Advaxis, Inc. an Extension to December 20, 2021, to Complete Merger Transaction with Biosight, Ltd. and Satisfy Initial Listing Requirements

On November 22, 2021 Advaxis, Inc. (Nasdaq: ADXS) ("Advaxis" or the "Company"), a clinical-stage biotechnology company focused on the development and commercialization of proprietary Lm-based antigen delivery products, reported that it has received a letter from the Nasdaq Hearings Panel (the "Panel") providing Advaxis an extension through December 20, 2021, to complete its business combination with Biosight, Ltd. ("Biosight") and demonstrate compliance with all applicable requirements for initial listing on The Nasdaq Capital Market (Press release, Advaxis, NOV 22, 2021, View Source [SID1234595943]).

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On July 6, 2021, Advaxis announced that it had entered into a merger agreement with Biosight, a privately held, Israel-based pharmaceutical company developing innovative therapeutics for hematological malignancies and disorders. On July 29, 2021, Advaxis attended a hearing before the Panel, to address the Company’s non-compliance with the $1.00 bid price requirement for continued listing on The Nasdaq Capital Market. By decision dated August 9, 2021, the Panel granted the Company an exception through November 22, 2021, to complete the merger with Biosight and evidence compliance with all applicable initial listing criteria.

Pursuant to the Nasdaq Listing Rules, the combined company will be required to meet all applicable initial listing requirements for The Nasdaq Capital Market upon the closing of the merger, including the $4 per share price requirement. While there can be no assurance, the Company believes that it will be able to close the merger and demonstrate compliance with all applicable requirements for initial listing on The Nasdaq Capital Market on or before December 20, 2021.

The Company’s special meeting of stockholders relating to its proposed merger with Biosight, initially held on November 16, 2021, has been adjourned to December 7, 2021, at 10:00 AM Eastern Time unless postponed or adjourned to a later date, in order to obtain the stockholder approvals necessary to complete the merger and related matters. Advaxis stockholders will be able to attend and participate in the Advaxis special meeting online by visiting www.virtualshareholdermeeting.com/ADXS2021SM where they will be able to listen to the meeting live, submit questions and vote.

CRISPR Therapeutics Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to CTX110™ for the Treatment of Relapsed or Refractory CD19+ B-cell malignancies

On November 22, 2021 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to CTX110, its wholly-owned allogeneic CAR-T cell therapy targeting CD19+ B-cell malignancies (Press release, CRISPR Therapeutics, NOV 22, 2021, View Source [SID1234595889]).

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"This RMAT designation is based on the encouraging clinical data we have presented thus far, and it is an important milestone that recognizes the transformative potential of CTX110 for the treatment of hematological malignancies," said Samarth Kulkarni, Ph.D., Chief Executive Officer of CRISPR Therapeutics. "We look forward to working closely with the FDA as we continue our efforts to bring this important new therapeutic modality to patients."

Established under the 21st Century Cures Act, RMAT designation is a dedicated program designed to expedite the drug development and review processes for promising pipeline products, including genetic therapies. A regenerative medicine therapy is eligible for RMAT designation if it is intended to treat, modify, reverse or cure a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the drug or therapy has the potential to address unmet medical needs for such disease or condition. Similar to Breakthrough Therapy designation, RMAT designation provides the benefits of intensive FDA guidance on efficient drug development, including the ability for early interactions with FDA to discuss surrogate or intermediate endpoints, potential ways to support accelerated approval and satisfy post-approval requirements, potential priority review of the biologics license application (BLA) and other opportunities to expedite development and review.

About CTX110
CTX110, a wholly owned program of CRISPR Therapeutics, is a healthy donor-derived gene-edited allogeneic CAR-T investigational therapy targeting Cluster of Differentiation 19, or CD19. CTX110 is being investigated in the ongoing CARBON trial.

About CARBON
The ongoing Phase 1 single-arm, multi-center, open label clinical trial, CARBON, is designed to assess the safety and efficacy of several dose levels of CTX110 for the treatment of relapsed or refractory B-cell malignancies.

Twist Bioscience Reports Fourth Quarter and Full Year Fiscal 2021 Financial Results

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.

Aptose to Present at the Piper Sandler 33rd Annual Healthcare Conference

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.

Perrigo Announces Voluntary Delisting from the Tel Aviv Stock Exchange (TASE)

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."