On March 25, 2024 Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), reported its financial results for the full year 2023, its recent business highlights, and a preview of select anticipated milestones (Press release, Sutro Biopharma, MAR 25, 2024, View Source [SID1234641413]).

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"The year 2023 was pivotal for Sutro, with the initiation of REFRαME-O1, our registration-directed study of luvelta for platinum-resistant ovarian cancer (PROC) patients, further validating our next-generation ADC capabilities. In addition, we advanced our earlier stage programs, strengthened our management team, and bolstered our already strong cash position with additional non-dilutive capital," said Bill Newell, Sutro’s Chief Executive Officer. "We look forward to continuing the momentum in 2024, with the initiation of a second registration-directed trial with luvelta, REFRαME-P1, for pediatric patients with CBF/GLIS AML, and two additional planned INDs. I am delighted with the strides we are taking towards meaningfully impacting the lives of cancer patients in need."

Recent Business Highlights and Select Anticipated Milestones

STRO-002, International Nonproprietary Name, "luveltamab tazevibulin," abbreviated as "luvelta," FolRα-Targeting ADC Franchise:

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In January 2024, Sutro hosted an investor webcast highlighting luvelta’s broad opportunity to address unmet needs in several FolRα-expressing cancers, including platinum-resistant ovarian cancer (PROC), endometrial cancer, CBFA2T3::GLIS2 (CBF/GLIS; RAM phenotype) acute myeloid leukemia (AML), and non-small cell lung cancer (NSCLC).
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The registration-directed trial, REFRαME-O1, for treatment of PROC is enrolling, with an anticipated ~140 sites in ~20 countries to be opened by the end of 2024. Enrollment of Part 1 of the trial is expected to be completed in the first half of 2024.
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In December 2023, data demonstrating anti-leukemic activity with luvelta, either as a single agent or in combination, in pediatric patients with CBF/GLIS AML, were presented at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (ASH 2023), including complete remission in 42% of patients with CBF/GLIS AML with ≥5% blasts and in 75% of pediatric patients with CBF/GLIS AML with <5% blasts.
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Enrollment of REFRαME-P1, a registration-enabling trial for pediatric patients with CBF/GLIS AML, is expected to be initiated in the second half of 2024.
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An Investigational New Drug (IND) application submission is planned for treatment of non-small cell lung cancer (NSCLC) in the first half of 2024.
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Continued clinical development is planned in combination with bevacizumab for the treatment of ovarian cancer and in endometrial cancer, as resources permit.

Additional Pipeline Development and Collaboration Updates:

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Sutro plans to submit an IND for STRO-003, a ROR1-targeting ADC, in 2024.
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Sutro plans to submit an IND for STRO-004, a tissue factor-targeting ADC, in 2025.
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Sutro continues to seek to maximize the value of its proprietary cell-free platform by working with partners on programs in multiple disease spaces and geographies and has generated from collaborators an aggregate of approximately $854 million in payments through December 31, 2023, including equity investments.
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In November 2023, Vaxcyte exercised its option to enter into a manufacturing rights agreement with Sutro to obtain control over the development and manufacture of cell-free extract for use under its license agreement with Sutro, including for Vaxcyte’s pneumococcal conjugate vaccine (PCV) franchise, which includes VAX-24 and VAX-31. Upon exercising the option, Vaxcyte paid Sutro $50 million and is obligated to pay Sutro an additional $25 million within six months. Upon the occurrence of certain regulatory milestones, Vaxcyte would be obligated to pay Sutro up to an additional $60 million.
Corporate Updates:

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Sutro continues to build a world-class leadership team through the promotion of Jane Chung to President and Chief Operating Officer, a newly created role in which she will be responsible for driving operational excellence, strategic growth, and overall business success at Sutro.
Full Year 2023 Financial Highlights

Cash, Cash Equivalents and Marketable Securities

As of December 31, 2023, Sutro had cash, cash equivalents and marketable securities of $333.7 million, as compared to $321.1 million as of September 30, 2023, and approximately 0.7 million shares of Vaxcyte common stock with a fair value of $41.9 million, which together provide a projected cash runway into the second half of 2025, based on current business plans and assumptions. Current market conditions provide a challenging financing environment. In this context, Sutro is continuing its process of evaluating its programs and spending.

Unrealized Gain from Increase in Value of Vaxcyte Common Stock

The non-operating, unrealized gain of $9.9 million for the year 2023 was due to the increase since December 31, 2022 in the estimated fair value of Sutro’s holdings of Vaxcyte common stock. Vaxcyte common stock held by Sutro will be remeasured at fair value based on the closing price of Vaxcyte’s common stock on the last trading day of each reporting period, with any non-operating, unrealized gains and losses recorded in Sutro’s statements of operations.

Revenue

Revenue was $153.7 million for the year ended December 31, 2023, as compared to $67.8 million for the same period in 2022, with the 2023 amount related principally to the Vaxcyte manufacturing rights agreement option exercise, Astellas and Merck collaborations, and the recognition of a contingent payment from Tasly. Future collaboration and license revenue under existing agreements, and from any additional collaboration and license partners, will fluctuate as a result of the amount and timing of revenue recognition of upfront, milestones, and other agreement payments.

Operating Expenses

Total operating expenses for the year ended December 31, 2023 were $243.0 million, as compared to $196.7 million for the same period in 2022. The year 2023 includes non-cash expenses for stock-based compensation of $24.9 million and depreciation and amortization of $6.8 million, as compared to $26.3 million and $5.7 million, respectively, in the comparable 2022 period. Total operating expenses for the year ended December 31, 2023 were comprised of research and development expenses of $180.4 million and general and administrative expenses of $62.6 million.

On March 25, 2024 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that the U.S. Food and Drug Administration (FDA) has issued Complete Response Letters (CRLs) for the Biologics License Application (BLA) for odronextamab in relapsed/refractory (R/R) follicular lymphoma (FL) and in R/R diffuse large B-cell lymphoma (DLBCL), each after two or more lines of systemic therapy (Press release, Regeneron, MAR 25, 2024, View Source [SID1234641412]). The only approvability issue is related to the enrollment status of the confirmatory trials. The CRLs – one for R/R FL and one for R/R DLBCL – did not identify any approvability issues with the odronextamab clinical efficacy or safety, trial design, labeling or manufacturing.

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Regeneron has been actively enrolling patients in multiple Phase 3 trials for odronextamab as part of the OLYMPIA program – one of the largest clinical programs in lymphoma. As the OLYMPIA program is intended to change the treatment paradigm of several B-cell non-Hodgkin lymphoma subtypes – including in earlier lines of therapy – in agreeing to the program, the FDA required that the trials include both dose-finding and confirmatory portions. Enrollment in the dose-finding portion has begun, but the CRLs indicate that the confirmatory portions of these trials should be underway and that the timelines to completion be agreed prior to resubmission. Regeneron is committed to working closely with the FDA and investigators to bring odronextamab to patients with R/R FL and R/R DLBCL as quickly as possible. Regeneron plans on sharing updates on enrollment and regulatory timelines later this year.

Regulatory review of odronextamab remains ongoing by the European Medicines Agency (EMA) for the treatment of R/R DLBCL and R/R FL. In the European Union, odronextamab was granted Orphan Drug Designation in DLBCL and FL.

The potential use of odronextamab in R/R DLBCL and R/R FL is currently under clinical development and has not been approved by any regulatory authority.

On March 25, 2024 Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies, reported the pricing of an underwritten offering of 21,010,000 shares of its common stock at a price of $10.00 per share and pre-funded warrants to purchase 3,000,031 shares of common stock (Press release, Nkarta, MAR 25, 2024, View Source [SID1234641411]). The pre-funded warrants are being sold at a price of $9.9999 per warrant, which represents the per share offering price for the common stock less the $0.0001 per share exercise price.

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New and existing investors participated in the offering, including Adage Capital Partners LP, Boxer Capital, Commodore Capital, Cormorant Asset Management, an affiliate of Deerfield Management, EcoR1 Capital, Janus Henderson Investors, OrbiMed, RA Capital Management, Ridgeback Capital Investments, Samsara BioCapital, SR One, and a leading mutual fund.

Gross proceeds to Nkarta from this offering are approximately $240.1 million, before deducting underwriting discounts and commissions and offering expenses. Nkarta intends to use the net proceeds from the offering to fund the continued research and clinical development of NKX019, the continued buildout of internal manufacturing capabilities, and for working capital and for general corporate purposes. The offering is expected to close on or about March 27, 2024, subject to customary closing conditions.

Leerink Partners, TD Cowen, Stifel and Mizuho are acting as joint bookrunners for the offering.

All securities in the offering are to be issued and sold by Nkarta. The offering was conducted pursuant to a shelf registration statement (File No. 333-270680), which was initially filed with the Securities and Exchange Commission ("SEC") on March 17, 2023 and declared effective by the SEC on May 5, 2023. The offering was made only by means of a prospectus supplement and accompanying prospectus describing the terms of the offering. Copies of the prospectus supplement and the accompanying prospectus relating to this offering may be obtained by contacting the following: Leerink Partners LLC, Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525 ext. 6105, or by email at [email protected]; Cowen and Company, LLC, 599 Lexington Avenue, New York, NY 10022, by telephone at (833) 297-2926, or by email at [email protected]; Stifel, Nicolaus & Company, Incorporated, Attention: Prospectus Department, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720 or by email at [email protected]; Mizuho Securities USA LLC, Attention: Equity Capital Markets, 1271 Avenue of the Americas, 3rd Floor, New York, New York 10020, by telephone at (212) 205-7602 or by email at [email protected]. These documents may also be obtained for free on the SEC’s website located at View Source

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities described herein, nor shall there be any offer, solicitation or sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

On March 25, 2024 Nkarta presented its corporate presentation (Press release, Nkarta, MAR 25, 2024, View Source [SID1234641410]).

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On March 25, 2024 Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, reported a preliminary update on recent clinical activity and expected near term milestones for its lead program MB-106 for the treatment of Acute Myeloid Leukemia (AML) following its Fiscal Year 2023 filing with the Securities and Exchange Commission (Press release, Moleculin, MAR 25, 2024, View Source [SID1234641409]). As previously announced, the Company will host a conference call and live audio webcast, today, March 25, 2024, at 8:30 AM ET (details below).

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"We remain highly encouraged by the positive data seen to-date in our Phase 1B/2 AnnAraC trial for AML," commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. "With a CRc rate of 60% as 2nd line therapy and with 50% of those being full CRs, AnnAraC has the potential to offer 2nd line patients a viable alternative, regardless of prior treatments or mutations. Importantly, we recently visited prominent key opinion leaders in Europe and the U.S. Without exception, they each believe there remains a significant unmet need for 2nd line AML therapies, that our results in 2nd line subjects are significant, and that, if approved, they would use Annamycin in their practice. We are seeing genuine enthusiasm for how Annamycin might change the paradigm."

"Understanding the continuing unmet need in AML is key to understanding Moleculin’s opportunity. It is so key that we created an informative animation of the patient journey to help investors realize our potential in AML. In brief, even though tremendous effort has been focused on targeted therapies in AML and five new drugs have been approved for 2nd line use, they are only expected to result in a positive outcome for about 7% of the total AML population. We believe that leaves nearly 60% of AML patients without a viable path to lasting remission. At the rate indicated by our latest data, Annamycin could more than double the number of 2nd line patients achieving a complete response from all the currently approved targeted therapies combined," added Mr. Klemp.

"Our growing body of data are now propelling our clinical and regulatory strategies toward our next phase of development. We are preparing for an End of Phase 2 meeting with FDA and believe following this meeting we will be in a position to commence a pivotal registration study as a 2nd line therapy in AML before year end," concluded Mr. Klemp.

Ongoing AML Clinical Trial Overview

The Company is currently conducting its Phase 1B/2 clinical trial evaluating Annamycin in combination with Cytarabine (also known as "Ara-C" and for which the combination of Annamycin and Ara-C is referred to as AnnAraC) for the treatment of subjects with AML as both first line therapy and for subjects who are refractory to or relapsed after induction therapy (MB-106). clinicaltrialsregister.eu: EudraCT 2020-005493-10 or clinicaltrials.gov: NCT05319587.

During 2023, Moleculin commenced its MB-106 clinical trial with AnnAraC for the treatment of AML in an all-comers trial, accepting subjects without regard to the number of prior therapies in the Phase 1 portion with a limit of two prior therapies in the Phase 2 portion. Nine clinical sites in Poland and Italy have been activated for the MB-106.

To date, 20 subjects have been enrolled in the full MB106 Phase 1B/2 study with two subjects not yet evaluable. At the end of January 2024, the Company completed recruiting the desired number of 2nd line subjects and began preparation for an End of Phase 2 (EoP2) meeting with the FDA. In addition, Moleculin expanded the MB-106 study protocol to include 1st line subjects to provide data to enable the designing of a potential confirmatory Phase 3 post-approval study, however, do not expect the addition of this cohort to delay the EoP2 meeting. The study has recruited three 1st line subjects to date with one CR and one not yet evaluable.

Moleculin’s current planned pathway for approval for Annamycin in combination with Cytarabine for the treatment of AML is as a 2nd line therapy. Therefore, the focus is primarily on securing an accelerated approval pathway for the treatment of 2nd line subjects (those who were relapsed from or refractory to a 1st line AML therapy, regardless as to whether the subject was deemed "fit" or "unfit"). Moleculin has begun recruiting 1st line subjects into this trial to provide data for a possible future confirmatory Phase 3 clinical trial in 1st line patients.

Summary of MB-106 Data

A summary table of the MB-106 preliminary results, which are subject to change, is shown below. The total CRs in both Phases to date in MB-106 represent a complete response composite (CRc) rate of 39% in all currently evaluable, intent to treat subjects (n= 18) with two additional subjects recruited not yet evaluable. These subjects had 0-6 prior therapies. This is comprised of a CR rate of 33% and CRi of 6%. Durability data are developing with one CRc having relapsed to date. The first CR subject was treated in February 2023 and remains durable after over a year and continues in remission. Durability of CRs is confirmed by repeat bone marrow aspirates (BMAs).The median age of all subjects recruited is 69, ranging from 19 to 78. Median durability will be established as the trial data mature. This trial may enroll up to 28 subjects, however, having already recruited the desired number of 2nd line subjects to support an EoP2 meeting with the FDA, the Company may elect to complete this trial with fewer than 28 subjects.

The trial continues recruitment for treatment as 1st line and 3rd line therapy. Since Moleculin intends to position AnnAraC for approval as a 2nd line therapy, the Company believes that the most important data from this trial are the results in 2nd line subjects (excluding subjects who are either 1st line or 3rd line and beyond). When stratified for that population (n=10), the CRc rate is 60%, being comprised of a CR rate of 50% and a CRi of 10%.

Table 1 – Summary of Annamycin Responses in MB-106 as of March 19, 2024

Study

Study MB-106 Combination Therapy– Phase 1B/2 All Lines (Range 1-7)

Study MB-106Combination Therapy– Phase 1B/2 As 1st Line

Study MB-106Combination Therapy– Phase 1B/2 As 2nd Line Only

All Subjects

Recruited

20

3

10

Subjects Not Yet Evaluable

2

1

0

Subjects Evaluable To Date

18

2

10

Subjects Evaluable Not Dosed Per Protocol

2

0

1

Median Prior Therapies

1

0

1

Median Age – Years (Range)

69 (19-78)

49 (19-69)

71 (53 – 78)

Complete Responses (CR)

6

1

5

CR with incomplete recovery (CRi)

1

0

1

Total Complete Response(s) (CRc)

7

1

6

Complete Response (CR) Rate

33%

50%

50%

Complete Response Composite (CRc) Rate

39%

50%

60%

Partial Responses (PRs)

2

0

1

CRc Relapsed To Date

1

0

1

BMT To Date

1

0

1

Durability of CR

Developing

Developing

Developing

(1,2,3,4)

(2,3,4)

(2,3,4)

Notes for Table 1: 1) The 19th subject, being treated as a 3rd line therapy, had two BMAs tested where they have been inconclusive, and we are awaiting further testing. This subject will move the CRc in the "MB-106 Phase 1B/2 All Lines" column to either 42% or 37% (n=19). The 20th subject is a first-line therapy subject and has just begun treatment; 2) Data from MB-106 is for intent to Treat subjects; 3) Data from MB-106 is preliminary and subject to change; and 4) Durability is developing.

Expected 2024 MB-106 Milestones

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Complete MB-106 Phase 1B/2 clinical trial.

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Present topline data from MB-106 clinical trial.

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Report outcome of MB-106 End of Phase 2 Meeting.

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Initiate pivotal program.

Conference Call and Webcast

Moleculin management will host its quarterly conference call and webcast for investors, analysts, and other interested parties Monday, March 25, 2024, at 8:30 AM ET.

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.