On August 4, 2021 NanoString Technologies, Inc. (NASDAQ:NSTG), a leading provider of life science tools for discovery and translational research, reported financial results for the second quarter ended June 30, 2021 (Press release, NanoString Technologies, AUG 4, 2021, View Source [SID1234585710]).

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Second Quarter Financial Highlights

Product and service revenue of $33.6 million, 59% year-over-year growth
Instrument revenue of $11.8 million, 21% year-over-year growth. Instrument revenue includes $7.4 million of GeoMx Digital Spatial Profiler (DSP) instrument revenue
Consumables revenue of $18.0 million, 115% year-over-year growth. Consumables revenue includes $3.8 million GeoMx DSP consumables revenue
Service revenue of $3.8 million, 29% year-over-year growth
Cash, cash equivalents and short-term investments of $398.0 million at June 30, 2021
"The momentum behind our spatial biology franchise continues to increase with each quarter. We generated record orders for GeoMx DSP systems in the second quarter and the launch of our Whole Transcriptome Atlases have driven a steady increase in GeoMx consumable pull-through. Our Spatial Molecular Imager has been garnering strong interest from a diverse set of researchers, including both existing GeoMx users and single cell researchers who are just beginning to embrace spatial biology," said Brad Gray, president & CEO of NanoString. "Meanwhile, our nCounter franchise achieved a major milestone with our one thousandth instrument placement and we’re proud of the continued scientific contribution from nCounter, with customers generating more than 300 new peer-reviewed publications in the second quarter."

GeoMx DSP

GeoMx Installed Base: Grew installed base to approximately 190 GeoMx DSP Systems at June 30, 2021, as compared to approximately 65 at June 30, 2020
GeoMx Mouse Whole Transcriptome Atlas: Began commercial shipments of the GeoMx Mouse Whole Transcriptome Atlas in the second quarter, which provides high throughput RNA profiling in the primary model organism for discovery research
GeoMx Technology Access Program (TAP): Generated approximately 90 new GeoMx TAP orders in the second quarter, of which over 70% utilized GeoMx Whole Transcriptome Atlas products
GeoMx Publications: Increased cumulative peer-reviewed publications to approximately 60 as of June 30, 2021, with approximately 10 new publications during the quarter
nCounter

nCounter Installed Base: Grew installed base to approximately 1,015 nCounter Analysis Systems at June 30, 2021, as compared to approximately 890 systems at June 30, 2020
nCounter Publications: Surpassed 4,600 cumulative peer-reviewed publications utilizing nCounter technology at June 30, 2021
Stem Cell Characterization Panel Launch: Launched the nCounter Stem Cell Characterization Panel for the analysis and optimization of stem cell lines used in the development of potential novel therapeutics
Parker Institute for Cancer Immunotherapy Collaboration: Announced a collaboration with Parker Institute for Cancer Immunotherapy, which will utilize nCounter technology to characterize cellular therapy regimens that may improve patient outcomes across all cancer types
2021 Outlook

The company updated its revenue outlook for 2021, with results expected as follows:

GeoMx DSP revenue of $48 to $50 million, as compared to previous guidance of $45 to $50 million, based on strong consumable utilization at NGS-enabled sites
nCounter revenue, inclusive of all service revenue, of $95 to $97 million, as compared to previous guidance of $95 to $100 million, reflecting strong demand in North America partially offset by a slower pace of pandemic recovery in EMEA and APAC
Total product and service revenue of $143 to $147 million, as compared to previous guidance of $140 to $150 million
The company reiterated its full-year outlook on gross margin, operating expenses and adjusted EBITDA.

Second Quarter Financial Results

We have elected to present selected non-GAAP, or adjusted, financial measures, including Adjusted EBITDA. These adjusted financial measures are calculated excluding certain items that may make it more challenging to compare our GAAP operating results across periods. Such items may include collaboration revenue, stock-based compensation, depreciation and amortization, or one-time charges such as transaction related fees and expenses or restructuring charges and severance costs. A reconciliation of adjusted financial measures to the nearest comparable GAAP financial measure can be found in the notes and table at the end of this press release.

Supplemental Information

As a supplement to the table above, we have posted to the investor relations section of our website, at www.nanostring.com, supplemental financial data that includes our adjusted financial measures as compared to the nearest comparable GAAP financial measures, for the second quarter and the six months ended June 30, 2021 and for each quarter of and the full year of 2020.

Conference Call

Management will host a conference call today beginning at 1:30 pm PT / 4:30 pm ET to discuss these results and answer questions. Investors and other interested parties can register for the call in advance by visiting View Source After registering, an email confirmation will be sent, including dial-in details and unique conference call codes for entry. Registration is open throughout the call, but to ensure connection for the full call, registration in advance is recommended. The link to the webcast and audio replay will be made available at the Investor Relations website: www.nanostring.com. A replay of the call will be available beginning August 4, 2021 at 7:30pm ET through midnight ET on August 11, 2021. To access the replay, dial (800) 585-8367 or (416) 621-4642 and reference Conference ID: 3414117. The webcast will also be available on our website for one year following the completion of the call.

On August 4, 2021 Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, reported financial results for the second quarter of 2021 (Press release, Dynavax Technologies, AUG 4, 2021, View Source [SID1234585709]).

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"Our successful execution in the second quarter of 2021 continued to build on the progress made in 2020. With the combined strength of opportunities from HEPLISAV-B and CpG 1018, we believe 2021 will be a transformational year for Dynavax," commented Ryan Spencer, Chief Executive Officer of Dynavax. "HEPLISAV-B achieved its highest quarterly revenue at $13.7 million and continues to increase market share, which reinforces our belief that it will become the standard of care in the U.S. for adult hepatitis B vaccinations."

Mr. Spencer continued, "Dynavax is also making progress on numerous collaborations for its proven CpG 1018 vaccine adjuvant across multiple indications, including COVID-19, pertussis, and universal flu. Our COVID-19 collaborations have advanced significantly in recent months with the execution of commercial supply agreements with Biological E and Clover Biopharmaceuticals, in addition to the two previously executed agreements with Valneva and Medigen. Multiple partners have reported that they currently intend to apply for emergency or conditional authorization for their COVID-19 vaccines in the second half of 2021. Importantly, these collaborations are generating meaningful revenue for Dynavax, with second quarter CpG 1018 revenue of $39 million. We continue to be excited about each of our partners’ clinical programs and believe that the emerging portfolio of product opportunities with CpG 1018 adjuvant has the potential to continue generating meaningful future value for Dynavax."

HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted]

Net product revenue for HEPLISAV-B was $13.7 million during the second quarter 2021, representing the highest quarterly HEPLISAV-B net sales to date, compared to $2.4 million for the second quarter 2020. This increase was primarily driven by continued success in the field targeted accounts and ongoing progress in national accounts.
Market share in accounts targeted by the field sales team increased to 30%, up from 21% in the second quarter of 2020.
Dynavax and Bavarian Nordic entered into a commercialization agreement for the marketing and distribution of HEPLISAV B in Germany.
CpG 1018 (Advanced Vaccine Adjuvant)

Net product revenue for CpG 1018 adjuvant during the second quarter 2021 was $39.0 million.
Dynavax and Biological E (Bio E) entered into a commercial supply agreement for the use of CpG 1018 adjuvant in the commercial production of Bio E’s subunit COVID-19 vaccine candidate, CORBEVAX. Upon completion of their Phase 2/3 and subsequently emergency use authorization (EUA) India’s Union Ministry of Health has reserved 300 million doses of CORBEVAX.
Dynavax and Clover Biopharmaceuticals entered into a commercial supply agreement for the use of CpG 1018 adjuvant in the commercial production of Clover’s COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum). In parallel, Clover announced an advanced purchase agreement with GAVI to supply up to 414 million doses of SCB-2019 (CpG 1018/Alum) through 2022 for the COVAX Facility.
The Coalition for Epidemic Preparedness Innovations (CEPI) expanded its agreement with Dynavax to provide funding to manufacture CpG 1018 for CEPI’s COVID-19 vaccine grantees, increasing total funding under the loan agreement from $99.0 million to $176.4 million to support Dynavax’s manufacturing costs.
Medigen Vaccine Biologics Corporation received EUA from the Taiwan Food and Drug Administration and received approval for inclusion in Taiwan’s COVID-19 vaccination immunization program for MVC-COV1901, its COVID-19 vaccine adjuvanted with CpG 1018.
Valneva SE reported positive initial results for Part A of the Phase 1/2 clinical trial of its COVID-19 vaccine candidate, VLA2001 adjuvanted with CpG 1018. Based on the positive results Valneva initiated a pivotal Phase 3 clinical trial, which is now fully enrolled. Valneva is also participating in a UK government-funded clinical trial looking at various COVID-19 ‘booster’ vaccines.
CONVERTIBLE DEBT OFFERING

In May 2020, we issued $225.5 million in aggregate principal amount of 2.50% convertible senior notes due 2026. As of June 30, 2021, the aggregate principal amount of our Convertible Notes was $225.5 million, excluding debt discount of $5.5 million.
A portion of the net proceeds from the offering were used to pay off an existing $190.2 million term loan in full, including the termination payment. In connection with the offering, we also entered into capped call transactions with certain financial institutions that are expected generally to reduce the potential dilution to common stock in certain circumstances, upon conversion of the notes.
This debt refinancing is expected to reduce interest expense by approximately $12.1 million on an annualized basis.
UPCOMING MILESTONES

CDC Advisory Committee on Immunization Practices expected to vote on a universal hepatitis b recommendation for all previously unvaccinated adults in October.
Multiple data readouts from our CpG 1018 COVID-19 collaboration partners with potential for emergency or conditional use authorization by the end of 2021.
Data from Tdap-1018 in the ongoing Phase 1 clinical trial, for an improved tetanus, diphtheria, and acellular pertussis booster vaccine candidate adjuvanted with CpG 1018 expected in first quarter 2022.
FINANCIAL RESULTS

Total Revenue. Total revenues for the second quarter of 2021 were $52.8 million, including $52.7 million of net product revenue, an increase from total revenue for the second quarter of 2020 of $2.7 million.

Product Revenue, Net. HEPLISAV-B product revenue, net was $13.7 million in the second quarter of 2021 compared to $2.4 million in the same period in 2020. CpG 1018 product revenue, net was $39.0 million in the second quarter of 2021 and there was no revenue in the same period in 2020. As CpG 1018 revenues are generally recorded upon shipment to a customer, there may be fluctuations in revenues between quarters as shipments often consist of large-sized batches.

Cost of Sales – Product. Cost of sales – product for the second quarter 2021 increased to $14.8 million, compared to $1.0 million for the second quarter of 2020. The increase was primarily due to manufacturing costs for increased volumes of CpG 1018 and HEPLISAV-B sold to customers.

Research and Development Expenses (R&D). R&D expenses for the second quarter of 2021 increased to $7.2 million, compared to $5.9 million for the second quarter of 2020. The increase is primarily associated with higher headcount and outside services to support vaccine clinical and development activities.

Selling, General and Administrative Expenses (SG&A). SG&A expenses for the second quarter of 2021 increased to $21.6 million, compared to $19.0 million for the second quarter of 2020. This increase is primarily driven by compensation and related personnel costs, including non-cash stock-based compensation, associated with higher headcount.

Income (loss) from Operations and Net Income (loss). Income from operations for the second quarter of 2021 was $9.2 million compared to a loss from operations of $23.3 million in the second quarter of 2020. Net income for the second quarter of 2021 was $4.5 million compared to a net loss of $51.6 million for the second quarter of 2020.

Earnings per share. Basic and diluted net income per share were $0.04 and $0.02, respectively, for the second quarter of 2021, compared to basic and diluted net loss per share of ($0.53) and ($0.53), respectively, in the second quarter of 2020.

Cash Position. Cash, cash equivalents and marketable securities totaled $345.8 million at June 30, 2021.

CONFERENCE CALL AND WEBCAST INFORMATION
Dynavax will hold a conference call today at 4:30 p.m. ET/1:30 p.m. PT. The live audio webcast may be accessed through the "Events & Presentations" page on the "Investors" section of the Company’s website at www.dynavax.com. Alternatively, participants may dial (866) 420-4066 or (409) 217-8237 and refer to conference ID 9970706. A replay of the webcast will be available for 30 days following the live event.

Please see Important Safety Information below.

For more information about HEPLISAV-B, visit View Source

About Hepatitis B
Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer and death. The hepatitis B virus is 50 to 100 times more infectious than HIV,I and transmission is on the rise. There is no cure for hepatitis B, but effective vaccination can prevent the disease.

In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person. The U.S. Centers for Disease Control (CDC) recommends vaccination for those at high risk for infection due to their jobs, lifestyle, living situations and travel to certain areas.II Because people with diabetes are particularly vulnerable to infection, the CDC recommends vaccination for adults age 19 to 59 with diabetes as soon as possible after their diagnosis, and for people age 60 and older with diabetes at their physician’s discretion.III Approximately 20 million U.S. adults have diabetes, and 1.5 million new cases of diabetes are diagnosed each year.IV

About HEPLISAV-B
HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax’s proprietary Toll-like Receptor (TLR) 9 agonist CpG 1018 to enhance the immune response. Dynavax has worldwide commercial rights to HEPLISAV-B.

Important U.S. Product Information
HEPLISAV-B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

Safety and effectiveness of HEPLISAV-B have not been established in adults on hemodialysis.

For full U.S. Prescribing Information for HEPLISAV-B, click here.

Important U.S. Safety Information (ISI)
Do not administer HEPLISAV-B to individuals with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B. Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration. The most common patient reported adverse reactions reported within 7 days of vaccination were injection site pain (23% to 39%), fatigue (11% to 17%) and headache (8% to 17%).

Important EU/EEA Product Information
HEPLISAV B is indicated for active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and older.
The use of HEPLISAV B should be in accordance with official recommendations.
It can be expected that hepatitis D will also be prevented by immunization with HEPLISAV B as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.

For full EU/EEA. Prescribing Information for HEPLISAV-B, click here.

Important EU/EEA Safety information
Do not receive HEPLISAV B if you have had a sudden life-threatening, allergic reaction after receiving HEPLISAV B in the past, or if you are allergic to any of components of this vaccine, including yeast. Signs of an allergic reaction may include itchy skin, rash, shortness of breath and swelling of the face or tongue.
Appropriate medical treatment and supervision should be readily available in case of rare anaphylactic reactions following the administration of the vaccine.
The administration of HEPLISAV B should be postponed in subjects suffering from acute severe febrile illness.
Immunocompromised persons may have a diminished immune response to HEPLISAV B.

Because of the long incubation period of hepatitis B, it is possible for unrecognised HBV infection to be present at the time of immunisation. HEPLISAV B may not prevent HBV infection in such cases.
There are very limited data on the immune response to HEPLISAV B in individuals who did not mount a protective immune response to another hepatitis B vaccine.
As a precautionary measure, it is preferable to avoid the use of HEPLISAV B during pregnancy. Vaccination during pregnancy should only be performed if the risk-benefit ratio at the individual level outweighs possible risks for the fetus.
The most common patient-reported side effects reported within 7 days of vaccination were pain, swelling or redness at the injection site, feeling tired, headache, muscle aches, feeling unwell and fever.

About CpG 1018 Adjuvant
CpG 1018 is the adjuvant used in HEPLISAV-B. Dynavax developed CpG 1018 adjuvant to provide an increased vaccine immune response, which has been demonstrated in HEPLISAV-B. CpG 1018 adjuvant provides a well- developed technology and a significant safety database, potentially accelerating the development and large-scale manufacturing of a COVID-19 vaccine.

On August 4, 2021 Celyad Oncology SA (Euronext & Nasdaq: CYAD) (the "Company") (Brussels:CYAD) (Paris:CYAD) (NASDAQ:CYAD), a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, reported an update on its financial results and recent business developments for the fiscal quarter ended June 30, 2021 (Press release, Celyad, AUG 4, 2021, View Source [SID1234585708]).

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"We continue to blaze a path forward by developing new technologies to advance allogeneic CAR T therapies, including our proprietary shRNA platform for allogeneic CAR T production and ‘armored’ CAR capabilities with co-expression of secreting cytokines, starting with IL-18. The innovations we are making through our clinical development pipeline and new technologies were the focus of our R&D day last month. This is an exciting time in our Company’s history as we plan for a steady stream of milestones in the second half of 2021," commented Filippo Petti, Chief Executive Officer of Celyad Oncology. "We plan on announcing multiple clinical updates in the next six months that are expected to help further the progress of our lead programs and proprietary shRNA platform for the development of next-generation allogeneic CAR Ts."

Second Quarter 2021 and Recent Business Highlights

Dr. Charles Morris was appointed as Chief Medical Officer in April 2021.
Preliminary data from the Phase 1 IMMUNICY-1 trial of CYAD-211 for the treatment of r/r MM were announced at the European Hematology Association (EHA) (Free EHA Whitepaper) 2021 Virtual Congress.
Research & Development Day held on July 20, 2021, during which the management team provided:
Updates on the allogeneic CAR T clinical candidates CYAD-211 and CYAD-101.
Highlights from the latest research from its proprietary shRNA platform, including the introduction of CYAD-203 – a novel allogeneic, IL-18-armored CAR T candidate for solid tumor now in IND-enabling studies.
Acquisition of an exclusive license from the Moffitt Cancer Center for an antibody directed to Tumor-associated glycoprotein (TAG-72), which will form the basis of a T cell engager to be used with our shRNA platform technology.
Pipeline Update

CYAD-101 – Allogeneic TIM-based NKG2D CAR T for mCRC

CYAD-101 is the Company’s first-in-class, allogeneic CAR T candidate engineered to co-express a chimeric antigen receptor (CAR) based on the NKG2D receptor and the novel inhibitory peptide TCR Inhibitory Molecule (TIM).

To the Company’s knowledge, CYAD-101 is the first investigational allogeneic CAR T candidate to generate evidence of clinical activity for the treatment of a solid tumor indication. This is based on data reported from the dose-escalation segment of the alloSHRINK Phase 1 trial evaluating CYAD-101 following FOLFOX (combination of 5-fluorouracil, leucovorin and oxaliplatin) preconditioning chemotherapy for the treatment of advanced metastatic colorectal cancer (mCRC).
CYAD-101 following FOLFOX preconditioning chemotherapy was observed to be well-tolerated with no evidence of Graft-versus-Host Disease (GvHD). In addition, two of 15 patients from the dose-escalation segment of the alloSHRINK trial achieved a confirmed partial response (PR). Median progression-free survival (mPFS) and median overall survival (mOS) from the dose-escalation segment was 3.9 months and 10.6 months, respectively. In addition, tumor burden decrease based on RECIST 1.1 criteria was observed in eight of 15 patients, including six of nine patients at the recommended dose of 1×109 CYAD-101 cells per infusion.
In September 2020, the Company entered a clinical trial collaboration with MSD, a tradename of Merck & Co., Inc., Kenilworth, NJ., USA, through a subsidiary. The Company will conduct the Phase 1b KEYNOTE-B79 clinical trial, which will evaluate CYAD-101 following FOLFOX preconditioning chemotherapy, with MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in refractory mCRC patients with microsatellite stable (MSS) / mismatch-repair proficient (pMMR) disease. Initiation of the KEYNOTE-B79 trial is expected in the fourth quarter of 2021.
CYAD-211 – Allogeneic shRNA-based, anti-BCMA CAR T for r/r MM

CYAD-211 is an investigational, shRNA-based allogeneic CAR T candidate for the treatment r/r MM. CYAD-211 is engineered to co-express a B cell maturation antigen (BCMA) targeting CAR and a single shRNA, which interferes with the expression of the CD3ζ component of the T-cell receptor (TCR) complex.

The Company recently announced preliminary data from the dose-escalation Phase 1 IMMUNICY-1 trial, evaluating the tolerability and clinical activity of a single infusion of CYAD-211 following preconditioning with cyclophosphamide (300 mg/m²) and fludarabine (30 mg/m²) given for three consecutive days.
In June 2021, preliminary data from the Phase 1 IMMUNICY-1 trial was presented at the EHA (Free EHA Whitepaper) congress that demonstrated no dose limiting toxicity (DLT), Graft-versus-Host disease (GvHD) or CAR T-cell-related encephalopathy syndrome (CRES) were observed in the first two dose levels (30×106 and 100×106 cells per infusion) of the trial. Two of the five evaluable patients at the first two dose levels achieved a partial response. In addition, CYAD-211 cells were detected by PCR-based methods in all six patients with evidence of a dose dependent increase in cell engraftment.
In July 2021, the Company reported data from the first patient at dose level three (300×106 cells per infusion) which continues to show dose dependent engraftment of CYAD-211 with no GvHD reported to date.
Enrollment in the trial is ongoing with plans to explore higher doses of preconditioning regimens in future cohorts.
CYAD-203 – Allogeneic shRNA-based, IL-18-armored NKG2D CAR T for Solid Tumors

CYAD-203 is the Company’s first armored CAR T candidate engineered to co-express the cytokine interleukin-18 (IL-18) with the NKG2D CAR receptor. To the Company’s knowledge, this therapy is on track to be the first IL-18 secreting allogeneic CAR T candidate. IL-18 is a proinflammatory cytokine that directly potentiates the anti-cancer activity of CAR T cells while also altering the balance of pro- and anti-inflammatory cells within tumor tissue.

Investigational New Drug (IND)-enabling studies are currently in-progress for the program. Submission of the IND application for CYAD-203 for treatment of solid tumors is expected in mid-2022.
CYAD-02 – Autologous NKG2D CAR-T for r/r AML and MDS

CYAD-02, the Company’s autologous CAR T candidate with shRNA technology that targets the NKG2D ligands MICA and MICB, is currently being evaluated for the treatment of r/r acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) in the Phase 1 CYCLE-1 dose-escalation trial.

To date, eleven patients have received treatment with CYAD-02 in the CYCLE-1 trial, with an enrollment of five patients at dose level three (1×109 cells per infusion).
Preliminary data from the dose level three cohort demonstrated that CYAD-02 was generally well-tolerated. One dose-limiting toxicity was reported at dose level three (cytokine release syndrome, grade 4), leading to expansion of that cohort to six patients. In addition, initial clinical activity has been observed which appears greater than that previously reported from the first-generation autologous NKG2D candidate consistent with a positive contribution from the shRNA-mediated reduction in MICA/B production.
Dose level three cohort of the CYCLE-1 trial is ongoing. Additional safety and efficacy data from the trial are expected by year-end 2021.
Upcoming Anticipated Milestones

Initiation of Phase 1b KEYNOTE-B79 trial evaluating CYAD-101 with KEYTRUDA for advanced mCRC patients with MSS / pMMR disease in fourth quarter of 2021.
Report additional data for the Phase 1 IMMUNICY-1 trial of CYAD-211 for r/r MM by year-end 2021.
Submission of an IND application for CYAD-203 for solid tumors in mid-2022.
Report additional data from the dose-escalation Phase 1 CYCLE-1 trial evaluating CYAD-02 in r/r AML and MDS by year-end 2021.
First Half 2021 Financial Results

Key financial figures for the first half of 2021, compared with the first half of 2020 and full year 2020, are summarized below:

On August 4, 2021 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer and population sequencing, reported financial results for the second quarter ended June 30, 2021 (Press release, Personalis, AUG 4, 2021, View Source [SID1234585707]).

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Second Quarter and Recent Highlights

Record quarterly revenue of $21.7 million in the second quarter of 2021 compared with $19.5 million in the second quarter of 2020, an 11% increase
Revenue of $8.2 million from biopharma and all other customers, excluding the U.S. Department of Veterans Affairs Million Veteran Program (VA MVP), in the second quarter of 2021 compared with $4.7 million in the second quarter of 2020, a 72% increase
Ended the second quarter with cash, cash equivalents, and short-term investments of $328.9 million as of June 30, 2021
Achieved milestone of delivering more than 125,000 whole human genome sequences to the VA MVP
"I’m proud to say that we were able to report record revenue once again this quarter and that we achieved our twentieth consecutive quarter of growth, as we converted an increasing number of orders into revenue. Revenue from biopharma and all other customers grew 72% over the same period of the prior year, and increased sequentially for the seventh consecutive quarter," said John West, Chief Executive Officer. "Recently, we achieved a significant milestone of sequencing our 125,000th whole human genome for the VA MVP, which highlights our expertise and ability to scale. In addition, our development efforts for NeXT Personal, our Minimal Residual Disease (MRD) offering that we expect to launch in 2021, remain on-track."

Second Quarter 2021 Financial Results

Revenue was $21.7 million in the three months ended June 30, 2021, up 11% from $19.5 million in the same period of the prior year.

Gross margin was 37.7% in the three months ended June 30, 2021, compared with 24.0% in the same period of the prior year.

Operating expenses were $23.1 million in the three months ended June 30, 2021, compared with $14.2 million in the same period of the prior year.

Net loss was $15.0 million in the three months ended June 30, 2021 and net loss per share was $0.34 based on a weighted-average basic and diluted share count of 44.0 million, compared with a net loss of $9.3 million and a net loss per share of $0.29 on a weighted-average basic and diluted share count of 31.7 million in the same period of the prior year.

Business Outlook

Personalis expects the following for the third quarter of 2021:

Total revenue to be approximately $22.2 million
Revenue from biopharma and all other customers, excluding VA MVP, to be in the range of $7.5 million to $8.5 million
Net Loss to be in the range of $17 million to $18 million; estimated outstanding shares of 44 million
Personalis expects the following for the full year of 2021:

Total revenue to be approximately $85 million
Revenue from biopharma and all other customers, excluding VA MVP, to be in the range of $33 million to $34 million
Net Loss to be in the range of $65 million to $70 million; estimated outstanding shares of 44 million
Webcast and Conference Call Information

Personalis will host a conference call to discuss the second quarter 2021 financial results after market close on Wednesday, August 4, 2021 at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. The conference call can be accessed live over the phone by dialing (866) 220-8061 for U.S. callers or (470) 495-9168 for international callers, using the conference ID: 8564509. The live webinar can be accessed at View Source

On August 4, 2021 Certara, the global leader in biosimulation, reported it will host the inaugural New Horizons in Pediatric Drug Development Symposium taking place October 28-29, 2021 (Press release, Certara, AUG 4, 2021, View Source [SID1234585706]). The two-day virtual symposium is being held to bring together thought leaders and innovators in pediatric drug development to share new developments in the field and to collaborate on new ideas to advance pediatric drug development into a new era.

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"We are thrilled to have such an amazing group of speakers and renowned experts to support the advancement of drug development in pediatrics," said Patrick Smith, PharmD., Senior Vice President of Integrated Drug Development at Certara and chair of the organizing committee. "Pediatric drug development is rapidly evolving, with exciting new tools and emerging technologies, which address some of the inherent complexities associated with developing drugs for children. We look forward to the exciting conversations this event will bring forth."

The symposium is spearheaded by an organizing committee comprised of regulatory and drug development experts in the biopharmaceutical industry. Keynote speaker, Lynne Yao, M.D., Director at the FDA Division of Pediatric and Maternal Health, Center for Drug Evaluation and Research, will discuss challenges and opportunities to accelerate global pediatric drug development. Additionally, the agenda features speakers who will speak about the regulatory environment, clinical trial innovation, and the changing landscape with the recent passing of the US FDA’s Research to Accelerate Cures and Equity for Children Act to expand and encourage pediatric drug development, specifically in oncology.

"Being passionate about paediatric development, I am very proud and honoured to be part of this symposium. This is the opportunity to bring together distinguished experts to share their views and experience, which will certainly benefit all involved," said Solange Corriol-Rohou, M.D., Senior Global Regulatory Policy Director at AstraZeneca. "It is amazing to see how paediatric development has evolved and been optimised these last few years. Multi-stakeholder collaboration has increased with the uptake of new tools and methods, such as digital technologies, extrapolation or quantitative approaches, for the benefit of children in need."