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HTG Molecular Diagnostics Reports Full Year 2020 Results

On March 25, 2021 HTG Molecular Diagnostics, Inc. (Nasdaq: HTGM) (HTG), a life science company whose mission is to advance precision medicine, reported its financial results for the year ended December 31, 2020 (Press release, HTG Molecular Diagnostics, MAR 25, 2021, View Source [SID1234577207]).

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Recent Business Highlights

In February 2021, released a second technical white paper characterizing HTG’s planned transcriptome panel using the HTG EdgeSeq technology (the "Panel") that is in late-stage development. The white paper addresses the feasibility and performance of a prototype of the Panel for multiple cancer indications, as compared to RNA sequencing ("RNA-Seq") including:

Ability to differentiate samples based on gene expression profiles;
Repeatability amongst replicates from multiple cancer indications with archived samples;
Accuracy of differential expression analysis using a direct comparison to RNA-Seq; and
Potential as a robust alternative to RNA-Seq for gene expression profiling while maintaining the advantages of the HTG EdgeSeq technology.
Launched an Early Access Program for the Panel in December 2020. Since this program was announced, 15 organizations have agreed to participate in this program. The Early Access Program is intended to allow select customers access to the panel in their laboratories or through services to be performed in HTG’s development laboratory prior to commercial launch of the Panel.

"Though it remains clear that COVID-19 placed significant pressure on our core oncology business, including planned studies and laboratory operations of our customers throughout 2020, we remained agile and continued to make strategic shifts in our business into areas less impacted by the pandemic throughout the year, and expect to continue to do so as we begin the next fiscal year," said John Lubniewski, President and CEO of HTG. "We believe strategic adjustments made throughout 2020 to lessen the impact of COVID-19 on our business have been working. Our efforts to focus on customer diversification to include a larger number of smaller and mid-sized biopharma customers and academic medical centers, who have appeared to return to work more quickly than our larger customers, resulted in programs with a number of new customers, including 9 new biopharma customers in 2020. In addition, we worked diligently to adjust spending and commercial efforts to mitigate the impacts of COVID-19 on our organization throughout 2020, and believe our full year operating loss, ending cash and short-term available-for-sale investments balances reflect those efforts. The ultimate impact of COVID-19 remains uncertain, but we continue to see positive trends in non-oncology opportunities and believe direct revenue from our core oncology business will continue to move toward pre-COVID levels as vaccines are rolled out and global economies continue returning to work in 2021."

Mr. Lubniewski continued, "Our product development team was able to perform on our key milestones throughout 2020 despite the challenges placed on our organization by COVID-19. We were very excited to share the details of our recent progress with the Panel in the white paper published in February and look forward to continued progress in the coming months as our development and marketing teams work toward design lock in the second quarter of 2021 and formal design verification and commercialization, currently scheduled for the third quarter of 2021. We look forward to the additional opportunities that this technology will present for HTG in the later part of 2021 and beyond."

Full Year 2020 Financial Highlights:

Total revenue for the year ended December 31, 2020 was $8.5 million, compared with $19.2 million for the year ended December 31, 2019. HTG believes the decrease in revenue is a result of the impact of the COVID-19 pandemic requiring the closure of customer facilities, causing a significant reduction in oncology-related clinical trial activity or limiting the ability of our customers to operate at pre-pandemic levels.

Product and product-related services revenue was $7.9 million for the year ended December 31, 2020, compared with $14.6 million for the year ended December 31, 2019. Throughout the pandemic, HTG’s ability to ship instruments and consumables to customer facilities and the ability of its customers to prepare and ship samples to HTG’s VERI/O laboratory for processing has been limited. In addition to the impacts of the COVID-19 pandemic, this decrease reflects a decline in lower margin subcontracted laboratory services revenue when compared with the year ended December 31, 2019.

Collaborative development services revenue for the year ended December 31, 2020 was $0.7 million compared with $4.6 million for the year ended December 31, 2019, reflecting the completion of remaining tasks under existing arrangements. The Company has ongoing sales efforts to identify and contract new programs in this area.

Net loss from operations for the year ended December 31, 2020 was $19.6 million, compared with $19.0 million for the year ended December 31, 2019. Net loss per share was $(4.51) for the year ended December 31, 2020 compared with $(7.60) for the year ended December 31, 2019.

Cash, cash equivalents and short-term available-for-sale securities totaled $28.7 million as of December 31, 2020, with current liabilities of approximately $7.2 million and non-current liabilities of $13.5 million.

Conference Call and Webcast:

HTG will host a conference call for the investment community today beginning at 4:30 p.m. Eastern Time. Conference call and webcast details are as follows:

Athersys Announces Financial Results for Fourth Quarter and Full Year 2020

On March 25, 2021 Athersys, Inc. (NASDAQ: ATHX) reported its fourth quarter 2020 and annual 2020 financial results and recent highlights (Press release, Athersys, MAR 25, 2021, View Source [SID1234577196]).

"Despite a difficult operating environment, Athersys has made meaningful progress over the past year," commented Mr. William (B.J.) Lehmann, Interim Chief Executive Officer of Athersys. "We made considerable progress in developing our large-scale manufacturing processes. On the clinical front, we took advantage of the opportunity, with the onset of the COVID-19 pandemic, to accelerate the development of our MultiStem therapy for ARDS with the launch of the MACOVIA study. The MASTERS-2 study moved forward but at a slower pace than expected. Importantly, we entered into a cooperation agreement with our partner, Healios, to put us on a better path to jointly prepare for potential commercialization of the MultiStem therapy in Japan.

"In 2021, we expect to see the top-line results from both the TREASURE and ONE-BRIDGE studies, the TREASURE study giving us the first look at late-stage clinical trial data for MultiStem treatment of ischemic stroke. We are also working to achieve proof-of-principle for our large-scale manufacturing processes, an important milestone on the way to establishing the capability to serve large potential markets such as ischemic stroke," added Mr. Lehmann.

Fourth Quarter, 2020 and Recent Highlights:

Assisted HEALIOS K.K. (Healios), our partner in Japan, in its regulatory preparations as it advanced enrollment to near completion in its TREASURE ischemic stroke and ONE-BRIDGE acute respiratory distress syndrome (ARDS) studies;
Reached a cooperation agreement with Healios to resolve the legal matter between its CEO and Athersys Board member, Dr. Kagimoto, and the Company, and to set the stage for addressing open matters important to continued development, regulatory progress and successful commercialization in Japan following approval;
Received INN designation for "invimestrocel" as the non-proprietary name for the MultiStem cell therapy and made progress in registering our proprietary brand name for the product candidate;
Received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for MultiStem therapy for the treatment of ARDS;
Initiated and conducting the MACOVIA study for the treatment of ARDS in COVID-19 patients, and amended the protocol with the FDA to include other pathogen-induced ARDS patients;
Launched the MATRICS-1 study evaluating MultiStem treatment in severe trauma patients, with the first patient enrolled in the fourth quarter;
Made important leadership hires in key areas, including Mr. Ivor Macleod as Chief Financial Officer and Ms. Maia Hansen as Senior Vice President, Operations and Supply Chain;
Appointed four new directors to our board, adding experience and diversity, to help the Company achieve its growth objectives and success;
Raised gross proceeds of approximately $57.6 million, before deducting the underwriting discount and offering expenses, through an underwritten public offering of 25.6 million shares of common stock, providing additional working capital for key initiatives;
Recognized revenues of $1.3 million and net loss of $22.2 million, or $0.11 net loss per share, for the quarter ended December 31, 2020; and
Had $51.5 million in cash and cash equivalents as of December 31, 2020, $61.5 million in cash and cash equivalents as of March 19, 2021.
"We believe deeply in the quality and distinctiveness of our science and technology and the potential to help patients in important critical care areas. Though there are risks ahead of us, we believe we are well-situated to advance our programs and Company over the course of this year," concluded Mr. Lehmann.

Fourth Quarter 2020 Financial Results

Revenues increased to $1.3 million for the three months ended December 31, 2020 compared to $0.3 million for the three months ended December 31, 2019. Our collaboration revenues are primarily derived from our Healios arrangement. We expect our collaboration revenues to vary over time as we contract with Healios to perform manufacturing services and as we potentially enter into new collaborations.

Research and development expenses increased to $18.7 million for the three months ended December 31, 2020 from $7.6 million for the comparable period in 2019. The $11.1 million increase is primarily associated with clinical trial and manufacturing process development costs, timing of reagent purchases used for our internal process development activities, and personnel costs, including stock compensation expense.

General and administrative expenses increased to $4.3 million for the three months ended December 31, 2020 from $2.4 million in the comparable period in 2019. The $1.9 million increase in the fourth quarter of 2020 over the same period of 2019 was due primarily to increased personnel costs, including stock compensation costs, as well as legal and professional services.

Net loss for the fourth quarter was $22.2 million in 2020 compared to a net loss of $9.9 million in the fourth quarter of 2019. The difference of $12.3 million reflects the above variances, as well as a decrease of $0.3 million in other income items.

Full Year 2020 Financial Results

Revenues decreased to $1.4 million for the year ended December 31, 2020 from $5.6 million in 2019. Our contract revenues from our collaboration with Healios decreased $4.1 million year over year. Our collaboration revenues fluctuate from period-to-period based on new licenses conferred and the delivery of goods and services under our arrangement with Healios.

Research and development expenses increased to $63.0 million for the year ended December 31, 2020 from $39.0 million for the year ended December 31, 2019. The $24.0 million increase in research and development expenses year-over-year was due primarily to increased clinical trial and manufacturing process development costs of $15.0 million, internal research supply costs of $4.2 million, personnel costs of $3.0 million, including stock-based compensation, outside service costs of $0.9 million, and other costs of $0.9 million.

General and administrative expenses increased to $15.9 million in 2020 from $11.4 million in 2019. The $4.5 million increase was due primarily to increases in personnel costs including stock-based compensation, legal and professional services, and other outside services.

Net loss was $78.8 million in 2020 compared to a net loss of $44.6 million in 2019. The difference of $34.2 million reflects the above variances, as well as an increase in other net expenses.

In the twelve months ended December 31, 2020, net cash used in operating activities was $61.8 million compared to $35.3 million in the twelve months ended December 31, 2019. The difference is primarily associated with overall increases in cash usage to fund our clinical development activity in 2020.

At December 31, 2020, we had $51.5 million in cash and cash equivalents, compared to $35.0 million at December 31, 2019.

We encourage shareholders to listen using the webcast link above. If you would like to dial in using the phone to ask a question, please register for the conference call ahead of time using the call registration link above. Once registered, you will receive an email containing the toll-free number, a direct entry passcode and a registrant ID.

A replay of the event will be available on the webcast link at www.athersys.com under the investors’ section approximately two hours after the call has ended. Shareholders may also call in for on-demand listening approximately three hours after the completion of the call until 11:59 PM Eastern Time on April 5, 2021, by dialing (800) 585-8367 or (416) 621-4642 and entering the conference code 8674678.

Thu, 25 Mar, 2021, 22:15 – English – Diamyd Medical carries out a directed share issue and raises proceeds of SEK 60 million

On March 25, 2021 Diamyd Medical reported that The Directed Share Issue of 2 400 000 B-shares was carried out with deviation from the existing shareholders’ preferential right after a resolution by the Board of directors based on the authorisation granted by the Anual General meeting held on November 26, 2020 (Press release, Diamyd Medical, MAR 25, 2021, View Source;ClipID=3929019 [SID1234577194]).

The proceeds from the Directed Share Issue will be used to support the Company regarding the pivotal Phase 3 trial with the diabetes vaccine Diamyd. The study is designed to confirm the efficacy and safety of Diamyd in individuals recently diagnosed with type 1 diabetes that carry the genetic HLA haplotype DR3-DQ2. Approximately 330 patients will be recruited for the study and the trial will be carried out at approximately 50 clinics in Europe and in the United States.

"We are delighted to see new investors in Diamyd Medical and the interest in supporting our phase 3 precision medicine trial in type 1 diabetes", says Ulf Hannelius, CEO of Diamyd Medical.

The subscription price was determined via a so-called accelerated book-building procedure led by G&W Fondkommission ("Financial adviser"). The subscription price corresponds to a discount of approximately 19,6 percent in relation to the closing price on Nasdaq First North Growth Market on March 25, 2021. Through the Directed Share Issue, the Company will receive gross proceeds of SEK 60 million.

The Directed Share Issue was primarily subscribed by a number of well-renowned investors, which included, among others Modelio Equity, Tellus Fonder, Fårö Capital and Thorén Tillväxt.

The Board of directors’ assessment, based on the accelerated book building procedure executed by the Financial adviser, is that the Directed Share Issue was carried out on customary terms in accordance with market conditions. The reason for the deviation from the shareholders’ preferential rights was to raise capital on market conditions for the Company’s continued expansion in a time and cost-effective manner, as well as to diversify the shareholder base with Swedish and international institutional investors.

Through the Directed Share Issue, the total the number of -shares in the Company will increase by 2 400 000 to 71 569 796 and the share capital will increase by SEK 243 414 to SEK 7 258 812. The Directed Share Issue entails a dilution of 3.4% of the total number of shares and 2.5% of the total number of votes for existing shareholders, based on the total number of shares in the Company after the Directed Share Issue.

In connection with the Directed Share Issue, the Company’s largest shareholder, Anders Essen-Möller, has agreed to lend 2 400 000 B-shares to Aktieinvest FK AB in order to facilitate delivery of the shares. The shares will be returned in connection with the Directed Share Issue being registered with the Swedish Companies Registration Office.

Adviser
G&W Fondkommission has been appointed Financial adviser in connection with the Directed Share Issue. Aktieinvest FK AB is the issuing agent.

PORTAGE BIOTECH HIGHLIGHTS INITIATION OF THE INVINCIBLE TRIAL, A PHASE 2 EARLY STAGE BREAST CANCER STUDY FROM INTENSITY THERAPEUTICS

On March 25, 2021 Portage Biotech Inc. (NASDAQ: PRTG, CSE: PBT.U) ("Portage" or the "Company") a clinical stage immuno-oncology company accelerating research and development to overcome immune resistance, reported that Intensity Therapeutics has executed agreements to conduct a Phase 2 study of INT230-6 (PORT-1) in early stage breast cancer in tandem with the Ottawa Hospital Cancer Centre and The Ontario Institute for Cancer Research (Press release, Portage Biotech, MAR 25, 2021, View Source [SID1234577193]).

PORT-1 is the first asset from the Intensity platform of intratumoral amphiphilic formulations. PORT-1 delivers potent cancer-killing agents directly into the tumor, immediately reducing cancer burden, breaking down the cytokine wall, and recruiting immune cells to attack residual disease.

The objectives of the INVINCIBLE Trial are to assess proliferative burden and pathological complete response (pCR). This study represents a new cancer treatment paradigm with the potential to kill the cancer and activate an immune response in as little as 4 weeks following administration. Comparatively, typical neoadjuvant chemotherapy treatment often requires administration over 4-6 months prior to surgery. If proven successful, this model could be expanded to other surgical settings without delaying the surgery.

"This approach is indicative of our strategy to provide improved options for different cancer settings by leveraging innovative ways to boost the immune system to fight cancer," said Dr. Ian Walters, chief executive officer of Portage Biotech who conceptualized this study. "This is one of multiple programs that will be yielding clinical data over the next 12-18 months. We expect eight additional phase 2 data reads for PORT-1, being conducted in collaboration with Bristol Myers Squibb and Merck, which will evaluate the asset as both a monotherapy and combination therapy with checkpoint inhibitors in various advanced metastatic settings. Beyond the PORT-1, we also expect data reads from trials of our first-in-class PORT-2 & PORT-3 iNKT agonists in the same timeframe."

To view the full announcement from Intensity Therapeutics, visit their website at: www.intensitytherapeutics.com.

Zentalis Pharmaceuticals Reports Fourth Quarter and Full Year 2020 Financial Results and Operational Update

On March 25, 2021 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers, reported financial results for the fourth quarter and full year ended December 31, 2020 and highlighted recent corporate accomplishments (Press release, Zentalis Pharmaceuticals, MAR 25, 2021, View Source [SID1234577192]).

"2020 was a pivotal year for Zentalis, marked by the advancement of our broad pipeline, multiple clinical and strategic collaborations, as well as successful public offerings," commented Dr. Anthony Sun, Chairman and Chief Executive Officer of Zentalis. "With the initiation of numerous studies at the end of 2020, our internally discovered candidates are now being investigated in a combined total of seven ongoing clinical trials, further exploring their potential to address a range of cancers. We believe our collaborations with global innovators in the biopharmaceutical and technology industries provide us with the resources needed to evaluate the full potential of our differentiated product candidates in the clinic as both monotherapies and in combinations."

Continued Dr. Sun, "Looking to the year ahead, we are strongly positioned to reach our upcoming milestones, starting with our late-breaker presentation discussing data from the Phase 1 portion of the Phase 1/2 monotherapy trial of ZN-c3 at AACR (Free AACR Whitepaper) in April. This readout, along with results from our other ongoing trials investigating ZN-c5, ZN-d5 and ZN-e4, is expected to deliver important insights into our clinical and regulatory strategies as we advance our objective of bringing improved therapies to cancer patients in need."

Program Highlights:

Zentalis initiated patient dosing in three combination and monotherapy clinical trials, which included a Phase 1b combination trial with ZN-c5 and abemaciclib (marketed as Verzenio by Eli Lilly) in ER+/HER2- advanced breast cancer, a Phase 1 combination dose escalation trial with ZN-c3 and chemotherapy in advanced ovarian cancer and a Phase 1 trial with ZN-d5 in acute myeloid leukemia and Non-Hodgkin’s lymphoma. Each trial will assess the safety, tolerability and pharmacokinetics of the respective candidate.

In February 2021, Zentalis entered into a strategic collaboration with Tempus to leverage its patient-derived organoid biological modeling platform to aid Zentalis in discovering and developing novel oncology therapies. The collaboration will initially aim to validate Zentalis’ WEE1 inhibitor, ZN-c3, and its DNA damage response pathway in genetically distinct patient populations.

Three abstracts, including a late-breaker oral presentation on ZN-c3, were accepted for presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021. Zentalis expects to report clinical data from the Phase 1 portion of its Phase 1/2 monotherapy trial of ZN-c3 in advanced solid tumors.

Zentera Therapeutics, Zentalis’ majority-owned joint venture, submitted two IND applications in China for ZN-c5 and ZN-c3 in December 2020 and February 2021, respectively. A third IND application for ZN-d5 is expected to be submitted in 2021.
Corporate Highlights:

In February 2021, the Company appointed Enoch Kariuki, Pharm.D., to the Board of Directors. Dr. Kariuki most recently served as Chief Financial Officer at VelosBio and has over a decade of experience in life sciences investment banking, strategic advising and business development.
Fourth Quarter and Full Year 2020 Financial Results

Cash and Marketable Securities Position: As of December 31, 2020, Zentalis had cash, cash equivalents and marketable securities of $338.5 million. Zentalis expects that its existing cash, cash equivalents and marketable securities, which includes the net proceeds of approximately $155.2 million from the August 2020 follow-on offering, will enable the Company to fund its operating expenses and capital expenditure requirements into 2023.

Research and Development Expenses: Research and development expenses were $29.5 million in the fourth quarter of 2020, compared to $11.9 million for the same period in 2019. This increase of $17.6 million was primarily due to increases in external research and development expenses related to our lead product candidates, as we advanced our Phase 1/2 clinical trials investigating ZN-c5, ZN-c3 and ZN-d5 in 2020. In addition, in 2020 we conducted additional preclinical studies, incurred additional manufacturing costs, and incurred increased costs for study and lab materials. Unallocated research and development expenses increased by $10.2 million primarily due to $5.3 million of additional employee related costs, of which $2.6 million was driven by non-cash stock-based compensation from incentive grants and increased headcount to support our platform development, $1.6 million of facilities and other allocated overhead expenses, $3.0 million of consulting, supplies and outside services, and decreased federal grant reimbursements of $0.3 million.
Research and development expenses for the full year were $84.9 million, compared with $38.4 million in 2019.

General and Administrative Expenses: General and administrative expenses for the fourth quarter were $10.7 million, compared to $3.0 million for the same period in 2019. This increase of $7.7 million was primarily attributable to an increase of $7.3 million in employee-related costs, of which $5.1 million was driven by non-cash stock-based compensation from incentive grants issued during the year and increased headcount to support our growth. The remaining increase in spend was primarily driven by professional service fees for legal services of $0.6 million, consulting and other outside services of $0.7 million, and insurance costs of $0.6 million, which were offset by allocated overhead expenses.
General and administrative expenses for the full year were $33.9 million, compared with $8.5 million in 2019.

Net Loss: The Company’s net loss for the fourth quarter of 2020 was $40.4 million, compared to a net loss of $14.5 million for the same period in 2019.
The Company’s net loss for the full year 2020 was $118.5 million, compared to a net loss of $46.4 million for the same period in 2019.

Impact from COVID-19 Pandemic: Though the impact of the COVID-19 pandemic to our business and operating results presents additional uncertainty and cannot be predicted with confidence, we continue to use the best information available to inform our critical accounting estimates.