On August 2, 2018 Aileron Therapeutics (Nasdaq:ALRN), the leader in the field of stapled peptide therapeutics for cancers and other diseases, reported that Manuel Aivado, SVP and Chief Medical Officer, will present at the Canaccord Genuity 38th Annual Growth Conference being held in Boston, MA (Press release, Aileron Therapeutics, AUG 2, 2018, View Source;p=RssLanding&cat=news&id=2361619 [SID1234528619]).

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Presentation Details:

Event: Canaccord Genuity 38th Annual Growth Conference
Date: Thursday, August 9, 2018
Time: 1:00 – 1:25 p.m. EDT
Location: Intercontinental Boston Hotel, Boston, MA

A live webcast of the presentation may be accessed from the Events & Presentations section of Aileron’s website. An archived version of the webcast will be available for replay following the event.

On August 2, 2018 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported financial results for the second quarter ended June 30, 2018, and provided a business update (Press release, Adaptimmune, AUG 2, 2018, View Source [SID1234528617]).

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"2018 is a year of delivery for Adaptimmune," said James Noble, Adaptimmune’s CEO. "We have completed multiple studies with the NY-ESO program, and released data showing responses in a second solid tumor. We have transitioned it to GSK as planned and will shortly be receiving payment of $27 million. We are now entirely focused on our wholly owned INDs, and remain on track to deliver initial response data from our MAGE-A10 and MAGE-A4 programs in the second half of 2018."

Clinical momentum in wholly owned programs

Adaptimmune will now focus its clinical, regulatory, and manufacturing organization on its wholly owned therapies – MAGE-A4, MAGE-A10, and AFP

·Dosing at one billion or more SPEAR T-cells across all studies with MAGE-A10 and MAGE-A4, and on track for response readouts from multiple solid tumors throughout the remainder of 2018.

·Initial safety data from AFP in hepatocellular carcinoma also on track for late 2018.

NY-ESO program transitioned to GSK

·As announced on July 24, 2018 (https://bit.ly/2LKhSvm), the NY-ESO SPEAR T-cell program has transitioned to GSK.

·Adaptimmune will receive $27.5 million (£21.2 million) from GSK as a result of the transition, as well as subsequent development and sales milestones and royalties based on successful development by GSK of this program.

Manufacturing

Adaptimmune is increasing the capacity of its dedicated manufacturing facility

·Routinely manufacturing SPEAR T-cells at the Navy Yard at target cell doses

Developing the capability at the Navy Yard to scale up to 30 manufacturing slots per month from the current number of 8 to 10 per month

·Maintaining 8 to 10 dedicated patient manufacturing slots per month at HCAT

Other corporate news

Adaptimmune is focused on its next stage of development and in a strong position to deliver success with SPEAR T-cell therapies

·Rafael Amado, Adaptimmune’s Chief Medical Officer, has assumed a new role as President of Research & Development effective from August 1, 2018. This brings together the clinical and research teams under a single leadership, which will allow better alignment and integration of all parts of R&D, from target identification and selection, to regulatory filings, enabling the delivery of Adaptimmune’s key priorities.

· Adaptimmune is ready for the next stage of clinical development and actively planning for registration trials, whether indication or target specific

· Funded through to early 2020 with cash and cash equivalents of $42.3 million and total liquidity(1) of $129.0 million, which does not include $27.5 million in payments from GSK as a result of the transition as this was invoiced after the second quarter

·Announced in April 2018 (https://bit.ly/2v7v3D3) that John Furey, Chief Operating Officer at Spark Therapeutics, was appointed as an independent Non-Executive Director to Adaptimmune’s Board of Directors, which became effective July 5, 2018

Financial Results for the three-month period ended June 30, 2018

Cash / liquidity position: As of June 30, 2018, Adaptimmune had cash and cash equivalents of $42.3 million and Total Liquidity(1) of $129.0 million, which does not include $27.5 million in payments from GSK as a result of the transition as this was invoiced after the second quarter

·Revenue: With effect from January 1, 2018, the Company has adopted a new accounting standard(2). Under this new accounting standard, revenue represents the upfront payment and milestones under the GSK Collaboration and License Agreement, which are recognized based on the percentage completion of the NY-ESO and PRAME development programs. Revenue for the three and six months ended June 30, 2018 was $9.0 million and $17.2 million, respectively. Revenue for the three and six months ended June 30, 2018 under the previous guidance would have been $3.3 million and $12.3 million, respectively, compared to $3.5 and $6.4 million for the same periods of 2017. The increase in revenue, compared to the six-month period in 2017, is primarily due to a reduction in the period over which the Company is recognizing revenue following GSK’s exercise of its option over the NY-ESO program in September 2017 and additional development milestones achieved.

·Research and development ("R&D") expenses: R&D expenses for the three and six months ended June 30, 2018 were $26.7 million and $52.0 million, respectively, compared to $19.6 million and $38.2 million for the same periods of 2017. The increase was primarily due to increased costs associated with clinical trials, manufacturing for clinical trials, and increased personnel costs.

· General and administrative ("G&A") expenses: G&A expenses for the three and six months ended June 30, 2018 were $11.3 million and $22.5 million, respectively, compared to $7.7 million and $14.2 million for the same periods of 2017. The increase was primarily due to increased personnel costs consistent with the Company’s planned growth, an increase in costs associated with developing its IT infrastructure and an increase in other corporate costs.

·Other (expense) income, net: Other expense for the three and six months ended June 30, 2018 was $15.4 million and $8.3 million, respectively, compared to an income of $3.2 million and $3.7 million for the same periods of 2017. Other income primarily comprises unrealized foreign exchange gains, which fluctuate depending on exchange rate movements and the amount of foreign currency assets and liabilities.

· Net loss: Net loss attributable to holders of the Company’s ordinary shares for the three and six months ended June 30, 2018 was $43.8 million and $64.6 million respectively ($(0.08) and $(0.11) per ordinary share) compared to $20.2 million and $42.0 million ($(0.04) and $(0.09) per ordinary share) in the same periods of 2017.

Financial guidance

The Company believes that its existing cash, cash equivalents, marketable securities and income from GSK upon transition of the NY-ESO program will fund the Company’s current operations through to early 2020.

Conference call information

The Company will host a live teleconference and webcast to provide additional details at 8:00 a.m. EDT (1:00 p.m. BST) today, August 2, 2018. The live webcast of the conference call will be available via the events page of Adaptimmune’s corporate website at www.adaptimmune.com. An archive will be available

(1) Total liquidity is a non-GAAP financial measure, which is explained and reconciled to the most directly comparable financial measures prepared in accordance with GAAP below.

(2) ASC 606, Revenue from Contracts with Customers.

after the call at the same address. To participate in the live conference call, please dial (833) 652-5917 (U.S.) or +1 (430) 775-1624 (International). After placing the call, please ask to be joined into the Adaptimmune conference call and provide the confirmation code (8149978).

On August 2, 2018 Emergent BioSolutions Inc. (NYSE: EBS) reported financial results for the quarter and six months ended June 30, 2018 (Press release, Emergent BioSolutions, AUG 2, 2018, View Source [SID1234528439]).

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Q2 2018 AND RECENT BUSINESS ACCOMPLISHMENTS

Completed Mutual Recognition Procedure for market authorization of BioThrax (Anthrax Vaccine Adsorbed) in five Concerned Member States within the European Union – Italy, the Netherlands, Poland, the U.K. and France; to date, BioThrax has received market authorization in four of the five countries.

Initiated an investment of up to $50 million over the next three years in the Camden fill/finish facility located in Baltimore, an expansion project that will significantly enhance the capabilities of this key site within the Company’s CDMO Business Unit.

Announced Framework Partnering Agreement under which the Company will provide technical and manufacturing support for the development and manufacture of a vaccine against Nipah virus in collaboration with Profectus BioSciences, Inc. and CEPI (Coalition for Epidemic Preparedness Innovations); under a separate agreement with Profectus, Emergent will retain the exclusive option to license and assume control of development activities for the Nipah virus vaccine from Profectus.

Initiated a Phase 1 clinical study of ZIKV-IG, the Company’s anti-Zika virus immune globulin being developed as a therapeutic intervention against Zika virus disease; the candidate was granted Fast Track designation by the U.S. Food and Drug Administration in December 2017.

2018 FINANCIAL PERFORMANCE

(I) Quarter Ended June 30, 2018 (Unaudited)

Revenues

Total Revenues
For Q2 2018, total revenues were $220.2 million, an increase of 118% over 2017. Total revenues reflect a significant increase in product sales.

Product Sales
For Q2 2018, product sales were $180.1 million, an increase of 183% as compared to 2017. The increase is principally attributable to sales of BioThrax and ACAM2000, (Smallpox (Vaccinia) Vaccine Live) previously expected in the first quarter as well as continued sales of both products in the second quarter.

Contract Manufacturing
For Q2 2018, revenue from the Company’s contract manufacturing operations was $23.6 million, an increase of 46% as compared to 2017. The increase primarily reflects manufacturing services at the Company’s Canton site.

Contracts and Grants
For Q2 2018, revenue from the Company’s development-based contracts and grants was $16.5 million, a decrease of 21% as compared to 2017. The decrease primarily reflects a reduction in R&D activities related to certain ongoing funded development programs.

Operating Expenses

Cost of Product Sales and Contract Manufacturing
For Q2 2018, cost of product sales and contract manufacturing was $89.2 million, an increase of 158% as compared to 2017. The increase was primarily attributable to the increase in product sales and contract manufacturing activities at the Company’s Bayview and Canton facilities.

Research and Development (Gross and Net)
For Q2 2018, gross R&D expenses were $24.7 million, a decrease of 4% as compared to 2017. The decrease primarily reflects lower costs associated with contract development services.

For Q2 2018, net R&D expense (calculated as gross research and development expenses minus contracts and grants revenue) was $8.2 million, an increase of $3.4 million as compared to 2017, reflecting increased investment in development-stage programs not currently funded in whole or in part by third-party partners. These include costs associated with the Raxibacumab (Anthrax Monoclonal Antibody) technology transfer and the SIAN device, an intranasal antidote spray device for the treatment of known or suspected acute cyanide poisoning.

Selling, General and Administrative
For Q2 2018, selling, general and administrative expenses were $39.5 million, an increase of 24% as compared to 2017, attributable primarily to increased professional services and compensation-related costs.

Income Taxes
For Q2 2018, the provision for income tax expense in the amount of $15.7 million includes a discrete benefit of $0.9 million primarily related to stock compensation activity resulting in an effective tax rate of 24%. Excluding the discrete benefit, the Q2 2018 effective tax rate was 25%.

Net Income & Adjusted Net Income
For Q2 2018, the Company recorded net income of $50.1 million, or $0.98 per diluted share, versus net income of $4.6 million, or $0.11 per diluted share, in 2017. (1).

For Q2 2018, the Company recorded adjusted net income of $54.7 million, or $1.07 per diluted share, versus adjusted net income of $6.6 million, or $0.13 per diluted share, in 2017. (1) (2)

(I) Six Months Ended June 30, 2018 (Unaudited)

Revenues

Total Revenues
For the six months of 2018, total revenues were $338.0 million, an increase of 55% over 2017. Total revenues reflect a significant increase in product sales.

Product Sales
For the six months of 2018, product sales were $255.8 million, an increase of 76% as compared to 2017. The increase is principally attributable to sales of ACAM2000 and Raxibacumab, both of which were acquired in Q4 2017.

Contract Manufacturing
For the six months of 2018, revenue from the Company’s contract manufacturing operations was $49.8 million, an increase of 47% as compared to 2017. The increase primarily reflects the completion of a milestone related to the expansion of certain contract manufacturing capabilities at the Company’s Lansing site and manufacturing services at the Company’s Canton site.

Contracts and Grants
For the six months of 2018, revenue from the Company’s development-based contracts and grants was $32.4 million, a decrease of 15% as compared to 2017. The decrease primarily reflects a reduction in revenue associated with the successful completion of multiple U.S. government development contracts, as well as reduced R&D activities related to certain ongoing funded development programs.

Operating Expenses

Cost of Product Sales and Contract Manufacturing
For the six months of 2018, cost of product sales and contract manufacturing was $147.2 million, an increase of 82% as compared to 2017. The increase was primarily attributable to the increase in product sales and contract manufacturing activities at the Company’s Bayview and Canton facilities.

Research and Development (Gross and Net)
For the six months of 2018, gross R&D expenses were $53.8 million, an increase of 16% as compared to 2017. The increase primarily reflects costs associated with contract development services, including the cost associated with the technology transfer of the Raxibacumab manufacturing process to the Company’s Bayview manufacturing site in Baltimore.

For the six months of 2018, net R&D expense was $21.4 million, an increase of $13.5 million as compared to 2017, reflecting increased investment in countermeasure development programs not currently funded in whole or in part by third-party partners, notably costs associated with the Raxibacumab technology transfer and the SIAN device, an intranasal antidote spray device for the treatment of known or suspected acute cyanide poisoning.

Selling, General and Administrative
For the six months of 2018, selling, general and administrative expenses were $79.7 million, an increase of 19% as compared to 2017, attributable primarily to increased professional services and compensation-related costs.

Income Taxes
For the six months of 2018, the provision for income tax expense in the amount of $11.2 million includes a discrete benefit of $3.2 million primarily related to stock compensation activity resulting in an effective tax rate of 20%. Excluding the discrete benefit, the six months of 2018 effective tax rate was 25%.

Net Income & Adjusted Net Income
For the six months of 2018, the Company recorded net income of $45.2 million, or $0.89 per diluted share, versus net income of $15.1 million, or $0.35 per diluted share, in 2017. (1)

For the six months of 2018, the Company recorded adjusted net income of $53.1 million, or $1.04 per diluted share, versus adjusted net income of $20.8 million, or $0.42 per diluted share, in 2017. (1) (2)

2018 FINANCIAL FORECAST & OPERATIONAL GOALS
The Company is reaffirming its full year 2018 financial performance forecast:
· Total Revenue
$715 million to $755 million
· Pre-Tax Income
$120 million to $140 million
· Net Income (3)
$95 million to $110 million
· Adjusted Net Income (2) (3)
$110 million to $125 million
· EBITDA (2) (3)
$175 million to $190 million

The Company is also reaffirming its full year 2018 operational goals:

Advance NuThrax development to enable Emergency Use Authorization filing with the FDA in 2018

Complete ACAM2000 deliveries; establish a multi-year follow-on contract with the U.S. government

Deliver Raxibacumab doses under current contract; advance technology transfer to the Company’s Bayview facility in Baltimore, Maryland

Progress pipeline to have at least four product candidates in advanced development

Complete an acquisition that generates revenue within 12 months of closing

Q3 2018 FINANCIAL FORECAST
The Company forecast for Q3 2018 total revenue is $165 million to $190 million.

FOOTNOTES
(1)
See "Calculation of Diluted Earnings Per Share."
(2)
See "Reconciliation of Net Income to Adjusted Net Income and EBITDA" for a definition of terms and a reconciliation table.
(3)
Reflects an estimated tax rate that includes the expected effects of the United States Tax Cuts and Jobs Act of 2017 on the Company’s 2018 income tax provision.

CONFERENCE CALL AND WEBCAST INFORMATION
Company management will host a conference call at 5:00 pm (Eastern Time) today, August 2, 2018, to discuss these financial results. This conference call can be accessed live by telephone or through Emergent’s website:

Live Teleconference Information:
Dial in: [US] (855) 766-6521; [International] (262) 912-6157
Conference ID: 93342423

Live Webcast Information:
Visit View Source for the live webcast feed.

A replay of the call can be accessed at www.emergentbiosolutions.com under "Investors."

On August 2, 2018 Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company focused on developing and commercializing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, reported financial results for the second quarter ended June 30, 2018 (Press release, Tetraphase, AUG 2, 2018, View Source [SID1234528425]).

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"In the second quarter of 2018, we moved closer to achieving our goal to bring XeravaTM (eravacycline) to market on a global level as an important new antibiotic for patients with serious, often life-threating, complicated intra-abdominal infections (cIAI)," said Guy Macdonald, President and Chief Executive Officer of Tetraphase. "We recently announced a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for Xerava in cIAI, and we expect a final decision on marketing authorization from the European Commission (EC) later this year. In the U.S., we are eagerly looking forward to a decision on our PDUFA (Prescription Drug User Fee Act) date of August 28, 2018 and we are actively preparing for the potential commercial launch of Xerava in the fourth quarter."

Mr. Macdonald added, "We also have continued to make progress on our eravacycline development plans in China, through Everest Medicines, our licensee in Asia. Everest recently submitted an Investigational New Drug (IND) application for eravacycline in cIAI to the China Food and Drug Administration (CFDA) for which we received a $2.5 million milestone payment. We are excited to be moving forward in this collaboration to bring eravacycline to patients in this part of the world. Along with the U.S. and Europe, we believe there is a significant market opportunity for eravacycline in China and other Asian territories for patients with serious infections caused by Gram-negative bacteria, particularly as resistance rates continue to rise."

Key Upcoming Milestones

Potential approval of Xerava in cIAI in U.S. – Q3 2018

Potential approval of Xerava in cIAI in Europe – 2H 2018

Potential commercial launch of Xerava in cIAI in the U.S. – Q4 2018

Complete phase 1 multiple ascending dose studies for TP-271 and TP-6076 – 2H 2018

Second Quarter and Recent Highlights

Announced that the CHMP of the EMA has recommended Xerava for approval as a treatment for adult patients with cIAI. The CHMP’s opinion will be reviewed by the EC which is expected to make a final decision within three months. If approved by the EC, marketing authorization for Xerava will be granted in all 28 countries of the European Union, Norway, Iceland and Liechtenstein.
Presented data at ASM Microbe 2018, including a poster presentation that shared a pooled analysis of IGNITE1 and IGNITE4, the Company’s phase 3 studies to evaluate the efficacy and safety of Xerava versus ertapenem and meropenem, respectively, in patients with cIAI. This is the first post-hoc analysis of IGNITE1 and IGNITE4 to compare the clinical and microbiological responses at the test-of-cure visit for patients in the two treatment groups, with an emphasis on the response of MDR pathogens to Xerava. The Company also presented data highlighting the in vitro activity of Xerava and comparators against Gram-negative isolates from a large-scale global surveillance study, as well as the activity of TP-6076 against carbapenem-resistant Acinetobacter baumannii isolates.
Announced Everest Medicines’ submission of an IND application for eravacycline in cIAI to the CFDA. Everest has the exclusive license to develop and commercialize eravacycline for the treatment of cIAI and other indications in China, Taiwan, Hong Kong, Macau, South Korea and Singapore. Tetraphase received a milestone payment of $2.5 million following Everest’s IND application submission with the CFDA in June 2018.
Second Quarter 2018 Financial Results
As of June 30, 2018, Tetraphase had cash and cash equivalents of $111.2 million and 52.9 million shares outstanding. The Company expects that its cash and cash equivalents, as well as expected revenue from its U.S. government awards, will be sufficient to fund operations through the third quarter of 2019.

Revenues during the second quarter of 2018 were $11.6 million compared to $1.6 million for the same period in 2017. The $11.3 million in total revenue consisted of a $7.0 million upfront license fee and the $2.5 million Chinese IND filing milestone, both earned under the Company’s license agreement with Everest Medicines Limited, as well as $2.1 million in contract and grant revenue under the Company’s U.S. government awards.

Research and development (R&D) expenses for the second quarter of 2018 were $14.4 million compared to $28.5 million for the same period in 2017. The decrease in R&D expenses was primarily due to the completion of our IGNITE phase 3 clinical studies for Xerava.

General and administrative expenses for the second quarter of 2018 were $7.2 million compared to $5.1 million for the same period in 2017. This increase was primarily due to pre-commercialization expenses.

For the second quarter of 2018, Tetraphase reported a net loss of $9.5 million, or ($0.18) per share, compared to a net loss of $31.8 million, or ($0.83) per share, for the same period in 2017.

About Xerava
Xerava is a novel, fully-synthetic fluorocycline antibiotic being developed for the treatment of cIAI and other serious infections, including those caused by MDR pathogens that have been highlighted as urgent public health threats by both the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC). Xerava has demonstrated potent in vitro activity against MDR pathogens, including carbapenem-resistant Enterobacteriaceae, Acinetobacter baumannii, and colistin-resistant bacteria carrying the mcr-1 gene.

Xerava was investigated for the treatment of cIAI as part of the Company’s Investigating Gram-negative Infections Treated with Eravacycline (IGNITE) phase 3 program. In IGNITE1, a pivotal phase 3 trial in patients with cIAI, twice-daily intravenous (IV) Xerava met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to ertapenem, was well-tolerated and achieved high cure rates in patients with Gram-negative pathogens, including resistant isolates. In IGNITE4, a second phase 3 clinical trial in patients with cIAI, twice-daily IV Xerava met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to meropenem, was well-tolerated and achieved high cure rates. Xerava has not been approved for commercial use.

On August 2, 2018 Epizyme, Inc. (NASDAQ: EPZM), a clinical-stage company developing novel epigenetic therapies, reported financial results for the second quarter of 2018 and provided key business updates (Press release, Epizyme, AUG 2, 2018, View Source [SID1234528418]).

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"In the second quarter, we presented encouraging new clinical data regarding tazemetostat’s anti-tumor activity and tolerability in follicular lymphoma and mesothelioma," said Robert Bazemore, president and chief executive officer of Epizyme. "As we enter the second half of 2018, we have focused the organization on several strategic priorities. First and foremost, we are working diligently to resolve the partial clinical hold and resume enrollment in tazemetostat clinical studies. In addition, we are progressing tazemetostat toward a first NDA for the treatment of epithelioid sarcoma, continuing to advance its development in follicular lymphoma based on the strength of our clinical data, and advancing our novel inhibitor of G9a, EZM8266, toward the clinic. We believe the actions we have taken will allow us to capitalize on our near-term tazemetostat opportunities while also extending our cash runway."

Partial Clinical Hold Update

A partial clinical hold pausing the enrollment of new patients into tazemetostat clinical trials was implemented in the second quarter of 2018 in the United States, France and Germany following a safety report of a single pediatric patient who developed a secondary T-cell lymphoblastic lymphoma (T-LBL). Epizyme has reconsented all patients in its clinical trials and updated its informed consent form based on this safety report. The company also reviewed the single T-LBL case in detail, recently completed a comprehensive assessment of tazemetostat safety data and clinical activity observed to date across clinical trials, and convened a panel of external experts to review and validate the assessment. This information will be included in a formal response to regulatory authorities.

Epizyme plans to continue its engagement with the U.S. Food and Drug Administration (FDA) in the weeks ahead and then finalize its response to regulatory authorities, including changes that may be proposed to study protocols. Once the company has gained alignment with regulators in the U.S., France and Germany, it is anticipated that the partial clinical hold would be lifted and that enrollment activities would be allowed to proceed in those countries.

ES Program Update

At the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in October 2018, Epizyme plans to present updated Phase 2 data from patients with epithelioid sarcoma (ES) who are receiving tazemetostat as a monotherapy. Enrollment in this trial was completed in July 2017. A recent assessment of interim data from the full 62-patient ES cohort in this study has shown that the objective response rate has remained consistent with what was observed in the initial 31 enrolled patients. In addition, durability data from the cohort continue to mature.

Epizyme is continuing to prepare its first New Drug Application (NDA) submission for tazemetostat for the treatment of patients with ES. In order to include more mature durability data

in its submission and based on the potential impact of the partial clinical hold on the timing of the company’s pre-NDA meeting with the FDA, Epizyme now plans to submit its NDA in the first half of 2019.

DLBCL Program Update

Epizyme has been conducting a Phase 2 trial that is assessing tazemetostat activity in cohorts of patients with relapsed and/or refractory diffuse large B-cell lymphoma (DLBCL). These cohorts include DLBCL patients with EZH2 activating mutations and with wild-type EZH2 who are receiving tazemetostat as monotherapy. The trial also includes a cohort of DLBCL patients who are receiving tazemetostat in combination with prednisolone. Epizyme has conducted an interim assessment of data from this trial and concluded that the clinical activity seen in these cohorts is not sufficient to warrant further development of tazemetostat in DLBCL as a monotherapy or in combination with prednisolone. Epizyme plans to present clinical data from each of these study cohorts at a medical meeting in the second half of 2018. The company has two additional combination studies in DLBCL ongoing and plans to evaluate other potential combinations in this aggressive and difficult-to-treat cancer longer term.

Recent Progress

New Chief Medical Officer: Epizyme recently appointed Dr. Shefali Agarwal as chief medical officer. In this role, Dr. Agarwal will oversee all of the company’s activities related to the global strategic development of tazemetostat and additional pipeline candidates. A trained medical oncologist, Dr. Agarwal brings to Epizyme nearly two decades of clinical research and regulatory expertise as well as leadership experience in clinical development, clinical operations and medical affairs.

Positive Data in Follicular Lymhoma (FL): At the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in Stockholm, positive interim data were reported from the follicular lymphoma cohorts in Epizyme’s ongoing Phase 2 study of tazemetostat in non-Hodgkin lymphoma. The data as of May 1, 2018 showed that tazemetostat continued to demonstrate meaningful clinical activity as a monotherapy and was generally well tolerated in adult patients with relapsed and/or refractory FL. An objective response rate (ORR) of 71 percent was observed in the cohort of FL patients with EZH2 activating mutations (n=28), with an interim median duration of response (DOR) of approximately 32 weeks. An ORR of 33 percent was observed in the fully-enrolled cohort of FL patients with wild-type EZH2 (n=54), with an interim median DOR of approximately 76 weeks. The median DOR figures in these cohorts continue to mature, with more than half of the responders still on therapy. After resolving the partial clinical hold, Epizyme plans to re-engage with the FDA to refine the company’s registration plans for tazemetostat in relapsed and/or refractory FL.

Clinical Activity in Mesothelioma: At the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, clinical data were reported from Epizyme’s Phase 2 study of tazemetostat as a monotherapy in relapsed and/or refractory malignant mesothelioma patients with BRCA1-associated protein 1 (BAP1) loss-of-function. The primary endpoint in this trial was met with 51 percent of patients (31/61) having achieved disease control at 12 weeks, exceeding the pre-specified disease control rate threshold of ³35 percent. Tazemetostat was generally well tolerated in this study.

Second Quarter 2018 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $215.6 million as of June 30, 2018, which compares to $247.9 million as of March 31, 2018.

Revenue: Revenue for the second quarter of 2018 was $12.0 million, which compares with $10.0 million in revenue for the second quarter of 2017. The increase is due to greater milestone-related revenue from the company’s collaboration and license agreement with GlaxoSmithKline.

R&D Expenses: Research and development (R&D) expenses were $31.3 million for the second quarter of 2018, which compares to $27.3 million for the second quarter of 2017. The increase is primarily due to greater tazemetostat manufacturing expense, increased clinical and regulatory activities associated with tazemetostat’s development and preclinical studies related to the company’s G9a inhibitor candidate.

G&A Expenses: General and administrative (G&A) expenses were $10.9 million for the second quarter of 2018, which compares to $11.2 million for the second quarter of 2017. The decline is primarily due to reduced consulting costs.

Net Loss: The company’s net loss was $29.1 million, or $0.42 per share, for the second quarter of 2018, which compares to a net loss of $28.0 million, or $0.48 per share, for the second quarter of 2017.

Financial Guidance

Epizyme has extended its cash runway guidance based on changes that are being made to its planned operating expenditures. The company now expects that its existing cash, cash equivalents and marketable securities will be sufficient to fund its planned operations into the fourth quarter of 2019.

Conference Call Reminder

As previously announced, management plans to host a conference call and webcast at 8:30 a.m. ET today to discuss the company’s second quarter 2018 results and other business updates. To participate, please dial (877) 844-6886 (domestic) or (970) 315-0315 (international) and refer to conference ID 5734199. A live webcast will be available in the investor section of the company’s website at www.epizyme.com. The webcast also will be archived on the website for 60 days.

About the Tazemetostat Clinical Trial Program

Tazemetostat, a first-in-class EZH2 inhibitor, is currently being studied as a monotherapy in ongoing Phase 2 programs in certain molecularly defined solid tumors, including epithelioid sarcoma and other INI1-negative tumors; follicular lymphoma (FL); and combination studies in diffuse large B-cell lymphoma (DLBCL) and non–small cell lung cancer (NSCLC).