Prelude Therapeutics Announces Clinical Trial Collaboration with BeiGene to Evaluate PRT2527 in Combination with Zanubrutinib in Hematologic Cancers

On March 15, 2023 Prelude Therapeutics Incorporated (Prelude) (Nasdaq: PRLD), a clinical-stage precision oncology company, reported a clinical trial collaboration with BeiGene, for future evaluation of its investigational CDK9 inhibitor, PRT2527, in combination with BeiGene’s BTK inhibitor, zanubrutinib, in hematologic malignancies (Press release, Prelude Therapeutics, MAR 15, 2023, View Source [SID1234628792]).

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!

Inhibition of BTK is an active therapeutic approach in several B cell malignancies and the combination of CDK9 inhibition with BTK inhibition has demonstrated, in recent data publications, synergistic clinical efficacy over BTK inhibition alone; hence, there is a strong rationale for studying the combination in patients with certain hematologic malignancies.

"The opportunity to combine Prelude’s potent, selective and potentially best-in-class CDK9 inhibitor with BeiGene’s next-generation highly efficacious and tolerable BTK inhibitor, zanubrutinib, reflects our commitment to bringing the most promising options to patients," said Jane Huang, MD, President and Chief Medical Officer, Prelude Therapeutics.

Under terms of the clinical trial collaboration agreement, BeiGene will provide zanubrutinib to Prelude, and Prelude will retain all global operational, development and commercialization rights and responsibilities for PRT2527.

About PRT2527

PRT2527 was designed to be a potent and selective Cyclin-dependent kinase 9, or CDK9, inhibitor. In preclinical studies, PRT2527 was shown to reduce MCL1 and MYC protein levels and was highly active in preclinical models at well-tolerated doses. PRT2527 has demonstrated high potency and kinase selectivity which may offer improved efficacy and safety compared to less selective CDK9 inhibitors, allowing for rapid development in combinations. PRT2527 is currently being studied as monotherapy in a Phase 1 dose-escalation study in advanced solid tumors, as well as in relapsed/refractory hematologic malignancies.

Nouscom Announces AACR 2023 Late-Breaking Presentation of Translational Phase 1b Data of NOUS-PEV, a Personalized Neoantigen Cancer Immunotherapy

On March 15, 2023 Nouscom, a clinical stage immuno-oncology company developing off-the-shelf and personalized viral vector immunotherapies, reported that new translational data obtained from the ongoing Phase 1b trial evaluating NOUS-PEV in patients with metastatic melanoma has been accepted for presentation in a Late-Breaking session at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, NousCom, MAR 15, 2023, View Source;utm_medium=rss&utm_campaign=nouscom-announces-aacr-2023-late-breaking-presentation-of-translational-phase-1b-data-of-nous-pev-a-personalized-neoantigen-cancer-immunotherapy [SID1234628791]). AACR (Free AACR Whitepaper) will be held in
person in Orlando, FL from 14th to 19th April. Poster Presentation Details:

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!

• Title: NOUS-PEV, a Personalized Cancer Immunotherapy targeting neoantigens,
induces long lasting, tumor infiltrating memory T cells
• Session Title: Late-Breaking Research: Clinical Research 2
• Date & Time: 18th April 2023, 9:00 AM – 12:30 PM EDT
• Location: Poster Section 35, Poster Board 11
• Poster Number: LB196
• Presenter: Dr. Elisa Scarselli, Chief Scientific Officer at Nouscom
The full abstract will be available on 14th April 2023 at 12pm EDT.

Navidea Biopharmaceuticals to Host Fourth Quarter 2022 Earnings Conference Call and Business Update

On March 15, 2023 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported it will host a conference call and webcast on Tuesday, March 21, 2023 at 5:00 p.m. (EDT) to discuss corporate developments and financial results for the fourth quarter and full year ended December 31, 2022 (Press release, Navidea Biopharmaceuticals, MAR 15, 2023, View Source [SID1234628790]).

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. Michael Rosol, Chief Medical Officer, and Erika Eves, Vice President of Finance and Administration, will host the call and webcast to discuss the financial results and provide an update on recent developments and clinical progress. Management will be available to answer questions live immediately following the earnings announcement and prepared remarks portion of the call.

To participate in the call and webcast, please refer to the information below:

Event: Fourth Quarter 2022 Earnings Conference Call and Business Update
Date: Tuesday, March 21, 2023
Time: 5:00 p.m. (EDT)
U.S. & Canada Dial-In: 877-407-0312
International Dial-In: +1 201-389-0899
Conference ID: 13736745
Webcast Link: View Source

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.

Moleculin to Report Full Year 2022 Financial Results on March 22, 2023 and Host Conference Call and Webcast

On March 15, 2023 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs, for hard-to-treat tumors and viruses, reported that it will report its financial results for the full year December 31, 2022 after market close on Wednesday, March 22, 2023 (Press release, Moleculin, MAR 15, 2023, https://moleculin.com/moleculin-to-report-full-year-2022-financial-results-on-march-22-2023-and-host-conference-call-and-webcast/ [SID1234628789]). Moleculin management will host a conference call and live audio webcast to discuss the operational and financial results on Thursday, March 23rd at 8:30 AM ET.

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 call will be hosted by members of Moleculin’s leadership team, Walter Klemp, Chairman and Chief Executive Officer, Dr. John Paul Waymack, Senior Chief Medical Officer, and Jonathan Foster, Executive VP & Chief Financial Officer. Interested participants and investors may access the conference call by dialing (877) 407-0832 (domestic) or (201) 689-8433 (international) and referencing the Moleculin Biotech Conference Call. The live webcast will be accessible on the Events page of the Investors section of the Moleculin website, moleculin.com, and will be archived for 90 days.

MaxCyte Reports Fourth Quarter and Full Year 2022 Financial Results

On March 15, 2023 MaxCyte, Inc., (NASDAQ: MXCT; LSE: MXCT), a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell therapeutics and to support innovative, cell-based research, reported its fourth quarter and full year ended December 31, 2022, financial results and provided initial 2023 revenue guidance (Press release, MaxCyte, MAR 15, 2023, View Source [SID1234628788]).

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!

Fourth Quarter and Full Year Highlights

·

Total revenue of $12.4 million in the fourth quarter of 2022, an increase of 22% over the fourth quarter of 2021.

·

Core business revenues grew 4% in the fourth quarter of 2022, with revenue growth from cell therapy customers growing 4% and revenue from drug discovery customers growing by 5%, over the fourth quarter of 2021.

·

Total revenue of $44.3 million for the full year 2022, an increase of 31% over the full year 2021.

·

Full year 2022 core business revenues grew 26%, led by cell therapy revenue growth of 33%, and revenue from drug discovery growing 8%.

·

Initial 2023 guidance for total revenue growth of 21% to 26% over 2022, including core revenue growth of 20% to 25% over 2022, and Strategic Platform License (SPL) program-related revenue of approximately $6 million.

·

Total cash, cash equivalents and short-term investments were $227.3 million as of December 31, 2022.

"We are pleased with our strong progress and performance in 2022 and look forward to continuing this positive momentum into 2023. Over the course of the year, we have made significant investments in our people, manufacturing capacity, and R&D infrastructure, which positions us well for our next stage of growth," said Doug Doerfler, President and CEO of MaxCyte.

"Our portfolio of partnerships continued to grow throughout 2022, having announced three new SPL partnerships as well as the recent addition of Catamaran Bio as a partner in early 2023. We also entered into a partnership with Vertex following the transfer of the exa-cel program from CRISPR. The partnership maintains our role in this program, for which Vertex is currently seeking regulatory marketing approval in the United States and Europe for Sickle Cell Disease and Beta-Thalassemia. We are continuing to see our partners make strong progress across their clinical programs and are focused on providing them with the in-house manufacturing and regulatory support that they will require as they move towards commercialization. Our partnership pipeline remains robust and growing as we begin 2023 and we are excited to see our partners achieve upcoming milestones and move the cell therapy industry forward."

The following table provides details regarding the sources of our revenue for the periods presented

Three Months Ended

Year Ended

December 31,

(Unaudited)

December 31,

(Unaudited)

2022

2021

%

2022

2021

%

(in thousands, except percentages

Cell therapy

$

7,544

$

7,264

4%

$

30,546

$

22,984

33%

Drug discovery

3,026

2,885

5%

9,100

8,395

8%

Program-related

1,854

3

NM*

4,616

2,515

83%

Total revenue

$

12,424

$

10,152

22%

$

44,262

$

33,894

31%

* Not Meaningful (NM)

Operational Highlights

·

Ended the year with 18 SPL partnerships, with the addition of partnerships with Intima Bioscience, LG Chem, and Curamys in 2022. With the addition of an SPL partnership with Catamaran Bio in early 2023, the total number of partnerships now stands at 19. Vertex Pharmaceuticals will use MaxCyte’s Flow Electroporation technology and ExPERT platform to support the gene-edited hemoglobinopathy cell therapy exa-cel, formerly known under CRISPR as CTX001. We entered into an SPL partnership with Vertex in 2022 for this transferred program. In addition, we retained our partnership with CRISPR therapeutics supporting CRISPR/Cas9-based therapies in immuno-oncology.

·

As of December 31, 2022, our 18 active SPL partner agreements allowed for over 125 potential programs; 16 of which were active programs currently in the clinic (defined as programs with at least a cleared IND or equivalent). If all potential programs successfully progress through the clinic to commercial approval, we estimate aggregate potential to generate pre-commercial milestone payments to us of over $1.55 billion in addition to sales-based commercial revenue due to us under existing agreements. At the end of 2021, there were 15 SPL partnerships covering over 95 programs with total potential pre-commercial milestones exceeding $1.25 billion.

·

As of December 31, 2022, we had over 600 instruments placed with customers, compared to over 500 instruments at the end of 2021.

·

Launched the ExPERT branded VLxTM, our large-scale Flow Electroporation platform.

·

Completed and occupied our new, 67,000 square foot, state of the art headquarters in Maryland’s I-270 biotech corridor, significantly increasing our in-house manufacturing capacity, as well as research and process development lab space.

·

Appointed Patrick J. Balthrop, Sr. to our board of directors as a non-executive member. Mr. Balthrop will also serve on the nominating and corporate governance committees of our board of directors.

In addition to revenue, management regularly reviews key business metrics to evaluate our business, measure performance, identify trends affecting our business, formulate financial projections and make strategic decisions. As of the dates presented, these key metrics were as follows

As of December 31,

2022

2021

2020*

Installed base of instruments (sold or leased)

>600

>500

>400

Number of active SPL partnerships

18

15

12

Total number of licensed clinical programs (SPL partnerships only)

>125

>95

>75

Total number of active licensed clinical programs under SPL partnerships currently in the clinic **

16

15

7

Total potential pre-commercial milestones under SPL partnerships

>$1.55 billion

>$1.25 billion

>$950 million

* Amounts presented as of December 31, 2020, give effect to one SPL entered into and additional INDs cleared in January 2021.

** Number of licensed clinical programs under SPLs are by number of product candidates and not by indication.

Fourth Quarter 2022 Financial Results

Total revenue for the fourth quarter of 2022 was $12.4 million, compared to $10.2 million in the fourth quarter of 2021, representing growth of 22%.

Core business revenue (instruments and disposables to cell therapy and drug discovery customers and excluding program-related revenue) was $10.6 million in 2022, compared to core business revenue of $10.1 million in 2021, representing growth of 4%, including 4% revenue growth from cell therapy customers and 5% revenue growth from drug discovery customers.

Our SPL program-related revenue was $1.9 million in the fourth quarter of 2022 as compared to immaterial SPL program-related revenue in the fourth quarter of 2021.

Gross profit for the fourth quarter of 2022 was $10.9 million (88% gross margin), compared to $8.9 million (88% gross margin) in the fourth quarter of 2021.

Operating expenses for the fourth quarter of 2022 were $17.6 million, compared to operating expenses of $13.9 million in the fourth quarter of 2021. The overall increase in operating expenses was primarily driven by increases in R&D, sales, and marketing headcount and occupancy expenses related to our new corporate headquarters.

Net loss for the fourth quarter of 2022 was $4.8 million compared to net loss of $4.9 million in the fourth quarter of 2021. EBITDA, a non-GAAP measure, was a loss of $5.8 million for the fourth quarter of 2022, compared to a loss of $4.5 million for the fourth quarter of 2021; stock-based compensation expense was $3.1 million in the fourth quarter of 2022 compared to $2.4 million in the fourth quarter of 2021.

Full Year 2022 Financial Results

Total revenue for 2022 was $44.3 million, compared to $33.9 million in 2021, representing growth of 31%.

Core business revenue for 2022 was $39.6 million, compared to $31.4 million for 2021, representing growth of 26%, including 33% revenue growth from cell therapy customers and 8% revenue growth from drug discovery customers.

Our SPL program-related revenue for 2022 was $4.6 million, compared to $2.5 million in SPL program-related revenue in 2021, representing growth of 83% in 2022.

Gross profit for 2022 was $39.2 million (88% gross margin), compared to $30.2 million (89% gross margin) in the prior year.

Operating expenses for 2022 were $66.5 million, compared to operating expenses of $48.4 million in 2021. The overall increase in operating expenses was principally driven by increases in headcount, occupancy, and public company expenses.

Full year 2022 net loss was $23.6 million compared to a loss of $19.1 million in 2021; full year 2022 EBITDA was a loss of $24.8 million compared to a loss of $17.4 million in 2021; total stock-based compensation for 2022 was $11.8 million, compared to $8.0 million for 2021.

Total cash, cash equivalents and short-term investments were $227.3 million as of December 31, 2022, compared to $255.0 million as of December 31, 2021.

2023 Revenue Guidance

Management is providing initial 2023 revenue guidance for total revenue, core business revenue and SPL program-related revenue.

Management expects full year 2023 total revenue growth of between 21% and 26% over 2022 including core business revenue growth of between 20% and 25% over 2022, and SPL program-related revenue of approximately $6 million.

Webcast and Conference Call Details

MaxCyte will host a conference call today, March 15, 2023, at 4:30 p.m. Eastern Time. Investors interested in listening to the conference call are required to register online. A live and archived webcast of the event will be available on the "Events" section of the MaxCyte website at View Source