On October 26, 2021 ASLAN Pharmaceuticals (Nasdaq: ASLN), a clinical-stage, immunology-focused biopharmaceutical company developing innovative treatments to transform the lives of patients, reported financial results for the third quarter ended September 30, 2021, and provided an update on recent corporate activities (Press release, ASLAN Pharmaceuticals, OCT 26, 2021, View Source [SID1234591947]).

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"This quarter, we were pleased to announce positive data from our Phase 1 multiple ascending dose trial of ASLAN004, supporting the potential of this first-in-class antibody as a differentiated, novel treatment for atopic dermatitis," said Dr Carl Firth, CEO, ASLAN Pharmaceuticals. "This quarter we also made key appointments to strengthen our management team and established a scientific advisory board comprised of global thought-leaders in dermatology and immunology. In addition, we expanded our US operations with a new office in Menlo Park, CA. We are entering the fourth quarter with strengthened operating position and poised to advance ASLAN004 in a 300-patient, Phase 2b trial before year-end, as well as advance our DHODH inhibitor, ASLAN003 into clinical trials early next year."

Third quarter 2021 and recent business highlights

Q3 and recent clinical developments

In September, positive top-line results were announced from the double-blind placebo-controlled MAD trial of ASLAN004. In the Intent to Treat (ITT) population, patients treated with ASLAN004 achieved a statistically significant improvement versus placebo in the primary efficacy endpoint of percent change from baseline in the Eczema Area Severity Index (EASI), and also showed significant improvements in other key efficacy endpoints: EASI-50, EASI-75, peak pruritus and the Patient-Oriented Eczema Measure (POEM).
In October, the Company announced a collaboration with renowned inflammatory skin disease expert Dr Emma Guttman-Yassky, MD PhD, to conduct research that will continue throughout ASLAN’s Phase 2b program to identify and characterize the effects of ASLAN004 on disease-associated skin and serum-biomarkers in adults with moderate-to-severe AD. Dr Guttman-Yassky is Chair of the Department of Dermatology at the Icahn School of Medicine at Mount Sinai and a world leader on inflammatory skin diseases. Her research has led to significant breakthroughs in the understanding of the immunologic basis of AD, providing the scientific community with greater clarity on the pathophysiology of the disease, which is complex and multifactorial.
In October, ASLAN-hosted the first in a series of Key Opinion Leader (KOL) webinars: the A4 Series: Aspects of Atopic Dermatitis and ASLAN004. For the first webinar, Associate Professor Jonathan Silverberg, MD PhD MPH, was a guest KOL speaker to discuss the heterogeneity in AD. To access a replay of this event, click here or go to the "Events and Presentations" section in ASLAN’s Investor Relations website at View Source A replay will be archived for 3 months immediately after the event.
Corporate updates

In July, ASLAN secured a loan facility with K2 HealthVentures of up to US$45.0 million of secured debt financing. The facility consists of a US$20.0 million initial term loan funded at closing, with the remaining US$25.0 million subject to certain terms and conditions. The proceeds will be used to advance the clinical development of ASLAN003 as well as for general corporate purposes.
In September, Dr Ferda Cevikbas was appointed as Executive Director, Head of Translational Science. Ferda joined ASLAN from Eli Lilly & Co where she was responsible for translational activities for lebrikizumab and other late-stage immunology projects. Prior to that, she was the Translational Scientist Lead for AD therapy, Eucrisa at Anacor / Pfizer, and held several academic positions at University of California, San Francisco. Ferda has a PhD from the University Hospital of Münster in Germany.
In September, a new Scientific Advisory Board (SAB) chaired by Dr Lawrence Eichenfield, MD FAAD, was established. Dr Eric Simpson, MD MCR, Dr Melinda Jennifer Gooderham, MSc MD FRCPC, Dr Jacob Thyssen, MD PhD DmSci, and Associate Professor Peter Foley, BMedSci MBBS MD FACD, were also appointed as members of the SAB.
In October, ASLAN opened a new office in the US in Menlo Park, California.
Anticipated upcoming milestones

First patient enrolment in global Phase 2b trial of ASLAN004 for AD expected in the fourth quarter of 2021.
Initiation of Phase 2 trial of ASLAN003 in inflammatory bowel disease expected in the first half of 2022.
Third quarter 2021 financial highlights

Cash used in operations for the third quarter of 2021 was US$7.6 million compared to US$2.6 million in the same period in 2020.
Research and development expenses were US$5.3 million in the third quarter of 2021 compared to US$2.2 million in the third quarter of 2020. The increase was driven primarily by preparations for the ASLAN004 Phase 2b clinical trial.
General and administrative expenses were US$2.8 million in the third quarter of 2021 compared to US$1.3 million in the third quarter of 2020. The increase was primarily driven by professional costs related to the debt financing activity completed in July, and the expansion of the US team.
Net loss for the third quarter of 2021 was US$8.6 million compared to a net loss of US$3.5 million for the third quarter of 2020.
Cash and cash equivalents totalled US$100.5 million as of September 30, 2021, compared to US$94.1 million as of June 30, 2021, and US$14.3 million as of December 31, 2020. Management believes that ASLAN’s cash and cash equivalents will be sufficient to fund operations through late 2023.
The weighted average number of ADSs outstanding in the computation of basic loss per share for the third quarter of 2021 was 69.7 million (representing 348 million ordinary shares) compared to 38.0 million (representing 190 million ordinary shares) for the third quarter of 2020. One ADS is the equivalent of five ordinary shares.

On October 26, 2021 Veracyte, Inc. (Nasdaq: VCYT) reported new data demonstrating the clinical utility of the company’s Decipher Prostate genomic classifier for guiding the timing and intensity of treatment in men experiencing prostate cancer progression following radical prostatectomy (Press release, Veracyte, OCT 26, 2021, View Source [SID1234591963]). The data, from a randomized, phase 3 trial conducted at 24 centers in Belgium, Germany, and Switzerland (SAKK 09/10), were presented today at the American Society for Radiation Oncology (ASTRO) Annual Meeting 2021 (abstract #94).

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Following radical prostatectomy, physicians typically monitor prostate cancer patients’ prostate-specific antigen (PSA) to identify biochemical recurrence. For those men who experience a subsequent rise in PSA, determining the optimal timing to initiate treatment and whether to add androgen deprivation therapy (ADT) to radiotherapy is challenging. Conventional clinical measures such as PSA and pathological findings following surgery are often insufficient to predict which patients will experience favorable oncologic outcomes with radiotherapy alone, and which will have disease that continues to progress.

To determine whether the Decipher Prostate genomic classifier could help identify those patients who would benefit from earlier intervention with radiotherapy or the addition of ADT to radiotherapy in this setting, researchers in the Swiss Group for Clinical Cancer Research (SAKK) and collaborating cancer centers assessed the outcomes and Decipher Prostate genomic risk for 226 prostate cancer patients from the SAKK 09/10 phase 3 randomized clinical trial. This study involved men experiencing a rise in PSA following radical prostatectomy, all of whom received radiotherapy without the addition of ADT. Patients in the Decipher Prostate analysis were followed for a median of 6.3 years.

"We’re pleased to have participated in this study, which explored a critical decision point in the management of men with prostate cancer," said Elai Davicioni, Ph.D., Veracyte’s senior vice president of Scientific and Clinical Operations, Urologic Cancers. "The side effects of ADT when given concurrently with radiotherapy are often difficult for patients to manage. Being able to identify those patients who are likely to have favorable outcomes with radiotherapy alone, as well as the men who would benefit most from adding ADT to radiotherapy, could significantly improve the management of men with biochemically recurrent prostate cancer."

The data shared at ASTRO today show that men with disease classified as Decipher high-risk were more than twice as likely as those whose disease was classified as Decipher low/intermediate-risk to experience biochemical and clinical progression with radiotherapy alone. Additionally, Decipher high-risk patients with PSA levels above 0.5 ng/mL who received radiotherapy alone had a nearly 90% risk of cancer recurrence in the five years following treatment.

"The results of our study suggest that men with higher Decipher Prostate scores should be considered for earlier intervention when experiencing a rise in PSA, and depending on PSA level at time of treatment, these men may receive the most benefit from the addition of ADT to radiotherapy," said Alan Dal Pra, M.D., director of Clinical Research at Sylvester Comprehensive Cancer Center, associate professor of radiation oncology at the University of Miami Miller School of Medicine, and lead author on the ASTRO abstract. "This type of genomic, risk-based approach can support more informed, individualized treatment planning."

On October 26, 2021 CANbridge Pharmaceuticals, Inc., a leading China-based global rare disease-focused biopharmaceutical company committed to the research, development, and commercialization of transformative therapies, reported that it has dosed the first patient in the CAN008 Phase 2 clinical trial to treat glioblastoma multiforme (GBM) in Mainland China (Press release, CANbridge Life Sciences, OCT 26, 2021, View Source [SID1234591981]).

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The multi-center, randomized, double-blind, placebo-controlled Phase 2 trial will compare standard-of-care (tumor removal, followed by radiation therapy plus temozolomide (TMZ)) with placebo, to standard-of-care with CAN008. The trial will investigate efficacy, as well as explore how select biomarkers correlate to outcome, to provide potential benefits to GBM patients.

The compound has been recognized by regulatory bodies in key international markets as potentially promising in the treatment of glioblastoma. It was granted orphan drug designation by the United States Food and Drug Administration (FDA) and received an orphan medicinal product designation by the European Medicines Agency (EMA) for the treatment of glioblastoma multiforme. In addition, it also was accepted into the EMA’s PRIME (Priority Medicines) program, which provides early and enhanced support to medicines that have the potential to address patients’ unmet needs. CANbridge completed the Phase 1 clinical trial of CAN008 plus temozolomide (TMZ), during and after radiation therapy, in patients with newly diagnosed glioblastoma multiforme (GBM). The results demonstrate that CAN008 has excellent safety and tolerability in patients with GBM and could potentially improve the quality life and the survival time of the patients

"Glioblastoma multiforme is the most common primary intracranial malignant tumor," said Professional Wenbin Li, Director of Comprehensive Treatment Ward of Neuro-Oncology, Beijing Tiantan Hospital, Capital Medical University. "Under the current standard treatment, the media survival time of patients is only 14.6 months, and the two-year survival rate is only 27%. The incidence in China has been increasing in recent years. The preliminary clinical trial results of CAN008 show that it has a good treatment effect trend, as well as very good safety and tolerability. We are pleased to participate in the domestic clinical study of CAN008 to provide a potential new treatment option for patients with glioblastoma."

"CAN008 is our first clinical product approved to commence clinical trials that has received a Class 1 new drug designation by China Food’s National Medical Products Administration," said James Xue, Ph.D., Founder, Chairman and CEO of CANbridge Pharmaceuticals, Inc. "The dosing of the first patient in CAN008 Phase 2 trial for the treatment of GBM in China represents a major milestone for CANbridge. We look forward to advancing this truly novel, fusion protein treatment for glioblastoma along the clinical pathway in China, where it might provide new options for patients."

About Glioblastoma (GBM)

Glioblastoma (GBM) is the most common malignant tumor of the central nervous system, accounting for 35.26% – 60.9% of intracranial tumors. It is classified by the World Health Organization (WHO) as a stage-IV cancer, according to the latest classification standard of intracranial tumors. GBM is highly infiltrative and aggressive and is not surgically curable, which leads to a high recurrence rate. Although the treatment of GBM, through resection radiotherapy and chemotherapy, has continuously improved, prognosis has not been substantially improved. The median survival time is still only 14.6 months.

According to the American Association of Neurological Surgeons AANS Statistics, the number of patients with GBM in western countries is 2-3/100,000 every year, accounting for 52% of intracranial tumors. The two-year and five-year survival rates are about 30% and 4-5%, respectively.

According to Frost & Sullivan, GBM patients in China accounted for 46.6 % of intracranial tumors, totaling 54,700 patients in 2020. With the aging population and aggravated levels of air pollution and ionizing radiation exposure, the number of patients with newly diagnosed glioblastoma in China is expected to reach 59,800 in 2025, and 64,400 in 2030.

About CAN008

CAN008 is a CD95 Fc fusion protein that blocks the interaction between CD95 receptor, and its cognate ligand CD95L, through binding to CD95L. CAN008 has a unique dual mechanism of action, which can not only inhibit the invasive growth and migration of tumor cells, but could also reduce the apoptosis of T cells induced by Caspase, and enhance immune recognition. Previous clinical trial data show that CAN008 has good safety, can effectively improve the quality-of-life of GBM patients, and can greatly prolong the survival time of patients. Based on this, European Medicines Agency (EMA) included CAN008 in the Priority Medicines (PRIME) program.

Note: The European Medicines Agency (EMA) officially launched the "PRIority MEdicines (PRIME)" plan on March 7, 2016, to accelerate the review process of drugs that could address medically underserved conditions.

On October 26, 2021 THERADIAG (ISIN: FR0004197747, Ticker: ALTER), a company specializing in in vitro diagnostics and Theranostics, reported the launch of a rights issue for a target amount of €5,334,745,24, at a price of €1.22 per share with a nominal discount of 30.05% to the closing price on 21 October 2021, and a ratio of 1 new share for every 2 existing shares (the "Rights Issue") (Press release, Theradiag, OCT 26, 2021, View Source [SID1234591930]).

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Bertrand de Castelnau, CEO of Theradiag, said: "Our strategic refocus on innovation and the commercial development of our two activities, Theranostics and in vitro diagnostics, has enabled us to post very solid growth in recent semesters and be close to breakeven in the first half of 2021[1]. On the basis of buoyant activity for our innovative solutions and a healthier cost structure, we are entering a new phase of profitable growth with the aim of strengthening our global leadership on the biotherapy monitoring market.

Theradiag stands out on this growing biotherapy monitoring market through its expertise and its ties with the healthcare professionals ecosystem in France and abroad. Building on these assets, the Company wants to begin a new chapter in its history through this fundraising operation that will enable it to finance the five projects that will structure its future growth:

Secure the quality and commercial supply of antibodies via the Humabdiag project developed thanks to the recent partnership with the University of Tours (bioproduction of human monoclonal antibodies);
Accelerate the internationalization of existing activities in the world’s main healthcare countries, and in particular accelerate sales in the United States (which already account for 19% of Theranostics revenue);
Develop a technological solution to ensure Near Patient Testing;
Invest in new therapeutic fields with a substantial medical need and strong growth (e.g. oncology, central nervous system, rheumatology, etc.);
Thanks to the expertise acquired in autoimmune diseases, reposition and revive FIDIS technology, in particular in the United States, and the activity covering serums used in quality control.
Through our current structure and these five routes of development that present substantial synergies, our unique positioning will provide a response to the substantial demand on the rapidly growing global biotherapy monitoring market.

In this perspective, the planned use of the funds raised in the capital increase will be as follows:

50% of the funds will be used to strengthen the sales team by recruiting sales professionals in the United States, France and the rest of the world, to develop the autoimmunity portfolio and to design a marketing campaign for Theradiag products;
30% of the funds to research new therapeutic areas, develop new products and adapt near-patient testing;
10% of the funds raised to accelerate product registrations in several countries, particularly the United States, in order to increase international sales; and
Up to 10% of the funds raised, in order to finance Theradiag’s working capital requirements, open subsidiaries and improve production facilities.
If the issue is limited to 75%, the funds will be used as follows:

50% of the funds will be used to strengthen the sales team by recruiting sales professionals in the United States, France and the rest of the world, to develop the autoimmunity portfolio and to design a marketing campaign for Theradiag’s products;
30% of the funds to research new therapeutic areas, develop new products and adapt near-patient testing;
10% of the funds raised to accelerate product registrations in several countries, particularly the United States, in order to increase international sales; and
10% of the funds raised to finance Theradiag’s working capital requirements, open subsidiaries and improve production facilities.
Theradiag is thus preparing for a new growth phase that requires the financial means to match its ambitions. We want to involve you in this new phase by launching a Rights Issue of approximately 5.3 million euros (through the issuance of up to 4,372,742 shares at a price of €1.22 each). The funds raised will be allocated to boost our R&D and internationalize our activities in our key geographic areas, which are France and the United States. Our goal is to achieve annual revenue of over €40 million[2] within five years while keeping our costs strictly under control in order to achieve an operating margin of between 20 and 30%. This ambition should be achieved through organic growth and the implementation of the five development axes described. With the exception of public grants and subsidies, the Company does not expect to call on other complementary financing".

Pierre Morgon, Chairman of the Board, adds: "We are determined to take Theradiag to a new dimension thanks to the added value of our solutions and the current dynamic of the market segments we are targeting. On behalf of the Board of Directors and our entire team, I would like to thank you for your trust in and support for this operation that should put Theradiag on a track to faster growth and contribute to strengthening its leadership position in biotherapy monitoring".

[1] The Company’s operating result and net result at 30 June 2021 amount to -178 K€ and -92 K€ respectively.

[2] The Company’s sales as at 30 June 2021 was €5.5 million.

On October 26, 2021 Avid Bioservices, Inc. (NASDAQ:CDMO), 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 that the company will be added to the S&P SmallCap 600 Index, effective prior to the open of trading on Friday, October 29, 2021 (Press release, Avid Bioservices, OCT 26, 2021, View Source [SID1234591948]).

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"We are pleased to be added to the S&P SmallCap 600 Index as it is a further demonstration of the momentum that Avid continues to generate as we successfully execute against our comprehensive growth strategy. This recognition is also an important testament to the hard work and key contributions that every member of the Avid team has made to the company’s ongoing success," said Nick Green, president and chief executive officer of Avid Bioservices.

The S&P SmallCap 600 Index is a stock market index established by Standard & Poor’s that is designed to measure the performance of the small-cap segment of the market and is composed of 600 constituent companies in the U.S. equities market. The index is designed to track companies that meet specific inclusion criteria to ensure that they are liquid and financially viable. To be included, companies must have an unadjusted market cap in the range of $850 million to $3.6 billion.