On March 23, 2021 CellMax Life, a molecular diagnostics company with proprietary technology for pre-cancer and cancer detection blood tests, and Sebela Pharmaceuticals, a market leader in gastroenterology, reported the closing of a strategic development and commercial collaboration agreement, as well as CellMax’s Series C financing (Press release, CellMax Life, MAR 23, 2021, View Source [SID1234577108]). Participation in the financing also includes a strategic investment from new investor, Aflac Ventures, the corporate venture arm of Aflac Incorporated (NYSE: AFL), and existing investor, ArtimanVentures.

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"Strategic financing from market leaders, Sebela and Aflac Ventures, is a testament to CellMax’s technology and vision," said Atul Sharan, chief executive officer, CellMax Life. "Sebela has a leading market position in the gastroenterology field in the United States. The financing will bring to life our vision of detecting colon cancer before it occurs through a globally marketed blood test that can detect pre-cancerous polyps."

The Series C financing will be used to accelerate the clinical development of CellMax’s multimodal liquid biopsy test, FirstSight, for the detection of colorectal cancer and pre-cancerous polyps, also known as advanced adenomas. CellMax recently initiated a multicenter U.S. study to further optimize its proprietary algorithm and cell capture techniques. CellMax and Sebela will collaborate on completing the development of FirstSight and, following approval from the U.S. Food and Drug Administration, Sebela will commercialize the test in the United States.

"For the last several years, we have closely followed the industry’s development of colorectal cancer liquid biopsies," said Alan Cooke, chief executive officer, Sebela Pharmaceuticals. "Sebela and our subsidiary, Braintree, have worked with gastroenterologists for over 35 years, and we expect FirstSight to play a central role in the future of colorectal cancer screening. FirstSight may not only enable the U.S. to exceed its 80% screening rate target, as set by the National Colorectal Cancer Roundtable, but can also help detect pre-cancerous adenomas early, referring patients to colonoscopy for preemptive removal."

This partnership complements Sebela’s portfolio of market-leading gastroenterology and colonoscopy preparation products, which are utilized to facilitate colonoscopies, the "gold standard" for the prevention and detection of colorectal cancer. Colonoscopies remain the only means of removing detected pre-cancerous lesions to prevent colorectal cancer.

At the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancer Symposium, Dr. Shai Friedland, professor of medicine at Stanford University Medical Center and chief of gastroenterology at the VA Palo Alto Health Care System, presented results from a prospective study performed on 458 subjects utilizing FirstSight, a multimodal assay comprised of circulating dysplastic epithelial cells and circulating tumor DNA mutation markers, in combination with a proprietary algorithm.

"A test that detects only colorectal cancer, and not adenomas, will result in missed opportunities to prevent cancer and subject patients to invasive cancer treatments," said Dr. Friedland. "Today, there is not a single non-invasive screening test that can accurately detect pre-cancerous polyps even nearly as effective as a colonoscopy. Our study data with the FirstSight blood test continues to show consistent ability to detect advanced adenomas with high sensitivity, enabling removal before they progress to carcinomas."

In clinical studies performed in the U.S. and Taiwan, FirstSight has demonstrated strong performance in detecting both advanced adenomas and colorectal cancer. FirstSight has also shown the ability to detect recurrent neoplasia following polypectomy. i-v

Colorectal cancer represents the second deadliest cancer in the U.S., despite being one of the most preventable.vi Additionally, screening adherence rates have fallen short of the 80% target, as only 68.8% of adults aged 50 to 75 years, and only 63.3% of adults aged 50 to 64 years, were up to date with colorectal cancer screening as of 2018.vii

On March 23, 2021 aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, reported fourth quarter and full year 2020 results and provided a corporate update (Press release, aTyr Pharma, MAR 23, 2021, View Source [SID1234577091]).

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"Amidst the backdrop of the COVID-19 pandemic, 2020 was a highly productive year for aTyr that included significant clinical, research and discovery advancements that we expect to yield value for the company throughout 2021," said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. "We are highly encouraged by our progress and look forward to building upon our programs and novel tRNA synthetase biology platform as we move forward this year."

"Most notably, we have advanced and expanded our clinical program for ATYR1923. We completed enrollment in our Phase 1b/2a trial for our lead interstitial lung disease (ILD) indication, pulmonary sarcoidosis, and data from this proof-of-concept study is expected in the third quarter of this year. We also reported positive results from a Phase 2 trial in patients with COVID-19, which demonstrated ATYR1923’s favorable safety profile and a signal of clinical activity. Furthermore, we gained key mechanistic insights from the study’s biomarker data, which showed that ATYR1923 is impacting inflammation in patients consistent with what we have seen preclinically, including inflammatory cytokines that are implicated in sarcoidosis and other forms of ILD."

"In order to accomplish such progress, we have remained steadfast with the efficient and judicious use of our capital. The capital we generated in 2020, including the upfront payment received under the Kyorin Agreement, and elimination of debt allowed us to end 2020 with approximately $31.7 million in cash. The year-end cash number, along with the more than $25.0 million we’ve received since year end from the receipt of a milestone payment and use of our equity vehicles, position us well to carry out our catalysts for the year ahead."

Fourth Quarter 2020 and Subsequent Period Highlights

Completed enrollment in its Phase 1b/2a multiple-ascending dose, placebo-controlled study of ATYR1923 in 37 patients with pulmonary sarcoidosis. Data is expected in the third quarter of this year.
Reported positive results from its Phase 2 randomized, double blind, placebo-controlled study of ATYR1923 in 32 COVID-19 patients with severe respiratory complications. The study met its primary safety endpoint and demonstrated a signal of activity through clinical improvement in the 3.0 mg/kg cohort compared to placebo. Biomarker data from the study showed that patients treated with ATYR1923 demonstrated a trend of overall improvement in 82% (14 of 17) of biomarkers analyzed compared to placebo. ATYR1923 reduced several inflammatory cytokines and chemokines, including those that are implicated in sarcoidosis and other ILD, which is consistent with findings from animal models. The data provides the first-in-patient mechanistic proof-of-concept for ATYR1923.
Under the collaboration and licensing agreement with Kyorin Pharmaceutical, Co., Ltd. (Kyorin) (the Kyorin Agreement) entered in early 2020 for the development and commercialization of ATYR1923 for ILD in Japan, aTyr has received $10.0 million in upfront and milestone payments.
Presented preclinical findings in a poster at the Keystone Symposia: Tumor Metabolism and the Microenvironment demonstrating that NRP2 is expressed on key immune suppressive cells, further validating NRP2 as a potential regulator of solid tumor progression.
Appointed leading cancer researcher Judith Varner, PhD, as a scientific advisor to the company to support the development of its NRP2 antibody programs. Dr. Varner, whose expertise includes myeloid cell biology and tumor macrophage signal transduction, currently serves as Professor in the Departments of Pathology and Medicine at the Moores Center at the University of California, San Diego.
Had two posters accepted for presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The posters, titled "The Neuropilin-2 targeting antibody ATYR2810 inhibits non-small cell lung cancer tumor growth in monotherapy and combination therapy" and "A domain-specific antibody to NRP2 down-regulated epithelial-mesenchymal transition genes and enhanced efficacy of standard-of-care therapeutics for aggressive breast cancer," were completed in conjunction with the company’s scientific advisor Dr. Arthur Mercurio and his lab at the Department of Molecular, Cell and Cancer Biology at the University of Massachusetts Medical School.
Presented a poster at the Society for Laboratory Automation and Screening International Conference and Exhibition describing the company’s novel approach to identify receptor targets for two extracellular tRNA synthetase fragments Alanyl-tRNA Synthetase (AARS) and Aspartyl-tRNA Synthetase (DARS), further validating the company’s biology platform.
Announced two tRNA synthetase discovery programs from its pipeline to investigate the functionality of selected fragments of AARS and DARS in cancer, fibrosis and inflammation. The programs will initially focus on natural killer cell biology.
Fourth Quarter 2020 Financial Results

Total revenues were $2.1 million and $0.1 million for the three months ended December 31, 2020 and 2019, respectively. The increase was due primarily to $2.0 million from license and collaboration agreement revenue under the Kyorin Agreement. Research and development expenses were $4.7 million and $3.6 million for the three months ended December 31, 2020 and 2019, respectively. The increase was due primarily to the progression of ATYR1923 clinical activities. General and administrative expenses were consistent between periods at $2.3 million and $2.5 million for the three months ended December 31, 2020 and 2019, respectively.

Year Ended 2020 Financial Results and Cash Position

Total revenues were $10.5 million and $0.4 million for the years ended December 31, 2020 and 2019, respectively. The increase was due primarily to $10.0 million from license and collaboration agreement revenue under the Kyorin Agreement. Research and development expenses were $17.3 million and $14.0 million for the years ended December 31, 2020 and 2019, respectively. The increase was due primarily to the progression of ATYR1923 clinical activities. General and administrative expenses were consistent between periods at $9.1 million and $9.4 million for the years ended December 31, 2020 and 2019, respectively.

As of December 31, 2020, aTyr had $31.7 million in cash, cash equivalents and investments. In November 2020, the company repaid all long-term loans. Since December 31, 2020, the company received $2.0 million related to the Kyorin Agreement, raised approximately $9.9 million in gross proceeds from its at the market offering program, before deducting commissions and offering expenses payable by aTyr and raised approximately $15.3 million in gross proceeds from its purchase agreement with Aspire Capital Fund, LLC.

The company expects its research and development expenses to increase in 2021 as it continues to develop ATYR1923 and ATYR2810 as well as its discovery programs.

Conference Call and Webcast Details

aTyr will host a conference call and webcast today at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time to discuss its financial results and provide a corporate update. Interested parties may access the call by dialing toll-free 844-358-9116 from the US, or 209-905-5951 internationally and using conference ID 3291668. Links to a live audio webcast and replay may be accessed on the aTyr website events page at: View Source An audio replay will be available for at least 90 days following the event.

About ATYR1923

aTyr is developing ATYR1923 as a potential therapeutic for patients with inflammatory lung diseases. ATYR1923, a fusion protein comprised of the immuno-modulatory domain of histidyl tRNA synthetase fused to the FC region of a human antibody, is a selective modulator of Neuropilin-2 that downregulates the innate and adaptive immune response in inflammatory disease states. aTyr recently completed enrollment in a proof-of-concept Phase 1b/2a trial evaluating ATYR1923 in patients with pulmonary sarcoidosis. This Phase 1b/2a study is a multi-ascending dose, placebo-controlled, first-in-patient study of ATYR1923 that has been designed to evaluate the safety, tolerability, steroid sparing effect, immunogenicity and pharmacokinetics profile of multiple doses of ATYR1923. In response to the COVID-19 pandemic, aTyr completed a Phase 2 clinical trial with ATYR1923 in COVID-19 patients with severe respiratory complications. This Phase 2 study was a randomized, double blind, placebo-controlled study that was designed to evaluate the safety and preliminary efficacy of a single dose of ATYR1923.

On March 23, 2021 Allarity Therapeutics A/S ("Allarity" or the "Company") reported that its Board of Directors has initiated a process to carry out a fully secured rights issue of units, consisting of new shares and warrants with pre-emptive subscription rights for the Company’s existing shareholders (the "Rights Issue") (Press release, Allarity Therapeutics, MAR 23, 2021, View Source [SID1234577064]). Upon full subscription in the Rights Issue, the Company will initially receive gross proceeds of approximately SEK 100 million. In the event that all warrants are exercised, the Company will receive additional gross proceeds of approximately SEK 200 million. The proceeds from the Rights Issue will strengthen the Company’s financial position and enable it to continue executing its strategy focused on the Company’s three high-priority programs. The Board of Directors also announces that it intends to convene the Annual General Meeting on 15 April 2021 in order to secure shareholder approval of the necessary authorizations to the Board of Directors for the proposed Rights Issue. Notice of the Annual General Meeting will be published through a separate press release.

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Summary of the proposed Rights Issue

The Rights Issue is subject to and will require shareholder approval to authorize the Board of Directors to resolve and implement the necessary changes to the Company’s Articles of Association, including the necessary authorizations to increase the share capital.
The Company has obtained a combination of subscription undertakings and guarantee commitments amounting to in aggregate approximately SEK 101 million, corresponding to approximately 100 percent of the Rights Issue, including undertakings from the Company’s largest shareholder.
Provided that the shareholders approve the necessary authorizations, the Board of Directors intends to resolve and finally approve the Rights Issue on or around 16 April 2021.
The proceeds from the Rights Issue will strengthen the Company’s financial position and enable it to continue executing its strategy focused on the Company’s three high-priority programs.
Each share held in the Company on the record date 7 May 2021 will entitle the shareholder to subscription of one (1) Unit Right. Two (2) Unit Rights confers the right to subscribe one (1) Unit.
One (1) Unit consists of one (1) newly issued share and one (1) warrant (series TO 3) in the Company. The Rights Issue consists of a maximum of 119,520,759 Units.
The subscription price per Unit is SEK 0.85.
Each warrant issued in the Rights Issue is intended to confer the right to subscribe for one (1) share against cash payment of SEK 1.70. The warrants may be exercised in a period of up to 24 months following the Rights Issue.
Proceeds from the Rights Issue will be approximately SEK 100 million before costs. The costs are estimated to approximately SEK 6 million excluding fees to underwriters. The underwriters’ fees are estimated to be approximately SEK 10 million. All fees will be paid in Units.
If all warrants issued in connection with the Rights Issue are exercised, the Company will receive an additional amount of approximately SEK 200 million.
Allarity’s CEO, Steve Carchedi, stated, "Allarity is now at a stage where we are fully focused on delivering clinical and commercial progress of our three high-priority projects, and the potential value inflection points for all of these projects may soon start to appear on our horizon, within this year and the next. This situation creates the right moment for our Company to present a highly competitive investment case to both our current and new shareholders."

Leon Sass, CEO of Sass & Larsen ApS, the Company’s largest shareholder, noted, "I am pleased to observe the progress the Company has made since the end of 2019, including the work toward possible COVID-19 treatment. Based on this performance, I am excited about the future and continuing to support the Company on its path to revolutionize cancer treatments for the benefit of patients across the world."

Background and reasons for the proposed Rights Issue

Allarity Therapeutics is a leading clinical-stage cancer therapeutics company realizing the promise of personalized cancer care by advancing three priority drug programs, dovitinib, stenoparib, and IXEMPRA together with their DRP companion diagnostics.

The Company expects to file its first New Drug Application (NDA) for dovitinib with the U.S. FDA within 2021, thereby initiating the final phase of preparations before a potential U.S. market approval. The company has previously received feedback from a pre-NDA meeting with the FDA, regarding possible approval for dovitinib used to treat renal cell carcinoma (RCC). In parallel, the Company is working on submitting a Pre-Market Approval (PMA) application with the U.S. FDA for use of the DRP companion diagnostic for dovitinib. FDA approval of this NDA and PMA would be the first time a DRP + drug combination has reached the cancer market, and would be a milestone for event for the Company and its DRP platform technology. Allarity holds global, exclusive rights to dovitinib.

Secondly, the Company is currently conducting a DRP-guided Phase 2 clinical trial to evaluate IXEMPRA for the treatment of third-line metastatic breast cancer. The Company’s protocol plans for an enrollment target of 60 IXEMPRA DRP-selected patients. Numerous trial sites are planned in Europe, including Belgium, England, Denmark, Finland, Poland and Germany. By using DRP for patient selection, Allarity aims to provide a superior clinical benefit to patients receiving IXEMPRA, as compared to historical clinical data from breast cancer patients treated with IXEMPRA but not selected with DRP. Allarity holds exclusive European option rights to IXEMPRA, which is already approved by the FDA for the treatment of metastatic breast cancer and is currently marketed by R-PHARM U.S.

Thirdly, the Company is currently advancing a Phase 2 trial of stenoparib for the treatment of advanced ovarian cancer at the Dana-Farber Cancer Institute (Boston, MA U.S.A.) using a DRP companion diagnostic to guide patient enrollment and improve therapeutic outcome. In addition, stenoparib has shown in vitro anti-viral activity against Coronavirus in pre-clinical studies and is now further being pre-clinical tested for its anti-viral properties against the British and South African variants of Coronavirus.

Oncology drug development requires capital, and the Company operates within a range of scenarios of how the Company may be funding its journey towards commercialization in the years ahead, beyond the capitalization plans published in this announcement. Such options include commercial partnering possibilities, listing on an exchange in the US, as many of the Company’s peers are listed on Nasdaq in the US, and on an ongoing basis applying for non-dilutive government funding.

That being said, given the advanced stage of all three high-priority programs, the Company has now reached a stage in its evolution where a significant capital raise is prudent.

Use of Issue Proceeds

The Rights Issue is expected to provide a substantial improvement in the Company’s financial position and to enable the further advancement of its three high-priority programs: IXEMPRA, dovitinib, and stenoparib, by rendering proceeds of approximately SEK 100 million before transaction costs.

Given the Company’s planned roadmap, it expects the net proceeds from the Rights Issue, together with existing liquidity and estimated future cash flows, to be sufficient to fund the Company until 1 February 2022 or possibly longer.

The estimation is based on assumptions about future costs of filing expenses of a New Drug Application and of maintaining two Phase 2 clinical trials in accordance with the Company’s expectations. Deviations from said assumptions with regards to cost levels and timing could have an effect on the Company’s financial position, including the runway the Rights Issue will provide for the company.

In the event that all warrants of this new series TO 3 are exercised for subscription of shares, the Company will receive additional issue proceeds of a maximum of approximately SEK 200 million before issue costs. The additional net proceeds from warrant series TO 3 are intended to be used to further strengthen the Company’s priority programs as noted in Use of Issue Proceeds above.

The Company will discontinue the use of convertible notes as a source of financing of its operations. The Company will meet its short-term financial obligations, until the Rights Issue has been completed, by utilizing a bridge-loan financing facility of SEK 25 million from investors participating in the underwriting consortium, which will be repaid with proceeds from the Rights Issue.

Terms and additional information about the Rights Issue

According to the proposed terms, the right to subscribe for Units with pre-emptive rights shall vest with those who on the record date of 7 May 2021 are registered as shareholders in the Company, whereby holding one (1) existing share in the Company entitles the shareholder to one (1) Unit Right. Two Unit Rights will entitle to subscription of one (1) Unit. One (1) Unit consists of one (1) newly issued share and one (1) warrant (series TO 3) in the Company.

The Units are issued at a subscription price of SEK 0.85 per Unit. In total, a maximum of 119,520,759 Units will be issued through the Rights Issue, corresponding to an amount of approximately SEK 100 million before transaction costs related to the Rights Issue.

The subscription period is expected to commence on 11 May 2021 and end on 21 May 2021, with a right for the Board of Directors to prolong the subscription period.

Subscription for Units without subscription rights will take place during the same time period, and in the event not all Units are subscribed for by use of subscription rights in accordance with the above, the Board of Directors shall, within the limit of the maximum amount of the Rights Issue, decide on allotment of Units subscribed for without subscription rights. First, such allotment shall be made to those who have subscribed for Units with subscription rights, regardless of whether they were shareholders on the record date or not, pro rata in relation to the number of Units subscribed for through exercise of subscription rights and, insofar this cannot be done, by drawing lots. Secondly, allotment shall be made to those who have subscribed for Units without subscription rights, pro rata in relation to the number of Units subscribed for and, insofar this cannot be done, by drawing lots. Thirdly, allotment shall be made to those who have entered into so-called top guarantee undertakings, in relation to such guarantee undertakings. Fourthly, allotment shall be made to those who have entered into so-called bottom guarantee undertakings, in relation to such guarantee undertakings.

Trading in Unit Rights is expected to take place on Nasdaq First North Growth Market from and including 11 May 2021 to and including 21 May 2021, provided that the necessary authorizations to the Board of Directors are adopted by the general meeting and an EU growth prospectus is approved by the Danish Financial Supervisory Authority.

Complete terms and conditions for the Rights Issue, information about the subscription undertakings and guarantee commitments and other information about the Company will be provided in the EU growth prospectus to be released before the commencement of the subscription period.

Preliminary timetable for the Rights Issue

15 April 2021: Annual General Meeting.
4 May 2021: Publication of the EU growth prospectus.
5 May 2021: Last day of trading in the share, including the right to receive subscription rights.
6 May 2021: First day of trading in the share, excluding the right to receive subscription rights.
7 May 2021: Record date for participation in the Rights Issue, i.e. holders of shares who are registered in the share register maintained by Euroclear Sweden AB on this date will receive subscription rights for participation in the Rights Issue with preferential right.
11 May – 21 May 2021: Trading in subscription rights.
11 May – 25 May 2021: Subscription period.
26 May 2021: Expected day for publication of the outcome of the Rights
Subscription undertakings and guarantee commitments

The Rights Issue is fully covered by subscription undertakings and guarantee commitments by the largest shareholder and external underwriters, representing 100% percent of the Rights Issue.

The subscription and guarantee commitments are not secured through bank guarantees, restricted funds, pledged assets or similar arrangements. Consequently, there is a risk that one or more parties will not fulfil their respective commitments.

Shares and dilution

Through the Rights Issue, and payments in Units related to issue costs and fees to Underwriters, the Company’s share capital will increase by up to a maximum of DKK 5,976,037.95 to DKK 17,928,113.90. Existing shareholders that do not participate in the Rights Issue will be diluted by a maximum of 37.52% but will have the possibility to gain economic compensation for the dilution effect by selling their subscription rights.

In the event that the Rights Issue and the warrants series TO 3 are both exercised in full, the share capital of the Company will increase from DKK 11,952,075.95 to DKK 23,904,151.85 and the total number of shares will increase from 239,041,519 shares to 478,083,037 shares. The dilution effect will amount to a maximum of 54.56%.

General meeting

The Annual General Meeting (AGM) to be held on 15 April 2021 determine whether shareholders approve of the Board of Directors’ resolution on the Rights Issue and issue of warrants series TO 3 as stated above. The Board of Directors has also resolved to propose amendments to the Company’s Articles of Association regarding changing the limits on the number of shares and share capital in order to enable the Rights Issue.

Advisors

Aalto Capital AB is the sole global coordinator and bookrunner in connection with the Rights Issue and Hagberg & Aneborn Fondkommission AB the issuing agent. Mazanti-Andersen Advokatpartnerselskab is legal advisor to the Company.

About the Drug Response Predictor – DRP Companion Diagnostic
Allarity uses its drug specific DRP to select those patients who, by the genetic signature of their cancer, are found to have a high likelihood of responding to the specific drug. By screening patients before treatment, the response rate can be significantly increased. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including genomic information from cell lines combined with clinical tumor biology and prior clinical trial outcomes. DRP is based on messenger RNA from the patient’s biopsies. DRP has proven its ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients in nearly 40 clinical studies that were examined, including an ongoing, prospective Phase 2 trial. The DRP platform can be used in all cancer types and is patented for more than 70 anti-cancer drugs.

On March 23, 2021 Labcorp (NYSE: LH), a leading life sciences company, reported the following statement (Press release, LabCorp, MAR 23, 2021, View Source [SID1234577059]):

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Labcorp continues to make progress executing our strategy and capitalizing on the power of our diagnostic and drug development businesses. We are successfully accelerating growth across our platform, while playing a critical role in the fight against COVID-19 and helping our clients develop next-generation solutions for other key therapeutic areas such as oncology, liver and kidney disease, Alzheimer’s and autoimmune disorders.

While we continue to see strong momentum across our operations, the Labcorp Board of Directors and management team believe that our value is not being appropriately reflected in the Company’s current stock price. Therefore, the Board of Directors is undertaking a review of the Company’s structure and capital allocation strategy to ensure we are best positioned to unlock shareholder value while we continue to support patients and customers around the world.

The Board will take the appropriate time to complete the review, and has engaged Goldman Sachs & Co. LLC as its financial advisor to support the process. Labcorp does not intend to comment further about this review until the Board has reached a conclusion.

Customers should continue to count on Labcorp to remain relentlessly focused on improving the health and lives of patients, including with the Company’s vital role in the fight against COVID-19.

On March 23, 2021 Alphamab Oncology (stock code: 9966.HK), reported financial results for the full year ended December 31, 2020 and highlighted recent progress and upcoming milestones (Press release, Alphamab, MAR 23, 2021, View Source [SID1234577056]).

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Dr. Ting Xu, Chairman and CEO of Alphamab Oncology, commented, "2020 is amilestone year for Alphamab Oncology. The company has been making significant progress with respect to our drug pipeline and business operations. The BLA for Envafolimab (KN035), potentially the world’s first subcutaneous PD-L1 inhibitor, has been accepted in last Dec. and was granted priority review; 4 pivotal clinical studies were initiated, 3 products under development were granted orphan drug designation by the U.S. FDA, and 9 INDs were approved; the bispecific antibody KN046 and KN026 have shown promising data in clinical studies conducted around the world; the company has reached strategic collaborations with 10 domestic and foreign partners including Pfizer, Sanofi, and Institut Pasteur of Shanghai, Chinese Academy of Sciences; the phase I production lines of our new manufacturing facilities, designed to house over 30,000L capacity in total, obtained drug production license.

In 2021, the company expects to launch its first product, which means the successful transition to commercial stage. At present, the company’s fully owned and highly differentiated pipeline products have expanded from 9 to 16. The company has expanded its management team with several senior executives, including Dr. Johannes Nippgen, former head of R&D Biopharma in China for EMD. This year, our first product, KN035, is going to be on the market and interim results expected from first phase III for KN046, multiple trial results will be presented at the upcoming international conferences , and a number of new pivotal/registration clinical studies will be launched…The company is fully prepared to meet new opportunities and challenges, we will continue to create value for our patients, our shareholders and society, and strive to fulfill the company’s mission and build a healthy and bright future."

Recent Business Highlights

Product Pipeline

Our highly differentiated pipeline, developed in house, consists of sixteen drug candidates. We have one biologic license application submitted, three in late clinical stage, and two to three in schedule for IND submission in 2021.

KN035 (Envafolimab)

Potentially the first subcutaneous PD-L1 inhibitor worldwide, offering advantages in safety, convenience, compliance, access to patients not suitable for intravenous infusion, andmore efficient utilization of healthcare resources. The first BLA for KN035, accepted by NMPA in December 2020, and is expected to be approved this year.

Events during the Reporting Period

The company presented clinical trial results of KN035 in patients with advanced tumors with mismatch-repair deficiency and a combination therapy with KN035 plus chemotherapy for advanced GC/GEJ at the 2020 ASCO (Free ASCO Whitepaper) Annual Meeting.
On July 16, 2020, we supported TRACON, our U.S. partner, to submit an IND application for a pivotal trial for KN035 in the soft tissue sarcoma subtypes (ENVASARC) of undifferentiated pleomorphic sarcoma and myxofibrosarcoma. On August 14, 2020, TRACON received an approval notification from FDA that the study may proceed in the United States.
In December 2020, the first patient was successfully dosed in the ENVASARC registration trial conducted in the United States.
On December 17, 2020, the BLA for KN035 was accepted by the NMPA. The BLA of KN035 is accepted for the treatment of MSI-H advanced colorectal cancer, GC/dMMR advanced solid tumors.
Events after the Reporting Period

In January 2021, KN035 was granted priority review by CDE of the NMPA.
KN046

a BsAb immune checkpoint inhibitor simultaneously targeting two clinically validated immune checkpoints, PD-L1 and CTLA-4, representing a potential breakthrough, next-generation immuno-oncology blockbuster drug. Currently, there are about 20 clinical trials of KN046 in different stages covering more than 10 types of tumors including NSCLC, TNBC, ESCC, HCC and pancreatic cancer in Australia, China, and the United States. The results from the clinical trials have shown favorable safety profile and efficacy signals of KN046.

Events during the Reporting Period

On April 15, 2020, Jiangsu Alphamab received an approval notification from FDA that it is safe to proceed with a phase II clinical trial of KN046 for NSCLC in the United States.
On May 12, 2020, Jiangsu Alphamab received IND approvals from CDE, including the evaluation of the efficacy, safety and tolerability of KN046 in combination with KN026 for HER2-positive or HER2 expression solid tumors in phase Ib clinical study; multi-center, open-label, phase Ib/II clinical trials for Ningetinib Tosylate in combination with KN046 for the treatment of advanced HCC.
We presented the preliminary efficacy and safety data of a dose escalation and expansion phase Ia/Ib clinical trial of KN046 in China in patients who have failed prior immune checkpoint inhibitors at the 2020 America Society of Clinical Oncology ("ASCO") Annual Meeting. The results indicate that KN046 showed a favorable safety profile and promising clinical benefit in advanced solid tumor patients who failed on prior ICI therapies.
On September 2, 2020, FDA granted ODD to KN046 for the treatment of thymic epithelial tumor.
On September 3, 2020, Jiangsu Alphamab officially launched a KN046 pivotal phase II clinical trial of KN046 for thymic carcinoma in China and the U.S.
In September 2020, Jiangsu Alphamab has achieved the first patient dosing in ENREACH-LUNG-01. ENREACH-LUNG-01 is a multi-center, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of KN046 in combination with the platinum-based chemotherapy in patients with advanced unresectable or metastatic squamous NSCLC.
Events after the Reporting Period

In January 2021, the first patient was successfully dosed in the ENREACH-Thymic registration trial, a pivotal phase II, open label, multi-center pivotal clinical study to evaluate efficacy, safety and tolerability of KN046 in subjects with thymic carcinoma.
In January 2021, we presented abstracts on the preliminary efficacy and safety of KN046 in combination with chemo-radiation therapy for the treatment of recurrent and metastatic ESCC at 2021 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium annual meeting.
In February 2021, the first patient dosing of KN046 in combination with Donafenib, an orally administered multikinase inhibitor, was accomplished in phase I/II clinical trials for the treatment of advanced or metastatic HCC.
We presented clinical data from a phase II clinical study of KN046 in patients with advanced NSCLC at WCLC 2020. With a median follow up of 13 months, the median PFS was 3.68 months (95% CI: 3.35, 7.29), among them, squamous NSCLC and non-squamous NSCLC were 7.29 months (3.68, 9.23) and 3.58 months (2.46, 5.52), respectively, which are numerically higher than historical data for PD-1 therapeutics in Chinese patients. It indicates that KN046 was well tolerated and effective as a second-line treatment for advanced NSCLC, which indicated promising PFS and OS benefits in NSCLC.
We presented preliminary safety and efficacy results of KN046 from a phase I clinical study of KN046 in treatment of patients with rare thoracic tumors at WCLC 2020. The confirmed ORR was 50%, unconfirmed ORR was 75%, and the DCR was 100% in thymic epithelial tumors.
KN026

a next-generation anti-HER2 BsAb that can simultaneously bind two distinct clinically validated epitopes of HER2, resulting in potentially superior efficacy.

Events during the Reporting Period

On May 12, 2020, Jiangsu Alphamab received IND approvals from CDE for new therapies of KN026, including the evaluation of the efficacy, safety and tolerability of KN046 in combination with KN026 for HER2-positive or HER2 expression solid tumors in phase Ib clinical study; and phase II clinical study to assess the effectiveness and safety of KN026 in monotherapy or combination therapy for HER2 low expression or HER2-positive recurrent/mBC.
We presented the preliminary safety, efficacy and PK results of an open-label, phase I clinical trial of KN026 in China in patients with HER2-positive mBC at the 2020 ASCO (Free ASCO Whitepaper) Annual Meeting. The results indicate that KN026 is well tolerated and has demonstrated encouraging anti-tumor activity in HER2-positive breast cancer patients who have failed standard anti-HER2 therapies.
We presented preliminary clinical data at the SITC (Free SITC Whitepaper) 2020. The combination therapy of KN026 and KN046 ("KN026+KN046 Combo") has achieved positive results in a clinical phase Ib trial for the treatment of HER2 aberrated solid tumors in patients who have failed standard therapy.
In December 2020, Jiangsu Alphamab had successfully dosed the first patient in SEARCH-01 study, a phase Ⅱ clinical trial of KN026 in combination with KN046. The SEARCH-01 trial is an open label, phaseⅡ and multi-center clinical study to evaluate the efficacy, safety and tolerability of KN026 in combination with KN046 for HER2-positive solid tumors.
In December 2020, FDA granted ODD to KN026 in combination with KN046 for the treatment of HER2-positive or low expressing GC or GEJ. This is the third ODD granted to the Company by FDA.
In December 2020, our Company received from the NMPA the IND approval for combination therapies of KN026 and palbociclib or combination therapy of KN026, palbociclib and fulvestrant for the treatment of HER2-positive locally advanced unresectable and/or metastatic breast cancer in patients who have failed the treatment of Trastuzumab and Taxanes.
Other Highlights

Events during the Reporting Period

On May 22, 2020, Jiangsu Alphamab and InxMed entered into a partnership agreement to jointly develop the combination therapy of KN046 and IN10018, a focal adhesion kinase inhibitor, to explore the synergistic effect of the combination of KN046 and IN10018.
On May 28, 2020, Jiangsu Alphamab and SLP entered into a new collaboration agreement to expand the original collaboration, pursuant to which both parties agreed to jointly develop an anti-tumor combination therapy with CT053 (Ningetinib Toluenesulfonate), a multi-target small molecule inhibitor, and KN046, for human solid tumors.
On June 9, 2020, Jiangsu Alphamab and Sanofi entered into an exclusive option agreement for the strategic collaboration to advance clinical studies investigating KN026 in combination with Sanofi’s product Taxotere in patients with HER2+ breast cancer.
On June 10, 2020, the Company and Institut Pasteur of Shanghai, Chinese Academy of Sciences ("Institut Pasteur of Shanghai") entered a cooperative development agreement on the co-development, manufacturing and commercialization of therapeutic antibody for COVID-19.
On June 19, 2020, Jiangsu Alphamab and Sinovent entered into a partnership agreement to jointly develop the combination therapy of KN046 and XNW7201, a small-molecule inhibitor, in oncology indications.
On July 30, 2020, Jiangsu Alphamab entered a partnership agreement with Kintor Pharmaceutical, to jointly develop the combination therapy of KN046 and GT90001 in HCC.
In July 2020, the Company was recognized as one of the first high-tech enterprises in Suzhou Free Trade Zone, and Foreign-funded R&D Center of Jiangsu province.
Dr. XU won the sixth "Suzhou Outstanding Talent Award" awarded by the Suzhou Municipal Government.
Alphamab Oncology (9966.HK) is included in The Hang Seng Composite Index.
At the end of November 2020, we were acknowledged as "Chinese Pharmaceutical Innovation Enterprises 100" in the 2020 China Healthcare Summit of Entrepreneurs, Scientists and Investors.
Our Company has been included in the Hong Kong Stock Connect list under the Shenzhen-Hong Kong Stock Connect, with effect from December 28, 2020.
Events after the Reporting Period

On January 6, 2021, our Company was awarded as the "Most Valuable Medical and Pharmaceutical Company" in the 5th Annual Awards Ceremony of Hong Kong Golden Stock held in Shenzhen.
Further expansion of Alphamab Oncology management team, including appointing Dr. Johannes Nippgen as Chief Medical Officer.
Facilities

On July 2020, the 2×2,000L production lines of the new manufacturing facilities of Jiangsu Alphamab, which is designed to house over 30,000L capacity in total, obtained drug production license issued by Jiangsu Drug Administration. These production lines are equipped with world-class equipment that meet the regulatory requirements of NMPA, FDA and European Medicines Agency for GMP.

Full Year 2020 Financial Summary

For the year ended December 31, 2020, the Group recorded other income of RMB111.1 million, as compared with RMB34.4 million for the year ended December 31, 2019, mainly include interest income, government grants and other miscellaneous income.
We recorded other losses of RMB117.6 million for the year ended December 31, 2020, as compared to RMB0.3 million for the year ended December 31, 2019. Our loss and total comprehensive expense amounted to RMB427.8 million for the year ended December 31, 2020, as compared with RMB832.7 million for the year ended December 31, 2019.
The R&D expenses of the Group amounted to RMB331.2 million for the year ended December 31, 2020, as compared with RMB166.7 million for the year ended December 31, 2019.
The administrative expenses amounted to RMB78.2 million for the year ended December 31, 2020 as compared with RMB117.7 million for the year ended December 31, 2019.