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 Aptose Biosciences Inc. (Nasdaq: APTO; TSX: APS), a clinical-stage company developing highly differentiated therapeutics that target the underlying mechanisms of cancer, reported that the Aptose management team will be participating in the Piper Sandler 33rd Annual Healthcare Conference, being held virtually (Press release, Aptose Biosciences, NOV 22, 2021, View Source [SID1234595944]).

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The Aptose presentation will take the form of a pre-recorded fireside chat, which will be available on the Piper Sandler conference website on demand from November 23 through December 2, 2021. A link to the presentation will be available on Aptose’s website www.aptose.com.

Management also will be participating in 1-on-1 investor meetings during the conference.

On November 22, 2021 Perrigo Company plc (NYSE; TASE: PRGO), a leading provider of Consumer Self-Care Products, reported that it is taking steps to voluntarily delist the Company’s ordinary shares from trading on the Tel Aviv Stock Exchange (TASE) (Press release, Perrigo Company, NOV 22, 2021, View Source [SID1234595890]). Perrigo is delisting its shares from the TASE after divesting its Israeli-based operations earlier this year. As such, Perrigo has requested that the TASE immediately initiate the process to delist the Company’s ordinary shares.

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Under Israeli law, the delisting of Perrigo’s ordinary shares from the TASE is expected to become effective three months after the date of the Company’s request to the TASE to delist the Company’s ordinary shares, which occurred on November 22, 2021. Perrigo ordinary shares will continue to be listed on the New York Stock Exchange (NYSE), and all of its ordinary shares now traded on the TASE are expected to be transferred to the NYSE where they can continue to be traded.

Perrigo CEO and President Murray S. Kessler commented, "Perrigo has undergone a significant transformation over the past three years. Part of this transformation included the divestiture of our Israeli-based assets earlier this year and we believe now is the appropriate time to delist."

On November 22, 2021 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported interim clinical results from the investigator-initiated phase 1-2 study at The University of Texas MD Anderson Cancer Center, evaluating cbNK cells pre-complexed with Affimed’s innate cell engager (ICE) AFM13 (Press release, Affimed, NOV 22, 2021, View Source [SID1234595909]).

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As of October 31, 2021, a total of 18 patients with CD30-positive relapsed or refractory Hodgkin and non-Hodgkin lymphomas (16 and 2 patients, respectively) were treated with the novel combination of cbNK cells pre-complexed with AFM13. A treatment cycle consists of lymphodepleting chemotherapy with fludarabine and cyclophosphamide followed two days later by a single infusion of cytokine-preactivated and expanded cbNK cells that are pre-complexed with AFM13, followed by three weekly infusions of AFM13 (200 mg) monotherapy. Responses are assessed on day 28 by FDG-PET and patients can receive up to two cycles. Three patients were treated with 1×106, three patients with 1×107 and 12 patients with 1×108 AFM13-pre-complexed cbNK cells per kg body weight.

As of the cutoff date, 16 of 18 patients had achieved an objective response to the treatment according to investigator assessment, with seven complete responses (CR) and nine partial responses (PR). Eleven of twelve patients treated at the recommended phase 2 dose level of 108 cbNK cells per kg had Hodgkin Lymphoma. In this cohort of patients treated at the recommended phase 2 dose, 100% responded after the first cycle of treatment with five CRs and seven PRs according to investigator assessment. Each of the patients in this cohort is eligible for a second treatment cycle, and updated data from this cohort will be reported at a later date. Treatment was well tolerated with five reported cases of transient infusion related reactions after the monotherapy infusions of AFM13. Of note, there were no instances of serious adverse events such as cytokine release syndrome, immune cell-associated neurotoxicity syndrome or graft-versus-host disease.

"The patients enrolled in this study were all heavily pre-treated with a median of 6 lines of prior therapy and had progressive disease after their previous line of therapy," said Dr. Andreas Harstrick, Chief Medical Officer at Affimed. "We are encouraged by the response rates that we continue to observe in these difficult to treat patients. The data are in line with data presented at AACR (Free AACR Whitepaper) earlier this year. We also continue to see a very good safety profile of the combination, which is important as many of these patients have been very heavily pretreated and cannot tolerate aggressive therapies. Combining our ICE molecules with NK cells is an integral part of our strategy to bring innovative therapies to patients in need. We believe these preliminary data provide further validation of this approach."

Conference Call/Webcast Information

Affimed will host a conference call and webcast on December 9th, 2021, at 8:30 a.m. EST to review the data. Affimed’s management will discuss the results to date, the current treatment landscape for CD30+ lymphomas, and next steps for the study. Dr. Yago L. Nieto, M.D., Ph.D, Department of Stem Cell Transplantation and Cellular Therapy, Division of Cancer Medicine from M.D Anderson Cancer Center will also be available during the call.

To access the call, please dial +1 (409) 220-9054 for U.S. callers, or +44 (0) 8000 323836 for international callers, and reference passcode 3065475 approximately 15 minutes prior to the call.

A live audio webcast of the conference call will be available in the "Webcasts" section on the "Investors" page of the Affimed website at View Source or View Source A replay of the webcast will be accessible at the same link for 30 days following the call.

About the Phase 1-2 Study

The University of Texas MD Anderson Cancer Center is studying AFM13 in an investigator-initiated phase 1-2 trial in combination with cord blood-derived allogeneic NK cells in patients with recurrent or refractory CD30-positive lymphomas. The first phase of this study involves dose escalation of pre-complexed NK cells, with patients receiving lymphodepleting chemotherapy followed by 1×106 NK cells/kg in Cohort 1; 1×107 NK cells/kg in Cohort 2; and 1×108 NK cells/kg in Cohort 3. The trial is designed to explore safety and to determine the recommended phase 2 dose and evaluate its activity. The recommended phase 2 dose was determined as 1×108 NK cells/kg. In each cohort, the dose of the pre-complexed NK cells with AFM13 is followed by weekly doses of 200 mg AFM13 monotherapy for three weeks, with each patient evaluated for dose-limiting toxicities and responses on day 28.

MD Anderson has an institutional financial conflict of interest with Affimed related to this research and has therefore implemented an Institutional Conflict of Interest Management and Monitoring Plan.

Additional information about the study can be found at www.clinicaltrials.gov (NCT04074746).

About AFM13

AFM13 is a first-in-class innate cell engager (ICE) that uniquely activates the innate immune system to destroy CD30-positive hematologic tumors. AFM13 induces specific and selective killing of CD30-positive tumor cells, leveraging the power of the innate immune system by engaging and activating natural killer (NK) cells and macrophages. AFM13 is Affimed’s most advanced ICE clinical program and is currently being evaluated as a monotherapy in a registration-directed trial in patients with relapsed/refractory peripheral T-cell lymphoma or transformed mycosis fungoides (REDIRECT). The study is actively recruiting. Additional details can be found at www.clinicaltrials.gov (NCT04101331).

On November 22, 2021 FogPharma, a biopharmaceutical company pioneering a new class of precision medicines potentially applicable to all therapeutic targets, including those previously considered "undruggable," reported the appointments of Lihua Yu, Ph.D., as chief data officer and Keith Orford, M.D., Ph.D., as chief medical officer and executive vice president of clinical and translational science (Press release, FogPharma, NOV 22, 2021, View Source [SID1234595926]).

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Dr. Yu, former president and chief data science officer of H3 Biomedicine Inc., will oversee the development and implementation of FogPharma’s data science strategy across all R&D functions and research programs, and will lead the company’s team building a diversified portfolio of advanced drug leads for multiple disease-driven targets.

Dr. Orford brings extensive medical and scientific expertise having led the transition of a number of oncology drug candidates from preclinical translational investigations through clinical development, and will oversee translational medicine and clinical development initiatives for FogPharma.

"Lihua and Keith are accomplished drug development executives and we are excited to welcome them to our growing leadership team," said Gregory Verdine, Ph.D., founder and chief executive officer of FogPharma. "It has been a fantastic year of progress at FogPharma — we closed a $107 million Series C financing round, continued to build out our multiplexed and machine learning-enabled drug discovery engine and further advanced our lead cancer programs, including our first-and-only-in-class direct β-catenin inhibitor. Keith and Lihua will be critical to our future success as we continue to scale."

Lihua Yu, Ph.D., as chief data officer

Dr. Yu brings over 20 years of experience and leadership in data sciences across computational biology, cancer genomics, research informatics, clinical genomics, real world data and evidence. Prior to joining FogPharma, Dr. Yu was the president and chief data science officer at H3 Biomedicine Inc., a U.S.-based precision medicine research & development subsidiary of Eisai Co. At H3, she held overall responsibilities for the company’s research and development, and was responsible for driving the expanded use of data and technology and leading the creation of a data science/cancer genomics/information-sharing engine supporting all phases of drug discovery and early clinical development. She led H3 during its transition from a drug discovery company to an early-phase drug development company. Prior to H3, she held roles of increasing responsibility at AstraZeneca and served as cancer bioinformatics leader. Dr. Yu earned her Ph.D. in biomedical engineering from Boston University working under Temple Smith, Ph.D., and her M.S. and B.S. in biomedical engineering from Tsinghua University in Beijing, China.

Keith Orford, M.D., Ph.D., as chief medical officer and executive vice president of clinical and translational science

Dr. Orford joins FogPharma from Calithera Biosciences, where as chief medical officer, he led the company’s clinical development, clinical operations, biometrics, pharmacovigilance and medical affairs functions. Prior to Calithera, Dr. Orford was the clinical development lead in the Immuno-Oncology and Combinations Development Performance Unit at GlaxoSmithKline, where he oversaw clinical development, including multiple early-stage clinical trials with targeted agents and immunotherapies. Prior to GlaxoSmithKline, he worked on early clinical development programs at Merck across multiple therapeutic areas. Previously, Dr. Orford was a research fellow and instructor at Massachusetts General Hospital and Harvard Medical School, where he trained in internal medicine and completed a postdoctoral fellowship in the laboratory of David Scadden, M.D., studying the epigenetic regulation of hematopoietic and embryonic stem cell differentiation. Dr. Orford received his undergraduate, M.D. and Ph.D. degrees from Georgetown University. His Ph.D. research elucidated the mechanism by which β-catenin is regulated by the Wnt signaling pathway.