On May 11, 2023 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, reported its operating results for the first quarter ended March 31, 2023 and provided pipeline updates (Press release, AnaptysBio, MAY 11, 2023, View Source [SID1234631483]).

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"We’re excited about our progress as we continue to develop best-in-class antibodies across a number of high-value immune cell modulatory targets. We have initiated our global Phase 2b trial in moderate-to-severe atopic dermatitis (AD) for ANB032, our BTLA agonist, and will host a virtual R&D event on May 25th to highlight the biologic and mechanistic rationale for developing a BTLA agonist in AD," said Daniel Faga, interim president and chief executive officer of AnaptysBio. "We believe our checkpoint agonists, rosnilimab and ANB032, as well as our CD122 antagonist, ANB033, have the potential to treat a broad range of autoimmune and inflammatory disorders by directly acting on immune cells that mediate disease pathology, and we remain well capitalized to execute on our broad development plan."

Updates on Wholly Owned Immune Cell Modulator Pipeline

Rosnilimab (PD-1 agonist antibody)

Anticipate initiation in Q3 2023 of a global Phase 2b trial in moderate-to-severe rheumatoid arthritis (RA)
Multi-hundred patient placebo-controlled trial assessing three dose levels of subcutaneously administered rosnilimab for up to 6 months on well-established endpoints including ACR20/50/70 and DAS28
Top-line interim data anticipated by mid-year 2025
Plan to initiate second global Phase 2 trial, in an indication to be announced, by year-end 2023
ANB032 (BTLA agonist antibody)

Initiated a global Phase 2b trial in moderate-to-severe AD
160 patient placebo-controlled trial assessing three dose levels of subcutaneously administered ANB032 (randomized 1:1:1:1) for a 14-week treatment duration on well-established endpoints, including EASI75 and IGA 0/1
Top-line interim data anticipated by year-end 2024
Presented poster on Phase 1 data for ANB032, a BTLA agonist for the treatment of moderate-to-severe AD, at International Societies for Investigative Dermatology (ISID) Annual Meeting, May 11, 2023, in Japan
Planning to host a virtual BTLA Agonist (ANB032) R&D Event on Thursday, May 25, 2023 at 1:15pm PT / 4:15pm ET
Management will host the event via conference call and webcast, with an accompanying slide presentation
The live audio webcast, as well as a replay of the presentation, will be available on the investor section of the AnaptysBio website at View Source
ANB033 (anti-CD122 antagonist antibody)

Plan to submit an Investigational New Drug (IND) application in H1 2024
Updates on Legacy Clinical-Stage Cytokine Antagonist Programs Available for Out-Licensing

Announced publication of Phase 2 GALLOP data for imsidolimab, an investigational, wholly owned, anti-IL-36R antagonist IgG4 antibody in generalized pustular psoriasis (GPP) in The British Journal of Dermatology on April 30, 2023

Anticipate top-line data from the ongoing GEMINI-1 Phase 3 trial in Q4 2023
Plan to out-license imsidolimab prior to potential FDA approval
GSK Immuno-Oncology Financial Collaboration

GSK announced publication of RUBY Phase 3 clinical data for JEMPERLI (dostarlimab-gxly), an anti-PD-1 antagonist antibody discovered at AnaptysBio and licensed to GSK, in The New England Journal of Medicine and presented simultaneously at ESMO (Free ESMO Whitepaper) Virtual Plenary and SGO Annual Meeting in March 2023
JEMPERLI has the potential for a first-in-class approval in primary advanced or recurrent endometrial cancer after meeting the primary endpoint in the pivotal RUBY Phase 3 trial demonstrating JEMPERLI plus chemotherapy significantly improved PFS versus chemotherapy plus placebo
GSK plans regulatory submissions in H1 2023
GSK anticipates top-line data from the ongoing FIRST Phase 3 trial, a randomized, double-blind, comparison of platinum-based therapy with dostarlimab and niraparib versus standard of care platinum-based therapy as first-line treatment of Stage III or IV nonmucinous epithelial ovarian cancer, in H2 2023
GSK anticipates top-line data from the ongoing COSTAR Lung Phase 3 trial, a randomized, open label 3-arm trial comparing cobolimab plus dostarlimab plus docetaxel to dostarlimab plus docetaxel to docetaxel alone in patients with advanced NSCLC who have progressed on prior anti-PD-(L)1 therapy and chemotherapy, in 2024
Stock Repurchase Program and Year-End Cash Guidance

Completed Stock Repurchase Program, authorized in January 2023, of $50.0 million of the Company’s outstanding common stock
Reiterating cash runway through year-end 2026 with expected year-end 2023 cash and investments of $370 – $385 million
First Quarter Financial Results

Cash, cash equivalents and investments totaled $526.1 million as of March 31, 2023, compared to $584.2 million as of December 31, 2022, for a decrease of $58.1 million. The decrease relates primarily to cash used for the stock repurchase program and operating activities.

Collaboration revenue was $1.4 million for the three months ended March 31, 2023, compared to $1.0 million for the three months ended March 31, 2022. The change is due to increased royalties recognized for sales of JEMPERLI and Zejula in the first quarter of 2023.

Research and development expenses were $35.0 million for the three months ended March 31, 2023, compared to $22.5 million for the three months ended March 31, 2022. The increase was due primarily to manufacturing and development costs for imsidolimab, rosnilimab, ANB032 and ANB033. The R&D non-cash, stock-based compensation expense was $2.8 million for the three months ended March 31, 2023 as compared to $1.7 million in the same period in 2022.

General and administrative expenses were $10.8 million for the three months ended March 31, 2023, compared to $10.2 million for the three months ended March 31, 2022. The G&A non-cash, stock-based compensation expense was $6.1 million for the three months ended March 31, 2023 and 2022.

Net loss was $44.3 million for the three months ended March 31, 2023, or a net loss per share of $1.58, compared to a net loss of $36.3 million for the three months ended March 31, 2022, or a net loss per share of $1.31.

On May 11, 2023 ALX Oncology Holdings Inc., ("ALX Oncology") (Nasdaq: ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, reported financial results for the first quarter ended March 31, 2023 and provided clinical development and operational highlights (Press release, ALX Oncology, MAY 11, 2023, View Source [SID1234631482]).

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"In the first quarter of 2023, we continued to make significant progress in advancing our lead program, evorpacept, through new collaborations and clinical trial starts," said Dr. Jaume Pons, Founder, President and Chief Executive Officer of ALX Oncology. "This included our recently announced clinical trial collaboration with Sanofi to evaluate evorpacept in combination with SARCLISA in patients with multiple myeloma, and the initiation of three new clinical studies. These studies encompass our initiation of a Phase 1 trial in urothelial cancer in combination with PADCEV, the initiation of a Phase 1 I-SPY-PI TRIAL for the treatment of patients with unresectable or metastatic HER-positive and HER2-low breast cancer in combination with ENHERTU in partnership with Quantum Leap Healthcare Collaborative ("Quantum Leap"), and the recently announced initiation of a Phase 2 investigator-sponsored trial of evorpacept, in combination with liposomal doxorubicin and KEYTRUDA in patients with recurrent platinum-resistant ovarian cancer."

Dr. Pons added, "We look forward to important readouts in the second half of 2023 from ASPEN-06, a randomized Phase 2 trial of evorpacept in combination with trastuzumab, paclitaxel and CYRAMZA (ramucirumab) for the treatment of patients with HER2-positive gastric/gastroesophageal junction cancer, and from ASPEN-02, a Phase 1b clinical trial of evorpacept in combination with azacitidine in patients with myelodysplastic syndromes. Additionally, in collaboration with Tallac Therapeutics, we remain on track to file an Investigational New Drug application in the first half of this year for ALTA-002, a SIRPa Toll-like receptor agonist antibody conjugate, that will broaden our immuno-oncology pipeline beyond evorpacept."

Recent Clinical Developments for Evorpacept

First patient dosed in Phase 2 investigator-sponsored trial of evorpacept in combination with KEYTRUDA in patients with ovarian cancer.
In May 2023, we announced the initiation of a Phase 2 investigator-sponsored trial of evorpacept in combination with liposomal doxorubicin and KEYTRUDA (pembrolizumab) in patients with recurrent platinum-resistant ovarian cancer at the UPMC Hillman Cancer Center. This is an open-label, single-arm Phase 2 clinical trial. The study is being led by Haider Mahdi, M.D., M.P.H., Assistant Professor, Department of Obstetrics, Gynecology and Reproductive Sciences, The University of Pittsburgh and UPMC Magee-Womens Research Institute.
Announced clinical trial collaboration with Sanofi to evaluate evorpacept in combination with SARCLISA in patients with multiple myeloma.
In April 2023, we entered into a clinical trial collaboration and supply agreement with Sanofi to evaluate evorpacept and SARCLISA (isatuximab-irfc), Sanofi’s monoclonal antibody that targets a specific epitope on the CD38 receptor on multiple myeloma cells, for the treatment of patients with relapsed or refractory multiple myeloma ("RRMM"). Under the terms of the agreement, Sanofi will conduct a Phase 1/2 study to evaluate the safety, efficacy, pharmacokinetics and biomarker data of evorpacept in combination with SARCLISA and dexamethasone in patients with RRMM.
First patient dosed in I-SPY-PI TRIAL evaluating evorpacept in combination with ENHERTU, a HER2 directed antibody-drug conjugate ("ADC"), in breast cancer.
In March 2023, we announced the dosing of the first patient in the I-SPY-PI TRIAL for the treatment of patients with breast cancer. Sponsored by Quantum Leap, this Phase 1 (open label), multi-center study arm is investigating evorpacept in combination with ENHERTU (fam-trastuzumab deruxtecan-nxki) to determine the safety, tolerability and efficacy of this drug combination in patients with unresectable or metastatic HER2-positive and HER2-low breast cancer.
First patient dosed in ASPEN-07 study evaluating evorpacept in combination with PADCEV, an ADC, in patients with urothelial cancer ("UC").
In February 2023, we announced the first patient was dosed in the Phase 1 ASPEN-07 study evaluating evorpacept in combination with PADCEV (enfortumab vedotin-ejfv), an ADC, in patients with UC. ASPEN-07 is a Phase 1, open-label, multi-center study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of evorpacept in combination with PADCEV in subjects with unresectable locally advanced or metastatic UC.
First Quarter 2023 Financial Results:

Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments as of March 31, 2023 were $256.2 million. ALX Oncology believes its cash, cash equivalents, investments along with the ability to draw down an additional $40 million of its term loan are sufficient to fund planned operations through mid-2025.

Research and Development ("R&D") Expenses: R&D expenses consist primarily of pre-clinical, clinical and manufacturing expenses related to the development of the Company’s current lead product candidate, evorpacept, and R&D employee-related expenses. These expenses for the three months ended March 31, 2023 were $24.8 million, compared to $17.1 million for the prior-year period. The increase was primarily due to an increase of $5.3 million in clinical costs from an increase in the number of active trials and patient enrollment as well as manufacturing of clinical trial materials to support a higher number of active clinical trials and future expected patient enrollment related to the advancement of evorpacept, an increase of $1.5 million in personnel and related costs primarily driven by headcount growth, and an increase of $1.1 million in stock-based compensation expense due to additional awards granted since March 31, 2022 offset by a decrease of $0.6 million related to the Tallac Collaboration for costs related to the IND filing planned for 2023 in which the primary work was completed in 2022.

General and Administrative ("G&A") Expenses: G&A expenses consist primarily of administrative employee-related expenses, legal and other professional fees, patent filing and maintenance fees, and insurance. These expenses for the three months ended March 31, 2023 were $7.4 million, compared to $7.7 million for the prior-year period. The small decrease year over year was primarily attributable to reduced stock-based compensation expense primarily due to forfeited stock options during the quarter and a decrease in other general and administrative costs due primarily to corporate legal and patent costs.

Net loss: GAAP net loss was $30.2 million for the first quarter ended March 31, 2023, or $0.74 per basic and diluted share, as compared to GAAP net loss of $24.5 million for the first quarter ended March 31, 2022, or $0.60 per basic and diluted share. Non-GAAP net loss was $23.8 million for the first quarter ended March 31, 2023, as compared to a non-GAAP net loss of $19.0 million for the first quarter ended March 31, 2022. A reconciliation of GAAP to non-GAAP financial results can be found at the end of this press release.

On May 11, 2023 Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, reported financial results for the first quarter ended March 31, 2023 (Press release, Alpine Immune Sciences, MAY 11, 2023, View Source [SID1234631481]).

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"So far this year, we have achieved important milestones in advancing clinical studies for povetacicept, our potential best-in-class dual BAFF/APRIL inhibitor being developed for multiple autoantibody-related diseases. The first participant was dosed in the RUBY-3 study of povetacicept in autoimmune glomerulonephritis and we are pleased with the high level of investigator interest in the study. We’ve also opened the RUBY-4 study of povetacicept in autoimmune cytopenias and are preparing to initiate enrollment this quarter," said Mitchell H. Gold, MD, Executive Chairman and Chief Executive Officer of Alpine. "We remain on track to deliver preliminary data from both the RUBY-3 and RUBY-4 studies by the end of the year as we continue to pursue our mission of bringing meaningful new therapies to people living with autoimmune or inflammatory diseases."

First Quarter 2023 Highlights

Povetacicept (ALPN-303)

Initiated and continues to enroll participants in RUBY-3, a phase 1b, open-label basket study of povetacicept in autoimmune glomerulonephritis, including IgA nephropathy, lupus nephritis, and primary membranous nephropathy.
Advanced preparations for initiating enrollment in RUBY-4, a phase 1b, open-label basket study of povetacicept in autoimmune cytopenias, including immune thrombocytopenia, warm autoimmune hemolytic anemia, and cold agglutinin disease.
Presented encore phase 1 data from the RUBY-1 study of povetacicept in healthy adults in an ePoster and oral presentation at the American Academy of Dermatology Annual Meeting and in a poster session at the International Society of Nephrology World Congress of Nephrology.
Presented pharmacokinetic and pharmacodynamic modeling and simulation data to support clinical development of povetacicept in a poster session at the American Society for Clinical Pharmacology & Therapeutics Annual Meeting.
Plans to present an updated clinical dataset from the RUBY-1 study in healthy adult volunteers at the European Alliance of Associations for Rheumatology (EULAR) 2023 Congress in June.
First Quarter 2023 Financial Results

As of March 31, 2023, Alpine’s cash and investments totaled $248.3 million, which the Company anticipates is sufficient to fund its planned operations through 2025. The Company recorded net losses of $13.3 million and $7.5 million for the quarters ended March 31, 2023 and 2022, respectively.

Collaboration revenue for the first quarter ended March 31, 2023 was $9.4 million compared to $13.6 million for the first quarter ended March 31, 2022.

The decrease in collaboration revenue relates primarily to the Company’s agreement with Horizon. Horizon collaboration revenues for the three-months period ended March 31, 2023 decreased by $4.2 million related to services rendered in connection with the Company’s two ongoing research programs for Horizon, whereas the higher 2022 period revenues were the result of substantial completion of the initial existing program with Horizon.

Research and development expenses for the first quarter ended March 31, 2023 were $19.6 million compared to $16.3 million for the first quarter ended March 31, 2022. The increase was primarily attributable to higher personnel-related expenses due to increased headcount to support clinical trial activities.

General and administrative expenses for the first quarter ended March 31, 2023 were $5.4 million compared to $4.8 million for the first quarter ended March 31, 2022. The increase was primarily attributable to increases in personnel costs.

Alpine Immune Sciences, Inc.

Selected Consolidated Balance Sheet Data

(In thousands)

March 31,
2023

December 31,
2022

(unaudited)

Cash and cash equivalents

$14,465

$13,376

Short-term investments

180,460

224,265

Total current assets

198,784

240,993

Long-term investments

53,170

35,481

Total assets

262,100

286,686

Total current liabilities

57,089

57,996

Total stockholders’ equity

169,543

179,420

Total liabilities and stockholders’ equity

262,100

286,686

Consolidated Statement of Operations and Comprehensive Income (Loss) Data

(In thousands, except share and per share amounts)

Three Months Ended March 31,

2023

2022

(unaudited)

Collaboration revenue

$9,387

$13,629

Operating expenses:

Research and development

19,581

16,311

General and administrative

5,398

4,775

Total operating expenses

24,979

21,086

Loss from operations

(15,592)

(7,457)

Other income (expense):

Interest income

2,418

145

Interest expense

(70)

(154)

Other, net

(22)

(57)

Loss before taxes

(13,266)

(7,523)

Income tax benefit (expense)

—

(4)

Net loss

$(13,266)

$(7,527)

Comprehensive income (loss):

Unrealized gain (loss) on investments

745

(774)

Unrealized loss on foreign currency translation

(31)

(14)

Comprehensive loss

$(12,552)

$(8,315)

Weighted-average shares used to compute basic and diluted net loss per share

47,568,149

30,267,472

Basic and diluted net loss per share

$(0.28)

$(0.25)

About Povetacicept (ALPN-303)

Povetacicept (ALPN-303) is a dual antagonist of the BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) cytokines, which play key roles in the activation and survival of B cells, particularly antibody-secreting cells. Based upon an engineered TACI (transmembrane activator and CAML interactor) domain, povetacicept has exhibited greater potency in preclinical studies versus wild-type TACI-based comparators, as well as other inhibitors of BAFF and/or APRIL alone. Povetacicept is in development for multiple B cell and/or autoantibody-related diseases, such as systemic lupus erythematosus, autoimmune glomerulonephritis, and autoimmune cytopenias.

About RUBY-3

RUBY-3 (NCT05732402) is a multiple ascending dose, multi-cohort, open label, phase 1b study of povetacicept in IgA nephropathy, lupus nephritis, and primary membranous nephropathy, where povetacicept is being administered for up to 48 weeks in disease- and dose-specific cohorts. Key endpoints include proteinuria, eGFR, renal response, and disease-related autoantibodies.

About RUBY-4

RUBY-4 (NCT05757570) is a multi-cohort, open label, phase 1b study of povetacicept in immune thrombocytopenia, autoimmune hemolytic anemia, and cold agglutinin disease, where povetacicept is being administered for up to 48 weeks in disease-specific cohorts. Key endpoints include respective blood cell counts, including durable responses, as well as disease-related autoantibodies.

On May 11, 2023 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer, reported an encore presentation of data from the Phase 1 ALPHA/ALPHA2 trials of ALLO-501/501A at the European Hematology Association (EHA) (Free EHA Whitepaper) Hybrid Congress on June 8–11, 2023 in Frankfurt, Germany (Press release, Allogene, MAY 11, 2023, View Source [SID1234631480]).

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The ALPHA/ALPHA2 trials were designed to assess the safety, tolerability, and preliminary efficacy at increasing dose levels of ALLO-501 and ALLO-501A, allogeneic CAR T cell product candidates that target CD19. In addition to exploring cell doses, these studies evaluated escalating doses of ALLO-647, Allogene’s proprietary investigational lymphodepleting antibody designed to prevent premature rejection of AlloCAR T cells, in combination with fludarabine and cyclophosphamide.

Allogene is conducting ALPHA2 and EXPAND, two potentially pivotal Phase 2 trials of ALLO-501A in large B cell lymphoma (LBCL) in sites across the U.S. and is expected to extend its clinical research footprint to Europe, Canada and Australia in 2023.

Allogene Presentation at the 2023 EHA (Free EHA Whitepaper) Hybrid Congress:

Title: Durable Responses Achieved with Anti-CD19 Allogeneic CAR T ALLO-501/501A in Phase 1 Trials of Autologous CAR T Naïve Patients with Relapsed/Refractory Large B Cell Lymphoma (R/R LBCL)

Presenter: Dr. Javier Munoz, M.D., M.B.A, Director of the Lymphoma Program at Mayo Clinic in Phoenix, Arizona
Abstract: P1125
Poster Session Display Date and Time: Friday, June 9, 2023, 18:00 – 19:00 CEST/ 9:00AM – 10:00AM PT/ 12:00PM – 1:00PM ET

About ALLO-501 and ALLO-501A
ALLO-501 and ALLO-501A are anti-CD19 AlloCAR T investigational products for the treatment of large B cell lymphoma. ALLO-501A, a next-generation anti-CD19 AlloCAR T, eliminates the rituximab recognition domains in ALLO-501, which could allow for use in a broader patient population, including NHL patients with recent rituximab exposure. This product candidate is currently being studied in an ongoing Phase 2 trial. In June 2022, the U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-501A in r/r LBCL.

On May 11, 2023 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that Orion Corporation, a global pharmaceutical company based in Finland, has selected bispecific lead antibodies and is exercising its option to develop these molecules under the existing research collaboration and license agreement between the two companies (Press release, Alligator Bioscience, MAY 11, 2023, View Source [SID1234631479]). Alligator will continue to generate additional data in order for Orion to select the final development candidate over the coming months. Upon exercise, the development option is conditional upon a milestone payment to Alligator.

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"The research collaboration conducted with Alligator to date has allowed us to identify several lead molecules which have potential to be selected for clinical development, making us keen to intensify and accelerate the research and nonclinical development of these compounds to have a final development candidate as soon as possible," said Outi Vaarala, Senior Vice President, Innovative Medicines Business and R&D, Orion Corporation Orion Pharma

"We are extremely pleased by our collaboration with Orion and proud to have been able to generate a high number of very attractive clones that has allowed Orion to select a few candidates in such a short amount of time.," said Søren Bregenholt, CEO of Alligator Bioscience. "This represents further validation of our technology platforms in identifying and developing high quality therapeutic antibodies with excellent manufacturing potential."

Under the initial agreement signed in 2021, Alligator employed its proprietary phage display libraries and RUBY bispecific antibody format to develop immuno-oncology product candidates based on design criteria identified by Orion. Alligator is eligible for development, approval and sales milestone payments in addition to royalties if Orion continues developing and commercializing the resulting product candidates.

In January 2023, Alligator and Orion announced the expansion of the original agreement to include the development of a second bispecific antibody.