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NeuBase Therapeutics Reports Financial Results for the Fiscal Third Quarter of 2019

On August 14, 2019 NeuBase Therapeutics, Inc. (NASDAQ: NBSE) ("NeuBase" or the "Company"), a biotechnology company developing next-generation antisense therapies to address genetic diseases, reported financial results for the three and nine month periods ended June 30, 2019, which only include the financial results for Ohr Pharmaceutical prior to the merger and associated financings (Press release, Ohr Pharmaceutical, AUG 14, 2019, View Source [SID1234538799]).

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"Over the past several months, we have positioned the Company with the capital and industry expertise required to advance our strategy to develop antisense oligonucleotide therapeutics by leveraging our PATrOL platform," said Dietrich Stephan, Ph.D., chairman and chief executive officer of NeuBase. "Looking ahead, we are developing next-generation antisense oligonucleotide therapeutics for rare genetic diseases with a goal of transforming patients’ lives. We are currently advancing several preclinical programs, including NT0100 to target Huntington’s Disease and NT0200 to target myotonic dystrophy."

Fiscal Third Quarter of 2019 and Recent Operating Highlights

●Shares of the Company’s common stock commenced trading on the Nasdaq Capital Market under the ticker symbol "NBSE" as of market open on July 15, 2019.
●Completed two financings raising an aggregate of approximately $14 million in gross proceeds, which occurred alongside the Nasdaq listing and included a $5 million investment from Greenlight Capital.
●Appointed four experienced executives from the biotechnology industry to the board of directors: Dr. Dov Goldstein, Dr. Diego Miralles, Dr. Franklyn Prendergast, and Eric Richman.
●Appointed Dr. Danith Ly, the primary inventor of NeuBase’s peptide nucleic acid (PNA) antisense oligonucleotide (PATrOL) platform technology, as the Company’s chief scientific officer.
●Expanded the scientific advisory board with the appointments of Dr. Samuel Broder (former National Cancer Institute Director) and Dr. George Church (Harvard Medical School professor).

Financial Results for the Three Months Ended June 30, 2019:

●For the three months ended June 30, 2019, the Company reported a net loss of approximately $1.1 million, or ($0.40) per share, compared to a net loss of approximately $0.5 million, or ($0.19) per share, in the three months ended June 30, 2018. Loss per share amounts have been retroactively adjusted for the reverse stock split effected on February 4, 2019.
●For the three months ended June 30, 2019, total operating expenses were approximately $1.1 million, consisting of approximately $0.9 million in general and administrative expenses, $0.1 million of research and development expenses, and $0.2 million in depreciation and amortization. This compares to total operating expenses of $1.2 million in the three months ended June 30, 2018, comprised of approximately $0.8 million in general and administrative expenses, $0.1 million in research and development expenses, and $0.3 million in depreciation and amortization.
●At June 30, 2019, the Company had cash and cash equivalents of approximately $1.4 million, compared to cash and equivalents of approximately $3.8 million at September 30, 2018. Subsequent to the end of the quarter, NeuBase completed two financings alongside the closing of the merger in July 2019, raising gross proceeds of approximately $14 million. The Company believes that its current cash balance will provide sufficient capital to fund operations through the end of fiscal 2020.

Financial Results for the Nine Months Ended June 30, 2019:

●For the nine months ended June 30, 2019, the Company reported a net loss of approximately $3.2 million, or ($1.12) per share, compared to a net loss of approximately $6.9 million, or ($3.36) per share, in the same period of 2018. Loss per share amounts have been retroactively adjusted for the reverse stock split effected on February 4, 2019.
●For the nine months ended June 30, 2019, total operating expenses were approximately $3.2 million, consisting of approximately $2.5 million in general and administrative expenses, $0.2 million of research and development expenses, and $0.5 million in depreciation and amortization. This compares to total operating expenses of approximately $7.5 million in the same period of 2018, consisting of approximately $2.9 million in general and administrative expenses, $4.2 million of research and development expenses, $0.8 million in depreciation and amortization, $0.7 million in impairment of goodwill, and $1.2 million in gain on settlement of accounts payable and long term liabilities.

Y-mAbs Announces Second Quarter 2019 Financial Results and Recent Corporate Developments

On August 14, 2019 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported financial results for the second quarter of 2019 (Press release, Y-mAbs Therapeutics, AUG 14, 2019, View Source [SID1234538780]).

"We are very pleased with our second quarter results, highlighted by prudent spending combined with notable progress in the preparation of the initial portions of our rolling BLAs for our two lead product candidates, naxitamab and omburtamab, for submission to the FDA later this year. We continue to solidify our position as a leader in pediatric oncology and as a company focused on rapidly developing therapies to extend and enhance the lives of those living with rare pediatric cancers," stated Thomas Gad, Founder, Chairman, President and Head of Business Development and Strategy.

Dr. Claus Moller, Chief Executive Officer, continued, "We believe our recent pre-BLA meeting with the FDA supports our ambition of initiating submission of a rolling BLA for naxitamab for the treatment of relapsed/refractory high-risk neuroblastoma in the fourth quarter of 2019, with the expectation that the final portion will be submitted in early 2020. We are also excited to initiate the submission of a rolling BLA for omburtamab for the treatment of central nervous system/leptomeningeal metastasis from neuroblastoma by the end of 2019, and expect to submit the two rolling BLAs almost concurrently. These are exciting times for Y-mAbs."

Second Quarter 2019 and Recent Corporate Developments

Subsequent to the end of the second quarter, on July 8, 2019, Y-mAbs announced that it has completed a successful pre-BLA meeting with the FDA regarding a potential pathway for FDA approval of naxitamab for the treatment of relapsed/refractory high-risk neuroblastoma. During the meeting, the Company reached alignment with the FDA on an Accelerated Approval Pathway for naxitamab along with a rolling BLA submission. The Company expects to submit the Clinical/Safety portion and the non-Clinical portion of the BLA in November 2019. For the Chemistry, Manufacturing and Controls (CMC) portion, the Company believes it will have sufficient data from the Process Performance Qualification (PPQ) batches to complete the CMC portion in early 2020. Y-mAbs continues to evaluate potential avenues to accelerate the submission of the CMC portion, and hopes to comply with FDA requirements at an earlier time.

Also subsequent to the end of the second quarter, on July 1, 2019, Y-mAbs announced the status of patient recruitment for the Company’s two pivotal phase II trials, one for omburtamab for the treatment of central nervous system/leptomeningeal metastasis (CNS/LM) from neuroblastoma and the other for naxitamab for the treatment of relapsed/refractory high-risk neuroblastoma. As of June 30, 2019, all of the 18 planned omburtamab patients had been enrolled in the study. The Company believes it remains on track to start submission of a rolling BLA in 2019 under the Breakthrough Therapy Designation that the Company previously received from the FDA. For naxitamab, more than 30 patients of a planned total of 37 patients in the Company’s Study 201 had been enrolled in the study as of June 30, 2019.

After the close of the second quarter, on July 1, 2019, Y-mAbs announced that the Company has entered into a development, manufacturing and supply agreement with SpectronRx in South Bend, Indiana, to secure access to clinical and commercial scale radiolabeling capacity for omburtamab. Under the terms of the agreement, SpectronRx has agreed to establish a manufacturing unit designated for Y-mAbs within its existing facilities, at which Y-mAbs believes both clinical and commercial supply of radiolabeled omburtamab can be produced.

On June 26, 2019, Y-mAbs announced the acceptance of two oral presentations and five poster presentations at the International Society of Pediatric Oncology (SIOP) Annual Congress for its two lead product candidates, naxitamab and omburtamab.

On May 15, 2019, Y-mAbs announced the acceptance of three poster presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting for its two lead product candidates, naxitamab and omburtamab.

On May 14, 2019, Y-mAbs announced an update on its GD2-GD3 Vaccine program for relapsed high-risk neuroblastoma. A total of 230 patients have received the GD2-GD3 Vaccine to date and Y-mAbs plans to begin using a newly manufactured Current Good Manufacturing Practice (cGMP) drug product in the fourth quarter of 2019.
Second Quarter 2019 Financial Results

Y-mAbs reported a net loss of $18.0 million, or $0.53 per basic and diluted share, for the three months ended June 30, 2019, compared to a net loss of $10.3 million, or $0.39 per basic and diluted share, for the three months ended June 30, 2018.

For the six months ended June 30, 2019, Y-mAbs reported a net loss of $34.0 million, or $0.99 per basic and diluted share, compared to a net loss of $17.8 million, or $0.66 per basic and diluted share, reported for the six months ended June 30, 2018.

Operating Expenses

Research and Development
Research and development expenses were $14.5 million for the three months ended June 30, 2019, compared to $8.3 million for the three months ended June 30, 2018, an increase of $6.2 million. The increase in research and development expenses primarily reflects the following:

$2.9 million increase in outsourced manufacturing for our two lead product candidates, naxitamab and omburtamab;
$2.2 million increase in outsourced research and supplies to support expanding development activities; and
$0.7 million increase in personnel costs.
Research and development expenses were $27.0 million for the six months ended June 30, 2019, compared to $14.5 million for the six months ended June 30, 2018, an increase of $12.5 million. The increase in research and development expenses primarily reflects the following:

$7.2 million increase in outsourced manufacturing for our two lead product candidates, naxitamab and omburtamab;
$3.5 million increase in outsourced research and supplies to support expanding development activities; and
$1.4 million increase in personnel costs.
General and Administration
General and administrative expenses were $4.1 million for the three months ended June 30, 2019, compared to $2.0 million for the three months ended June 30, 2018, an increase of $2.1 million. Such increase in general and administrative expenses primarily reflects the following:

$1.4 million increase in personnel costs; and
$0.5 million increase in commercial infrastructure.
General and administrative expenses were $7.9 million for the six months ended June 30, 2019, compared to $3.2 million for the six months ended June 30, 2018, an increase of $4.7 million. Such increase in general and administrative expenses primarily reflects the following:

$2.8 million increase in personnel costs; and
$0.8 million increase in commercial infrastructure costs.
Cash and Cash Equivalents
The Company had approximately $120.2 million in cash and cash equivalents as of June 30, 2019, compared to $147.8 million as of December 31, 2018. The decrease of $27.6 million was primarily attributable to the increased costs of operation as the Company prepares for its submission of rolling BLAs for naxitamab and omburtamab and the build-up of the Company’s commercial infrastructure.

Webcast and Conference Call

The Company will host a conference call today at 4:30 pm Eastern Time. To participate in the call, please dial (877) 407-0792 (domestic) or (201) 689-8263 (international) and reference the access code 13693605. A webcast will be available at: View Source

Oncolytics Biotech® Announces Pricing of Its USD $3.7M – CDN $4.9M Public Offering of Common Share and Warrants

ON August 14, 2019 Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) (the "Company"), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported an update to confirm that its previously announced underwritten public offering of USD $3.7M (CDN $4.9M) was priced at USD $0.81 (CDN $1.07) (Press release, Oncolytics Biotech, AUG 14, 2019, View Source [SID1234538779]).

All other details of the previous release are correct and copied below:

Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) (the "Company"), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported the pricing of its previously announced underwritten public offering (the "Offering") of 4,619,773 common shares and warrants to purchase up to 4,619,773 common shares at a combined public offering price of $0.81 per share and warrant, resulting in gross proceeds of approximately USD 3.7M. Each warrant has an exercise price of $0.90 per common share, is exercisable immediately and will expire 5 years from the date of issuance. The common shares and the accompanying warrants can only be purchased together in this Offering but will be issued separately.

The Offering is expected to close on or about August 16, 2019, subject to the satisfaction of customary closing conditions. Oncolytics has also granted to the underwriter a 30-day option to purchase up to an additional 692,965 common shares and/or warrants to purchase up to 692,965 common shares, at the public offering price per common share and warrant, less underwriter discounts and commissions. The Offering is subject to customary closing conditions, including Nasdaq and TSX approvals.

The Company intends to use the net proceeds of this Offering for research and development activities and working capital purposes.

Ladenburg Thalmann & Co. Inc., a subsidiary of Ladenburg Thalmann Financial Services Inc. (LTS), is acting as the sole book-running manager in connection with the Offering.

The Offering is being made pursuant to a U.S. registration statement on Form F-10, declared effective by the United States Securities and Exchange Commission (the "SEC") on May 7, 2018 (the "Registration Statement"), and the Company’s existing Canadian short form base shelf prospectus (the "Base Shelf Prospectus") dated May 4, 2018. The prospectus supplements relating to the Offering (together with the Base Shelf Prospectus and the Registration Statement, the "Offering Documents") have been filed with the Alberta Securities Commission in Canada, and with the SEC in the United States. No common shares or warrants will be offered or sold to Canadian purchasers. The Offering Documents will contain important detailed information about the securities being offered. Before you invest, you should read the Offering Documents and the other documents the Company has filed with the SEC for more complete information about the Company and the Offering. Copies of the Offering Documents will be available for free by visiting the Company’s profiles on the SEDAR website maintained by the Canadian Securities Administrators at www.sedar.com or the SEC’s website at www.sec.gov. Alternatively, when available, copies of the final prospectus supplement can also be obtained from Ladenburg Thalmann & Co. Inc., Attn: Prospectus Department, 277 Park Avenue, 26th Floor, New York, New York 10172 or by email at [email protected].

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

Genmab Announces Financial Results for the First Half of 2019 and Updates 2019 Financial Guidance

On August 14, 2019 Genmab reported that Interim Report for the First Half of 2019(Press release, Genmab, AUG 14, 2019, View Source [SID1234538770])

Highlights

Registration statement filed with the U.S. Securities and Exchange Commission for the proposed public offering of American Depository Shares and application submitted for listing of the ADSs on the Nasdaq Global Select Market under the symbol "GMAB." The public offering and listing were completed in July.
Agreement signed with Janssen Biotech, Inc. (Janssen) to collaborate exclusively on next-generation CD38 antibody product candidate, HexaBody-CD38.
The U.S. Food and Drug Administration (U.S. FDA) approved DARZALEX (daratumumab) in combination with lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
The U.S. FDA granted Priority Review for daratumumab in combination with bortezomib, thalidomide and dexamethasone as treatment for newly diagnosed patients with multiple myeloma who are candidates for autologous stem cell transplant.
Janssen initiated Phase III study to examine daratumumab plus lenalidomide as maintenance treatment in patients with newly diagnosed multiple myeloma.
DARZALEX net sales increased 49% over H1 2018 to USD 1,403 million, resulting in royalty income of DKK 1,169 million.
Genmab is updating its 2019 financial guidance due to increased royalty income related to the sales of DARZALEX and increased operating expenses as a result of the advancement of our product pipeline, resulting in a small increase in projected operating income.
"The first half of 2019 brought truly transformational change to Genmab as we began the process of becoming a dual-listed company, with the potential to trade shares in both the U.S. (in the form of ADSs) and in Denmark. We also built upon our already successful relationship with Janssen with the signing of an agreement to collaborate exclusively on the next-generation CD38 antibody product candidate, HexaBody-CD38. We have seen encouraging pre-clinical data from HexaBody-CD38 and believe it has the potential to extend the promise of CD38-targeted therapies beyond what is currently available for patients," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "In addition to these key events, the first half of 2019 also saw the highly anticipated U.S. FDA approval for DARZALEX, based on the Phase III MAIA data. Now that this indication has been approved many more patients in the U.S. who are newly diagnosed with multiple myeloma will have a DARZALEX containing regimen as a choice for their initial therapy."

Financial Performance First Half of 2019

Revenue was DKK 1,365 million in the first half of 2019 compared to DKK 1,191 million in the first half of 2018. The increase of DKK 174 million, or 15%, was mainly driven by higher DARZALEX royalties and reimbursement income from our collaborations with Seattle Genetics and BioNTech, partly offset by the one-time payment from Novartis of USD 50 million (DKK 304 million) during the first half of 2018 for lost potential milestones and royalties following announcement of Novartis’ intention to transition Arzerra (ofatumumab) to limited availability via compassionate use programs for chronic lymphocytic leukemia (CLL) in non-U.S. markets.
Net sales of DARZALEX by Janssen were USD 1,403 million in the first half of 2019 compared to USD 943 million in the first half of 2018, an increase of USD 460 million, or 49%. According to Johnson & Johnson, sales in the second quarter of 2019 included a one-time adjustment related to the completion of pricing and reimbursement discussions in certain European countries, which positively impacted this worldwide second quarter operational growth by 16 percentage points.
Operating expenses were DKK 1,254 million in the first half of 2019 compared to DKK 732 million in the first half of 2018. The increase of DKK 522 million, or 71%, was driven by the advancement of enapotamab vedotin and tisotumab vedotin, additional investments in our product pipeline, and the increase in new employees to support the expansion of our product pipeline.
Operating income was DKK 111 million in the first half of 2019 compared to DKK 459 million in the first half of 2018. As anticipated, the decrease of DKK 348 million, or 76%, was driven primarily by increased operating expenses and the one-time payment from Novartis in 2018.
Subsequent Event

July: Completion of public offering and listing of American Depository Shares (ADSs) on Nasdaq Global Select Market under the symbol "GMAB". Gross proceeds from the issuance of new shares amounted to USD 506 million (DKK 3,368 million) with a corresponding increase in share capital of 2,850,000 ordinary shares or 28,500,000 American Depository Shares ("ADSs"). Further, the underwriters’ exercised in full their option to purchase an additional 427,500 ordinary shares or 4,275,000 ADSs bringing the total gross proceeds of the offering to USD 582 million (DKK 3,873 million). The public offering price of $17.75 per ADS, corresponded to a subscription price of DKK 1,181.80 per New Share at the U.S. dollar/DKK exchange rate of DKK 6.6580 per USD 1.00 on July 17, 2019, multiplied by the ADS-to-share ratio of ten-to-one. Underwriting commissions paid were USD 32 million (DKK 213 million). Total share capital following the public offering amounted to DKK 64,967,643.
Outlook
Genmab is updating its 2019 financial guidance published on February 20, 2019 due to increased royalty income related to the sales of DARZALEX and increased operating expenses as a result of the advancement of our product pipeline.

MDKK Revised Guidance Previous
Guidance
Revenue 4,800 4,600
Operating expenses (2,750) (2,600)
Operating income 2,050 2,000
Conference Call
Genmab will hold a conference call in English to discuss the results for the first half of 2019 today, Wednesday, August 14, at 6:00 pm CEST, 5:00 pm BST or 12:00 pm EDT. To join the call dial
+1 631 510 7495 (U.S. participants) or +44 2071 928000 (international participants) and provide conference code 4966139.

A live and archived webcast of the call and relevant slides will be available at www.genmab.com.

Contact:
Marisol Peron, Corporate Vice President, Communications & Investor Relations
T: +1 609 524 0065; E: [email protected]

For Investor Relations:
Andrew Carlsen, Senior Director, Investor Relations
T: +45 3377 9558; E: [email protected]

SELLAS Life Sciences Provides Business Update and Reports Second Quarter 2019 Financial Results

On August 14, 2019 SELLAS Life Sciences Group, Inc. (Nasdaq:SLS) ("SELLAS" or the "Company"), a late-stage biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported financial results for the quarter ended June 30, 2019 (Press release, Sellas Life Sciences, AUG 14, 2019, View Source [SID1234538766]).

"In recent months, we have made clinical advancements across our pipeline of novel cancer peptide vaccines, particularly with our program for galinpepimut-S (GPS) in combination with anti-PD-1 therapies where we believe these treatments may be synergistic," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "As we look forward, we anticipate the following key milestones during the remainder of the year: (i) initiation of our Phase 3 registrational study of GPS in patients with acute myeloid leukemia (AML), (ii) first patient dosed in the investigator-sponsored study of GPS in combination with nivolumab in patients with malignant pleural mesothelioma (MPM), and (iii) initial clinical data from our Phase 2 trial of nelipepimut-S (NPS) in ductal carcinoma in situ (DCIS). Additionally, in the first quarter of 2020, initial clinical data is expected from our Phase 1/2 basket study of GPS in combination with KEYTRUDA (pembrolizumab)."

Dr. Stergiou added, "Importantly, with our recent follow-on offering, we strengthened our balance sheet in order to support our clinical development programs through what we believe will be value-creating inflection points. We look forward to hosting our first R&D Investor Day in November where we will present our GPS immunotherapy programs in greater detail, particularly the Phase 3 AML study, and key opinion leaders will discuss the current treatments of solid tumors and hematologic malignancies and the potential role of GPS in treating these devastating diseases."

Recent Pipeline Highlights

Galinpeptimut-S (GPS) Program
The Company’s planned Phase 3 registrational randomized, open-label study comparing GPS in the maintenance setting to investigators’ choice of best available treatment in adult AML patients who have achieved hematologic complete remission, with or without thrombocytopenia (CR2/CR2p), after second-line antileukemic therapy and who are deemed ineligible for or unable to undergo allogeneic stem-cell transplantation is expected to be initiated in the fourth quarter of 2019.
In July 2019, the Company announced the dosing of the first patient in its Phase 1/2 open-label, non-comparative, multicenter, multi-arm study of GPS in combination with Merck’s anti-PD-1 therapy, pembrolizumab, in patients with selected WT1-positive advanced cancers, including both solid tumors and hematologic malignancies. The study is initially evaluating patients with ovarian cancer (second or third line) and colorectal cancer (third or fourth line), to be followed by patients with AML who are unable to attain deeper morphological response than partial on hypomethylating agents and who are not eligible for allogeneic hematopoietic stem cell transplant and patients with triple negative breast cancer (TNBC) (second line), and small cell lung cancer (second line). The primary endpoints of this study include safety and overall response rate, and secondary endpoints include progression-free survival, overall survival and immune response correlates. Initial clinical data is expected from the study in the first quarter of 2020.
In April 2019, the Company announced an agreement with Memorial Sloan Kettering Cancer Center to conduct an investigator-sponsored clinical trial of GPS in combination with Bristol-Myers Squibb’s anti-PD-1 therapy, nivolumab, in patients with MPM. The Phase 1 open-label clinical study will enroll patients with MPM who harbor relapsed or refractory disease after having received frontline standard of care multimodality therapy with study drug provided by both SELLAS and Bristol-Myers Squibb.
In April 2019, SELLAS was granted its first licensed patent in China, covering additional analog peptides of the Wilms’ tumor oncogene protein (WT1), shown to induce enhanced T cell responses.

Nelipepimut-S (NPS) Program
In August 2019, SELLAS announced completion of enrollment in a Phase 2 investigator-sponsored trial of NPS in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) in women with DCIS of the breast who are HLA-A2+ or A3+ positive, express HER2 at IHC 1+, 2+, or 3+ levels, and are pre- or post-menopausal. The Phase 2 trial is sponsored and operated by the National Cancer Institute to study NPS’ potential clinical effects in earlier-stage disease. The primary endpoint of the trial is the difference in the frequency of newly induced NPS-cytotoxic T lymphocytes (CTL; CD8+ T-cell) in peripheral blood between the two arms of the study, using a dextramer assay. Initial data from this trial is expected by the end of 2019.
In June 2019, immune response data from a preplanned analysis in the cohort of patients with TNBC from the prospective, randomized, single-blinded, controlled Phase 2b independent investigator-sponsored clinical trial of NPS +/- trastuzumab (Herceptin) targeting HER2 low-expressing breast cancer patients were presented at the 55th Annual ASCO (Free ASCO Whitepaper) Meeting. The data showed highly clinically indicative increases in immune responses in the NPS plus trastuzumab patients as compared to the trastuzumab-alone arm.
Recent Corporate Highlights

In June 2019, SELLAS announced the closing of an underwritten public offering of (i) 26,367,200 shares of common stock together with common stock warrants (common warrants) to purchase 26,367,200 shares of common stock and (ii) 73,632,800 pre-funded warrants, with each pre-funded warrant exercisable for one share of common stock, together with common warrants to purchase 73,632,800 shares of common stock, for net proceeds of approximately $13.4 million.
R&D Investor Day Scheduled

The Company will host its first R&D Investor Day in New York, NY on Friday, November 15, 2019. The agenda includes updates regarding the GPS Phase 3 AML clinical trial and Phase 1/2 basket study in combination with pembrolizumab, and scientific discussions from key opinion leaders in cancer immunotherapeutics, including Dr. Hagop M. Kantarjian, MD, Professor and Chair of the Department of Leukemia at the University of Texas MD Anderson Cancer Center, and principal investigator of the Phase 3 AML clinical trial.

Second Quarter 2019 Financial Results

Cash Position: As of June 30, 2019, cash and cash equivalents totaled approximately $12.8 million, which includes the net proceeds of approximately $13.4 million from the Company’s underwritten public offering of shares of common stock and pre-funded warrants and accompanying common stock warrants to purchase shares of common stock consummated in June 2019.

R&D Expenses: Research and development expenses were $1.4 million for the second quarter of 2019, as compared to $1.6 million for the second quarter of 2018. The $0.2 million decrease was primarily attributable to a $0.5 million decrease in personnel related expenses due to reduced headcount and a $0.3 million decrease in outsourced clinical and regulatory consulting services. These decreases were partially offset by a $0.5 million increase in clinical trial expenses related to the Company’s ongoing basket trial of GPS in combination with pembrolizumab and a $0.1 million increase in licensing fees. Research and development expenses for the six months ended June 30, 2019 were $3.2 million, as compared to $3.4 million for the same period in 2018. The decrease of $0.2 million was primarily attributable to a $0.8 million decrease in personnel related expenses resulting from reduced headcount, partially offset by a $0.3 million increase in clinical trial expenses for the GPS basket trial and an increase of $0.3 million in licensing fees.

G&A Expense: General and administrative expenses were $2.6 million for the second quarter of 2019, as compared to $4.9 million for the second quarter of 2018. The $2.3 million decrease was primarily due to a $1.3 million decrease in legal fees, a $0.4 million decrease in public company costs, a $0.3 million decrease in personnel related expenses due to reduced headcount and a $0.3 million decrease in other expenses. General and administrative expenses for the first half of 2019 were $5.1 million, as compared to $8.8 million for the six months ended June 30, 2018. The $3.7 million decrease during the period was primarily related to a $1.8 million decrease in legal fees, a $0.5 million decrease in public company costs, a $0.4 million decrease in accounting and audit fees, a $0.3 million decrease in personnel related expenses due to reduced headcount, a $0.3 million decrease in outsourced consulting fees and a $0.4 million decrease in other expenses.

Net Loss: Net loss attributable to common stockholders was $4.1 million for the second quarter of 2019, or a basic and diluted loss per share attributable to common stockholders of $0.13, as compared to a net loss attributable to common stockholders of $8.5 million for the second quarter of 2018, or a basic and diluted loss per share attributable to common stockholders of $1.26. Net loss attributable to common stockholders was $9.1 million for the six months ended June 30, 2019, or a basic and diluted loss per share attributable to common stockholders of $0.33, as compared to a net loss attributable to common stockholders of $18.5 million for the six months ended June 30, 2018, or a basic and diluted loss per share attributable to common stockholders of $2.89.

Keytruda and Herceptin are registered trademarks of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA, and Genentech, Inc., respectively, and are not trademarks of SELLAS. The manufacturers of these brands are not affiliated with and do not endorse SELLAS or its products.