New Grant of Options

On December 2, 2020 Redx Pharma (AIM:REDX), the drug discovery and development company focused on cancer and fibrosis, reported new options awarded under the Redx All Employee Share Option Scheme (the "Scheme"), as adopted on 1 July 2020 (Press release, Redx Pharma, DEC 2, 2020, View Source [SID1234573529]).

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The Board has authorised the conditional grant of additional options to Lisa Anson (Chief Executive Officer) and Richard Armer (Chief Scientific Officer) on 2 December 2020, both of whom are classed as PDMRs, as set out further below. The options are being granted at 56p per ordinary share, being the price of the Placing and Open Offer announced earlier today, with the grant becoming unconditional once the Placing Shares and the Open Offer Shares have been admitted to trading on AIM, which is dependent, inter alia, on the passing by Shareholders of certain resolutions at the General Meeting of the Company being convened at 11.00 a.m. on 21 December 2020.

Once the option grant becomes unconditional, any subsequent vesting will be subject to certain time and performance criteria having been met.

In addition, options over a further 1,350,000 Ordinary Shares of 1p each will be granted on 2 December 2020 to certain new staff of the company under the Scheme on an unconditional basis. These options will also be granted at 56p, and are not subject to performance conditions.

Following the grants referred to above, and assuming the associated conditions are met in relation to the conditional grant, the Company will have granted options over a total of 28,057,964 Ordinary Shares representing 10.2 per cent. of the share capital in issue following completion of the Placing and the associated issue of 32,806,159 Ordinary shares to Redmile and Sofinnova in aggregate pursuant to their conversion of £5,084,954.65 of the principal amount of the convertible loan notes issued to them

on 4 August 2020 (but ignoring any Ordinary Shares issued in the Open Offer, the take-up of which is currently uncertain). In addition, certain ex-employees continue to hold options, totalling 2,340,800 shares, representing 0.9 per cent. of the share capital that will be in issue following completion of the Placing and aforementioned conversion (but not the Open Offer). The number of options that may be awarded under the Scheme, and all prior share incentive plans, remains limited such that the aggregate number of Ordinary Shares of 1p each under option will be less than 15 per cent. of the total issued share capital of the Company.

Curis to Host Virtual Event to Discuss CA-4948 Clinical Data

On December 2, 2020 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that it will host a virtual KOL event on Tuesday, December 8, 2020, at 8:00 am ET (Press release, Curis, DEC 2, 2020, View Source [SID1234572081]).

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The event will discuss progress to date for first-in-class IRAK4 kinase inhibitor, CA-4948, including data presented at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition from the Phase 1 study in patients with non-Hodgkin lymphoma and new clinical data from the Phase 1 study in patients with acute myeloid leukemia and myelodysplastic syndromes.

The event will be led by James Dentzer, President and CEO, and will include a presentation by Dr. Amit Verma, Professor of Medicine-Oncology at Albert Einstein College of Medicine, and Director of the MDS Program at Montefiore Medical Center in Bronx, NY. Dr Verma and members of Curis leadership will be available to answer questions at the end of the event.

A live webcast of the presentation will be available under "Events & Presentations" in the Investors section of the Company’s website at www.curis.com. A replay of the webcast will be available on the Curis website for 90 days following the event.

Targovax ASA: Invitation to online presentation at 10:00 CET 2 December

On December 2, 2020 Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors, reported that it will present data from its melanoma and mesothelioma trials in an online webcast at 10:00am CET (Press release, Targovax, DEC 2, 2020, View Source [SID1234572102]).

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With reference to the press release issued 1 December 2020 (see link here), Targovax will present data from its phase 1 trial combining ONCOS-102 and the anti-PD1 checkpoint inhibitor (CPI) pembrolizumab (Keytruda) in patients with advanced, unresectable melanoma who have had disease progression despite treatment with anti-PD1 CPI.

Data from the randomized phase 1/2 trial of ONCOS-102 in combination with standard-of-care (SoC) chemotherapy in patients with malignant pleural mesothelioma (MPM), which was released 24 November 2020 (see link here), will also be presented in the webcast.

The webcast starts at 10:00am CET and you can join the webcast here. It will be possible to ask questions during the presentation. A replay of the webcast will be available in the Investor section under "Presentations" after the event.

Avid Bioservices Reports Financial Results for Second Quarter Fiscal 2021 and Recent Developments

On December 2, 2020 Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, reported financial results for the second quarter and first six months of fiscal 2021, ended October 31, 2020 (Press release, Avid Bioservices, DEC 2, 2020, View Source [SID1234572083]).

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Highlights Since July 31, 2020

"During the second quarter, we recorded strong revenues, expanded our customer base and project pipeline, and advanced the company’s expansion plans," stated Nicholas Green, president and chief executive officer of Avid Bioservices. "Driven by growth in customer demand, the company achieved higher-than-expected revenues and margins, and generated operating cash flow and income from operations during the period. In consideration of these results combined with our substantial backlog and our visibility into customer demand, we are raising revenue guidance for fiscal 2021 from between $76 and $81 million to between $84 and $88 million.

"On the business development front, our team continues to execute, signing new business orders and project expansion orders with existing customers for $28 million during the quarter and increasing backlog to $67 million, our highest level since becoming a pure-play CDMO.

"With respect to operations, we have completed a comprehensive review of our options and have initiated a phased approach plan for expansion. Phase 1, which is currently underway, is focused on the streamlining of existing facilities. We are confident that this work will allow us to optimize capacity, increase revenue, minimize near-term expense, and best align our expansion with growth in customer demand.

"And finally, it is important to note that we continue to execute our business and achieve growth without interruption to our operations as a result of the COVID-19 pandemic. This resilience is due largely to the diligence and dedication of our employees. Despite these challenging times, Avid’s incredible workforce remains committed to excellence to ensure the highest quality product for our clients."

Financial Highlights and Guidance

The company is increasing revenue guidance for the full fiscal year 2021 from between $76 million and $81 million to between $84 million and $88 million.

Revenues for the second quarter of fiscal 2021 were $21.1 million, a 15% increase compared to revenues of $18.3 million recorded during the second quarter of fiscal 2020. The year-over-year increase in revenue was primarily attributable to the growth in the number and scope of in-process and/or completed manufacturing runs during the quarter. In addition, the increase in manufacturing revenues included the recognition of $1.7 million from changes in estimated variable revenue consideration as a result of completing performance obligations for certain projects during the quarter, therefore increasing revenue recognized for those projects during the period. For the first six months of fiscal 2021, revenues were $46.5 million, a 38% increase as compared to revenues of $33.6 million in the prior year period. The increase in revenues can be attributed to a $13.6 million increase in manufacturing revenues primarily due to an increase in the number and scope of in-process and/or completed manufacturing runs during the first six months of fiscal 2021, partially offset by a $0.7 million decrease in process development revenues.

As of October 31, 2020, revenue backlog was $67 million, an increase of 12% compared to $60 million at the end of the first quarter of fiscal 2021, and an increase of 3% compare to $65 million at the end of last fiscal year. The company expects to recognize the majority of this backlog over the next twelve months.

Gross margin for the second quarter of fiscal 2021 was 30%, a significant increase compared to a gross margin of 18% for the second quarter of fiscal 2020. The increase in gross margin for the 2021 quarter was primarily attributable to the growth in manufacturing revenues, including the $1.7 million in additional manufacturing revenue recognized, as previously discussed. Excluding the $1.7 million in additional variable revenue consideration, gross margin for the second quarter was approximately 24%. Gross margin for the first six months of fiscal 2021 was 32%, a significant increase compared to 13% in the prior year period. This increase was also primarily due to the growth in manufacturing revenues.

Selling, general and administrative expenses ("SG&A") for the second quarter of fiscal 2021 were $4.2 million, an increase compared to $3.5 million recorded for the second quarter of fiscal 2020. The increase during the 2021 quarter was due primarily to increases in payroll related costs, including stock-based compensation. For the first six months of fiscal 2021, SG&A expenses were $8 million, consistent with $8 million for the prior year period.

For the second quarter of fiscal 2021, the company recorded a consolidated net income attributable to common stockholders of $0.8 million or $0.01 per basic and diluted share, as compared to a consolidated net loss attributable to common stockholders of $1.9 million or $0.03 per basic and diluted share, for the second quarter of fiscal 2020. For the first six months of fiscal 2021, the company recorded a consolidated net income attributable to common stockholders of $4.5 million or $0.08 per basic and diluted share, compared to a consolidated net loss attributable to common stockholders of $6.1 million or $0.11 per basic and diluted share, for fiscal 2020.

Avid reported $35.7 million in cash and cash equivalents as of October 31, 2020, an increase of $7.5 million compared to cash of $28.2 million at the end of the first quarter of fiscal 2021, and consistent with $36.3 million in cash as of the prior fiscal year ended April 30, 2020. The company also generated cash flows from operating activities of $8.1 million during the six months ended October 31. 2020.
More detailed financial information and analysis may be found in Avid Bioservices’ Quarterly Report on Form 10-Q, which will be filed with the Securities and Exchange Commission today.

Recent Corporate Developments

Signed orders for $28 million during the quarter with new and existing customers, driving Avid’s backlog to its highest level since transitioning to a dedicated CDMO.
Developed plans for a two-phased expansion of our Myford facility. The first phase, which has commenced, expands the production capacity of our existing Myford North facility by adding a second downstream processing suite. The second phase, the timing of which will be dictated by revenue growth and projected customer demand, will further expand capacity through the build out of a second manufacturing train, including both upstream and downstream processing suites within Myford South.

The company estimates the first phase will take approximately 12 to 15 months to complete at an estimated cost of approximately $15 million and may increase the company’s annual revenue generating capacity by up to $50 million, bringing the combined annual revenue generating capacity of our Franklin and Myford North facilities to up to $170 million.
Conference Call

Avid will host a conference call and webcast this afternoon, December 2, 2020, at 4:30 PM EST (1:30 PM PST).

To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the Avid Bioservices conference call. To listen to the live webcast, or access the archived webcast, please visit: View Source

Targovax announces impressive objective responses as well as effects on non-injected lesions in ONCOS-102 trial in anti-PD1 refractory melanoma patients

On December 2, 2020 Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors, reported that the combination of ONCOS-102 and pembrolizumab (Keytruda) has demonstrated 35% best objective response rate (ORR) in anti-PD1 refractory malignant melanoma (Press release, Targovax, DEC 2, 2020, View Source [SID1234572102]).

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In this two-part, open label phase 1 trial the combination of ONCOS-102 and the anti-PD1 checkpoint inhibitor (CPI) pembrolizumab has been tested in patients with advanced, unresectable melanoma who have had disease progression despite treatment with anti-PD1 CPI. This is a particularly challenging patient population, which is resistant to approved immunotherapies and has few treatment alternatives available.

For the trial overall, tumor responses were observed in 7 out of 20 evaluable patients treated with the ONCOS-102 and pembrolizumab combination, translating into an ORR of 35% by RECIST 1.1 criteria.

In addition, there were multiple examples of responses in non-injected lesions, including 2 patients where a non-injected lesion completely disappeared, indicating that ONCOS-102 can induce systemic anti-tumor immunity.

Prof. Jedd Wolchok, Investigator, Memorial Sloan Kettering Cancer Centre, New York said: "Checkpoint inhibitors have had a significant impact on the way we treat melanoma; however, a subset of patients still does not respond or become resistant to treatment. Therefore, there is a high medical need for immune activating agents to overcome resistance to checkpoint blockade. ONCOS-102 is one such agent that can re-sensitize patients to anti-PD1 therapy. Although these are early data, observing objective responses with some occurring in non-injected lesions in this first exploratory phase 1 trial is encouraging, and we will follow with great interest as ONCOS-102 moves forward into later-stage development."

The trial was designed with two parts assessing different dosing regimens. In Part 1, 9 patients were given 3 intra-tumoral ONCOS-102 injections during the first week, followed by systemic treatment with pembrolizumab every third week for up to 24 weeks. As reported in July 2019, preliminary tumor responses were observed in 3 out of 9 patients in at least one CT scan (see link here). 1 patient has since been determined as non-evaluable (trial inclusion criteria not met), and these numbers have now been updated to 3 out of 8 patients with ORR for Part 1.

12 more patients were enrolled in Part 2 of the trial, where an extended dosing regimen of 12 intra-tumoral ONCOS-102 injections was tested; 4 injections during the first two weeks followed by concomitant administration of ONCOS-102 and pembrolizumab from week 3 and every third week for up to 24 weeks. Tumor responses were observed in 4 out of the 12 patients in at least one CT scan. Notably, the patients in Part 2 had markedly more advanced disease than in Part 1, with the majority diagnosed as stage IV metastatic melanoma when entering the trial. Importantly, both regimens had favorable tolerability profiles, with no safety concerns.

These data are very strong compared to other therapies in development for the same indication in combination with anti-PD1 CPI, including TLR-9 agonists and other oncolytic viruses, which have reported ORR of ca. 25-30%. As such, the observed ONCOS-102 response rate and effect in non-injected lesions can be considered class-leading for the treatment of anti-PD1 refractory malignant melanoma.

Oystein Soug, Chief Executive Officer of Targovax, commented: "These impressive efficacy data in anti-PD1 refractory melanoma are the most important clinical results for Targovax to date. The data clearly confirm our hypothesis that ONCOS-102 can benefit cancer patients resistant to checkpoint inhibition by triggering local and systemic immune activation. They also provide evidence of clinical efficacy and establishes ONCOS-102 as one of the most promising combination partners to checkpoint inhibitors. We will now carefully analyze the immunological data and are planning for a confirmatory melanoma trial for the ONCOS-102 and checkpoint inhibitor combination."

The trial (NCT03003676) was conducted at three sites in the US and one site in Norway, with Memorial Sloan Kettering CC being the coordinating site.

Online presentation:

Targovax management will present the data in a live webcast 2 December 2020 at 10:00 CET. You can join the webcast here. It will be possible to ask questions during the presentation. A replay of the webcast will be available in the Investor section under "Presentations" after the event.