On May 12, 2022 ADC Therapeutics SA (NYSE: ADCT), reported that results from the pivotal Phase 2 clinical trial of camidanlumab tesirine (Cami) in patients with relapsed or refractory Hodgkin lymphoma have been accepted for an oral presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress (EHA2022), which will be held virtually and in Vienna, Austria from June 9-12, 2022 (Press release, ADC Therapeutics, MAY 12, 2022, View Source [SID1234614330]).

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!

"We continue to be encouraged by the data from our ongoing pivotal Phase 2 trial demonstrating the efficacy and safety of Cami as a single agent for patients with relapsed or refractory Hodgkin lymphoma," said Joseph Camardo, MD, Chief Medical Officer of ADC Therapeutics. "As we advance Cami toward a potential BLA submission, we look forward to sharing these data with the hematology community at EHA (Free EHA Whitepaper)2022."

Details of ADC Therapeutics’ oral presentation are as follows:

Camidanlumab Tesirine: Updated Efficacy And Safety In An Open-Label, Multicenter, Phase 2 Study Of Patients With Relapsed Or Refractory Classical Hodgkin Lymphoma (R/R CHL)Presentation Date and Time: Friday, June 10, 2022, 11:45 am – 12:00 pm CEST // 5:45 am – 6 am EDT

Presentation Date and Time: Friday, June 10, 2022, 11:45 am – 12:00 pm CEST // 5:45 am – 6 am EDT

Session Title: Hodgkin lymphoma – Clinical

Session Room: Hall A8

Abstract Code: S201

Presenter: Carmelo Carlo-Stella, MD, Department of Biomedical Sciences, Humanitas University, and Department of Oncology and Hematology, IRCCS Humanitas Research Hospital, Milan, Italy

Details of ADC Therapeutics’ poster presentations are as follows:

Health-Related Quality Of Life And Tolerability Of Loncastuximab Tesirine In High-Risk Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma Treated In A Phase 2 Clinical Trial (LOTIS 2)

Session Date and Time: Friday, June 10, 2022, 16:30 – 17:45 CEST // 10:30 am – 11:45 am EDT

Location: Hall D

Abstract Code: P1717

Real-World Characteristics And Clinical Outcomes In Relapse/Refractory Diffuse Large B-Cell Lymphoma Patients Who Received Car-T Therapy

Session Date and Time: Friday, June 10, 2022, 16:30 – 17:45 CEST // 10:30 am – 11:45 am EDT

Location: Hall D

Abstract Code: 1182

Real-World Characteristics And Clinical Outcomes In Relapse/Refractory Diffuse Large B-Cell Lymphoma Post Car-T Failure

Session Date and Time: Friday, June 10, 2022, 16:30 – 17:45 CEST – 10:30 am – 11:45 am EDT

Location: Hall D

Abstract Code: 1181

Titles of ADC Therapeutics’ abstracts accepted for publication only are as follows:

·A Phase 2, Open-Label Study Of Loncastuximab Tesirine In Combination With Rituximab (LONCA-R) In Previously Untreated Unfit/Frail Patients With Diffuse Large B-Cell Lymphoma (DLBCL) (LOTIS-9) [Trials in progress]

·Long-term survival projections of loncastuximab tesirine-treated patients in relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL)

·Phase 3 Randomized Study of Loncastuximab Tesirine in Combination With Rituximab (Lonca-R) Versus Immunochemotherapy in Patients With R/R DLBCL (LOTIS-5) [Trials in progress]

Please note: times and locations are tentative and subject to change.

About Camidanlumab Tesirine (Cami)

Camidanlumab tesirine (Cami) is an antibody drug conjugate (ADC) comprised of a monoclonal antibody that binds to CD25 (HuMax-TAC, licensed from Genmab A/S), conjugated to the pyrrolobenzodiazepine (PBD) dimer payload, tesirine. Once bound to a CD25-expressing cell, Cami is internalized into the cell where enzymes release the PBD-based payload, killing the cell. This applies to CD25-expressing tumor cells and also to CD25-expressing Tregs. The intra-tumoral release of its PBD payload may also cause bystander killing of neighboring tumor cells, and PBDs have also been shown to induce immunogenic cell death. All of these properties of Cami may enhance immune-mediated anti-tumor activity.

Cami is being evaluated in a pivotal Phase 2 clinical trial in patients with relapsed or refractory Hodgkin lymphoma and a Phase 1b clinical trial as monotherapy and in combination with pembrolizumab in solid tumors.

About ZYNLONTA (loncastuximab tesirine-lpyl)

ZYNLONTA is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.

The U.S. Food and Drug Administration (FDA) has approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL not otherwise specified, DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.

On May 12, 2022 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a biopharmaceutical company focused on the discovery and development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers, reported financial results for the quarter ended March 31, 2022 (Press release, Kinnate Biopharma, MAY 12, 2022, View Source [SID1234614347]).

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 company continues to make meaningful progress with our pipeline candidates, inclusive of our pan-RAF inhibitor, KIN-2787, and our FGFR inhibitor, KIN-3248, both in the clinic, and with initial data from the Phase 1 KN-8701 clinical trial forthcoming later this year for KIN-2787," said Nima Farzan, Chief Executive Officer of Kinnate. "We remain focused on developing a new generation of small molecule kinase inhibitors that target a wide range of cancers, including those that resist current treatment, and we are incredibly proud that in just four years we have advanced two compounds into clinical trials, with several more compounds in the pipeline. Our consistent, disciplined use of capital and updated cash runway guidance is expected to enable Kinnate to fund scientific innovation and operations into early 2024."

Recent Business Highlights and Corporate Update:

KIN-2787, pan-RAF inhibitor

Initial monotherapy data from the ongoing Phase 1 KN-8701 clinical trial expected in the fourth quarter of 2022.
Upon meeting a combination of pre-specified milestones in the ongoing Phase 1 KN-8701 clinical trial, initiated combination portion of KN-8701 to study KIN-2787 with binimetinib in NRAS-mutant melanoma; initial data expected in the first half of 2023.
Abstract highlighting the company’s KIN-2787 program was accepted for publication at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting taking place June 3-7, 2022, in Chicago, Illinois. The abstract is titled: Antitumor activity of KIN-2787, a next-generation pan-RAF inhibitor, in combination with MEK inhibition in preclinical models of human NRAS mutant melanoma.
Presented three separate poster presentations highlighting (1) preclinical activity of KIN-2787 in BRAF alteration positive and NRAS-mutant melanoma models, (2) an overview of the KN-8701 clinical trial design and (3) a clinico-genomics study and outcome analysis that documented the common occurrence of BRAF Class II and Class III alterations across solid tumors, at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. (View release)
KIN-3248, FGFR Inhibitor

Abstract highlighting KIN-3248 was accepted for poster presentation during the ASCO (Free ASCO Whitepaper) 2022 Annual Meeting. The abstract is titled: Design and rationale of a first-in-human (FIH) phase 1/1b study evaluating KIN-3248, a next-generation, irreversible (irrev), pan-FGFR inhibitor (FGFRi), in adult patients with solid tumors harboring FGFR2 and/or FGFR3 gene alterations (NCT05242822).
Announced that the first patient has commenced treatment in KN-4802 (NCT05242822), a Phase 1 clinical trial evaluating KIN-3248. KIN-3248 is a next-generation pan-FGFR inhibitor being developed for the treatment of intrahepatic cholangiocarcinoma (ICC) and urothelial carcinoma (UC), as well as other solid tumors. KN-4802 will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-cancer activity of KIN-3248 in FGFR inhibitor naïve and pretreated cancer patients with FGFR2 and/or FGFR3 gene alterations. (View release)
Corporate Update

Expanded the organization to 68 full-time employees as of March 31, 2022, of which 52 were engaged in research and development activities, and subsequently appointed the following senior leaders:
Ben Powell, Vice President, Discovery Biology
Priyanka Shah, Vice President, IR & Communications
First Quarter 2022 Financial Results

Cash and Cash Equivalents and Investments Position: As of March 31, 2022, the total of cash and cash equivalents and investments was $302.4 million, exclusive of Kinnjiu’s cash. Existing cash and cash equivalents and investments as of March 31, 2022 with budget reallocation is expected to fund current operations, including initiation of multiple registrational studies, into early 2024.
Research and Development Expenses: First quarter research and development expenses for 2022 were $19.6 million, compared to $12.7 million for the same period in 2021.
General and Administrative Expenses: First quarter general and administrative expenses for 2022 were $7.4 million, compared to $4.8 million for the same period in 2021.
Net Loss: First quarter net loss for 2022 was $26.9 million, compared to $17.5 million for the same period in 2021.

On May 12, 2022 Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ: ENSC, OTC: ENSCW), a clinical-stage biotech company applying transformative chemistry to improve prescription drug safety and performance focused on reducing abuse and overdose, reported financial results for the first quarter 2022 (Press release, Leisure Acquisition, MAY 12, 2022, View Source [SID1234614365]).

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. Lynn Kirkpatrick, Chief Executive Officer of Ensysce, commented, "The first few months of 2022 are off to an exciting start, evident in the most recent clinical results from trials PF614-102 and PF614-MPAR-101. As we progress on our studies and clinical trials, we are closer to realizing our mission – providing abuse and overdose protection where needed. I look forward to our upcoming corporate update call next week to discuss the recent results from the trials, especially regarding the longer-lasting profile of PF614 and the encouraging initial data from our overdose protection study. Additionally, we expect the Bioequivalence (BE) trial data of our TAAP opioid, PF614, to be available prior to the end of the second quarter, positioning PF614 as our first commercial candidate and demonstrating progress towards our goal to bring a unique pipeline of products to the market."

TAAPTM (Opioid Abuse Deterrent Program) Updates

●On May 5, 2022, the Company announced clinical trial results from trial PF614-102 confirming the safety and longer-lasting profile of PF614 versus Oxycontin.

●The results of the study show the longer-lasting half-life of PF614 versus OxyContin as seen in the prior Phase 1 single-ascending dose study of PF614 oral solution versus OxyContin. We believe this data confirms the findings from our Phase 1 study that demonstrate PF614 should provide true twice-daily dosing.

●The safety data for the study also showed that PF614 performed similarly to OxyContin with no serious treatment emergent adverse events recorded.

The second part of the PF614-102 study, the bioequivalence (BE) arm, continues to be analyzed and as reported previously, we anticipate that this BE data will be available by the end of the second quarter of 2022. The Company believes that the data will support the 505(b)(2) regulatory path for clinical development of PF614, an abbreviated pathway to FDA approval.

●Human abuse liability (HAL) studies to determine labeling claims for PF614 are scheduled to initiate in the second quarter of 2022.

●PF614 is designed using the abuse protective platform TAAP, Trypsin Activated Abuse Protection, a chemical modification which inactivates the active ingredient in Ensysce’s opioid products, including PF614, until swallowed and exposed to the enzyme trypsin in the digestive system. Our TAAP platform, which we believe provides abuse protection and resistance to manipulation and other forms of recreational drug abuse, should also control the rate of release of the active opioid.

MPARTM (Opioid Abuse Deterrent and Overdose Protection Program) Updates

●On May 5, 2022, the Company announced initial results from trial PF614-MPAR-101, providing first human data showing the potential for overdose protection with MPAR, Multi-Pill Abuse Resistance.

●This data demonstrated how the combination product PF614-MPAR could reduce the trypsin activation and reduce the release of oxycodone in a simulated overdose situation. It also demonstrated the PF614 in the systemic circulation (simulated injection) did not convert to oxycodone. We believe this is the first step to identifying the first MPAR drug product that will be marketed in the coming years.

●The study is continuing with additional subjects enrolling to receive PF614 and trypsin inhibitor nafamstat in various combinations through the third quarter of 2022. Safety and pharmacokinetic results are expected by the end of the third quarter 2022.

Financial Results

●Cash – Cash and cash equivalents were $8.4 million as of March 31, 2022, as compared to $12.3 million at December 31, 2021. Cash used in operating activities for the first quarter of 2022 totaled $3.4 million, an increase from $0.5 million in the first quarter of 2021 that primarily resulted from the clinical advancement of our product candidates and increased costs related to operating as a public company.

●Federal Grants – Funding from federal grants was $0.6 million for the first quarter of 2022 compared to $0.3 in the comparable year ago quarter. Funding increased by $0.4 million under the MPAR Grant, offset by a decrease of $0.1 million under the OUD Grant, due to the timing of research activities eligible for funding.

●Research & Development Expenses – R&D expenses were $3.1 million for the first quarter of 2022 compared to $0.3 million in the comparable year ago quarter. The increase was primarily the result of increased external research and development costs related to preclinical and clinical programs for PF614 and PF614-MPAR.

●General & Administrative Expenses – G&A expenses were $2.3 million for the first quarter of 2022 compared to $0.5 million for the same period in 2021. The increase was primarily a result of increased expenses related to operating as a public company, including legal and accounting fees and director and officer insurance expenses.

●Other Income (Expense) – Total other income (expense), was income of $3.9 million in the first quarter of 2022 and expense of $0.4 million in the first quarter of 2021. The income in the 2022 period is due to non-cash valuation adjustments of current obligations of the Company. The 2021 expense primarily reflects non-cash interest expense on notes that were converted on June 30, 2021.

●Net Income (Loss) – Net loss for the first quarter of 2022 was $1.0 million compared to net loss of $0.9 million for the comparable year ago period. As we are a clinical stage biotech company, our research and development of, and regulatory approvals for, our product candidates are expected to continue, resulting in expected losses for the foreseeable future.

Additional Company Highlights

●On February 8, 2022, the Company added further depth to its Board of Directors with the appointment of Lee Rauch.

●On April 18, 2022, the Company announced the appointment of Dr. Nily Osman as Chief Medical Officer.

Corporate Update Conference Call

Management will host a corporate update conference call on Tuesday, May 17, 2022, at 11:00am ET to provide a corporate update and review the recently discussed results from Clinical Trials PF614-102 and PF614-MPAR-101. 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.

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, June 14, 2022. 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 13729812.

On May 12, 2022 Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, reported financial results for the quarter ended March 31, 2022 and provided recent business highlights (Press release, Shattuck Labs, MAY 12, 2022, View Source [SID1234614381]).

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!

"We are now completing the monotherapy dose-escalation study for SL-172154 in ovarian cancer patients and are focused on the initiation and rapid clinical execution of multiple combination studies in both hematologic and solid tumors. This expansion is a critical step in establishing SL-172154 as both a first- and best-in-class CD47 inhibitor and CD40 agonist, and we continue to expect SL-172154 to differentiate from other CD47 inhibitors and CD40 agonists in terms of safety, pharmacodynamic activity, and efficacy in combinations. The next 18 months are shaping up to be a defining period for establishing CD47 inhibition as a key macrophage checkpoint in multiple indications, and we look forward to providing initial combination data from SL-172154 in the first half of 2023," said Taylor Schreiber, M.D., Ph.D., and Chief Executive Officer of Shattuck.

First Quarter 2022 Recent Business Highlights and Other Recent Developments

ARC Clinical-Stage Pipeline and Preclinical Pipeline

SL-172154 (SIRPα-Fc-CD40L)

Continued Enrollment of SL-172154 Phase 1A Dose-Escalation Clinical Trial in Platinum-Resistant Ovarian Cancer: This open-label, multi-center, dose-escalation clinical trial is evaluating the safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamic effects of SL-172154 administered intravenously in patients with platinum resistant ovarian cancer. Full dose-escalation data from the trial are expected in the first half of 2023.
Phase 1B Clinical Trial of SL-172154 in Combination with Liposomal Doxorubicin Expected to Begin in the Second Half of 2022: This clinical trial will evaluate the safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamics effects of SL-172154 in combination with liposomal doxorubicin in patients with advanced, platinum-resistant ovarian cancer and is anticipated to begin enrollment in the second half of 2022. Initial combination data from the trial are expected in the first half of 2023. Additional combination trials with SL-172154 in ovarian cancer and novel agents are currently being planned.
Enrollment Continues in SL-172154 Phase 1A/B Clinical Trial in Acute Myeloid Leukemia (AML) and Higher-Risk Myelodysplastic Syndromes (HR-MDS): The trial is evaluating the safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamic effects of SL-172154, as both monotherapy and in combination. In both HR-MDS and TP53 mutant AML, SL-172154 will be combined with azacitidine. In AML, SL-172154 will be evaluated in combination with both azacitidine and venetoclax. Initial data from the monotherapy and combination dose escalation portions of the trial are expected in the first half of 2023.
Data for Intratumorally Administered SL-172154 Phase 1 Clinical Trial in Squamous Cell Carcinoma of the Head and Neck or Skin to be Presented in the Second Half of 2022: Shattuck anticipates presenting data from the clinical trial in the second half of 2022. Shattuck may continue further development of SL-172154 in squamous cell carcinoma of the head and neck (HNSCC) or skin (CSCC) via intravenous administration following selection of a recommended Phase 2 dose in ovarian cancer.
SL-279252 (PD1-Fc-OX40L)

Continued Enrollment of SL-279252 Phase 1 Dose-Escalation Clinical Trial in Advanced Solid Tumors: Enrollment of patients with primarily PD-L1 selected tumors continues in the Phase 1 open-label, multi-center, dose-escalation clinical trial to evaluate the safety, tolerability, pharmacokinetics, anti-tumor activity and pharmacodynamic effects of SL-279252 in patients with advanced solid tumors and lymphoma. Top-line data from all treated subjects across the full dose range are anticipated in the second half of 2022.
Preclinical

Presented Preclinical Data on SL-9258 at AACR (Free AACR Whitepaper) in April: Preclinical data for SL-9258 (TIGIT-Fc-LIGHT), a dual TIGIT inhibitor and HVEM/LTβR agonist, were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (AACR) (Free AACR Whitepaper) in April 2022. These data, from studies in a mouse model, provided preclinical evidence for anti-tumor activity of the murine equivalent of SL-9258 in PD-1 acquired resistant tumors and increased tumor rejection in comparison to TIGIT blocking antibodies. In these preclinical models, TIGIT-Fc-LIGHT outperformed TIGIT blocking antibodies independent of PD-L1 or DNAM-1 (CD226) expression. TIGIT-Fc-LIGHT was also evaluated and well tolerated in non-human primates and observed similar on-target pharmacodynamic activity to what was characterized in the mouse model. Together, these results suggest that TIGIT-Fc-LIGHT may provide clinical benefit to patients that are refractory to conventional checkpoint blockade therapy.
Presented Preclinical Data at AACR (Free AACR Whitepaper) on GADLEN Platform: Shattuck also presented preclinical data highlighting the potential of GADLENs to direct gamma delta T cells to kill tumor cells and, in the process, further elucidate tumor cell markers which are important for the therapeutic activity of gamma delta T cell-based therapies. Butyrophilin heterodimeric fusion proteins from Shattuck’s GADLEN platform showed enhanced tumor cell killing targeting CD19 and CD20 and demonstrated preclinical proof of concept in the treatment of cancer.
Clinical Pipeline Product Candidate to be Selected in 2022: As Shattuck looks to advance its preclinical pipeline, a new product candidate from the ARC or GADLEN platform is anticipated to be selected in the second half of 2022.
Upcoming Events

H.C. Wainwright 2022 Global Investment Conference

Management will participate in investor one-on-one meetings and give a corporate presentation during the H.C. Wainwright 2022 Global Investment Conference from May 24-26, 2022. A live and archived audio webcast of the presentation will be available by visiting the Events & Presentations section of the Company’s website.

First Quarter 2022 Financial Results

Cash Position: As of March 31, 2022, cash and cash equivalents and short-term investments were $239.2 million, as compared to $321.2 million as of March 31, 2021.
Research and Development (R&D) Expenses: R&D expenses were $19.2 million for the quarter ended March 31, 2022, as compared to $10.3 million for the quarter ended March 31, 2021. This increase was primarily driven by increases in process development costs and manufacturing of trial materials and personnel-related costs.
General and Administrative (G&A) Expenses: G&A expenses were $5.0 million for the quarter ended March 31, 2022, as compared to $4.4 million for the quarter ended March 31, 2021. This increase was primarily driven by increases in compensation related and other operating costs.
Net Income/Loss: Net loss was $24.5 million for the quarter ended March 31, 2022, or $0.58 per basic and diluted share, as compared to a net loss of $11.8 million for the quarter ended March 31, 2021, or $0.28 per basic and diluted share.
2022 Financial Guidance

Shattuck believes its cash and cash equivalents and short-term investments will be sufficient to fund its operations into the second half of 2024, beyond results from its Phase 1 clinical trials of SL-172154 and SL-279252. This cash runway guidance is based on the Company’s current operational plans and excludes any additional funding that may be received or business development or additional clinical development activities that may be undertaken.

About SL-172154

SL-172154 (SIRPα-Fc-CD40L) is an investigational ARC fusion protein designed to simultaneously inhibit the CD47/SIRPα checkpoint interaction and activate the CD40 costimulatory receptor to bolster an anti-tumor immune response in patients with advanced cancer. Two Phase 1 clinical trials are ongoing, the first for patients with advanced and platinum resistant ovarian cancer (NCT04406623) and the second for patients with AML and HR-MDS (NCT05275439).

About SL-279252

SL-279252 (PD1-Fc-OX40L) is an investigational ARC fusion protein designed to simultaneously inhibit the PD-1/PD-L1 interaction and activate the OX40 receptor in patients with advanced cancers. A Phase 1 trial in patients with solid tumors and lymphoma is ongoing (NCT03894618).

On May 11, 2022 Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the first quarter ending March 31, 2022 and provided a business update (Press release, Savara, MAY 12, 2022, View Source [SID1234614400]).

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!

"As recently reported, we continue to steadily advance IMPALA-2, our pivotal Phase 3 clinical trial of molgramostim, a novel inhaled biologic," said Matt Pauls, Chair and CEO, Savara. "Despite the ongoing global unpredictability of COVID-19 and current geopolitical issues affecting Europe, we reaffirm our guidance of top line data by the end of 2Q 2024. With a cash position of ~$152M at the end of the first quarter of 2022, and a recent debt refinancing that reduced our cost of capital and strengthened our balance sheet, we believe that we are funded through 2025."

First Quarter Financial Results (Unaudited)

Savara’s net loss for the three months ended March 31, 2022 was $8.3 million, or $(0.05) per share, compared with a net loss of $10.2 million, or $(0.13) per share, for the three months ended March 31, 2021.

Research and development expenses decreased by $1.9 million, or 25.1%, to $5.7 million for the three months ended March 31, 2022 from $7.6 million for the three months ended March 31, 2021. The decrease was primarily attributable to an ~$2.5 million decrease in costs associated with the close-out and wind-down of activities related to the inhaled vancomycin development program. This decrease was partially offset by an ~$0.5 million increase in costs associated with the molgramostim development program for the treatment of aPAP. Molgramostim costs are related to the continued screening and enrollment of patients as well as Chemistry, Manufacturing, and Controls ("CMC") activities associated with the IMPALA-2 trial.

General and administrative expenses decreased by $0.4 million, or 15.3%, to $2.4 million for the three months ended March 31, 2022 from $2.8 million for the three months ended March 31, 2021. The decrease was primarily due to administrative and compensation costs associated with streamlining certain operational activities that were initiated during the third quarter of 2021.

As of March 31, 2022, the Company had cash, cash equivalents, and short-term investments of ~$152 million and debt of ~$25 million.