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Fusion Antibodies collaborates with QUB Led Project in Multi-Million Pound Funding Bid

On August 12, 2020 Fusion Antibodies reported that a Belfast-based bid led by Queens University Belfast (QUB), is the only bid from Northern Ireland to be selected for the next stage of the UK Research and Innovation’s Strength in Places Fund (SIPF) (Press release, Fusion Antibodies, AUG 12, 2020, View Source [SID1234563503]).

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Fusion Antibodies is one of the Northern Ireland Precision Biomarkers and Therapeutics Consortium (NIBT), which is behind the bid. The consortium brings together partners from industry and academia including; Almac Group, Sonrai Analytics, Proaxsis, Diaceutics, and Exploristics.
The aim of the Consortium is to build on Northern Ireland’s existing strengths in digital health and biosciences to develop new, more cost-effective targeted drugs and antibodies and new ways of diagnosing cancer and other conditions.
The SIPF long-term aim is to boost research and innovation capacity and secure highly skilled jobs to the region to enhance its competitiveness and prosperity, and we support this application from Northern Ireland’s life and health science sector.

Paul Kerr, CEO of Fusion Antibodies said:

"We are incredibly excited to be a member of the Northern Ireland Therapeutics Consortium. This alliance between Queens University and other industry bodies has been established to drive and support ambitious growth within our Life Sciences sector.

"The NIBT will drive collaboration and connectivity across business, academia and health organisations.

"Not only is this early-stage funding a major endorsement of our plans, it is also an opportunity for the consortium to boast Northern Ireland as the ideal environment for cutting-edge healthcare R&D and innovations, benefiting patient health and economic growth alike."
The bid is one of just 17 ambitious projects to receive early-stage funding to develop full-stage proposals.
Teams behind these projects will now submit their bids to UK Research and Innovation (UKRI), with four to eight of the strongest set to receive between £10m and £50m each to carry out projects designed to drive substantial economic growth.
UKRI Strength in Places Fund lead, David Sweeney, said:
"Strength in Places is a flagship fund for UKRI. We welcome the focus of the UK Government’s R&D Roadmap in unlocking economic opportunities around local economy in more places around the UK.
"I am delighted with the range of bids funded across the UK in the second wave of Strength in Places that will foster the local ecosystems to support innovation and sustained growth and strengthen collaboration between industry and our world-class research base."

Nymox Announces $9 Million Registered Direct Offering

On August 12, 2020 Nymox Pharmaceutical Corporation (NASDAQ: NYMX) reported it has entered into definitive agreements with institutional and accredited investors for the purchase and sale of shares of its common stock at a purchase price of $2.50 per share in a registered direct offering for gross proceeds of approximately $9 million before deducting placement agent fees and expenses (Press release, Nymox, AUG 12, 2020, View Source [SID1234563502]). The closing of the offering is expected to occur on or about August 14, 2020, subject to the satisfaction of customary closing conditions.

Nymox intends to use the proceeds for general corporate purposes, including working capital.

A.G.P./Alliance Global Partners is acting as sole placement agent for the offering.

This offering is being made pursuant to an effective shelf registration statement on Form F-3 (File No. 333-237564) previously filed with the U.S. Securities and Exchange Commission (the "SEC"). A prospectus supplement describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected]. Interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that Nymox has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about Nymox and such offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy 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.

MobileODT completed $4 million series round C

On August 12, 2020 MobileODT, the developer of the EVA System for cervical cancer screening, reported the completion of a $4 million series C fundraising round (Press release, MobileODT, AUG 12, 2020, https://www.mobileodt.com/press-releases/mobileodt-completed-4-million-series-round-c/ [SID1234563488]). The round will enable MobileODT to further develop an AI (Augmented Intelligence) clinical decision support technology for the evaluation of cervical cancer at the point of care. The round was led by OrbiMed Israel Partners, with participation from Tristel, Tara Health and Laerdal. To date, the company has raised $26 million.

As the second most common cancer among women, after breast cancer, cervical cancer causes 311,000 deaths annually worldwide[1]. The most tragic fact about cervical cancer is it can be easily treated if caught early. Globally, 932 million women require cervical cancer screening, yet almost 600 million women will never be tested[2] due to lack of access to healthcare. MobileODT’s novel AI technology, VisualCheck, will automatically predict how a highly trained colposcopist may evaluate a cervix, to make quality screening more accessible.

This round was led by newly appointed CEO, Leon A. Boston. Mr. Boston’s extensive experience leading medical technology companies through various stages comes at a critical time for MobileODT. "Launching VisualCheck to the world markets will be a game changer in women’s health," said Boston. "We have a tremendous opportunity to close the gap between lack of access and lack of experts in the field of cervical cancer screening,and reduce the number of unnecessary deaths of women globally."

According to Boston, "There is a great deal of complexity in developing an AI product and the company has undergone major changes to get to this point. We now have the right team and technology to make VisualCheck a reality for women’s health."

Recently, the company completed initial validation of its AI VisualCheck technology. Preliminary results show high agreement rates between the AI algorithm and leading experts in cervical cancer. VisualCheck is planned to be released later this year.

Cassava Sciences Announces Second Quarter 2020 Financial Results and Mid-year Business Review

On August 12, 2020 Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, reported financial results for the second quarter ended June 30, 2020 and provided a mid-year business review (Press release, Pain Therapeutics, AUG 12, 2020, View Source [SID1234563487]).

Financial Update
For the second quarter ended June 30, 2020, net loss was $1.1 million, or $0.05 per share, compared to a net loss of $1.1 million, or $0.06 per share, for the same period in 2019. Net cash used in operations was $2.0 million during the first six months of 2020. Net cash use in full-year 2020 is still expected to be approximately $5.0 million. The Company’s cash and cash equivalents were $25.3 million as of June 30, 2020, with no debt.

Update on Market Awareness
In June 2020, Cassava Sciences’ stock was added to the Russell 2000 and Russell 3000 Indexes. These indexes are intended to provide institutional investors and other market participants with exposure to the performance of certain segments of the U.S. stock market.

Update on Phase 2b Study With PTI-125
In Q2 2020, Cassava Sciences completed a randomized, placebo-controlled, double-blind study of its lead drug candidate, PTI-125, in patients with mild-to-moderate Alzheimer’s disease (N=64). This study was substantially funded by a research grant award from the National Institutes of Health (NIH).

As previously reported, the drug was safe and well-tolerated. An outside lab (with whom the Company had no prior work experience) generated an initial bioanalysis in which the study missed its pre-specified primary outcome, defined as a drug effect on cerebrospinal fluid (CSF) levels of tau protein and other biomarker assessments. The data set from that initial bioanalysis showed unnaturally high variability and other problems, such as no correlation among changes in levels of biomarkers over 28 days, even in the placebo group, and different biomarkers of disease moving in opposite directions in the same patient. Overall, we believe data from the initial bioanalysis can be interpreted as anomalous and highly improbable.

We are now conducting a comprehensive analysis of clinical results of our Phase 2b study, including evaluating the effects of PTI-125 on cognition. Data collected from this analysis will constitute final clinical results of our Phase 2b study of PTI-125 in Alzheimer’s disease. We anticipate announcing such results in September 2020.

"Our Phase 2b study was well-conducted, but we believe the analysis of results is a re-do," said Remi Barbier, President & CEO. "This effort is on-going. I believe the outcome of our Phase 2b study will be better understood after final clinical results are announced in September 2020."

Update on Open-label Study with PTI-125 – Initiated in March, Now Over 50% Enrolled
In March 2020, Cassava Sciences announced the initiation of an open-label, multi-center study of PTI-125 at 100 mg twice-daily for 12 months. Every study participant receives drug treatment in an open-label design. This on-going study has a target enrollment of approximately 100 patients with mild-to-moderate Alzheimer’s disease. The study has exceeded 50% enrollment.

Update on SavaDx
On July 15, 2020, scientists for Cassava Sciences were invited by a scientific conference to give a keynote presentation on SavaDx, an investigational diagnostic to detect Alzheimer’s disease with a simple blood test. In addition to showing that SavaDx could distinguish and stratify patients with Alzheimer’s disease, this presentation provided direct evidence for target engagement and for the treatment effects of PTI-125. Target engagement is a crucial step in drug research because it shows that our small molecule drug candidate binds to its intended site of action in cells and confirms that treatment effects are caused by the drug hitting its target. The science presentation is available on-line at: View Source

Financial Highlights for Second Quarter 2020

At June 30, 2020, cash and cash equivalents were $25.3 million, compared to $23.1 million at December 31, 2019, with no debt.
Cash balance included $3.8 million in proceeds from exercise of warrants in the first six months of 2020. Approximately 1.4 million warrants remain outstanding, each with an exercise price of $1.25 per share. All warrants expire February 2021.
Net cash used in operations during the six months ended June 30, 2020 was $2.0 million, net of reimbursements received from NIH grant awards.

Net cash use for full year 2020 is expected to be approximately $5.0 million, consistent with previous financial guidance.
Research grant funding reimbursements of $1.1 million were received from NIH and recorded as a reduction in research and development (R&D) expenses in the second quarter of 2020. This compared to $1.4 million of NIH grant receipts received for the same period in 2019.
R&D expenses were $0.6 million compared to $0.3 million for the same period in 2019. The decrease was due primarily to lower NIH reimbursement compared to the prior year.
General and administrative (G&A) expenses were $0.8 million, consistent with the same period in 2019.
About Alzheimer’s Disease
Alzheimer’s disease is a progressive brain disorder that destroys memory and thinking skills. Currently, there are no drug therapies to halt Alzheimer’s disease, much less reverse its course. In the U.S. alone, approximately 5.8 million people are currently living with Alzheimer’s disease, and approximately 487,000 people age 65 or older developed Alzheimer’s in 2019.1 The number of people living with Alzheimer’s disease is expected to grow dramatically in the years ahead, resulting in a growing social and economic burden.2

About PTI-125
Cassava Sciences’ lead therapeutic product candidate is for the treatment of Alzheimer’s disease. PTI-125 is a proprietary, small molecule (oral) drug that restores the normal shape and function of altered filamin A (FLNA), a scaffolding protein, in the brain. Altered FLNA in the brain disrupts the normal function of neurons, leading to Alzheimer’s pathology, neurodegeneration and neuroinflammation. The underlying science is published in peer-reviewed scientific journals, including Journal of Neuroscience, Neurobiology of Aging, Journal of Biological Chemistry and Journal of Prevention of Alzheimer’s Disease.

About SavaDx
SavaDx is Cassava Sciences’ investigational diagnostic to detect Alzheimer’s disease. The goal of SavaDx is to make the detection of Alzheimer’s as simple as getting a blood test, possibly years before the appearance of any overt clinical symptoms. This clinical-stage program is substantially funded by a research grant award from the National Institutes of Health (NIH).

Atreca Reports Second Quarter 2020 Financial Results and Recent Corporate Developments

On August 12, 2020 Atreca, Inc. (Atreca) (NASDAQ: BCEL), a clinical-stage biotechnology company focused on developing novel therapeutics generated through a unique discovery platform based on interrogation of the active human immune response, reported financial results for the second quarter ended June 30, 2020, and provided an overview of recent developments (Press release, Atreca, AUG 12, 2020, View Source [SID1234563486]).

"The second quarter was eventful for Atreca as we continue to execute on our various development objectives," said John Orwin, Chief Executive Officer. "We recently presented preclinical data for ATRC-101 demonstrating that its novel target is induced by chemotherapeutics and further validating its novel mechanism of action. Our Phase 1b first-in-human study evaluating ATRC-101 continues to enroll patients and now has five trial sites active. In addition, our recently announced strategic collaboration with Xencor to develop bispecific T cell-engaging antibodies underscores the value of novel targets in oncology and the ability of our technology platform to attract weaponization partners. We believe these milestones, coupled with our strengthened financial position from the completion an equity financing in July, position us well for continued progress in the second half of 2020."

Recent Developments and Highlights

A Phase 1b first-in-human study evaluating ATRC-101 in patients with select solid tumor cancers is ongoing. Screening continues in the study and patients are currently being enrolled in the second dose cohort. To date, five clinical trial sites have been activated. Atreca expects to announce initial safety data from the study in late 2020 or early 2021. In addition to monotherapy expansion cohorts, clinical trials of ATRC-101 in combination with a PD-1 inhibitor and in combination with a chemotherapeutic are planned for 2021.

Atreca hosted a webinar in June to present new preclinical data regarding the novel target and mechanism of action of ATRC-101, demonstrating both innate and adaptive immune system activation and target induction via chemotherapy.

Atreca entered into a strategic collaboration and license agreement with Xencor, Inc. to research, develop and commercialize T cell-engaging bispecific antibodies as potential therapeutics in oncology. Under a three-year discovery program, Atreca will provide antibodies against novel tumor targets from which Xencor will engineer XmAb bispecific antibodies that also bind to the CD3 receptor on T cells. Up to two joint programs will be mutually selected for further development and commercialization, with each partner sharing 50 percent of costs and profits. Atreca and Xencor may also pursue up to two programs independently, with a mid-to high-single digit percent royalty payable on net sales.

Atreca strengthened its financial position with the completion of a public equity offering in July 2020, resulting in net proceeds of approximately $117.5 million.

Atreca appointed Ms. Kristine M. Ball to the Company’s board of directors. Ms. Ball brings more than 25 years of life sciences industry experience focused primarily on finance, corporate development and strategic planning.

Atreca continues to collaborate with BeiGene, and IGM Biosciences on a potential novel antibody treatment for COVID-19.
Second Quarter 2020 Financial Results

As of June 30, 2020, cash, cash equivalents and investments totaled $148.8 million. In addition, Atreca completed a public equity offering in July 2020 resulting in net proceeds of approximately $117.5 million, and after deducting the underwriting discounts and commissions and estimated offering expenses.

Research and development expenses for the three months ended June 30, 2020 were $14.2 million, including non-cash share-based compensation expense of $1.8 million.

General and administrative expenses for the three months ended June 30, 2020 were $6.5 million, including non-cash share-based compensation expense of $1.6 million.

Atreca reported a net loss of $20.0 million, or basic and diluted net loss per share attributable to common stockholders of $0.71, for the three months ended June 30, 2020.