Pieris Pharmaceuticals Reports Second Quarter 2019 Cash Position and Provides Corporate Update

On August 1, 2019 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer and other indications, reported its cash position for the second quarter of 2019 ended June 30, 2019, and provided an update on the Company’s recent and future developments (Press release, Pieris Pharmaceuticals, AUG 1, 2019, View Source [SID1234538017]).

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In the first half of 2019, we made significant progress on our clinical milestones, and we expect that momentum to build into the end of the year," said Stephen S. Yoder, President and Chief Executive Officer of Pieris. "Last quarter, we presented two clinical data sets, including data from the phase 1 single ascending dose study of PRS-060, an inhaled IL-4 receptor alpha antagonist for moderate-to-severe asthma that was found to be safe and well-tolerated in the study and demonstrated favorable pharmacokinetics and robust target engagement. Looking ahead, we are pleased to announce that we will present data from the phase 1 multiple ascending dose study of that candidate, including the drug’s FeNO-reducing potential versus placebo, at the European Respiratory Society International Congress this fall. We are also pleased to announce that we plan to present data from the phase 1 dose-escalation study of PRS-343, a 4-1BB/HER2 bispecific for HER2-positive solid tumors, at a medical meeting later this year."

PRS-060: Pieris will present detailed data from the ongoing phase 1 multiple ascending dose study of PRS-060, an inhaled IL-4 receptor alpha antagonist for moderate-to-severe asthma, at the 2019 European Respiratory Society International Congress on October 1, 2019. This study is evaluating the safety, tolerability, and potential of PRS-060 to reduce fractional exhaled nitric oxide (FeNO) versus placebo in patients with mild asthma and elevated levels of FeNO. The Company presented data from the phase 1 single ascending dose study of PRS-060 at the 2019 American Thoracic Society International Conference earlier this year. In that study, PRS-060 was found to be safe and well-tolerated in 54 healthy volunteers, in addition to demonstrating favorable pharmacokinetics and robust target engagement. Upon completion of a phase 2a study sponsored and funded by AstraZeneca, Pieris will have separate options to co-develop and, subsequently, to co-commercialize the drug candidate. PRS-060 is the lead candidate in Pieris’ five-program respiratory collaboration with AstraZeneca.
Respiratory Pipeline: Pieris initiated an additional discovery-stage respiratory program in its alliance with AstraZeneca, bringing the total number of active programs to four; AstraZeneca may initiate one additional program within the alliance. Pieris also initiated an additional proprietary respiratory discovery-stage program and continues to advance the two proprietary discovery-stage programs it initiated last year.
PRS-343: Pieris continues to enroll and treat patients in a phase 1 dose-escalation study of PRS-343, a 4-1BB/HER2 bispecific for HER2-positive solid tumors and plans to report comprehensive data from the study at a medical meeting later this year. The Company also continues to enroll the dose-escalation phase 1 study of PRS-343 in combination with atezolizumab and intends to report data from the study later this year.
Immuno-Oncology Pipeline: Pieris plans to file an IND application for PRS-344, a 4-1BB/PD-L1 bispecific the Company is developing as part of its immuno-oncology collaboration with Servier, later this year. Pieris holds exclusive commercialization rights in the U.S. for PRS-344 and will receive royalties on ex-U.S. sales for this program.
PRS-080: Pieris presented data from the phase 2a study of PRS-080, a half-life-optimized hepcidin antagonist for anemia, at the 24th European Hematology Association (EHA) (Free EHA Whitepaper) Congress. In that study, PRS-080 was safe and well-tolerated, potently inhibited hepcidin, yielded robust iron mobilization, and increased transferrin saturation. At 8mg/kg, there was preliminary evidence of hemoglobin increase in patients treated with PRS-080. ASKA Pharmaceutical Co. currently has an exclusive option for PRS-080 for Japan and other Asian territories. Following delivery of a final study report, ASKA will decide whether to exercise its option to develop and commercialize PRS-080 in those territories.
Board Appointments: Pieris appointed Dr. Maya Said to the Company’s Board of Directors. Dr. Said is the founder and Chief Executive Officer of Outcomes4Me, a health technology company focused on providing patients diagnosed with cancer and other chronic life altering diseases with personalized treatment options as well as outcomes information. Her prior experience includes positions at Novartis, where she served as Senior Vice President, Global Head of Oncology Policy & Market Access, and at Sanofi, where she served as Vice President, Head of Strategy, Science Policy & External Innovation, Global R&D.
Cash Position: Cash, cash equivalents and investments totaled $99.7 million as of June 30, 2019, compared to a cash, cash equivalents and investments balance of $128.1 million as of December 31, 2018.
Additional Financials: Our second quarter 2019 financials will be released with our 10-Q, expected to be filed by Friday, August 9, 2019.
Conference Call:

Pieris management will host a conference call beginning at 8:00 AM Eastern Daylight Time on Thursday, August 1, 2019 to provide a corporate update. Individuals can join the call by dialing +1-877-407-8920 (US & Canada) or +1-412-902-1010 (International). An archived replay of the call will be available by dialing +1-877-660-6853 (US & Canada) or +1-201-612-7415 (International) and providing the Conference ID #: 13661472.

Navidea Biopharmaceuticals Schedules Second Quarter 2019 Earnings Conference Call and Business Update

On August 1, 2019 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported it will host a conference call and webcast on Thursday, August 8, 2019 at 5:00 p.m. (EDT) to discuss its financial results for the second quarter of 2019 (Press release, Navidea Biopharmaceuticals, AUG 1, 2019, View Source [SID1234538016]).

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Jed Latkin, Chief Executive Officer, Erika Gibson, Director of Finance and Administration, and Dr. Michael Rosol, Chief Medical Officer, of Navidea, will host the call and webcast to discuss the financial results and provide an update on recent developments and clinical progress. Management will be available to answer questions live immediately following the earnings announcement part of the call.

To participate in the call and webcast, please refer to the information below:

Event:

Q2 2019 Earnings and Business Update Conference Call

Date:

Thursday, August 8, 2019

Time:

5:00 p.m. (EDT)

U.S. & Canada Dial-in:

877-407-0312

International Dial-in:

+1 201-389-0899

Conference ID:

13693119

Webcast Link: View Source

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.

About Navidea

Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on its Manocept platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision-making, and targeted treatment. Navidea’s

Kura Oncology Reports Second Quarter 2019 Financial Results and Provides Corporate Update

On August 1, 2019 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported second quarter 2019 financial results and provided a corporate update (Press release, Kura Oncology, AUG 1, 2019, View Source [SID1234538015]).

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"The past quarter was highlighted by impressive data from our ongoing Phase 2 trial of tipifarnib in peripheral T-cell lymphoma (PTCL)," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "These data support the potential to register tipifarnib in both the angioimmunoblastic T-cell lymphoma (AITL) and PTCL not otherwise specified (PTCL-NOS) populations. In addition, we took further steps toward broadening the potential of farnesyl transferase inhibition to treat other CXCL12-driven indications of high unmet need, including diffuse large B-cell lymphoma (DLBCL), cutaneous T-cell lymphoma (CTCL), acute myeloid leukemia (AML) and pancreatic cancer. These advancements, along with the continued execution of our registration-directed study in HRAS mutant head and squamous cell carcinomas (HNSCC), are important steps toward establishing tipifarnib as a first-in-class farnesyl transferase inhibitor for patients with certain genetically defined cancers."

"As we look toward the second half of this year and early next year, we anticipate a number of milestones across our pipeline programs," continued Dr. Wilson, "including an update from our ongoing Phase 2 trial of tipifarnib in HRAS mutant HNSCC and other squamous cell carcinomas (SCCs), additional Phase 2 data in AITL, completion of the dose-escalation portion of the Phase 1 trial of our ERK inhibitor, KO-947, and initiation of the Phase 1 trial of our menin-MLL inhibitor, KO-539. With our successful public offering in June, we have greater resources and flexibility to continue to create value across our pipeline."

Recent Highlights

Registration-directed trial of tipifarnib in HRAS mutant HNSCC – Kura continues to execute on its initial registration-directed trial of tipifarnib in HRAS mutant HNSCC. The clinical trial has two cohorts: A non-interventional screening and outcomes cohort (SEQ-HN) and a treatment cohort (AIM-HN). AIM-HN is designed to enroll at least 59 evaluable patients with HRAS mutant HNSCC who have received prior platinum-based therapy. AIM-HN initiated in November 2018 and is expected to take approximately two years to fully enroll.

Positive Phase 2 trial of tipifarnib in AITL and CXCL12-driven PTCL – In June 2019, Kura reported positive data from its ongoing Phase 2 trial of tipifarnib in patients with relapsed or refractory PTCL, including clinical proof-of-concept in the trial’s two expansion cohorts: 1) patients with AITL, an aggressive form of T-cell lymphoma often characterized by high levels of CXCL12 expression, and 2) patients with PTCL who lack a single nucleotide variation in the 3’-untranslated region of the CXCL12 gene. The Company believes these data could support the potential registration of tipifarnib in both the AITL and PTCL-NOS patient populations and intends to seek regulatory feedback on next steps for this program. In addition, Kura plans to continue enrolling AITL patients in the trial and expects to provide additional data from this cohort at a medical meeting later this year.

Expanded patent protection for tipifarnib in the U.S. and Europe – The U.S. Patent and Trademark Office recently issued two new patents further protecting tipifarnib, including a method of treating patients with HRAS mutant HNSCC with any farnesyl transferase inhibitor and a method of treating patients with HRAS mutant non-small cell lung carcinoma with tipifarnib. In addition, the European Patent Office granted a patent directed to the use of tipifarnib as a method of treating patients with HRAS mutant HNSCC. The new patents have an expiration date of August 2036, excluding any possible patent term extension.

Dose escalation in Phase 1 trial of KO-947 advancing – Kura continues to evaluate dosing regimens for KO-947, its potent and selective small molecule inhibitor of ERK, in an ongoing Phase 1 trial, with a goal of reaching a recommended Phase 2 dose or maximum tolerated dose. The Company expects to complete the dose-escalation portion of the trial by the end of 2019.

Orphan Drug Designation to KO-539 for treatment of AML – Last week, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to KO-539, Kura’s menin-MLL inhibitor for the treatment of AML. The FDA cleared the investigational new drug application for KO-539 in March 2019, and the Company is in the final stages of study startup for a Phase 1 clinical trial of KO-539 in relapsed or refractory AML.

Successful public offering strengthens cash position – In June 2019, Kura completed a public offering in which the Company sold an aggregate of 6,785,000 shares of common stock at a price of $17.00 per share. Net proceeds from the public offering, after deducting underwriting discounts, commissions and offering expenses, were approximately $108.1 million.
Financial Results

Research and development expenses for the second quarter of 2019 were $11.4 million, compared to $11.5 million for the second quarter of 2018.

General and administrative expenses for the second quarter of 2019 were $4.5 million, compared to $3.8 million for the second quarter of 2018.

Net loss for the second quarter of 2019 was $14.9 million, or $0.38 per share, compared to a net loss of $14.7 million, or $0.45 per share, for the second quarter of 2018.

Cash, cash equivalents and short-term investments totaled $261.4 million as of June 30, 2019, which includes net proceeds of approximately $108.1 million from a public offering completed in June 2019, compared with $179.0 million as of December 31, 2018.

Management expects that current cash, cash equivalents and short-term investments will be sufficient to fund current operations into the second half of 2021.
Upcoming Milestones

Initiation of the Phase 1 trial of KO-539 in relapsed or refractory AML in the second half of 2019

Additional data from the ongoing Phase 2 trial of tipifarnib in HRAS mutant HNSCC and other SCCs in the fourth quarter of 2019

Additional data from the AITL expansion cohort in the ongoing Phase 2 trial of tipifarnib in the fourth quarter of 2019

Completion of the dose-escalation portion of the Phase 1 trial of KO-947 by the end of 2019

Additional data from the ongoing Phase 2 trial of tipifarnib in chronic myelomonocytic leukemia (CMML) in the first half of 2020

Initiation of a proof-of-concept study of tipifarnib in pancreatic cancer in the first half of 2020
Conference Call and Webcast

Kura’s management will host a webcast and conference call today at 4:30 p.m. ET / 1:30 p.m. PT, August 1, 2019, to discuss the financial results for the second quarter 2019 and provide a corporate update. The live call may be accessed by dialing (877) 516-3514 for domestic callers and (281) 973-6129 for international callers and entering the conference code: 5261899. A live webcast of the call will be available from the Investors and Media section of the Company’s website at www.kuraoncology.com, and a replay will be available shortly after the live event.

Iovance Biotherapeutics Reports Second Quarter 2019 Financial Results and Provides Corporate Update

On August 1, 2019 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported financial results from second quarter and first six months of 2019 and provided a corporate update (Press release, Iovance Biotherapeutics, AUG 1, 2019, View Source [SID1234538014]).

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"We have had a highly productive second quarter at Iovance," commented Maria Fardis, Ph.D., MBA, president and chief executive officer of Iovance Biotherapeutics. "We presented data for both melanoma and cervical programs at ASCO (Free ASCO Whitepaper), met with the FDA to define our registration path for LN-145, received Breakthrough Therapy Designation for LN-145, and broke ground for our commercial manufacturing facility. Based on FDA feedback, we expect to submit a Biologics License Application (BLA) for LN-145 for advanced cervical cancer in late 2020. This time frame potentially overlaps with the expected timing of a submission in the advanced melanoma indication. In addition, we continue to expand the Iovance team and build our corporate infrastructure in anticipation of making TIL therapy broadly accessible to all patients that may benefit from this treatment approach."

Recent Achievements and Upcoming Milestones

Clinical

.Data from the C-144-01 melanoma study and from the C-145-04 cervical cancer study were presented in June 2019 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting. Data from the C-145-04 study in 27 patients demonstrated an objective response rate (ORR) of 44 percent. At 7.4-month median follow-up, the median duration of response (DOR) had not been reached. Interim results from the C-144-01 study in 66 patients demonstrated an ORR of 38 percent. At 8.8-month median follow-up, median DOR had not been reached.
·Enrollment for Cohort 4, the pivotal cohort of the C-144-01, is on target for completion of enrollment in the first quarter of 2020.
·Study C-145-04 has been expanded to dose 75 patients to address the expected sample size in anticipation of a BLA submission in late 2020.
·The first patient has been dosed in the IOV-COM-202 study evaluating TIL monotherapy or TIL plus pembrolizumab in patients with melanoma, head and neck cancer, or non-small cell lung cancer (NSCLC). The company has amended the protocol for IOV-COM-202 to add an additional cohort to treat PD-1 naive NSCLC patients with TIL and pembrolizumab. The total number of patients expected to enroll in the study was increased to 48. This study has received regulatory approval for conduct in EU and Canada.
·To date, over 200 patients have been treated with TIL therapy at Iovance.

Regulatory

·In May 2019, LN-145 was granted Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of advanced cervical cancer patients who have progressed during or after chemotherapy.
·At an End of Phase 2 meeting, the FDA acknowledged that the ongoing C-145-04 study of TIL therapy LN-145 may be sufficient to support registration in the treatment of patients with advanced cervical cancer. We plan to include in the BLA, patients who have progressed following initial systemic therapy for recurrent or metastatic disease, which constitutes almost all of the more advanced patients enrolled to date. The protocol may further be amended to enroll additional patients in order to support a BLA submission.

Research

·A poster entitled "Iovance Peripheral Blood Lymphocytes (PBL): A Potential Cell Therapy Strategy for the Treatment of Chronic Lymphocytic Leukemia" was presented at the 24th Congress of European Hematology Association (EHA) (Free EHA Whitepaper) in June 2019. The poster described the company’s nine-day manufacturing process and preclinical results for IOV-2001, PBL for chronic lymphocytic leukemia, created from 50 mL of blood.
·In July 2019, the company entered into a clinical trial agreement with the University of Montreal Health Centre (CHUM), under which CHUM will conduct a clinical study that it has designed using PD-1 positive selected TIL. The PD-1 positive TIL to be used in the study will be manufactured by a GMP cell processing facility within the University of Montreal network using a process developed by CHUM. Iovance also has an option to negotiate an exclusive license to the technology from CHUM. Iovance is expanding its footprint in Canada with this collaboration.

Corporate

·In May 2019, the company entered into a long-term lease agreement to build an approximately 136,000 square foot commercial-scale production facility in Philadelphia for commercial and clinical production of autologous TIL products. The company and its partners began construction of the facility in June 2019.
·Friedrich Graf Finckenstein, M.D., joined the company as chief medical officer.
·Athena Countouriotis, M.D., was appointed to the company’s board of directors.
·The company currently owns seven recently granted or allowed U.S. patents for compositions and methods of treatment in a broad range of cancers relating to its Gen 2 manufacturing process, including U.S. Patent Nos. 10,166,257, 10,130,659, and 10,272,113. The company’s owned and licensed intellectual property portfolio also includes patent applications relating to TIL, marrow infiltrating lymphocyte, and PBL therapies; methods of manufacturing; the use of costimulatory molecules in TIL therapy and manufacturing; stable and transient genetically-modified TIL therapies; and methods of treating patient subpopulations.

Second Quarter 2019 Financial Results

Net loss for the second quarter ended June 30, 2019, was $47.6 million, or $0.38 per share, compared to net loss of $30.7 million, or $0.34 per share for the second quarter ended June 30, 2018.

Research and development expenses were $39.3 million for the second quarter of 2019, an increase of $14.7 million compared to $24.6 million for the second quarter of 2018. The increase in research and development expenses was primarily attributable to costs associated with the transfer of the manufacturing process to additional facilities to increase our manufacturing capacity, an increase in total patients in our clinical studies which in turn resulted in higher study costs, and an increase in research and development employees.

General and administrative expenses were $10.9 million for the second quarter of 2019, an increase of $4.1 million compared to $6.8 million for the second quarter of 2018. The increase was primarily attributable to new general and administrative employees and higher stock-based compensation, legal expenses related to the intellectual property portfolio and real estate and external market research costs as we prepare for commercialization.

Six Months Ended June 30, 2019 Financial Results

Net loss for the six months ended June 30, 2019, was $84.5 million, or $0.68 per share, compared to net loss of $57.2 million, or $0.65 per share for the same period ended June 30, 2018.

Research and development expenses were $70.2 million for the six months ended June 30, 2019, an increase of $25.7 million compared to $44.5 million for the same period ended June 30, 2018. The increase in research and development expenses was primarily attributable to costs associated with the transfer of the manufacturing process to additional facilities to increase our manufacturing capacity, higher costs for drugs used in the clinical studies, an increase in total patients in our clinical studies which in turn resulted in higher study costs, and an increase in the number of research and development employees.

General and administrative expenses were $19.9 million for the six months ended June 30, 2019, an increase of $6.1 million compared to $13.8 million for the same period ended June 30, 2018. The increase was primarily attributable to the addition of general and administrative employees and higher stock-based compensation, legal expenses related to intellectual property, and external market research expenses.

Cash, Cash Equivalents, Short-Term Investments and Restricted Cash

At June 30, 2019, the company held $409.6 million in cash, cash equivalents, short-term investments and restricted cash as compared to $440.0 million at March 31, 2019. During the second quarter the company used $33.8 million for operating activities. The company anticipates that the year-end balance of cash, cash equivalents, short-term investments and restricted cash may be between $310 and $320 million.

Webcast and Conference Call

Iovance will host a conference call and live audio webcast to discuss financial results and provide a corporate update today at 4:30 p.m. EDT.

To participate in the conference call, please dial 1-844-646-4465 (domestic) or 1-615-247-0257 (international) and reference the access code 7574927. A live and archived webcast can be accessed in the Investors section of the company’s website at www.iovance.com.

Intellia Therapeutics Announces Second Quarter 2019 Financial Results and Company Update

On August 1, 2019 Intellia Therapeutics, Inc. (NASDAQ:NTLA), reported operational highlights and financial results for the second quarter ended June 30, 2019 (Press release, Intellia Therapeutics, AUG 1, 2019, View Source [SID1234538013]).

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"We continue to build our in vivo and engineered cell therapy pipeline in support of our mission to develop curative genome editing therapies for patients," said Intellia President and Chief Executive Officer John Leonard, M.D. "With IND-enabling toxicology studies underway for NTLA-2001, we are well-positioned to submit an IND in mid-2020 for the first systemically delivered CRISPR/Cas9-based therapy for transthyretin amyloidosis. Additionally, by the end of this year, we plan to select our first engineered cell therapy development candidate to treat acute myeloid leukemia."

Second Quarter 2019 and More Recent Operational Highlights

ATTR Program: Intellia’s first in vivo development candidate, NTLA-2001, is for the treatment of transthyretin amyloidosis (ATTR). As part of an ongoing durability study of the Company’s lead lipid nanoparticle (LNP) formulation in support of NTLA-2001, we have demonstrated six months of durable liver editing with sustained reduction of circulating transthyretin (TTR) protein (average reduction >95%) following a single dose in non-human primates (NHPs). The Company announced today it has conducted its pre-investigational new drug (IND) meeting with the U.S. Food and Drug Administration (FDA), has initiated IND-enabling toxicology studies and expects to submit an IND application for NTLA-2001 in mid-2020. Additionally, the Company’s supply chain operations are in place to support manufacturing of Phase 1 materials. NTLA-2001 is being co-developed with Regeneron Pharmaceuticals, Inc. (Regeneron), with Intellia as the lead development and commercialization party.
AML Program: Intellia’s lead T cell receptor (TCR)-based therapy uses engineered T cells to target Wilms’ Tumor 1 (WT1) for the treatment of acute myeloid leukemia (AML). During the second quarter of 2019, the Company and its research collaborators at IRCCS Ospedale San Raffaele initiated functional testing of multiple lead TCRs in patient-derived xenograft models and remain on track to nominate a development candidate by the end of 2019. In parallel, Intellia has begun establishing manufacturing capabilities to support clinical evaluation.

In Vivo Insertion in NHPs: As previously disclosed, Intellia demonstrated the first CRISPR/Cas9-mediated, targeted transgene insertion in the liver of NHPs, using Factor 9 (F9) as a model gene. F9 is a gene that encodes for the Factor IX (FIX) protein, a blood-clotting protein that is missing or defective in hemophilia B patients. The study is a collaborative effort between Intellia and Regeneron, using Intellia’s LNP delivery system of CRISPR/Cas9 with an adeno-associated virus (AAV) containing a proprietary bi-directional insertion template. Following a single dose of the hybrid LNP-AAV delivery system containing an F9 DNA template, the Company demonstrated that the circulating human FIX protein levels achieved at day 14 were durable through the two months of completed observation and were within the normal human range (source: Amiral et al, Clin. Chem., 1984). Additionally, the NHP data expands on the durability of clinically relevant human FIX protein levels achieved in mice for over 12 months. Intellia is currently working closely with Regeneron on moving the program forward and is also independently evaluating the hybrid LNP-AAV delivery system for targeted insertion across several other transgenes of interest in an in vivo setting.

Expanded Management Team: In May, Intellia announced the appointment of Laura Sepp-Lorenzino, Ph.D., as executive vice president and chief scientific officer. Dr. Sepp-Lorenzino brings decades of leadership and research and development experience and leads Intellia’s drug research organization.

Upcoming Milestones

The Company has set forth the following for pipeline progression:

ATTR:
° Commence manufacturing of NTLA-2001 Phase 1 materials by the end of 2019
° Submit IND application for NTLA-2001 in mid-2020
AML:
° Nominate first engineered cell therapy development candidate by the end of 2019
Platform:
° Present additional in vivo and engineered cell therapy data at upcoming scientific conferences by the end of 2019

Second Quarter 2019 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $275.8 million as of June 30, 2019, compared to $314.1 million as of December 31, 2018. The decrease was driven by cash used to fund operations of $59.8 million, which was offset in part by $7.9 million of net equity proceeds raised from the Company’s At The Market ("ATM") offerings, $7.0 million of funding received under the Novartis collaboration, $4.1 million of ATTR cost reimbursements made by Regeneron, and $2.6 million in proceeds from employee-based stock plans.
ATM Proceeds Due: The Company has $27.1 million in current assets on the balance sheet as of June 30, 2019 related to proceeds due from the ATM offerings that were received in the first week of July 2019.
Collaboration Revenue: Collaboration revenue increased by $3.4 million to $11.1 million during the second quarter of 2019, compared to $7.7 million during the second quarter of 2018. The increase in collaboration revenue in 2019 was primarily driven by amounts recognized from the expansion of the existing collaboration with Novartis, as well as by amounts recognized under the Company’s ATTR Co/Co agreement with Regeneron. As previously disclosed, Regeneron is obligated to fund approximately 50% of the development costs for the ATTR program.
R&D Expenses: Research and development expenses increased by $2.0 million to $25.5 million during the second quarter of 2019, compared to $23.5 million during the second quarter of 2018. This increase was primarily driven by the advancement of Intellia’s pipeline and the expansion of the research and development organization.
G&A Expenses: General and administrative expenses increased by $5.3 million to $13.1 million during the second quarter of 2019, compared to $7.8 million during the second quarter of 2018. This increase was primarily driven by personnel-related costs to support Intellia’s larger research and development organization, and an increase in legal and intellectual property (IP) costs.
Net Loss: The Company’s net loss was $25.7 million for the second quarter of 2019, compared to $22.2 million during the second quarter of 2018.
Financial Guidance

Intellia expects that its cash, cash equivalents, marketable securities and proceeds due from the ATM offerings as of June 30, 2019, as well as technology access and funding from Novartis and Regeneron, will enable Intellia to fund its anticipated operating expenses and capital expenditure requirements into the second half of 2021. This expectation excludes any potential milestone payments or extension fees that could be earned and distributed under the collaboration agreements with Novartis and Regeneron or any strategic use of capital not currently in the Company’s base-case planning assumptions.

Conference Call to Discuss Second Quarter 2019 Earnings

The Company will discuss these results on a conference call today, August 1, 2019, at 8 a.m. ET.

To join the call:

U.S. callers should dial 866-575-6539 and use conference ID# 6223506, approximately five minutes before the call.
International callers should dial +1 856-344-9299 and use conference ID# 6223506, approximately five minutes before the call.
A replay of the call will be available through the Events and Presentations page of the Investor Relations section of the Company’s website at www.intelliatx.com, beginning on August 1, 2019 at 12 p.m. ET.