On May 7, 2024 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company, reported financial results for the first quarter ended March 31, 2024 (Press release, Repare Therapeutics, MAY 7, 2024, View Source [SID1234642796]).

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"This was a quarter of clinical progress as we await key, near-term data on a rich set of distinctive clinical approaches for our four wholly-owned compounds in 2024," said Lloyd M. Segal, President and Chief Executive Officer of Repare. "We have agreement with the FDA regarding our recommended Phase 2 dose (RP2D) for our lunresertib plus camonsertib combination, with significantly improved tolerability at the RP2D with our updated dosing schedule. We are seeing continuing trends of patient response and benefit, and we are on track to report the updated dataset in the fourth quarter of 2024. Our objective is to determine the best opportunity for a registrational trial, to start in 2025. Additionally, we are initiating a small clinical trial to rapidly confirm a camonsertib monotherapy signal in non-small cell lung cancer (NSCLC) and expect that readout to be available in 2025. Our clinical portfolio also includes the LIONS trial of our RP-1664 PLK4 inhibitor, the PKMYT1 and WEE1 inhibitor combination in MYTHIC, and the upcoming clinical start of our Polθ inhibitor program, RP-3467, in the second half of 2024."

First Quarter 2024 and Recent Portfolio Highlights:

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Lunresertib (RP-6306)
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On track for a potential registrational trial decision in gynecologic expansion cohorts in the fourth quarter of 2024 based on the Phase 1 expansion in MYTHIC trial evaluating lunresertib in combination with camonsertib in patients harboring CCNE1 amplification or FBXW7 or PPP2R1A deleterious alterations. Grade 3 anemia has been significantly reduced to 25% as of the March 2024 cut-off date in patients treated at the RP2D and updated dosing schedule, from 45% as previously presented at the September 2023 data cut-off date. The U.S. Food and Drug Administration (FDA) has agreed with

the RP2D of lunresertib 80mg BID and camonsertib 80mg QD. Efficacy and tolerability assessment at RP2D is ongoing, and the Company expects to present data from the dose expansion cohorts in patients with ovarian and endometrial cancer in the fourth quarter of 2024.
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First patient was dosed in April 2024 in the Phase 1 MYTHIC clinical trial evaluating lunresertib in combination with Debio 0123, a highly selective, brain-penetrant, clinical WEE1 inhibitor, in advanced solid tumors harboring CCNE1 amplification or FBXW7 or PPP2R1a deleterious alterations. The primary endpoints are safety, tolerability and RP2D, as well as preliminary efficacy of the combination. Repare is expected to report initial data from this trial in 2025.
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Initial data from the Phase 1 MINOTAUR trial evaluating lunresertib in combination with FOLFIRI for the treatment of advanced solid tumors demonstrated no significant incremental toxicities in the combination of lunresertib and FOLFIRI over FOLFIRI alone. In addition, Repare has observed favorable tolerability in colorectal and other gastrointestinal tumors, unlike some other agents combined with irinotecan. This data will be presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Gastrointestinal (GI) Cancers Congress 2024, taking place in Munich, Germany on June 26-29.
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Camonsertib (RP-3500)
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Regained global development and commercialization rights for camonsertib from Roche, effective May 7, 2024. Since inception of the Roche camonsertib collaboration, Repare has earned a cumulative total of $182.6 million from Roche, including the upfront and milestone payments, in addition to certain additional reimbursements from Roche.
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Initiating Phase 2 TRESR expansion in approximately 20 patients with ATM-mutated (ATMm) NSCLC, supported by early, promising camonsertib monotherapy signal in patients with ATMm NSCLC from the ongoing Phase 1/2 TRESR trial. Repare is expected to report initial data in 2025.
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RP-1664
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First patient dosed in the multicenter, open-label Phase 1 dose escalation trial (LIONS) of its polo-like kinase 4 (PLK4) inhibitor, RP-1664, in adult and adolescent patients with TRIM37-high and other biomarkers in February 2024.
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RP-3467
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Initiation of a Phase 1 dose finding trial of RP-3467, a potential best-in-class Polθ ATPase inhibitor, is expected in the second half of 2024.
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Other Highlights
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In March 2024, Bristol-Myers Squibb exercised its one remaining option to in-license an undruggable target for a combined total of five druggable targets and one undruggable target over the course of the collaboration.
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In April 2024, Repare announced the appointment of Steven H. Stein, M.D., Chief Medical Officer of Incyte Corporation, to Repare’s Board of Directors, effective as of June 17, 2024, the date of the Company’s upcoming annual meeting of shareholders (the "Annual Meeting"). The Company also announced that Todd Foley has decided not to stand for re-election as a director of the Company following the end of his current term as a Class I director on the date of the Annual Meeting, after serving more than seven years on the Board.

Summary of Expected Milestones:

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H1 2024
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Initial Phase 1 MINOTAUR (lunresertib + FOLFIRI combination) data to be reported at ESMO (Free ESMO Whitepaper) GI in June 2024
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H2 2024
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Camonsertib monotherapy expansion to NSCLC in TRESR
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Initiation of Phase 1 clinical trial of RP-3467
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Additional data from dose expansion cohorts for the MYTHIC lunresertib + camonsertib combination in ovarian and endometrial cancers by end of Q4 2024
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2025
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Lunresertib + Debio 0123 combination data
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Camonsertib monotherapy data in NSCLC
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Initiate first pivotal trial in an indication for lunresertib + camonsertib
First Quarter 2024 Financial Results:

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Cash, cash equivalents and marketable securities: Cash, cash equivalents and marketable securities as of March 31, 2024 were $237.0 million, as compared to $223.6 million as of December 31, 2023. The Company believes that its cash, cash equivalents, and marketable securities are sufficient to fund its current operational plans at least into mid-2026.
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Revenue from collaboration agreements: Revenue from collaboration agreements was $52.4 million and $5.7 million for the three months ended March 31, 2024 and 2023, respectively. The increase in revenue for the three-month period was primarily due to the $40.0 million Roche milestone achievement in the first quarter of 2024.
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Research and development expenses, net of tax credits (Net R&D): Net R&D expenses were $33.0 million and $31.8 million for the three months ended March 31, 2024 and 2023, respectively. The increase in Net R&D for the three-month period was primarily due to higher direct external costs related to the progress of Repare’s lunresertib clinical program, offset by lower direct external costs of its camonsertib clinical program.
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General and administrative (G&A) expenses: G&A expenses were $8.6 million and $8.5 million for the three months ended March 31, 2024 and 2023, respectively.
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Net income (loss): Net income was $13.2 million, or $0.30 per diluted share, for the three months ended March 31, 2024, and net loss was $34.9 million, or $0.83 per diluted share, for the three months ended March 31, 2023.

On May 7, 2024. Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its novel and proprietary CellFX Nanosecond Pulsed Field Ablation (nsPFA) technology, reported business updates and financial results for the first quarter ended March 31, 2024 (Press release, Pulse Biosciences, MAY 7, 2024, View Source [SID1234642795]).

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Recent Business Highlights

CellFX nsPFA Percutaneous Electrode

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March 2024, received FDA 510(k) clearance for use in the ablation of soft tissue in percutaneous and intraoperative surgical procedures.

CellFX nsPFA Cardiac Clamp

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Remain in the 510(k) process while continuing productive dialogue with FDA regarding the go-forward regulatory path.

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FDA has requested clinical data in support of the regulatory filing and discussions regarding the required clinical data are underway.
● Submitted first-in-human feasibility study to take place at several centers in the Netherlands to the Ethics Committee and anticipate a response in the next several weeks.

CellFX nsPFA 360° Cardiac Catheter

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At the Heart Rhythm Society (HRS) meeting in Boston, May 16th to the 19th, CellFX nsPFA energy will be showcased across 6 poster presentations and abstracts in addition to a live case demonstrating pulmonary vein isolation at the PFA Live Case Summit.

Announcement of Rights Offering

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The Company’s Board of Directors has approved a planned rights offering of up to $60 million worth of units that will be available to all holders of record of the Company’s common stock.

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Company has decided to change the rights offering record date from May 16, 2024 to a date in mid-June. New record date will be announced by the Company once all necessary SEC filings have been completed.
● Assuming the rights offering is fully subscribed at the Initial Price, the Company will receive gross proceeds of up to $60 million, less expenses related to the rights offering, and upon exercise of all the warrants, would receive additional proceeds of up to $66 million. A fully subscribed rights offering would fund the growth plans of the Company into the first quarter of 2026.

"I am incredibly proud of the team’s accomplishments to start the year. Our proprietary CellFX nsPFA energy has demonstrated the potential to advance the standards of care for both soft tissue ablation and the treatment of atrial fibrillation. FDA clearance of the CellFX nsPFA Percutaneous Electrode System along with the posters, abstracts and a live case highlighting the CellFX nsPFA 360° Cardiac Catheter at HRS next week are early validations of our technology and its potential," said Kevin Danahy, President and Chief Executive Officer of Pulse Biosciences. "We remain focused on delivering the benefits of CellFX nsPFA to patients and providers following further clinical evaluations and regulatory clearances. For the remainder of the year, we are focused on executing our CellFX nsPFA percutaneous electrode pilot program to initiate the commercial launch and, all the while, continuing to advance the clinical and regulatory work with our CellFX nsPFA Surgical Clamp and 360° Cardiac Catheter."

First Quarter 2024 Financial Results

Total GAAP costs and expenses, representing research and development and general and administrative expenses, for the three months ended March 31, 2024, were $10.6 million compared to $9.6 million for the prior year period. The increase in GAAP costs and expenses was primarily driven by an increase in non-cash stock-based compensation expense, which was $1.8 million for the three months ended March 31, 2024, compared to $0.9 million for the prior year period. The remaining increase in costs and expenses compared to the prior year was driven by an increase in research and development expenses to support the development of the CellFX nsPFA product portfolio. Non-GAAP costs and expenses for the three months ended March 31, 2024, were $8.6 million, compared to $8.3 million for the prior year period.

GAAP net loss for the three months ended March 31, 2024 was ($10.1) million compared to ($9.8) million for the three months ended March 31, 2023. Non-GAAP net loss for the three months ended March 31, 2024 was ($8.1) million compared to ($8.6) million for the three months ended March 31, 2023.

Cash and cash equivalents totaled $34.9 million as of March 31, 2024, compared to $54.1 million as of March 31, 2023 and $44.4 million as of December 31, 2023. Cash used in the first quarter of 2024 was $9.5 million compared to $7.2 million in the same period in the prior year and $6.9 million used in the fourth quarter of 2023. The sequential quarterly increase was driven mainly by $2.0 million in 2023 annual cash bonus payouts.

Reconciliations of GAAP to non-GAAP cost and expenses and net loss have been provided in the tables following the financial statements in this press release. An explanation of these measures is also included below under the heading "Non-GAAP Financial Measures."

Webcast and Conference Call Information

Pulse Biosciences’ management will host a conference call today, May 7, 2024, beginning at 1:30pm PT. Investors interested in listening to the conference call may do so by dialing 1-877-704-4453 for domestic callers or 1-201-389-0920 for international callers. A live and recorded webcast of the event will be available at View Source

On May 07, 2024 OPKO Health, Inc. (NASDAQ: OPK) reported business highlights and financial results for the three months ended March 31, 2024 (Press release, Opko Health, MAY 7, 2024, View Source [SID1234642794]).

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First quarter business highlights include the following:

Entered into an agreement with Labcorp to sell select assets of BioReference Health. The transaction includes the sale of BioReference Health’s laboratory testing businesses focused on clinical diagnostics and women’s health, excluding operations in New York and New Jersey, for $237.5 million. These assets comprise patient service centers, certain customer contracts and operating assets, which account for approximately $100 million in annualized revenue. BioReference Health will continue to offer oncology and urology diagnostic services nationwide, as well as maintain its full operations in New York and New Jersey. This transaction is expected to streamline BioReference Health’s laboratory services business while retaining its core operations to better position the division for sustained growth and profitability. The transaction is subject to customary closing conditions and applicable regulatory approvals, including under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended. The transaction is anticipated to close in the second half of 2024.

The IND application for MDX2001, a tetraspecific antibody for the treatment of solid tumor cancers, received FDA clearance. MDX2001 is designed to optimize T-cell function while preventing tumor antigen escape. The first patient is expected to be enrolled in a Phase 1 trial to evaluate safety, tolerability, pharmacokinetics and anti-tumor activity in the second quarter of 2024.

The global launch of NGENLA is ongoing by OPKO’s partner, Pfizer. NGENLA is approved in over 50 countries including the U.S., Japan, EU Member States, Canada and Australia. OPKO is entitled to gross profit sharing based on sales of both NGENLA and Pfizer’s daily growth hormone product, Genotropin. In addition, OPKO is entitled to an additional $100 million in potential milestone payments associated with approvals for an adult indication for growth hormone deficiency and additional pediatric indications.
First Quarter Financial Results

Pharmaceuticals: Revenue from products in the first quarter of 2024 were $38.1 million compared to $40.4 million in the first quarter of 2023, resulting from lower sales in OPKO’s international operating companies and foreign currency exchange fluctuations, partially offset by an increase in sales of Rayaldee to $6.9 million from $6.6 million. Revenue from the transfer of intellectual property and other was $8.7 million in the first quarter of 2024 compared with $64.8 million in the 2023 period, which included $5.6 million in gross profit share and royalty payments for NGENLA and Pfizer’s Genotropin in the 2024 quarter compared with $3.1 million in the same period for 2023. The decrease in revenue from the transfer of intellectual property and other is primarily attributable to one-time milestone payments received in 2023 including a $50.0 million upfront payment from Merck, a $7.0 million milestone payment from Vifor Fresenius Medical Care Renal Pharma triggered by the German price approval for Rayaldee and a $2.5 million milestone payment from Nicoya Therapeutics for the submission of its IND application for Rayaldee to China’s Center for Drug Evaluation. Total costs and expenses declined to $74.5 million in the first quarter of 2024 from $86.3 million in the prior-year period primarily due to a $10.6 million, or 33%, decrease in research and development expense as the 2023 period included a non-recurring payment to Sanofi related to our Merck collaboration, partially offset by increased activity within our ModeX development programs. Operating loss was $27.7 million in the first quarter of 2024 compared with operating income of $19.0 million in the first quarter of 2023, again with 2023 benefiting from over $59 million in milestones as described above.

Diagnostics: Revenue from services in the first quarter of 2024 was $126.9 million compared with $132.4 million in the prior-year period, with the decline primarily due to lower clinical testing volume. Total costs and expenses were $161.3 million in the first quarter of 2024 compared with $172.4 million in the first quarter of 2023, reflecting the continued implementation of cost-reduction initiatives. Included in first quarter 2024 results were revenue from services of approximately $27.8 million and total costs and expenses of approximately $34.8 million related to assets being acquired by Labcorp. Operating loss was $34.4 million in the first quarter of 2024 compared with $40.0 million in the 2023 period.

Consolidated: Consolidated total revenues for the first quarter of 2024 were $173.7 million compared with $237.6 million for the comparable period of 2023. Operating loss for the first quarter of 2024 increased to $71.5 million from $30.6 million for the 2023 quarter, with the 2023 quarter benefiting from the non-recurring license payments described above totaling $59.5 million. First quarter 2024 results included a non-cash, non-recurring expense of $26.3 million related to an embedded derivative as part of our convertible debt. In addition, both periods benefited from the increase of GeneDx’s stock price of $22.7 million and $8.3 million, respectively, for 2024 and 2023. As a result, net loss for the first quarter of 2024 was $81.8 million, or $0.12 per share, compared with $18.3 million, or $0.02 per share, for the 2023 quarter.

Cash and cash equivalents: Cash and cash equivalents were $75.6 million as of March 31, 2024. In January, OPKO completed the sale of $230.0 million aggregate principal amount of 3.75% Convertible Senior Notes due 2029 and exchanged approximately $144.4 million of the Company’s outstanding 4.50% Convertible Senior Notes due 2025. The Company used approximately $50.0 million of the net proceeds to repurchase shares of the Company’s common stock from purchasers of the notes. Additionally, OPKO issued and sold approximately $71.1 million aggregate principal amount of its 3.75% Convertible Senior Notes due 2029 to several holders, including Company affiliates, in exchange for the outstanding 5% Convertible Promissory Notes and accrued interest.
Conference Call and Webcast Information

OPKO’s senior management will provide a business update, discuss first quarter financial results, provide financial guidance and answer questions during a conference call and live audio webcast today beginning at 4:30 p.m. Eastern time. Participants are encouraged to pre-register for the conference call here. Callers who pre-register will receive a unique PIN to gain immediate access to the call and bypass the live operator. Participants may register at any time, including up to and after the call start time. Those unable to pre-register may participate by dialing 833-630-0584 (U.S.) or 412-317-1815 (International). A webcast of the call can also be accessed at OPKO’s Investor Relations page and here.

A telephone replay will be available until May 21, 2024 by dialing 877-344-7529 (U.S.) or 412-317-0088 (International) and providing the passcode 6926223. A webcast replay will be available beginning approximately one hour after the completion of the live conference call here.

On May 7, 2024 Nuvectis Pharma reported its quarterly results for 2024 (Press release, Nuvectis Pharma, MAY 7, 2024, View Source [SID1234642793]).

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On May 7, 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 the presentation of positive interim data for Annamycin from its ongoing acute myeloid leukemia (AML) clinical development program (Press release, Moleculin, MAY 7, 2024, View Source [SID1234642792]). As previously announced, the Company will host a virtual AML Clinical Day, today, May 7, 2024, at 11:00 AM ET (details below) to discuss these results.

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"Adding the latest two subjects in MB-106 AML trial with AnnAraC brings the composite complete remission (CRc) rate up from 37% to 45% for all of the 20 subjects with prior therapies ranging from none to six. This adds to our growing body of positive data which continues to provide a clear line of sight for our clinical and regulatory strategies towards registration for Annamycin in AML," commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. "Focusing on 2nd line subjects, a CRc rate of 60% 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. While we believe that the full trial results are impressive, we continue to believe that our results in 2nd line subjects, where there is a significant unmet need, are exceptional and believe the CRc rate demonstrated by AnnAraC in 2nd line patients substantially exceeds the performance reported by any drug currently approved for use in 2nd line AML."

"We continue to progress our preparations 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 early next year," added 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 clinical trial.

To date, 20 subjects have been enrolled in the full MB-106 Phase 1B/2 study. The median durability of remission (DoR) is 4.9 months and climbing. DoR is defined as the time from initiation of treatment to the point of disease relapse or death. 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 for the added indication of 1st line subjects, however, the Company does not expect the addition of this cohort to delay the EoP2 meeting. The study has recruited three 1st line subjects to date with two achieving CRs.

Moleculin’s current planned pathway for initial NDA approval indication 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 of whether the subject was deemed "fit" or "unfit" for intensive chemotherapy). Moleculin continues to recruit 1st line subjects into MB-106 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 is shown below. These subjects had 0-6 prior therapies. The preliminary data for MB-106 demonstrate a CRc rate of 45% and an overall remission rate (ORR) of 55% for all subjects, regardless of the number of prior treatments (N=20). Segmenting the MB-106 subject population for 1st line (N=3) and, most notably, 2nd line (N=10) therapies in the trial, yields a CRc rate of 67% and 60% and an ORR of 67% and 70%, both respectively.

Median durability for MB-106 is 4.9 months and climbing with one death (suspected to be related to pneumonia) and one relapse to date out of the 9 CRcs. The first subject with a CRc (and who has yet to relapse) was treated in February 2023. 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 updated 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 initial 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). All data from MB-106 are interim, preliminary, and subject to change until a clinical trial report is published.