On August 1, 2019 Aduro Biotech, Inc. (NASDAQ: ADRO), a clinical-stage biopharmaceutical company focused on developing therapies targeting the Stimulator of Interferon Genes (STING) and A Proliferation Inducing Ligand (APRIL) pathways for the treatment of cancer, autoimmune and inflammatory diseases, reported financial results for the second quarter ended June 30, 2019.

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"Several important clinical study results have helped inform the development of our STING and APRIL programs thus far in 2019. We look forward to initiating the study of ADU-S100 and pembrolizumab in head and neck cancer as we continue to explore the synergies of STING agonists with checkpoint inhibitors," said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. "We continue to focus our development efforts for BION-1301 on IgA nephropathy, the most common type of glomerulonephritis worldwide for which there is no approved drug treatment option. We look forward to advancing the development of our STING and APRIL programs to provide the greatest potential benefit to patients." Isaacs continued, "Our cash position remains strong with $251.6 million at the end of the second quarter, and we will continue investing in our lead assets to generate additional meaningful data read-outs over the next 12 to 24 months."

Recent Highlights

Cleared three of five healthy volunteer dose cohorts in the single ascending dose portion of the Phase 1 clinical trial of BION-1301 for the treatment of IgA nephropathy

Presented findings from the ongoing Phase 1b study of ADU-S100 (MIW815) in combination with spartalizumab (PDR001) in patients with advanced, metastatic treatment-refractory solid tumors or lymphomas in an oral presentation at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting

Presented findings from the dose escalation portion of the Phase 1/2 study of BION-1301 in patients with relapsed or refractory multiple myeloma in two poster presentations at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting

Presented three abstracts at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019, including updated preclinical data on ADU-S100

Appointed immuno-oncology drug development expert, Dimitry Nuyten, M.D., Ph.D., as chief medical officer

Appointed financial and life sciences industry expert, James Welch, as interim chief financial officer

Appointed life sciences industry veteran, Frank Karbe, to the board of directors

Financial Results

Cash Position – Cash, cash equivalents and marketable securities totaled $251.6 million at June 30, 2019, compared to $277.9 million at December 31, 2018. Cash spend year to date was offset by the receipt of a $12 million upfront payment received in the first quarter of 2019 from the 2018 license agreement with Eli Lilly.

Revenue – Revenue was $4.9 million for the second quarter of 2019 and $8.8 million for the six months ended June 30, 2019, compared to $2.6 million and $9.3 million, respectively, for the same periods in 2018. The increase in revenue for the quarter was primarily due to ratable recognition of the upfront payment received from Eli Lilly in the first quarter of 2019.

The decrease in revenue year to date was primarily due to fluctuations in revenue recognized under our Novartis collaboration, which is dependent on the clinical timelines and progress under the research and collaboration agreement.

Expenses –

Research and development expenses were $16.9 million for the second quarter of 2019 and $36.4 million for the six months ended June 30, 2019, compared to $19.4 million and $39.5 million, respectively, for the same periods in 2018. The quarter and year to date costs decreased primarily due our strategic reset in January 2019, which resulted in reduced headcount and stock-based compensation expense. The reset also resulted in reduced spending towards deprioritized programs partially offset by higher spending towards our STING and APRIL programs.

General and administrative expenses were $8.0 million for the second quarter of 2019 and $17.2 million for the six months ended June 30, 2019, compared to $8.8 million and $17.9 million, respectively, for the same periods in 2018. The quarter and year to date costs decreased primarily due to our strategic reset in January 2019, which resulted in reduced headcount and stock-based compensation expense.

Net Loss – Net loss for the second quarter of 2019 was $18.6 million or $0.23 per share and $42.0 million or $0.53 per share for the six months ended June 30, 2019, compared to net loss of $24.4 million or $0.31 per share and $45.9 million or $0.59 per share, respectively, for the same periods in 2018.

On August 1, 2019 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer,reported financial results for the second quarter ended June 30, 2019 and provided a business update (Press release, Adaptimmune, AUG 1, 2019, View Source [SID1234537996]).

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James Noble, Adaptimmune CEO said: "I have spent twenty years in the field of T-cell receptors and am convinced that they will have an important role in treating patients. We have already seen compelling data in sarcoma with ADP-A2M4 and have recently started a trial with a next-generation SPEAR T-cell and a combination trial with low-dose radiation to improve the depth and durability of responses. It is my final pleasure as CEO to be handing over to Adrian – I know that he will do an excellent job in taking the Company through its next evolution towards commercialization. The changes that he is already introducing and the plans for the future will bring energy and focus to the tasks ahead, accelerating execution across the Company."

Adrian Rawcliffe, incoming Adaptimmune CEO said: "Looking forward, I intend to further focus the Company on increasing the pace of execution, which has already enabled us to initiate our first late-stage trial: SPEARHEAD-1, our first next-gen trial: SURPASS, and the low-dose radiation sub-study in recent weeks. In addition, we will strengthen our capabilities to be ready to launch our first product in 2022. Finally, we intend to leverage the state-of-the-art integrated capabilities that we have built in research, development and supply, to apply them in cell therapy more broadly."

Clinical programs

Initiated Phase 2 SPEARHEAD-1 trial with ADP-A2M4 in synovial sarcoma and myxoid/ round cell liposarcoma patients

Initiated SURPASS trial with ADP-A2M4CD8 — the first next-generation trial with SPEAR T-cells

Preclinical data show that these next-generation SPEAR T-cells may improve long term T-cell function as well as antitumor activity

Initiated low-dose radiation sub-study of ADP-A2M4 Phase 1 trial in collaboration with the MD Anderson Cancer Center

There is emerging data showing that low-dose radiation could enhance T-cell tumor trafficking and responses

Focusing efforts on ADP-A2M4, ADP-A2M4CD8, and ADP-A2AFP, with enrollment in the ADP-A2M10 trials closing by the end of 2019

Will provide clinical updates on all ongoing clinical trials at medical conferences

At ESMO (Free ESMO Whitepaper) 2019, Brian Van Tine, MD, PhD of Washington University in St. Louis will present an oral presentation titled "ADP-A2M4 (MAGE-A4) in patients with Synovial Sarcoma" on September 30, 2019

Since our last clinical update, the Company has reported serious adverse events (SAEs) in three patients

All three patients received the highest lymphodepletion regimen: fludarabine (30mg/m2/day for 4 days) and cyclophosphamide (1800 mg/m2/day for 2 days)

One patient in each of the ADP-A2M10 and ADP-A2M4 trials had reports of severe prolonged pancytopenia. Both patients subsequently died of complications.

In the third patient (in the ADP-A2M4 trial) there was one report of Grade 3 neurotoxicity. The patient subsequently died of a stroke that the Company believes was unrelated to SPEAR T-cell therapy.

Subsequently, the protocols for all ADP-A2M4 and ADP-A2M10 trials have been amended to include changes in eligibility criteria and reversion to the previously used lower dose of cyclophosphamide

These protocol changes have been communicated to the FDA

Commercial readiness

Working with Vineti as part of Adaptimmune’s strategy to deliver products through clinical trials and into scaled-up production post approval. Vineti is the first cloud-based software platform to efficiently take T-cell therapies through clinical trials and into mainstream medicine at commercial scale.

Pipeline

· Initiated collaboration with Alpine Immune Sciences to develop next-generation products

· Progress with allogeneic program continues with updates to be presented at future conferences

Other corporate news

Today’s changes to the Executive Team follow the Company’s recent news that Adrian Rawcliffe will assume the role of Chief Executive Officer on September 1, 2019, succeeding James Noble who will transition to a non-executive director role

John Lunger, previously SVP Manufacturing and Supply Chain, is promoted to the Executive Team as Chief Patient Supply Officer from August 1, 2019, as Adaptimmune gears up for commercial delivery of products to patients

Rafael Amado, President of R&D, will leave the Company on August 12, 2019

The new Executive Team will comprise Adrian Rawcliffe (Chief Executive Officer), Bill Bertrand (Chief Operating Officer), Helen Tayton-Martin (Chief Business Officer and co-Founder), and John Lunger (Chief Patient Supply Officer)

The Company is recruiting a Chief Medical Officer and a Chief Financial Officer

Financial Results for the three-month period ended June 30, 2019

Cash / liquidity position: As of June 30, 2019, Adaptimmune had cash and cash equivalents of $34.6 million and Total Liquidity(1) of $133.4 million.

· Revenue: Revenue for both the three and six months ended June 30, 2019 was $0.2 million, compared to $9.0 million and $17.2 million for the same periods in 2018. The revenue in the three and six months ended 2019 is due to the commencement of development on the third target nominated by GSK under the Collaboration and License Agreement, whereas the revenue for the same periods in 2018 was recognized due to the performance under the NY-ESO transition program and the PRAME development plan, which were completed in 2018.

·Research and development (R&D) expenses: R&D expenses for the three and six months ended June 30, 2019 were $25.5 million and $47.5 million, respectively, compared to $26.6 million and $52.0 million for the same periods of 2018. The decreases in both periods were primarily due to a reduction in expenditure associated with the NY-ESO program, which was transferred to GSK on July 23, 2018.

·General and administrative (G&A) expenses: G&A expenses for the three and six months ended June 30, 2019 were $10.1 million and $21.9 million respectively, compared to $11.3 million and $22.5 million for the same periods of 2018. The decreases in both periods are due to a reduction in general corporate costs including travel and IT expenditure.

·Other expense, net: Other expense, net for the three and six months ended June 30, 2019 was $6.3 million and $0.9 million respectively, compared to an expense of $15.4 million and $8.3 million for the same periods of 2018. Other expense, net primarily comprises unrealized foreign exchange losses, 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 month periods ended June 30, 2019 was a loss of $41.1 million and $68.5 million respectively, and $(0.07) and $(0.11) per ordinary share respectively, compared to a loss of $43.8 million and $64.6 million respectively and $(0.08) and $(0.11) per ordinary share respectively in the same periods of 2018.

Financial guidance

The Company believes that its existing cash, cash equivalents and marketable securities will fund the Company’s current operations through the third quarter of 2020.

Conference Call and Webcast Information

The Company will host a live teleconference at 8:00 a.m. EDT (1:00 p.m. BST) today, August 1, 2019. The live webcast of the conference call will be available in the investor section of Adaptimmune’s corporate website at www.adaptimmune.com. An archive will be available after the call at the same address. To participate in the live conference call, please dial (833) 652-5917 (U.S. or Canada) 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 (8299695).

On August 1, 2019 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory and dermatological diseases, reported it will report financial results for the second quarter 2019, Thursday, August 8th, after U.S. financial markets close (Press release, Aclaris Therapeutics, AUG 1, 2019, View Source [SID1234537994]).

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Management will conduct a conference call at 5:00 PM ET to discuss Aclaris’ financial results and provide a general business update. The conference call will be webcast live over the Internet and can be accessed by logging on to the "Investors" page of the Aclaris Therapeutics website, www.aclaristx.com, prior to the event. A replay of the webcast will be archived on the Aclaris Therapeutics website for 30 days following the call.

To participate on the live call, please dial (844) 776-7782 (domestic) or (661) 378-9535 (international), and reference conference ID 3391498 prior to the start of the call.

On August 1, 2019 IVERIC bio, Inc. (Nasdaq: ISEE) reported financial and operating results for the second quarter ended June 30, 2019 and provided a business update (Press release, Ophthotech, AUG 1, 2019, View Source [SID1234537986]).

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"We are pleased with the Company’s progress as we achieved several milestones to advance and expand our gene therapy pipeline for orphan inherited retinal diseases, or IRDs," stated Glenn P. Sblendorio, Chief Executive Officer and President of IVERIC bio. "We entered into exclusive global license agreements for rights to gene therapy product candidates for the treatment of BEST1-related IRDs and Leber congenital amaurosis type 10, or LCA10. We are encouraged by new research data from our miniCEP290 collaboration that support our plans to move this program forward in LCA10, and we expanded our gene therapy portfolio with the addition of a minigene research program for USH2A related IRDs, including Usher syndrome type 2A and USH2A-associated nonsyndromatic autosomal recessive retinitis pigmentosa. Manufacturing activities for IC-100 and IC-200, our two lead gene therapy product candidates, are currently ongoing using state-of-the-art manufacturing capabilities of Paragon Gene Therapy, part of Catalent Biologics."

Kourous A. Rezaei, MD, Chief Medical Officer of IVERIC bio added, "With the addition of the USH2A program to our portfolio, IVERIC bio is seeking to treat vision loss associated with what are reportedly the most common form of autosomal dominant retinitis pigmentosa (rhodopsin-mediated) and the most common form of autosomal recessive retinitis pigmentosa (USH2A-related). Retinitis pigmentosa is the most common orphan IRD. We look forward to presenting our gene therapy pipeline and discussing our programs in greater detail with highly-recognized gene therapy scientists and key opinion leaders in retinal diseases at our upcoming Gene Therapy R&D Investor Day."

Second Quarter 2019 and Recent Highlights

Orphan IRD Gene Therapy Programs

IC-100: Rhodopsin-Mediated Autosomal Dominant Retinitis Pigmentosa (RHO-adRP)
Natural history studies and IND-enabling activities for IC-100 are ongoing. The Company expects to initiate a Phase 1/2 clinical trial for IC-100 in the second half of 2020.

IC-200: BEST1-Related IRDs
In April 2019, the Company entered into an exclusive global license agreement with the University of Pennsylvania and the University of Florida Research Foundation for rights to develop and commercialize novel adeno-associated virus (AAV) gene therapy product candidates for the treatment of BEST1-related IRDs, including Best vitelliform macular dystrophy, also known as Best disease. The Company expects to initiate a Phase 1/2 clinical trial for IC-200 in the first half of 2021.

miniCEP290: Leber Congenital Amaurosis Type 10 (LCA10)
Encouraging results from the Company’s collaboration with the University of Massachusetts Medical School (UMass Medical School) in its miniCEP290 program led the Company to exercise its option and, in July 2019, the Company entered into an exclusive global license agreement with the University of Massachusetts for rights to develop and commercialize mutation independent novel AAV minigene therapy product candidates for the treatment of LCA10, which is due to mutations in the CEP290 gene and is the most common type of LCA.

miniUSH2A: USH2A-Related IRDs Including Usher Syndrome Type 2A and USH2A-Associated Nonsyndromatic Autosomal Recessive Retinitis Pigmentosa
In July 2019, the Company entered into a sponsored research agreement with UMass Medical School and an exclusive option agreement with the University of Massachusetts for rights to develop and commercialize novel AAV gene therapy product candidates utilizing a mutation independent minigene therapy approach for the treatment of USH2A-related IRDs. This group of orphan IRDs include Usher syndrome Type 2A and USH2A-associated nonsyndromatic autosomal recessive retinitis pigmentosa.

Gene Therapy Manufacturing
In June 2019, the Company announced that it had entered into a strategic manufacturing relationship with Paragon Gene Therapy, part of Catalent Biologics. This agreement is for production and manufacturing of AAV vectors for pre-clinical activities and planned Phase 1/2 clinical trials for IC-100 and IC-200.

Gene Therapy R&D Investor Day Scheduled
The Company will host its first "Gene Therapy R&D Investor Day" in New York, NY on Friday, September 13, 2019. The agenda includes updates from IVERIC bio’s management on its gene therapy portfolio in orphan IRDs, and scientific discussions from gene therapy scientists and key opinion leaders in orphan inherited retinal diseases including;

Guangping Gao, PhD, University of Massachusetts Medical School

William A. Beltran, DVM, PhD, University of Pennsylvania

Charles A. Gersbach, Duke University

Hemant Khanna, PhD, University of Massachusetts Medical School

Gustavo D. Aguirre, VMD, PhD, University of Pennsylvania School of Veterinary Medicine

Andreas K. Lauer, MD, Oregon Health & Science University

Bart P. Leroy, MD, PhD, Ghent University and Children’s Hospital of Philadelphia

Alfred S. Lewin, PhD, University of Florida

Therapeutic Programs
The Company expects initial top-line data for its ongoing Phase 2b clinical trial of Zimura (avacincaptad pegol), a C5 complement inhibitor, for the treatment of geographic atrophy secondary to dry age-related macular degeneration to be available in the fourth quarter of 2019. The Company expects initial top-line data for its Phase 2b clinical trial of Zimura for the treatment of autosomal recessive Stargardt disease to be available in the second half of 2020.

Second Quarter 2019 Financial Results

Operational Update
As of June 30, 2019, the Company had $106.9 million in cash and cash equivalents. After taking into account the Company’s recent in-licensing transaction for its miniCEP290 program and sponsored research agreement for its miniUSH2A program, the Company reaffirms its estimate that year-end 2019 cash and cash equivalents will range between $80 million and $85 million. This estimate is based on its current 2019 business plan, including the continuation of its current research and development programs. This estimate does not reflect any additional expenditures, including associated development

costs, in the event the Company in-licenses or acquires any new product candidates or commences any new sponsored research programs.

R&D Expenses: Research and development expenses were $10.0 million for the quarter ended June 30, 2019, compared to $8.5 million for the same period in 2018. For the six months ended June 30, 2019, research and development expenses were $17.7 million compared to $16.2 million for the same period in 2018. Research and development expenses increased primarily due to increases in costs associated with the Company’s gene therapy programs and HtrA1 inhibitor program, offset by decreases in costs associated with the Company’s Zimura programs, personnel expenses and professional and consulting fees.

G&A Expenses: General and administrative expenses were $5.2 million for the quarter ended June 30, 2019, compared to $6.3 million for the same period in 2018. For the six months ended June 30, 2019, general and administrative expenses were $10.7 million compared to $12.0 million for the same period in 2018. General and administrative expenses decreased primarily due to decreases in costs to support the Company’s operations and infrastructure.

Net Income: The Company reported a net loss for the quarter ended June 30, 2019 of $14.4 million, or ($0.35) per diluted share, compared to a net loss of $13.2 million, or ($0.37) per diluted share, for the same period in 2018. For the six months ended June 30, 2019, the Company reported a net loss of $26.9 million or ($0.65) per diluted share, compared to a net loss of $26.3 million or ($0.73) for the same period in 2018.

Conference Call/Web Cast Information
IVERIC bio will host a conference call/webcast to discuss the Company’s financial and operating results and provide a business update. The call is scheduled for August 1, 2019 at 8:00 a.m. Eastern Time. To participate in this conference call, dial 800-458-4121 (USA) or 323-794-2597 (International), passcode 3528260. A live, listen-only audio webcast of the conference call can be accessed on the Investors section of the IVERIC bio website at www.ivericbio.com. A replay will be available approximately two hours following the live call for two weeks. The replay number is 888-203-1112 (USA Toll Free), passcode 3528260.

On August 1, 2019 Intrexon Corporation (NASDAQ: XON), a leader in the engineering and industrialization of biology to improve the quality of life and health of the planet, reported it will release second quarter and first half 2019 financial results after the market closes on Thursday, August 8th, 2019 (Press release, Intrexon, AUG 1, 2019, View Source [SID1234537985]). The Company will host a conference call that day at 5:30 PM ET to discuss the results and provide a general business update.

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The conference call may be accessed by dialing 1-888-317-6003 (Domestic US), 1-866-284-3684 (Canada), and 1‑412-317-6061 (International) and providing the number 4443860 to join the Intrexon Corporation Call. Participants may also access the live webcast through Intrexon’s website in the Investors section at View Source