GlycoMimetics Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

On August 17, 2023 GlycoMimetics, Inc. (the "Company") (NASDAQ:GLYC) reported that the Compensation Committee of the Company’s Board of Directors approved the grant on August 14 , 2023 of a non-qualified stock option award to purchase an aggregate of 110,000 shares to Gaetano Bonifacio, M.D., the Company’s new Vice President, Global Medical Affairs (Press release, GlycoMimetics, AUG 17, 2023, View Source [SID1234634470]). The award was granted as an inducement equity award outside of the Company’s Amended and Restated 2013 Equity Incentive Plan in accordance with NASDAQ Listing Rule 5635(c)(4) and was made as an inducement material to the acceptance of employment with the Company by the new employee.

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The award was comprised of an option to purchase 110,000 shares of the Company’s common stock, par value $0.001 per share (the "Common Stock"), subject to vesting as to 25% of the underlying shares on August 14, 2024, and as to the remaining underlying shares in equal monthly installments over 36 months thereafter. The option grant has an exercise price of $1.65 per share, the closing price of the Common Stock on the date of grant, and is subject to the terms and conditions of a stock option agreement and the GlycoMimetics, Inc. Amended and Restated Inducement Plan, which provides for the granting of stock options and other equity awards to new employees.

Geron Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

On August 17, 2023 Geron Corporation (Nasdaq: GERN) reported that it has granted non-statutory stock options to purchase an aggregate of 189,850 shares of Geron common stock as inducements to newly hired employees in connection with commencement of employment with the Company (Press release, Geron, AUG 17, 2023, View Source [SID1234634469]).

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The stock options were granted on August 16, 2023 at an exercise price of $2.70 per share, which is equal to the closing price of Geron common stock on the date of grant. Stock options representing an aggregate of 185,220 shares have a 10-year term and vest over four years, with 12.5% of the shares underlying the options vesting on the six-month anniversary of commencement of employment for the respective employees and the remaining shares vesting over the following 42 months in equal installments of whole shares, subject to continued employment with Geron through the applicable vesting dates. Stock options representing an aggregate of 4,630 shares have a 10-year term and vest in full upon achievement of a certain regulatory milestone, subject to continued employment with Geron through the applicable vesting date. All of the stock options were granted as material inducement to employment in accordance with Nasdaq Listing Rule 5635(c)(4) and are subject to the terms and conditions of the stock option agreements covering the grants and Geron’s 2018 Inducement Award Plan, which was adopted December 14, 2018 and provides for the granting of stock options to new employees.

Evogene Reports Second Quarter 2023 Financial Results

On August 17, 2023 Evogene Ltd. (Nasdaq: EVGN, TASE: EVGN), a leading computational biology company aiming to revolutionize life-science-based product discovery and development utilizing cutting-edge computational biology technologies across multiple market segments, reported its financial results for the second quarter period ended June 30, 2023 (Press release, Evogene, AUG 17, 2023, View Source [SID1234634468]).

Ofer Haviv, Evogene’s President and Chief Executive Officer, stated: "The second quarter of 2023 marked a period of remarkable achievements for the Evogene group. It was a pivotal point in the transformation that Evogene has been undergoing since the creation of our three AI tech engines in 2019. Listing some of the main achievements in this period: announcing the receiving of purchase orders in the aggregate amount of $11.3 million for Casterra’s elite castor seeds; execution of a licensing agreement between Lavie Bio and Corteva, which includes an upfront payment of $5 million, in addition to milestone and royalty payments; closing of a financial round for Biomica in the amount of $20 million; significant infrastructure and computational architecture improvements, including new applications, in our tech-engines resulting in new capabilities, and better automation, scalability, and speed; and last but not least, receiving the trust of high quality investors demonstrated by an investment in Evogene’s equity in the gross amount of $8.5 million in our recent financing round, all happening in a relatively short timeframe. These are clear signals that the Evogene Group is on the right path to success."

Mr. Haviv further stated: "In parallel, Evogene is increasing its efforts to establish direct collaborations with leading companies in new domains of activity, areas not currently covered by our subsidiaries, for product development leveraging our tech-engines. Although these discussions have only recently begun, the responses we have received to our unique offering have been positive, and we hope that some of these discussions will materialize into collaborative agreements in the near future."

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Evogene and Subsidiaries – Highlights

Evogene Ltd.

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In July, Evogene successfully concluded a fundraising round, securing total gross proceeds of $8.5 million. The securities issued in this round were ordinary shares only and it did not include any warrant coverage.

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In July, Evogene unveiled the latest enhancement to its ChemPass AI tech-engine: TargetSelector, a groundbreaking application designed to streamline target-protein discovery. TargetSelector uses predictive machine learning algorithms and genomic data to help researchers identify novel target proteins for innovative products. This addition to the ChemPass AI tech-engine, strongly position us to forge strategic partnerships with industry leaders, expediting product development and delivering novel solutions to pressing global needs, such as developing sustainable new pesticides and therapeutics.

Biomica Ltd. – develops microbiome-based therapeutics, leveraging Evogene’s MicroBoost AI tech-engine.

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In April 2023, Biomica completed a $20 million financing round with a post-money valuation of $50 million, led by a $10 million investment from Shanghai Healthcare Capital.

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BMC128, the company’s leading candidate in its immune-oncology program, is currently in phase 1 clinical trial at Rambam Health Care Campus in Israel, aiming to evaluate its safety alongside BMS Opdivo for Non-small-cell lung cancer, melanoma, and Renal cell carcinoma; the trial has enrolled 6 out of the planned 10-12 patients.

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In August 2023, Biomica opened a second site in Israel at The Davidoff Cancer Center, to open the trial to additional potential patients for its BMC128 phase 1 clinical trial.

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Biomica reported positive results from pre-clinical studies of BMC426 and BMC427 for Irritable bowel syndrome (IBS) treatment, in collaboration with Prof. Kara Gross Margolis at New York University. The studies showed that the live bacterial consortia were effective in reducing visceral pain, a major IBS symptom. Biomica will conduct additional pre-clinical studies and prepare for clinical trials.

Lavie Bio Ltd. – develops and commercializes microbiome-based ag-biological products, utilizing Evogene’s MicroBoost AI tech-engine.

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Lavie Bio entered a licensing agreement with Corteva, conferring exclusive rights to Corteva for advancing and commercializing Lavie Bio’s lead bio-fungicides, LAV311 and LAV312 – targeting fruit rots. This agreement follows two years of independent field validation trials conducted by both companies. Lavie Bio will receive an initial payment of $5 million, in two installments, and will also be eligible for additional future milestone payments and royalties from Corteva’s sales of the products.

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Thrivus, Lavie Bio’s bio-inoculant for spring wheat, has received regulatory approval from the Canadian Food Inspection Agency (CFIA). This approval triples the product’s sales territory, expanding its global reach. Thrivus is already being used in the United States, where it has demonstrated its efficacy in increasing Hard Red Spring Wheat production by an average of 3-4 bushels per acre. This translates to a 4X return on investment for farmers.

AgPlenus Ltd. – aims to develop and commercialize next-generation crop protection products, utilizing Evogene’s ChemPass AI tech-engine.

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Dr. Adrian Percy, an accomplished agricultural scientist with over 20 years of experience, joined AgPlenus’ board of directors.

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The integration of Evogene’s TargetSelector application into AgPlenus’s technology platform, powered by the ChemPass AI tech-engine, enhances the ability to identify new mode-of-action mechanisms, urgently needed to address the growing resistance of pests to existing commercial products. This advancement strengthens AgPlenus’s potential for forging strategic partnerships with industry leaders.

Casterra Ltd. – provides an integrated end-to-end solution for large-scale castor bean cultivation, utilizing Evogene’s GeneRator AI tech-engine.

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In June, Casterra signed a framework agreement with a prominent oil and gas company. The agreement secured initial purchase orders worth $9.1 million for the supply of castor seeds to be cultivated in specific African territories.

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Later in June, Casterra received another purchase order, valued at $2.2 million, for additional territories in Africa.

Consolidated Financial Results Summary

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As of June 30, 2023, Evogene had consolidated cash, cash equivalents and short-term bank deposits of approximately $33.9 million. Of this sum, Biomica accounted for $16.8 million, and Lavie Bio holds $7.1 million. Evogene, together with Casterra, Canonic, and AgPlenus, possessed an aggregate of $10.0 million in cash.

The injection of funds from the last round in July, total gross proceeds of $8.5 million, strengthens Evogene’s financial position and provides the Company with the resources needed to execute its plans effectively and in a timely fashion. An example of such financial need is the significant increase in the required working capital of our wholly owned subsidiary, Casterra, to produce the castor seeds needed to fulfill the purchase orders received in the last months, totaling $11.3 million.

It is important to note that the $10 million reflected in the June 30th cash balance of Evogene together with Casterra, Canonic and AgPlenus, do not include funds raised by Evogene in July and any amount due under the purchase orders received by Casterra in the last few months, which are expected to be supplied during the second half of the year and at the beginning of next year. Further, note that the $7.1 million reflected in the cash balance of Lavie Bio, does not include the $5 million expected to be received as an upfront payment from the licensing agreement with Corteva that was announced in July.

During the second quarter, the consolidated cash usage was approximately $5.6 million, which included $2.8 million used by Lavie Bio and Biomica.

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Revenues for the second quarter of 2023 were approximately $654 thousand compared to approximately $312 thousand in the same period the previous year. The revenue increase was primarily due to revenues recognized per the collaboration agreement of Evogene’s subsidiary AgPlenus with Corteva and from sales of Lavie Bio’s Thrivus product.

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R&D expenses for the second quarter of 2023, which are reported net of non-refundable grants received, were approximately $5.4 million and remained stable as compared to approximately $5.4 million in the same period in the previous year.

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Sales and marketing expenses were approximately $928 thousand for the second quarter of 2023 and slightly decreased as compared to approximately $962 thousand in the same period in the previous year. The main contributor to this decrease in expense was a reduction in personnel expenses at Canonic.

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General and administrative expenses were approximately $1.8 million in the second quarter of 2023, compared to approximately $1.7 million in the same period in the previous year. The increase is mainly due to expenses related to share-based compensation.

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Operating loss for the second quarter of 2023 was approximately $7.9 million, compared to an operating loss of approximately $8.0 million in the same period in the previous year.

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Financing income, net of financing expenses, for the second quarter of 2023 was $0.1 million in comparison to financing expenses, net of financing income, of $1.7 million in the same period in the previous year. This difference was mainly due to the U.S. Dollar and Shekel exchange rate differences between periods, a decrease in marketable securities value in the second quarter of 2022 and an increase in interest income during the second quarter of 2023.

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Net loss for the second quarter of 2023 was approximately $7.8 million, compared to a net loss of approximately $9.8 million in the same period in the previous year, mainly due to the financing expenses (income) differences as mentioned above.

For the full press release (includes financial tables), click here.

For an accessible file (includes financial tables), click here.

Evogene has published its updated investor presentation, which can be found on its investor relations’ website at:

View Source

Evaxion Announces Business Update and Second Quarter 2023 Financial Results

On August 17, 2023 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company), a clinical-stage biotechnology company specializing in the development of AI-driven immunotherapies, reported a business update and announced its second quarter 2023 financial results (Press release, Evaxion Biotech, AUG 17, 2023, View Source [SID1234634466]).

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"At Evaxion, we believe that AI-powered, personalized cancer vaccines have the potential to transform the care of patients with melanoma and other cancers. Early-stage clinical data reported at AACR (Free AACR Whitepaper) 2023 and ASCO (Free ASCO Whitepaper)23 indicated that patients treated with our vaccines, EVX-01 or EVX-02, in combination with a checkpoint inhibitor, experienced a treatment benefit, with good overall tolerability" said Per Norlén, Chief Executive Officer of Evaxion. "These data support the potential clinical utility for personalized cancer immunotherapy and the opportunity to advance our next-generation, DNA-based candidate, EVX-03, towards clinical trials in cancer patients."

"Additionally, at a time of positive industry data and renewed interest in personalized cancer vaccines, Evaxion is making excellent scientific progress. Utilization of two new, proprietary technologies, including the AI platform ObsERV, which enables identification of novel cancer antigens called ERVs, which are patient-specific cancer targets of viral origin, plus our novel genetic adjuvant, are believed to further enhance the efficacy of EVX-03," said Per, concluding, "On a separate note, we were pleased to present preclinical proof-of-concept data at the Gordon Conference showing that EVX-B1 can clear staphylococcus infections. Taken together, these clinical advances and proof-of-concept milestones highlight the potential for Evaxion’s AI-powered technology to address unmet medical needs in oncology and infectious diseases. The recent completion of an up to $20 million USD financing will support progression of our current studies and operations, while initiation of EVX-03 phase 1 activities are subject to additional funding."

Anticipated milestones

· Q4 2023 – Interim results of EVX-01 Phase 2 trial in melanoma

· Q4 2023 – Clinical trial application for EVX-03*

*Subject to additional funding in the range of $5-10 million secured before initiation

Recent Milestones (April to August 2023)

Completion of financing commitments totaling up to USD 20 million

[Press Release with hyperlink]. Evaxion announced completion of a financing commitment totaling up to $20 million with Global Growth Holding Limited, available in tranches over the next three years.

The financing is intended to cover the company’s working capital needs, including the advancement of EVX-03 to Phase 1 readiness.

Promising preclinical data presented at the Staphylococcal Diseases Gordon Research Conference

[Press Release with hyperlink]. Preclinical data showed EVX-B1, a vaccine against Staphylococcus aureus (S. aureus) containing AI-identified antigens, is highly protective against S. aureus disease in pre-clinical models and that EVX-B1 effectively clears S. aureus infections.

Promising early clinical data presented for EVX-01 and EVX-02

· EVX-01 presentation at ASCO (Free ASCO Whitepaper)23. Phase 1 results showed positive clinical responses in 8 out of 12 patients receiving EVX-01 in combination with a checkpoint inhibitor. The trial also met primary endpoints for tolerability and safety, with only mild AEs being related to EVX-01.

· EVX-02 presentation at AACR (Free AACR Whitepaper) 2023. Phase 1/2a results showed that all 10 patients with late stage melanoma who completed EVX-02 treatment demonstrated robust and treatment-specific immune responses and were relapse-free at their last assessment.

R&D Day Highlights Preclinical Data on genetic adjuvant technology

R&D Day 2023. In a series of talks from its scientists and collaborators, Evaxion provided an introduction to its proprietary genetic adjuvant technology developed to enhance the effectiveness of DNA and mRNA vaccines. The genetic adjuvant can be encoded into either DNA or mRNA vaccines to boost the immune response. Preclinical data show that the technology boosts both B cell and T cell immune responses, making it applicable to a wide range of vaccines, both for cancer and for infectious disease.

Second Quarter of 2023 Financial Results

· Cash position: As of June 30, 2023, cash and cash equivalents were $7.1 million as compared to $13.2 as of December 31, 2022. Operating spending for the second quarter of 2023 was offset by the proceeds from issue of shares and exercise of warrants. We expect that our existing cash and cash equivalents, will be sufficient to fund our operating expenses and capital expenditure requirements into December 2023.

· Research and Development expenses were $2.9 million for the quarter ended June 30, 2023 as compared to $4.1 million for the quarter ended June 30, 2022. The decrease in research and development expenses was primarily due to a decrease of $0.7 million in external costs related to finalized clinical trials and a decrease in employee-related costs of $0.5 million due to reduced headcount.

· General and Administrative expenses were $2.7 million for the quarter ended June 30, 2023 as compared to $2.1 million for the quarter ended June 30, 2022. The increase in general and administrative expenses was primarily due to an increase of $0.3 million in external costs related to overhead and professional fees and an increase in employee-related costs of $0.2 million. These increases are due to the timing of funding projects and business initiatives compared to 2022 and the expansion of the organization throughout 2022 to meet the requirements as a listed company.

· Net loss was $5.7 million for the quarter ended June 30, 2023 or ($0.21) per basic and diluted share as compared to a net loss of $4.8 million, or ($0.20) per basic and diluted share for the quarter ended June 30, 2022.

Webcast

Evaxion will host a webcast on Tuesday, August 22, at 8:00 a.m. EDT.

To access the webcast, please visit:

View Source

Notes and abbreviations:

ASCO23 = the 2023 Annual Meeting of the American Society for Clinical Oncology, AACR (Free AACR Whitepaper) 2023 = the 2023 Annual Meeting for the American Association for Cancer Research (AACR) (Free AACR Whitepaper), ERVs = endogenous retroviruses

Alpha Tau Announces Robust Long-Term Safety and Efficacy Data from Multiple Clinical Trials of Alpha DaRT

On August 17, 2023 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported initial long-term safety and tumor control outcomes for patients with unresectable, recurrent, or locally advanced head and neck or skin tumors treated Alpha DaRT across four prospective trials conducted at several international institutions (Press release, Alpha Tau Medical, AUG 17, 2023, View Source [SID1234634465]).

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Between February 2017 and December 2022, 81 lesions in 71 patients were treated with Alpha DaRT in four prospective feasibility trials whose objective was to assess early toxicity and tumor response outcomes. The median follow-up was 14 months (range: 2-51 months). A complete response (CR) was observed in 89% of treated lesions (n=72), 10% (n=8) demonstrated a partial response, and one patient was not evaluable. The two-year actuarial local recurrence-free survival (LRFS) was 77% [95% CI: 63–87]. Variables including recurrent vs non-recurrent lesions, baseline tumor size, or histology did not impact long-term outcomes. Twenty percent of patients developed treatment-related acute grade 2 toxicity (such as dermatitis radiation, local pain at the treatment site or pruritus), which subsequently resolved with conservative treatment; there were no grade 3 or higher related acute toxicities. There was no grade 2 or higher late toxicities observed in this cohort, defined as toxicities occurring six months or later after Alpha DaRT treatment.

"We are excited to share these longer-term data on outcomes from treatment with Alpha DaRT," noted Uzi Sofer, Alpha Tau’s CEO. "We have seen continued encouraging outcomes for patients treated with Alpha DaRT, with 89% complete response rate and no grade 3 or higher toxicities, demonstrating outstanding potential for patients." Dr. Robert Den, Alpha Tau’s CMO, added, "These data answer an important question for Alpha Tau, namely, whether the strong short-term local responses we’ve seen will lead to long-term tumor control. The answer is a resounding yes, with a 77% durable tumor control rate at 2 years. We are looking forward to continued generation of additional data from our clinical trials, including our U.S. pivotal multicenter ReSTART trial (Recurrent SCC Treatment with Alpha DaRT Radiation Therapy), our pancreatic cancer trial being conducted in Montreal, Canada, and other exciting trials underway or scheduled to launch soon."

Prof. Aron Popovtzer, Head of the Sharett Institute of Oncology at Hadassah Medical Center in Jerusalem, and a principal investigator in several of the trials, commented, "The ongoing and consistent strength of the results from treatment with Alpha DaRT speaks volumes about the transformative potential of Alpha DaRT for a broad array of patients with difficult-to-treat solid tumors."

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.