On November 12, 2021 CatalYm, reported the presentation of expanded clinical and new preclinical data for its lead candidate CTL-002, an antibody targeting the novel cancer target GDF-15, at the 36th Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting (Press release, Catalym, NOV 12, 2021, View Source [SID1234595386]). The results will be presented in two poster presentations on November 13, 2021 and will include data from the ongoing first-in-human trial "GDFather" (GDF-15 Antibody-mediated Effector cell Relocation) as well as preclinical data characterizing the potential of GDF-15 as a therapeutic target for the treatment of multiple solid tumor indications. The conference is taking place, both in person (Washington, D.C.) and virtually, from November 10 – 14, 2021.

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"Based on GDF-15’s overexpression in a wide variety of tumors and strong correlation with poor survival, we are making it our mission to develop a therapy to neutralize GDF-15 to make a positive impact for the large population of patients unresponsive to checkpoint inhibitors. The data presented today are really interesting based on the demonstration of CTL-002-mediated GDF-15 neutralization and T cell activity in patients, further strengthening our therapeutic concept," commented Prof. Dr. Eugen Leo, Chief Medical Officer at CatalYm.

Dr. Phil L’Huillier, Chief Executive Officer at CatalYm added, "GDFather is the most advanced clinical trial of a GDF-15-targeting therapeutic, and we are delighted to further update the scientific community on our rapid progress with our unique approach. With the enrollment in all dose levels of the escalation part now completed, we look forward to providing first efficacy read-outs in the near term."

The poster titled "A phase I, first-in-human clinical trial of the GDF-15 neutralizing antibody CTL-002 in subjects with advanced stage solid tumors (Acronym: GDFATHER)" provides an update on the ongoing Phase 1 trial assessing CTL-002 as a monotherapy or in combination with nivolumab. Dose levels 1-4 have been completed safely with excellent tolerability and no adverse effects. Preliminary pharmacodynamics for dose levels 1-3 are indicative of CTL-002-mediated GDF-15 neutralization, as well as a tumor-selective influx of T cells in the majority of enrolled patients.

The second poster, "Tumor-derived GDF-15 prevents therapy success of checkpoint inhibitors by blocking T-lymphocyte recruitment", describes the preclinical validation of GDF-15 as a druggable therapeutic target and CatalYm’s lead candidate CTL-002, a monoclonal antibody designed to neutralize GDF-15. The results further strengthen the pivotal role GDF-15 plays in preventing effective immune cell infiltration. CTL-002 is shown to restore the ability of immune cells to enter the tumor microenvironment in vivo validating the GDF-15-specific antibody as a strong candidate for cancer treatment.

All posters presented in the poster hall will be made available as virtual ePosters throughout the SITC (Free SITC Whitepaper) 36th Annual Meeting and can be accessed in the "Science" section on CatalYm’s website under publications.

About the GDFather Trial

The GDFather trial (GDF-15 antibody-mediated effector cell relocation) is an ongoing first-in-human study and consists of two parts. In the dose escalation phase (Part A), up to 24 patients will receive escalating doses of CTL-002 in a "3+3" manner with the lead candidate given as a monotherapy and followed by combination with an anti-PD-1 checkpoint inhibitor. In the second dose expansion phase (Part B, phase 2a), several cohorts with tumors identified to be GDF-15-dependent will be treated to further evaluate safety and preliminary efficacy of CTL-002 treatment.

About CTL-002

CTL-002 is a humanized, monoclonal antibody designed to neutralize the tumor-produced Growth Differentiation Factor-15 (GDF-15). GDF-15 secretion by the tumor has been shown to prevent T cell migration into the tumor and suppresses T cell function and the adaptive immune response in the tumor microenvironment. This enables the tumor to evade the immune system and become resistant to standard of care and current immunotherapy approaches such as checkpoint inhibitors. CTL-002 counteracts these immuno-suppressive mechanisms by neutralizing GDF-15, enhancing the infiltration of immune cells into the tumor, improving both priming of T cells by dendritic cells and tumor killing by T cells and NK cells

On November 12, 2021 Candel Therapeutics, Inc. ("Candel" or "the Company") (Nasdaq: CADL), a late clinical stage biopharmaceutical company developing novel oncolytic viral immunotherapies, reported financial results for the third quarter ended September 30, 2021 and provided a corporate update (Press release, Candel Therapeutics, NOV 12, 2021, View Source [SID1234595385]).

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"With the completion of our IPO in August 2021 and multiple data readouts across our product candidates expected over the next 12 months, we are well-capitalized and in a strong position to advance on the Company’s goal to bring novel oncolytic viral immunotherapies to patients with cancer," said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel Therapeutics. "In the quarter and recent weeks, we expanded visibility of our technology and clinical programs with six presentations at medical conferences, highlighting clinical observations for our lead product candidate from our adenoviral platform, CAN-2409, in prostate cancer and our lead product candidate from our HSV platform, CAN-3110, in high-grade glioma, two areas of significant unmet need."

Third Quarter 2021 & Recent Highlights

In September, Scott E. Eggener, MD, principal investigator, presented data at the AdMeTech Foundation’s Fifth Global Summit on Precision Diagnosis and Treatment of Prostate Cancer, highlighting safety observations from the Company’s phase 2 clinical trial of CAN-2409 in patients with localized, low to intermediate risk prostate cancer undergoing active surveillance.
Also in September, E. Antonio Chiocca, MD, PhD, FAANS, principal investigator, presented clinical and immunological biomarker data from the phase 1 clinical trial of CAN-3110 in patients with recurrent high-grade glioma at the 16th Meeting of the European Association of Neuro-Oncology.
In October, Dr. Tak provided a technology overview at the Cambridge Healthtech Institute’s 9th Annual Immuno-Oncology Summit in a session titled Novel Oncolytic Viral Immunotherapies for Solid Tumors.
Separately, at the Hanson Wade 6th Annual Oncolytic Virotherapy Summit held in October, Dr. Tak highlighted Candel’s approach with its novel oncolytic viral immunotherapies, CAN-2409 and CAN-3110, to immunize against a patient’s own tumor neo-antigens. Also at this conference, Dr. Chiocca presented on the Company’s CAN-3110 program in glioblastoma.
In October, the Company announced the appointment of Mace L. Rothenberg, MD, as a senior advisor to Dr. Tak. Dr. Rothenberg, an industry veteran with more than 30 years of experience across government, academia and industry, will help support the Company’s continued growth and acceleration.
Also in October, the Company’s Chief Medical Officer, Laura K. Aguilar, MD, PhD, presented data on patient-reported tolerability of intraprostatic injections at the 28th Annual Prostate Cancer Foundation Scientific Retreat. These data further support patient receptiveness to intra-prostatic injection of CAN-2409 and its comparability, in terms of tolerance, to routine intra-prostatic biopsies.
In early November, the Company had two presentations at the 13th International Oncolytic Virus Conference Meeting. Dr. Chiocca provided details on the first-in-human clinical trial of CAN-3110 in glioblastoma. Dr. Tak gave a talk in a Special Session, titled Leveraging Viral Oncolytic Immunotherapy Platform to Tip the Balance in Favor of the Immune System that highlighted recent advancements of CAN-2409 and CAN-3110 development, including the enrollment completion and patient tolerability data from the phase 3 trial in prostate cancer, and the blinded safety data from the phase 2 clinical trial in patients with prostate cancer undergoing active surveillance.
Also in November, the Company’s Vice President, Head of Research, Francesca Barone, MD, PhD, presented novel biomarker data from the ongoing phase 1 open-label, dose-escalation clinical trial of CAN-3110 in patients with recurrent high-grade glioma at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting. The presentation focused on the biological findings of this study, showed the ability of CAN-3110 to induce immune activation both locally, in the tumor microenvironment, and systemically in peripheral blood of treated patients.
Key Upcoming Milestones

Patrick Y. Wen, MD, principal investigator, will present initial safety data on CAN-2409 in combination with nivolumab from a phase 1 clinical trial in high-grade glioma at the 26th Annual Meeting of the Society for Neuro-Oncology (SNO) in November.
Financial Results for the Third Quarter Ended September 30, 2021

Cash Position: Cash and cash equivalents as of September 30, 2021 were $88.4 million, as compared to $35.1 million as of December 31, 2020. The increase was due to successful completion of the Company’s initial public offering in August 2021, which provided net proceeds of $71.3 million, after deducting underwriting discounts and commissions and offering expenses and the use of $18.3 million to fund operating activities and capital expenditures for the nine months ended September 30, 2021. Based on current plans and assumptions, the Company expects that its existing cash and cash equivalents will be sufficient to fund its operations into the second quarter of 2023.

Research & Development Expenses: Research and development expenses were $5.3 million and $11.3 million for the three and nine months ended September 30, 2021, respectively, as compared to $1.8 million and $5.2 million for the comparable periods of 2020. The increases were primarily due to increased personnel-related costs, including stock-based compensation, for additional headcount to support the ongoing clinical trials for Candel’s product candidates as well as increased clinical development costs. Excluding stock-based compensation expense of $1.5 million for the three months ended September 30, 2021, and $2.0 million for the nine months ended September 30, 2021, research and development expenses for the three and nine months ended September 30, 2021, were $3.8 million and $9.3 million, respectively.

General and Administrative Expenses: General and administrative expenses were $2.8 million and $6.8 million for the three and nine months ended September 30, 2021, respectively, as compared to $1.0 million and $2.6 million for the comparable periods of 2020. The increases were primarily due to increased personnel-related costs, including stock-based compensation, for additional headcount required to support the growth of the Company and the transition to a public company, an increase in professional fees associated with Candel’s preparation for the IPO completed in August 2021 and costs associated with operating as a public company. Excluding stock-based compensation expense of $0.4 million for the three months ended September 30, 2021, and $1.4 million for the nine months ended September 30, 2021, general and administrative expenses for the three and nine months ended September 30, 2021, were $2.4 million and $5.4 million, respectively.

Total Operating Expenses: Total operating expenses were $8.1 million and $18.1 million for the three and nine months ended September 30, 2021, respectively, as compared to $2.8 million and $7.8 million for the comparable periods of 2020. The increases were primarily due to increased personnel-related costs, including stock-based compensation, for additional headcount required to support the growth of the Company and the transition to a public company, an increase in professional fees associated with Candel’s preparation for the IPO completed in August 2021, an increase in costs associated with operating as a public company and increased clinical development costs. Excluding stock-based compensation expense of $1.9 million for the three months ended September 30, 2021, and $3.4 million for the nine months ended September 30, 2021, total operating expenses for the three and nine months ended September 30, 2021, were $6.2 million and $14.7 million, respectively.

Net Loss: Net loss was $16.2 million and $37.7 million for the three and nine months ended September 30, 2021, respectively, as compared to $2.6 million and $7.2 million for the comparable periods of 2020. The net loss for the three and nine months ended September 30, 2021, includes a noncash charge of $8.3 million and $20.6 million for the change in the fair value of the Company’s warrant liability and stock-based compensation of $1.9 million and $3.4 million, respectively. Excluding the noncash charges for the change in the warrant liability and excluding the stock-based compensation, the net loss for the three and nine months ended September 30, 2021, was $6.0 million and $13.7 million, respectively.

On November 12, 2021 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, reported it will release its unaudited financial results for the quarter ended September 30, 2021 on Thursday, November 18, 2021, before the US markets open (Press release, BioLineRx, NOV 12, 2021, View Source [SID1234595384]).

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The Company will host a conference call on Thursday, November 18, 2021 at 10:00 a.m. EST featuring remarks by Philip Serlin, Chief Executive Officer. The conference call will be available via webcast and can be accessed through the Investor Relations page of BioLineRx’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast.

To dial into the conference call, please dial +1-866-744-5399 from the U.S. or +972-3-918-0644 internationally. A replay of the conference call will be available approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx’s website. A dial-in replay of the call will be available until November 21, 2021; please dial +1-888-295-2634 from the U.S. or +972-3-925-5904 internationally.

On November 12, 2021 BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) reported that the company will present at the following upcoming virtual investor conferences (Press release, BioCryst Pharmaceuticals, NOV 12, 2021, View Source [SID1234595383]):

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2021 Jefferies London Healthcare Conference—pre-recorded fireside chat available beginning Thursday, November 18 at 3:00 a.m. ET

Piper Sandler 33rd Annual Virtual Healthcare Conference—pre-recorded fireside chat available beginning Monday, November 22 at 10 a.m. ET

4th Annual Evercore ISI HeathCONx Conference on Wednesday, December 1 at 3:05 p.m. ET

JMP Securities Hematology and Oncology Summit on Monday, December 6 at 1:00 p.m. ET
Links to the live audio webcast of the Evercore and JMP presentations, and replays of all presentations, may be accessed in the Investors section of BioCryst’s website at http://www.biocryst.com.

On November 12, 2021 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported its financial results for the third quarter ended September 30, 2021 and provided an update on recent corporate developments (Press release, Bio-Path Holdings, NOV 12, 2021, View Source [SID1234595382]).

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"The clinical and regulatory advances made during the third quarter position us to initiate two key trials with prexigebersen-A in solid tumors and BP1002 in relapsed/refractory acute myeloid leukemia (AML) patients," stated Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "Looking to the balance of the year, we look forward to presenting safety and preliminary efficacy data from our ongoing Phase 2 trial of prexigebersen for the treatment of AML before an audience of world-leading oncologists at the American Society for Hematology Annual Meeting. Collectively, the progress we are making throughout 2021 is bringing us one step closer to achieving our goal of bringing new medicines to the fight against cancer."

Recent Corporate Highlights

Clearance of IND Application for Phase 1/1b Clinical Trial of Prexigebersen-A. In October, Bio-Path announced that the U.S. Food and Drug Administration (FDA) had reviewed and cleared the Investigational New Drug (IND) application to initiate a Phase 1/1b clinical trial of prexigebersen-A (liposomal Grb2-A or BP1001-A) in patients with solid tumors, including ovarian, endometrial, pancreatic and triple negative breast cancer. Prexigebersen-A is a modified drug product with the same drug substance as prexigebersen but includes formulation enhancements to produce smaller drug nanoparticles.

Clearance of IND Application for BP1002. In August, the Company announced that the FDA had reviewed and cleared the IND application for BP1002 (liposomal Bcl-2), the Company’s second drug candidate, for an initial Phase 1/1b clinical trial that will evaluate the ability of BP1002 to treat refractory/relapsed AML patients.
Financial Results for the Third Quarter Ended September 30, 2021

The Company reported a net loss of $2.1 million, or $0.29 per share, for the three months ended September 30, 2021, compared to a net loss of $3.0 million, or $0.80 per share, for the three months ended September 30, 2020.

Research and development expense for the three months ended September 30, 2021 decreased to $1.0 million, compared to $2.0 million for the three months ended September 30, 2020, primarily due to timing of activities related to our clinical trial for prexigebersen in AML and timing of drug material manufacturing and shipping activities.

General and administrative expense for the three months ended September 30, 2021 increased to $1.1 million, compared to $1.0 million for the three months ended September 30, 2020, primarily due to increased stock-based compensation expense.

As of September 30, 2021, the Company had cash of $26.6 million, compared to $13.8 million at December 31, 2020. Net cash used in operating activities for the nine months ended September 30, 2021 was $7.1 million, compared to $8.4 million for the comparable period in 2020. Net cash provided by financing activities for the nine months ended September 30, 2021 was $20.0 million.
Conference Call and Webcast Information

Bio-Path Holdings will host a conference call and webcast today at 8:30 a.m. ET to review these third quarter 2021 financial results and to provide a general update on the Company. To access the conference call please dial (844) 815-4963 (domestic) or (210) 229-8838 (international) and refer to the conference ID 6684508. A live audio webcast of the call and the archived webcast will be available in the Media section of the Company’s website at www.biopathholdings.com.