On August 26, 2021 Adagene Inc. ("Adagene") (Nasdaq: ADAG), a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based immunotherapies, reported financial results for the six months ended June 30, 2021, and provided corporate updates (Press release, Adagene, AUG 26, 2021, View Source [SID1234586930]).

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"During the first half of 2021, we advanced our clinical pipeline of three highly differentiated immuno-oncology candidates, while building a robust pipeline of novel preclinical programs that leverage our unique computational biology and artificial intelligence (AI) powered technology platforms," said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene. "With three Merck collaborations now in place, we’ve refined our global clinical development strategies to enhance efficiency and optimize our plans moving forward, while we anticipate key upcoming data from ongoing trials. Our pipeline aims to transform cancer therapy with the first of a new class of agonist antibodies targeting CD137, as well as new modalities and novel combinations to unlock the value of CTLA-4 as a proven target and the backbone of future immunotherapies. Applying our unique technology platforms and translational expertise, our goal is to strike a balance between safety and efficacy, addressing the core challenge of oncology drug development."

Recent Highlights and Upcoming Milestones

ADG106: This NEObody program is a fully human ligand-blocking, agonistic anti-CD137 IgG4 monoclonal antibody (mAb) that is being evaluated in patients with advanced solid tumors and/or non-Hodgkin’s lymphoma.

Evaluated ADG106 in 98 patients in phase 1 monotherapy dose escalation trials in U.S. (ADG106-1001) and China (ADG106-1002):
ADG106 monotherapy was well tolerated at doses of 3 mg/kg and 5 mg/kg. Limited treatment emergent adverse events were observed (i.e., limited liver toxicity or hematologic abnormalities). Results showed evidence of efficacy with a 56% disease control rate, and more than 30% tumor shrinkage was observed in 75% of patients with positive biomarker expression (via retrospective analysis), including a partial response evaluated by RECIST v1.1 in a patient with a solid tumor who failed multiple prior therapies.
Data from these trials were published at the ASCO (Free ASCO Whitepaper) 2021 Annual Meeting.
Continued dose escalation in a phase 1b/2 trial (ADG106-1008) evaluating safety and preliminary efficacy of ADG106 in combination with toripalimab, an approved anti-PD-1 in China. This trial is targeting biomarker-enriched tumors in patients who failed prior standard and/or immuno-oncology therapies.
Preliminary data from this trial demonstrate target engagement as shown by a dose-dependent pharmacodynamic biomarker, consistent with the monotherapy trials.
Implementing a biomarker-enriched tumor targeting strategy for a phase 1b/2 trial of ADG106 in combination with pembrolizumab (ADG106-P2001; KEYNOTE-D12) in the U.S. and Asia Pacific (APAC), integrating earlier plans for the ADG106-2001 trial. Data from this trial are expected in 2022.
Upcoming ADG106 milestones:
H2 2021
Results from ongoing trial in combination with toripalimab (ADG106-1008)
Complete patient follow up in monotherapy trials in the U.S. (ADG106-1001) and China (ADG106-1002)
2022
Results from combination trial with pembrolizumab (ADG106-P2001)
ADG116: This NEObody program, targeting a unique epitope of CTLA-4, is being evaluated in patients with advanced/metastatic solid tumors. ADG116 is designed to enhance efficacy by potent Treg depletion in the tumor microenvironment (TME) and to maintain its physiological function by soft ligand blocking in order to address safety concerns associated with existing CTLA-4 therapeutics.

Continued dose escalation in a global phase 1 clinical trial evaluating the safety and tolerability of ADG116 in patients with advanced/metastatic solid tumors (ADG116-1003):
ADG116 has shown no dose-limiting toxicities at doses up to 6 mg/kg, which is twice the 3 mg/kg dose level approved for the commercially available CTLA-4 therapy in specific indications. Dosing at 10 mg/kg is being initiated.
This trial is on track to be expanded this year with two combination cohorts investigating safety and preliminary efficacy of ADG116 with either toripalimab or ADG106 in patients with advanced/metastatic solid tumors, integrating earlier plans for the ADG106-1003 trial.
Obtained approval of Investigational New Drug application (IND) from China’s National Medical Products Administration (NMPA) for a phase 1 monotherapy trial in China (ADG116-1002).
On track to advance a phase 1 trial of ADG116 in combination with pembrolizumab (ADG116-P001; KEYNOTE C97) in the U.S. and APAC in 2022.
Upcoming ADG116 milestones:
H2 2021
Results from ongoing dose escalation of ADG-116 monotherapy (ADG116-1003)
2022
Results from ongoing dose escalation of combination cohorts, including the combination of ADG116 with toripalimab and ADG106 (ADG116-1003), respectively
Results from combination trial with pembrolizumab (ADG116-P001)
ADG126: The SAFEbody program targets CTLA-4 with a compelling preclinical profile and is designed to provide enhanced safety. ADG126 is designed for conditional activation in the TME, as well as to enhance efficacy by potent Treg depletion and to maintain its physiological function by soft ligand blocking in order to expand the therapeutic index and further address safety concerns with existing CTLA-4 therapies.

Continued dose escalation in a global phase 1 clinical trial evaluating the safety and tolerability of ADG126 in patients with advanced/metastatic solid tumors (ADG126-1001).
In April 2021, presented an update on preclinical data at the AACR (Free AACR Whitepaper) Annual Meeting. Preclinical data demonstrated ADG126 was well tolerated at doses up to 200 mg/kg, with an encouraging antitumor response in multiple immune-competent mouse tumor models in a dose-dependent manner both as a single agent and in combination with anti-PD-1 and other therapies.
Submitted IND to NMPA for a phase 1, dose-escalation and cohort expansion trial of ADG126 in China as monotherapy, and in combination with toripalimab, to evaluate safety and preliminary efficacy in patients with advanced/metastatic solid tumors (ADG126-1002).
On track to advance a phase 1 trial of ADG126 in combination with pembrolizumab (ADG126-P001; KEYNOTE-C98) in the U.S. and APAC in 2022.
Upcoming ADG126 milestones:
H2 2021
Results from ongoing dose escalation of ADG126 monotherapy (ADG126-1001)
2022
Results from dose escalation and cohort expansion of ADG126 (ADG126-1002)
Results from combination trial with pembrolizumab (ADG126-P001)
Preclinical Discovery Programs: The company continues to expand and advance a pipeline of innovative preclinical programs leveraging its NEObody, SAFEbody and/or POWERbody technologies to support the goal of submitting more than ten INDs or equivalent applications in the next three to five years.

Currently, five programs utilizing POWERbody and SAFEbody technologies are undergoing IND-enabling studies, including a highly differentiated anti-CD47 program, and bispecific T-cell engager programs that target both liquid and solid tumors.
All five programs have a robust Chemistry, Manufacturing and Controls (CMC) profile with encouraging preclinical safety and efficacy data.
Since March 31, 2021, the company has advanced two additional programs into CMC activity, further enhancing its portfolio of future IND candidates.
Upcoming preclinical discovery milestones:
2021
Continue advancement of multiple candidates undergoing IND-enabling studies
2022
Submission of multiple INDs or equivalent to advance innovative candidates from the company’s deep, broad, and differentiated preclinical discovery pipeline
Collaborations:

Established clinical trial collaboration and supply agreements with Merck for all three clinical candidates:
In July 2021, Adagene entered into two clinical collaborations with Merck, a leader in immuno-oncology. The collaborations include two open-label, dose escalation and expansion clinical studies to evaluate Adagene’s anti-CTLA-4 mAb product candidates, ADG116 and ADG126, in combination with pembrolizumab for patients with advanced/metastatic solid tumors, respectively.
In August 2021, Adagene entered into a third clinical collaboration with Merck to evaluate ADG106 in combination with pembrolizumab in advanced or metastatic solid and/or hematological malignancies.
Advanced the company’s ongoing collaboration with Guilin Sanjin Pharmaceutical Co., Ltd., or Sanjin, and its affiliates to develop two different monoclonal antibodies:
ADG104, an anti-PD-L1 monoclonal antibody, demonstrated promising data in ongoing phase 1b and phase 2 clinical trials concurrently in China. As of June 30, 2021, 4 patients had partial responses, 16 had stable disease, and a disease control rate of 50% was observed in 40 evaluable patients with various tumor types who received ADG104 monotherapy.
The second program, an anti-CSF-1R monoclonal antibody, received IND approval from the NMPA in March, and a phase 1 trial is expected to initiate dosing soon.
Corporate Updates

The company announced, effective immediately, a change in composition of the board of directors (the "Board") of Adagene Inc. Mr. Yu Miao, a director designated by JSR Limited pursuant to the current effective shareholders agreement, has resigned from the Board due to personal reasons. Mr. Miao confirms that he has no disagreement with the company. Adagene is appreciative of Mr. Miao for his service and valuable contributions to the Board.
The company has further strengthened its leadership team with recent hires across functions:
Steve Fischkoff, M.D., was appointed as interim Chief Medical Officer of Adagene. Dr. Fischkoff is a board-certified medical oncologist who has been active in the pharmaceutical industry for approximately 30 years. Previously, while at Medarex, Dr. Fischkoff led the clinical development of Yervoy (ipilumumab), the first checkpoint inhibitor and the only anti-CTLA-4 product approved by the U.S. Food and Drug Administration. He also served as the clinical lead from first-in-human through submission and approval in the U.S. and the EU of Humira (adalimumab), the world’s top selling pharmaceutical product, at Knoll Pharmaceuticals and Abbott Laboratories.
Jin Shang, Ph.D., was appointed as Senior Vice President of Global Regulatory Affairs. Dr. Shang brings more than 20 years of research, drug development and regulatory experience in the biopharmaceutical industry and most recently served as Director of Regulatory Affairs, Oncology at AstraZeneca, and previously held positions at Sun Pharma, Morphic Therapeutic, and Merck.
Wenlin Zeng, Ph.D., was appointed as Vice President of Cell Line and Upstream. Dr. Zeng will manage cell line and upstream process development, as well as oversee subsequent manufacturing of biological products. Dr Zeng brings more than 20 years of experience in cell line development, cGMP cell banking and drug substance manufacturing. She most recently served as Senior Director at Gilead and previously held positions at Forty-Seven, NGM Bio, Advanced Bioscience Laboratories, GlaxoSmithKline, MedImmune Vaccines, Abgenix and Scios.
Ami C. Knoefler was appointed as Vice President of Investor Relations and Corporate Communications. She has more than 25 years of global experience in pharmaceutical, biotech and medical technology communications. She most recently served as Senior Director at Ascendis Pharma, and previously held positions at Jazz Pharmaceuticals, PDL BioPharma, Abgenix and Bristol-Myers Squibb.
Expanded the Scientific and Strategic Advisory Board (SAB) to include pioneers in the immuno-oncology field: Steve Fischkoff, M.D., Stanley Frankel, M.D., FACP and Robert Spiegel, M.D., FACP. Adagene’s SAB is comprised of industry leaders who have played a key role in the field of immuno-oncology. The SAB will work cohesively with management and other key advisors to provide strategic input as the company pursues global clinical development of its transformative, expanding pipeline.
In July, Adagene authorized a share repurchase program under which the Company may repurchase up to US$20 million of its ordinary shares in the form of American depositary shares.
Financial Highlights

Cash and Cash Equivalents
Cash and cash equivalents were US$208.3 million as of June 30, 2021, compared to US$75.2 million as of December 31, 2020. The increase was mainly due to net proceeds of US$145.9 million from the company’s Initial Public Offering in February 2021. In addition, in March 2021, Adagene received US$11.0 million from Exelixis, Inc., as per the terms of the collaboration and license agreement.

Prepayments and Other Current Assets
Prepayments and other current assets were US$5.4 million as of June 30, 2021, compared to US$3.8 million as of December 31, 2020. The increase was driven by expanded R&D activities and associated advanced payments made.

Contract Liabilities
Contract liabilities were US$11.1 million as of June 30, 2021, compared to US$0.7 million as of December 31, 2020. The increase was due to the collaboration and license agreement signed with Exelixis as the related performance obligations have not been fulfilled.

Net Revenue
Net revenue was US$1.4 million for the six months ended June 30, 2021, compared to US$0.3 million for the same period in 2020. The increase was due to a payment of US$1.2 million from Dragon Boat Pharmaceuticals, a subsidiary of Sanjin, related to fulfillment of performance obligations associated with the companies’ collaboration to develop antibody-based therapies.

Research and Development Expenses
Research and development expenses were US$31.5 million for the six months ended June 30, 2021, compared to US$14.9 million for the same period in 2020. The increase was primarily attributable to an (i) increase in payroll and other related personnel costs by US$4.3 million due to headcount growth and average payroll increase in research and development, (ii) increase in non-cash share-based compensation expenses by US$3.1 million, and (iii) increase in costs related to preclinical testing and clinical trials due to progression of the programs and increased contract manufacturing costs by US$8.0 million. Adagene incurred US$16.6 million for project ADG106, ADG116 and ADG126 for the six months ended June 30, 2021, compared to US$13.0 million for the same period in 2020. Besides, Adagene incurred US$14.8 million for preclinical product candidates, research pipeline and others for the six months ended June 30, 2021, compared to US$1.9 million for the same period in 2020.

General and Administrative (G&A) Expenses
G&A expenses were US$7.4 million for the six months ended June 30, 2021, compared to US$4.7 million for the same period in 2020. The increase was primarily due to an (i) increase in headcount and average payroll and (ii) increase in professional fees and office expenses.

Net Loss
The net loss attributable to Adagene Inc.’s shareholders was US$37.2 million for the six months ended June 30, 2021, compared to US$18.2 million for the six months ended June 30, 2020.

Non-GAAP Net Loss
Non-GAAP net loss, which is defined as net loss attributable to ordinary shareholders for the period after excluding (i) share-based compensation expenses and (ii) accretion of convertible redeemable preferred shares to redemption value was US$27.0 million for the six months ended June 30, 2021, compared to US$11.1 million for the six months ended June 30, 2020. Please refer to the section in this press release titled "Reconciliation of GAAP and Non-GAAP Results" for details.

Non-GAAP Financial Measures

The Company uses non-GAAP net loss and non-GAAP net loss per ordinary shares for the year/period, which are non-GAAP financial measures, in evaluating its operating results and for financial and operational decision-making purposes. The Company believes that non-GAAP net loss and non-GAAP net loss per ordinary shares for the year/period help identify underlying trends in the Company’s business that could otherwise be distorted by the effect of certain expenses that the Company includes in its loss for the year/period. The Company believes that non-GAAP net loss and non-GAAP net loss per ordinary shares for the year/period provide useful information about its results of operations, enhances the overall understanding of its past performance and future prospects and allows for greater visibility with respect to key metrics used by its management in its financial and operational decision-making.

Non-GAAP net loss and non-GAAP net loss per ordinary shares for the year/period should not be considered in isolation or construed as an alternative to operating profit, loss for the year/period or any other measure of performance or as an indicator of its operating performance. Investors are encouraged to review non-GAAP net loss and non-GAAP net loss per ordinary shares for the year/period and the reconciliation to their most directly comparable GAAP measures. Non-GAAP net loss and non-GAAP net loss per ordinary shares for the year/period here may not be comparable to similarly titled measures presented by other companies. Other companies may calculate similarly titled measures differently, limiting their usefulness as comparative measures to the Company’s data. The Company encourages investors and others to review its financial information in its entirety and not rely on a single financial measure.

Non-GAAP net loss and non-GAAP net loss per ordinary shares for the year/period represent net loss attributable to ordinary shareholders for the year/period excluding (i) share-based compensation expenses, and (ii) accretion of convertible redeemable preferred shares to redemption value. Share-based compensation expense is a non-cash expense arising from the grant of stock-based awards to employees. The Company believes that the exclusion of share-based compensation expenses from the net loss in the Reconciliation of GAAP and Non-GAAP Results assists management and investors in making meaningful period-to-period comparisons in the Company’s operating performance or peer group comparisons because (i) the amount of share-based compensation expenses in any specific period may not directly correlate to the Company’s underlying performance, (ii) such expenses can vary significantly between periods as a result of the timing of grants of new stock-based awards, and (iii) other companies may use different forms of employee compensation or different valuation methodologies for their share-based compensation.

Please see the "Reconciliation of GAAP and Non-GAAP Results" included in this press release for a full reconciliation of non-GAAP net loss and non-GAAP net loss per ordinary shares for the year/period for the year/period to net loss attributable to ordinary shareholders for the year/period.

On August 26, 2021 Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, reported that the first person has been dosed in China as part of the global Phase 3 registration trial, TROPiCS-04, in metastatic urothelial cancer (UC) (Press release, Everest Medicines, AUG 26, 2021, View Source [SID1234586946]).

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The multicenter, open-label randomized controlled trial will evaluate sacituzumab govitecan-hziy (SG) compared with standard of care chemotherapeutic options in people with metastatic or locally advanced unresectable UC who have progressed after prior therapy with a platinum-based regimen and anti-programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) therapy. The trial includes two study arms to evaluate SG compared to treatment of physician’s choice (TPC). The primary endpoint of the trial is overall survival.

"We are excited to continue advancing development of SG for people in China with metastatic UC – a devastating and fatal disease that continues to experience increasing incidence in the region," said Dr. Yang Shi, Chief Medical Officer for Oncology at Everest Medicines. "This comprehensive and ongoing global study has the potential to add to the existing and robust suite of data already generated for this novel therapeutic candidate."

About Urothelial Cancer

Urothelial cancer is the one of the most common malignancies diagnosed in China, with the five-year survival rate of metastatic UC estimated to be only 4.6%.[1] There is a significant need for new treatment options for people with UC who have failed platinum-based chemotherapies and checkpoint inhibitors. Urothelial cancer begins in urothelial cells that line the urethra, bladder, ureters, renal pelvis, and some other organs that make up the urinary system. It is estimated that there are more than 80,000 new cases of UC and nearly 33,000 deaths from UC in China per year.[2]

About Sacituzumab Govitecan-hziy

Sacituzumab govitecan-hziy is a first-in-class, antibody-drug conjugate (ADC) directed at TROP-2, a membrane antigen that is over-expressed in many common epithelial cancers. SG received accelerated approval for advanced or metastatic UC following platinum-containing chemotherapy and a PD-1/PD-L1 inhibitor in the U.S. in April 2021.

On August 26, 2021 Johnson & Johnson (NYSE: JNJ) reported thayt it will participate in the Cantor Virtual Global Healthcare Conference on Tuesday, September 28th (Press release, Johnson & Johnson, AUG 26, 2021, View Source;johnson-to-participate-in-the-cantor-virtual-global-healthcare-conference-301363618.html [SID1234586947]). Mathai Mammen, Global Head, Research & Development Janssen Research Development and Scott White, Company Group Chairman NA Pharmaceuticals will represent the Company in a session scheduled at 10:00 a.m. (Eastern Time).

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This webcast will be available to investors and other interested parties by accessing the Johnson & Johnson website at www.investor.jnj.com.

A webcast replay will be available approximately 48-hrs after the live webcast.

On August 26, 2021 Starpharma (ASX: SPL, OTCQX: SPHRY) reported its annual report and financial results for the year ended 30 June 2021 (Press release, Starpharma, AUG 26, 2021, View Source [SID1234586932]).

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Financial Results

Cash position at 30 June 2021 of $60.5M
Net cash burn[1] of $16.5M[2] (FY20: $2M)
Receipt of $5.7M R&D tax incentive
Total revenue and other income of $3.5M (FY20: $7.1M); Revenue in the prior year included $4.3 million from AstraZeneca for a US$3 million development milestone
Reported loss of $19.7M (FY20: $14.7M)
Key activities

VIRALEZE

Developed VIRALEZE, a novel antiviral nasal spray using already approved agent, SPL7013, and undertook scale-up, manufacturing, and other supply chain activities, ahead of launch.
Registered VIRALEZE in Europe and India, and progressed regulatory activities for countries in multiple other regions.
On 25 March 2021, signed a sales and distribution agreement for VIRALEZE with LloydsPharmacy, one of the largest pharmacy groups in the UK.
LloydsPharmacy launched VIRALEZE in the UK online on 30 March 2021 and in-store in April 2021.
Starpharma launched VIRALEZE in countries in Europe in May 2021 via its dedicated product webstore.
Advanced commercial discussions for local distribution arrangements for VIRALEZE in India and in a number of other countries, including various European countries and other international regions.
Conducted extensive antiviral testing on the VIRALEZE antiviral agent:
Confirmed SPL7013 is virucidal against important coronavirus SARS-CoV-2[3] variants Delta, Alpha, Gamma, Beta and Kappa, in laboratory studies.
Demonstrated potent activity of SPL7013 against respiratory pathogen RSV (respiratory syncytial virus) and influenza, in laboratory studies, further expanding the potential uses for VIRALEZE.
Confirmed SPL7013 is active against other pandemic respiratory viruses "SARS" and "MERS", in laboratory studies, supporting the potential use of VIRALEZE in future pandemics.
Published extensive antiviral data for SPL7013 (the antiviral agent in VIRALEZE) in the prestigious international scientific journal, Antiviral Research[4].
In a SARS-CoV-2 challenge in vivo in a humanised mouse model of coronavirus infection, VIRALEZE administered nasally reduced viral load by >99.9% (vs. saline control) in the lungs and trachea of animals challenged with SARS-CoV-2.
Awarded $1 million in matched funding by the Australian Government’s Medical Research Future Fund (MRFF) Biomedical Translation Bridge (BTB) Program to expedite development and commercialisation of VIRALEZE.
Successfully completed a clinical safety study in humans, in which VIRALEZE was safe and very well tolerated, with no absorption of SPL7013 into the bloodstream
DEP Drug Delivery Platform

AstraZeneca expedited and expanded its DEP AZD0466 clinical program, into a multi‑region phase 1/2 trial, with an initial focus on haematological cancers to support rapid development and registration.
Continued progress and recruitment into DEP irinotecan phase 2 trial, with 54 patients now recruited, with multiple patients exhibiting encouraging efficacy signals observed, including impressive tumour shrinkage and reductions in tumour marker levels for multiple tumour types, including breast, colorectal, ovarian, pancreatic, lung and oesophageal cancer. Clinical trial preparations continue for the addition of combinations with DEP irinotecan, thereby expanding the potential market opportunity.
Continued progress and recruitment into DEP docetaxel clinical trials with 50 patients now recruited and with multiple patients exhibiting encouraging efficacy signals observed, including prolonged stable disease, significant tumour shrinkage, reductions in tumour marker levels including in patients with hard-to-treat tumours such as pancreatic, oesophageal, cholangiocarcinoma, and gastric cancer.
Continued progress and recruitment into DEP cabazitaxel phase 2 trial with 42 patients now recruited and with multiple patients exhibiting efficacy signals in prostate cancer, including radiological responses, significant reductions in prostate-specific antigen (PSA) and lack of new bone metastases. Multiple heavily pre-treated patients also exhibited efficacy signals in gastro-oesophageal, ovarian, cholangiocarcinoma, lung, thymic and head and neck cancers.
Signed a Research Agreement with Merck & Co., Inc., (MSD) to conduct a preclinical research evaluation of dendrimer-based Antibody Drug Conjugates (ADCs) utilising Starpharma’s DEP
Signed and commenced a new DEP partnership with leading Chinese pharmaceutical company Chase Sun to develop several DEP nanoparticle formulations for an anti-infective drug.
Starpharma’s second radiopharmaceutical candidate, DEP HER2-lutetium, outperformed in a human breast cancer model.
Progressed development of several internal DEP candidates and programs, including DEP gemcitabine, DEP ADCs, and DEP radiopharmaceutical candidates for both therapeutic and diagnostic applications.
Starpharma continued to progress its undisclosed DEP partnered programs.
Developed and patented a DEP version of Gilead’s remdesivir (Veklury) with improved injection volume and pharmacokinetic characteristics.
Starpharma was invited to present its DEP technology at the prestigious, international Controlled Release Society (CRS) Virtual Annual Meeting, during a session called ‘Success Stories from Bench to Trials to Market’.
VivaGel Portfolio

VivaGel BV achieved TGA approval for an expansion of the marketing authorisation for VivaGel BV (Fleurstat BVgel) to include prevention of recurrent bacterial vaginosis – bringing the approved indications for VivaGel BV (Fleurstat BVgel) in line with those in Europe and Asia.
VivaGel BV was launched in the Nordic region, and new regulatory approvals were also received for countries in Africa and the Middle East, and further submissions were prepared.
In the US, a formal dispute resolution process is ongoing with the FDA as part of the regulatory process for VivaGel BV, and COVID-19 has had an impact on timing.
LifeStyles launched the VivaGel condom in countries in Europe, marketed under LifeStyles’ Manix and Akuel brands of condoms as the Absolute Dual Protection condom.
Corporate activities

Starpharma completed an oversubscribed A$48.9 million share placement and share purchase plan.
Starpharma concluded the year in a strong financial position with a cash balance of $60.5 million. Cash inflows from financing activities for the financial year include net proceeds of $46.9 million resulting from an equity placement and share purchase plan completed in September/October. Revenues for the year totalled $2.2 million, including $1.8 million for product sales, royalty, and research revenue from commercial partners, and interest income of $0.4 million. Other income of $1.3 million included $0.9 million of grant funding awarded by the Australian Government’s Medical Research Future Fund to expedite development and commercialisation of VIRALEZE. The net loss after tax for the year was $19.7 million, compared to $14.7 million last year. The key driver of this movement was the $4.4 million reduction in revenue in FY21 compared to the prior year due to the receipt of a US$3 million milestone payment from AstraZeneca in FY20. There was also a $1.1 million unfavourable unrealised foreign exchange movement (loss in FY21 of $0.8 million, gain in FY20 of $0.3 million) on foreign currencies held during FY21, compared to the prior corresponding period. Following the first launch of VIRALEZE in late March 2021, the product’s revenue for FY21 was $0.8 million. Starpharma originally supplied LloydsPharmacy with $1.4 million of VIRALEZE product, of which $0.7 million of revenue was not recognised for FY21 with stock returned following the temporary pause of sales and the likely repackaging requirements. Returned UK stock is scheduled to undergo repackaging shortly, incorporating a longer shelf-life as additional stability data is now available. This stock will then be made available for sale with the extended shelf-life.

Starpharma CEO, Dr Jackie Fairley, commented: "2021 has been a remarkable year for all of us around the world. Despite the impact of the unrelenting global pandemic, Starpharma was able to continue to recruit into our three DEP phase 2 clinical programs and achieve a number of important commercial milestones across the business. These included the rapid development and launch of VIRALEZE and the continued rollout of VivaGel products, as well as two new commercial DEP partnerships, and important progress for our three internal DEP phase 2 products. In parallel, we continued to build and advance new DEP assets into the preclinical pipeline in exciting and high-value areas like radiopharmaceuticals and Antibody Drug Conjugates (ADCs).

"It was fantastic to see our partner AstraZeneca expedite and expand its clinical program for their first DEP product, AZD0466, into a multi-region phase 1/2 study with the aim of facilitating marketing approvals as soon as possible. We also signed an exciting new partnership with leading global pharmaceutical company MSD (Merck & Co., Inc.) in the area of DEP ADCs, and progressed commercial discussions with potential partners for further potential DEP agreements. Internally, each of our three phase 2 clinical trials for DEP docetaxel, DEP cabazitaxel, and DEP irinotecan continued to recruit well despite the impact of COVID-19. We also developed further DEP assets, including DEP radiopharmaceutical candidates, into the preclinical pipeline".

Commenting on VIRALEZE, Dr Fairley said "The company is extremely proud to have developed, registered and launched VIRALEZE ahead of schedule and in time for it to play a role in the evolving situation in Europe. We were pleased to launch the product in the UK via LloydsPharmacy and online in other parts of Europe. VIRALEZE is now also registered in India and available online to consumers in multiple regions. Throughout the year, Starpharma continued to test SPL7013, the antiviral agent in VIRALEZE, against further respiratory viruses and new variants of SARS-CoV-2 as they emerged, with multiple laboratory studies showing that SPL7013 is virucidal, inactivating >99.9% against all four ‘Variants of Concern’, including the important Delta variant. The broad-spectrum activity of SPL7013 against multiple viruses and new variants is an important feature for the product, which demonstrates the potential further uses for VIRALEZE.

"In the year ahead, we will continue to advance our clinical DEP assets and expand our portfolio by progressing preclinical programs and leveraging Starpharma’s DEP platform to engage with new potential partners and increase market opportunities. The company also remains on track to progress further registrations, distribution arrangements and launches for VIRALEZE in other regions, while also supporting its partners to progress further registrations and launches of VivaGel products," concluded Dr Fairley.

Starpharma has published a standalone ESG (Environment, Social & Governance) Report which is available at View Source

Download ASX Announcement: Starpharma annual report and full year financial results (PDF, 5MB)

[1] Net cash burn is considered a non-IFRS value and has not been audited in accordance with Australian Accounting Standards. Net cash burn is calculated by the movement in cash and cash equivalents between reporting periods, adjusted for the impact of the capital raising during the period.

[2] Excluding the $46.9 million of equity raising net proceeds.

[3] SARS-CoV-2 is the virus that causes COVID-19.

On August 26, 2021 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported that the Company will release its 2021 fiscal year end financial results after the close of the U.S. financial markets on September 2, 2021 (Press release, MEI Pharma, AUG 26, 2021, View Source [SID1234586948]). The Company will host a conference call and live webcast with the investment community to provide a corporate overview and update the same day at 5:00 p.m. ET.

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Conference Call & Webcast Information

When: September 2, 2021, 5:00 p.m. ET
Dial-in: 1-833-974-2378 (United States) or 1-412-317-5771 (International)
When requested, please ask the operator to join the MEI Pharma earnings call
Please join the conference call at least 10 minutes early to register. You can access the live webcast under the investor relations section of MEI’s website at: www.meipharma.com. A replay of the conference call will be archived for at least 30 days after the call.