance is a noteworthy milestone for our XCART program and demonstrates our overall commitment to protecting the innovation of our significantly differentiated, proprietary approach to personalized CAR T therapy."

The XCART technology platform is a significantly differentiated, proprietary approach to personalized CAR T lymphoma therapy targeting tumor-specific neoantigens that target independently of CD19 or other surface antigens that are common to both normal and malignant B-cells. It was designed to utilize an established screening technique to identify polypeptide domains that selectively bind to the unique B-cell receptor (BCR) on the surface of an individual lymphoma patient’s malignant B-cell clones. This BCR-selective targeting domain is engineered into the antigen-binding domain of a chimeric antigen receptor (CAR), creating the possibility of a CAR T treatment that should only recognize a given patient’s malignant B-cell clones. XCART is currently in pre-clinical development for the treatment of Non-Hodgkin lymphoma and progressing toward IND-enabling studies.

This Notice of Allowance concludes the substantive examination of this patent application and will result in the issuance of a U.S. patent after administrative processes are completed. The U.S. patent scheduled to issue from this application will expire in 2038.