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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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.

On August 9, 2021 Thermo Fisher Scientific Inc. (NYSE: TMO) ("Thermo Fisher") reported that it has priced an offering of $3.1 billion aggregate principal amount (the "Offering") of the following notes (Press release, Thermo Fisher Scientific, AUG 9, 2021, View Source [SID1234586157]):

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$700 million aggregate principal amount of its 1.750% senior notes due 2028, at the issue price of 99.952% of their principal amount,
$1.2 billion aggregate principal amount of its 2.000% senior notes due 2031, at the issue price of 98.827% of their principal amount, and
$1.2 billion aggregate principal amount of its 2.800% senior notes due 2041, at the issue price of 99.508% of their principal amount.
The Offering is expected to close on or about August 23, 2021, subject to customary closing conditions. The notes will pay interest on a semi-annual basis.

Thermo Fisher intends to use the net proceeds of the Offering to pay a portion of the cash consideration payable for the pending acquisition of PPD, Inc., a Delaware corporation.

The joint book-running managers for the Offering are Barclays Capital Inc., Morgan Stanley & Co. LLC, BofA Securities, Inc. and Citigroup Global Markets Inc.

The Offering is being made pursuant to an effective registration statement on Form S-3 filed with the U.S. Securities and Exchange Commission (the "SEC"). Prospective investors should read the prospectus forming a part of that registration statement and the prospectus supplement related to the Offering and the other documents that Thermo Fisher has filed with the SEC for more complete information about Thermo Fisher and this Offering. These documents are available at no charge by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, Thermo Fisher, the underwriters or any dealer participating in this offering will arrange to send you the prospectus if you request it by calling Barclays Capital Inc. toll-free at 1-888-603-5847; Morgan Stanley & Co. LLC toll-free at 1-866-718-1649; BofA Securities, Inc. toll-free at 1-800-294-1322;or Citigroup Global Markets Inc. toll-free at 1-800-831-9146.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the notes, nor shall there be any offer, solicitation or sale of the notes in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

On August 9, 2021 Fulgent Genetics, Inc. (NASDAQ: FLGT) ("Fulgent" or the "Company"), a technology-based genetic testing company focused on transforming patient care in oncology, infectious and rare diseases, and reproductive health, reported that it has acquired CSI Laboratories ("CSI") to expand its presence in somatic molecular diagnostics and cancer testing (Press release, CSI Laboratories, AUG 9, 2021, View Source [SID1234586156]).

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CSI was founded in 1997 to provide a client- and patient-focused model of cancer diagnostic testing for pathologists, community hospitals, and their patients. CSI offers more than 400 unique tests with a focus on oncology and capabilities across flow cytometry, cytogenetic analysis, fluorescence in-situ hybridization ("FISH"), immunohistochemistry, and molecular genetics. CSI’s philosophy of providing expert diagnostic testing with speed, precision, and care, is highly complementary with Fulgent’s core value proposition of offering a broad menu of actionable diagnostic tests with quality results and rapid turnaround time.

Strategic Rationale:

– Expansion into somatic genetic testing market, which is expected to grow to $16.8 billion by 2030

– Realize synergies by leveraging Fulgent’s best-in-class technology and Next Generation Sequencing ("NGS") expertise in new oncology markets

– Geographic expansion of CSI’s reach beyond the Southeastern part of the United States

With the acquisition of CSI, Fulgent will significantly expand its capabilities in molecular diagnostics and oncologic testing. Fulgent will leverage its established technology platform, NGS expertise, lab operations, and sales infrastructure in conjunction with CSI’s extensive cancer testing menu to establish a differentiated foothold in oncologic testing in the United States. The combination of CSI’s extensive molecular diagnostics test menu and Fulgent’s NGS expertise, given its proprietary technology platform, will create a novel, comprehensive cancer testing solution for customers across the United States.

Fulgent’s Chief Medical Officer, Dr. Larry Weiss, will oversee the integration of CSI’s capabilities into Fulgent’s platform and the future operations of the company’s oncologic testing efforts. Fulgent expects to bolster the scale of CSI’s offerings with a new state-of-the-art cancer testing laboratory in California, which it believes will complement CSI’s existing operations in Alpharetta, Georgia.

"We are extremely excited to add CSI Laboratories’ expertise and team to the Fulgent family," said Ming Hsieh, Chairman and CEO of Fulgent. "Their high standards for test quality and customer service fit extremely well with our values and culture at Fulgent. We look forward to adding their extensive oncologic and molecular diagnostic testing capabilities to our platform."

"CSI has an outstanding reputation for providing excellent pathology and oncology services in the southeastern United States. We expect CSI will serve as an anchor to Fulgent’s cancer testing capabilities, bringing their expertise and experience to a national oncologic centered client base, and expanding their broad pathology and molecular offerings by leveraging Fulgent’s leadership in Next Generation Sequencing," said Dr. Larry Weiss, Chief Medical Officer at Fulgent. "Our vision is to combine Fulgent’s excellence in NGS with the broad, high-quality oncologic testing menu already existing in CSI and bring it to a national client base. We expect the addition of CSI will deliver customers a superior experience relative to competitors who offer one-dimensional NGS testing or broader menus without NGS expertise."

"This is an exciting day for CSI Laboratories’ team members, clients and patients, and we are excited to join forces with a company that shares our same level of commitment to the cancer community, " said Ron Ghafary, founder of CSI Laboratories. "We look forward to expanding our cancer testing capabilities on Fulgent’s genomic testing platform and continuing to differentiate ourselves through our expertise, high-quality results and high-touch service model that our clinicians and staff deliver on a daily basis."

Advisors

Piper Sandler acted as the exclusive financial advisor and Mintz Levin, Cohn, Ferris, Glovsky and Popeo served as legal counsel to Fulgent Genetics, Inc. in connection with the transaction.