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Agenus Reports Third Quarter 2018 Financial Results and Provides Corporate Update

On November 6, 2018 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology (I-O) company with a pipeline of immune checkpoint antibodies, cancer vaccines and adoptive cell therapies1, provided a corporate update and reported financial results for the third quarter of 2018 (Press release, Agenus, NOV 6, 2018, View Source [SID1234530830]).

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"We have made substantial operational advances. These are unprecedented for a company of our size but also for the field of I-O," said Garo H. Armen, Ph.D., Chairman and CEO of Agenus. "We have shown that our CTLA-4 and PD-1 antibodies are active in the clinic with clinical benefit seen in the majority of the more than 130 patients treated. Recently we met with the FDA to confirm our clinical path to a BLA filing. In addition to these, our discovery engines have produced 4 INDs which have been filed this year, including our next generation CTLA-4. We plan to finish the year with two additional IND filing of first-in-class bispecifics. We also expect the closure of at least one corporate partnership transaction by year end."

Key operational and business updates

Operational Achievements:
PD-1 & CTLA-4 show clinical benefit in majority of patients across multiple solid tumors, including cervical cancer
Clinical benefit rate of 68% and 63% for AGEN2034 & AGEN18842
FDA meeting confirms path to BLA filing for lead molecules
Three trials are ongoing to leverage accelerated approval pathways
New discoveries advance to clinic
Four INDs filed in 2018, including Next-Gen CTLA-4, AGEN1181
Two First-in-class bispecific IND filings on track by year end
2018 Payment milestones triggered in partnerships with Incyte, Merck
LAG-3 (INCAGN02385) and TIM-3 (INCAGN02390) in the clinic with milestones received and to be received in Q4
Undisclosed target with Merck entered clinic also generating a milestone payment
Sales of GSK’s Shingrix, containing QS-21 Stimulon, have significantly exceeded earlier sales projections
Partnership discussions on track to be concluded by year end
Manufacturing Speed and Innovation driving advances to the clinic:
Setting industry records for clinical & pivotal grade material
3-5x faster for lead compounds
First-in-class bispecific, AGEN1223, manufactured at scale in <2 months
AgenTus Cell Therapy Business:
Lead identified for IND filing; private financing and plans for IPO underway
Third Quarter 2018 Financial Results

Cash and cash equivalents were $46.3 million at the end of the 3rd quarter compared to $43.2 million and $60.2 million at June 30, 2018 and December 31, 2017 respectively. Subsequent to the end of 3rd quarter, Agenus announced the completion of a private financing of $40 million with a single investor netting the company approximately $39.9 million.

For the third quarter ended September 30, 2018, we reported a net loss of $34 million or $0.29 per share compared to a net loss for same period in 2017 of $37 million, or $0.37 per share. In the third quarter, we recognized revenue of $13 million which includes a milestone achieved and non-cash royalties earned.

For the nine months ended September 30, 2018, we had a net reported loss of $113 million or $1.04 per share compared to a net reported loss for the same period in 2017 of $86 million or $0.88 per share. The increased net loss reflects reduced revenue during 2018 due to accelerated milestones received during 2017 from Incyte and the 2018 loss on early extinguishment of debt.

Conference Call, Webcast and Prepared Statement Information

Conference Call Information:

Date: Tuesday November 6, 2018

Time: 8:30 a.m. ET

Domestic Dial-in Number: (844) 492-3727

International Dial-in Number: (412) 317-5118

Conference ID: Agenus

Live Webcast: accessible from the Company’s website at View Source or with this link View Source

A replay will be available on the Company’s website approximately two hours after the call and will remain available for 90 days.

Protagonist Therapeutics Reports Third Quarter 2018 Financial Results and Provides Corporate Update

On November 6, 2018 Protagonist Therapeutics, Inc. (Nasdaq:PTGX) reported its financial results for the third quarter ended September 30, 2018, and provided a corporate update on its clinical development programs (Press release, Protagonist, NOV 6, 2018, View Source [SID1234530829]).

"We are pleased to report continued progress from each of the three clinical programs evaluating differentiated and novel therapeutics enabled by our proprietary peptide engineering platform," commented Dinesh V. Patel, Ph.D., Protagonist President and Chief Executive Officer. "We recently presented safety and efficacy data from the Phase 2 PROPEL study. Notably, these data show dose-dependent histologic remission in ulcerative colitis patients. The cumulative data for PTG-100, which now includes clinical, endoscopic, histologic and biomarker data, is supportive of the GI-restricted, oral targeted therapy approach for potential treatment of inflammatory bowel diseases."

"In addition, we recently announced successful completion of the Phase 1 clinical trial of the oral interleukin-23 receptor antagonist PTG-200. We are working closely with our partner Janssen Biotech to support the U.S. IND filing for a Phase 2 Crohn’s trial in the coming months."

"Our hepcidin mimetic PTG-300 is on track for initiation of an open label, global, phase 2 trial in beta-thalassemia patients by year end. We are encouraged to note that PTG-300 now has Orphan Drug Designation both from the U.S. FDA and European Medicines agency, as well as Fast Track designation from the U.S. FDA for beta-thalassemia."

Product Development Update:

PTG-100

· Clinical data from the PROPEL Study presented at the recent United European Gastroenterology Week demonstrated that treatment with PTG-100, an oral, gut-restricted alpha-4-beta-7 integrin antagonist peptide, was well tolerated and associated with higher rates of clinical remission relative to placebo.

· The dose-dependent increase in rates of histologic remission, the blood biomarker data and topline safety data presented at the meeting expand upon the clinical remission and endoscopic response results announced previously in August 2018 that involved an independent, blinded re-read of endoscopies and had demonstrated signals of clinical efficacy.

· The totality of the data from the Phase 2 PROPEL study in UC patients provides first evidence of safety and clinical efficacy with an oral alpha-4-beta-7-integrin specific antagonist agent and supports further development of PTG-100.

PTG-200

· The Phase 1 study of PTG-200, an oral peptide IL-23 receptor antagonist partnered with Janssen Biotech, was successfully completed. Top-line results from this randomized, double-blind, placebo-controlled, single- and multiple-dose escalation study in 80 normal healthy volunteers demonstrated that PTG-200 treatment was well tolerated, with no serious adverse events or dose-limiting toxicities observed. Pharmacokinetic and pharmacodynamic parameters were consistent with the gastrointestinal-restricted design of PTG-200.

· Results from this study provide the first clinical data in support of PTG-200 and creates a path forward for its evaluation as a potential first-in-class oral IL-23 pathway based therapeutic for treatment of IBD.

·Protagonist and Janssen Biotech are working towards filing a U.S. IND in the coming months to support a Phase 2 clinical study in Crohn’s disease patients.

PTG-300

·The Company remains on track to initiate a global Phase 2 clinical trial in beta-thalassemia patients in the fourth quarter of 2018.

· The U.S. FDA granted Fast Track Designation to PTG-300 for the treatment of chronic anemia due to ineffective erythropoiesis in patients with beta-thalassemia. This designation will facilitate the future development and expedite the review process of PTG-300.

· The European Medicines Agency granted Orphan Drug Designation to PTG-300 in the treatment of beta-thalassemia. Orphan drug designation from the US FDA had been previously granted for PTG-300 for potential treatment of beta-thalassemia. An orphan designation provides regulatory and financial incentives for development as well as certain benefits upon regulatory approval, if received.

Corporate Update — Financing:

· Protagonist announced the completion of a financing with investors including BVF Partners L.P. and their affiliates for gross proceeds of $22 million in August 2018. This enables the company to fund the development of its multiple clinical assets in diverse disease indications addressing unmet medical needs.

Financial Results

Protagonist reported a net loss of $8.7 million and $25.1 million, respectively, for the third quarter and first nine months of 2018, as compared to a net loss of $4.8 million and $33.9 million, respectively, for the same periods of 2017. The increase in net loss for the third quarter of 2018 as compared to the prior year period was driven primarily by a decrease in revenue under the Janssen Collaboration Agreement related to proportional performance as measured by actual costs incurred as a percentage of budgeted costs, and increases in research and development (R&D) and general and administrative (G&A) expenses. The decrease in net loss for the first nine months of 2018 as compared to the prior year period was driven primarily by an increase in revenue under the Janssen Collaboration Agreement, which became effective in the third quarter of 2017, partially offset by increases in R&D and G&A expenses. The net loss for the third quarter and first nine months of 2018 includes non-cash stock-based compensation of $2.0 million and $4.8 million, respectively, as compared to $1.2 million and $3.1 million, respectively, for the same periods of 2017.

R&D expenses for the third quarter and first nine months of 2018 were $12.1 million and $45.2 million, respectively, as compared to $11.2 million and $34.5 million, respectively, for the same periods of 2017. The increases in R&D expenses were primarily due to costs related to contract manufacturing and the preparation for and conduct of clinical trials for our product candidates. R&D expenses for the third quarter and first nine months of 2018 included increases in salaries and employee-related expenses due to an increase in R&D personnel.

G&A expenses for the third quarter and first nine months of 2018 were $3.4 million and $10.2 million, respectively, as compared to $2.6 million and $8.7 million, respectively, for the same periods of 2017. The increases in G&A expenses were primarily due to increases in salaries and employee-related expenses to support the growth of our operations.

Protagonist ended the third quarter with $138.5 million in cash, cash equivalents and investments. The company expects to have sufficient financial resources to fund operations to mid-2020.

BioCryst Reports Third Quarter 2018 Financial Results

On November 6, 2018 BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) reported financial results for the third quarter ended September 30, 2018 (Press release, BioCryst Pharmaceuticals, NOV 6, 2018, View Source [SID1234530828]).

"With enrollment in APeX-2 complete, and the successful results from ZENITH-1, we are excited with the momentum that is building towards meeting the urgent demand of HAE patients for an oral therapy option to prevent and treat their attacks," said Jon Stonehouse, president and chief executive officer of BioCryst.

"We have many significant milestones lined up over the next several months and we are focused on delivering high quality APeX-2 data in the second quarter of 2019, filing our New Drug Application (NDA) for BCX7353 in the fourth quarter of 2019 and advancing at least one additional pipeline program into the clinic in the first half of the year," Stonehouse added.

Upcoming Key Milestones:

Complete the 250 mg and 500 mg dose cohorts of the ZENITH-1 clinical trial for acute treatment of hereditary angioedema (HAE) attacks with BCX7353 (Q1 2019)

Meet with U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for input on the design of a Phase 3 clinical trial of BCX7353 for acute treatment of HAE attacks, and commence the Phase 3 trial (Summer 2019)

Report results from the APeX-2 clinical trial (Q2 2019)

Advance at least one preclinical program into the clinic and begin the Phase 1 clinical trial (1H 2019)

File NDA for BCX7353 for prevention of HAE attacks with FDA (Q4 2019)

Third Quarter 2018 Financial Results

For the three months ended September 30, 2018, total revenues were $1.5 million, compared to $8.8 million in the third quarter of 2017. The decrease was primarily associated with two infrequent 2017 events that did not recur in 2018. A $5.0 million milestone payment associated with the FDA approval of a supplemental New Drug Application (sNDA) for RAPIVAB (peramivir injection), extending its availability for the treatment of acute uncomplicated influenza to pediatric patients two years and older, and the recognition of $1.5 million of peramivir product sales to the company’s commercial partner, Green Cross Corporation.

Research and development (R&D) expenses for the third quarter of 2018 increased to $22.0 million from $17.5 million in the third quarter of 2017, primarily due to increased spending on the company’s HAE and preclinical programs.

General and administrative (G&A) expenses for the third quarter of 2018 increased to $7.9 million, compared to $3.3 million in the third quarter of 2017. The increase was primarily due to merger-related costs associated with the company’s terminated merger with Idera Pharmaceuticals, Inc. (Idera).

Interest expense was $2.3 million in the third quarter of 2018, compared to $2.1 million in the third quarter of 2017.

Net loss for the third quarter of 2018 was $29.6 million, or $0.28 per share, compared to a net loss of $15.1 million, or $0.18 per share, for the third quarter 2017.

Cash, cash equivalents and investments totaled $151.0 million at September 30, 2018, and reflect a decrease from $159.0 million at December 31, 2017. Cash and investments reflect the proceeds from a July 2018 enhancement to our credit facility and an August 2018 public equity offering, offset by normal operating expenses and merger related costs incurred in the nine-month period. Net operating cash use for the third quarter 2018 was $29.4 million, and for the first nine months of 2018 was $70.7 million.

Year to Date 2018 Financial Results

For the nine months ended September 30, 2018, total revenues were $17.9 million, compared to $21.3 million in the first nine months of 2017. The decrease in revenue was primarily associated with infrequent revenue events that occurred in 2017 that did not recur in 2018, as well as a decrease of revenue from galidesivir development under U.S. Government contracts. Those 2017 events were the recognition of $4.1 million of royalty revenue from Japanese government stockpiling of RAPIACTA and the recognition of $1.5 million of peramivir product sales to the company’s commercial partner, Green Cross Corporation. In the nine-month periods, there was a $5.0 million milestone and $7.0 million of deferred revenue both associated with the EMA’s approval of peramivir (ALPIVAB) recognized in the second quarter of 2018, and two infrequent events that occurred in the third quarter of 2017, as discussed in the third quarter commentary above.

R&D expenses in the first nine months of 2018 increased to $61.5 million from $50.0 million in the first nine months of 2017, primarily due to increased spending on our HAE and preclinical programs. These increases were partially offset by a decrease in the company’s peramivir and galidesivir development spending in 2018.

G&A expenses for the first nine months of 2018 increased to $25.0 million, compared to $9.2 million in the first nine months of 2017. The increase was primarily due to approximately $11 million of merger-related costs associated with the company’s terminated merger with Idera and a $4.9 million reserve for collectability of the EMA approval milestone of peramivir.

Interest expense was $6.8 million in the first nine months of 2018, compared to $6.3 million in the first nine months of 2017.

Net loss for the first nine months of 2018 was $73.8 million, or $0.73 per share, compared to a net loss of $46.2 million, or $0.58 per share, for the first nine months of 2017.

Third Quarter 2018 Corporate Developments

On September 17, 2018, BioCryst announced that the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, had awarded BioCryst an additional $3.5 million to support clinical trials of galidesivir in patients with yellow fever.

On September 6, 2018, BioCryst announced that the Centers for Disease Control and Prevention (CDC) had awarded BioCryst a $34.7 million contract for the procurement of up to 50,000 doses of BioCryst’s approved antiviral influenza therapy, RAPIVAB (peramivir injection) over a five-year period.

On September 4, 2018, BioCryst announced initial results from the ZENITH-1 trial showing that a single 750 mg oral dose of BCX7353 was well tolerated and superior to placebo (p<0.05) against the majority of efficacy endpoints evaluated in HAE patients suffering an acute attack.

On August 6, 2018, BioCryst announced it has received Fast Track Designation by the FDA for BCX7353 for the prevention of angioedema attacks in patients with hereditary angioedema.

On August 6, 2018, BioCryst announced the full exercise of the underwriters’ option to purchase additional shares and the completion of its public offering resulting in the sale of 10,454,546 shares of its common stock at a price of $5.50 per share. The net proceeds from this offering were approximately $53.4 million, after deducting underwriting discounts and commissions and other estimated offering expenses.

On July 25, 2018, BioCryst announced that results from the Phase 2, APeX-1 trial of BCX7353 for the prevention of attacks in patients with HAE were published in the July 26th issue of The New England Journal of Medicine.

On July 20, 2018, BioCryst entered into a $30 million secured loan facility with MidCap Financial Trust as administrative agent and lender (MidCap), pursuant to the terms and conditions of that certain Amended and Restated Credit and Security Agreement. The Credit Agreement replaces the Credit and Security Agreement dated as of September 23, 2016.

On July 10, 2018, BioCryst announced that it had terminated the previously announced merger agreement with Idera following the company’s stockholders’ failure to approve the adoption of the merger agreement. Pursuant to the merger agreement, the company reimbursed Idera $6 million in July 2018.
Financial Outlook for 2018

Based upon development plans, merger-related incurred costs from the terminated merger agreement with Idera and awarded government contracts, BioCryst continues to expect its previously issued 2018 financial outlook to be appropriate, with net operating cash use to be in the range of $85 to $105 million, and its 2018 operating expenses to be in the range of $90 to $110 million. The company’s operating expense range excludes equity-based compensation expense due to the difficulty in reliably projecting this expense, as it is impacted by the volatility and price of the company’s stock, as well as by the vesting of the company’s outstanding performance-based stock options.

Conference Call and Webcast

BioCryst management will host a conference call and webcast at 8:30 a.m. ET today to discuss the financial results and provide a corporate update. The live call may be accessed by dialing 877-303-8027 for domestic callers and 760-536-5165 for international callers and using conference ID #9090479. A live webcast of the call and slides will be available online at the investors section of the company website at www.biocryst.com. Please connect to the website at least 15 minutes prior to the start of the conference call to ensure adequate time for any software download that may be necessary. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID # 9090479.

About BCX7353

Discovered by BioCryst, BCX7353 is a novel, oral, once-daily, selective inhibitor of plasma kallikrein currently in development for the prevention and treatment of angioedema attacks in patients diagnosed with HAE. BCX7353 was generally safe and well tolerated in the Phase 2 APeX-1 clinical trial. BioCryst is currently conducting the Phase 3 APeX-2 clinical trial and the long-term safety APeX-S clinical trial, both evaluating two dosage strengths of BCX7353 administered orally once-daily as a preventive treatment to reduce the frequency of attacks in patients with HAE. BioCryst is also conducting the ZENITH-1 clinical trial. ZENITH-1 is a proof-of-concept Phase 2 clinical trial testing an oral liquid formulation of BCX7353 for the treatment of acute angioedema attacks.

Principia Biopharma Reports Third Quarter Financial Results

On November 6, 2018 Principia Biopharma Inc. (Nasdaq: PRNB), a clinical-stage biopharmaceutical company dedicated to bringing transformative oral therapies to patients with significant unmet medical needs in immunology and oncology, reported financial results for the third quarter ended September 30, 2018 (Press release, Principia Biopharma, NOV 6, 2018, View Source [SID1234530827]).

"The completion of our IPO with gross proceeds of approximately $122.2 million was the highlight of the third quarter for Principia. In addition, we continued with preparations for our upcoming PRN1008 Phase 3 trial in patients with pemphigus, and we achieved an important milestone in our collaboration with Sanofi for our BTK inhibitor PRN2246," said Martin Babler, Chief Executive Officer of Principia.

Third Quarter Financial Results

For the three months ended September 30, 2018, Principia reported net income of $6.7 million compared to a net loss of $7.1 million for the same period in 2017.

Collaboration revenue was $18.6 million for the three months ended September 30, 2018, compared to $1.5 million for the same period in 2017. The increase was due to the revenue recognition of an upfront payment of $40.0 million received in December 2017, as well as the revenue recognition of milestone payments totaling $15.0 million received in 2018, related to the Company’s collaboration with Sanofi.

Total research and development expenses were $9.2 million for the three months ended September 30, 2018, including stock-based compensation expense of $0.3 million, compared to $6.1 million for the same period in 2017, including stock-based compensation expense of $0.2 million. The increase in total research and development expenses was mainly due to an increase in PRN1008 program costs related to the initiation of an ITP clinical trial in December 2017, certain manufacturing campaigns as well as an increase in employee related expenses.

General and administrative expenses were $2.9 million for the three months ended September 30, 2018, including stock-based compensation expense of $0.4 million, compared to $1.3 million for the same period in 2017, including stock-based compensation expense of $0.1 million. The increase in total general and administrative expenses was primarily attributable to employee related expenses and facility costs.

Cash, cash equivalents, and short-term investments were $188.3 million as of September 30, 2018, compared to $41.1 million as of December 31, 2017. The increase in cash reflects net proceeds of $49.8 million from Principia’s Series C convertible preferred stock financing, and $113.6 million from Principia’s initial public offering (IPO).

Idera Pharmaceuticals Reports Third Quarter 2018 Financial Results and Provides Corporate Update

On November 6, 2018 Idera Pharmaceuticals, Inc. (NASDAQ: IDRA), a clinical-stage biopharmaceutical company focused on the development, and ultimately the commercialization, of therapeutic drug candidates for both oncology and rare disease indications characterized by small, well-defined patient populations with serious unmet medical needs, reported its financial and operational results for the third quarter ended September 30, 2018 (Press release, Idera Pharmaceuticals, NOV 6, 2018, View Source [SID1234530826]).

"The third quarter of 2018 was marked by continued focus and execution throughout our company advancing the tilsotolimod ILLUMINATE 301 trial toward approval in our lead indication in anti-PD-1 refractory or relapsed metastatic melanoma. We also made significant progress framing our plans to expand the development of tilsotolimod to additional tumor types," stated Vincent Milano, Idera’s Chief Executive Officer.

"Over these past several years, through all of the preclinical studies, translational data collections and ultimately our early clinical experiences, it’s becoming clearer to us that the potential utility of tilsotolimod is not limited to melanoma and is certainly not limited by the location or type of tumor," continued Milano. "We look forward to providing our next clinical update from the ILLUMINATE 204 trial in the first half of December as well as laying out our expansion plans for the program in the beginning of 2019."

"The majority of our company’s focus is and will remain towards maximizing the opportunity with, and more importantly, the number of patients that can benefit from, tilsotolimod. At the same time, we recognize and embrace the concept of continuing to build Idera for the future. To that end, we will continue to be aggressive in our pursuit of additional assets to further drive value for our shareholders, and more importantly, meet the needs of patients suffering from rare diseases with serious unmet needs."

Clinical Development Program Updates:

ILLUMINATE (tilsotolimod) Clinical Development

ILLUMINATE 301 — Randomized Phase 3 trial of intratumoral tilsotolimod in combination with ipilimumab versus ipilimumab alone in patients with PD-1 refractory/relapsed metastatic melanoma:

· Trial initiated in the first quarter of 2018;

· 42 of the planned up to 110 sites across 12 countries have been activated for the randomization of patients into the trial;

· ILLUMINATE 301 Trials in Progress (TiPS) presentation on trial design featured at the 2018 Congress of the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper);

· Planned enrollment of approximately 300 patients with Overall Response Rate ("ORR") and Overall Survival as primary endpoints; and

· U.S. Food and Drug Administration granted Fast Track Designation in fourth quarter of 2017 for tilsotolimod in combination with ipilimumab for the treatment of patients with unresectable or metastatic melanoma following failure of PD-1 inhibitor treatment.

ILLUMINATE 204 — Phase 1/2 trial of intratumoral tilsotolimod in combination with either ipilimumab or pembrolizumab in patients with PD-1 refractory/relapsed metastatic melanoma:

Ipilimumab Combination Arm — Phase 2 Recruitment Ongoing

· Enrollment continues at 10 U.S. clinical trial sites;

· Two additional sites planned for initiation in November 2018;

· ILLUMINATE 204 Trial Data update presented at ESMO (Free ESMO Whitepaper) 2018 demonstrated both abscopal effect as well as the potential of intratumoral tilsotolimod to overcome known resistance mechanisms to ipilimumab treatment as a monotherapy.

· Earlier this year at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, the company presented clinical efficacy and safety data from the first 21 evaluable patients demonstrating:

· Confirmed RECIST v1.1 responses (including 2 Complete Responses [CR]) were observed in 8 of these 21 subjects (38.1%);

· Overall 15 patients out of 21 evaluable for efficacy (71.4%) experienced disease control (CR, PR, or SD);

· The combination regimen was generally well tolerated. 6/26 subjects (23%) had immune-related toxicities indicating that IMO-2125 + ipilimumab does not appear to add toxicity versus ipilimumab alone;

· Injection-related toxicities were grade 1-2 transient fever and flu-like symptoms lasting <48 hours;

· 15/26 patients (57.7%) with lesions accessible only by image-guided injection (5 deep visceral lesions and 10 lymph nodes) were included; and

· The company plans to provide a data update on up to 35 evaluable patients in first half of December 2018.

Pembrolizumab Combination Arm — Phase 1 Dose Escalation Ongoing

· Enrollment in the last dosing cohort (32 mg) ongoing with one patient remaining to complete enrollment (priority enrollment has been towards the ipilimumab combination arm of ILLUMINATE 204).

· One patient in the cohort testing 16mg intratumoral tilsotolimod in combination with pembrolizumab continues on study with a confirmed complete response (CR).

ILLUMINATE 101 — Phase 1b trial of intratumoral tilsotolimod monotherapy in patients with refractory solid tumors:

· Completed enrollment in all four dose ranging cohorts; 41 patients enrolled;

· Continuing enrollment into the refractory melanoma cohort at the 8 mg dose of intratumoral tilsotolimod as monotherapy;

· Translational data continues to be collected, analyzed and is planned to be submitted for presentation at a medical oncology conference in 2019.

Investigator Sponsored Trials (IST)

Idera is supportive of several Investigator Sponsored Trials and continues to evaluate additional proposals:

· A Phase 1/2 open label study of intratumoral tilsotolimod in combination with intratumoral ipilimumab and IV nivolumab in a protocol open to multiple tumor types including non-small cell lung cancer (NSCLC), melanoma, squamous cell carcinoma of the head and neck and urothelial carcinoma. The principal investigator initiating this trial is Aurélien Marabelle, MD, PhD, Clinical Director of the Cancer Immunotherapy Program at Institut Gustave Roussy, Villejuif, France; and

· A Phase 2 placebo-controlled study of intradermal administration of tilsotolimod in patients with T3/T4 primary melanoma scheduled to undergo a combined re-excision and sentinel node biopsy (SNB) procedure. The principal investigators initiating this trial are Bas Koster, MD and Tanja de Gruijl, PhD at The VU University Medical Center, Amsterdam, the Netherlands.

Corporate Updates:

During the quarter, the following Corporate Organizational Changes were announced:

· Howard Pien appointment to Idera’s Board of Directors on September 18, 2018, filling the seat previously held by Julian Baker.

· Bryant D. Lim joined Idera as General Counsel and Secretary to the Board of Directors, effective September 10, 2018;

· Chief Financial Officer Louis J. Arcudi III’s planned departure from the company related to the company’s consolidation to PA headquarters, effective October 31, 2018;

· Vice President of Finance John J. Kirby’s appointment as Principal Financial Officer and Principal Accounting Officer, effective October 31, 2018; and

Financial Results

Third Quarter Results

Net loss applicable to common stockholders for the three months ended September 30, 2018 was $11.6 million, or $0.43 per basic and diluted share, compared to net loss applicable to common stockholders of $14.5 million, or $0.78 per basic and diluted share, for the same period in 2017. Revenue in each of the three months ended September 30, 2018 and 2017 was nominal. Research and development expenses for the three months ended September 30, 2018 totaled $8.9 million compared to $10.9 million for the same period in 2017. General and administrative expense for the three months ended September 30, 2018 totaled $4.0 million compared to $3.9 million for the same period in 2017. Merger-related costs, net for the three months ended

September 30, 2018 amounted to a net credit of $3.8 million and was comprised of a $6.0 million fixed expense reimbursement received in connection with the termination of the company’s proposed merger with BioCryst Pharmaceuticals, Inc., which was terminated in July 2018; partially offset by $2.2 million of expenses incurred in connection with the transactions contemplated by the related merger agreement. No such costs were incurred during 2017. Restructuring costs for the three months ended September 30, 2018 totaled $3.0 million and are a result of our decision in July 2018 to wind-down our discovery operations, reduce the workforce in Cambridge, Massachusetts that supported such operations, and close our Cambridge facility. No such costs were incurred during 2017.

As of September 30, 2018, the company’s cash and cash equivalents totaled $82.5 million. The company currently anticipates that, based on its current operating plan, its existing cash and cash equivalents will be sufficient to fund company operations into the first quarter of 2020.