On August 31, 2022 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, reported that Janux management will participate and present at two upcoming investor conferences (Press release, Janux Therapeutics, AUG 31, 2022, View Source [SID1234618840]). Details are as follows:

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Citi’s 17th Annual BioPharma Conference
Forum: 1×1 In-Person Investor Meetings
Date: Wednesday, September 7, 2022
Location: Boston, Massachusetts

H.C. Wainwright 24th Annual Global Investment Conference
Forum: Virtual Fireside Chat and Virtual Investor Meetings
Dates: Monday, September 12 to Thursday, September 15, 2022

The fireside chat will be available for on-demand viewing beginning September 12 at 7:00 a.m. ET via the Investors & Media section of Janux’s website. An archived replay of the webcast will be available on the website for approximately 90 days following the presentation.

On On August 31, 2022, ImmunityBio, Inc. (the "company" or "we") reported that entered into a series of transactions including, in part, a new debt financing resulting in $125.0 million of gross proceeds, along with the amendment and restatement of the company’s nearest term debt maturity to extend the maturity from December 17, 2022 to December 31, 2023 and an adjustment to the interest rate to match the new debt issuance, and the amendment and restatement of the company’s fixed-rate debt maturing September 30, 2025 to add an equity conversion feature, in each case as further described below (Filing, 8-K, ImmunityBio, AUG 31, 2022, View Source [SID1234618946]).

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New $125.0 million Variable-Rate Promissory Note
On August 31, 2022, we executed a $125.0 million promissory note with Nant Capital, LLC ("Nant Capital"), an entity affiliated with Dr. Patrick Soon-Shiong, our Executive Chairman and Global Chief Scientific and Medical Officer. This note bears interest at Term Secured Overnight Financing Rate ("Term SOFR") plus 8.0% per annum. The accrued interest shall be payable quarterly on the last business day of March, June, September and December, commencing on September 30, 2022. The outstanding principal amount and any accrued and unpaid interest are due on December 31, 2023. We may prepay the outstanding principal amount, together with any accrued interest at any time, in whole or in part, without premium or penalty.
We received net proceeds of $124.4 million from this financing, net of a $0.6 million origination fee paid to the lender, which we intend to use for commercialization efforts, clinical trials, working capital and general corporate purposes.
Amendment and Restatement of Variable-Rate Promissory Note due December 17, 2022
As of June 30, 2022, we had a $300.0 million variable-rate promissory note with Nant Capital. This note bore interest at Term SOFR plus 5.4% per annum, which was paid quarterly. We may prepay the outstanding principal amount, together with any accrued interest at any time, in whole or in part, without premium or penalty. In the event of a default on the loan (as defined in the promissory note), including if we do not repay the loan at maturity, the company has the right, at its sole option, to convert the outstanding principal amount and accrued and unpaid interest due under this note into shares of the company’s common stock at price of $5.67 per share.
On August 31, 2022, the terms of the variable-rate promissory note were amended and restated to extend the maturity date of the loan from December 17, 2022 to December 31, 2023, increase the spread on the loan from 5.4% to 8.0% per annum, and reset the quarterly interest payment date from the 17th to the last business day of March, June, September and December, commencing on September 30, 2022. No other material terms or conditions of this variable-rate promissory note were modified as part of this amendment and restatement.
Amendment and Restatement of Fixed-Rate Promissory Notes due September 30, 2025
We had six outstanding fixed-rate promissory notes with Nant Capital, NantWorks, LLC, NantCancerStemCell, LLC, and NantMobile, LLC (all entities affiliated with Dr. Soon-Shiong) in an aggregate amount of $312.5 million, including accrued interest, as of June 30, 2022. These notes bear interest at a rate ranging from 3.0% to 6.0% per annum, provide that the outstanding principal is due and payable on September 30, 2025, and accrued and unpaid interest is payable either upon maturity or, with respect to one of the notes, on a quarterly basis. We may prepay the outstanding principal amount of any advance under such notes, together with accrued and unpaid interest, at any time, in whole or in part, without premium or penalty, subject to an advance notice period of at least five business days, during which the lender can convert the amount requested to be prepaid by the company into shares of company common stock, as part of the amendment and restatement described below.
On August 31, 2022, the terms of each fixed-rate promissory note were amended and restated to include a conversion feature that gives each lender the right at any time, at its sole option, to convert the entire outstanding principal amount and accrued and unpaid interest due under each note at the time of conversion into shares of the company’s common stock at a price of $5.67 per share. No other material terms or conditions of these fixed-rate promissory notes were modified as part of these amendments.
The foregoing description of the related-party promissory notes does not purport to be complete and is qualified in its entirety by reference to the full text of the notes, copies of which will be filed with the company’s Quarterly Report on Form 10-Q for the period ended September 30, 2022 and are incorporated herein by reference.

On August 31, 2022 Evogene Ltd. (Nasdaq: EVGN) (TASE: EVGN), a leading computational biology company targeting to revolutionize life-science product discovery and development across multiple market segments, reported its financial results for the second quarter ended June 30, 2022 (Press release, Evogene, AUG 31, 2022, View Source [SID1234618807]).

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Mr. Ofer Haviv, Evogene’s President and Chief Executive Officer, stated, "We are very pleased with the two recent important developments that have taken place at the Evogene group: namely, the strategic collaboration and $10 million investment by ICL, a leading global specialty minerals company, into our subsidiary, Lavie Bio; as well as the launch of the Phase I first in human clinical trial, by our subsidiary, Biomica."

"The strategic collaboration between ICL and Lavie Bio and $10 million investment, combines Lavie Bio’s ag-biologicals expertise, built on Evogene’s Microboost AI tech engine, with ICL’s fertilizer experience, enabling the development of a pipeline of innovative bio-stimulant products for agriculture. Especially in a time of food scarcity, high prices, and macroeconomic uncertainty, Lavie Bio and ICL’s shared vision is to enhance global food quality, agricultural sustainability, and increased productivity. ICL will join Corteva, a major U.S. agricultural chemical and seed company, as well as Evogene, as a new shareholder of Lavie Bio and I am very proud that these two agricultural giants have a strong interest in what Evogene has built."

"From Evogene’s standpoint, this investment in our subsidiary Lavie Bio, is an additional key milestone that demonstrates the power of our business model, whereby we are leveraging the value of our tech engines through dedicated subsidiaries. It shows that our hard work in building, investing in and strengthening our subsidiaries, all of which are leveraging our underlying computational predictive biological tech engines, is the right strategy and bears fruit."

Continued Mr. Haviv, "The second important development was the launch by Biomica of its phase I clinical trial and the announcement that the first patient was dosed in its Phase I clinical trial for its microbiome-based immuno-oncology drug candidate, BMC128. The drug candidate is a consortium of microbes, which Biomica selected through a microbiome analysis via our MicroBoost AI tech engine."

"While Evogene has traditionally leveraged its platform and AI technology engines towards agriculture, Biomica is proof that we are uniquely positioned to play an important role in human health and is strong validation that our technology can be leveraged across multiple and massive industries."

"Finally, we continued to strengthen our management team, recently adding Eyal Ronen, as Executive Vice President of Business Development bringing us over 20 years of extensive business development experience with biotech companies. Eyal’s focus is to create and bring us additional value by building new partnerships or forming new subsidiaries, leveraging our technology engines and expanding our activities into new areas. I strongly believe that Evogene has significant untapped potential in its technology engines, and Eyal will focus on realizing some of that value."

Mr. Haviv added, "Evogene today is at a key inflection point, whereby we are meeting critical milestones and the inherent value of our subsidiaries is becoming increasingly obvious. Evogene’s goal in the near term, is to continue to bring high value-adding partners and investors at the subsidiary level, who understand and can value the potential from the products that our subsidiaries are developing. This we believe will demonstrate in a very public way, the significant untapped value contained within our activities."

"Our target is that each subsidiary will have its own financial resources to support its activities until its success, while we at Evogene, in addition to being a major shareholder, continue to play a major role in maintaining and building their competitive advantage through our tech-engines."

"In parallel, we are targeting and exploring the potential to establish new activities that can benefit from our technology. This is the main mission of our new EVP of Business Development, Eyal Ronen, and we are already starting to see some of his positive impact," concluded Mr. Haviv.

Consolidated Financial Results Summary

Cash position: Evogene continues to maintain a solid financial position for its activities with approximately $35.3 million in consolidated cash, cash related accounts and marketable securities as of June 30, 2022. Approximately $3.6 million of Evogene’s consolidated cash is appropriated to its subsidiary, Lavie Bio. The Company does not have bank debt. It is noted that these amounts do not include the recent $10 million investment of ICL in Lavie Bio, which was fully received in August 2022 and will be reflected in the financial statements of the Company for the third quarter.

During the second quarter of 2022, the consolidated cash usage was approximately $9.3 million, or approximately $6.4 million, excluding Lavie Bio. Out of the $9.3 million, $1.7 million is a non-cash charge related to foreign exchange expenses due to US Dollar and New Israeli Shekel exchange rate differences and a decrease in the market value of marketable securities on Evogene’s balance sheet.

As previously stated, Evogene’s full year net cash burn rate, excluding exchange rate impacts in 2022, is expected to be in the range of $26-28 million including Lavie Bio and $18-20 million excluding Lavie Bio, which manages its own cash position.

Revenues: Revenues for the second quarter were $312 thousand, in comparison to $135 thousand in the same period the previous year. Revenues were primarily due to the initial sales of Lavie Bio’s Thrivus product (previously branded as Result) and sales of Canonic products in the Israeli market.

R&D expenses for the quarter, which are reported net of non-refundable grants received, were $5.4 million, in comparison to $5.0 million in the same period the previous year. The increase in R&D expenses were primarily due to:

Biomica’s ongoing phase I trial of its first-in-human proof-of-concept study in its immuno-oncology program; and
Lavie Bio’s activities supporting the production and commercialization of its inoculant product;
Business Development expenses were approximately $1.0 million for the second quarter of 2022, in comparison to $0.7 million in the same period the previous year. The increase in the Business Development expenses was primarily due to recruitment of business development personnel supporting the commercialization activities of Evogene’s subsidiaries.

General and Administrative expenses remained stable, and for the second quarter of 2022 were $1.7 million, in comparison to $1.8 million in the same period in the previous year.

Operating loss: Operating loss for the second quarter of 2022 was $8.0 million in comparison to $7.4 million in the same period in the previous year.

Financing expenses for the second quarter of 2022 were $1.7 million in comparison to financing income of $0.6 million in the same period in the previous year. The increase in financing expenses was mainly due to the US Dollar and New Israeli Shekel exchange rate differences between periods and a decrease in marketable securities value as mentioned above.

Net loss: The net loss for the second quarter of 2022 was $9.8 million in comparison to a net loss of $6.9 million in the same period in the previous year. The increase in net loss was mainly due to the financing expenses as described above.

The Company’s investor presentation can be viewed at the above link, which is in the investor relations section of the company website.

Replay Information: A replay of the conference call will be available approximately two hours following the completion of the call.

To access the replay, please dial 1-888-326-9310 toll free from the United States, or +972-3-925-5901 internationally. The replay will be accessible following the call for three days. An archive of the webcast will be available on the Company’s website

On August 31, 2022 Sensei Biotherapeutics, Inc. (NASDAQ: SNSE), an immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer, reported preliminary preclinical data from mouse and non-human primate studies of SNS-101, a monoclonal antibody targeting the immune checkpoint VISTA (V-domain Ig suppressor of T cell activation) (Press release, Sensei Biotherapeutics, AUG 31, 2022, View Source [SID1234618824]).

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"These preclinical data demonstrate that our conditionally active, pH-selective antibody successfully overcomes pharmacokinetic issues associated with targeting the VISTA immune checkpoint, including target-mediated drug disposition and cytokine release syndrome, in these models. The data also differentiate SNS-101 from non-selective antibodies by showing expansion of naïve and memory T cell phenotypes in vivo, as well as significant enhancement of anti-tumor effects in combination with anti-PD-1 antibodies as compared to anti-PD-1 antibodies alone," said Robert Pierce, M.D., Chief R&D Officer. "These results represent important progress for our SNS-101 program and a potential breakthrough for the field of VISTA inhibition as a novel therapeutic approach in multiple solid tumor indications. We are thrilled with these preliminary results and the potential of SNS-101 to provide a new standard of care to patients in need of innovative treatment options."

In a whole-blood assay at neutral pH, a clinical-stage, pH-independent VISTA antibody induced release of pro-inflammatory cytokines, such as IFNy and TNF, at substantially higher levels of concentration compared with Sensei’s pH-selective VISTA antibody SNS-101, across doses ranging from 1 g/mL to 100 g/mL. These preclinical data support the Company’s hypothesis that pH-driven, conditional binding of SNS-101 could be an effective mechanism for preventing the on-target, off-tumor VISTA binding that has been shown to drive cytokine release syndrome in human patients.

SNS-101 also displayed a favorable pharmacokinetic profile in non-human primates compared with a clinical-stage, pH-independent VISTA antibody. Whereas the pH-independent antibody exhibited target-mediated drug disposition and clearance from the blood within hours of administration due to interaction with VISTA-positive immune cells, the SNS-101 concentration declined linearly with a median half-life of approximately three weeks. These data strongly support the Company’s belief that SNS-101’s selective binding to VISTA at low pH, like that found in the tumor microenvironment, has potential to mitigate the pharmacokinetic and safety issues associated with off-tumor binding and unregulated activity.

Finally, experiments in a mouse tumor model demonstrated a significant increase in the production of anti-tumor CD8+ T cells among animals treated with a combination of SNS-101 and anti-PD-1 antibodies compared with PD-1 alone, which correlated with tumor growth inhibition. Because CD8+ T cells are essential tumor-destroying immune cells, these data provide encouraging evidence that this therapeutic combination has potential to generate a highly effective anti-tumor response in patients.

IND-enabling studies are underway to evaluate the potential of SNS-101 as a novel treatment for solid cancers, both as a monotherapy and in combination with the blockade of other immune checkpoints. The Company plans to file an IND during the first half of 2023. Additional information from these studies can be found in the Company’s corporate presentation, available on the Company’s website, and in its SEC filings. More detailed findings will be published at upcoming scientific conferences.

On August 31, 2022 GenScript Biotech, the world’s leading biotech company, reported its annual results as of June 30, 2022 (Press release, GenScript, AUG 31, 2022, View Source [SID1234618841]).

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"In the first half of 2022, GenScript Group has delivered satisfactory results across all business segments," said Dr. Patrick Liu, Rotating CEO of GenScript. "Our life science business reported steady growth while focusing on R&D innovation and leveraging superior technology platforms to get into emerging fields. Thanks to excellent market capabilities and track record, ProBio’s macromolecular CDMO and GCT CDMO business maintained strong momentum. In the future, ProBio will focus on medium-sized and large pharma and biotech customers and add value to our service projects. By improving product mix, Bestzyme improved its profitability. Bestzyme will optimize its enzyme product portfolio and industrial-grade manufacturing capability, and capture new opportunities in the synthetic biology field. Legend and its partner Janssen successfully commercialized Carvykti. As Legend moves cilta-cel into earlier line clinical trials, Carvykti will benefit more patients worldwide. 2022 marks the 20th anniversary of GenScript. GenScript has developed a diversified business portfolio over years. GenScript will stay committed to the corporate culture and mission to "make people and nature healthier through biotechnology" and create value for our shareholders and investors."

Results Analysis of the Four Business Segments

As the Group has reallocated back office administrative expenses into each business segment following the establishment of Probio legal entities in the second half of 2021, segment operating profit is not directly comparable to the same period in 2021.

Life-science Services and Products

During the Reporting Period, revenue of life-science services and products amounted to approximately US$176.0 million, representing an increase of 15.8% over the same period in 2021. The gross profit was approximately US$99.8 million during the Reporting Period, representing an increase of 8.8% as compared with approximately US$91.7 million for the same period in 2021. The gross profit margin decreased from 60.3% for the same period in 2021 to 56.7% this Reporting Period. The operating profit of life-science services and products during the Reporting Period was approximately US$26.0 million.

The increase in revenue was mainly attributable to the (i) continued growth in molecular biology, protein and antibody business, (ii) successful commercialisation of innovative platforms such as sgRNA, and partially offset by (iii) the decrease in sales in COVID-19 related products and the negative impact on sales due to pandemics in Shanghai, China. Production efficiency gains contributed positively to gross profit margin while (i) loss from overseas production during the initial capacity ramp-up, (ii) increased freight and duty costs, and (iii) decreased price and volume of COVID-19 related products all had negative impacts on gross profit margin. The operating profit was positively impacted by growth in revenue and gross profit while negatively impacted by (i) increased expenses brought by operation and depreciation of overseas production capacity, and (ii) increment in labor costs brought by research and development.

Biologics Development Services

During the Reporting Period, revenue of biologics development services amounted to approximately US$62.7 million, representing an increase of 99.0% over the same period in 2021. Total backlog for biologics development services reached US$228.0 million as at June 30, 2022. The gross profit was approximately US$16.2 million during the Reporting Period, representing an increase of 62.0% as compared with approximately US$10.0 million for the same period in 2021. Adjusted gross profit was US$23.9 million during the Reporting Period, representing an increase of 125.5% over the same period in 2021. Adjusted gross profit margin expanded from 33.7% for the same period in 2021 to 38.1% this Reporting Period. Adjusted operating profit during the Reporting Period was approximately US$3.2 million.

The growth of revenue was mainly attributable to the (i) significant increase of customer projects from overseas business, (ii) expanded capacity and productivity of pre-clinical and clinical development, and(iii) shorter delivery time for antibody discovery and process development. The adjusted gross profit and adjusted operating profit were positively impacted by higher capacity utilization and production efficiency gains.

Industrial Synthetic Biology Products

During the Reporting Period, revenue of industrial synthetic biology products amounted to approximately US$16.8 million, representing a decrease of 6.7% over the same period in 2021. The gross profit was approximately US$7.2 million, representing an increase of 41.2% as compared with approximately US$5.1 million for the same period in 2021. The gross profit margin increased from 28.3% for the same period in 2021 to 42.9% this Reporting Period. The operating profit of industrial synthetic biology products was approximately US$0.4 million during the Reporting Period, whilst the operating loss was approximately US$0.7 million for the same period in 2021.

The decrease in revenue was mainly due to the (i) active pruning of low or negative profit products, (ii) the feed industry in China downturn which led to reduction of use of feed enzymes, and (iii) the situation in Ukraine and Russia which caused the decrease of orders in Eastern Europe. The increase in both gross profit and operating profit was primarily attribute to the (i) adjustment of product portfolio and enhancement of the promotion of high-margin products, (ii) improvement of production process and workflow, and (iii) profit from the license of patents.

Cell Therapy

During the Reporting Period, revenue of cell therapy amounted to approximately US$57.1 million, representing an increase of 68.4% over the same period in 2021. The gross profit was approximately US$52.1 million during the Reporting Period, representing an increase of 53.7% as compared with approximately US$33.9 million for the same period in 2021. The operating loss of cell therapy was approximately US$180.1 million during the Reporting Period, whilst the operating loss was US$168.9 million for the same period in 2021.

The increase in both revenue and gross profit was primarily attributable to the additional milestones achieved in 2021 and 2022, and thus the further recognition of contract revenue from collaboration with Janssen on developing cilta-cel. The operating loss was primarily attributable to the (i) investment in clinical trials resulting from higher patients enrollment and more pipelines, (ii) cost for commercial preparation activities for the launch of cilta-cel, and (iii) expansion of administrative functions.

Revenue

During the Reporting Period, the Group recorded revenue of approximately US$304.7 million, representing an increase of 32.7% from approximately US$229.6 million for the same period in 2021. This is mainly attributable to (i) the continued increase of non-cell therapy products and services from major strategic customers and new competitive services and products, especially in biologics development services, and (ii) the increase of contract revenue derived from Legend’s collaboration with Janssen with new milestones achieved.

Gross profit

During the Reporting Period, the Group’s gross profit increased by 26.6% to approximately US$175.5 million from approximately US$138.6 million for the same period in 2021. This is mainly attributable to the (i) rapid growth of revenue, and (ii) operational efficiency improvement.

The increase in gross profit was partially offset by (i) increased share-based compensation expenses to production teams, particularly in biologics development services, and (ii) increased shipping cost. Adjusted gross profit increased by 31.4% over the same period in 2021.

Selling and distribution expenses

During the Reporting Period, the Group’s selling and distribution expenses increased by 49.1% to approximately US$86.9 million from approximately US$58.3 million for the same period in 2021. This increase is mainly driven by (i) more investment on talent with recruiting experienced personnel with competitive packages, (ii) increased expenses, primarily attributable to the global expansion of our business, and (iii) increased marketing expenses related to Legend’s collaboration with Janssen. Adjusted selling and distribution expenses increased 45.3% over the same period in 2021.

Administrative expenses

During the Reporting Period, the Group’s administrative expenses increased by 41.4% to approximately US$79.6 million from approximately US$56.3 million for the same period in 2021. This is mainly attributable to (i) more investment on talent with recruiting experienced personnel with competitive package and share-based compensation expenses for all business segments, and (ii) the reinforcement of some key administrative functions to support the Group’s overall business expansion and compliance. Adjusted administrative expenses increased 31.0% over the same period in 2021.

Research and development expenses

During the Reporting Period, the research and development expenses kept stable and increased by 1.3% to approximately US$177.4 million from approximately US$175.1 million for the same period in 2021. This is mainly attributable to (i) the continuous investment in talents with competitive package and share-based compensation expenses, and (ii) continuous investment in new products and services, which will significantly strengthen our competitiveness. Adjusted research and development expenses decreased by 1.4% over the same period in 2021.