Cellectis to Present Data at the 2018 ASGCT Annual Meeting

On May 10, 2018 Cellectis (Euronext Growth: ALCLS – Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), reported that three posters regarding the Company’s allogeneic off-the-shelf CAR-T product candidates and one poster associated with the Company’s technology will be presented at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting to be held from May 16 to 19, 2018, in Chicago, Illinois (Press release, Cellectis, MAY 10, 2018, file:///C:/Users/LENOVO/Downloads/20180510_PR_ASGCT.pdf [SID1234526472]).

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• Universal CAR T-Cells Targeting CS1 (UCARTCS1) for the Treatment of Multiple Myeloma

Agnès Gouble1, Roman Galetto1, Rohit Mathur3, Stephanie Filipe1, Isabelle ChionSotinel1,
Jing Yang3, Jin He3, Robert Z. Orlowski3, Sattva S. Neelapu3 and Julianne
Smith2
1Cellectis SA, 8 rue de la croix Jarry, 75013 Paris, France
2Cellectis, Inc., 430 East 29th Street, 10016 New York, NY
3Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer
Center, 1515 Holcombe Blvd., Houston, TX 77030
Poster number: 130
Cancer – Targeted Gene & Cell Therapy I
Wednesday, May 16, 2018 at 5:30 PM – Stevens Salon C, D

• Repurposing endogenous immune pathways to improve chimeric antigen receptor T-cells potency

M. Sachdeva1, B. Busser1, S. Temburni1, A. Juillerat1, L. Poirot2, P. Duchateau2, J.
Valton1;
1Cellectis, Inc., New York, NY
2Cellectis, Paris, France
Poster number: 774
Cell Therapies III
Friday, May 18, 2018 at 5:45 PM – Stevens Salon C, D

• Engineering CAR T-Cells with an Integrated off Switch to Enhance Safety Performance

Alexandre Juillerat1, Diane Tkach1, Brian W. Busser1, Sonal Temburni1, Julien Valton1,
Aymeric Duclert2, Laurent Poirot2 and Philippe Duchateau2
1Cellectis, Inc., 430E, 29th Street, NYC, NY 10016
2Cellectis SA, 8 rue de la Croix Jarry, 75013 Paris, France
Poster number: 739
Cancer – Immunotherapy, Cancer Vaccines III
Friday, May 18, 2018 at 5:45 PM – Stevens Salon C, D
Presented by Allogene Therapeutics, Inc.:

• Cynomolgus macaque gene-edited CAR T-cell platform: towards a reliable in vivo allogeneic model to assess safety and Efficacy

Diego A. Vargas-Inchaustegui1, Rory Dai1, Alexandre Juillerat2, Christopher Do1, Kris
Poulsen1, Thomas Pertel1, Barbra Sasu1 1Allogene Therapeutics, Inc., South San Francisco, CA,
2Cellectis, Inc., New York, NY
Poster number: 131
Cancer – Targeted Gene & Cell Therapy I
Wednesday, May 16, 2018 at 5:30 PM – Stevens Salon C, D

Abstracts are available on the ASGCT (Free ASGCT Whitepaper) website. The 4 posters to be presented at the 2018 ASGCT (Free ASGCT Whitepaper) Annual Meeting will be available on the Cellectis website after May 19, 2018.

Juniper Pharmaceuticals Reports First Quarter 2018 Financial and Operating Results

On May 10, 2018 Juniper Pharmaceuticals (Nasdaq: JNP), a diversified healthcare company with core businesses of its CRINONE (progesterone gel) franchise and fee-for-service pharmaceutical development and manufacturing business, JPS, reported financial results for the three-month period ended March 31, 2018 (Press release, Juniper Pharmaceuticals, MAY 10, 2018, View Source [SID1234526504]). Cash and equivalents were $20.7 million at March 31, 2018 compared to $21.4 million at December 31, 2017.

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"We made tremendous progress thus far this year having achieved two important strategic priorities for 2018 aimed at building shareholder value, while also driving strong growth momentum in our core businesses," said Alicia Secor, Chief Executive Officer. "At the beginning of the year, we successfully secured an extension of our supply agreement for CRINONE, and we expect to realize continued long-term growth in this important core business."

Ms. Secor added, "More recently, we executed on our goal of finding a partner for the development and commercialization of our intravaginal ring (IVR) technology. Our agreement with Daré Bioscience provides for significant milestone payments for each IVR candidate and royalties on any future sales. Our engagement with Rothschild to pursue strategic alternatives is progressing, and in parallel we remain very focused on the growth of our core businesses, JPS and CRINONE, which are on track to deliver continued double-digit growth for 2018."

First Quarter and Recent Corporate Highlights

Announced a 4.5-year extension through 2024 of the CRINONE supply agreement with Merck KGaA, Darmstadt, Germany.
Successfully secured an exclusive, worldwide license agreement with Daré Bioscience for the development and commercialization of the Company’s IVR technology platform, including its three preclinical IVR candidates targeting unmet needs in women’s health. Under the agreement, Daré Bioscience will be responsible for conducting all research, development and commercial activities for this program.
Rothschild continues to act as an independent financial advisor to assist the Company in the exploration of additional strategic alternatives as part of the ongoing effort to enhance shareholder value.
Appointed Richard Messina to the Company’s Board of Directors. Mr. Messina brings to the Board the perspective of a long-term shareholder.
First Quarter Financial Results

"Growth in our core businesses has continued into 2018 with CRINONE product revenues up 30% and revenues from JPS up 55% for the quarter ended March 31, 2018 versus the same quarter in 2017," said Jeff Young, Chief Financial Officer at Juniper. "We remain in a solid financial position, expect to continue to deliver double-digit growth in our core businesses, and to be cash flow positive for full year 2018."

First quarter total revenues increased 38% to $15.5 million, compared with $11.2 million for the quarter ended March 31, 2017.

Product revenues were $10.1 million compared to $7.7 million in the first quarter of 2017, driven by continued in-market growth of CRINONE (progesterone gel) by Merck KGaA, Darmstadt, Germany.

Service revenues from Juniper Pharma Services were $5.5 million, an increase of $1.9 million, versus the first quarter of last year, driven by new and existing customer growth.

Gross profit increased 39% to $6.5 million as compared to $4.7 million in the prior year quarter.

Total operating expenses were $5.5 million in the first quarter of 2018, a $0.7 million decrease as compared to the prior year quarter.

Juniper recorded net income of $0.8 million in the first quarter of 2018, or $0.06 per diluted share, compared to a net loss of $1.4 million, or $0.13 net loss per diluted share, in the same period of 2017.

Liquidity

Cash and cash equivalents were $20.7 million as of March 31, 2018 versus $21.4 million at December 31, 2017.

Conference Call

As previously announced, Juniper’s management will hold a conference call to discuss financial results for the first quarter ended March 31, 2018, as follows:

Date:

May 10, 2018

Time:

8:30 a.m. ET

Dial-in numbers:

Toll free: (866) 374-4635 (U.S.), (855) 669-9657 (Canada), or International: (412) 902-4218

Webcast (live and archive): www.juniperpharma.com, under "Investors" or click here.

The teleconference replay will be available approximately one hour after completion through Thursday, May 17, 2018, at (877) 344-7529 (U.S.), (855) 669-9658 (Canada) or (412) 317-0088 (International). The replay access code is 10119657.

The archived webcast will be available for one year via the aforementioned URLs.

The AngloNordic Life science conference

On May 10, 2018 MonTa Biosciences reported that attend the AngloNordic Life science conference in London on Mya 24th to meet investors and network with other European biotechs and investors (Press release, MonTa Biosciences, MAY 10, 2018, View Source [SID1234618633])

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Sierra Oncology Reports First Quarter Results

On May 10,2018 Sierra Oncology, Inc. (Nasdaq: SRRA), a clinical stage drug development company focused on advancing next generation DNA Damage Response (DDR) therapeutics for the treatment of patients with cancer, reported its financial and operational results for the first quarter ended March 31, 2018 (Press release, Sierra Oncology, MAY 10, 2018, View Source [SID1234526417]).

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"In late February 2018, we provided a comprehensive update on the development program for our Checkpoint kinase 1 (Chk1) inhibitor, SRA737. We also announced planned amendments to our SRA737 Monotherapy Phase 1/2 trial that are now being implemented, which include expanding the overall size of the trial and adding a sixth cohort targeting CCNE1-driven high grade serous ovarian cancer (HGSOC). This cohort is of high interest to us given mounting evidence for the role that CCNE1 amplification has in driving replication stress in cancer and the corresponding reliance on Chk1 in order to manage this replication stress. Analogous to poly ADP-ribose polymerase (PARP) inhibitors, which first exhibited robust activity in patients harboring BRCA mutations, emerging evidence suggests that Chk1 inhibitors such as SRA737 may prove effective in defined genetic backgrounds of high replication stress, such as CCNE1 amplification," said Dr. Nick Glover, President and CEO of Sierra Oncology. "We are also pleased to report that we have advanced our Phase 1/2 Low-Dose Gemcitabine Combination trial into the Cohort Expansion Phase 2 portion, which is targeting enrollment of 80 genetically-selected patients across four indications, with a comparable biological orientation based on both exogenous (low-dose gemcitabine) and intrinsic genetic drivers of replication stress. An update from this trial and preliminary data from the Monotherapy trial are anticipated in the fourth quarter of 2018."

During the first quarter, Sierra reported signing a supply agreement with Janssen Research & Development, LLC pursuant to which they will supply TESARO’s ZEJULA (niraparib), an orally administered PARP inhibitor, facilitating the initiation of a combination trial of niraparib with SRA737 in patients with prostate cancer in the fourth quarter of 2018. The trial is to be led by Professor Johann de Bono, Regius Professor of Cancer Research, Head of the Division of Clinical Studies and Professor in Experimental Cancer Medicine at The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust.

Subsequent to the end of the quarter, Sierra presented preclinical results for SRA737, including late-breaking data, in two posters at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) 2018 Annual Meeting, demonstrating that SRA737 has anti-tumor activity across a broad range of settings, including as monotherapy in aggressive CCNE1-driven HGSOC patient-derived xenografts and in combination with a PARP inhibitor in tumor cells that have acquired resistance to PARP inhibitors and/or platinum therapy.

Sierra is also currently designing a clinical study evaluating SRA737 in combination with immuno-oncology agents, which potentially could be submitted to regulatory authorities in the fourth quarter of 2018.

In addition to SRA737, Sierra is also advancing SRA141, a potent, selective, orally bioavailable small molecule inhibitor of cell division cycle 7 kinase (Cdc7). SRA141 is currently undergoing preclinical research in preparation for an Investigational New Drug Application (IND) submission to the U.S. Food and Drug Administration (FDA) expected in the second half of 2018.

First Quarter 2018 Financial Results (all amounts reported in U.S. currency)
Research and development expenses were $8.3 million for the first quarter of 2018, compared to $8.0 million for the first quarter of 2017. The increase was primarily due to an increase of $1.7 million in clinical trial costs partially offset by decreases of $0.9 million in third-party manufacturing costs related to SRA737 and SRA141, and $0.5 million in research, preclinical and other support costs. Research and development expenses included non-cash stock-based compensation of $1.0 million for both the first quarter of 2018 and of 2017.

General and administrative expenses were $3.4 million for the first quarter of 2018, compared to $3.1 million for the first quarter of 2017. This increase was primarily due to an increase in personnel-related costs and professional fees. General and administrative expenses included non-cash stock-based compensation of $0.5 million for both the first quarter of 2018 and of 2017.

Net loss was $11.5 million for the first quarter of 2018, compared with a net loss of $11.1 million for the first quarter of 2017.

Cash and cash equivalents totaled $133.8 million as of March 31, 2018, compared to $100.3 million as of December 31, 2017. This increase was due to an underwritten public offering of 21,850,000 shares of common stock in March 2018, pursuant to which the company raised net proceeds of $46.0 million, net of underwriting discounts, commissions and offering expenses. The company believes that its existing cash and cash equivalents will be sufficient to fund current operating plans through approximately mid-2020. At March 31, 2018, there were 74,309,681 shares of common stock issued and outstanding and stock options to purchase 10,202,831 shares of common stock issued and outstanding.

Checkpoint Therapeutics Reports First Quarter 2018 Financial Results and Recent Corporate Highlights

On May 10,2018 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ:CKPT), a clinical-stage, immuno-oncology biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers, reported financial results and recent corporate highlights for the first quarter ended March 31, 2018 (Press release, Checkpoint Therapeutics, MAY 10, 2018, https://www.cnbc.com/2018/05/10/globe-newswire-checkpoint-therapeutics-reports-first-quarter-2018-financial-results-and-recent-corporate-highlights.html [SID1234526473]).

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James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "In the first quarter of 2018, Checkpoint continued to execute on milestones to advance the development of our lead immuno-oncology and targeted therapy clinical programs, while also strengthening our financial position. Notably, we completed an underwritten public offering in March, raising net proceeds of $20.8 million to continue to fund our development programs, and initiated the first dose expansion cohorts in the Phase 1 trials of CK-301, our fully human anti-PD-L1 antibody, and CK-101, our third-generation EGFR inhibitor. We look forward to reporting initial data from these expansion cohorts in the second half of 2018, and are targeting the initiation of our first registration trial for CK-301 in first-line non-small cell lung cancer in the first quarter of 2019."

Financial Results:

Cash Position: As of March 31, 2018, Checkpoint’s cash and cash equivalents totaled $34.9 million, compared to $19.2 million at December 31, 2017, an increase of $15.7 million.
R&D Expenses: Research and development expenses for the first quarter of 2018 were $6.9 million, compared to $3.7 million for the first quarter of 2017, an increase of $3.2 million.
G&A Expenses: General and administrative expenses for the first quarter of 2018 were $2.2 million, compared to $1.4 million for the first quarter of 2017, an increase of $0.8 million.
Net Loss: Net loss attributable to common stockholders for the first quarter of 2018 was $8.8 million, or $0.35 per share, compared to a net loss of $4.4 million, or $0.20 per share, for the first quarter of 2017.
Recent Corporate Highlights:

In March 2018, Checkpoint completed an underwritten public offering that raised net proceeds of $20.8 million.
Also in March 2018, Checkpoint completed the dose escalation portion of the ongoing Phase 1 clinical trial of CK-301, a fully human anti-PD-L1 antibody, in selected recurrent or metastatic cancers, and initiated the first dose expansion cohort, which is evaluating an 800 mg dose of CK-301 administered every two weeks.
In April 2018, Checkpoint presented preclinical data on BET inhibitor CK-103 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. CK-103 demonstrated combinatorial effects in an in vivo model with anti-PD-1 antibodies, which may support its development as an anti-cancer agent alone and in combination with Checkpoint’s anti-PD-L1 antibody CK-301.