On May 8, 2018 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, 2018 (Press release, Syndax, MAY 8, 2018, View Source [SID1234526234]). In addition, the Company provided a clinical and business update. As of March 31, 2018, Syndax had $113.2 million in cash, cash equivalents and short-term investments.

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"Syndax is off to a strong start in 2018 and we believe this momentum will carry us through the balance of what we expect will be a milestone-rich and potentially transformative year. This includes the progression free survival readout from our ongoing pivotal Phase 3 E2112 trial, for which results are expected in the third quarter," said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "We also look forward to sharing additional data from multiple cohorts of the ENCORE 601 program, including biomarker analyses, later this quarter at the ASCO (Free ASCO Whitepaper) Annual Meeting. The ENCORE program represents a key pillar of our clinical strategy and is supported by an extensive correlative science program designed to identify biomarkers that could predict which patients will respond to our combination therapies."

Pipeline Updates

The Phase 3 registration trial of entinostat plus exemestane in advanced hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+, HER2-) breast cancer, E2112, is 92% enrolled as of the end of April. ECOG-ACRIN Cancer Research Group, the trial sponsor, has notified the Company that the Data Safety Monitoring Committee (DSMC) completed the final progression free survival (PFS) analysis and the first interim analysis for overall survival in November 2017. Earlier this quarter, the DSMC also notified Syndax that it conducted a subsequent interim overall survival analysis. The trial is proceeding as planned, and Syndax continues to anticipate that enrollment will be complete in the third quarter of 2018, at which time the result of the PFS analysis will be released to the Company.

Enrollment in the PD-(L)1 refractory melanoma ENCORE 601 cohort is now complete. The Company will present Phase 2 data from all evaluable patients at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Meeting in June. Later this quarter, the Company plans to communicate a registration strategy for entinostat in this indication.

Enrollment in the PD-(L)1 refractory non-small cell lung cancer (NSCLC) ENCORE 601 cohort is now complete. Phase 2 data from all evaluable patients in this cohort will be presented at ASCO (Free ASCO Whitepaper) next month, including updated results from the Company’s biomarker analyses.

Initial enrollment in the first stage of the ENCORE 601 cohort of patients with microsatellite stable colorectal cancer (MSS-CRC) completed in the third quarter of 2017. The Company expects to share preliminary data from this cohort at ASCO (Free ASCO Whitepaper). The ENCORE 601 trial is being conducted in collaboration with Merck, through a subsidiary. The two companies recently agreed to expand this cohort, and expect to continue enrolling patients to the first stage later this quarter. A decision on whether to continue to the second stage of this cohort is expected in the first half of 2019.

Enrollment of the Phase 2 portion of ENCORE 602, the Phase 1b/2 clinical trial evaluating the combination of entinostat plus Genentech’s PD-(L)1 inhibitor atezolizumab (TECENTRIQ) in patients with triple negative breast cancer, remains on track to complete later this quarter. Topline results are now anticipated in the first half of 2019.

Enrollment is now complete in the Phase 2 portion of ENCORE 603, the Phase 1b/2 clinical trial evaluating entinostat in combination with Pfizer/Merck KGaA’s BAVENCIO in patients with ovarian cancer. Topline results are expected in the first half of 2019.

Dosing of patients with solid tumors in the Phase 1 multiple ascending dose (MAD) clinical trial of SNDX-6352 is ongoing. The Company anticipates presenting data from this trial and disclosing a Phase 2 strategy in the second half of 2018. In February, the Company entered into a clinical collaboration with AstraZeneca to evaluate the efficacy and safety of SNDX-6352 in combination with durvalumab (IMFINZI), AstraZeneca’s human monoclonal antibody directed against PD-(L)1, in multiple solid tumors. Initial work focusing on establishing the safety of this combination is expected to begin this quarter.

Development of the Company’s portfolio of Menin-Mixed Lineage Leukemia (MLL) inhibitors, in-licensed from Vitae Pharmaceuticals, Inc., a subsidiary of Allergan plc, is ongoing. Data from this program were recently presented in both oral and poster presentations at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The Company expects to initiate clinical trials for this program in the first half of 2019.

First Quarter 2018 Financial Results

As of March 31, 2018, Syndax had cash, cash equivalents and short-term investments of $113.2 million and 24,697,944 shares issued and outstanding.

First quarter 2018 research and development expenses increased to $15.3 million from $9.6 million for the comparable period in the prior year. The increases were primarily due to an increase in development activities of $2.8 million, legal and professional fees of $1.7 million and increased employee compensation expense of $1.3 million. The increase in development activities was primarily due to increases in spending related to the increased CMC costs for SNDX-6352, and development of the Menin program, partially offset by completion of the Phase 1 clinical pharmacology trials and decrease in E2112 costs. The increase in employee compensation costs was primarily due to increased headcount.

General and administrative expenses totaled $4.8 million during the first quarter of 2018, compared to $3.9 million for the comparable period in the prior year. The increase in general and administrative expenses was primarily due to an increase in professional fees of $0.7 million as well as an increase in legal fees of $0.2 million. The increase in professional fees was primarily due to pre-commercialization activities. The increase in legal fees was primarily due to an increase in patent-related legal expenses.

For the three months ended March 31, 2018, Syndax reported a net loss attributable to common stockholders of $19.4 million or $0.79 per share compared to $13.0 million or $0.71 per share for the comparable prior year period.

Financial Guidance

Today the Company provided operating expense guidance for the second quarter and full year 2018. For the second quarter and full year 2018, research and development expenses are expected to be $15 to $18 million and $62 to $70 million, respectively, and total operating expenses are expected to be $20 to $23 million and $82 to $90 million, respectively.

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, Tuesday, May 8, 2018.

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: 7087078
Domestic Dial-in Number: 1-855-251-6663
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.

On May 8, 2018 EyePoint Pharmaceuticals (NASDAQ:EYPT), a specialty biopharmaceutical company committed to developing and commercializing innovative ophthalmic products, reported operating and financial results for its fiscal 2018 third quarter and nine months ended March 31, 2018 and provided a company update (Press release, pSivida, MAY 8, 2018, View Source [SID1234526250]).

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"The acquisition of Icon Bioscience, Inc. and its FDA approved product, DEXYCU, significantly increases EyePoint Pharmaceuticals’ revenue potential and accelerates our planned transformation to a sustainable growth company," said Nancy Lurker, President and Chief Executive Officer. "The combination of experienced executives leading our commercial team and the additional capital from EW Healthcare and SWK positions EyePoint to successfully execute on the launch of two new products in the first half of 2019, pending favorable regulatory review of YUTIQ. In addition, we anticipate the annual revenue potential for DEXYCU to be $150 – $200 million by the end of the third year on the market."

Key Recent Accomplishments

Acquired privately-held Icon Bioscience, Inc. and its FDA approved product, DEXYCU.

DEXYCU was approved by the FDA on February 9, 2018, for the treatment of postoperative inflammation and is administered as a single intraocular injection at the end of surgery.

EyePoint has expanded the DEXYCU global IP portfolio with Notices of Allowance for two additional patents, including potential claims relating to a method of treating inflammation of an eye following cataract surgery by delivering extremely small (4-6µL) amounts of dexamethasone in acetyl triethyl citrate. These two additional patents, once allowed, will extend to 2032 and 2034.

A New Drug Application (NDA) for YUTIQ (fluocinolone acetonide intravitreal implant) 0.18 mg three-year treatment for noninfectious posterior segment uveitis was submitted to the Food and Drug Administration (FDA) in January and was accepted for filing in March with a November 5, 2018 PDUFA date.

EyePoint has enhanced the healthcare and capital markets expertise of the Board of Directors with the appointment of Ron Eastman, a Managing Director at EW Healthcare Partners with over 40 years of experience in building healthcare companies.

EyePoint has hired experienced executives to lead the Company’s commercial team and to ensure successful execution of the launches of DEXYCU and YUTIQ

EyePoint presented data on YUTIQ at the Association for Research in Vision and Ophthalmology (ARVO) 2018 Annual Meeting.

EyePoint delisted from the Australian Securities Exchange effective as of May 7, 2018.
Strengthened Balance Sheet

The Company had cash and cash equivalents totaling $16.3 million at March 31, 2018 and, subject to stockholder approval at a special meeting of shareholders scheduled for June 22, 2018, has capital commitments of an additional $30.5 million from EW Healthcare, a third-party investor and SWK. Therefore, the Company is currently projecting a cash balance of approximately $38.0 million at June 30, 2018, the end of its current fiscal year.

The Company expects these proceeds will provide the financial resources to commence the launch of DEXYCU and YUTIQ.
Near-Term Goals and Upcoming Milestones

Gain approval of the second tranche investment by EW Healthcare at the June 22, 2018 special meeting of stockholders.

Implement the Company’s four-pillar commercialization plan:
— Complete the build out of the sales organization;
— Implement the marketing plan;
— Continue to progress market access programs; and
— Initiate medical education initiatives.

Secure pass-through reimbursement for DEXYCU.

Receive FDA approval for YUTIQ based on the PDUFA action date of November 5, 2018.

Present data at leading medical congresses, including for YUTIQ at the American Society of Retina Specialists (ASRS) annual meeting being held in Vancouver from July 20-25.

Launch DEXYCU and YUTIQ (subject to FDA approval) in the first half of calendar 2019.
Fiscal Third Quarter and Nine-Month Results

Revenue for the third fiscal quarter ended March 31, 2018, totaled $928,000 compared to $590,000 for the prior year quarter. Revenues in both periods were derived from feasibility study agreements and royalty income. Operating expenses for the three months ended March 31, 2018 decreased slightly to $5.6 million from $5.8 million a year earlier, due primarily to lower clinical trial costs and stock-based compensation expense, partially offset by higher regulatory and clinical consulting services in support of YUTIQ and higher personnel and related expenses. Net loss for the quarter ended March 31, 2018 was $7.0 million, or $0.15 per share, compared to a net loss of $5.1 million, or $0.15 per share, for the prior year quarter.

Revenue for the nine months ended March 31, 2018 was $2.2 million compared to $6.8 million for the nine months ended March 31, 2017. The prior year period included the recognition of deferred collaborative research and development revenue totaling $5.6 million resulting from the termination of the Pfizer collaboration agreement. Excluding Pfizer, revenues from feasibility study agreements and royalty income increased to $2.2 million for the nine months ended March 31, 2018 compared to $1.2 million in the prior year period. Operating expenses for the first nine months of fiscal 2018 were $18.7 million compared to $19.3 million a year earlier. Net loss for the nine months ended March 31, 2018 was $18.7 million, or $0.43 per share, compared to a net loss of $12.4 million, or $0.36 per share for the corresponding fiscal 2017 year-to-date period. There are currently 54,029,917 common shares outstanding.

In connection with the first tranche EW Healthcare investment, and subject to stockholder approval, the Company agreed to issue units to EW Healthcare and a participating third-party investor, with each unit consisting of the right to purchase (a) one share of Common Stock and (b) one warrant to purchase a share of Common Stock. The purchase price of the common stock and the exercise price of the warrant are both subject to price collars that provide for either a premium or discount to the original price paid in the first tranche investment by EW Healthcare. Because of the collar, the number of units to be issued will be subject to some variability. This second tranche investment will be voted upon at a special meeting of stockholders to be held on June 22, 2018. Accounting guidance required that the future obligation to issue units in the second tranche transaction be recorded as a derivative liability and to be re-measured to fair value at each balance sheet date. As a result of the initial re-measurement, the Company recorded a non-cash charge to non-operating expense of $2.3 million as change in fair value of derivative liability for the three and nine months ended March 31, 2018.

Conference Call Information

The conference call may be accessed by dialing (877) 312-7507 from the U.S. and Canada, or (631) 813-4828 from international locations. The conference ID is 1758647. A live webcast will be available on the Investor Relations section of the corporate website at View Source

A replay of the call will be available beginning May 8, 2018, at approximately 7:30 p.m. ET and ending on May 15, 2018, at 11:59 p.m. ET. The replay may be accessed by dialing (855) 859-2056 within the U.S. and Canada or (404) 537-3406 from international locations, Conference ID Number: 1758647. A replay of the webcast will also be available on the corporate website during that time.

On May 8, 2018 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK), a clinical-stage oncology company focused on biomarker-defined cancers, reported its first quarter 2018 financial results for the period ended March 31, 2018 (Press release, Merrimack, MAY 8, 2018, View Source [SID1234526268]).

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"At Merrimack, we set out to design targeted solutions with pharmacological properties to match our team’s understanding of cancer pathways and drug metabolism. We have been focused on executing this strategy as we advance the ten wholly-owned programs across our clinical and preclinical pipeline, each addressing biomarker-defined cancers," said Richard Peters, M.D., Ph.D., President and Chief Executive Officer. "We look forward to our three upcoming clinical readouts: randomized Phase 2 data for istiratumab (MM-141) in pancreatic cancer and seribantumab (MM-121) in non-small cell lung cancer and Phase 1 data for MM-310 in solid tumors."

First Quarter and Recent Highlights

Key events from the first quarter and more recently include:

Appointment of Lee Newcomer, M.D., M.H.A., former Senior Vice President for Oncology and Genetics and Chief Medical Officer at UnitedHealthcare and board-certified medical oncologist, to Merrimack’s Scientific Advisory Board (SAB). Dr. Newcomer, with his perspective on medical oncology and patient access, joins distinguished experts in precision oncology, bioengineering, drug discovery and clinical development on Merrimack’s SAB; and

Presentation of preclinical data at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. Merrimack hosted four poster sessions, highlighting preclinical data from MM-310 as well as other preclinical programs currently in development.
Upcoming Milestones

Merrimack anticipates the following upcoming clinical milestones:

Top-line results in the first half of 2018 from the CARRIE study, an event-driven, randomized Phase 2 clinical trial evaluating istiratumab (MM-141) added to standard of care in patients with front-line metastatic pancreatic cancer who have high serum levels of free IGF-1;

Top-line results in the second half of 2018 from the SHERLOC study, an event-driven, randomized Phase 2 clinical trial evaluating seribantumab (MM-121) added to standard of care in patients with heregulin positive non-small cell lung cancer; and

Safety data and maximum tolerated dose in the second half of 2018 from the Phase 1 clinical study of MM-310 in patients with solid tumors.
First Quarter 2018 Financial Results

The following summarizes Merrimack’s financial results for the three months ended March 31, 2018:

Research and development expenses for the three months ended March 31, 2018 were $13.1 million, compared to $21.6 million for the three months ended March 31, 2017. Research and development spending for the first quarter of 2018 was lower versus the comparable period in 2017, primarily due to Merrimack’s refocused clinical and preclinical pipeline;

General and administrative expenses for the three months ended March 31, 2018 were $4.3 million, compared to $5.6 million for the three months ended March 31, 2017. General and administrative spending for the first quarter of 2018 was lower versus the comparable period in 2017, primarily due to a decrease in corporate expenses related to headcount levels following the asset sale to Ipsen S.A.;

Net loss from operations for the three months ended March 31, 2018 was $17.8 million, or $1.33 per share, compared to a net loss from continuing operations of $28.7 million, or $2.20 per share, for the three months ended March 31, 2017;

As of March 31, 2018, Merrimack had cash and cash equivalents and marketable securities of $76.3 million, compared to $93.4 million as of December 31, 2017; and

As of March 31, 2018, Merrimack had 13.3 million shares of common stock, $0.01 par value per share, outstanding.
Financial Outlook

Merrimack continues to believe that its cash and cash equivalents and marketable securities of $76.3 million as of March 31, 2018 and certain potential net milestone payments anticipated from Shire will be sufficient to fund its planned operations into the second half of 2019.

Conference Call and Webcast

Merrimack will host a live conference call and webcast today, Tuesday, May 8, 2018 at 8:30 am ET, to provide an update on its operational progress and a summary of these financial results.

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 1596995. A listen-only webcast of the call can be accessed in the Investors section of Merrimack’s website, investors.merrimack.com, and a replay of the call will be archived there for six weeks following the call.

On May 8, 2018 Alligator Bioscience (Nasdaq Stockholm: ATORX), a biotechnology company developing antibody-based pharmaceuticals for tumor-directed immunotherapy, and Aptevo Therapeutics Inc. (Nasdaq: APVO), a biotechnology company focused on developing novel immuno-oncology and hematology therapeutics, reported the presentation of new preclinical data supporting ALG.APV-527 as a promising new immunotherapeutic candidate for the treatment of a variety of 5T4-expressing solid tumors (Press release, Alligator Bioscience, MAY 8, 2018, View Source [SID1234538677]).

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ALG.APV-527 is designed to simultaneously target 5T4 and the co-stimulatory receptor 4-1BB (CD137) to promote potent, tumor-directed immune T-cell activation. 5T4 is a well-defined tumor antigen expressed on many different types of malignancies including, non-small cell lung, renal, pancreas, prostate, breast, colorectal, gastric, ovarian and cervical cancers. Conversely, 5T4 has limited expression on normal tissues, making it an attractive target for cancer immunotherapy.

New ALG.APV-527 preclinical data show that ALG.APV-527 has the potential to selectively activate and enhance tumor specific T cell responses at the tumor site without triggering systemic immune activation. Notably, the preclinical in vitro and in vivo data show that ALG.APV-527:

Stimulates increased T cell activation in the presence of 5T4-expressing cells
Localizes to the site of 5T4 positive tumors in an in vivo melanoma tumor model
Inhibits tumor growth in a 5T4 expressing in vivo human colon carcinoma model
Has an extended, antibody-like serum half-life of 9 days in an experimental model
The data were recently presented at the PEGS Summit 2018 and American Association of Immunologists (AAI) annual meeting and will be presented next week at the Annual Meeting of Cancer Immunotherapy (CIMT) (Free CIMT Whitepaper).

"Taken together, the accumulating preclinical data package for ALG.APV-527 support its potential to provide effective tumor-directed immune activation with reduced systemic side effects. We are continuing to advance this candidate and look forward to commencing clinical development in 2019," said Christina Furebring, Senior Vice President Research at Alligator.

"Our collaboration with Alligator Bioscience continues to yield encouraging data supporting the advantages of this novel pathway for targeted immunotherapy of cancer," said Jane Gross, Ph.D., Chief Scientific Officer for Aptevo. "As a first-in-class molecule, ALG.APV-527 showcases the versatility of our ADAPTIR platform in generating bispecific antibodies with unique mechanisms of action and a therapeutic profile that is more consistent with traditional antibodies, including an extended half-life, desirable antibody-like manufacturing characteristics and increased potency and stability."

Aptevo and Alligator believe that the precise targeting of 4-1BB within the tumor microenvironment can overcome some of the limitations seen with other 4-1BB therapies. ALG.APV-527 employs a novel mechanism of action, 4-1BB x 5T4 binding, to direct the therapeutic immune response towards the tumor, thereby potentially reducing the harmful side effects of systemic immune stimulation while providing a strong tumor directed immune activation.

About ALG.APV-527
ALG.APV-527 is a bispecific antibody (4-1BB x 5T4) intended for tumor-directed treatment of solid cancers. ALG.APV-527 was built using Aptevo’s ADAPTIR bispecific platform and combines binding domains sourced from the ALLIGATOR-GOLD human scFV library. The ALG.APV-527 bispecific antibody consists of two parts, one part activating tumor-specific T cells through the co-stimulatory receptor 4-1BB, the other part binding to the 5T4 protein expressed on the surface of tumor cells. This enables the immune-activating effect of ALG.APV-527 to be directed specifically to the tumor and not against normal tissue.

On May 8, 2018 TG Therapeutics, Inc. (NASDAQ: TGTX) reported its financial results for the first quarter ended March 31, 2018 and recent company developments (Press release, Manhattan Pharmaceuticals, MAY 8, 2018, View Source [SID1234526205]).

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Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, stated, "2018 is off to a great start as we continue to advance our major pivotal programs and bolster our product pipeline, most recently with the addition of a BTK inhibitor program. As we move into the second quarter and the remainder of the year, we look forward to the announcement of topline data from our UNITY-CLL trial, completion of enrollment into the current cohorts of the UNITY-NHL study, final MS Phase 2 data, significant enrollment in our MS phase 3 program as well as filing decisions related to the Company’s first BLA/NDA later in the year." Mr. Weiss continued, "We believe 2018 will be a pivotal year for the Company as approval pathways across multiple indications become clearer and position us for future success."

First Quarter and Recent Highlights

BTK License: Entered into an exclusive global license agreement with Jiangsu Hengrui Medicine Co., Ltd. (or "Hengrui") to obtain worldwide rights, excluding Asia but including Japan, for the development of Hengrui’s Bruton’s Tyrosine Kinase (BTK) inhibitor program, including the lead candidate, TG-1701.
Umbralisib Lancet Publication: Results from the Phase 1 first-in-human study of umbralisib (TGR-1202), the Company’s novel once-daily PI3K delta inhibitor, were published in The Lancet Oncology.
TG-1601 Preclinical Data: Presented the first preclinical data from TG-1601, the Company’s novel BET inhibitor, at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting.
Ublituximab Data in Multiple Sclerosis: Presented clinical and MRI data from the Phase 2 trial of ublituximab (TG-1101) in RMS at the 3rd Annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2018 and the American Academy of Neurology (AAN) 70th Annual Meeting.

Remaining 2018 Milestones

Present top-line overall response rate data from the UNITY-CLL Phase 3 trial of ublituximab plus umbralisib in front line and relapsed/refractory Chronic Lymphocytic Leukemia (CLL).
Prepare and potentially file the Company’s first BLA and/or NDA.

Complete enrollment in the current arms of the UNITY-NHL trial, including the Follicular Lymphoma, Marginal Zone Lymphoma, and Diffuse Large B-Cell Lymphoma cohorts.
Present updated clinical data from ongoing oncology trials and final results from the Phase 2 trial of ublituximab in Multiple Sclerosis (MS) at major medical meetings during 2018.

Financial Results for the First Quarter 2018

Cash Position: Cash, cash equivalents, investment securities, and interest receivable were $109.2 million as of March 31, 2018. Pro-forma cash, cash equivalents, investment securities, and interest receivable as of March 31, 2018 (excluding our second quarter 2018 operations) are approximately $123.3 million, after giving effect to $14.1 million of net proceeds from the utilization of the Company’s at-the-market ("ATM") sales facility during the second quarter of 2018.

Other R&D Expenses: Other research and development (R&D) expense (not including non-cash compensation) was $32.2 million for the three months ended March 31, 2018 compared to $20.4 million for the three months ended March 31, 2017. Included in other research and development expense for the three months ended March 31, 2018 was $14.5 million of clinical trial expense and $9.6 million of manufacturing and CMC expenses for Phase 3 clinical trials and potential commercialization. The current period increase in Other R&D expenses is primarily due to the ongoing clinical development programs and related manufacturing costs for TG-1101 and TGR-1202.

●Other G&A Expenses: Other general and administrative (G&A) expense (not including non-cash compensation) was $2.1 million for the three months ended March 31, 2018 as compared to $1.3 million for the three months ended March 31, 2017. Other G&A expenses for the three months ended March 31, 2018 remained relatively flat compared to the first quarter of 2017, and we expect Other G&A expenses to increase modestly through the remainder of 2018.

●Net Loss: Net loss was $41.5 million for the three months ended March 31, 2018, compared to a net loss of $27.7 million for the three months ended March 31, 2017. Excluding non-cash items the net loss for the three months ended March 31, 2018 was approximately $33.2 million.

●Financial Guidance: Net cash utilized for operating activities during the three months ended 2018 was approximately $28.0 million. The Company believes its cash, cash equivalents, investment securities, and interest receivable on hand as of March 31, 2018, inclusive of the proceeds raised subsequent to the first quarter, will be sufficient to fund the Company’s planned operations through mid-2019.

Conference Call Information

The Company will host an investor conference call today, May 8, 2018, at 8:30am ET, to discuss the Company’s first quarter 2018 financial results and provide a business outlook for the remainder of 2018.

In order to participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics First Quarter 2018 Earnings Call. A live webcast of this presentation will be available on the Events page, located within the Investors & Media section, of the Company’s website at www.tgtherapeutics.com. An audio recording of the conference call will also be available for replay at www.tgtherapeutics.com, for a period of 30 days after the call.