On May 7, 2020 Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing novel small molecule therapeutics to treat unmet needs in autoimmunity and cancer, reported its first quarter 2020 financial results and corporate highlights (Press release, Kezar Life Sciences, MAY 7, 2020, View Source [SID1234557272]).

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"During this unprecedented health crisis, I’ve been deeply impressed by our team’s focus and continued execution across both of our programs," said John Fowler, Kezar’s Chief Executive Officer. "We are working closely with all the sites participating in our trials with KZR-616 and look forward to sharing new data from the Phase 1b portion of our MISSION study next month. In addition, we will present more preclinical data on our novel protein secretion inhibitor, KZR-261, in an e-poster during ASCO (Free ASCO Whitepaper) 2020 and remain on track for an IND submission in the first quarter of 2021."

Recent Clinical and Business Highlights

Appointment of Chief Medical Officer

Kezar appointed Noreen Roth Henig, MD as Chief Medical Officer. Dr. Henig is a seasoned leader whose career spans clinical practice, academic medicine, translational science, clinical development, medical and regulatory affairs. As an integral member of the Company’s Executive Leadership team, Dr. Henig will oversee all aspects of the Company’s clinical development, regulatory strategy, and medical affairs.

KZR-616 – Selective Immunoproteasome Inhibitor

On April 9, 2020, Kezar provided a statement on the impact of the COVID-19 pandemic to its clinical operations relating to KZR-616:

Kezar’s three clinical trials with KZR-616 (MISSION, MARINA, and PRESIDIO) remain active, but due to the unprecedented impact of the COVID-19 pandemic on the healthcare system, delays are anticipated for Phase 2 clinical development and data release milestones.

Kezar’s clinical team is working closely with clinical trial sites around the world to provide them with guidance for patients to safely enroll and continue on study.

Home health care services are available for patients participating in clinical trials with KZR-616.

Virtual site initiations and patient visits are being conducted where applicable.

As the Phase 1b portion of the MISSION study is open-label, the next updated data release is expected by the end of the second quarter in conjunction with a major medical conference.

KZR-261 – Protein Secretion Program

KZR-261, a first-in-class protein secretion inhibitor, has demonstrated broad anti-tumor activity in preclinical models of both solid and hematologic malignancies. Additional preclinical data will be presented in an e-poster during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (ASCO20) Virtual Scientific Program at the end of May.

Preclinical work with KZR-261 remains on track towards the anticipated submission of an Investigational New Drug application in the first quarter of 2021.

Business Update

On February 4, 2020, Kezar closed an underwritten public offering with gross proceeds of approximately $56.8 million, before deducting underwriting discounts and offering expenses. In the public offering, Kezar sold 16,115,385 shares of common stock at $2.60 per share and pre-funded warrants to purchase 2,884,615 shares of common stock at $2.599 per share, each with an exercise price of $0.001 per share. In addition, the underwriters exercised in full an option to purchase an additional 2,850,000 shares of common stock in the offering.

Financial Results

Cash, cash equivalents and marketable securities totaled $123.4 million as of March 31, 2020, compared to $78.2 million as of December 31, 2019. The increase in cash, cash equivalents and marketable securities was primarily attributable to the net proceeds from the underwritten public offering in February 2020, net of cash used by the Company in operations to advance its clinical stage programs and preclinical research and development. The Company believes that its current cash, cash equivalent and marketable securities are sufficient to fund planned operations into the third quarter of 2022.

Research and development expenses for the first quarter of 2020 increased by $1.6 million to $7.5 million, compared to $5.9 million in the first quarter of 2019. This increase was primarily related to advancing both the KZR-616 clinical program in multiple indications and the protein secretion preclinical program.

General and administrative expenses for the first quarter of 2020 increased by $0.6 million to $3.0 million, compared to $2.4 million in the first quarter of 2019. The increase was primarily due to an increase in personnel expenses, including non-cash stock-based compensation.

Net loss for the first quarter of 2020 was $10.0 million, or $0.30 per basic and diluted common share, compared to a net loss of $7.6 million, or $0.40 per basic and diluted common share, for the first quarter of 2019.

Total shares of common stock outstanding were 38.2 million as of March 31, 2020. Additionally, there were outstanding pre-funded warrants to purchase 2.9 million shares of common stock at an exercise price of $0.001 per share and options to purchase 4.1 million shares of common stock at a weighted average exercise price of $6.21 per share as of March 31, 2020.

About KZR-616

KZR-616 is a novel, first-in-class, selective immunoproteasome inhibitor with broad therapeutic potential across multiple autoimmune diseases. Preclinical research demonstrates that selective immunoproteasome inhibition results in a broad anti-inflammatory response in animal models of several autoimmune diseases, while avoiding immunosuppression. Data generated from Phase 1a and 1b trials provide evidence that KZR-616 potentially avoids adverse effects caused by currently marketed non-selective proteasome inhibitors, which we believe prevent them from being utilized as a chronic treatment in autoimmune disorders. Phase 2 trials are underway for the treatment of lupus nephritis (MISSION), dermatomyositis and polymyositis (PRESIDIO), and autoimmune hemolytic anemia and immune thrombocytopenia (MARINA).

About KZR-261

KZR-261, a novel, first-in-class protein secretion inhibitor, is the first clinical candidate to be nominated from Kezar’s research and discovery efforts targeting protein secretion pathways. KZR-261 is a broad-spectrum anti-tumor agent that acts through direct interaction and inhibition of Sec61 activity. The compound was discovered at Kezar through a robust medicinal chemistry campaign in which several scaffolds were progressed through the company’s proprietary platform evaluating Sec61 modulation. As a result, Kezar has established a broad library of protein secretion inhibitors. KZR-261 has demonstrated several encouraging properties that lead to its potential to be an anti-cancer agent for the treatment of solid and hematologic malignancies. IND-enabling activities are currently underway, and an IND submission in solid tumors is expected to be filed in the first quarter of 2021.

On May 7, 2020 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) reported financial results for its fiscal second quarter ended March 31, 2020 (Press release, Arrowhead Research Corporation, MAY 7, 2020, View Source [SID1234557271]). The company is hosting a conference call at 4:30 p.m. EDT to discuss results.

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Conference Call and Webcast Details

Investors may access a live audio webcast on the Company’s website at View Source For analysts that wish to participate in the conference call, please dial 855-215-6159 or 315-625-6887 and provide Conference ID 7566917.

A replay of the webcast will be available on the company’s website approximately two hours after the conclusion of the call and will remain available for 90 days. An audio replay will also be available approximately two hours after the conclusion of the call and will be available for 3 days. To access the audio replay, dial 855-859-2056 or 404-537-3406 and provide Conference ID 7566917.

Selected Recent Events

Dosed the first patients in AROHSD1001, a Phase 1/2 clinical study of ARO-HSD, the company’s investigational RNAi therapeutic being developed as a treatment for patients with alcohol related and nonalcohol related liver diseases, such as nonalcoholic steatohepatitis

Completed enrollment of the first sequential cohort in the AROAAT2002 study, a pilot open-label, multi-dose, Phase 2 study to assess changes in a novel histological activity scale in response to ARO-AAT over time in patients with alpha-1 antitrypsin deficiency associated liver disease

Completed planned enrollment in AROANG1001, a Phase 1 clinical study of ARO-ANG3, the company’s investigational RNAi therapeutic being developed for the treatment of mixed dyslipidemia

Completed discovery and optimization work and advanced ARO-Lung2, Arrowhead’s investigational RNAi therapeutic being developed for the treatment of chronic obstructive pulmonary disorder (COPD), into IND-enabling studies with a planned CTA filing in in the first half of 2021. ARO-Lung2 is against an undisclosed gene target and is the company’s second inhaled RNAi candidate to leverage the Targeted RNAi Molecule (TRiMTM) platform to the target pulmonary epithelium

Started a development program to address the current novel coronavirus that causes COVID-19 and other possible future pulmonary-borne pathogens. No additional details about this program are being disclosed at this time

Reported interim multiple-dose results on two cardiometabolic candidates ARO-APOC3, being developed as a potential treatment for patients with severe hypertriglyceridemia, and ARO-ANG3, being developed for the treatment of mixed dyslipidemia, showing high levels of reduction in APOC3, ANGPTL3, triglycerides, and other lipid parameters

Completed a regulatory submission to begin a Phase 1/2a clinical trial of ARO-ENaC, the company’s investigational RNAi therapeutic being developed as a treatment for patients with cystic fibrosis

Expanded Arrowhead’s senior management team with the hiring of Jim Hassard as chief commercial officer

Opened a second Research and Development facility in San Diego, which allows Arrowhead to tap into additional skill sets in one the country’s premier biotech hubs and also expands capacity for preclinical models to do more early research work in parallel

On May 7, 2020 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, reported its financial results for the first quarter ended March 31, 2020 and provided an update on recent developments (Press release, IGM Biosciences, MAY 7, 2020, View Source [SID1234557270]).

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"While these unprecedented times have presented many unique challenges, thanks to the hard work and dedication of the entire IGM team, we continue to make good progress," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "Notably, we recently announced a collaboration with Atreca and BeiGene which will allow us to evaluate the potential of our novel IgM and IgA antibodies for the treatment of COVID-19. Beyond this exciting new program, we continue to expect initial data from our Phase 1 trial of IGM-2323 in relapsed/ refractory NHL in the second half of 2020, as well as the filing of an IND for IGM-8444 later this year."

Recent Highlights and Pipeline Updates:

Collaboration with Atreca and BeiGene for COVID-19: In April 2020, IGM, Atreca, Inc., and BeiGene, Ltd. announced plans to collaborate to help address the COVID-19 pandemic. The companies will leverage their combined technology and expertise in an effort to discover, develop, and manufacture novel IgM and IgA antibodies targeting SARS-CoV-2 for the potential treatment of COVID-19. If research, manufacturing, and regulatory activities proceed very well, then the companies believe that an antibody may be ready to begin clinical testing in the first half of 2021.

IGM-2323

Phase 1 data expected in the second half of 2020: IGM continues to expect to report initial data from the Phase 1 trial evaluating IGM-2323 in patients with relapsed/refractory B cell NHL, the first-in-human application of IGM’s engineered IgM antibody technology, in the second half of 2020.
IGM-8444

IGM-8444 data to be presented at the ASCO (Free ASCO Whitepaper) Annual Meeting. The poster, titled "IGM-8444 as a potent agonistic Death Receptor 5 (DR5) IgM antibody: Induction of tumor cytotoxicity, combination with chemotherapy and in vitro safety profile," will be made available online via the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program beginning on Friday, May 29, at 8:00 a.m. ET.
IND filing in 2020: IGM continues to expect to file an IND with the FDA for IGM-8444 in 2020, initially for the treatment of patients with solid tumors. IGM-8444 is an IgM antibody targeting the Death Receptor 5 (DR5) protein, which is broadly expressed on a broad range of solid and hematologic malignancies.
IGM-7354

IND filing in 2021: IGM continues to expect to file an IND with the FDA for IGM-7354, the Company’s third clinical candidate, in 2021. IGM-7354 is a targeted IL-15 immune stimulating antibody which demonstrates another use of IGM’s novel J chain based bispecific technology. In this case, the immune stimulating IL-15 is displayed on the J chain of an anti-PD-L1 IgM antibody, which serves to display the immune stimulating IL-15 on the surface of PD-L1 positive cells, such as cancer cells.
First Quarter 2020 Financial Results:

Cash and Investments: Cash and investments as of March 31, 2020 were $219.0 million, compared to $236.6 million as of December 31, 2019.
Research and Development (R&D) Expenses: For the first quarter of 2020, R&D expenses were $14.6 million, compared to $5.9 million for the same period in 2019.
General and Administrative (G&A) Expenses: For the first quarter of 2020, G&A expenses were $4.0 million, compared to $1.4 million for the same period in 2019.
Net Loss: For the first quarter of 2020, net loss was $17.6 million, or a loss of $0.58 per share, compared with a net loss of $7.5 million, or a loss of $16.86 per share, for the same period in 2019.
Shares Outstanding: Weighted-average shares outstanding for the first quarter of 2020 were 30.5 million, compared to 0.4 million for the same period in 2019.
2020 Financial Guidance:

IGM reiterates its previously issued financial guidance which consisted of non-GAAP operating expenses for 2020 of approximately $75 – $85 million, excluding estimated non-cash stock-based compensation expense of approximately $8 million. Including non-cash stock-based compensation expense, IGM estimates GAAP operating expenses for 2020 of $83 – $93 million. IGM also expects to end 2020 with a balance of over $140 million in cash and investments.

On May 7, 2020 CTI BioPharma Corp. (Nasdaq: CTIC) reported its financial results for the first quarter ended March 31, 2020 (Press release, CTI BioPharma, MAY 7, 2020, View Source [SID1234557269]).

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"With a sufficient cash runway into Q4 2021, we have the resources to continue to advance pacritinib as quickly as possible as a potential treatment for severely thrombocytopenic myelofibrosis patients through the execution of the ongoing Phase 3 PACIFICA trial," said Adam R. Craig, M.D., Ph.D. "Additionally, in response to the global COVID-19 pandemic, as pacritinib has the potential to reduce the inflammatory response to the infection, which can lead to acute respiratory distress and mechanical ventilation, we recently announced the initiation of PRE-VENT, a Phase 3 double-blind, placebo-controlled, multicenter study of pacritinib for the treatment of hospitalized patients with severe COVID-19, including patients with and without cancer. We look forward to providing updates on the PRE-VENT trial in the coming months. With regards to the PACIFICA Phase 3 trial timeline, we anticipate at least a three-month delay to enrollment due to the COVID-19 pandemic."

First Quarter Financial Results
Operating loss was $11.9 million for the first quarter of 2020, compared to operating loss of $10.5 million for the same period in 2019. The increase in operating loss in the first quarter of 2020 as compared to operating loss in the same period in 2019 resulted primarily from expenses related to provisions for our Italian Value Added Tax receivables due to uncertainty regarding the collectability of such receivables as a result of the recent COVID-19 global pandemic, partially offset by decreases in research and development expenses and restructuring expenses.

License and contract revenues for the three months ended March 31, 2019 were $0.6 million while no revenues were recognized for the same period in 2020. The decrease is primarily due to royalty and other revenues recognized in 2019 from Les Laboratoires Servier and Institut de Recherches Internationales Servier ("Servier") related to transition period activities pursuant to the terms of the Termination and Transfer Agreement with Servier.
Net loss attributable to common stockholders for the first quarter of 2020 was $12.2 million, or $(0.20) for basic and diluted loss per share, compared to net loss attributable to common stockholders of $10.8 million, or $(0.19) for basic and diluted loss per share, for the same period in 2019.

As of March 31, 2020, cash, cash equivalents and short-term investments totaled $81.1 million, compared to $33.7 million as of December 31, 2019. We expect current cash, cash equivalents and short-term investments will enable us to fund our operations into the fourth quarter of 2021.

On May 7, 2020 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported its financial results for the first quarter ended March 31, 2020. In addition, the Company provided a clinical and business update (Press release, Syndax, MAY 7, 2020, View Source [SID1234557268]).

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"During the first quarter, we generated significant momentum that we believe will take us through what we expect will be a transformational year for Syndax, with key data readouts expected across the entirety of our portfolio," said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "We continue to anticipate the final overall survival readout from E2112, our Phase 3 registration trial of entinostat plus exemestane in HR+, HER2- breast cancer later this quarter, with a potential regulatory filing for entinostat in HR+ breast cancer by year end. Supported by the compelling overall survival benefit observed in the Phase 2b ENCORE 301 trial, we believe the combination of entinostat and exemestane has strong potential to serve as a much-needed option in a setting for which existing therapies are inadequate. While we await this final readout, we remain focused on preparations to establish ourselves as a fully integrated oncology company, with a potential launch expected in 2021."

Dr. Morrison added, "Beyond entinostat, we were pleased to recently announce initial Phase 1 data from the AUGMENT-101 trial of SNDX-5613, our oral menin inhibitor, in adults with relapsed/refractory acute leukemias. These data provide the first clinical evidence that inhibition of the menin-MLL1 interaction can induce response in patients with MLL-r acute leukemias. We believe that SNDX-5613 has great potential to serve as an effective intervention for both MLL-r acute leukemias and NPM1 mutant AML, and we look forward to presenting additional data from this trial in the fourth quarter of this year. With a strong balance sheet, which includes proceeds from our recent follow-on offering, we believe we are well positioned to execute on upcoming milestones."

Pipeline Updates

Entinostat

Syndax continues to anticipate that the E2112 trial will reach 410 death events this quarter, which will trigger the final overall survival (OS) analysis. E2112 is the Company’s NCI-sponsored, ECOG-ACRIN-led Phase 3 registration trial of entinostat, a Class I selective HDAC inhibitor, plus exemestane in advanced hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+, HER2-) breast cancer. A positive OS assessment would allow the Company to file for full regulatory approval in the U.S.

The E2112 trial design was informed by the Phase 2b ENCORE 301 trial, the results of which led to entinostat’s Breakthrough Therapy designation in HR+ breast cancer, in which patients receiving the entinostat/exemestane combination demonstrated a clinically meaningful OS benefit over treatment with exemestane alone. In preparation for the potential launch of entinostat in the U.S. in 2021, the Company is actively engaged in the expansion of its commercial and medical affairs functions.
SNDX-5613

Syndax recently announced initial clinical data from the Phase 1 portion of its ongoing open-label Phase 1/2 AUGMENT-101 trial of SNDX-5613, the Company’s potent, highly selective oral menin inhibitor. Data presented serve as the first clinical evidence that inhibition of the menin-MLL1 interaction can induce response in patients with mixed lineage leukemia rearranged (MLL-r) acute leukemias. The presentation, which was featured at the 2020 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting I, also highlighted preclinical findings, including data recently published in Cancer Cell and Science magazine, supporting the potential of single-agent menin-MLL inhibition to serve as an effective intervention for both MLL-r acute leukemias and nucleophosmin (NPM1) mutant acute myeloid leukemia (AML). A copy of the presentation is available on Syndax’s website under Publications, Menin-MLLR Inhibitors.

The AUGMENT-101 trial is a Phase 1/2 open-label trial designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of orally administered SNDX-5613. The Phase 1 dose escalation portion of AUGMENT-101 was recently separated into two cohorts based on concomitant treatment with a strong CYP3A4 inhibitor. Arm A will enroll patients not receiving a strong CYP3A4 inhibitor, while Arm B will enroll patients receiving a strong CYP3A4 inhibitor. The Phase 1 dose escalation portion of AUGMENT-101 is currently enrolling adults with relapsed/refractory acute leukemias including MLL-r and NPM1 mutant acute leukemias and is expected to establish a recommended Phase 2 dose for both cohorts by the fourth quarter of 2020. The Phase 2 portion will evaluate efficacy, as defined by complete response rate (per International Working Group response criteria), across three expansion cohorts: MLL-r acute lymphoblastic leukemia (ALL), MLL-r AML and NPM1 mutant AML. The Company expects to present additional results from AUGMENT-101 at a medical conference in the fourth quarter of 2020.
The Company recently announced that SNDX-5613 was granted Orphan Drug Designation for the treatment of adult and pediatric AML by the U.S. Food and Drug Administration (FDA).
Axatilimab

Enrollment continues across the Company’s Phase 1/2 trial evaluating axatilimab, its anti-CSF-1R monoclonal antibody, for the treatment of chronic graft versus host disease (cGVHD). The Phase 1 portion continues to explore alternate dose and schedules, while the Phase 2 expansion is evaluating the benefit of treatment at 1 mg/kg every two weeks. The Company expects to present additional results from the Phase 1/2 trial in the fourth quarter of 2020.
Data from the Phase 1 trials exploring axatilimab, both as a monotherapy and in combination with IMFINZI (durvalumab) in patients with locally-advanced or metastatic solid tumors, were summarized in two oral presentations at the AACR (Free AACR Whitepaper) Virtual Annual Meeting I. The data indicate that axatilimab is tolerated well in solid tumor patients and provide evidence of its ability to deplete circulating pro-inflammatory monocytes. A recommended Phase 2 dose of axatilimab for the treatment of patients with solid tumors was determined as monotherapy and in combination with IMFINZI (durvalumab). A copy of each presentation is available on Syndax’s website under Publications, Axatilimab.
Financial Update and Guidance

As of March 31, 2020, Syndax had cash, cash equivalents and short-term investments of $99.0 million and 36.1 million shares and share equivalents issued and outstanding which included 30.2 million shares of common stock and pre-funded warrants to purchase 5.8 million shares of common stock.

In May 2020, Syndax closed an underwritten public offering whereby the Company sold 5,555,556 shares of common stock at a price of $18.00 per share. The aggregate net proceeds received by the Company were $93.7 million, net of underwriting discounts and commissions and estimated offering expenses payable by the Company. The offering allows for an additional 833,333 shares to be issued pursuant to the underwriters’ exercise of their option to purchase additional shares of common stock.

In February 2020, Syndax issued 3,036,719 shares of its common stock and 1,338,287 pre-funded warrants to purchase common stock at $8.00 per share, representing a premium of 20% to the share price at market close on Thursday, January 30, 2020. As a result of the offering, Syndax received net proceeds of $34.9 million.

In February 2020, the Company entered into an agreement with Hercules Capital, Inc. (NYSE: HTGC) for a term loan of up to $30.0 million, consisting of an initial tranche of $20.0 million that was funded at the closing with the potential for a second tranche of $10.0 million subject to satisfaction of certain terms and conditions

First quarter 2020 research and development expenses decreased to $9.6 million from $11.3 million for the prior year period. The first quarter decrease was primarily due to reduced CMC activities and a net decrease in clinical activities.

General and administrative expenses for the first quarter 2020 increased to $5.9 million from $3.9 million for the prior year period. The increase was primarily due to increased pre-commercialization expenses and increased employee related expenses.

For the three months ended March 31, 2020, Syndax reported a net loss attributable to common stockholders of $19.1 million or $0.56 per share compared to $14.3 million or $0.53 per share for the prior year period.

Financial Guidance

Today the Company provided operating expense guidance for the second quarter of 2020. Financial guidance for the second half of 2020 will be issued after the Company announces the result of the E2112 study. The Company expects operating expenses for the second quarter of 2020 to increase over the quarterly operating expenses reported for the first quarter of 2020. Research and development (R&D) expenses will increase, primarily due to increased development activities for SNDX-5613. Second quarter G&A expenses are expected to be similar to the first quarter G&A expenses. For the second quarter of 2020, R&D expenses are expected to be $12 to $14 million, and total operating expenses are expected to be $18 to $20 million. Given its cash operating expense guidance, the Company expects to end the second quarter of 2020 with approximately $175 million of cash, which provides the financial flexibility to take advantage of key development milestones.

Conference Call and Webcast

In connection with the earnings release, Syndax’s management team will host a conference call and live audio webcast at 4:30 p.m. ET today, Thursday, May 7, 2020.

The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company’s website at www.syndax.com. Alternatively, the conference call may be accessed through the following:

Conference ID: 5579109
Domestic Dial-in Number: (855) 251-6663
International Dial-in Number: (281) 542-4259
Live webcast: View Source

For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Investors section of the Company’s website, www.syndax.com.