On August 4, 2020 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported that its offer to acquire all of QIAGEN’s ordinary shares for an increased price of €43.00 per share in cash will expire at 24:00 hours (Frankfurt am Main local time) / 18:00 hours (New York local time) on Monday, August 10, 2020 (Press release, Thermo Fisher Scientific, AUG 4, 2020, View Source [SID1234562811]).

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On July 16, 2020, Thermo Fisher and QIAGEN announced that they had entered into an amendment to their acquisition agreement following good faith discussions between the parties. The revised offer price of €43.00 per QIAGEN share represents Thermo Fisher’s best and final offer.

QIAGEN’s Supervisory Board and Managing Board reaffirmed their unanimous support for the offer and unanimously recommend that all QIAGEN shareholders accept and tender all of their QIAGEN shares in the offer prior to the end of the acceptance period. Each of the members of the Supervisory Board and Managing Board has tendered all of their QIAGEN shares in the offer.

If the minimum acceptance threshold of 66.67% of QIAGEN’s issued and outstanding ordinary share capital is not satisfied at the end of the acceptance period on August 10, 2020, the offer will automatically terminate and QIAGEN will be required to pay Thermo Fisher USD 95 million in cash. Thermo Fisher will not launch another offer in the event the current offer fails to meet the minimum acceptance threshold.

Advisors

J.P. Morgan Securities LLC and Morgan Stanley & Co. LLC are serving as financial advisors to Thermo Fisher, and Wachtell, Lipton, Rosen & Katz is serving as legal counse

On August 4, 2020 Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis to advance the science of precision health, reported financial results for the three months ending June 30, 2020 (Press release, Quanterix, AUG 4, 2020, View Source [SID1234562810]).

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"We’re encouraged to report yet another quarter that exceeded expectations and lays the groundwork for recovery to maintain to our strong growth trajectory in the second half of the year, despite the continued challenges brought on by the coronavirus pandemic," said Kevin Hrusovsky, Chairman and Chief Executive Officer, Quanterix. "Quanterix has been quick to respond to the crisis with critical testing advances powered by our Simoa technology’s ultra-sensitivity. Through close linkages with KOLs across the Powering Precision Health (PPH) ecosystem, we’ve advanced important research and facilitated several strategic partnerships aimed at accelerating vital testing and public health solutions. In tandem, we continue to make remarkable gains in neurology as it relates to the long-term impacts of COVID-19 and the ongoing challenge to unlock the secrets of degenerative conditions, such as Alzheimer’s disease and Multiple Sclerosis. Numerous pharmaceutical organizations are relying on our neurology assays for Nf-L and newly launched p-tau181 to study these diseases more effectively in blood and support pivotal drug trials. Despite the uncertain global outlook, we’re encouraged by our ability to pivot to capitalize on new opportunities, the validation we’ve received via hundreds of peer-reviewed journals, and the opportunity before us to support public health at a critical time in history. Our precision health vision has never been more important and essential. We look forward to sharing more about our progress during our earnings call."

Second Quarter 2020 Financial Highlights

Key financial results from the second quarter of 2020 are shown below:

·Q2 total revenue was $13.1M versus prior year Q2 of $13.5M, a decrease of 3%;
·Q2 product revenue was $6.8M versus prior year Q2 of $8.8M, a decrease of 23%;
·Q2 service and other revenue was $6.3M versus prior year Q2 of $4.8M, an increase of 33%;

1H 2020 Financial Highlights

Key financial results for the first half of 2020 are shown below:

·1H total revenue was $28.9M versus prior year 1H of $25.9M, an increase of 12%;
·1H product revenue was $16.6M versus prior year 1H of $18.3M, a decrease of 9%; and
·1H service and other revenue was $12.1M versus prior year 1H of $7.6M, an increase of 60%

Second Quarter 2020 Business Highlights – Expanding RUO Market Opportunities & Accelerating Clinical Diagnostic Validation & Potential

COVID-19

·COVID-19 testing remains fraught with challenges, including potentially high false negative rates due to nasal sampling issues and potentially false positives due to RNA fragments remaining after viral infection has dissipated. The NIH, FDA and CDC are aggressively attempting to innovate new testing approaches to scale better testing solutions. We continue to accelerate our development of differentiated testing solutions, utilizing Simoa’s ultra-sensitivity to support ongoing study of the SARS-CoV-2 virus, and innate and adaptive immune response in blood. The quarter saw considerable advances in applying Simoa’s ultra-sensitivity to serology and antigen viral testing, leading to attractive and strategic opportunities with prominent healthcare, diagnostics and government institutions.

·We won several population studies with one of the largest multi-national, healthcare payor groups using home sampling dry blood spots for COVID-19 population surveillance and nursing home investigation. While initially COVID-19 is the focus, longer-term we feel home care biomarker precision health surveillance for other disease categories (Neurology, Immunology, Cardiology, Oncology & Others) has the potential to enable earlier detection and therapy intervention, increasing the efficiency of healthcare solutions.
·We have been selected to receive a $2.8M workplan 1 award under the National Institute of Health (NIH) Rapid Acceleration of Diagnostics Program (RADx) to assess the feasibility of a home-based SARS-CoV-2 Antigen detection test in blood using our Simoa technology. Successful development of such a test has the potential to lower costs, reduce false negatives and positives and eliminate the need for Personal Protective Equipment to take the sample and overall dependence on the nasopharangeal (NP) swab supply chain fraught with scale up challenges.
·While our response to the pandemic has been highly productive across many fronts, our Q2 2020 Product Revenue was adversely impacted by a reduction in customer activity due to COVID-19 ($6.8M, -23% vs. Q2 2019). Service and other revenue, due to aggressive expansion of Accelerator services to support customers facing disruption due to COVID-19, offset the Product Revenue shortfall ($6.3M, +33% vs. Q2 2019). Q2 GAAP gross margin was 39.7% versus prior year Q2 of 51.2%; Q2 non-GAAP gross margin was 44.1% versus prior year Q2 of 51.2%. Q2 2020 gross margin included 354 bps of adverse impact from our successful HD-X trade-in program and 300 bps of adverse impact from lower absorption due to lower Product Revenue. Use of Cash in Q2 2020 was restricted to $7.6M through proactive working-capital management to offset P&L loss net of non-cash items.
·
We expanded our Accelerator Services capacity to support customers undergoing disruptions and helped them sustain their research and clinical trials during the COVID-19 pandemic. These measures enhanced customer satisfaction & loyalty, enabled growth in our Lab Services (+95% in the 1H 2020 vs 1H 2019) and laid the foundation for conducting population studies and building a Specialty Lab infrastructure for Laboratory Developed Testing (LDT) in the future.

·Our next-generation Simoa HD-X analyzer is delivering on its promise of increased reliability & performance, as observed in the feedback of our high-volume customers and KOLs in the PPH ecosystem, paving the way for increased utilization and consumable growth.
·The COVID-19 pandemic has enabled Quanterix to highlight the importance of its ultra-sensitive and specific assay technology and demonstrate its potential for advancing home care precision health.

Neurology

·We launched ready-to-use kits of N2PA neurology panels, in addition to completing development and a successful early access program for N4PE and tau phosphorylated at threonine 181 (p-tau181), a highly specific biomarker for the study of Alzheimer’s disease pathology, in cerebral spinal fluid (CSF), serum and plasma. A PPH p-Tau-181 webinar received impressive response from KOLs, researchers and investors. Pre-orders for the assay exceeded expectations, with the first supply of the assay selling out in advance of the commercial launch, anticipated in early September.

·Supported neurofilament light (Nf-L) Clinical Validation through large normative study conducted by University of Basel, Switzerland, with 11,000 healthy controls and over 18,000 samples, initial results and findings are being prepared for publication.
·Saw expanded potential for our leading sNf-L assay as a critical biomarker of neuronal damage, with early work showing promise to measure long-term neurological impacts among COVID-19 patients and NIH studies demonstrating that Nf-L is a viable biomarker to detect and predict the severity of traumatic brain injury, outperforming other blood test in predictive and diagnostic performance.
·Began initial support of Alzheimer’s Clinical Drug Trial with a large pharmaceutical company including trials with five neuro biomarkers, including pTau-181 and pTau-217.
·Biogen completed submission of the biologics license application (BLA) to the FDA seeking approval of aducanumab, its first-in-line investigational treatment for Alzheimer’s disease. Novartis’ multiple sclerosis (MS) drug ofatumumab, which utilized Nf-L as secondary end-point, is under review with FDA. These advances are set to expand the use of biomarker testing using tools such as our Neuro menu and transform how healthcare is practiced in Neurology.

Platform

·Our sponsorship of Powering Precision Health (PPH) enabled a series of Think Tank Webinars that resulted in frontline researchers accelerating their deployment of Simoa in critical hot zones. These symposiums attracted over 1000 Key Opinion Leaders (KOLs) and helped inform acute care, immune response monitoring and treatment strategies in disease hubs across the globe.
·Solidified Simoa’s technological leadership in highly sensitive biomarker detection by achieving a 100x sensitivity improvement of the digital enzyme-linked immunosorbent assay (ELISA) using an advanced version of the technology that powers the Company’s HD-X and SR-X Ultra-Sensitive Biomarker Detection Systems. The breakthrough, published in the journal Lab on a Chip, has the potential to further expand Simoa’s measurement and analysis capabilities to a wider range of soluble protein biomarkers, including many critical to understanding COVID-19.
·Appeared on Passionate Pioneers with Mike Biselli, a nationally ranked healthcare innovation podcast, and MassBio: Possible Talk, a prominent speaker series hosted by Massachusetts’ leading life science advocacy group, to discuss opportunities to drive critical COVID-19 research advances using Simoa.
·Quanterix Simoa technology has now been highlighted in a total of 881 peer-reviewed publications. Notably, June was a record month for Simoa journals, with 34 studies published.

Conference Call

In conjunction with this announcement, Quanterix Corporation will host a conference call on August 4 at 5:00 p.m., EDT. Individuals interested in listening to the conference call may do so by dialing (833) 686-9351 for domestic callers, or (612) 979-9890 for international callers. Please reference the following conference ID: 8942449

A live webcast will also be available at: View Source

The webcast will be available on the Company’s website, View Source, for one year following completion of the call.

On August 4, 2020, Deciphera Pharmaceuticals, Inc. (the "Company") reported that it entered into an Open Market Sale AgreementSM (the "Sales Agreement"), with Jefferies LLC ("Jefferies"), pursuant to which the Company may issue and sell shares of its common stock, $0.01 par value per share, having aggregate offering sales proceeds of up to $200,000,000 (the "Shares") from time to time through Jefferies as its sales agent (Filing, 8-K, Deciphera Pharmaceuticals, AUG 4, 2020, View Source [SID1234562809]). The Shares to be sold under the Sales Agreement, if any, will offered and sold pursuant to the Company’s automatic shelf registration statement on Form S-3ASR (File No. 333-236389), which became effective when filed with the Securities Exchange Commission on February 12, 2020, and the prospectus supplement dated August 4, 2020 to be filed by the Company.

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Upon delivery of a placement notice and subject to the terms and conditions of the Sales Agreement, Jefferies may sell the Shares by any method permitted by law deemed to be an "at the market offering" as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended. The Company may sell the Shares in amounts and at times to be determined by the Company from time to time subject to the terms and conditions of the Sales Agreement, but it has no obligation to sell any of the Shares under the Sales Agreement.

The Company or Jefferies may suspend or terminate the offering of Shares upon notice to the other party and subject to other conditions. Jefferies will act as sales agent on a commercially reasonable efforts basis consistent with its normal trading and sales practices and applicable state and federal law, rules and regulations and the rules of Nasdaq.

The Company will pay Jefferies a cash commission of up to 3.0% of gross proceeds from the sale of the Shares pursuant to the Sales Agreement. The Company has also agreed to provide Jefferies with customary indemnification and contribution rights.

The offering of Shares pursuant to the Sales Agreement will terminate upon the earlier of (i) the sale of all Shares subject to the Agreement or (ii) termination of the Sales Agreement in accordance with its terms.

The foregoing description of the Sales Agreement is not complete and is qualified in its entirety by reference to the full text of the Sales Agreement, a copy of which is attached as Exhibit 10.1 hereto and is incorporated herein by reference.

Goodwin Procter LLP, counsel to the Company, has issued a legal opinion relating to the Shares. A copy of such legal opinion, including the consent included therein, is attached as Exhibit 5.1 hereto.

This Current Report on Form 8-K shall not constitute an offer to sell or solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities law of such state or jurisdiction.

On August 4, 2020 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol, reported its results for the quarter ended June 30, 2020 (Press release, Corcept Therapeutics, AUG 4, 2020, View Source [SID1234562808]).

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Financial Highlights
•Revenue of $88.6 million, a 23 percent increase from second quarter 2019
•GAAP diluted net income of $0.23 per share, compared to $0.17 per share in second quarter 2019
•Non-GAAP diluted net income of $0.32 per share, compared to $0.25 per share in second quarter 2019
•Cash and investments of $409.6 million, compared to $349.0 million at March 31, 2020
•Reaffirmed 2020 revenue guidance of $355 – 375 million
Revenue was $88.6 million in the second quarter, compared to $72.3 million in the second quarter of 2019. Second quarter revenue was $4.7 million lower than in the first quarter, primarily because in March 2020 some patients refilled their prescriptions a few days earlier than usual as a safeguard against pandemic-related delays. These safety stocks were consumed in the second quarter. This shift in refill timing increased shipments of Korlym tablets in the first quarter and decreased them by a similar amount in the second quarter.
We reaffirm our 2020 revenue guidance of $355 – 375 million.
Second quarter GAAP net income was $28.3 million, compared to $20.2 million in the same period last year. Excluding non-cash expenses related to stock-based compensation and the utilization of deferred tax assets, together with related income tax effects, non-GAAP net income in the second quarter was $39.7 million, compared to $31.0 million in the second quarter of 2019. A reconciliation of GAAP to non-GAAP net income is included below.
Second quarter operating expenses were $53.3 million, compared to $47.6 million in the second quarter of 2019, primarily due to increased spending to conduct clinical trials in Cushing’s syndrome, antipsychotic-induced weight gain and solid tumors and to formulate and manufacture the company’s proprietary, selective cortisol modulators and to increased employee recruiting and compensation expense.
Cash and investments were $409.6 million at June 30, 2020, an increase of $60.6 million from March 31, 2020.
"Patients with Cushing’s syndrome are at elevated risk of infection with the novel coronavirus," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. "Our clinical specialists, medical science liaisons and patient advocates have done an excellent job helping physicians provide the care these patients need, despite the challenges posed by the Covid-19 pandemic.
"The pandemic’s impact on Corcept has been varied," Dr. Belanoff added. "As our first and second quarter results showed, pandemic-related changes in patient refill choices can shift revenue from one quarter to another. More fundamentally, while the heightened vulnerability of patients with Cushing’s syndrome to Covid-19 has caused patients to stay on therapy, which tends to increase demand for Korlym, it remains difficult for doctors to arrange the tests and on-going monitoring needed to diagnose new patients and optimize their care. In addition, many patients are reluctant to leave their homes, even to visit their doctor. And opportunities for our clinical specialists to meet with physicians in person remain limited, although telephone and video conference contact is becoming more common.
"We expect that these countervailing forces will continue in coming quarters, but also expect any changes to be manageable and reiterate our 2020 revenue guidance of $355 – 375 million."

Cushing’s Syndrome
•Phase 3 trial of relacorilant in patients with all etiologies of Cushing’s syndrome (GRACE) continues at 60 sites in the United States, Europe and Israel; NDA submission planned for second quarter 2022
•Enrollment underway in Phase 3 trial of relacorilant in patients with Cushing’s syndrome of adrenal origin (GRADIENT)
"Although the Covid-19 pandemic has slowed patient enrollment and clinical site activation, our Cushing’s syndrome program continues to make important progress," said Andreas Grauer, MD, Corcept’s Chief Medical Officer. "We opened five additional clinical sites in GRACE, our pivotal trial of relacorilant to treat patients with all etiologies of Cushing’s syndrome, bringing the total to 60. Enrollment activity has increased, particularly in Europe, where pandemic-related restrictions have eased. We plan to submit relacorilant’s NDA, based on the results of GRACE, in the second quarter of 2022.
"In addition, enrollment has begun in GRADIENT, our double-blind, placebo-controlled, Phase 3 trial with a planned total of 130 patients whose Cushing’s syndrome is caused by an adrenal adenoma or adrenal hyperplasia.1 GRADIENT is the first controlled clinical trial of medical treatment in this etiology of the disease.
Solid Tumors
•Completed enrollment in controlled, Phase 2 trial of relacorilant plus nab-paclitaxel in patients with metastatic ovarian cancer; results expected in first half 2021
•Initiated Phase 3 trial of relacorilant plus nab-paclitaxel in patients with metastatic pancreatic cancer (RELIANT)
•Selection of optimum dose of exicorilant plus enzalutamide in patients with castration-resistant prostate cancer expected by year-end
•Phase 1b trial of relacorilant plus PD-1 checkpoint inhibitor pembrolizumab in patients with metastatic or unresectable adrenal cancer expected to start in third quarter 2020
"Our development of relacorilant as a potential treatment for solid tumors recently achieved two important milestones," said Dr. Grauer. "We completed enrollment in our controlled, Phase 2 trial of relacorilant combined with nab-paclitaxel to treat patients with metastatic ovarian cancer. We also initiated RELIANT, our Phase 3 trial of relacorilant plus nab-paclitaxel in patients with metastatic pancreatic cancer. Data from our open-label, Phase 1/2 trial in patients with these tumors were very encouraging.2 Replicating those results in these larger, more rigorous trials would be an important medical advance."
Our controlled, Phase 2 trial of relacorilant plus nab-paclitaxel in patients with metastatic, platinum-resistant ovarian cancer has enrolled its goal of 178 patients, at 28 sites in the United States, Canada and Europe. Participants were randomly assigned to receive either relacorilant plus nab-paclitaxel or nab-paclitaxel alone. The trial’s primary endpoint is progression free survival, with secondary endpoints including objective response rate and duration of objective response. Data is expected in the first half of next year.
RELIANT has a planned enrollment of 80 patients with metastatic pancreatic cancer, with an interim analysis of data from the first 40 patients. Each patient will receive relacorilant plus nab-paclitaxel. The primary endpoint is objective response rate, with secondary endpoints including progression-free survival and duration of response. RELIANT will be conducted at 20 sites in the United States. We believe sufficiently positive results would support accelerated approval by the FDA.
"In the third quarter, we plan to initiate an open-label, 20-patient, Phase 1b trial of relacorilant combined with the PD-1 checkpoint inhibitor pembrolizumab in patients with metastatic or unresectable adrenal cancer that produces excess cortisol," said Dr. Grauer. "These patients respond poorly to pembrolizumab monotherapy and also suffer
1 See our 2020 ENDO poster at the Research & Pipeline / Publications tab of our website.
2 See our ASCO (Free ASCO Whitepaper) poster at the Investors / Events tab of our website.

from Cushing’s syndrome. By modulating the effects of excess cortisol, including cortisol-induced immune suppression, relacorilant may both treat the symptoms of Cushing’s syndrome and allow pembrolizumab achieve its full cancer-killing effect."
Metabolic Diseases
•Enrollment continues in double-blind, placebo-controlled, Phase 2 trial of miricorilant to reverse recent APIWG (GRATITUDE)
•Double-blind, placebo-controlled Phase 2 trial (GRATITUDE 2) of miricorilant to reverse long-standing antipsychotic-induced weight gain (APIWG) planned to start in third quarter 2020
•Double-blind, placebo-controlled Phase 2 trial of miricorilant in patients with non-alcoholic steatohepatitis (NASH) planned to start in fourth quarter 2020
"Miricorilant has shown great promise as a treatment for APIWG," said Dr. Grauer. "In our Phase 1b trial, healthy subjects given olanzapine plus miricorilant gained less weight and had lower triglycerides and less sharply elevated liver enzymes than subjects who received olanzapine plus placebo – despite being treated for only two weeks. We hope to confirm and extend these results in the GRATITUDE trials.
"Our on-going GRATITUDE trial is testing the ability of miricorilant to reduce recent weight gain caused by antipsychotic medications in 100 patients with schizophrenia," added Dr. Grauer. "Study participants continue to receive their established dose of antipsychotic medication and either 600 milligrams of miricorilant or placebo for 12 weeks. Our second trial, GRATITUDE 2 will test the same effect in patients with long-standing APIWG.
"Completion of formulation work for miricorilant has allowed us to advance by one quarter the start of our second Phase 2 trial in patients with APIWG and our first Phase 2 trial in patients with NASH," said Dr. Grauer.
Conference Call
We will hold a conference call on August 4th, 2020, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). To participate, dial 1-800-353-6461 from the United States or 1-334-323-0501 internationally approximately ten minutes before the start of the call (passcode 6800706). A replay will be available through August 18, 2020 at 1-888-203-1112 in the United States and 1-719-457-0820 internationally (passcode 6800706).

On August 4, 2020 Idera Pharmaceuticals, Inc. ("Idera" or the "Company") (Nasdaq: IDRA) reported its financial and operational results for the second quarter ended June 30, 2020 (Press release, Idera Pharmaceuticals, AUG 4, 2020, View Source [SID1234562807]).

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"Idera meaningfully advanced its clinical pipeline and strengthened its financial resources in the first part of 2020. Further encouraged by data from ILLUMINATE-204, which we reported in the second quarter, we continue to work diligently against our timelines for ILLUMINATE-301. Those timelines currently remain on track for data in the first quarter of 2021, despite disruptions from the global impact of COVID-19," stated Vincent Milano, Idera’s Chief Executive Officer. "In addition, as part of our ‘beyond melanoma’ strategy, early data from ILLUMINATE-206 reinforces our optimism in the potential of tilsotolimod in patients with micro-satellite stable colorectal cancer. Lastly, our team’s outstanding perseverance and dedication to our patients combined with the further financing we recently secured will help us continue to execute these key objectives and potentially beyond."

Corporate Update

Since March 31, 2020, the Company entered into two private placement financings of up to $40.7 million, with $5.0 million received in April 2020 and $5.1 million received in July 2020. The Company anticipates that its current cash, cash equivalents, and short-term investments will fund our operations into the second quarter of 2021. With the Company’s current financing vehicles, there exists the possibility to extend that runway through subsequent proceeds to fund the potential NDA filing and commercial launch of tilsotolimod.

ILLUMINATE (tilsotolimod) Clinical Development Updates

ILLUMINATE-301: Randomized phase 3 trial of tilsotolimod in combination with Yervoy* (ipilimumab) versus Yervoy alone in patients with anti-PD-1 refractory advanced melanoma:

•Primary endpoint family of overall response rate (ORR) by blinded independent review using RECIST v1.1 and overall survival (OS);
•Trial initiated in March 2018;
•Enrollment completed in March 2020; and
•ORR and other preliminary data expected in the first quarter of 2021.

ILLUMINATE-206: Phase 2, open-label, multicohort, multicenter study to test the safety and effectiveness of tilsotolimod in combination with Yervoy and Opdivo* (nivolumab) for the treatment of solid tumors:
·Trial initiated in September 2019 with the microsatellite stable colorectal cancer (MSS-CRC) cohort;
·Initial safety run-in of 10 patients, which included Yervoy at 1 mg/kg every 8 weeks and Opdivo at 3 mg/kg every 2 weeks, showed that the regimen was generally well tolerated;
·Planned changes in the study design intended to improve potential outcomes in this patient population include increasing Yervoy dosing frequency to every 3 weeks and limiting the number of allowed prior lines of treatment to 2; and
·Enrollment of the next 10 patients is targeted to begin in the fourth quarter of 2020, with data anticipated in the second quarter of 2021.

ILLUMINATE-204: Phase 1/2 trial of tilsotolimod in combination with Yervoy or Keytruda± (pembrolizumab) in patients with anti-PD-1 refractory advanced melanoma:

•Final topline results released in April 2020 from the recommended phase 2 dose (RP2D) of 8 mg of tilsotolimod in combination with Yervoy, which is the treatment regimen being evaluated in the Company’s registrational trial, ILLUMINATE-301; and
•Final data from the trial will be shared in a Mini Oral presentation at the ESMO (Free ESMO Whitepaper) Virtual Congress 2020, to be held September 19-21, 2020.

Second Quarter Financial Results

Research and development expenses for the three months ended June 30, 2020 totaled $5.4 million compared to $10.0 million for the same period in 2019. General and administrative expense for the three months ended June 30, 2020 totaled $2.6 million compared to $2.9 million for the same period in 2019. Additionally, during the three months ended June 30, 2020, we recorded $0.9 million and $15.3 million non-cash warrant revaluation loss and non-cash future tranche right revaluation loss, respectively, related to securities issued in connection with our December 2019 private placement transaction.

As a result of the factors above, net loss applicable to common stockholders for the three months ended June 30, 2020 was $24.2 million, or $0.72 per basic and diluted share, compared to net loss applicable to common stockholders of $11.2 million, or $0.39 per basic and diluted share, for the same period in 2019. Excluding the non-cash loss of approximately $16.3 million for the three months ended June 30, 2020 related to the securities issued in connection with the December 2019 private placement transaction, net loss applicable to common stockholders was $8.0 million, or $0.24 per basic and diluted share (calculated based upon the basic weighted-average number of common shares, due to the antidilutive effect of net loss).

As of June 30, 2020, our cash, cash equivalents, and short-term investments totaled $31.0 million. Based on our current operating plan, we anticipate that our current cash, cash equivalents, and short-term investments, including $5.1 million gross proceeds in cash received in July 2020 pursuant to the July 2020 Securities Purchase Agreement, will fund our operations into the second quarter of 2021.