On March 16, 2022 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, reported its financial results for the fourth quarter and year ended December 31, 2021 and provides a corporate update (Press release, BioLineRx, MAR 16, 2022, View Source [SID1234610165]).

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Significant events and achievements during the fourth quarter 2021 and subsequent period:

Commissioned a comprehensive third-party market assessment of the US stem cell mobilization market, which identified a commercial opportunity in the US of ~$360 million;
Completed a successful pre-NDA meeting with the FDA, at which the FDA agreed that the Company’s proposed regulatory data package is sufficient to support an NDA submission in stem cell mobilization. To that end, the Company intends to submit its NDA in this indication in mid-2022;
Announced significantly positive and commercially relevant results from a pharmacoeconomic cost effectiveness study comparing Motixafortide + G-CSF versus G-CSF alone and indirectly comparing Motixafortide + G-CSF versus plerixafor + G-CSF. Both analyses demonstrated substantial cost savings from using Motixafortide and further strengthened the case for use of Motixafortide as a primary mobilization agent for all multiple myeloma patients undergoing autologous stem cell transplantation (ASCT);
Versus plerixafor + G-CSF, the study found that the addition of Motixafortide to G-CSF is associated with a net cost savings of ~$30,000 per patient (not including the cost of Motixafortide).
Versus G-CSF alone, the study found that the addition of Motixafortide to G-CSF is associated with a net cost savings of ~$19,000 per patient (not including the cost of Motixafortide).
Delivered one oral and three poster presentations at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition, which was held December 11-14, 2021. The oral presentation highlighted the successful GENESIS Phase 3 pivotal trial;
Announced formation of Immuno-Oncology Scientific Advisory Board comprised of recognized leaders in the fields of cancer immunology, intra-tumoral injections and clinical development. The SAB will provide guidance on the Company’s ongoing AGI-134 anti-cancer vaccine program and other potential immuno-oncology initiatives;
Completed recruitment of part 2 of ongoing Phase 1/2a trial of AGI-134 in solid tumors;
Ended the fourth quarter on solid financial footing, with cash and cash equivalents of $57.1 million.
"The opportunity for Motixafortide in stem-cell mobilization is significant," stated Philip Serlin, Chief Executive Officer of BioLineRx. "We recently commissioned a comprehensive third-party market assessment which identified a $360 million addressable annual opportunity in the US. We continue to maintain optionality among a number of commercialization alternatives, as we believe the very concentrated end market, where approximately 80 transplant centers in the US conduct the vast majority of stem cell transplant procedures, would require a limited commercialization footprint. In the meantime, in order to ensure that Motixafortide is well positioned for a timely and robust US launch that will maximize the value of the asset, we have initiated a number of pre-commercialization launch activities.

At the same time, we are very pleased with the additional results of our pharmacoeconomic study, which demonstrate a significant cost benefit for Motixafotide plus G-CSF as compared to plerixafor plus G-CSF, one of the main current treatment options. These results, together with the overwhelmingly positive results from our GENESIS Phase 3 study, give us tremendous optimism for the potential of Motixafortide to become the new standard of care mobilization agent for multiple myeloma patients – the first true advancement in stem cell mobilization since the approval of plerixafor in 2008.

Following our very productive pre-NDA meeting with FDA that we completed in December, we are diligently working to submit the NDA and position the product for commercialization. We anticipate the NDA submission will occur in mid-2022."

"With over $57 million in cash, we believe we are well financed to extract maximum value from Motixafortide in SCM while at the same time advancing our other pipeline programs," concluded Mr. Serlin.

Upcoming Expected Milestones:

Submission of NDA to FDA for Motixafortide as novel mobilization agent for multiple myeloma patients undergoing autologous stem cell transplantation in mid-2022;
Announce initial results for Part 2 of Phase 1/2a trial of AGI-134 in solid tumors in H2 2022;
Initiate Phase 2 study of AGI-134 in 2023;
Potential FDA approval of Motixafortide in 2023;
Potential US launch of Motixafortide in SCM in 2023.
Financial Results for the Year Ended December 31, 2021:

Research and development expenses for the year ended December 31, 2021 were $19.5 million, an increase of $1.3 million, or 7.1%, compared to $18.2 million for the year ended December 31, 2020. The increase resulted primarily from an increase in expenses associated with the AGI-134 phase 1/2a study, as well as an increase in payroll and related-expenses due to a company-wide salary reduction related to the COVID-19 pandemic in the comparable 2020 period, offset by lower expenses associated with the completed Motixafortide GENESIS and COMBAT clinical trials.

Sales and marketing expenses for the year ended December 31, 2021 were $1.0 million, an increase of $0.2 million, or 19.4% compared to $0.8 million for the year ended December 31, 2020. The increase resulted primarily from an increase in consultancy services related to Motixafortide.

General and administrative expenses for the year ended December 31, 2021 were $4.3 million, an increase of $0.4, or 10.0% compared to $3.9 million for the year ended December 31, 2020. The increase resulted primarily from an increase in directors’ and officers’ insurance expenses.

The Company’s operating loss for the year ended December 31, 2021 amounted to $24.8 million, compared to an operating loss of $22.9 million for the year ended December 31, 2020.

Non-operating expenses amounted to $1.8 million for the year ended December 31, 2021, compared to non-operating expenses of $5.7 million for the year ended December 31, 2020. Non-operating expenses for both periods primarily relate to fair-value adjustments of warrant liabilities and issuance expenses related to the ATM.

Net financial expenses amounted to $0.4 million for the year ended December 31, 2021, compared to net financial expenses of $1.4 million for the year ended December 31, 2020. Net financial expenses for both periods primarily relate to interest paid on loans, offset by investment income earned on bank deposits.

The Company’s net loss for the year ended December 31, 2021 amounted to $27.1 million, compared with a net loss of $30.0 million for the year ended December 31, 2020.

The Company held $57.1 million in cash, cash equivalents and short-term bank deposits as of December 31, 2021.

Net cash used in operating activities for the year ended December 31, 2021 was $23.6 million, compared to $23.2 million for the year ended December 31, 2020. The $0.4 million increase in 2021 was primarily the result of an increase in research and development expenses.

Net cash used in investing activities for the year ended December 31, 2021 was $38.2 million, compared to net cash provided by investing activities of $16.7 million for the year ended December 31, 2020. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits during the respective periods.

Net cash provided by financing activities for the year ended December 31, 2021 was $57.7 million, compared to $17.9 million for the year ended December 31, 2020. The cash flows in 2021 primarily reflect the underwritten public offering of the Company’s ADSs in January 2021, warrant exercises, and net proceeds from the ATM facility, offset by repayments of the loan from Kreos Capital. The cash flows in 2020 primarily reflect the registered direct offerings of ADSs in May and June 2020, as well as net proceeds from the ATM facility, offset by repayments of the loan from Kreos Capital.

Conference Call and Webcast Information

BioLineRx will hold a conference call today, Wednesday, March 16 at 10:00 a.m. EDT. To access the conference call, please dial +1-866-744-5399 from the US or +972-3-918-0644 internationally. The call will also 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.

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 March 18, 2022; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.

A copy of the Company’s annual report on Form 20-F for the year ended December 31, 2021 has been filed with the U.S. Securities and Exchange Commission at View Source and posted on the Company’s investor relations website at View Source The Company will deliver a hard copy of its annual report, including its complete audited consolidated financial statements, free of charge, to its shareholders upon request to Mali Ze’evi, Chief Financial Officer, at [email protected].

On March 16, 2022 MAIA Biotechnology, Inc., a targeted therapy, immuno-oncology company focused on developing potential first-in-class oncology drugs ("MAIA"), reported that it has raised an additional $2.4 million in an equity offering of its common stock (Press release, MAIA Biotechnology, MAR 16, 2022, View Source [SID1234610185]). The proceeds of the financing will advance MAIA’s programs and will support the initiation of a Phase 2 clinical trial (THIO-101) evaluating the administration of THIO followed by cemiplimab in patients with advanced Non-Small Cell Lung Cancer (NSCLC).

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"This latest funding round advances our clinical development plans for THIO and gives us additional runway to execute on our plans," said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. "Our cash position stands at over $11 million and there is no long-term debt on our balance sheet. Our investor support remains very strong and we are thrilled to work together with investors who are committed to developing novel oncology therapies to improve patients’ lives."

About the Phase 2 Clinical Trial in Advanced Non-Small Cell Lung Cancer (NSCLC)

This trial (THIO-101) will be the first to test THIO’s potential anticancer effects and immune system activation effects in NSCLC patients by administering THIO in advance of administration of the checkpoint inhibitor cemiplimab (co-developed by Regeneron and Sanofi), potentially allowing for immune activation and PD-1 sensitivity to take effect. The trial will test the hypothesis that low doses of THIO administered prior to checkpoint inhibitor treatment will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or progressed after first-line treatment regimen containing a checkpoint inhibitor.

The THIO-101 trial will assess the safety, mechanistic activity and immune system activation of four THIO dose levels, each in separate arms. Each dosing arm will then be evaluated further for efficacy based on Overall Response Rate (ORR), Duration of Response (DoR), Progression Free Survival (PFS) and Overall Survival (OS). Additional patients may be recruited for further clinical evaluation in any of the THIO arms based on safety and clinical benefit. Each arm of the trial will enroll up to 41 evaluable patients.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a telomere-targeting agent currently in clinical development to evaluate its activity in NSCLC. Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. THIO is being developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

On March 16, 2022 Synthetic Biologics, Inc. (NYSE American: SYN), a diversified clinical-stage company developing therapeutics designed to treat diseases in areas of high unmet need, reported financial results for the year ended December 31, 2021, and provided a corporate update (Press release, Synthetic Biologics, MAR 16, 2022, View Source [SID1234610277]).

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Recent Developments:

VCN acquisition: Synthetic Biologics completed the acquisition of privately held VCN Biosciences, developer of a novel oncolytic adenovirus (OV) platform designed for intravenous (IV), intravitreal (IVit) and intratumoral delivery to trigger tumor cell death, improve access of co-administered cancer therapies to the tumor, and promote a robust and sustained anti-tumor response by the patient’s immune system.
Pipeline updates: The acquisition of VCN Biosciences transformed Synthetic Biologics’ pipeline with the addition of VCN’s lead clinical-stage drug candidate, VCN-01, as well as preclinical stage VCN-11, which incorporates a proprietary albumin binding domain in the virus shell with the potential to extend the effectiveness of the therapy.
In February of 2022, VCN-01 received Orphan Drug Designation (ODD) from the U.S. FDA for the treatment of retinoblastoma; VCN-01 has previously been granted ODD by the EMA for the treatment of pancreatic cancer.
Regulatory agency recognition builds upon the encouraging clinical data generated to date; VCN-01 has been evaluated in 72 patients across four Phase 1 clinical trials, including patients with pancreatic cancer, head and neck squamous cell carcinoma, colorectal cancer, and retinoblastoma.
Enrollment progressed in the Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant (HCT) recipients for the prevention of acute graft-versus-host-disease; and topline data for this cohort are expected in H1 2022.
Completed dosing and follow-up in a Phase 1, placebo-controlled, multiple ascending dose study of SYN-020 in healthy volunteers; SYN-020 was very well tolerated at all doses and patient samples are undergoing pharmacokinetic and pharmacodynamic analyses.
Anticipated Milestones:

VCN-01

Initiation of VCN-01 dosing in an investigator sponsored study of brain tumors at the University of Leeds (H1 2022).
Initiation of VCN-01 dosing in combination with mesothelin-directed CAR-T cells for pancreatic and ovarian cancer in an investigator sponsored study at the University of Pennsylvania (H1 2022).
Initiation of a Phase 2 study of VCN-01 in combination with standard-of-care chemotherapy (gemcitabine/nab-paclitaxel) as a first line therapy in newly diagnosed metastatic PDAC patients (H2 2022).
Initiation of a Phase 2/3 pivotal trial of VCN-01 as either an adjunct to chemotherapy or a potential rescue therapy in pediatric patients with advanced retinoblastoma (early 2023).
VCN-11

Evaluating CMOs for GMP manufacture of VCN-11.
Preclinical studies characterizing VCN-11 are on-going.
SYN-004

Data read out from the first cohort of the SYN-004 study in allo-HCT patients (H1 2022).
SYN-020

Top-line data from the multiple ascending dose study of SYN-020 in healthy volunteers (H1 2022).
Planning for the initiation of a Phase 2a study of SYN-020 (H2 2022).
"2021 was a monumental year for the Company, setting the stage for continued progress and a number of important upcoming milestones in 2022," said Steven A. Shallcross, Chief Executive Officer of Synthetic Biologics. "The recent acquisition of VCN Biosciences positions us at the forefront of oncolytic virus development. VCN’s systemically administered, selectively replicating adenoviruses are designed to break down the tumor stroma, which hides the tumor from the patient’s immune system. In turn, this improves the anti-tumor effect of the oncolytic virus, as well as chemotherapies and immuno-oncology products."

Mr. Shallcross continued, "We are poised for another exciting year ahead as we anticipate the initiation of multiple international studies, including a Phase 2 clinical trial of intravenous VCN-01 in combination with standard-of-care chemotherapy as a first line therapy in newly-diagnosed metastatic PDAC patients, as well as a Phase 2/3 pivotal trial of intravitreal VCN-01 as either an adjunct to chemotherapy or a potential rescue therapy in pediatric patients with advanced retinoblastoma. We do not plan any clinical activities in Eastern Europe; however, we recognize that the war in the Ukraine may have follow-on effects globally that could adversely impact the cost and conduct of our international clinical trials. We will seek to mitigate this impact where possible. In parallel with our development of VCN-01, we continue to advance the clinical development of both SYN-004 and SYN-020 and look forward to providing further updates on key upcoming milestones. We remain well-capitalized through the end of 2023 and highly encouraged by the potential for each of our clinical programs."

Year Ended December 31, 2021 Financial Results
General and administrative expenses increased to $6.5 million for the year ended December 31, 2021, from $5.0 million for the year ended December 31, 2020. This increase of 28.7% is primarily composed of increased consulting and legal costs related to the VCN acquisition, higher insurance costs, audit fees, and public relations expenses. The charge relating to stock-based compensation expense was $0.3 million for the year ended December 31, 2021, compared to $0.3 million for the year ended December 31, 2020.

Research and development expenses increased to $7.8 million for the year ended December 31, 2021, from $5.1 million for the year ended December 31, 2020. This increase of 53% is primarily the result of increased clinical trial expenses as we continued dosing patients in the Phase 1b/2a clinical trial of SYN-004, the dosing of healthy volunteers in the SAD and MAD Phase 1 clinical trials for SYN-020, and by higher indirect program costs for the year ended December 31, 2021, including an increase in manufacturing costs for SYN-020. We anticipate research and development expense to increase as our ongoing clinical trials continue to enroll patients and new patients are enrolled in the VCN-01 clinical trials. Research and development expenses also included a charge relating to non-cash stock-based compensation expense of $76,000 for the year ended December 31, 2021, compared to $66,000 for the year ended December 31, 2020.

Other income was $6,000 for the year ended December 31, 2021, compared to other income of $44,000 for the year ended December 31, 2020. Other income for the year ended December 31, 2021 and 2020 is primarily composed of interest income from investments.

Cash and cash equivalents totaled $67.3 million as of December 31, 2021, an increase of $61.1 million from December 31, 2020.

For further details on Synthetic Biologics’ financial results refer to the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission.

Conference Call

Synthetic Biologics will host a conference call at 4:30 p.m. ET today to review year end 2021 operational highlights and financial results. Individuals may participate in the live call via telephone by dialing (877) 451-6152 (domestic) or (201) 389-0879 (international) and using the conference ID: 13727535. Participants are asked to dial in 15 minutes before the start of the call to register. Investors and the public can access the live and archived webcast of this call via the "News & Media" section of the company’s website, View Source, under "Events" or by clicking here, for 90 days after the call.

On March 16, 2022 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported that it will announce its financial results for the full year and fourth quarter 2021 on Wednesday, March 30th, 2022 (Press release, BioNTech, MAR 16, 2022, View Source [SID1234610166]). BioNTech invites investors and the general public to join a conference call and webcast with investment analysts on the same day at 8.00 a.m. EDT (2.00 p.m. CEST) to report its financial results and provide a corporate update for the fourth quarter and full year 2021.

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The slide presentation and audio of the webcast will be available via this link.

To participate in the conference call, please dial the following numbers ten minutes prior to the start and provide the Conference ID:

Participants may also access the slides and the webcast of the conference call via the "Events & Presentations" page of the Investor Relations section of the Company’s website at View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.

On March 16, 2022 Exscientia (Nasdaq: EXAI) reported that it will report financial results for the fourth quarter and full year ended December 31, 2021, on Wednesday, March 23, 2022 after U.S. market close (Press release, Exscientia, MAR 16, 2022, View Source [SID1234610186]). Following the announcement, the Company will host a conference call and webcast at 12:30 p.m. GMT / 8:30 a.m. ET on Thursday, March 24, 2022, to provide an overview of the company’s unique end-to-end technology platform and Exscientia’s work to fully automate drug discovery and development.

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A webcast of the live call can be accessed by visiting the "Investors and Media" section of the Company’s website at investors.exscientia.ai. Alternatively, the live conference call can be accessed by dialing +1 (888) 330 3292 (U.S.), +44 (203) 433 3846 (U.K.), +1 (646) 960 0857 (International) and entering the conference ID: 8333895. A replay will be available for 90 days under "Events and Presentations" in the "Investors and Media" section of the Exscientia website.