On May 11, 2022 Enveric Biosciences (NASDAQ: ENVB) ("Enveric" or the "Company"), a neuroscience-focused biotechnology company developing next-generation, psychedelic-inspired mental health medicines, reported plans to transfer and spin-off its cannabinoid clinical development pipeline assets to a wholly-owned subsidiary, Acanna Therapeutics Inc. ("Acanna"), by way of dividend to Enveric shareholders (Press release, Enveric Biosciences, MAY 11, 2022, View Source [SID1234614276]). The spin-off transaction will be subject to various conditions, including Acanna meeting the qualifications for listing on The Nasdaq Stock Market, and if successful, would result in two standalone public companies.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr. Joseph Tucker, CEO of Enveric Biosciences, commented, "In these challenging markets, the Board and Management team have spent considerable time evaluating the best way to create additional value for all stakeholders – patients, shareholders, and employees. We believe it would be in the best interest of our shareholders to spin-off 100% equity ownership of our cannabinoid clinical development pipeline. Upon completion of the proposed transaction, each resulting public company would be able to focus all its resources on the development of its respective pipeline assets, enabling, we anticipate, greater opportunity for product development success."

Acanna has secured an initial $1MM from an investor in a Series A Convertible Preferred Stock and Warrant financing. Under the terms of the investment, Acanna will, subject to certain other conditions, receive an additional $4MM upon completion of the spin-off into an independent, separately traded public company listed on The Nasdaq Stock Market. Following the spin-off and the investment of an aggregate of $5MM, that investor is expected to hold 25% of Acanna and warrants to acquire additional shares. Palladium Capital Group acted as a financial advisor to Enveric. Please see the Current Report on Form 8-K filed by Enveric on May 11, 2022, for further details.

Dr. Tucker continued, "For Enveric and Acanna, this spin-off transaction would allow each company to commit 100% of its efforts and capabilities towards developing its respective drug candidate portfolio. For Enveric, going forward, we intend to focus on mental health. We believe that Enveric’s achievements in the last year, including preparations for a clinical trial, positive preclinical data, and ongoing expansion of our drug candidate portfolio, the Psybrary, position us well for the future."

Strategic Rationale for Spinoff
The Company believes that spinning off the cannabinoid assets will allow Enveric and Acanna to maximize long-term value for all stakeholders. Following the proposed transaction, both Enveric and Acanna intend to:

Have separate, focused management teams with the knowledge and skills to deploy appropriate strategies and meet the unique requirements for each company’s operations.
Allocate capital more efficiently and strategically to develop their respective assets further.
Provide unique investment characteristics of interest to the capital markets.

On May 11, 2022 Onconova Therapeutics, Inc. (NASDAQ: ONTX), ("Onconova"), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported financial results for the three months ended March 31, 2022, and provided a business update (Press release, Onconova, MAY 11, 2022, View Source [SID1234614215]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Highlights for the first quarter of 2022 and recent weeks include:

The ongoing Phase 1 solid tumor trials of narazaciclib in the United States and China continue to generate encouraging safety data with the maximum tolerated dose not yet reached in either trial. The trial in the United States is currently enrolling into its fourth dose cohort, which is evaluating a 160 mg dose administered orally each day (i.e. continuous daily dosing). The trial in China is enrolling into its fifth dose cohort, which is evaluating a 200 mg dose administered orally once a day on days 1-21 of 28-day cycles. A protocol amendment is being prepared to enable further dose escalation in the trial in China.
An abstract titled "Narazaciclib’s kinase inhibitory activity is differentiated from approved CDK4/6 inhibitors in preclinical models," has been accepted for publication at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
Rigosertib’s investigator-sponsored program has seen progress across multiple ongoing and planned trials. The expansion cohort of the Phase 1/2a study of oral rigosertib plus nivolumab in patients with KRAS+ non-small cell lung cancer (NSCLC) continues to enroll patients, as does the Phase 2 trial of rigosertib monotherapy in advanced squamous cell carcinoma associated with recessive dystrophic epidermolysis bullosa (RDEB-associated SCC). A planned Phase 2 trial of rigosertib plus pembrolizumab in patients with metastatic melanoma was recently cleared to proceed by the United States Food and Drug Administration (FDA) following a review of its protocol.
Management Commentary

"We are pleased to be advancing two highly differentiated therapeutic candidates towards near-term milestones with cash runway expected to extend for at least eighteen months," said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. "We remain on track to identify narazaciclib’s recommended Phase 2 dose later this year, which will enable us to move forward into later-stage studies designed to evaluate its safety and efficacy in monotherapy and combination settings. As we finalize the specifics of these upcoming trials, we will continue to be informed by the results of our ongoing Phase 1 program and preclinical studies. The results of these studies to-date set narazaciclib apart from currently approved CDK4/6 inhibitors, and we look forward to building on these data in future trials."

Dr. Fruchtman continued, "Rigosertib’s investigator sponsored study program is also moving towards key catalysts. Later this quarter, our collaborators expect to initiate a Phase 2 study evaluating rigosertib plus anti-PD-1 therapy in metastatic melanoma patients refractory to checkpoint blockade. This trial is supported both by preclinical data that demonstrate rigosertib’s immunotherapeutic effects, and prior clinical results from the ongoing investigator sponsored study of the rigosertib-anti-PD-1 combination therapy in KRAS-mutated NSCLC. These initial results showed the studied doublet generating responses in refractory patients who previously failed therapy with a checkpoint inhibitor, a finding we hope to replicate in melanoma. We have continued to amass data in NSCLC since this initial readout, and look forward to providing updated results from the ongoing Phase 1/2a trial by the end of the year. The advancement of this and rigosertib’s other investigator-sponsored studies is expected to serve as a valuable complement to our narazaciclib program, which remains our core focus."

First Quarter Financial Results

Cash and cash equivalents as of March 31, 2022, were $50.8 million, compared with $55.1 million as of December 31, 2021. The Company believes that its cash and cash equivalents will be sufficient to fund ongoing clinical trials and business operations for at least eighteen months.

Research and development expenses were $2.0 million for the first quarter of 2022, compared with $1.9 million for the first quarter of 2021.

General and administrative expenses were $2.2 million for the first quarter of 2022, compared with $2.2 million for the first quarter of 2021.

Net loss for the first quarter of 2022 was $4.1 million, or $0.20 per share on 20.9 million weighted average shares outstanding, compared with a net loss of $4.7 million, or $0.32 per share for the first quarter of 2021 on 14.6 million weighted average shares outstanding.

Conference Call and Webcast

Onconova will host an investment community conference call today beginning at 4:30 p.m. Eastern Time, during which management will discuss financial results for the first quarter of 2022, provide a business update, and answer questions. Interested parties can participate by dialing (855) 428-5741 (domestic callers) or (210) 229-8823 (international callers) and using conference ID 7369861.

A live webcast of the conference call will be available in the Investors & Media section of the Company’s website at www.onconova.com. A replay of the webcast will be available on the Onconova website for 90 days following the call.

On May 11, 2022 Oncotelic Therapeutics, Inc. ("Oncotelic" or the "Company") (OTCQB:OTLC), reported the grant of patent application no. 15/753,882 entitled "USE OF VDAS TO ENHANCE IMMUNOMODULATING THERAPIES AGAINST TUMORS" by the US Patent Office (Press release, Oncotelic, MAY 11, 2022, View Source [SID1234614233]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The claims of the patent are directed to a pharmaceutical composition for producing an anti-tumor effect in a subject suffering from cancer or a tumor, comprising a Vascular Disrupting Agent (VDA) comprising a combretastatin agent and one or more antibodies selected from the group consisting of: a CTLA-4 antibody, a PD-i antibody, a PD-Li antibody, and a PD-L2 antibody in amounts effective therefore in a pharmaceutical carrier, where in the VDA is combretastatin Al diphosphate (CAl P) or combretastatin A4 phosphate (CA4P) or others.

"With the completion of the Joint Venture with Dragon Overseas Capital Limited for OT-101, we are now in the position to strengthen Mateon’s legacy assets including CA4P and Oxi4503," said Dr. Vuong Trieu, CEO and Chairman. "Given our team experience in VDA space as well as Abraxane and Cynviloq, we feel that we can successfully redeploy CA4P and Oxi4503 for the treatment of difficult to treat cancers either alone or in combination with Pembrolizumab/Keytruda."

On May 11, 2022 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported that the Company will participate in a fireside chat at the Guggenheim Securities Radiopharmaceuticals Day in New York, New York on Tuesday, May 17, 2022 at 3:00 p.m. ET. Presenting on behalf of Fusion will be Chief Executive Officer John Valliant, Ph.D (Press release, Fusion Pharmaceuticals, MAY 11, 2022, View Source [SID1234614247]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast of the event will be available on the "Events and Presentations" page in the "Investors & Media" section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 60 days following the presentation.

On May 11, 2022 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, reported its financial results for the first quarter ended March 31, 2022 and provides a corporate update (Press release, BioLineRx, MAY 11, 2022, View Source [SID1234614171]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Significant events and achievements during the first quarter 2022 and subsequent period:

Progressed the New Drug Application (NDA) for Motixafortide in stem cell mobilization, remaining on track to submit mid-year;
Advanced critical pre-launch activities while maintaining full optionality with respect to Motixafortide commercialization plans in the U.S., if approved;
Commissioned a comprehensive third-party market assessment of the US stem cell mobilization market, which identified a commercial opportunity of ~$360 million annually in the U.S. alone;
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:
– 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).

Completed recruitment of part 2 of ongoing Phase 1/2a trial of AGI-134 in solid tumors;
Ended the first quarter on solid financial footing, with cash and cash equivalents of $50.6 million, sufficient to fund operations, as currently planned, into the first half of 2024.
"During the first quarter and subsequent period, we continued to prepare our New Drug Application for Motixafortide in stem cell mobilization, and we remain on track for submission to the FDA mid-year, consistent with our prior guidance," stated Philip Serlin, Chief Executive Officer of BioLineRx. "In parallel, we are advancing a range of critical pre-launch activities, should Motixafortide be approved, while maintaining full optionality with respect to our commercialization plans, in light of the highly concentrated end market in the U.S., in which 80 transplant centers conduct the vast majority of stem cell transplant procedures.

"The third-party commercial market assessment that we recently commissioned estimates the size of the stem cell mobilization market to be $360 million annually in the U.S. alone and growing. In this respect, the overwhelmingly positive results from our GENESIS Phase 3 study, together with the very compelling cost savings identified through our pharmacoeconomic cost effectiveness studies, give us optimism that Motixafortide, if approved, can quickly become a core component of a new mobilization paradigm in multiple myeloma patients, and in potential other indications as well.

"With over $50 million in cash, we believe we are well financed to extract maximum value from Motixafortide in stem cell mobilization while at the same time advancing our other pipeline programs, allowing us to achieve notable corporate and clinical milestones into the first half of 2024," 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;
Initial results from 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 Quarter Ended March 31, 2022:

Research and development expenses for the quarter ended March 31, 2022 were $4.4 million, an increase of $0.1 million, or 3.7%, compared to $4.3 million for the quarter ended March 31, 2021. The increase resulted primarily from an increase in expenses associated with the AGI-134 study, offset by lower expenses associated with the completed Motixafortide GENESIS and COMBAT clinical trials.

Sales and marketing expenses for the quarter ended March 31, 2022 were $0.7 million, an increase of $0.5 million, or 313% compared to $0.2 million for the quarter ended March 31, 2021. The increase resulted primarily from an increase in market research and consultancy services, as well as initiation of pre-launch activities related to Motixafortide.

General and administrative expenses for the quarter ended March 31, 2022 were $1.0 million, similar to the comparable period in 2021.

The Company’s operating loss for the quarter ended March 31, 2022 amounted to $6.1 million, compared to an operating loss of $5.4 million for the quarter ended March 31, 2021.

Non-operating income amounted to $1.3 million for the quarter ended March 31, 2022, compared to non-operating expenses of $4.6 million for the quarter ended March 31, 2021. Non-operating income (expenses) for both periods primarily relate to fair-value adjustments of warrant liabilities on the Company’s balance sheet.

Net financial expenses amounted to $0.1 million for the quarter ended March 31, 2022, compared to net financial expenses of $0.2 million for the quarter ended March 31, 2021. 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 quarter ended March 31, 2022 amounted to $4.9 million, compared with a net loss of $10.2 million for the quarter ended March 31, 2021.

The Company held $50.6 million in cash, cash equivalents and short-term bank deposits as of March 31, 2022, compared with $57.1 million as of December 31, 2021.

Net cash used in operating activities was $5.6 million for the quarter ended March 31, 2022, compared with net cash used in operating activities of $6.2 million for the quarter ended March 31, 2021. The $0.6 million decrease in net cash used in operating activities between the two periods was primarily the result of changes in operating asset and liability items in the two periods, i.e., a smaller increase in prepaid expenses and other receivables in 2022 versus 2021, as well as increase in accounts payable and accruals in 2022, versus a decrease in the 2021 period.

Net cash provided by investing activities was $5.0 million for the quarter ended March 31, 2022, compared to net cash used in investing activities of $36.3 million for the quarter ended March 31, 2021. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits.

Net cash used in financing activities was $1.0 million for the quarter ended March 31, 2022, compared to net cash provided by financing activities of $41.9 million for the quarter ended March 31, 2021. The cash flows in 2022 primarily reflect repayments of the loan from Kreos Capital. The cash flows in 2021 primarily reflect the underwritten public offering of ADSs in January 2021, warrant exercises, and net proceeds from an ATM facility, offset by repayments of the loan from Kreos Capital.

Conference Call and Webcast Information

BioLineRx will hold a conference call today, Wednesday, May 11 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 May 13, 2022; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.