On November 23, 2020 ImmuPharma PLC (LSE:IMM) (Euronext Growth Brussels: ALIMM), the specialist drug discovery and development company, reported that L1 Capital Global Opportunities Master Fund ("L1") has converted $200,000 (plus accrued but unpaid interest) of the convertible security issued pursuant to the convertible security deed dated 10 June 2020, details of which were announced by the Company on 11 June 2020 (Press release, ImmuPharma, NOV 23, 2020, View Source [SID1234571559]). The conversion price is 11p per share resulting in the issue by the Company of 1,430,510 new ordinary shares of 10p each in the Company ("New Ordinary Shares").

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New Ordinary Shares and Admission

The New Ordinary Shares have been allotted today and are issued credited as fully paid and will rank pari passu in all respects with the Company’s existing issued ordinary shares.

An application will be made for the New Ordinary Shares to be admitted to trading on the AIM market of the London Stock Exchange ("AIM") and Euronext Growth Brussels ("Admission"). It is anticipated that Admission to AIM will occur at 8.00am on or around Thursday 26 November 2020.

The New Ordinary Shares represent 0.58% of the Company’s enlarged issued share capital.

Total Shares in Issue

For the purposes of the Disclosure Guidance and Transparency Rules of the Financial Conduct Authority ("DTR"), the Board of ImmuPharma hereby notifies the market that following Admission, the Company’s total issued share capital will consist of 247,716,315 Ordinary Shares with a nominal value of 10p each.

This figure may be used by Shareholders as the denominator for the calculations by which they may determine if they are required to notify their interest in, or a change to their interest in, the Company under the DTR.

The allotment of the New Ordinary Shares is being made pursuant to existing authorities to allot shares and other relevant securities and to disapply pre-emption rights under section 551 of the Companies Act 2006, which the Directors were given at the Company’s Annual General Meeting held on 18 June 2020.

On November 23, 2020 Constellation Pharmaceuticals, Inc. (Nasdaq: CNST), a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, reported that it will host a virtual analyst/investor event and conference call on December 7 at 8:00 AM EDT to discuss the data from two oral presentations and two posters on the MANIFEST clinical trial for CPI-0610 being presented at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (Press release, Constellation Pharmaceuticals, NOV 23, 2020, View Source [SID1234571579]).

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The event will include:

a review of the clinical and translational data from MANIFEST presented during ASH (Free ASH Whitepaper), including 24-week data from 50 – 60 first-line and 90 –100 second-line myelofibrosis patients, and
a physician panel discussion and question-and-answer session with Dr. John Mascarenhas, Associate Professor of Medicine at the Icahn School of Medicine at Mount Sinai- New York and Dr. Serge Verstovsek, Professor of Medicine at University of Texas MD Anderson Cancer Center.
This event will be webcast live and can be accessed on the Investor Relations section of Constellation’s website at View Source To participate in the live question-and-answer session, please dial (877) 473-2077 (domestic) or (661) 378-9662 (international) and refer to conference ID 7164095.

About MANIFEST

MANIFEST is an open-label Phase 2 clinical trial of CPI-0610 in patients with myelofibrosis (MF), a rare cancer of the bone marrow that disrupts the body’s normal production of blood cells. Constellation is evaluating CPI-0610 in combination with ruxolitinib in JAK-inhibitor-naïve MF patients (Arm 3), with a primary endpoint of the proportion of patients with a ≥35% spleen volume reduction from baseline (SVR35) after 24 weeks of treatment. Constellation is also evaluating CPI-0610, either as a monotherapy in patients who are resistant to, intolerant of, or ineligible for ruxolitinib and no longer on the drug (Arm 1), or as add-on therapy in combination with ruxolitinib in patients with a sub-optimal response to ruxolitinib or MF progression (Arm 2). Patients in Arms 1 and 2 are being stratified based on Transfusion Dependence (TD) status. The primary endpoint for the patients in cohorts 1A and 2A, who were TD at baseline, is conversion to Transfusion Independence for 12 consecutive weeks. The primary endpoint for the patients in cohorts 1B and 2B, who were not TD at baseline, is the proportion of patients with a ≥35% spleen volume reduction from baseline after 24 weeks of treatment.

On November 23, 2020 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 2020 ended September 30, 2020 (Press release, Twist Bioscience, NOV 23, 2020, View Source [SID1234571596]).

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"We ended our fiscal year with record revenue and orders against the backdrop of a global pandemic and significant uncertainty," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "While we are proud of the new products we introduced to aid in the fight against COVID-19, which complemented our revenue, it was our core synthetic biology and next-generation sequencing (NGS) product lines that drove our overarching success.

"We have aggressive plans for growth and expansion in fiscal 2021 and beyond, continuing to build our foundation for sustained success across synthetic biology, NGS, biopharma and DNA data storage."

FISCAL 2020 FINANCIAL RESULTS

Orders: Total orders received for fiscal 2020 were $116.7 million compared to $70.0 million for fiscal 2019.
Revenue: Total revenues were $90.1 million for fiscal 2020 compared to $54.4 million for fiscal 2019.
Cost of Revenues: Cost of revenues for fiscal 2020 was $61.4 million compared to $47.4 million for fiscal 2019.
Research and Development Expenses: Research and development expenses for fiscal 2020 were $43.0 million compared to $35.7 million for fiscal 2019.
Selling, General and Administrative Expenses: Selling, general and administrative expenses for fiscal 2020 were $103.3 million compared to $80.1 million for fiscal 2019.
Net Loss: Net loss for fiscal 2020 was $139.9 million, or $3.57 per share, compared to $107.7 million, or $3.92 per share, for fiscal 2019.
Cash Position: As of September 30, 2020, the company had $290.0 million in cash, cash equivalents and short term investments.
FISCAL 2020 FOURTH QUARTER FINANCIAL RESULTS

Orders: Total orders received for the fourth quarter of fiscal 2020 were $42.7 million, compared to $20.0 million for the same period of fiscal 2019.
Revenue: Total revenues were $32.4 million for the fourth quarter of fiscal 2020 compared to $15.7 million for the same period of fiscal 2019.
Cost of Revenues: Cost of revenues for the fourth quarter of fiscal 2020 was $17.6 million compared to $12.4 million for the same period of fiscal 2019.
Research and Development Expenses: Research and development expenses for the fourth quarter of fiscal 2020 were $11.7 million compared to $10.5 million for the same period of fiscal 2019.
Selling, General and Administrative Expenses: Selling, general and administrative expenses for the fourth quarter of fiscal 2020 were $27.2 million compared to $24.4 million for the same period of fiscal 2019.
Net Loss: Net loss for the fourth quarter of fiscal 2020 was $24.3 million, or $0.54 per share, compared to $31.2 million, or $0.96 per share, for the fourth quarter of fiscal 2019.
"Over the last year, we delivered on revenue, orders, margin and product pipeline in a very challenging environment," commented Jim Thorburn, CFO of Twist. "We have a strong balance sheet and momentum moving into fiscal 2021, and look forward to an exciting year ahead."

Fiscal Fourth Quarter 2020 and Recent Highlights

Shipped products to approximately 2,200 customers in fiscal 2020, versus approximately 1,300 in fiscal 2019.
Presented data on our Twist Custom Target Capture Panel, Fast Hybridization Enrichment System and our Target Enrichment for Infectious Disease at the American Society of Human Genetics 2020 Annual Meeting.
Announced broad strategic partnership with Neogene Therapeutics, Inc. to leverage Neogene’s proprietary expertise in targeting tumor neo-antigens, mutated proteins found in cancer cells due to cancer-associated DNA mutations, together with Twist’s DNA synthesis platform and product lines to develop personalized chimeric antigen receptor (CAR) T cell therapies and T cell receptor (TCR) therapies for patients with cancer.
Reported preclinical data demonstrating the potent neutralizing effects of multiple potential therapeutic antibodies identified by Twist Biopharma, both Immunoglobulin G (IgG) antibodies and substantially smaller single domain VHH "nanobodies," against SARS-CoV-2, the virus that causes COVID-19. These neutralizing effects were found to be comparable to or better than those seen with antibody candidates derived from patients who had recovered from COVID-19. The data were collected from studies conducted by Saint Louis University and independently verified by scientists at Colorado State University.
Achieved significant milestones on our DNA data storage roadmap to miniaturize the silicon platform technology down to 150 nanometer pitch or less. Twist is now consistently able to synthesize DNA using five-micron devices at a 10 micron pitch. In addition, we have fabricated our next R&D-stage silicon chip with 300 nanometer devices on a one-micron pitch chip.
Formed the DNA Data Storage Alliance with leading technology and synthetic biology companies to create a comprehensive industry roadmap designed to help the industry achieve interoperability between solutions and help establish the foundations for a cost-effective commercial archival storage ecosystem for the explosive growth of digital data.
New Netflix Original Series ’Biohackers’ stored in Twist’s synthetic DNA.
Fiscal 2021 Financial Guidance

The following statements are based on Twist’s current expectations for fiscal 2021. 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 2021, Twist provided the following financial guidance:

Revenue expected in the range of $110 million to $118 million
Revenue from Ginkgo Bioworks expected to be approximately $11 to $12 million
Synbio revenue excluding Ginkgo Bioworks is expected to be in the range of $41 to $44 million
NGS revenue is estimated to be in the range of $54 to $58 million
Biopharma revenue is estimated to be approximately $4 million
Gross margin is expected to be approximately 32% for fiscal 2021
Operating expenses including R&D and SG&A are expected to be $174 million for the year
Net loss expected in the range of $136 million to $141 million to reflect our increased investments in our commercial organization and research and development activities
R&D is expected to be approximately $60 million
Stock-based compensation is expected to be approximately $20 million
Depreciation is expected to be $7 million
Capital expenditures are expected to be $30 million, including expansion into "Factory of the Future"
Fiscal 2021 First Quarter Financial Guidance

For the first quarter of fiscal 2021, Twist provided the following financial guidance:

Revenue expected in the range of $25 million to $26 million
COVID-19 Considerations

During the three months ended September 30, 2020, financial results of the Company were not significantly affected by the COVID-19 outbreak. However, the extent to which the COVID-19 outbreak affects Twist’s future financial results and operations is subject to a high degree of uncertainty and will depend on future developments, including the duration, spread and treatment of the outbreak domestically and abroad.

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 2947139. A telephonic replay of the conference call will be available beginning approximately four hours after the call through November 30, 2020 and may be accessed by dialing (855) 859-2056 (domestic) or (404) 537-3406 (international). The replay conference ID is 2947139. The webcast replay will be available for two weeks.

Given the circumstances globally, it is recommended to dial-in at most 15 to 20 minutes prior to the call start to reduce waiting times. If a participant will be listen-only, they are encouraged to listen via the webcast on Twist’s investor page.

On November 23, 2020 Immunocore (the "Company"), a late-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious and autoimmune, reported that its Phase 3 IMCgp100-202 clinical trial of tebentafusp (IMCgp100) vs. investigator choice in metastatic uveal melanoma (mUM) has met the pre-defined boundaries for statistical significance of the primary endpoint of Overall Survival (OS) in its first pre-planned interim analysis conducted by the independent data monitoring committee (Press release, Immunocore, NOV 23, 2020, View Source [SID1234571630]). The OS Hazard Ratio (HR) in the intent-to-treat population favored tebentafusp, HR=0.51 (95% CI: 0.36, 0.71); p< 0.0001, over investigator’s choice (82% pembrolizumab; 12% ipilimumab; 6% dacarbazine). Although not yet mature, the Kaplan-Meier estimates suggest a 1-year OS rate of approximately 73% vs 58%, respectively. The efficacy data confirm the promising OS observed in the phase 2 study IMCgp100-102 in previously treated mUM which will be presented next month at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Virtual Congress 2020.

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Bahija Jallal, Chief Executive Officer of Immunocore said: "A positive survival benefit for tebentafusp represents a major step towards bringing a potential new treatment for cancer patients with a high unmet need. If approved, tebentafusp would be the first new therapy to improve overall survival in 40 years and to be specifically indicated for metastatic uveal melanoma, a disease with poor survival and where new therapies are urgently needed. We look forward to sharing these data with the medical community and Health Authorities in the near future."

Tebentafusp is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector domain. It is engineered to specifically target gp100, a lineage antigen expressed in melanocytes and melanoma, and is the first molecule developed using Immunocore’s ImmTAC technology platform designed to redirect and activate T cells to recognize and kill tumor cells. Tebentafusp has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) and has previously been granted orphan drug designation for uveal melanoma by the FDA and Promising Innovative Medicine designation under UK Early Access to Medicines Scheme.

"To our knowledge, this is the first survival benefit for any TCR therapeutic and for any bispecific in a solid tumor. The survival benefit observed in a randomized trial against checkpoint inhibitors validates our ImmTAC platform as we expand to study other cancers with high unmet need," said David Berman, Head of R&D, "Uveal melanoma has one of the lowest tumor mutational burdens (TMB) and these results suggest our ImmTAC platform should be evaluated in tumors with low or high TMB status."

The Phase 3 IMCgp100-202 clinical trial is designed to evaluate the OS of tebentafusp compared to investigator’s choice (either dacarbazine, ipilimumab or pembrolizumab) in patients with previously untreatedmUM. 378 patients were randomized in a 2:1 ratio to either tebentafusp or investigator’s choice. Final results from IMCgp100-202 are expected to be presented at an upcoming scientific conference and to be submitted for publication in a peer-reviewed journal.

On November 23, 2020 NeuBase Therapeutics, Inc. (NASDAQ: NBSE) ("NeuBase" or the "Company"), a biotechnology company accelerating the genetic revolution using a new class of synthetic medicines, reported that Dietrich A. Stephan, Ph.D., Chief Executive Officer of NeuBase, will participate in a virtual fireside chat at the 32nd Annual Piper Sandler Virtual Healthcare Conference taking place between December 1-3, 2020, as well as in a panel discussion at the 3rd Annual Evercore ISI HealthCONx Conference, which is also being held from December 1-3, 2020 (Press release, NeuBase Therapeutics, NOV 23, 2020, View Source [SID1234571560]).

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A webcast of the Piper Sandler fireside chat will be available on the Piper Sandler conference site from November 23rd to December 3rd. In addition, this webcast will also be available on the NeuBase website, www.neubasetherapeutics.com, for 90 days following the recording of the presentation.