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New Therapeutic Antibody Discovery Collaboration

On September 9, 2021 Twist Bioscience Corporation, a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, reported a broad-based research collaboration with Boehringer Ingelheim International GmbH to use Twist’s proprietary antibody libraries to discover therapeutic antibodies against multiple targets provided by Boehringer Ingelheim (Press release, Boehringer Ingelheim, SEP 9, 2021, View Source [SID1234587473]).

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"Boehringer Ingelheim believes Twist’s ability to generate potent, diverse therapeutic antibodies by mining its comprehensive libraries, combined with our extensive capabilities and experience in drug discovery and development, will enable us to deliver breakthrough opportunities to patients," said Clive R. Wood, Ph.D., Senior Corporate Vice President and Global Head of Discovery Research at Boehringer Ingelheim. "We look forward to working with Twist on molecular targets in a broad range of disease areas," added Wood.

Under the terms of the agreement, Twist Biopharma, a division of Twist, will utilize its "Library of Libraries," a panel of synthetic antibody phage display libraries derived only from sequences that exist in the human body, to identify potential therapeutic antibody candidates. Twist and Boehringer Ingelheim will work together to validate and optimize any resulting new antibody candidates, which could be researched against a range of therapeutic areas. Boehringer Ingelheim retains exclusive worldwide rights to develop and commercialize any therapeutic antibodies discovered as part of the collaboration.

Twist will receive an upfront payment for each program entry. In addition, Twist has the potential to earn up to a total of $710 million in success-based clinical, regulatory and commercial milestone payments for the multiple target discovery programs.

"This discovery collaboration with Boehringer Ingelheim covering numerous targets truly illustrates the power of our antibody libraries. We have the ability to generate precise antibodies to a diverse range of targets, which together with Boehringer Ingelheim’s strength in drug development capabilities, could mean multiple new, more personalized treatments in the future for patients," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist.

Avalo Therapeutics presented a Corporate presentation

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

ImmunoPrecise Reports Financial Results and Recent Business Highlights for First Quarter Fiscal Year 2022

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]).

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.

Heat Biologics to Present at the H.C. Wainwright 23rd Annual Global Investment Conference

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]).

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.

Greenwich LifeSciences Provides Updates on Recent and Upcoming Developments

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]).

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.