On August 10, 2015 MabVax Therapeutics Holdings, Inc. (OTCQB: MBVX), a clinical-stage oncology drug development company, provided a corporate update and reported financial results for the quarter ended June 30, 2015 (Filing, 8-K, Telik, AUG 10, 2015, View Source [SID:1234507187]).

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"We are reporting progress toward achieving our near-term drug development milestones and with our capital formation," stated MabVax’s President and Chief Executive Officer David Hansen. "We completed a $11.7 million equity financing led by OPKO Health, Inc., and its Chairman and Chief Executive Officer, biotech investor and entrepreneur Dr. Phillip Frost, which put MabVax in one of the best financial positions in our corporate history. We finished the second quarter with approximately $7.2 million in cash and equivalents, including the release on June 30, 2015, of $3.5 million of funds from the equity financing to the Company that were being held in escrow by OPKO Health, Inc. and Frost Gamma Investment Trust. We believe that our current cash position is sufficient to support our near-term drug discovery and development efforts."

"The encouraging results from our non-human primate safety study for HuMab 5B1 further support our plan to file two Investigational New Drug applications, or INDs, with the FDA by 2015 year-end and begin both clinical trials in the first quarter of 2016," he added. "The GMP manufacturing of our clinical supplies of HuMab 5B1-based product for both clinical trials is on track for delivery in the fourth quarter of this year."

MabVax plans to initiate two complementary Phase I clinical trials in the first quarter of 2016. One clinical trial is aimed at determining the safety and potential utility of HuMab 5B1 as a therapeutic agent in subjects with metastatic pancreatic cancer. The second clinical trial is aimed at demonstrating the utility of 89Zr-HuMab 5B1, the Company’s radio-labeled HuMab 5B1 antibody, as a next-generation PET imaging agent for the diagnosis, staging, and management of pancreatic cancer.

Second Quarter and Recent Highlights

Significant financing transaction with a leading investor – April 10, 2015 – closed on approximately $11.7 million in a private placement led by OPKO Health, Inc. and its Chairman and CEO Dr. Phillip Frost. On June 30, 2015, OPKO Health, Inc. and Frost Gamma Investment Trust investments in the aggregate of $3.5 million associated with the financing were released from escrow.

Encouraging results of non-human primate toxicology study – On May 5, 2015, announced results from non-GLP toxicology testing of HuMab 5B1 antibody completed by a leading independent contract research organization. These results detailed that the antibody, administered in either a single dose or repeated doses, produced no significant adverse findings even at the highest dosage levels tested. Non-human primates in this acute dose range finding study were challenged with multiple dose levels to assess drug pharmacokinetics, as well as with repeated doses of the antibody to identify any adverse toxicology signals. These studies were conducted in the most relevant animal models with material produced by the Company’s GMP manufacturing partner. The antibody as tested is representative of the clinical supply material scheduled for delivery later this year for the planned Phase I clinical trials.

Rockefeller University Collaboration – In July 2015, entered into a research collaboration agreement to supply Rockefeller University’s Laboratory of Molecular Genetics and Immunology with antibody material to explore the mechanism of action of constant region (Fc) variants of the HuMab 5B1 in the role of tumor clearance. The Company will supply additional research materials as requested by the university, which is evaluating ways to optimize the function.

Second Quarter 2015 Financial Results

• Grant revenues totaled approximately $137,000.

• Research and development expenses were $2.3 million.

• General and administrative expenses totaled approximately $4.2 million.

• Net loss for the quarter was $6.4 million, or $0.29 per share, on approximately 25.2 million shares of common stock outstanding.

• Completed $11.7 million financing including the release of $3.5 million in funds held in escrow.

• At June 30, 2015, cash and cash equivalents totaled $7.2 million.

About HuMab 5B1

In pre-clinical research, MabVax’s HuMab 5B1 antibody has demonstrated high specificity, affinity and lack of cross-reactivity with closely related antigens. The antibody has also shown potent cancer cell killing capacity and efficacy in animal models of pancreatic, colon and small cell lung cancer. When combined with a radio-label as a novel PET imaging agent, 89Zr-HuMab 5B1 has demonstrated high image resolution of tumors in established xenograft animal models, making it attractive as a potential companion diagnostic for the therapeutic product.

On August 10, 2015 Stemline Therapeutics, Inc. (Nasdaq:STML), a clinical stage biopharmaceutical company developing novel oncology drugs that primarily target cancer stem cells (CSCs) and tumor bulk, reported financial results for the quarter ended June 30, 2015 (Press release, Stemline Therapeutics, AUG 10, 2015, View Source [SID:1234507184]).

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Ivan Bergstein, M.D., Stemline’s Chief Executive Officer, commented, "This quarter, we began enrollment in the expansion stage of our SL-401 pivotal trial in BPDCN, a highly aggressive malignancy of unmet medical need. This follows completion of the lead-in stage of this trial, wherein we evaluated multiple cycle SL-401 administration at escalating doses in first-line and relapsed/refractory BPDCN as well as relapsed/refractory AML. In the lead-in, we established a dose and schedule for the expansion stage, and observed major objective responses, including complete responses, some with gross clearance of bulky disease in multiple organ systems in BPDCN. We are encouraged by both the lack of cumulative side effects and cases of ongoing efficacy seen thus far with multiple cycles. The expansion stage focuses on relapsed/refractory BPDCN patients, which we believe could support registration. We look forward to updating and reporting detailed data at upcoming medical conferences."

Dr. Bergstein continued, "With the expansion stage of our BPDCN pivotal trial underway, we continue to pursue additional opportunities to expand SL-401’s potential in other malignancies, and have opened trials in early and late stage AML and high-risk myeloproliferative neoplasms. We also continue to advance and position our other pipeline candidates, SL-701 and SL-801. With a strong cash position and multiple programs advancing in a variety of indications, we remain well positioned to achieve our objective of building a leading commercial stage biopharmaceutical company."

Second Quarter 2015 Financial Results Review

Stemline ended the second quarter of 2015 with $109.0 million in cash, cash equivalents and investments, as compared to $58.6 million as of December 31, 2014. In the first quarter of 2015, the Company completed an equity offering raising $68.6 million in gross cash proceeds on the sale of 4.4 million common shares.

For the second quarter of 2015, Stemline had a net loss of $10.2 million, or $0.58 per share, compared with a net loss of $6.0 million, or $0.47 per share, for the same period in 2014.

Research and development expenses were $8.2 million for the second quarter of 2015, which reflects an increase of $4.1 million compared with $4.1 million for the second quarter of 2014. The higher expenses during the second quarter were primarily attributable to the SL-401 clinical program due largely to the ramp up of patient accrual.

General and administrative expenses were $2.2 million for the second quarter of 2015, which reflects an increase of $0.2 million compared with $2.0 million for the second quarter of 2014. The higher costs were primarily attributable to an increase in stock based compensation expense relating to administrative employees.

On August 10, 2015 Puma Biotechnology, Inc. (NYSE: PBYI), a development stage biopharmaceutical company, reported financial results for the second quarter ended June 30, 2015 (Filing, 8-K, Puma Biotechnology, AUG 10, 2015, View Source [SID:1234507176]).

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Unless otherwise stated, all comparisons are for the second quarter and first half of the year 2015 compared to the second quarter and first half of the year 2014.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported a net loss applicable to common stock of $64.7 million, or $2.01 per share, for the second quarter of 2015, compared to a net loss of $38.8 million, or $1.29 per share, for the second quarter of 2014. Net loss applicable to common stock for the first half of 2015 was $117.1 million, or $3.68 per share, compared to $58.6 million, or $1.96 per share, for the first half of 2014.

Adjusted net loss applicable to common stock was $36.5 million, or $1.13 per share, for the second quarter of 2015, compared to adjusted net loss applicable to common stock of $31.6 million, or $1.05 per share, for the second quarter of 2014. Adjusted net loss applicable to common stock for the first half of 2015 was $68.8 million, or $2.16 per share, compared to $46.3 million, or $1.55 per share, for the first half of 2014. Adjusted net loss applicable to common stock excludes stock-based compensation expense, which represents a significant portion of overall expense and has no impact on the cash position of the Company. For a reconciliation of adjusted net loss applicable to common stock to reported net loss applicable to common stock, please see the financial tables at the end of this news release.

Net cash used in operating activities for the second quarter of 2015 was $34.6 million. Net cash used in operating activities for the first half of 2015 was $84.6 million. At June 30, 2015, Puma had cash and cash equivalents of $59.8 million and marketable securities of $222.5 million, compared to cash and cash equivalents of $38.5 million and marketable securities of $102.8 million at December 31, 2014. Puma’s current level of cash and cash equivalents and marketable securities includes net proceeds of approximately $205.0 million from a public offering of the Company’s common stock, which was completed in January 2015.

"During the second quarter of 2015 we presented data from the Phase III ExteNET trial at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting," said Alan H. Auerbach, chairman and chief executive officer of Puma. "The positive study demonstrated that treatment with neratinib as extended adjuvant treatment following adjuvant treatment with trastuzumab in women with early-stage HER2 positive breast cancer reduced the risk of disease recurrence by 33%. The two-year disease-free survival rate was 93.9% in the neratinib arm versus 91.6% in the placebo arm. We anticipate our NDA filing for neratinib for the extended adjuvant setting during the first quarter of 2016. Also in the second quarter of 2015, we expanded the second cohort in the Phase II basket trial, which is evaluating the safety and efficacy of neratinib in patients with solid tumors who have an activating HER2 mutation. The second cohort includes patients with metastatic non-small cell lung cancer and whose tumors have a HER2 mutation.

"We expect to continue to execute on our ongoing Phase II and Phase III trials of PB272 in the second half of 2015 and beyond.
In addition, during the second half of 2015, we expect to (i) publish Phase III
ExteNET trial results in the extended adjuvant treatment of early stage HER2-positive breast cancer (anticipated in the third quarter of 2015); (ii) perform additional presentations of the ExteNET Phase III trial (anticipated in the third and fourth quarters of 2015); (iii) complete our ongoing Phase II FB-7 trial of PB272 as a neoadjuvant treatment for patients with HER2-positive breast cancer (anticipated in the third quarter of 2015); (iv) report data from our Phase II trial of PB272 in HER2 non-amplified breast cancer that has a HER2 mutation (anticipated in the fourth quarter of 2015); (v) report initial data from the Phase II trial of neratinib in extended adjuvant HER2 positive early stage breast cancer using loperamide prophylaxis (anticipated in the fourth quarter of 2015); (vi) complete the ongoing Phase II trial of PB272 in patients with HER2-positive metastatic breast cancer that has metastasized to the brain (anticipated in the second half of 2015); and (vii) expand additional cohorts in our Phase II basket trial of PB272 in patients with solid tumors with activating HER2 mutations (anticipated in the second half of 2015)."

Operating Expenses
Based on GAAP, operating expenses were $64.9 million for the second quarter of 2015, compared to $38.9 million for the second quarter of 2014. Operating expenses for the first half of 2015 were $117.5 million compared to $58.7 million for the first half of 2014.

General and Administrative Expenses:
Based on GAAP, general and administrative expenses were $5.5 million in the second quarter of 2015, compared to $3.9 million in the second quarter of 2014. General and administrative expenses for the first half of 2015 were $13.4 million compared to $7.4 million for the first half of 2014.

Research and Development Expenses:
Based on GAAP, research and development expenses were $59.4 million in the second quarter of 2015, compared to $35.0 million in the second quarter of 2014. Research and development expenses for the first half of 2015 were $104.1 million, compared to $51.3 million for the first half of 2014.

On August 10, 2015 OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED) reported financial results for the quarter ended June 30, 2015 and provided an update on progress toward 2015 corporate objectives and clinical development milestones, including new data from the Phase 1b clinical trial of demcizumab in non-small cell lung cancer (NSCLC) (Filing, 8-K, OncoMed, AUG 10, 2015, View Source [SID:1234507173]).

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"OncoMed’s second quarter highlighted data from several presentations at the American Academy of Cancer Research and American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meetings, including positive results from our Phase 1b demcizumab and tarextumab clinical trials. The impressive response rate and survival data, as well as safety and biomarker data reported from these studies, set the stage for our four ongoing Phase 2 randomized clinical trials for demcizumab and tarextumab," said OncoMed’s Chairman and Chief Executive Officer, Paul J. Hastings. "Today, we are updating the survival data for the truncated dose demcizumab cohorts of our Phase 1b clinical trial in non-small cell lung cancer. These updated data provide further evidence of prolonged survival for a large subset of patients treated with a demcizumab regimen being utilized in our ongoing DENALI Phase 2 clinical trial in NSCLC."

OncoMed provided updated survival data from 23 patients who received truncated doses of demcizumab plus carboplatin and pemetrexed in the company’s Phase 1b clinical trial in NSCLC. At ASCO (Free ASCO Whitepaper), OncoMed reported Phase 1b clinical trial data in NSCLC for 23 advanced-stage patients who received continuous dosing of demcizumab plus standard-of-care chemotherapy, which showed 43 percent (10 of 23) of patients were alive past two years, demonstrating prolonged survival in this subset of patients. At that time, survival data for 23 patients who received truncated doses of demcizumab plus chemotherapy were showing a similar trend toward improved survival, but the data were less mature. With an additional 3.5 months follow-up for all subjects, no additional deaths have been observed among treated patients. Fifty-two percent (12 of 23) of patients who received truncated doses of demcizumab plus carboplatin and pemetrexed remain alive between 8 and 30 months after treatment and median overall survival has not been reached as of the date of data cut off. These increasingly mature data provide further evidence of prolonged survival in a large subset of demcizumab-treated patients being treated with the regimen being used in OncoMed’s ongoing DENALI Phase 2 clinical trial in NSCLC. OncoMed management will review these updated results today during the planned second quarter 2015 financial results conference call.

"The updated survival data from our Phase 1b clinical trial in first-line advanced stage non-small cell lung cancer reveals impressive long term survival outcomes for the patients treated with truncated dosing demcizumab and chemotherapy," said Jakob Dupont, M.D., Chief Medical Officer. "We are pleased to observe this prolonged tail of the survival curve for patients treated with truncated dosing demcizumab, which is the regimen being utilized in our Phase 2 DENALI clinical trial. The fact that the prolonged tail of the survival curve is observed for patients receiving both continuous and truncated demcizumab dosing is encouraging."

OncoMed Announces Financial Results for the Second Quarter 2015

Recent Business Highlights

• Presented new data from Phase 1b clinical trials of demcizumab (anti-DLL4, OMP-21M18) in patients with first-line advanced non-small cell lung cancer (NSCLC) and pancreatic cancer and for tarextumab (anti-Notch 2/3, OMP-59R5) in small cell lung cancer at the 2015 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

• Demcizumab administered on a continuous basis in combination with carboplatin and pemetrexed in NSCLC demonstrated survival of greater than two years in a subset of 43 percent (10 of 23) of patients. A retrospective analysis of biomarkers for patients receiving demcizumab with carboplatin and pemetrexed in NSCLC revealed that patients whose tumors showed higher numbers of tumor infiltrating lymphocytes (TILs) prior to treatment appear to be the best responders.

• Demcizumab administered with Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin bound) and gemcitabine in first-line advanced pancreatic cancer demonstrated extended progression-free survival, prolonged overall survival and robust anti-tumor activity. The Phase 2 YOSEMITE study is ongoing.

• In 68 patients across the Phase 1b trials, truncated dosing of demcizumab was shown to be safe with no cases of moderate to severe cardiopulmonary toxicity.

• Tarextumab appeared to have dose-dependent and biomarker-driven activity when combined with etoposide and platinum therapy in small cell lung cancer. Patients who received the three-drug combination containing the highest doses of tarextumab and whose tumors tested positive for Notch3 gene expression demonstrated superior anti-tumor response and survival. The phase 2 PINNACLE study is ongoing.

• Initiated dosing of patients on the Phase 1a/1b clinical trial for anti-RSPO3 (OMP-131R10), the first drug in its class to target the R-spondin-LGR pathway, an important cancer stem cell pathway identified by OncoMed researchers.

• Presented seven posters at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting including preclinical research on: the immunomodulatory activities of anti-DLL4 and anti-cancer synergies with anti-PD1; tarextumab’s impact on cancer stem cell frequency; biomarker studies for anti-Notch1 (OMP-OMP-52M51), ipafricept (FZD8-Fc, OMP-54F28) and anti-RSPO3 and evidence of Wnt combination synergies with taxane-based chemotherapeutics.

• Highlighted discovery-stage immuno-oncology pipeline during the company’s first Research and Development Day, including the identification of a T-cell activating agent, GITRL-Fc, and a novel activating receptor for the known checkpoint inhibitor PD-L2, both of which are wholly-owned. Additional novel biologics directed to undisclosed immuno-oncology targets are being developed independently and in collaboration with Celgene.

• Appointed Rick Winningham, Chairman and Chief Executive Officer of Theravance Biopharma, to the Board of Directors.

Second Quarter 2015 Financial Results

Cash, cash equivalents and short-term investments totaled $200.2 million as of June 30, 2015, compared to $213.0 million as of March 31, 2015.

Revenues for the second quarter 2015 totaled $4.7 million, as compared to $6.0 million in the second quarter of 2014. The decrease in revenue over the same period in 2014 was primarily due to a change in the amortization of upfront payment fees under our partnership with Bayer.

Research and development (R&D) expenses for the second quarter 2015 were $22.0 million compared with $18.2 million for the same period in 2014. Increases in R&D expenditures in the three months ended June 30, 2015 were primarily attributable to increased personnel expenses, as well as increased program costs associated with the advancement of OncoMed’s lead clinical-stage product candidates into four randomized Phase 2 trials.

OncoMed Announces Financial Results for the Second Quarter 2015

General and administrative (G&A) expenses for the quarter ended June 30, 2015 were $4.3 million, compared to $3.4 million for the same three-month period in 2014. The increased costs during the second quarter 2015 of $0.8 million were attributable to higher employee-related costs.

Net loss for the second quarter 2015 was $21.6 million ($0.72 per share), compared to $15.6 million ($0.53 per share) for the same three-month period of 2014. The change in net loss for second quarter of 2015 was primarily due to an increase in operational expenses, especially research and development costs.

2015 Full-Year Financial Guidance Reiterated

• 2015 full-year cash expenses are expected to total $100-$110 million, excluding non-cash stock-based compensation, depreciation, and amortization expenses

• OncoMed projects a 2015 year-end cash, cash equivalents and short-term investments balance of over $120 million, before considering the receipt of any potential collaboration milestones

• OncoMed could receive more than $150 million in milestone and option payments from partners during 2015 and 2016

On August 10, 2015Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK), a biopharmaceutical company discovering, developing and preparing to commercialize innovative medicines paired with companion diagnostics for the treatment of cancer, reported its second quarter 2015 financial results (Press release, Merrimack, AUG 10, 2015, View Source/releasedetail.cfm?ReleaseID=926918" target="_blank" title="View Source/releasedetail.cfm?ReleaseID=926918" rel="nofollow">View Source [SID:1234507162]). Merrimack will host a live conference call and webcast today, Monday, August 10 at 4:30 p.m., Eastern time, to provide an update on Merrimack’s progress as well as a summary of these results.

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Investors and the general public are invited to listen to the call by dialing (877) 564-1301 (domestic) or (224) 357-2394 (international) five minutes prior to the start of the call and providing the passcode 97495685. A listen-only webcast of the call can be accessed in the Investors section of Merrimack’s website, View Source, and a replay of the call will be archived there for six weeks following the call.

Key Recent Events

Acceptance of New Drug Application (NDA) and receipt of Priority Review designation by the U.S. Food and Drug Administration (FDA) for MM-398 with a goal of October 24, 2015 as the action date for the NDA under the Prescription Drug User Fee Act (PDUFA date);

Expansion of MM-398 imaging study to metastatic breast cancer;

Addition, effective August 11, 2015, of Dr. Yasir Al-Wakeel as Chief Financial Officer and head of Corporate Development; and
Addition of John Dineen, former CEO of GE Healthcare, to its Board of Directors.

Upcoming Milestones

Merrimack anticipates the following milestones in 2015:

MM-398 NDA PDUFA date of October 24, 2015;
Commercial launch of MM-398, pending approval by the FDA;
Initiation of a clinical trial of MM-398 in front-line metastatic pancreatic cancer;
Initiation of a clinical trial of MM-398 in front-line HER2-negative gastric cancer;
Initiation of a clinical trial of MM-151 in EGFR-positive colorectal cancer;
Continued enrollment in HERMIONE, a Phase 2 clinical trial designed to support a potential Accelerated Approval application to the FDA for MM-302 in patients with HER2-positive metastatic breast cancer;
Continued enrollment in a Phase 2 clinical trial of MM-121 in patients with heregulin-positive, locally advanced or metastatic non-small cell lung cancer; and

Continued enrollment in a Phase 2 clinical trial of MM-141 in patients with front-line metastatic pancreatic cancer who have high serum levels of free IGF-1.

Second Quarter 2015 Financial Results

Revenue for the second quarter of 2015 was $36.6 million compared with revenue of $27.8 million for the second quarter of 2014, an increase of $8.7 million or 31%. This increase was attributable to $36.6 million of revenue recognized related to Merrimack’s collaboration with Baxalta during the second quarter of 2015, including $20.0 million of non-recurring revenue recognized related to a milestone that was achieved when the European Medicines Agency (EMA) accepted for review a Marketing Authorization Application (MAA) filed by Baxalta for MM-398. This increase was offset by $27.8 million of decreased revenue due to the termination of Merrimack’s collaboration with Sanofi effective December 17, 2014.

Research and development expenses increased $9.0 million over the corresponding quarter of the preceding year. This increase was primarily attributable to $10.6 million of increased MM-398 expenses, primarily due to costs associated with a non-recurring $11.0 million milestone event that was incurred in the second quarter of 2015 and paid in July 2015 related to the EMA accepting for review an MAA filed by Baxalta for MM-398.

General and administrative expenses increased $4.4 million over the corresponding quarter of the preceding year. This increase was primarily attributable to increased infrastructure and personnel expenses as Merrimack prepares for the potential commercialization of MM-398 and increased facility-related costs.

Merrimack’s net loss for the second quarter of 2015 was $22.9 million, or basic and diluted net loss per share available to common stockholders of $0.21, as compared to a net loss for the second quarter of 2014 of $18.3 million, or basic and diluted net loss per share available to common stockholders of $0.17.

Financial Outlook

Merrimack expects to be able to fund operations into 2016 through its unrestricted cash and cash equivalents and available-for-sale securities of $67.7 million as of June 30, 2015, anticipated cost sharing reimbursements from Baxalta and the anticipated receipt of $51.5 million of net milestones related to MM-398 from Baxalta in 2015, after offsetting payments to PharmaEngine. Any cash inflows from Merrimack’s at-the-market (ATM) offering program, business development, sales of MM-398, if it receives marketing approval, and any additional net milestones related to MM-398 that Merrimack receives from Baxalta in 2016, after offsetting milestone payments to PharmaEngine, would provide further funding for Merrimack’s operations.