On November 22, 2021 Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, reported financial results and business highlights for the fourth quarter and full year fiscal 2021 ended September 30, 2021 (Press release, Twist Bioscience, NOV 22, 2021, View Source [SID1234595925]).

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"Fiscal 2021 was a transformational year for Twist, as we delivered significant revenue growth by diversifying and expanding our customer base in synbio and NGS, as well as introduced new and innovative products," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "In biopharma, as of the end of September 2021, we had 34 partners, 41 active and 32 completed programs, with 35 of those programs having milestone payments and/or royalties associated with them. In addition, subject to regulatory approval, we expect to have the first Twist-discovered antibody in the clinic in 2022 and we also signed an agreement to acquire Abveris, which will augment our capabilities by adding animal-based discovery. In data storage, we achieved several technical milestones and are now preparing for early access launch with our 1-micron proof-of-concept chip."

FISCAL 2021 FINANCIAL RESULTS

Orders: Total orders received for fiscal 2021 were $159.5 million compared to $116.7 million for fiscal 2020.
Revenue: Total revenues for fiscal 2021 were $132.3 million compared to $90.1 million for fiscal 2020.
Cost of Revenues: Cost of revenues for fiscal 2021 was $80.6 million compared to $61.4 million for fiscal 2020.
Research and Development Expenses: Research and development expenses for fiscal 2021 were $69.1 million compared to $43.0 million for fiscal 2020.
Selling, General and Administrative Expenses: Selling, general and administrative expenses for fiscal 2021 were $135.9 million compared to $103.3 million for fiscal 2020.
Net Loss: Net loss for fiscal 2021 was $152.1 million, or $3.15 per share, compared to $139.9 million, or $3.57 per share, for fiscal 2020.
Cash Position: As of September 30, 2021, the company had $477.9 million in cash, cash equivalents and short-term investments.
FISCAL 2021 FOURTH QUARTER FINANCIAL RESULTS

Orders: Total orders received for the fourth quarter of fiscal 2021 were $45.2 million, compared to $42.7 million for the same period of fiscal 2020. The fourth quarter of fiscal 2020 included a single $9 million order.
Revenue: Total revenues were $38.0 million for the fourth quarter of fiscal 2021, compared to $32.4 million for the fourth quarter of fiscal 2020. The fourth quarter of fiscal 2020 included a single $9 million order that was shipped and recognized as revenue in the quarter.
Cost of Revenues: Cost of revenues for the fourth quarter of fiscal 2021 was $22.5 million compared to $17.6 million for the same period of fiscal 2020.
Research and Development Expenses: Research and development expenses for the fourth quarter of fiscal 2021 were $19.4 million compared to $11.6 million for the same period of fiscal 2020.
Selling, General and Administrative Expenses: Selling, general and administrative expenses for the fourth quarter of fiscal 2021 were $38.2 million compared to $27.2 million for the same period of fiscal 2020.
Net Loss: Net loss for the fourth quarter of fiscal 2021 was $41.2 million, or $0.84 per share, compared to $24.3 million, or $0.54 per share, for the fourth quarter of fiscal 2020.
"We reported record revenue for both the quarter and the fiscal year, as well as a gross margin of more than 40% for the quarter and 39% for the year," commented Jim Thorburn, CFO of Twist. "We expect fiscal 2022 to be a year of investment in the biopharma and data storage areas, as well as ramping up production at the Factory of the Future to set the stage for escalating growth moving forward."

Fiscal Fourth Quarter 2021 and Recent Highlights

SynBio and NGS

Shipped products to approximately 2,900 customers in fiscal 2021, versus approximately 2,200 in fiscal 2020.
Shipped more than 372,000 genes during fiscal 2021, compared with approximately 338,000 in fiscal 2020.
Launched Exome 2.0, an exome panel designed with thoughtfully curated content that includes comprehensive coverage of genes responsible for rare diseases, inherited disorders, and germline cancers in humans.
Expanded expert-led Twist Alliance Panel partnerships with leading scientific institutions. product offering. Twist now offers expert-curated high quality target enrichment panels, with content designed by experts from Regeneron Genetics Center (SNP Diversity Panel), the Broad Institute (Clinical Research Exome), Victoria Clinical Genomics Services and AnchorDx (Pan-cancer MethylationPanel). A suite of products in rare disease from Centogene is in process and will be available soon.
Continued our commitment to scientists working to understand the spread and evolution of SARS-CoV-2 by launching Twist Synthetic SARS-CoV-2 RNA Controls for variants of concern Delta Plus AY.1 and AY.2, as well as variants under monitoring including Iota & Epsilon.
BioPharma and DNA Data Storage

Announced a definitive agreement to acquire Abveris (formerly known as AbX Biologics, Inc.), a privately held company in vivo antibody discovery services company developing the next generation of biologics, cell therapies, vaccines, and diagnostics in partnership with global biopharma leaders. Abveris offers comprehensive antibody discovery and characterization services using its proprietary DiversimAb family of hyperimmune mouse models, the output of which can be humanized using the Twist antibody optimization solution to develop superior biologics for rapid clinical advancement.
Launched Revelar Biotherapeutics, Inc., an independently operated new biotechnology company in which Twist retained a significant minority ownership interest, to develop and commercialize an antibody that neutralizes all known variants of concern of the SARS-CoV-2 virus, discovered and optimized by Twist Biopharma, a division of Twist Bioscience. In addition, Revelar will have the ability to leverage Twist Biopharma’s antibody discovery and optimization platform to license additional antibodies for up to five targets over the next four years.
Reported data on an internally discovered antibody candidate that, in pseudovirus assays demonstrated a potent ability to bind to diverse SARS-CoV-2 variant mutations, including strains with the E484K, N501Y, D614G, Y453F and K417N mutations, indicating this therapeutic antibody may be effective in treating many strains of COVID-19. The data were published in Science.
Signed a broad-based research collaboration with Boehringer Ingelheim International GmbH to use Twist’s proprietary antibody libraries to discover therapeutic antibodies against multiple targets provided by Boehringer Ingelheim.
Expanded our agreement with Invetx to include discovery of best-in-class antibodies to treat multiple diseases in cats and dogs.
Announced a collaboration with Adicet Bio, Inc. to accelerate the discovery of gamma delta T cell therapies against five undisclosed targets.
Announced a collaboration with deepCDR Biologics, a private company focused on applying deep learning algorithms to antibody discovery and optimization.
Achieved a significant milestone in the Intelligence Advanced Research Projects Activity’s (IARPA) Molecular Information Storage (MIST). Twist demonstrated the ability to synthesize a select set of DNA sequences in less than one day on a silicon chip designed for DNA data storage with silicon sites spaced 1 micron apart.
Corporate

Hired Steffen Hellmold as SVP, business development for DNA data storage.
Appointed Dennis Cho as general counsel and chief ethics and compliance officer.
Fiscal 2022 Financial Guidance

The following statements are based on Twist’s current expectations for fiscal 2022. The following statements are forward-looking, and actual results could differ materially depending on market conditions and the factors set forth under "Forward-Looking Statements" below. Twist does not plan to update, nor does it undertake any obligation to update, this outlook in the future.

For the full fiscal year 2022, Twist provided the following financial guidance:

Revenue is expected in the range of $173 million to $181 million without Abveris and $183 million to $193 million assuming the close of the acquisition of Abveris in the first quarter of fiscal 2022
Synbio revenue including Ginkgo Bioworks is expected to be in the range of $67 to $70 million
NGS revenue is estimated to be in the range of $94 to $96 million
Biopharma revenue is estimated to be approximately $22 to $27 million, including Abveris
Gross margin is expected to be between 35% and 37% for fiscal 2022 which reflects the impact of costs associated with ramping our Wilsonville "Factory of the Future" facility comes online; excluding these costs, gross margin would be 42% to 44%
Operating expenses including R&D and SG&A are expected to be $315 million for the year
Net loss is expected to be approximately $250 million to reflect increased investments in our commercial organization and research and development activities
R&D is expected to be approximately $130 million
Stock-based compensation is expected to be approximately $47 million
Depreciation is expected to be $13 million
Capital expenditures are expected to be $80-$90 million, including build out of the "Factory of the Future"
Fiscal 2022 First Quarter Financial Guidance

For the first quarter of fiscal 2022, Twist provided the following financial guidance:

Revenue is expected in the range of $37 million to $39 million
Conference Call Information

The company plans to hold a conference call and live audio webcast for analysts and investors today at 8:00 a.m. Eastern Time to discuss its financial results and provide an update on the company’s business. The call can be accessed by dialing (866) 688-0947 (domestic) or (409) 217-8781 (international) and refer to the conference ID 4608297. A telephonic replay of the conference call will be available beginning approximately four hours after the call through November 29, 2021 and may be accessed by dialing (855) 859-2056 (domestic) or (404) 537-3406 (international). The replay conference ID is 4608297. The webcast replay will be available for two weeks. If a participant will be listen-only, they are encouraged to listen via the webcast on Twist’s investor page.

On November 22, 2021 Gennao Bio, a privately held genetic medicines company developing first-in-class, targeted nucleic acid therapeutics, reported that Claudine Prowse, Ph.D., chief financial officer, will present at the Piper Sandler 33rd Annual Virtual Healthcare Conference, being held November 29, 2021 to December 2, 2021 (Press release, Gennao Bio, NOV 22, 2021, View Source [SID1234595924]). A pre-recorded webcast of the presentation will be available beginning at 10:00 AM ET on November 22, 2021, on the company’s website, www.gennao.com, and will be archived for 30 days.

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On November 22, 2021 Novocure (NASDAQ: NVCR) reported that the final patient has been enrolled in the phase 3 pivotal LUNAR trial evaluating the efficacy of Tumor Treating Fields (TTFields) together with immune checkpoint inhibitors or docetaxel for treatment of patients with advanced stage 4, non-small cell lung cancer (NSCLC) following progression while on or after platinum-based therapy (Press release, NovoCure, NOV 22, 2021, View Source [SID1234595923]). Non-small cell lung cancer impacts nearly 200,000 patients every year in the U.S., and lung cancer is the leading cause of cancer-related death globally.

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"LUNAR marks Novocure’s second phase 3 pivotal study to complete enrollment this quarter and is our first of several late-stage clinical trials expected to deliver final data over the next two years," said William Doyle, Novocure’s Executive Chairman. "LUNAR will provide the first randomized dataset to evaluate increased survival when Tumor Treating Fields is used together with immunotherapy, versus immunotherapy alone. I am proud of our employees and am grateful to our principal investigators and patients for their courage and dedication to advancing clinical studies."

LUNAR is a phase 3 pivotal trial testing the effectiveness of TTFields in combination with immune checkpoint inhibitors or docetaxel versus immune checkpoint inhibitors or docetaxel alone for patients with stage 4 NSCLC who progressed during or after platinum-based therapy. It is estimated that approximately 46,000 patients receive second-line treatment for stage 4 NSCLC each year in the U.S. The primary endpoint is superior overall survival of patients treated with TTFields plus immune checkpoint inhibitors or docetaxel versus immune checkpoint inhibitors or docetaxel alone. TTFields therapy is intended principally for use in combination with other standard-of-care treatments, and LUNAR was designed to generate data that contemplates multiple outcomes. Patients will be followed for 12 months with final data expected year-end 2022.

About Lung Cancer

Lung cancer is the most common cause of cancer-related death worldwide, and NSCLC accounts for approximately 85% of all lung cancers. It is estimated that approximately 193,000 patients are diagnosed with NSCLC each year in the U.S. Physicians use different combinations of surgery, radiation and pharmacological therapies to treat NSCLC, depending on the stage of the disease. Surgery, which may be curative in a subset of patients, is usually used in early stages of the disease. Since 1991, radiation with a combination of platinum-based chemotherapy drugs has been the first-line standard of care for locally advanced or metastatic NSCLC. Certain immune checkpoint inhibitors have recently been approved for the first-line treatment of NSCLC and the standard of care in this setting appears to be evolving rapidly. The standard of care for second-line treatment is also evolving and may include platinum-based chemotherapy for patients who received immune checkpoint inhibitors as their first-line regimen, pemetrexed, docetaxel or immune checkpoint inhibitors.

About Tumor Treating Fields

Tumor Treating Fields, or TTFields, are electric fields that disrupt cancer cell division. Fundamental scientific research on TTFields extends across more than two decades and, in all preclinical research to date, TTFields have demonstrated a consistent anti-mitotic effect. TTFields therapy is intended principally for use together with other standard-of-care cancer treatments. There is a growing body of evidence that supports TTFields’ broad applicability with certain other cancer therapies, including radiation therapy, certain chemotherapies and certain immunotherapies. In clinical research and commercial experience to date, TTFields therapy has exhibited no systemic toxicity, with mild to moderate skin irritation being the most common side effect. The TTFields global development program includes a network of preclinical collaborators and a broad range of clinical trials across all phases, including four phase 3 pivotal trials in a variety of tumor types. To date, more than 20,000 patients have been treated with TTFields therapy.

On November 22, 2021 NeoImmuneTech, Inc. (KOSDAQ: 950220), a clinical-stage T cell-focused biopharmaceutical company, reported that data from Phase 1 of an ongoing study at the Society for Neuro-Oncology (SNO) annual meeting (Press release, NeoImmuneTech, NOV 22, 2021, View Source [SID1234595922]). The data show that NT-I7, a novel long-acting human IL-7, was well tolerated following chemoradiation in patients with high-grade gliomas (HGG), supporting continued evaluation in the Phase 2 portion of the study.

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The data were presented as an oral presentaion, titled "A phase I/II study evaluating the safety and efficacy of a novel long-acting interleukin-7, NT-I7, for patients with newly diagnosed high-grade gliomas after chemoradiotherapy," by lead author Jian Li Campian, M.D., Ph.D., of Mayo Clinic. The data show that NT-I7’s maximum tolerated dose in this cohort was 720 µg/kg. Despite the concomitant administration of chemotherapy (temozolomide, TMZ), the absolute lymphocyte count (ALC) persistently increased 1.3–4.1 fold at week 4 after NT-I7 injection, suggesting that NT-I7 as a single agent could be an effective approach to counteract the treatment-related lymphopenia associated with shorter survival that is commonly observed in HGG patients after chemoradiation.

The median progression-free survival for MGMTp unmethylated GBM was 11.6 months, compared to 5.3 months commonly reported in chemoradiation studies. Strikingly, NT-I7 single agent preferentially expanded memory stem T cells (Tscm), a self-renewing T cell subset that has shown better antitumor activity compared with other memory T cell subsets. Thus, although further studies are necessary to determine the clinical benefit, NT-I7 as a single agent added to neoadjuvant chemotherapy has shown encouraging efficacy signals in this aggressive indication.

"We are pleased to report encouraging data on NT-I7 following chemotherapy in high-grade gliomas, which are aggressive and can have a severe impact on patients," said Se Hwan Yang, Ph.D., President and Chief Executive Officer of NeoImmuneTech. "NT-I7’s demonstrated ability to increase ALC and its high tolerability in this patient population supports continued investigation to further assess its potential to improve outcomes for patients living with this devastating disease."

About NT-I7
NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed for oncologic and immunologic indications, in which T cell amplification and enhanced functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). In clinical trials to date, NT-I7 has exhibited favorable PK/PD and safety profiles, both as a monotherapy and in combination with other anticancer treatments. NT-I7 is being studied in multiple clinical trials in solid tumors and as a vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.

On November 22, 2021 Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a clinical-stage company advancing an integrated and sustainable pipeline of genetic therapies for rare childhood disorders, reported Gaurav Shah, M.D., Chief Executive Officer, will participate in a fireside chat at the Evercore ISI 4th Annual HEALTHCONx Virtual Conference on Wednesday, Dec. 1, 2021 at 10:55 a.m. ET (Press release, Rocket Pharmaceuticals, NOV 22, 2021, View Source [SID1234595920]).

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A live audio webcast of the presentation will be available under "Events" in the Investors section of the Company’s website at View Source The webcast replay will be available on the Rocket website following the conference.