On February 4, 2022 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 first quarter of fiscal 2022 ended December 31, 2021 (Press release, Twist Bioscience, FEB 4, 2022, View Source [SID1234607741]).

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"We’ve started the year strong reporting record orders and revenue, with SynBio particularly robust in the first quarter of fiscal 2022," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "We continue to introduce new products to enable exciting applications like liquid biopsy and minimal residual disease, expanding our customer base and our market opportunities in NGS."

"Our biopharma team added 8 new partners and 21 new programs with the integration of Abveris bringing an additional 72 ongoing programs, while advancing our internal candidates. We expect the first Twist Biopharma-discovered antibody to be in clinical trials this year. In addition, we announced that our first DNA data storage solution would be a Century Archive, storing data for 100 years," continued Dr. Leproust.

FISCAL 2022 FIRST QUARTER FINANCIAL RESULTS

·Orders: Total orders received for the first quarter of fiscal 2022 were $49.6 million compared to $33.6 million for the same period of fiscal 2021.
·Revenue: Total revenues for the first quarter of fiscal 2022 were $42.0 million compared to $28.2 million for the first quarter of fiscal 2021.
·Cost of Revenues: Cost of revenues for the first quarter of fiscal 2022 was $27.1 million compared to $18.2 million for the same period of fiscal 2021.
·Research and Development Expenses: Research and development expenses for the first quarter of fiscal 2022 were $22.6 million compared to $14 million for the same period of fiscal 2021.
·Selling, General and Administrative Expenses: Selling, general and administrative expenses for the first quarter of fiscal 2022 were $51.1 million compared to $28.8 million for the same period of fiscal 2021.
·Net Loss: Net loss attributable to common stockholders for the first quarter of fiscal 2022 was $45.6 million, or $0.91 per share, compared to $32.9 million, or $0.72 per share, for the same period of fiscal 2021.
·Cash Position: As of December 31, 2021, the company had $408.7 million in cash, cash equivalents and investments.

Recent Highlights:

SynBio and NGS

·Shipped products to approximately 1,800 customers in the first quarter of fiscal 2022, versus approximately 1,500 in the first quarter of fiscal 2021.
·Shipped approximately 125,000 genes during the first quarter of fiscal 2022, compared with approximately 84,000 in the first quarter of fiscal 2021.
·Previewed Twist Enzymatic Synthesis 3.0, a low-cost, scarless DNA synthesis process
·Introduced the Twist Alliance Canine Exome, a whole exome target enrichment panel to enable next generation sequencing in canine genomic research.
·Began shipping synthetic RNA positive controls for the SARS-CoV-2 omicron (B.1.1.529/BA.1) variants first identified in South Africa.
·Launched the Twist 96-Plex Library Prep Kit, a high-performance, cost-effective library preparation kit for next-generation sequencing (NGS). This product is a Twistified version of a product acquired through the iGenomX acquisition in 2021.
·Launched the Twist cfDNA Pan-cancer Reference Standards, a high-quality standardized control for use in the development and continuous monitoring of liquid biopsy tests capable of detecting cancer from blood samples.

BioPharma and DNA Data Storage

·Announced that RBT-0813, an innovative bispecific antibody discovered by Twist Biopharma and licensed to Revelar Biotherapeutics, binds to and neutralizes the Omicron and Delta variants of SARS-CoV-2 in live virus studies.
·Signed a strategic collaboration with Sosei Group Corporation to discover therapeutic antibodies against G protein-coupled receptors (GPCR) identified by Sosei Heptares.
·Signed an agreement with Artisan Development Labs Inc. to discover novel antibodies against five undisclosed targets, with an option to expand with additional targets.
·Announced a licensing agreement with Abcam under which Abcam will use a proprietary Twist VHH phage library for antibody discovery, development and commercialization for diagnostic and research applications.
·Announced the Century Archive, which we expect to be Twist’s first commercial DNA data storage solution.

Corporate

·Issued first ESG report which can be accessed at: View Source

Updated 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.

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

·Revenue is now expected to be in the range of $189 million to $198 million
oSynBio revenue including Ginkgo Bioworks is expected to be in the range of $70 million to $72 million
oNGS revenue is estimated to be in the range of $94 to $96 million
oBiopharma revenue is estimated to be approximately $25 to $30 million
·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 $335 million for the year
·Net loss is expected to be approximately $260 million, reflecting the impact of the Abveris acquisition in stock-based compensation
oR&D is expected to be approximately $130 million
oStock-based compensation is expected to be approximately $74 million
oDepreciation is expected to be $13 million
oCapital expenditures are expected to be $80-$90 million, including building out the "Factory of the Future"

Conference Call Information

The company plans to hold a conference call and live audio webcast for analysts and investors at 8:00 a.m. Eastern Time today 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 3886933. A telephonic replay of the conference call will be available beginning approximately four hours after the call through February 11, 2022 and may be accessed by dialing (855) 859-2056 (domestic) or (404) 537-3406 (international). The replay conference ID is 3886933. 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 February 4, 2022 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that Dr. Dean Li, executive vice president and president, Merck Research Laboratories, is scheduled to participate in a virtual fireside chat at the Guggenheim Oncology Conference 2022 on Feb. 9, 2022, at 2:30 p.m. EST (Press release, Merck & Co, FEB 4, 2022, View Source [SID1234607758]).

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Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at View Source and-presentations/.

On February 4, 2022, Nuvectis Pharma, Inc. (the "Company"), reported that entered into an Underwriting Agreement (the "Underwriting Agreement") with H.C. Wainwright & Co., LLC, as representative of the several underwriters named therein (the "Underwriters") (Filing, Nuvectis Pharma, FEB 4, 2022, View Source [SID1234607776]). Pursuant to the Underwriting Agreement, the Company agreed to sell in an underwritten offering (the "Offering") an aggregate of 3,200,000 shares (the "Shares") of the Company’s common stock, par value $0.00001 per share (the "Common Stock"), at an offering price of $5.00 per share, for gross proceeds of $16,000,000, less underwriting discounts and commissions and offering expenses. The Shares are being offered by the Company pursuant to a registration statement on Form S-1 (File No. 333-260099), initially filed with the Securities and Exchange Commission (the "Commission") on October 6, 2021, as amended, and declared effective on February 4, 2022. The Company subsequently filed a registration statement on Form S-1MEF (File No. 333-262512) pursuant to Rule 462(b) under the Securities Act of 1933, as amended, which was effective immediately upon filing.

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The closing of the Offering is subject to satisfaction of customary closing conditions set forth in the Underwriting Agreement and is expected to occur on or about February 8, 2022.

The summary of the Underwriting Agreement set forth above does not purport to be complete and is subject to and qualified in its entirety by reference to the text of the Underwriting Agreement, a form of which is filed herewith as Exhibit 1.1. The Underwriting Agreement includes customary representations, warranties, closing conditions and covenants by the Company and the Underwriters.

On February 3, 2022 Replimune Group Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel class of tumor-directed oncolytic immunotherapies, reported financial results for the fiscal third quarter ended December 31, 2021 and provided a business update (Press release, Replimune, FEB 3, 2022, View Source [SID1234607671]).

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"We are looking forward to hosting an investor event next month to present on commercial strategy and RP2/3 development plans as well as provide anticipated data updates," said Philip Astley-Sparke, Chief Executive Officer of Replimune. "At the event we intend to present our plans to establish a broad, high value skin cancer franchise with RP1 and provide a thorough overview of our mid-stage development plans for the RP2/3. We will also review other key milestones that we expect to achieve over the next year, including the release of data from registrational studies that we believe will highlight our platform’s potential to become a cornerstone of cancer treatment."

Corporate Updates

Replimune to host an investor event in March 2022. The event will review updated data from completed IGNYTE cohorts in non-melanoma skin cancer (NMSC) and melanoma. In addition, the Company intends to present initial data from the ongoing study in anti-PD1 failed NMSC and from its ARTACUS trial, a Phase 1b/2 trial of RP1 as monotherapy in solid organ transplant recipients with skin cancer. The Company will also provide a detailed overview of its RP2/3 program including the Phase 2 development plan.
Presented updated RP2 data at the 2021 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting. In November, the Company presented updated interim data from its ongoing Phase 1 trial of RP2 alone and in combination with Opdivo (nivolumab) that demonstrated the potential clinical utility of RP2 in patients with hard-to-treat, anti-PD1 failed cancers, including durability of response, together with biomarker data demonstrating the ability of RP2 to turn immunologically ‘cold’ tumors ‘hot.’
Upcoming Milestones

CERPASS – Registration-directed Phase 2 clinical trial in cutaneous squamous cell carcinoma (CSCC)

RP1 in combination with Libtayo (cemiplimab-rwlc) in CSCC: The Company is actively enrolling patients in a registration-directed, global, randomized, controlled, 180-patient Phase 2 clinical trial (CERPASS) evaluating RP1 in combination with Libtayo vs. Libtayo alone in patients with advanced CSCC. The Company expects to complete enrollment in mid-year 2022 and the trigger for the primary data analysis to be six months thereafter.
IGNYTE – Multi-cohort Phase 2 clinical trial of RP1 combined with Opdivo (nivolumab)

Anti-PD-1 failed melanoma cohort: The Company continues to enroll patients in the 125-patient cohort of the IGNYTE Phase 2 clinical trial in patients with anti-PD1 failed melanoma. The Company expects to release initial directional data from this cohort in late 2022.

Non-melanoma skin cancer (NMSC) cohort: The Company continues to enroll patients with anti-PD-1 failed NMSC. The Company expects to provide initial data from this cohort in the first quarter of 2022.

Anti-PD(L)-1 failed non-small cell lung cancer (NSCLC) cohort: Enrollment is open in a 30-patient cohort of RP1 in combination with Opdivo in anti-PD(L)-1 failed NSCLC patients, with initial data expected to be released in late 2022.
ARTACUS – Phase 1b/2 clinical trial of RP1 as monotherapy in solid organ transplant recipients with skin cancer

Enrollment continues in this 65-patient clinical trial with potential registrational intent, assessing the safety and efficacy of RP1 in organ transplant recipients with skin cancer. The Company expects to present initial data from this clinical trial in the first quarter of 2022.
RP2 and RP3

RP2 alone and in combination with Opdivo in difficult-to-treat cancers: The Company has initiated the expansion of the Phase 1 clinical trial of RP2 in combination with Opdivo, with a focus on patients with liver metastases from various prevalent tumor types including patients with lung, breast and gastrointestinal cancers. The Company expects to release initial expansion patient data in late 2022.

RP3 alone and in combination with Opdivo: The Company is enrolling patients in a Phase 1 clinical trial for RP3, with initial data expected to be released in the first quarter of 2022. The Company expects to start enrolling patients to be treated with RP3 in combination with Opdivo this quarter, including patients with various prevalent tumor types such as lung, breast, head and neck cancer and gastrointestinal cancers. The Company expects to release initial expansion patient data in late 2022.

RP2 and/or RP3 next stage development including in patients with liver metastases from a range of tumor types: The Company remains on track to initiate a broad Phase 2 clinical development program with RP2 and/or RP3, intended to include a range of prevalent tumor types, including in patients with liver metastases, around mid-year 2022. Details of this plan remain on track to be presented in the first quarter of 2022.
Financial Highlights

Cash Position: As of December 31, 2021, cash, cash equivalents and short-term investments were $420.2 million, as compared to $476.3 million as of March 31, 2021. This decrease was primarily related to cash utilized in operating activities in advancing the Company’s expanded clinical development plan.

Based on the current operating plan, Replimune believes that existing cash, cash equivalents and short-term investments will fund operating expenses and capital expenditure requirements into the second half of 2024, excluding any confirmatory trial required by the FDA or other regulatory body.
R&D Expenses: Research and development expenses were $19.4 million for the third quarter ended December 31, 2021, as compared to $14.3 million for the third quarter ended December 31, 2020. This increase was primarily due to increased clinical and manufacturing expenses driven by the Company’s lead programs and increased personnel expenses. Research and development expenses included $1.8 million in stock-based compensation expenses for the third quarter ended December 31, 2021.

G&A Expenses: General and administrative expenses were $10.3 million for the third quarter ended December 31, 2021, as compared to $6.0 million for the third quarter ended December 31, 2020. The increase was primarily driven by personnel-related costs, including sales and marketing personnel associated with pre-launch planning and initial build of the Company’s commercial infrastructure. General and administrative expenses included $4.1 million in stock-based compensation expenses for the third quarter ended December 31, 2021.

Net Loss: Net loss was $29.7 million for the third quarter ended December 31, 2021, as compared to a net loss of $21.8 million for the third quarter ended December 31, 2020.
About CERPASS
CERPASS is Replimune’s registration-directed randomized, global Phase 2 clinical study to compare the effects of Libtayo alone versus a combination of Libtayo and Replimune’s investigational oncolytic immunotherapy RP1. The clinical trial is enrolling 180 patients with locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC) who are naïve to anti-PD-1 therapy. The clinical trial will evaluate complete response (CR) rate and overall response rate (ORR) as its two primary efficacy endpoints as assessed by independent review, as well as duration of response, progression-free survival (PFS), and overall survival (OS) as secondary endpoints. The study is being conducted under a clinical trial collaboration agreement with Regeneron in which the costs of the trial are shared and full commercial rights retained by Replimune. Libtayo is being jointly developed by Regeneron and Sanofi. Libtayo is a registered trademark of Regeneron.

About IGNYTE
IGNYTE is Replimune’s multi-cohort Phase 1/2 trial of RP1 plus Opdivo. There are 4 tumor specific cohorts currently enrolling in this clinical trial including a 125-patient cohort in anti-PD-1 failed cutaneous melanoma. This cohort was initiated after completing enrollment in a prior Phase 2 cohort in the same clinical trial of approximately 30 patients with melanoma. The additional cohorts are in non-melanoma skin cancers which includes both naïve and anti-PD-1 failed CSCC, in anti-PD1 failed microsatellite instability high, or MSI-H/dMMR tumors and anti-PD(L)-1 failed non-small cell lung cancer, or NSCLC. This trial is being conducted under a collaboration and supply agreement with Bristol-Myers Squibb Company. Opdivo is a registered trademark of Bristol-Myers Squibb Company.

About RP1
RP1 is Replimune’s lead product candidate and is based on a proprietary new strain of herpes simplex virus engineered and genetically armed to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

About RP2 & RP3
RP2 and RP3 are derivatives of RP1 that express additional immune-activating proteins. RP2 expresses an anti-CTLA-4 antibody-like molecule and RP3 additionally expresses the immune co-stimulatory pathway activating proteins CD40L and 4-1BBL. RP2 and RP3 are intended to provide targeted and potent delivery of these proteins to the sites of immune response initiation in the tumor and draining lymph nodes, with the goal of focusing systemic immune-based efficacy on tumors and limiting off-target toxicity.

On February 3, 2022 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel products for serious rare and ultra-rare genetic diseases, reported that it will host a conference call on Thursday, February 10, 2022, at 5:00 pm ET to discuss its financial results and corporate update for the fourth quarter and the year ended December 31, 2021 (Press release, Ultragenyx Pharmaceutical, FEB 3, 2022, https://ir.ultragenyx.com/news-releases/news-release-details/ultragenyx-host-conference-call-fourth-quarter-and-full-year-6 [SID1234607686]).

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The live and replayed webcast of the call will be available through the company’s website at View Source To participate in the live call by phone, dial (855) 797-6910 (USA) or (262) 912-6260 (International) and enter the passcode 2087696. The replay of the call will be available for one year.