On August 11, 2020 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported financial results and corporate highlights for the second quarter 2020, as well as anticipated corporate milestones for the remainder of the year (Press release, Surface Oncology, AUG 11, 2020, View Source [SID1234563390]).

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"The second quarter of 2020 was one of great progress for Surface on several fronts. We advanced multiple programs in clinical development, entered into a clinical collaboration with Merck and secured additional financial resources via top-tier investors," said Jeff Goater, chief executive officer. "Our team has done an amazing job adapting to challenges from the global COVID-19 pandemic. To date, our clinical and preclinical timelines have not been impacted by the pandemic and we continue to monitor the situation. I could not be more proud of what we have accomplished, nor more excited about what is to come for Surface in the second half of 2020."

Recent Corporate Highlights:

In April, initiated a Phase 1 clinical trial of its first-in-class antibody SRF388, which targets the immunosuppressive cytokine IL-27. The study design is based on a compelling translational hypothesis supported in part by a study presented at American Association for Cancer Research (AACR) (Free AACR Whitepaper) this year demonstrating that high levels of IL-27 correlate strongly with the risk of developing liver cancer. Presentation can be found here.
In May, entered into a clinical trial collaboration with Merck (NYSE: MRK) to evaluate the safety and efficacy of combining Surface’s SRF617, an investigational antibody therapy targeting CD39, with Merck’s KEYTRUDA (pembrolizumab), the first anti-PD-1 therapy approved in the United States. This combination will be studied as a future component of the ongoing first-in-human Phase 1/1b study of SRF617 and will be evaluated in patients with solid tumors, with a focus on patients with gastric cancer and those who have developed resistance to checkpoint inhibition — both areas of high unmet need.
In the second quarter, raised approximately $39 million combined through its At-the-Market (ATM) facility and its venture debt facility. The ATM offering included participation based upon interest received from EcoR1 Capital LLC, Venrock Healthcare Capital Partners, BVF Partners L.P., and RS Investments, a Victory Capital investment franchise.
In June, presented updated preclinical data on SRF813 and lead candidates SRF617 and SRF388 at the 2020 AACR (Free AACR Whitepaper) virtual annual meeting. Presentations can be found in the Posters & Publications section on this page.
Advanced SRF813, a high affinity, fully human IgG1 antibody against CD112R (PVRIG) into IND-enabling studies. Preclinical studies support SRF813’s differentiated profile compared to the leading competitor and have indicated CD112R (PVRIG) inhibition activates both NK and T cells, resulting in robust anti-tumor activity and immunological memory.
Continued progression of the ongoing Phase 1/1b trial of NZV930 (targeting CD73) by Surface Oncology’s partner Novartis.
Selected Anticipated 2020 Corporate Milestones:

Preclinical data presentations anticipated at Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in November 2020
Initial clinical updates for both SRF617 and SRF388 anticipated by the end of 2020
IND filing for SRF813 mid 2021
Financial Results:

As of June 30, 2020, cash, cash equivalents and marketable securities were $112.5 million, compared to $105.2 million on December 31, 2019.

Research and development (R&D) expenses were $9.5 million for the second quarter ended June 30, 2020, compared to $13.2 million for the same period in 2019. This decrease was primarily driven by a reduction in expenses associated with contract manufacturing and other IND-enabling activities, as a result of the SRF617 and SRF388 IND filings in 2019, offset by an increase in spend on the SRF617 and SRF388 Phase 1 clinical trials, which began in 2020. R&D expenses included $0.7 million in stock-based compensation expense for the second quarter ended June 30, 2020.

General and administrative (G&A) expenses were $5.0 million for the second quarter ended June 30, 2020, compared to $5.4 million for the same period in 2019. This decrease was primarily due to decreased personnel costs and professional fees as a result of the strategic restructuring announced in January 2020. G&A expenses included $1.3 million in stock-based compensation expense for the second quarter ended June 30, 2020.

For the second quarter ended June 30, 2020, net loss was $14.8 million, or basic and diluted net loss per share attributable to common stockholders of $0.44. Net loss was $17.8 million for the same period in 2019, or basic and diluted net loss per share attributable to common stockholders of $0.64.

Financial Outlook:

Surface Oncology continues to project that current cash and cash equivalents are sufficient to fund the Company into 2022.

On August 11, 2020 Atomwise, the company deciphering human disease via the largest AI-drug discovery portfolio, reported that it has closed $123 million in an oversubscribed Series B financing led by B Capital Group and Sanabil Investments (Press release, Atomwise, AUG 11, 2020, View Source [SID1234563354]). The funding round includes returning investors DCVC, BV, Tencent, Y Combinator, Dolby Ventures, AME Cloud Ventures, as well as new backing from two top ten global insurance companies. This brings the total amount of capital raised to date to almost $175 million. The company has appointed Raj Ganguly of B Capital Group as a new board member and Hani Enaya of Sanabil as a board observer.

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"Over the past three years, our platform AtomNet has tackled — and succeeded — in finding small molecule hits for more undruggable targets than any other AI drug discovery platform," said Abraham Heifets, CEO and co-founder of Atomwise. "With support from our new and existing investment partners, we will be able to leverage this to develop our own pipeline of small molecule drug programs, further grow our portfolio of joint-venture investments, and realize our vision to create better medicines that can improve the lives of billions of people."

With the new investment, Atomwise will continue to scale its AI technology platform and team. The company plans to expand its work with corporate partners, which currently include major players in the biopharma space such as Eli Lilly and Company, Bayer, Hansoh Pharmaceuticals, and Bridge Biotherapeutics, as well as emerging biotechnology companies like StemoniX and SEngine Precision Medicine. Atomwise has signed more than $5.5 billion in total deal value with corporate partners to date.

The company will also leverage the financing to build its own internal pipeline tackling historically undruggable and other challenging disease targets. Atomwise will continue to grow its portfolio of joint ventures with leading researchers using AtomNet for drug discovery, like those it has launched with X-37, Atropos Therapeutics, Theia Biosciences and vAIrus, with a goal to commercialize high potential candidates through the drug development process.

Atomwise created the first convolutional neural networks (CNN) for drug discovery, and since its founding in 2012 has continually developed and improved its AI-based drug discovery technology. The company’s AI technology has been used by academic researchers at institutes around the world and drug developers — including top-100 pharmaceutical and emerging biotechnology companies, a rapidly growing market estimated to reach $729B in global market value by 2025. Researchers and companies struggle with access to AI-based drug discovery technology, due to overall cost and lack of expertise — something which requires computational scientists, drug discovery experts, software and systems engineers for AI and ML. To date, Atomwise has provided AI technology to over 750 research collaborations addressing over 600 disease targets, and worked with top-pharmaceutical and biotechnology partners, to design new drugs for "undruggable" targets with speed and scale.

Through these academic collaborations, Atomwise has enriched its AtomNet technology with experimental data and conducted the largest screening of molecules in human history — today at over 16 billion molecules for virtual screening. From the continued use of AtomNet among research teams, Atomwise has gained a valuable breadth of experimental data, including the largest diversity of drug target sites, homology models, protein classes, and disease areas of any AI platform. The company’s technology is covered by 19 issued patents, and research partnerships have generated 17 pending patent applications and several peer-reviewed publications. Atomwise has 285 active drug discovery partnerships with researchers at top universities around the world, and recently announced 15 research collaborations with global universities to explore broad-spectrum therapies for COVID-19, targeting 15 unique and novel mechanisms of action.

"New technologies are enabling better and faster R&D for the life science industry," said Raj Ganguly, co-Founder and Managing Partner at B Capital Group. "The advancements Atomwise has made with its computational drug discovery platform have effectively cut months or even years off of the R&D lifecycle. More importantly, however, they are solving biology problems previously believed to be unsolvable by researchers and delivering that capability to everyone from academics to big pharma. We’re excited to continue to partner with the Atomwise team on its mission to develop new, more effective therapies."

A spokesperson for Sanabil Investments added, "We chose to lead this B round as Atomwise has shown clear leadership in developing better medicines for the world, and has become the number one global leader in applying and scaling its AI platform for drug discovery programs. Even more important is the prominence and strategic reputation of the new and returning investors, and their expertise in AI, drug discovery and pharma. They all believe, like we do, that Atomwise will use the funding to strengthen and develop their strategic advantages where it counts."

If you’re a drug discovery team interested in learning more about Atomwise, please visit our website or email [email protected].

On August 10, 2020 JW Therapeutics, a clinical-stage biopharmaceutical company focused on developing, manufacturing and commercializing cell therapies for patients in China, reported entering into a development and commercialization agreement with Lyell Immunopharma to advance adoptive T cell therapy for the treatment of hepatocellular carcinoma in China and ASEAN countries (Press release, JW Therapeutics, AUG 10, 2020, View Source [SID1234638724]).

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The collaboration combines Lyell’s proprietary T cell anti-exhaustion technology, which is intended to preserve or maintain T cell function, with JW Therapeutics’ recent acquisition of Syracuse and its ARTEMIS technology platform. The companies’ complementary capabilities in developing and manufacturing cell-based products may help advance new treatment options for patients in China and other parts of Asia.

JW Therapeutics and Lyell Immunopharma intend to seek additional opportunities for collaboration in research, development, and commercialization of products in China.

Terms of the collaboration were not disclosed.

On August 10, 2020 PDS Biotechnology Corporation ("PDS Biotech" or the "Company") (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune T-cell activating technology, reported that it intends to offer and sell shares of its common stock in an underwritten public offering (Press release, PDS Biotechnology, AUG 10, 2020, View Source [SID1234570259]). All of the shares in the offering are to be sold by PDS Biotech. PDS Biotech intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares sold in the offering to cover over-allotments, if any. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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PDS Biotech intends to use the proceeds from this offering to fund working capital and general corporate purposes.

Oppenheimer & Co. Inc. is acting as the sole book-running manager for the offering.

This offering by PDS Biotech is being made pursuant to an effective registration statement on Form S-3 (File No. 333-240011) previously filed with the U.S. Securities and Exchange Commission ("SEC") on July 22, 2020 and declared effective on July 31, 2020, and the accompanying prospectus contained therein. The offering of the shares of common stock will be made by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC, and will be available on the SEC’s website at View Source or by contacting Oppenheimer & Co. Inc. at 85 Broad Street, 26th Floor, New York, NY 10004, Attention: Equity Syndicate Prospectus Department, by telephone at (212) 667-8055, or by email at [email protected].

Before investing in this offering, you should read in their entirety the preliminary prospectus supplement and the accompanying prospectus and the other documents that PDS Biotech has filed with the SEC that are incorporated by reference in the preliminary prospectus supplement and the accompanying prospectus, which provide more information about PDS Biotech and such offering.

This press release shall not constitute an offer to sell or a 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.

On August 10, 2020 Diffusion Pharmaceuticals Inc. (Nasdaq: DFFN) ("Diffusion" or "the Company"), a cutting-edge biotechnology company developing new treatments for life-threatening medical conditions by improving the body’s ability to deliver oxygen to the areas where it is needed most, reported financial results for the three and six months ended June 30, 2020 and provided a business update (Press release, Diffusion Pharmaceuticals, AUG 10, 2020, View Source [SID1234568922]).

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Highlights from the second quarter of 2020 and recent weeks include:

Initiation of an international clinical development program in hospitalized patients with COVID-19. Low oxygen levels occur as a consequence of damage to the lungs from COVID-19, often resulting in mechanical ventilation and, if that is ineffective, multiple organ failure – the leading cause of death from COVID-19. Diffusion believes that the oxygen-enhancing mechanism of action of TSC could benefit such patients.
The TSC/Covid-19 clinical development program will begin with an open-label lead-in trial which, if successful, will be followed by one or more randomized double-blinded clinical trials. The lead-in trial will test TSC in 24 hospitalized COVID-19 patients at the Romanian National Institute of Infectious Diseases (NIID). Diffusion expects to begin dosing in this study in the third quarter, with data read-out in the fourth quarter of 2020. In addition to safety, the lead-in trial will collect data on possible increased oxygenation, thereby helping the Company determine TSC dosing for follow-on studies.
Following the recent successful completion of the 19-patient open-label, dose-escalation lead-in safety portion of the trial, the Company has continued pursuit of partnership efforts for its Phase 3 INTACT (INvestigating Tsc Against Cancerous Tumors) program with TSC plus standard of care (SOC) for patients newly diagnosed with inoperable glioblastoma multiforme (GBM).
The Company’s Phase 2 160-patient on-ambulance clinical trial testing TSC for the treatment of acute stroke continues, but on a limited basis because of the on-going pandemic. This program, featuring the PHAST-TSC (Pre-Hospital Administration of Stroke Therapy-TSC) trial, will ultimately involve a total of 23 hospitals across urban, suburban and rural areas in Los Angeles County and Central Virginia when conditions permit more robust operations.
On May 29, 2020 the Company") announced that it received written notice from the Nasdaq Listing Qualifications Staff of the NASDAQ Stock Market LLC ("Nasdaq") stating that the Company regained compliance with the applicable Nasdaq minimum bid price continued listing standard and the matter was now closed.
During the quarter, the Company sold common stock raising $10.3 million and also raised $7.6 million from the exercise of outstanding warrants, for net proceeds of $17.9 million during the reporting period.
"This is an exciting time for Diffusion as we prepare for first enrollment in our global clinical trial program using TSC for the treatment of hospitalized COVID-19 patients," said David Kalergis, chairman and chief executive officer of Diffusion. "Given the severity of the worldwide pandemic, regulatory authorities in the U.S. and Europe have put in place measures to expedite the testing of therapeutics and have been generous in their guidance in light of emerging knowledge. Protocol changes based on this guidance have been incorporated into the development program so that data from any patient, wherever located, can be included to help support planned future regulatory filings in both the U.S. and Europe.

"We also raised funds during the quarter, which will largely be used to advance our TSC clinical development plan, with an emphasis on the COVID-19 program," Mr. Kalergis continued. "At quarter-close we had more than $25 million in cash, the largest cash balance on hand since becoming a public company. In addition, to better help our investors, potential partners and the public stay informed, we are currently revamping our website to reflect the impact of our COVID-19 program on TSC’s development, with the revised website launch targeted for later this quarter."

Second Quarter Financial Results

Research and development expenses were $2.2 million for the second quarter of 2020, compared with $1.5 million for second quarter of 2019. The increase was attributable to a $0.6 million increase in costs associated with follow on work for our 19 patient run-in Phase 3 trial for GBM, a $0.3 million increase in expense related to our open-label Phase 1b lead-in trial for TSC in COVID-19 patients, and a $0.3 million increase in associated manufacturing costs as we ramp up the trial. These increases were offset in part by a $0.5 million decrease in costs associated with the delay in our Phase 2 stroke trial due to the COVID-19 pandemic

General and administrative expenses were $1.5 million for the second quarter of 2020, compared with $1.1 million for the second quarter of 2019. The increase was mainly due to higher professional fees, salaries and wages.

Diffusion had cash and cash equivalents of $25.6 million as of June 30, 2020, compared with $14.2 million as of December 31, 2019. During the second quarter the Company completed an offering of 11.4 million shares of common stock for net proceeds of $10.3 million. In addition, the Company received proceeds of $7.6 million from the exercise of 13.0 million warrants and the exchange and exercise of a further 5.0 million warrants. Diffusion believes its cash and cash equivalents as of June 30, 2020 are sufficient to fund operating expenses and capital expenditures, including clinical trials, into the fourth quarter of 2021.