On August 9, 2021 City of Hope, a world-renowned cancer research and treatment center, reported that acclaimed Pacific Shores Medical Group has joined City of Hope (Press release, City of Hope, AUG 9, 2021, View Source [SID1234586163]). This agreement significantly expands City of Hope’s clinical network and provides thousands of patients in Southern California with increased access to breakthrough discoveries and lifesaving treatments.

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City of Hope adds seven locations – Glendale, Huntington Beach, Irvine, Newport Beach, Torrance and two in Long Beach – in one of the largest clinical network expansions in its history. With locations across five counties, City of Hope is delivering advanced cancer care closer to where people live — alleviating the burden on patients who have had to travel far from home for world-class and highly specialized cancer treatment.

"Together with the highly esteemed providers joining us from Pacific Shores, we continue to advance the delivery of cancer care and expand patient access to City of Hope’s unparalleled research, treatment and care," said Robert W. Stone, president and chief executive officer, City of Hope, and the Helen and Morgan Chu Chief Executive Officer Distinguished Chair. "Pacific Shores allows us to continue expanding our mission to serve more patients, families and communities across Southern California and beyond."

The 14 Pacific Shores physicians, 11 nurse practitioners and physician assistants and more than 200 staff members became part of City of Hope on Aug. 9, 2021. Pacific Shores patients will be able to continue to receive excellent care with their current physicians, while gaining access to the expertise of more than 1,000 City of Hope researchers and highly specialized physicians, hundreds of additional clinical trials, pioneering treatments, expanded cancer education and prevention resources, and new innovations that are making care more convenient and effective.

"Pacific Shores physicians chose to join City of Hope because of a shared interest in advancing cancer medicine through research, clinical trials and breakthrough treatments. We are delighted that our patients will have unprecedented access to City of Hope’s leading-edge treatments, extensive clinical trials and highly specialized cancer expertise. Additionally, our physicians and staff welcome the opportunity to count on many world-renowned scientists and clinicians as colleagues and collaborators," said N. Simon Tchekmedyian, M.D., founder and CEO of Pacific Shores Medical Group.

"As a Pacific Shores patient for 23 years, I am grateful that I will continue to have my trusted physician’s care now at City of Hope — known for saving the lives of people with cancer," said Elizabeth Lucas, 84, of Long Beach. "This is care that is the best of all possible combinations. I’m getting world-renowned care close to my home."

Established in 1986, Pacific Shores Medical Group has locations across Los Angeles and Orange counties. A cancer care pioneer, Pacific Shores is recognized for excellence in cancer therapy practices, receiving certification from the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Quality Oncology Practice Initiative. It is also one of the most experienced cancer groups in the country, with more than 80,000 patient visits a year.

"This is exactly what is needed in the pursuit to treat and cure cancer – a coming together of a best-in-class physician group and a world-renowned academic cancer research and treatment institution," said Edward S. Kim, M.D., M.B.A., physician-in-chief, City of Hope Orange County, and vice physician-in-chief, City of Hope National Medical Center. "City of Hope is leading the way in re-defining how cancer breakthroughs are delivered – equitably and efficiently – to communities."

Pacific Shores joining City of Hope adds to City of Hope’s expanding footprint in Orange County, where it is developing a cancer campus of the future and a network of advanced cancer care. Lennar Foundation Cancer Center is scheduled to open in the summer of 2022, followed by the county’s only specialty hospital exclusively focused on treating and curing cancer scheduled to open in 2025. City of Hope Newport Beach, the first phase of City of Hope Orange County’s expansion, has been serving patients since January 2020.

"By welcoming Pacific Shores patients, physicians and staff to City of Hope, we are fulfilling our promise of bringing our advanced cancer care into the heart of our communities. City of Hope is honored to work with the nation’s leading researchers and clinicians, and we are privileged to welcome these like-minded experts from Pacific Shores to our team. Hope is indeed growing across the Southern California region," said Annette M. Walker, president, City of Hope Orange County.

On August 9, 2021 MaxCyte, Inc. (Nasdaq: MXCT) (LSE: MXCT, MXCN), a leading provider of cell-engineering platform technologies, reported the signing of a clinical and commercial license with Sana Biotechnology, Inc. (Nasdaq: SANA), a company focused on creating and delivering engineered cells as medicines (Press release, MaxCyte, AUG 9, 2021, View Source [SID1234586161]).

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Under the terms of the agreement, Sana Biotechnology obtains non-exclusive clinical and commercial rights to use MaxCyte’s Flow Electroporation technology and ExPERT platform. In return, MaxCyte is entitled to receive platform licensing fees and program-related milestone payments.

Doug Doerfler, President and CEO of MaxCyte, said: "We are delighted to support Sana’s ex vivo cell therapy programs and recognize the potential of the company’s novel hypoimmune cell platform to advance treatments for serious diseases. This agreement represents an important achievement for MaxCyte as we continue to expand the use of our next-generation technology platform to support the development of innovative treatments."

MaxCyte’s ExPERT instrument portfolio represents the next generation of leading, clinically-validated, electroporation technology for complex and scalable cell engineering. By delivering high transfection efficiency, seamless scalability and enhanced functionality, the ExPERT platform delivers the high-end performance essential to enable the next wave of biological and cellular therapeutics.

On August 9, 2021 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation cancer and autoimmune therapeutics, reported its financial results for the quarter ended June 30, 2021, its recent business highlights, and provided a preview of anticipated selected milestones in the second half of 2021 (Press release, Sutro Biopharma, AUG 9, 2021, View Source [SID1234586160]).

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"Additional follow-up data from our STRO-002 dose-escalation data were presented at ASCO (Free ASCO Whitepaper) and these data continue to demonstrate meaningful clinical benefit for women with advanced ovarian cancer. Enrollment in the dose-expansion cohort is ongoing and we look forward to providing an update later this year," said Bill Newell, Sutro’s Chief Executive Officer. "Our ADC collaborations with Bristol Myers Squibb and EMD Serono continue to make progress in the clinic. We are also encouraged by the strength of the Merck cytokine collaboration, with the first product candidate in IND-enabling studies and additional potential product candidates under development. These high-value partnerships add to the breadth of Sutro’s accomplishments in developing novel therapeutics to expand much-needed treatment options for cancer patients."

Recent Business Highlights and Anticipated Second Half 2021 Milestones

STRO-002, FolRα-Targeting ADC: Enrollment continues in the Phase 1 dose-expansion cohort for patients with advanced ovarian cancer.

The dose-escalation cohort of the Phase 1 trial completed enrollment as of August 31, 2020, and updated data were reported in May 2021 and presented as a poster at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Annual Meeting in June 2021.
The enrollment for the dose-expansion cohort of the Phase 1 trial is ongoing, with additional sites activated in the US and a CTA approved to initiate the study in Spain.
Sutro is expected to report initial data for the dose-expansion cohort in the second half of 2021; the data are expected to inform regulatory interactions and registration strategy as well as enable the identification of the broadest patient population that may benefit from STRO–002.
STRO-001, CD74-Targeting ADC: Enrollment is ongoing in the Phase 1 dose-escalation for patients with B-cell malignancies, including patients with lymphoma and multiple myeloma.

STRO-003: Preclinical development is underway and a product candidate is expected to be unveiled in the second half of 2021.

Merck Collaboration: First product candidate is in IND-enabling studies.

In April 2021, Merck initiated IND-enabling toxicology studies for the first program under the July 2018 cytokine derivatives collaboration, for which Sutro earned a $15 million milestone payment.
Additionally, research on the second cytokine derivative program is continuing.
BMS Collaboration: Phase 1 trial for CC-99712, BCMA-targeting ADC for patients with multiple myeloma, is ongoing.

EMD Serono Collaboration: Phase 1 trial for M1231, a first-in-class bispecific ADC targeting MUC1–EGFR for development in solid tumors, is ongoing.

Merck KGaA, EMD Serono (EMD Serono) began enrolling patients in the first quarter of 2021 in the dose-escalation portion of a Phase 1 trial of M1231 for treatment of metastatic solid tumors, including non-small cell lung cancer (NSCLC) and esophageal squamous cell carcinoma.
Sutro earned a milestone payment based on a patient enrollment achievement in the M1231 in the second quarter of 2021.
Vaxcyte Relationship: Partnership with Vaxcyte is exploring the potential of conjugated vaccines utilizing the power of Sutro’s cell-free technology.

Leadership Updates: Sutro continues to strengthen leadership through the addition of a Chief Commercial Officer, promotion of a Chief Portfolio Strategy & Alliance Officer, and additions to the Scientific Advisory Board.

Jane Chung joins the company as the Chief Commercial Officer and will provide patient, provider, thought leader and reimbursement insights as Sutro’s clinical programs advance. Ms. Chung has more than 20 years of pharmaceutical and biotechnology experience, having most recently served as President of AstraZeneca Canada, as well as previous roles at Onyx Pharmaceuticals and Genentech, and is a registered pharmacist.
Nicki Vasquez, Ph.D., has been promoted to Chief Portfolio Strategy & Alliance Officer and will provide continued support of portfolio strategy development, execution, and alliance leadership. Dr. Vasquez has led Alliance and Portfolio Management since 2015. Prior to Sutro, she was VP of Program & Portfolio Management at StemCells, Inc. and was previously at Elan Pharmaceuticals. Dr. Vasquez obtained her doctoral degree in immunology from the University of California, San Diego, and received her post-doctoral training at Genentech.
Robert Abraham, Ph.D., joined the Sutro Scientific Advisory Board in July 2021. Dr. Abraham is currently Chief Scientific Officer at Vividion Therapeutics and also an Adjunct Professor in Pharmacology at the University of California, San Diego, and is at the Sanford Burnham Prebys Medical Discovery Institute. Previously, he was Senior Vice President and Group Leader of the Oncology R&D Group at Pfizer.
Stanley R. Frankel, M.D., joined the Sutro Scientific Advisory Board in June 2021. Dr. Frankel is currently Chief Medical Officer at Cytovia Therapeutics and is also an Adjunct Associate Professor of Medicine at the Vagelos College of Physicians and Surgeons at Columbia University, New York.
Second Quarter 2021 Financial Highlights

Cash, Cash Equivalents and Marketable Securities

As of June 30, 2021, Sutro had cash, cash equivalents and marketable securities of $283.4 million, as compared to $326.5 million as of December 31, 2020, with projected runway into the second half of 2023, based on current business plans and assumptions. This does not include the value associated with Sutro’s holdings of approximately 1.6 million shares of Vaxcyte common stock. As of June 30, 2021, the fair value of the Vaxcyte common stock held by Sutro was $35.3 million.

Unrealized Gain (Loss) from Decrease in Value of Vaxcyte Common Stock

The non-operating, unrealized gain of $4.3 million and unrealized loss of $6.4 million for the three and six months ended June 30, 2021 were due to the increase since March 31, 2021 and the decrease since December 31, 2020, respectively, in the estimated fair value of Sutro’s holdings of Vaxcyte common stock. Vaxcyte common stock held by Sutro will be remeasured at fair value based on the closing price of Vaxcyte’s common stock on the last trading day of each reporting period, with any non-operating, unrealized gains and losses recorded in Sutro’s statements of operations.

Revenue

Revenue was $28.0 million and $42.7 million for the three and six months ended June 30, 2021, respectively, compared to $9.5 million and $16.6 million for the same periods in 2020, related principally to the Merck, BMS, and EMD Serono collaborations. Future collaboration revenue from Merck, BMS, and EMD Serono, and from any future collaboration partners, will fluctuate as a result of the amount and timing of revenue recognition of upfront, milestones, and other collaboration agreement payments.

Operating Expenses

Total operating expenses for the three and six months ended June 30, 2021 were $37.9 million and $71.5 million, respectively, compared to $25.9 million and $52.2 million for the same periods in 2020, including non-cash stock-based compensation of $5.9 million and $3.0 million, and depreciation and amortization expense of $1.1 million and $1.1 million, in the three months ended June 30, 2021 and 2020, respectively. Total operating expenses for the three months ended June 30, 2021 were comprised of research and development expenses of $25.3 million and general and administrative expenses of $12.5 million, which are expected to increase in 2021 as Sutro’s internal product candidates advance in clinical development and additional general and administrative expenses are incurred as a public company.

On August 9, 2021 Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system, reported that it will release its financial results for the second quarter 2021 and financial and business update on Monday, August 16, 2021 (Press release, Protalix, AUG 9, 2021, View Source [SID1234586159]). The Company’s management will host a conference call to discuss the financial results and provide a business update on recent corporate and clinical developments at 8:30 a.m. Eastern Daylight Time (EDT).

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Conference Call Details:

The conference call will be webcast live from the Company’s website and will be available via the following links:

Webcast Details:

Company Link: View Source
Webcast Link: View Source
Conference ID: 13721687

Please access the websites at least 15 minutes ahead of the conference to register, download and install any necessary audio software.

The conference call will be available for replay for two weeks on the Events Calendar of the Investors section of the Company’s website, at the above link.

On August 9, 2021 Aethlon Medical, Inc. (Nasdaq: AEMD), a medical technology company focused on developing products to diagnose and treat life and organ threatening diseases, reported financial results for its first quarter ended June 30, 2021 and provided an update on recent developments (Press release, Aethlon Medical, AUG 9, 2021, View Source [SID1234586158]).

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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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Company Updates

Aethlon Medical is continuing the research and clinical development of our Hemopurifier to bind and remove COVID-19 viral particles, including many variant COVID-19 particles of interest and related exosomes.

As disclosed in our last earnings release on June 24, 2021, the Aethlon Hemopurifier has demonstrated binding of SARS-CoV-2 spike protein and binding and removal from circulation of SARS-CoV-2 virus from a human patient. This is in addition to the Hemopurifier’s previously demonstrated binding of numerous pathogenic viruses. This new information has stimulated clinical researchers to express interest in joining our ongoing clinical trial investigating the Hemopurifier for the treatment of patients with SARS-CoV-2/COVID-19 infection. This trial is being conducted under the open Investigational Device Exemption (IDE) for the Hemopurifier in life threatening viral infections. This trial will allow for up to 40 of these patients to be treated under a new Early Feasibility Study (EFS) protocol at up to 20 clinical sites in the U.S. During the quarter, Cooper Medical Center, located in Camden, N.J., joined the trial. Additionally, the Company is in late-stage clinical trial agreement discussions to bring on board other key U.S. medical centers and interested international medical centers. The Company anticipates finalizing our selection of a Contract Research Organization to supervise these clinical trials in the near future.

Financial Results for the First Quarter Ended June 30, 2021

At June 30, 2021, Aethlon Medical had a cash balance of approximately $25.2 million.

During the three months ended June 30, 2021, we raised approximately $17.5 million in net proceeds from the issuance of common stock in a combination of a registered direct financing and ATM sales.

Aethlon recorded approximately $115,000 of government contract revenue on its Phase 2 Melanoma Cancer Contract in the three months ended June 30, 2021. We also recorded approximately $17,000 of revenue related to our cost reimbursable subaward arrangement with the University of Pittsburgh in connection with an NIH contract entitled "Depleting Exosomes to Improve Responses to Immune Therapy in HNNCC." As a result, the Company recorded total government contract revenue of approximately $132,000 in the three months ended June 30, 2021. Aethlon did not record any government contract revenue in the three months ended June 30, 2020.

Consolidated operating expenses for the three months ended June 30, 2021 were approximately $2.2 million, compared to $1.4 million for the three months ended June 30, 2020. This increase of approximately $800,000, or 58%, in the 2021 period was due to increases in payroll and related expenses of approximately $580,000, in general and administrative expenses of approximately $221,000, and in professional fees of approximately $19,000.

The $580,000 increase in payroll and related expenses was primarily due to the combination of a $234,000 increase in R&D payroll as the result of hiring additional scientists, a $210,000 bonus payment to our CEO as the result of achieving certain milestones in his employment contract, a $64,000 increase in general and administrative payroll expense as the result of additional headcount and a $36,000 increase in stock-based compensation.

The $221,000 increase in general and administrative expenses was primarily due to a $133,000 increase in our subcontractor expenses related to our government contracts and a $74,000 increase in insurance expenses.

The $19,000 increase in professional fees was primarily due to a $50,000 increase in legal fees which was partially offset by a $22,000 decrease in scientific consulting expenses and a $6,000 decrease in accounting expenses.

Other expense was nominal during the first quarter ended June 30, 2021.

As a result of the changes in revenues and expenses noted above, the Company’s net loss before noncontrolling interests increased to approximately $2.1 million for the three months ended June 30, 2021, from approximately $1.4 million for the three months ended June 30, 2020.

The unaudited condensed consolidated balance sheet for June 30, 2021 and the unaudited condensed consolidated statements of operations for the three month periods ended June 30, 2021 and 2020 follow at the end of this release.

Conference Call

The Company will hold a conference call today, Monday, August 9, 2021 at 4:30 p.m. Eastern Time to review financial results and recent corporate developments. Following management’s formal remarks, there will be a question and answer session.

Interested parties can register for the conference by navigating to View Source

Please note that registered participants will receive their dial in number upon registration.

Interested parties without internet access or unable to pre-register may dial in by calling:
All callers should ask for the Aethlon Medical, Inc. conference call.

A replay of the call will be available approximately one hour after the end of the call through September 9, 2021. The replay can be accessed via Aethlon Medical’s website or by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international) or Canada Toll Free at 1-855-669-9658. The replay conference ID number is 10159282.