On May 11, 2020 Marker Therapeutics, Inc. (Nasdaq:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported financial results for the first quarter ended March 31, 2020 (Press release, Marker Therapeutics, MAY 11, 2020, View Source [SID1234557614]).

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"While we are eager to initiate our planned Phase 2 trial with our novel MultiTAA-specific T cell therapy in patients with acute myeloid leukemia (AML), we anticipate that the initiation of our trial will be delayed by the impacts the COVID-19 pandemic has had on our clinical trial partners and throughout our supply chain. As a result of the uncertainty, we believe it is prudent to withdraw our prior guidance on the timing of this trial until the outlook clarifies," said Peter L. Hoang, President & CEO of Marker Therapeutics. "Despite these pandemic-related effects, we remain optimistic that when the study opens, there will be significant patient interest. We are moving expediently in the interim to secure clinical trial sites and are monitoring the situation closely to prioritize the health and wellness of our employees and the patients we serve."

Continued Mr. Hoang: "We continue to be encouraged by the potential of our MultiTAA-specific T cell therapy to change the treatment paradigm for patients with both liquid and solid tumors. Recently, we received Orphan Drug designation from the U.S. FDA for MT-401, our MultiTAA-specific T cell product candidate to treat patients with AML post-stem cell transplant, our lead indication. Additionally, we are looking forward to soon reporting an update from an ongoing academic-sponsored trial in pancreatic adenocarcinoma, which will be presented during the upcoming ASCO (Free ASCO Whitepaper) annual meeting."

PROGRAM UPDATES

Multi-Antigen Targeted (MultiTAA) T Cell Therapies

Phase 2 AML Trial Update
Due to the COVID-19 pandemic, Marker expects to be delayed in initiating its planned Phase 2 trial in post-transplant AML patients per previously communicated timelines. Under an amended trial protocol announced in February 2020, the U.S. FDA cleared the Company to initiate the trial, beginning with a safety lead-in. Marker has paused opening the study for enrollment of the first three patients, as the manufacturing facility it utilizes to supply study drug remains closed during the pandemic. The Company continues to identify potential trial sites in the interim, in addition to establishing its own manufacturing facility. The latter portion of the safety lead-in, which involves use of a new reagent, remains on hold until the FDA reviews and accepts the final data and certificate of analysis. The alternate supplier providing these has informed the Company that it will be delayed in providing the reagent.

Orphan Drug Designation Granted for MultiTAA T Cell Therapy in AML
In April, the FDA’s Office of Orphan Products Development granted Orphan Drug designation to MT-401, Marker’s MultiTAA-specific T cell product candidate for the treatment of patients with post-transplant AML. Orphan designation is granted to advance the evaluation and development of safe and effective therapies for the treatment of rare diseases or conditions affecting fewer than 200,000 people in the U.S.

Pancreatic Cancer Data Update During ASCO (Free ASCO Whitepaper)
Updated data from an ongoing Phase 1/2 clinical trial being conducted with Marker’s MultiTAA-specific T cell product at the Baylor College of Medicine (BCM) in patients with pancreatic adenocarcinoma will be presented during the Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)—which due to the COVID-19 pandemic, will be held virtually. As previously reported, in the front-line treatment arm in combination with standard-of-care chemotherapy, clinical benefit was observed in correlation with the post-infusion detection of tumor-reactive T cells in patients’ peripheral blood. These T cells exhibited activity against both targeted antigens and non-targeted TAAs, indicating induction of antigen spreading. To date, there has not been any cytokine release syndrome or neurotoxicity observed in this trial.

T Cell-Based Vaccines

Phase 2 Triple Negative Breast Cancer Trial Results
Marker’s T cell-based vaccine program in triple negative breast cancer has delivered the following results as of September 30, 2019:

Based on a preliminary analysis of 34 patients enrolled in the triple negative breast cancer trial, 31 patients showed meaningful immune response to vaccine treatment;
Of 80 patients treated at 11 clinical sites, 16 have shown disease progression following treatment with TPIV200.
FINANCING UPDATE

On March 2, 2020, Marker announced that the Company entered into a Common Stock Purchase Agreement of up to $30 million with Aspire Capital Fund, LLC, a Chicago-based institutional investor and long-term Marker shareholder.
FIRST QUARTER 2020 FINANCIAL RESULTS

Cash Position and Guidance: At March 31, 2020, Marker had cash and cash equivalents of $40.3 million. The Company believes that its existing cash and cash equivalents will fund its operating expenses and capital expenditure requirements into the second quarter of 2021.

R&D Expenses: Research and development expenses were $3.8 million for the quarter ended March 31, 2020 compared to $2.8 million for the quarter ended March 31, 2019. The increase was primarily attributable to headcount-related personnel expenses.

G&A Expenses: General and administrative expenses were $2.8 million for the quarter ended March 31, 2020 and March 31, 2019.

Net Loss: Marker reported a net loss of $6.5 million for the quarter ended March 31, 2020, compared to a net loss of $5.3 million for the quarter ended March 31, 2019.

Conference Call and Webcast
The Company will host a webcast and conference call to discuss its first quarter 2020 financial results and provide a corporate update today at 5:00 p.m. EDT.

The webcast will be accessible in the Investors section of the Company’s website at markertherapeutics.com. Individuals can participate in the conference call by dialing 877-407-8913 (domestic) or 201-689-8201 (international) and referring to the "Marker Therapeutics First Quarter 2020 Earnings Call."

The archived webcast will be available for replay on the Marker website following the event.

On May 11, 2020 INOVIO (NASDAQ: INO), a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to protect and treat people from infectious diseases, cancer, and diseases associated with HPV, reported financial results for the quarter ended March 31, 2020 (Press release, Inovio, MAY 11, 2020, View Source [SID1234557611]). INOVIO’s management will host a live conference call and webcast at 4:30 p.m. Eastern Time today to discuss financial results and provide a general business update, including the company’s development of INO-4800, one of the leading COVID-19 vaccine candidates currently in U.S. Phase 1 clinical trials.

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INOVIO’s President and Chief Executive Officer Dr. J. Joseph Kim said, "INOVIO had a very productive first quarter, laying the foundation for a transformative year for the company. Our recent and ongoing clinical developments across all of our programs continue to demonstrate the differentiating value and broad applicability of our DNA medicines platform. When the COVID-19 pandemic emerged in early January, INOVIO was able to leverage its DNA medicines platform and early funding from CEPI to be one of the first companies to advance a vaccine candidate for COVID-19 into a Phase 1 clinical trial. INOVIO’s dedicated team of vaccine developers was able to quickly build and expand a global coalition of collaborators, partners, manufacturers, and funders to advance the INO-4800 program.

"Most importantly, while safely conducting global clinical trials during this COVID pandemic has been a significant challenge, INOVIO is on track to deliver key 2020 clinical and regulatory milestones including the planned reporting of REVEAL 1 Phase 3 top-line efficacy data for VGX-3100 in Q4 and the presentation of 12-month overall survival results from the Phase 1/2 clinical trial of INO-5401 immunotherapy in a very hard to treat cancer in glioblastoma multiforme (GBM) at the ASCO (Free ASCO Whitepaper)20 Virtual Conference later this month."

INOVIO First Quarter Highlights

Infectious Diseases

INO-4800: COVID-19

Since achieving initial funding from the Coalition for Epidemic Preparedness Innovations (CEPI) in January, INOVIO advanced INO-4800 from vaccine construct to human dosing in just 83 days and initiated Phase 1 clinical testing at two sites in the U.S. on April 6. Within three weeks the 40 healthy volunteers study was fully enrolled. Interim immune responses and safety results are expected in late June.

Study participants will receive two doses of INO-4800 four weeks apart. The Phase 1 study is designed to assess the safety profile and immunogenicity of INO-4800 in support of advancing to a larger Phase 2/3 efficacy trial, which is being prepared to start this summer upon regulatory approval.

INOVIO also received significant funding from government and private sources to support vaccine development and manufacturing scale-up as well as forge a critical partnership to advance the development of INO-4800 in South Korea and China. Funders include:

The Coalition for Epidemic Preparedness Innovations (CEPI), which awarded INOVIO a total grant to date of $17.2 million to support INO-4800 Phase 1 clinical trial in the US and a second Phase 1/2 clinical trial in South Korea.
The Bill & Melinda Gates Foundation, which awarded INOVIO a $5 million grant on March 12 to accelerate testing and production scale-up of the company’s proprietary, commercial-grade CELLECTRA 3PSP smart device, which provides intradermal delivery of INO-4800. INOVIO plans to accelerate the testing and scale-up of the CELLECTRA 3PSP devices to support large-scale manufacturing of INO-4800 doses by the end of 2020.
The Department of Defense, which awarded Ology Bioservices $11.9 million on March 24 to work with INOVIO on DNA technology transfer to rapidly manufacture DNA vaccines. This work is supported by the Office of the Assistant Secretary of Defense for Health Affairs with funding from the Defense Health Agency.
In addition, INOVIO is collaborating with Beijing Advaccine Biotechnology Co. to advance the development of INO-4800 in China. INOVIO will leverage Advaccine’s expertise to conduct a Phase 1 trial in China in parallel with INOVIO’s clinical development efforts in the U.S. and South Korea. INOVIO and Advaccine plan to seek additional funding and collaboration opportunities to support the advancement of INO-4800 in China.

Preclinical research data has been accepted for a peer-reviewed publication in Nature Communications, demonstrating robust antibody and T cell responses in several animal models with INO-4800 vaccination. INOVIO is also conducting several animal challenge studies with leading organizations like Public Health England and the Commonwealth Science and Industrial Research Organization (CSIRO) in Australia.

INO-4700: Middle East Respiratory Syndrome (MERS)

INOVIO’s DNA vaccine INO-4700 to protect against Middle East Respiratory Syndrome (MERS), which is caused by a coronavirus, showed positive interim 16-week results in a Phase 1/2a trial, with study participants demonstrating strong antibody and T cell immune responses after two or three 0.6 mg doses delivered intradermally with the company’s CELLECTRA device. INOVIO reported that 88 percent of participants demonstrated seroconversion after a two-dose regimen (at weeks 0 and 8), while for participants who received three doses (at weeks 0, 4 and 12), 84 percent seroconverted after two doses and 100 percent after three doses, as measured by a binding antibody assay against the full-length S protein (ELISA). Additionally, 92 percent of vaccine recipients in both groups were able to neutralize the virus based on a neutralization assay (EMC2012-Vero neutralization). Robust T cell responses were observed in 60 percent of vaccine recipients after the two- dose regimen and 84 percent of those in the three-dose group (ELISpot assay). Interestingly, a single 0.6 mg dose of INO-4700 resulted in a 74 percent binding antibody response rate and a 48 percent neutralization antibody response rate.

"The positive Phase 2a data for INO-4700 in MERS is a great foundation for the development of our COVID-19 INO-4800 vaccine, but most importantly we have demonstrated the power of our strategy and delivery system for defending against infectious diseases," Dr. Kim said.

HPV-associated Diseases

VGX-3100: Precancerous Cervical, Vulvar, and Anal Dysplasias (High grade squamous intraepithelial lesion or HSIL)

INOVIO announced positive interim data from two separate open-label Phase 2 studies of its lead DNA medicine candidate VGX-3100 in both anal and vulvar HSIL patients. Interim results were presented in a virtual session at the annual American Society for Colposcopy and Cervical Pathology meeting.

VGX-3100 Safety and Efficacy Highlights for Anal Dysplasia

The first 20 subjects on VGX-3100 demonstrated safety results consistent with the known safety profile of VGX-3100. There were no drug-related serious adverse events.
75% showed an overall decrease in the number of lesions 6 months after treatment and 50% of subjects showed no HPV-16/18 associated precancerous lesions
Results further support proof of concept for DNA medicines as also demonstrated in prior VGX-3100 Phase 2b study in high-risk HPV-associated precancerous cervical dysplasia
VGX-3100 Safety and Efficacy Highlights for Vulvar Dysplasia

Safety results are consistent with the known safety profile of VGX-3100. There were no drug-related serious adverse events.
80% (8 of 10 subjects) showed an overall decrease in the lesion area six months after treatment and 20% (2 of 10 of subjects) completely resolved their vulvar HSIL, which compares to a spontaneous regression of 1.5% to 5%.
Results further support proof of concept for DNA medicines as also demonstrated in prior VGX-3100 Phase 2b study in high-risk HPV-associated precancerous cervical dysplasia.
Less than 5% of women with vulvar HSIL exhibit spontaneous resolution.
The success of surgery for vulvar HSIL is marginal, as the recurrence rate of high grade vulvar pre-cancer is approximately 30 to 50% three years post-treatment.
INO-3107: Recurrent Respiratory Papillomatosis (RRP)

The U.S. Food and Drug Administration (FDA) accepted INOVIO’s Investigational New Drug (IND) application to evaluate INO-3107 in a Phase 1/2 trial for treatment of recurrent respiratory papillomatosis (RRP). The Phase 1/2 trial is expected to enroll approximately 63 subjects in the U.S. and will evaluate the efficacy, safety, tolerability, and immunogenicity of INO-3107 in subjects with HPV 6 and/or 11-associated RRP who have required at least two surgical interventions per year for the past three years for the removal of associated papilloma(s). As RRP is a rare, orphan disease, INOVIO plans to work with the FDA’s Office of Orphan Products Development (OOPD) in an effort to attain Orphan Disease designation for INO-3107.

INOVIO and its collaborators published data from a pilot compassionate use clinical trial in RRP in the scientific journal Vaccines. The article, entitled "Immune Therapy Targeting E6/E7 Oncogenes of Human Papillomavirus Type 6 (HPV-6) Reduces or Eliminates the Need for Surgical Intervention in the Treatment of HPV-6 Associated Recurrent Respiratory Papillomatosis," detailed the clinical efficacy observed in the pilot study of two patients with RRP.

Immuno-Oncology

INO-5401: Newly-diagnosed Glioblastoma Multiforme (GBM)

The Phase 1/2 trial is evaluating INO-5401, a T cell-activating immunotherapy candidate encoding for three tumor-specific antigens (hTERT, WT1, and PSMA), and INO-9012, an immune activator encoding IL-12, in combination with Libtayo, a PD-1 blocking antibody produced by Regeneron Pharmaceuticals in collaboration with Sanofi, with radiation and chemotherapy, in 52 subjects with newly-diagnosed GBM. There are two cohorts in this trial. Cohort A includes 32 participants with a tumor with an unmethylated O[6]-methylguanine-deoxyribonucleic acid (DNA) methyltransferase (MGMT) promoter. Cohort B includes 20 participants with a tumor with a MGMT methylated promoter.

INOVIO will present the 12-month overall survival efficacy data at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (ASCO20) later this month.

INO-5151: Castration-Resistant Prostate Cancer

INOVIO published data from the company’s completed Phase 1b study with INO-5150 that demonstrated a slowing of Prostate-Specific Antigen Doubling Time (PSADT), a measure of clinical impact, in men with biochemically relapsed prostate cancer in the scientific journal, Molecular Therapy in an article entitled "CD8+ T Cell Impact Rising PSA in Biochemically Relapsed Cancer Patients Using Immunotherapy Targeting Tumor-Associated Antigens." Eighty five percent (53 out of 62) of patients remained radiographically progression-free at Week 72 of the study. INO-5151 (a combined formulation of INO-5150 and INO-9012), is currently being tested in one arm (Cohort C) of an exploratory platform study in combination with nivolumab, a PD-1 inhibitor (Bristol-Myers Squibb), and a FLT3 Ligand (Celldex) in castration resistant prostate cancer patients. This study is being conducted and funded by the Parker Institute for Cancer Immunotherapy (PICI) and the Cancer Research Institute (CRI), as part of Inovio’s previously established clinical collaboration agreement.

First Quarter 2020 Financial Results

Total revenue was $1.3 million for the three months ended March 31, 2020, compared to $2.8 million for the same period in 2019. Total operating expenses were $26.6 million compared to $31.4 million for the same period in 2019.

INOVIO’s net loss for the quarter ended March 31, 2020 was $32.5 million, or $0.26 per basic and diluted share, compared to $29.2 million, or $0.30 per basic and diluted share, for the quarter ended March 31, 2019.

Revenue

The year over year decrease in revenue under collaborative research and development arrangements was primarily due to less revenue recognized from our collaboration with AstraZeneca offset by milestone revenue earned from our affiliated entity PLS.

Operating Expenses

Research and development (R&D) expenses for the three months ended March 31, 2020 were $19.1 million compared to $24.4 million for the same period in 2019. The decrease in R&D expenses was primarily related to a decrease in employee compensation expense due to lower employee headcount, a decrease in clinical trial related expenses and an increase in contra-research and development expense recorded from grant agreements.

General and administrative (G&A) expenses were $7.4 million for the three months ended March 31, 2020 versus $7.0 million for the same period in 2019. The increase in G&A expenses was primarily related to an increase in work performed related to corporate marketing and communications, partially offset by the foreign currency exchange rate differences related to our outstanding convertible bonds that are denominated in Korean Won.

Capital Resources

As of March 31, 2020, cash and cash equivalents and short-term investments were $270.0 million compared to $89.5 million as of December 31, 2019. As of March 31, 2020, the Company had 145,915,100 common shares outstanding and 178,731,214 common shares outstanding on a fully diluted basis, after giving effect to the exercise, vesting and conversion, as applicable, of its outstanding options, restricted stock units, convertible preferred stock, and convertible debt.

The end of quarter cash position included net proceeds of $208.2 million the Company received by selling 43,148,952 shares of common stock during the three months ended March 31, 2020 under an at-the-market (ATM) sales agreement.

Subsequent to the quarter, the Company sold an additional 12,041,178 shares of common stock for net proceeds of $121.7 million, under an ATM agreement entered into on April 3, 2020, to sell shares of common stock with aggregate gross proceeds of up to $150 million.

INOVIO’s balance sheet and statement of operations are provided below. Additional information is included in INOVIO’s quarterly report on Form 10-Q for the quarter ended March 31, 2020, which can be accessed at: View Source

Conference Call / Webcast Information

INOVIO’s management will host a live conference call and webcast at 4:30 p.m. Eastern Time today to discuss INOVIO’s financial results and provide a general business update.

The live webcast and a replay may be accessed by visiting INOVIO’s website at View Source Telephone replay will be available approximately one hour after the call at 877-344-7529 (US toll-free) or 412-317-0088 (international toll) using replay access code 10143530.

About INOVIO’s Global Coalition Advancing INO-4800

INOVIO has assembled a global coalition of collaborators, partners and funders to rapidly advance the development of INO-4800. R&D collaborators to date include the Wistar Institute, the University of Pennsylvania, Université Laval, and the University of Texas. INOVIO has partnered with Beijing Advaccine and the International Vaccine Institute to conduct clinical trials of INO-4800 in China and South Korea, respectively. INOVIO is also assessing preclinical efficacy of INO-4800 in several animal challenge models with Public Health England (PHE) and Commonwealth Scientific and Industrial Research Organization (CSIRO) in Australia. INOVIO is also working with a team of contract manufacturers including VGXI, Inc., Richter-Helm, and Ology Biosciences. INOVIO is also seeking additional external funding and partnerships to scale up the manufacturing capacities to satisfy the urgent global demand for a safe and effective vaccine. To date, CEPI, the Bill & Melinda Gates Foundation, and the US Department of Defense have contributed significant funding to the advancement and manufacturing of INO-4800.

About INO-4800

INO-4800 is INOVIO’s DNA vaccine candidate created to protect against the novel coronavirus SARS-CoV-2, which causes COVID-19. INO-4800 was designed using INOVIO’s proprietary DNA medicine platform rapidly after the publication of the genetic sequence of the coronavirus that causes COVID-19. INOVIO has deep experience working with coronaviruses and is the only company with a Phase 2a vaccine for a related coronavirus that causes Middle East Respiratory Syndrome (MERS).

About INOVIO’s DNA Medicines Platform

INOVIO has 15 DNA medicine clinical programs currently in development focused on HPV-associated diseases, cancer, and infectious diseases, including coronaviruses associated with MERS and COVID-19 diseases being developed under grants from the Coalition for Epidemic Preparedness Innovations (CEPI). DNA medicines are composed of optimized DNA plasmids, which are small circles of double-stranded DNA that are synthesized or reorganized by a computer sequencing technology and designed to produce a specific immune response in the body.

INOVIO’s DNA medicines deliver optimized plasmids directly into cells intramuscularly or intradermally using INOVIO’s proprietary hand-held smart device called CELLECTRA. The CELLECTRA device uses a brief electrical pulse to reversibly open small pores in the cell to allow the plasmids to enter, overcoming a key limitation of other DNA and other nucleic acid approaches, such as mRNA. Once inside the cell, the DNA plasmids enable the cell to produce the targeted antigen. The antigen is processed naturally in the cell and triggers the desired T cell and antibody-mediated immune responses. Administration with the CELLECTRA device ensures that the DNA medicine is efficiently delivered directly into the body’s cells, where it can go to work to drive an immune response. INOVIO’s DNA medicines do not interfere with or change in any way an individual’s own DNA. The advantages of INOVIO’s DNA medicine platform are how fast DNA medicines can be designed and manufactured, the stability of the products which do not require freezing in storage and transport, and the robust immune response, safety profile, and tolerability that have been demonstrated in clinical trials.

With more than 2,000 patients receiving INOVIO investigational DNA medicines in more than 6,000 applications across a range of clinical trials, INOVIO has a strong track record of rapidly generating DNA medicine candidates with potential to meet urgent global health needs.

On May 11, 2020 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, reported the commencement of a proposed underwritten public offering of approximately $100,000,000 of shares of its common stock (Press release, Akebia, MAY 11, 2020, View Source [SID1234557610]). All shares being offered are to be sold by the Company. The Company also intends to grant the underwriters a 30-day option to purchase up to approximately $15,000,000 of additional shares of its common stock.

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J.P. Morgan Securities LLC and Piper Sandler & Co. are acting as the book-running managers for the proposed offering. BTIG, LLC and Mizuho Securities USA LLC are acting as the lead managers, and H.C. Wainwright & Co., LLC is acting as the co-manager for the proposed offering. The proposed offering is subject to market and other conditions and there can be no assurance as to whether or when the proposed offering may be completed, or as to the actual size or terms of the offering.

The proposed offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-223585) previously filed with the Securities and Exchange Commission (SEC). The offering will be made only by means of a preliminary prospectus supplement and accompanying prospectus, copies of which may be obtained, when available, from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204; or by email at [email protected] or Piper Sandler & Co., Attn: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by phone at (800) 747-3924; or by email at [email protected]. You may also get these documents for free by visiting the SEC’s website at www.sec.gov.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in the offering, nor shall there be any sale of these securities in any jurisdiction in which an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

On May 11, 2020 Reata Pharmaceuticals, Inc. (Nasdaq: RETA) ("Reata," the "Company," or "we"), a clinical-stage biopharmaceutical company, reported financial results for the quarter ended March 31, 2020, and provided an update on the Company’s business and product development programs (Press release, Reata Pharmaceuticals, MAY 11, 2020, View Source [SID1234557609]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Recent Company Highlights

Reata recently announced changes to its clinical programs and operations as a result of the COVID-19 pandemic. For each clinical development program, Reata developed and implemented changes designed to mitigate risk to patients; comply with regulatory, institutional, and government guidance; and maintain the integrity of our ongoing clinical studies. At this time, we expect that data collection for the ongoing CARDINAL study of bardoxolone methyl (bardoxolone) in chronic kidney disease caused by Alport syndrome will not be significantly impacted by the COVID-19 pandemic. We have observed no significant data loss during this period.

When the FALCON trial for bardoxolone in ADPKD was paused in March, we implemented adjustments similar to those implemented for CARDINAL. We have observed no significant data loss in the FALCON trial to date. For the FALCON study, we have been able to continue treatment of patients enrolled in the study, but because in-clinic visits are necessary to enroll new patients, we have had to pause enrollment of new patients into the study. Clinical trial sites are starting to reopen, and we are hopeful that we may be able to resume screening of patients for FALCON as early as this quarter at some sites.

Additionally, we do not believe that the COVID-19 pandemic will have a significant impact on our ability to execute on the planned New Drug Application submissions for bardoxolone in Alport syndrome or omaveloxolone in Friedreich’s ataxia.

First Quarter Financial Highlights

Cash and Cash Equivalents

On March 31, 2020, we had cash and cash equivalents of $624.5 million, as compared to $664.3 million at December 31, 2019.

Collaboration Revenue

Collaboration Revenue was $1.4 million in the first quarter of 2020, as compared to $7.8 million for the same period of the year prior. Revenue for the first quarter of 2020 included $1.2 million from the Kyowa Kirin Co., Ltd. license agreement and $0.2 million from other sources.

GAAP and Non-GAAP Research and Development (R&D) Expenses

R&D expenses according to generally accepted accounting principles in the U.S. (GAAP) were $47.7 million for the first quarter of 2020, as compared to $26.1 million for the same period of the year prior.

Non-GAAP R&D expenses were $36.1 million for the first quarter of 2020, as compared to $24.4 million for the same period of the year prior.1

GAAP and Non-GAAP General and Administrative (G&A) Expenses

GAAP G&A expenses were $20.8 million for the first quarter of 2020, as compared to $10.0 million for the same period of the year prior.

Non-GAAP G&A expenses were $13.0 million for the first quarter of 2020, as compared to $7.5 million for the same period of the year prior.1

GAAP and Non-GAAP Net Loss

The GAAP net loss for the first quarter of 2020 was $48.9 million, or $1.47 per share, on both a basic and diluted basis, as compared to a GAAP net loss of $29.2 million, or $0.98 per share, on both a basic and diluted basis, for the same period of the year prior.

The increase in GAAP net loss is driven primarily by an increase in expenses, offset by an income tax benefit. Higher expenses were driven by an increase in research and development activities, including personnel-related costs to support this growth. Under the provisions of the Coronavirus Aid, Relief, and Economic Security Act (the "CARES Act"), we recognized a tax benefit of $22.1 million.

The non-GAAP net loss for the first quarter of 2020 was $29.6 million, or $0.89 per share on both a basic and diluted basis, as compared to a non-GAAP net loss of $24.9 million, or $0.84 per share, on both a basic and diluted basis, for the same period of the year prior.1

Reiterates Cash Guidance

The Company reiterated that it expects existing cash and cash equivalents to be sufficient to enable it to fund operations through the end of 2021.

_________________
1 See "Use of Non-GAAP Financial Measures" below for a description of non-GAAP financial measures and a reconciliation between GAAP and non-GAAP R&D expenses, GAAP and non-GAAP G&A expenses, and GAAP and non-GAAP net loss, respectively, appearing later in the press release.

Non-GAAP Financial Measures

This press release contains non-GAAP financial measures, including non-GAAP R&D expenses, non-GAAP G&A expenses, non-GAAP operating expenses, non-GAAP net loss and non-GAAP net loss per common share – basic and diluted. These measures are not in accordance with, or an alternative to, GAAP, and may be different from non-GAAP financial measures used by other companies.

The Company defines non-GAAP R&D expenses as GAAP R&D expenses less stock-based compensation expense, non-GAAP G&A expenses as GAAP G&A expenses less stock-based compensation expense, non-GAAP operating expenses as GAAP operating expenses less stock-based compensation expense and reacquired license rights expense, non-GAAP net loss as GAAP net loss plus stock-based compensation expense and reacquired license rights expense, and non-GAAP net loss per common share – basic and diluted as GAAP net loss per common share – basic and diluted plus stock-based compensation expense and reacquired license rights expense. During the three months ended March 31, 2020 and 2019, the Company did not incur any reacquired license rights expense; therefore, this expense is not included in the reconciliations below for the measures for non-GAAP operating expenses, non-GAAP net loss, and non-GAAP net loss per common share – basic and diluted for these periods. The Company has excluded the impact of stock-based compensation expense, which may fluctuate from period to period based on factors including the variability associated with performance-based grants for stock options and restricted stock units and changes in the Company’s stock price, which impacts the fair value of these awards. The Company has excluded the impact of reacquired license rights expense because the Company believes its impact makes it difficult to compare its results to prior periods and anticipated future periods.

Because management believes certain items such as stock-based compensation expense and reacquired license rights expense can distort the trends associated with the Company’s ongoing performance, the following measures are often provided, excluding special items, and utilized by the Company’s management, analysts, and investors to enhance consistency and comparability of year-over-year results, as well as to industry trends, and to provide a basis for evaluating operating results in future periods: non-GAAP net loss; non-GAAP net loss per common share – basic and diluted; non-GAAP R&D expenses; non-GAAP G&A expenses; and non-GAAP operating expenses.

The Company believes the presentation of these non-GAAP financial measures provides useful information to management and investors regarding the Company’s financial condition and results of operations. When GAAP financial measures are viewed in conjunction with these non-GAAP financial measures, investors are provided with a more meaningful understanding of the Company’s ongoing operating performance and are better able to compare the Company’s performance between periods. In addition, these non-GAAP financial measures are among those indicators the Company uses as a basis for evaluating performance, allocating resources and planning and forecasting future periods. These non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP financial measures. A reconciliation between these non-GAAP measures and the most directly comparable GAAP measures is provided later in this press release.

Conference Call Information

Reata’s management will host a conference call on May 11, 2020 at 4:30 PM ET. The conference call will be accessible by dialing (844) 348-3946 or (213) 358-0892 (international) using the access code: 6936548. The webcast link is View Source

First quarter 2020 financial results to be discussed during the call will be included in an earnings press release that will be available on the company’s website shortly before the call at View Source and will be available for 12 months after the call. The audio recording and webcast will be accessible for at least 90 days after the event at View Source.

On May 11, 2020 ASLAN Pharmaceuticals (Nasdaq:ASLN, TPEx:6497), a clinical-stage immunology and oncology focused biopharmaceutical company developing innovative treatments to transform the lives of patients, reported financial results for the first quarter ended 31 March 2020 and provided an update on its clinical activities (Press release, ASLAN Pharmaceuticals, MAY 11, 2020, View Source [SID1234557555]).

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Dr Carl Firth, Chief Executive Officer, ASLAN Pharmaceuticals, said: "The COVID-19 pandemic has brought about unprecedented changes and affected many worldwide. We have been putting strategies in place to mitigate risks to our development programs, including opening sites in different geographies where restrictions are easing. We are also taking steps to ensure that we emerge from this situation stronger and ready to initiate our planned phase 2b study of ASLAN004 for atopic dermatitis in 1H 2021, building our US presence as we grow a team there and prepare to file an Investigational New Drug application with the US FDA."

First quarter 2020 and recent business highlights

Clinical development

ASLAN004

As announced on 13 April, recruitment for the second dose cohort of the multiple ascending dose (MAD) study in atopic dermatitis (AD) has been paused in light of government restrictions in Singapore to contain the spread of COVID-19. ASLAN is closely monitoring government guidance around the restrictions, which were extended until 1 June 2020 on 21 April.

ASLAN still expects to announce unblinded, interim data from the study later this year but will review the timelines when the tightened restrictions are lifted in Singapore and recruitment into the study recommences.

To accelerate recruitment, ASLAN has identified several clinical sites in Australia that could join the ongoing MAD study.

Varlitinib

Two abstracts on varlitinib have been accepted for presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) virtual congress on 29 May. An abstract on the results from the TreeTopp study was accepted for poster presentation and the second abstract, on the comparison of therapeutic responses by using CT imaging, will be available in the virtual library.

Anticipated upcoming milestones for ASLAN004

Interim, unblinded data from the 3 dose cohorts (up to 24 patients) expected in 2H 2020, and initiation of the expansion cohort (an additional 18 patients).

Opening of clinical trial sites in Australia and filing of IND application with the US FDA in the middle of 2020.

Completion of MAD clinical trial in moderate-to-severe AD patients in 1H 2021.

Initiation of Phase 2b study of ASLAN004 for AD in 1H 2021.

First quarter 2019 financial highlights

Cash used in operations for the first quarter of 2020 was US$5.2 million compared to US$7.2 million in the same

period in 2019.

Research and development expenses were US$2.4 million in the first quarter of 2020 compared to US$4.4 million in the first quarter of 2019. The decrease was driven by the completion of clinical studies related to varlitinib and lower manufacturing expenses.

General and administrative expenses were US$1.0 million in the first quarter of 2020 compared to US$2.3 million in the first quarter of 2019. The decrease was primarily due to earlier restructuring efforts which resulted in a decrease in headcount and staffing costs.

Net loss for the first quarter of 2020 was US$3.0 million compared to a net loss of US$4.3 million for the first quarter of 2019.

Cash, cash equivalents and short-term investments totaled US$16.9 million as of 31 March 2020 compared to US$22.2 million as of 31 December 2019. Weighted average shares outstanding for the first quarter of 2020 was 190.0 million compared to 160.2 million for the first quarter of 2019. One American Depositary Share is the equivalent of five ordinary shares.