On March 30, 2023 Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC), a clinical-stage biotech company applying transformative chemistry to improve prescription drug safety, reported financial results for the fourth quarter and full year of 2022 (Press release, Ensysce Biosciences, MAR 30, 2023, View Source [SID1234629602]).

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Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce, commented, "Our focus remains on execution and advancing clinical development plans for our programs that provide strong pain relief using our PF614 and PF614-MPAR drug products. This has been evident in the recently released news regarding completion of enrollment of our first PF614-MPAR study and completion of the clinical stage of two human abuse potential studies for PF614. These studies add to the clinical support demonstrating that Ensysce has a novel approach for delivering effective pain management and safely alleviating severe pain in patients requiring an opioid analgesic. These recent accomplishments move us closer to our Phase 3 plans and toward bringing what we believe is the ‘Next Generation of Analgesia’ for severe pain to commercialization."

TAAPTM (Opioid Abuse Deterrent Program) Updates

Our lead program, PF614 is a "Trypsin-Activated Abuse Protection" (TAAPTM) extended-release oxycodone. The Company’s TAAPTM technology is designed to control release, be highly resistant to tampering, and reduce abuse through a unique chemical modification that is activated by trypsin. The achievements highlighted below advance the company toward Phase 3 clinical evaluation.

On February 28, 2023, the Company announced the database lock for the oral Human Abuse Potential (HAP) study of PF614. With the database lock, no further change to the trial data is permissible.
On January 4, 2023, the Company announced that it had successfully completed the clinical portion of study PF614-104, ‘A Randomized, Double-Blind, Placebo- and Active-Controlled, Crossover Study to Evaluate the Oral Abuse Potential of PF614 Compared with Oxycodone Immediate-Release Tablets, and Placebo in Non-Dependent Recreational Opioid Users’ (ClinicalTrials.gov: NCT05571345) conducted by Dr. Vince Clinical Research.
On November 14, 2022, the Company announced that it received written guidance from the FDA that an acute pain indication may be appropriate for the Company’s lead Trypsin Activated Abuse Protection (TAAPTM) product, PF614.
On October 31, 2022, the Company announced positive topline results from an intranasal human abuse potential (HAP) study for PF614 showing inhalation of PF614 did not produce the ‘drug liking’ effects of crushed oxycodone. Ensysce’s TAAPTM technology is designed to limit activation to oral administration, be highly resistant to tampering to reduce abuse.
MPARTM (Opioid Abuse Deterrent and Overdose Protection Program) Updates

PF614-MPAR is a combination abuse-protected product designed to overcome prescription drug overdose. MPAR (Multi-Pill Abuse Resistance) reduces the release of the opioid in an overdose situation, providing the additional layer of protection to Ensysce’s TAAP pain medications. The select achievements outlined below demonstrate how Ensysce has progressed, what we believe is the first prescription drug overdose protection technology to be developed.

On March 22, 2023, the Company announced the completion of enrollment in the final stage of the Phase 1 study, PF614-MPAR-101. This study was conducted by Dr. Maria Bermudez MD, at Quotient Sciences, Miami, Florida.
On December 19, 2022, the Company announced data from the initial stage of PF614-MPAR-101 successfully demonstrating the overdose protection qualities of its drug product, PF614-MPAR.
On December 5, 2022, the Company announced that it had completed the clinical portion of the initial stage of PF614-MPAR-101, entitled ‘Single-Dose Study to Evaluate the Pharmacokinetics of oxycodone and PF614, when PF614 Solution is Co-Administered with Nafamostat, as an Immediate-Release Solution and/or Extended-Release (ER) Capsule Formulations in Healthy Subjects’, conducted by Dr. Maria Bermudez MD, at Quotient Sciences, Miami, Florida.
Financial Results

Cash – Cash and cash equivalents were $3.1 million as of December 31, 2022, as compared to $4.5 million as of September 30, 2022, and $12.3 million as of December 31, 2021. Subsequent to year-end, the Company completed a $3.0 million registered direct offering for the sale of 3,571,431 shares of the Company’s common stock at a purchase price of $0.84 per share.
Federal Grants – Funding under federal grants was $1.4 million for the fourth quarter of 2022 compared to $1.6 million in the comparable year ago quarter. For the full year 2022, funding from federal grants was $2.5 million compared to $3.5 million for full year 2021. The differences are primarily related to both pre-clinical and clinical activities for the MPARTM program.
Research & Development Expenses – R&D expenses were $6.4 million for the fourth quarter of 2022 compared to $2.2 million for the same period in 2021 and $19.8 million for the full year of 2022 compared to $4.7 million for the full year of 2021. The increases were primarily the result of increased external research and development costs related to the clinical programs for PF614 and PF614-MPAR.
General & Administrative Expenses – G&A expenses were $1.2 million for the fourth quarter of 2022 compared to $1.5 million for the same period of 2021 and $6.9 million for the full year of 2022 compared to $18.7 million for the full year of 2021. The decrease for the full year period was primarily driven by a one-time $11.6 million non-cash expense related to warrants issued under a share subscription facility.
Other Income (Expense) – Total other income (expense), net was income of $0.7 million for the fourth quarter of 2022 compared to expense of $8.0 million for the same period of 2021. For the full year periods, total other income (expense), net was income of $0.0 million in 2022 compared to expense of $9.3 million in 2021. The change in other expenses is primarily due to non-cash fair value adjustments for convertible notes and warrants.
Net Loss – Net loss for the fourth quarter of 2022 was $5.5 million compared to $10.0 million for the fourth quarter of 2021. For the full year of 2022, net loss was $24.2 million compared to $29.1 million for the full year of 2021. As a clinical stage biotech company, our continued research and development efforts toward regulatory approvals for our product candidates are expected to result in losses for the foreseeable future.
Corporate Update Conference Call

As previously announced, CEO, Dr. Lynn Kirkpatrick, CFO, Dave Humphrey, and CMO, Dr. William Schmidt, will host a conference call on Tuesday, April 11, 2023, at 11:00am ET to provide a corporate update and review the recently released results from the oral HAP study of PF614. The call will conclude with Q&A from participants. An accompanying presentation will be posted prior to the call to the Company’s investor relations website.

Date: Tuesday, April 11, 2023
Time: 11:00am ET
U.S. Dial-in: 1-877-407-0792
International Dial-in: 1-201-689-8263
Webcast: ENSC Corporate Update Call

Please dial in at least 10 minutes before the start of the call to ensure timely participation. A playback of the call will be available through Tuesday, May 9, 2023. To listen, call 1-844-512-2921 within the United States and Canada or 1-412-317-6671 when calling internationally. Please use the replay pin number 13737179.

Ensysce Biosciences, Inc.
Condensed Consolidated Statements of Operations

2021 2020 2021 2020
Three Months Ended December 31,
Year Ended
December 31,
2022 2021 2022 2021
Federal grants
$ 1,433,463 $ 1,635,292 $ 2,523,383 $ 3,531,199
Operating expenses:
Research and development
6,441,927 2,187,850 19,835,875 4,690,082
General and administrative
1,192,322 1,454,187 6,909,603 18,711,548
Total operating expenses
7,634,249 3,642,037 26,745,478 23,401,630
Loss from operations
(6,200,786 ) (2,006,745 ) (24,222,095 ) (19,870,431 )
Total other income (expense), net
722,710 (8,030,379 ) 14,410 (9,275,470 )
Net income (loss)
$ (5,478,076 ) $ (10,037,124 ) $ (24,207,685 ) $ (29,145,901 )
Adjustments to net income (loss)
(43,832 ) (802,926 ) (877,811 ) (740,950 )
Net income (loss) attributable to common stockholders
$ (5,521,908 ) $ (10,840,050 ) $ (25,085,496 ) $ (29,886,851 )
Net income (loss) per share attributable to common stockholders, basic and diluted
$ (1.52 ) $ (8.93 ) $ (11.62 ) $ (29.64 )
Ensysce Biosciences, Inc.
Condensed Consolidated Statements of Cash Flows

2021 2020
Year Ended December 31,
2022 2021
Net cash used in operating activities
$ (17,887,439 ) $ (8,242,177 )
Net cash provided by investing activities
4,500 -
Net cash provided by financing activities
8,765,905 20,312,699
Change in cash and cash equivalents
(9,117,034 ) 12,070,522
Cash and cash equivalents at beginning of period
12,264,736 194,214
Cash and cash equivalents at end of period
$ 3,147,702 $ 12,264,736
Ensysce Biosciences, Inc.
Condensed Consolidated Balance Sheets

December 31, December 31,
2022 2021
Assets
Current assets:
Cash and cash equivalents
$ 3,147,702 $ 12,264,736
Prepaid expenses and other current assets
2,151,467 3,397,857
Total current assets
5,299,169 15,662,593
Other assets
585,883 754,756
Total assets
$ 5,885,052 $ 16,417,349
Liabilities and stockholders’ deficit
Current liabilities:
Accounts payable
$ 2,943,791 $ 301,104
Accrued expenses and other liabilities
2,253,809 3,432,407
Notes payable and accrued interest
4,266,610 12,748,155
Total current liabilities
9,464,210 16,481,666
Long-term liabilities
450,494 8,093,741
Total liabilities
9,914,704 24,575,407
Stockholders’ deficit
(4,029,652 ) (8,158,058 )
Total liabilities and stockholders’ equity
$ 5,885,052 $ 16,417,349

On March 30, 2023 Cardinal Health (NYSE: CAH) reported that it has plans to release third-quarter financial results for its fiscal year 2023 on May 4, prior to the opening of trading on the New York Stock Exchange (Press release, Cardinal Health, MAR 30, 2023, View Source [SID1234629601]). The company will webcast a discussion of these results beginning at 8:30 a.m. Eastern.

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To access the webcast and corresponding slide presentation, visit Cardinal Health’s Investor Relations page. No access code is required. Presentation slides and a webcast replay will be available on the Investor Relations page for 12 months.

On March 30, 2023 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, reported its financial results for the fourth quarter and full year ended December 31, 2022 and provided an update on recent developments (Press release, IGM Biosciences, MAR 30, 2023, View Source [SID1234629589]).

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"During 2022 we continued to extend the application of our IgM antibody platform by preparing imvotamab for clinical trials in autoimmune diseases and signing an exclusive worldwide collaboration agreement with Sanofi to develop novel IgM agonist antibodies for oncology and autoimmune diseases," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "Also, and perhaps most significantly, the initial clinical results from IGM-8444, our anti-death receptor 5 IgM antibody, highlight the exciting potential of IgM antibodies as agonist antibody medicines. We are announcing today that we have dosed the first patient in our randomized clinical trial of IGM-8444 in combination with standard of care FOLFIRI chemotherapy and bevacizumab in second line metastatic colorectal cancer patients. We are also pleased with the expanded safety and efficacy data for imvotamab at 100 mg that we have developed through our non-Hodgkin’s lymphoma clinical trials, and we believe that imvotamab’s encouraging safety profile may be an important differentiating factor in the exciting new field of T cell engagers in autoimmune disease."

Mr. Schwarzer continued, "We expect that 2023 will also be an important year for the expansion and validation of IGM’s platform. Already this year, we have treated the first patients in our initial clinical study of IGM-7354, an IgM targeted immunostimulatory IL-15 cytokine, which could be used for the treatment of patients with solid and hematologic malignancies, potentially in combination with cellular therapies, such as CAR-T and CAR-NK cells. We are also initiating clinical studies of IGM-2644, our CD38 x CD3 T cell engaging IgM antibody, which we hope will prove to be a safe and more potent form of anti-CD38 therapy for multiple myeloma, including for patients who have previously been treated with daratumumab. We also plan to file Investigational New Drug applications and initiate clinical studies for imvotamab in multiple autoimmune diseases this year, beginning with systemic lupus erythematosus and rheumatoid arthritis."

Pipeline Updates

IGM-8444 (DR5)

First patient dosed in randomized colorectal cancer clinical trial. The Company announced today that it has treated the first patient in a randomized clinical trial of IGM-8444, an IgM agonist antibody targeting death receptor 5 (DR5), plus FOLFIRI and bevacizumab in second line metastatic colorectal cancer. The study is designed to assess the benefit of IGM-8444 when combined with the current standard of care regimen of FOLFIRI and bevacizumab. The Company will be assessing both the 3 mg/kg and 10 mg/kg dose levels of IGM-8444 with a primary endpoint of progression free survival and secondary endpoints of overall response rate and overall survival as compared to the current standard of care treatment arm.
Encouraging data in combination with FOLFIRI. As announced in January 2023, IGM-8444 showed an encouraging safety profile which was broadly comparable to that expected from chemotherapy alone in this setting. Specifically, no signs of drug related clinically significant hepatotoxicity were observed, as only Grade 1 and Grade 2 transient drug related liver enzyme elevations were seen. In patients with metastatic colorectal cancer, the combination of IGM-8444 and FOLFIRI showed promising activity at 3 mg/kg, with multiple confirmed responses observed, including some in patients who had previously progressed on FOLFIRI.
Clinical biomarker data supports activity and dose response across multiple dose levels. Clinical biomarker data from 64 patients treated in monotherapy and combination dose cohorts across multiple dose levels of IGM-8444 in the Company’s ongoing Phase 1 clinical trial showed that virtually all of these patients (60 of 64) showed an increase in levels of the cell death biomarker caspase-3 following treatment with IGM-8444. This increase began to be seen after the initial dose of IGM-8444 and showed a trend towards a dose dependent increase between the two highest dose levels tested of 3 mg/kg and 10 mg/kg.
First patient dosed in venetoclax combination. The Company also announced today that it has dosed the first patient in its IGM-8444 plus venetoclax and azacytidine Phase 1 combination cohort in subjects with acute myeloid leukemia.
Dosing ongoing in the fifth birinapant dose cohort. The Company further announced today that it is currently treating patients in its fifth birinapant Phase 1 combination dose escalation cohort. To date, there have not been any observed dose limiting toxicities in combination with birinapant.
Imvotamab (CD20 x CD3)

Advancing into multiple autoimmune clinical trials. The Company announced today that it plans to file Investigational New Drug (IND) applications in the second quarter of 2023 this year to begin clinical testing of imvotamab in severe systemic lupus erythematosus and severe rheumatoid arthritis. The Company believes that the clinical safety and efficacy profile of imvotamab positions it very well for the exciting new area of treating autoimmune disease with T cell engagers.
Cytokine release incidence of less than 10% at 100 mg dose level. The Company announced today that as of its most recent data assessment the incidence of cytokine release syndrome was nine percent (9%) combined over all safety evaluable patients treated with the 100 mg titration weekly dosing regimen in its Phase 1 and Phase 2 non-Hodgkin’s lymphoma (NHL) studies.
DLBCL complete response rate greater than 30% at 100 mg dose level. The Company also announced today that, although the patient numbers are very small and additional patients currently on treatment may respond, as of its most recent data assessment it has achieved a complete response rate of greater than 30% combined over all efficacy evaluable diffuse large B cell lymphoma patients treated with the 100 mg titration weekly dosing regimen in its Phase 1 and Phase 2 NHL studies.
Redirecting clinical development efforts to autoimmune disease. In light of its plans for the extensive clinical development of imvotamab in autoimmune diseases and the limited commercial opportunities in monotherapy treatment of NHL, the Company announced today that it has decided to cease further monotherapy clinical development efforts for imvotamab in NHL. The Company continues to believe that the safety and efficacy profile of imvotamab positions it well as a combination partner for the treatment of NHL, and it plans to focus its future efforts in NHL on evaluating combination opportunities and partnerships for imvotamab.
IGM-7354 (IL-15 x PD-L1)

Phase 1 trial initiated. As previously announced, the Company has initiated a clinical trial exploring the safety, efficacy and biomarker activity of IGM-7354, an IgM targeted immunostimulatory IL-15 cytokine, in the treatment of patients with solid tumors.
First two patients dosed. The Company announced today that it has successfully dosed two patients in its clinical trial of IGM-7354 without any drug related safety issues to date.
Preclinical data presented. In November 2022, the Company presented preclinical results at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. The data was featured in a poster titled "IGM-7354, an anti-PD-L1/IL-15 IgM immunocytokine, activates and expands NK cells and effector memory CD8+ T cells in vivo".
IGM-2644 (CD38 x CD3)

IND clearance. The Company announced today that the U.S. Food and Drug Administration has cleared its IND application for a Phase 1 dose escalation trial of IGM-2644, a CD38 x CD3 IgM T cell engaging antibody, in patients with recurrent or refractory multiple myeloma. This study will investigate the initial safety and efficacy of IGM-2644 in patients who have progressed on previous therapies. The Company’s ultimate clinical development goal is to establish IGM-2644 as a safe and more potent anti-CD38 therapy, particularly for patients who have received prior daratumumab treatment.
Preclinical data. In December 2022, the Company presented preclinical data for IGM-2644 at the ASH (Free ASH Whitepaper) Annual Meeting and Exposition. The results were featured in a poster presentation titled "IGM-2644, a Novel CD38 x CD3 Bispecific IgM T Cell Engager Demonstrates Potent Efficacy on Myeloma Cells with an Improved Preclinical Safety Profile", which highlighted IGM-2644’s greater complement dependent cytotoxicity activity as compared to conventional IgG anti-CD38 antibodies. Additionally, IGM-2644 achieved potent T cell dependent cellular cytotoxicity (TDCC) killing of daratumumab-resistant cell lines with minimal cytokine release and potent TDCC killing of myeloma patient samples.
Fourth Quarter and Full Year 2022 Financial Results

Cash and Investments: Cash and investments as of December 31, 2022 were $427.2 million, compared to $229.5 million as of December 31, 2021.
Collaboration Revenue: For the fourth quarter and year ended 2022, collaboration revenues were $0.4 million and $1.1 million, respectively, compared to no revenue for the same period in 2021.
Research and Development (R&D) Expenses: For the fourth quarter and year ended 2022, R&D expenses were $45.0 million and $179.3 million, respectively, compared to $39.2 million and $127.0 million for the fourth quarter and year ended 2021, respectively.
General and Administrative (G&A) Expenses: For the fourth quarter and year ended 2022, G&A expenses were $11.6 million and $49.7 million, respectively, compared to $11.5 million and $38.3 million for the fourth quarter and year ended 2021, respectively.
Net Loss: For the fourth quarter of 2022, net loss was $52.6 million, or a loss of $1.19 per share, compared to a net loss of $50.6 million, or a loss of $1.50 per share, for the fourth quarter of 2021. For the year ended 2022, net loss was $221.1 million, or a loss of $5.32 per share, compared to a net loss of $165.2 million, or a loss of $4.93 per share, for the year ended 2021.
2023 Financial Guidance
The Company expects full year 2023 GAAP operating expenses of $290 million to $300 million, including estimated non-cash stock-based compensation expense of approximately $50 million, and full year collaboration revenue of approximately $3 million related to the Sanofi agreement. The Company expects to end 2023 with a balance of approximately $200 million in cash and investments, and for the balance to enable it to fund its operating expenses and capital expenditure requirements into the second half of 2024.

Conference Call and Webcast
IGM will host a live conference call and webcast at 4:30 p.m. EDT today, March 30, 2023, to discuss the Company’s financial results and provide a corporate update. The webcast can be accessed by clicking the link: View Source and will also be available on the "Events and Presentations" page in the "Investors" section of the Company’s website.

On March 30, 2023 iBio CDMO LLC, a wholly owned subsidiary of iBio, Inc. (the "Company") and Woodforest National Bank ("Woodforest") reported that it has entered into the Fourth Amendment to the Credit Agreement (the "Fourth Amendment") that was entered into on November 1, 2021, as amended (the "Credit Agreement"), which within the Fourth Amendment Woodforest agreed to (i) reduce the percentage of any payment to Woodforest the Company is required to make from the proceeds of sales of its common stock under its at-the-market facility from 40% to 20%, (ii) reduce the percentage of any payment to Woodforest the Company is required to make from the proceeds of sales of its equipment from 40% to 20%, and (iii) allow the Company to retain $2,000,000 million of the $5,100,000 million that the Company received from Fraunhofer USA Inc. ("Fraunhofer") as part of its legal settlement with them (the "Fraunhofer Settlement Funds"), with the remaining $3,000,000 million being held in a Company account at Woodforest (Filing, iBioPharma, MAR 30, 2023, View Source [SID1234629588]). In addition, the Company is obligated to (y) deliver to Woodforest an executed copy of a purchase agreement (the "Purchase Agreement") for the sale of the 130,000 square foot cGMP manufacturing facility in Bryan, Texas, no later than April 14, 2023, and (z) pay to Woodforest a fee in the amount of $75,000 on the earlier of the date of the closing of the Purchase Agreement, or the Maturity Date (as defined in the Credit Agreement). No assurance can be given that the Company will be able to enter into a Purchase Agreement no later than April 14, 2023, as required by the Fourth Amendment despite ongoing negotiations undertaken for such sale. The failure to enter into a Purchase Agreement no later than April 14, 2023 is an immediate default under the Credit Agreement.

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On March 17, 2023, the Company received a payment of $5,100,000 from Fraunhofer related to the Fraunhofer Settlement Funds and in accordance with the Fourth Amendment, transferred $3,000,0000 to a Company account at Woodforest on March 24, 2023.

In addition, on March 24, 2023, the Company, as guarantor, entered into the Fourth Amendment to the Guaranty, which was executed on November 1, 2021, as amended (the "Guaranty"), which reduced the Liquidity Covenant (as defined in the Credit Agreement, which required the Company to maintain a certain level of unrestricted cash) from $7,500,000 to $1,000,000.

The descriptions of the Fourth Amendment to the Credit Agreement and the Fourth Amendment to the Guaranty do not purport to be complete and are qualified in their entirety by reference to the Fourth Amendment to the Credit Agreement and the Fourth Amendment to the Guaranty, copies of which are filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 2.02. Results of Operations and Financial Condition.

The information set forth in Item 8.01 is incorporated by reference into this Item 2.02.

Item 2.03. Creation of Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant.

The information set forth in Item 1.01 is incorporated by reference into this Item 2.03.

Item 8.01. Other events

During the first calendar quarter of 2023, the Company has received an aggregate of approximately$3.8 million from (i) the sale of the Company’s common stock by Cantor Fitzgerald & Co. as sales agent pursuant to the Controlled Equity Offering SM Sales Agreement, dated as of November 25, 2020, and (ii) the exercise of a portion of the Series A and Series B warrants issued by the Company in the offering that closed on December 9, 2022.

On March 30, 2023 Gandeeva Therapeutics, Inc., a precision medicine company focused on designing and developing novel therapeutics guided by cryogenic electron microscopy (cryo-EM) and machine learning, reported the initiation of a research collaboration with Moderna Inc. (NASDAQ: MRNA) to explore applications of Gandeeva’s differentiated technology platform for a Moderna program (Press release, Gandeeva Therapeutics, MAR 30, 2023, View Source [SID1234629587]).

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"We are excited to begin working with Moderna on a specific application of our AI-enabled cryo-EM platform that leverages our technology infrastructure and deep experience in structural biology and medicinal chemistry," said Sriram Subramaniam, Ph.D., Founder and CEO of Gandeeva Therapeutics. "Through our internal pipeline programs and collaborations, we are aggressively pursuing the development of first-in-class modalities in targeting difficult-to-drug protein-protein interactions."

Under the research agreement, Gandeeva and Moderna will study and validate the application of Gandeeva’s proprietary cryo-EM platform approach for an undisclosed Moderna target. Gandeeva will receive research payments from Moderna. Additional terms of the agreement were not disclosed.