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

●

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

●

Present topline data from MB-106 clinical trial.

●

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

●

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.

Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders, reported financial results for the fourth quarter and full year 2023, as well as corporate and clinical highlights (Press release, Equillium, MAR 25, 2024, View Source [SID1234641407]).

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"The past year we have been focused on clinical execution that has set up the potential milestones we have in front of us in 2024," said Bruce Steel, chief executive officer at Equillium. "The Phase 1b EQUALISE study of itolizumab in patients with lupus nephritis is now complete. We presented positive data from this study at the annual meetings of both ASN and ACR in the fourth quarter last year and we expect to deliver the topline data to our partner Ono in the coming weeks. We expect to announce the results of the interim review by the data monitoring committee of our Phase 3 EQUATOR study of itolizumab in patients with acute graft-versus-host disease in the third quarter, which would represent the final data deliverable to trigger Ono’s option exercise period, which will expire three months following such deliverables. If Ono exercises their option to acquire our rights to itolizumab we would receive an exercise payment of approximately $331 million, which would significantly extend our cash runway beyond the second half of 2025—our current guidance—and we would remain eligible to receive approximately $101 million in additional milestone payments.

"Our lead multi-cytokine inhibitor, EQ101, a first in class, tri-specific inhibitor targeting IL-2, IL-9 and IL-15, has completed enrollment in a Phase 2 study for the treatment of moderate to severe alopecia areata. There remains a large unmet medical need for safer alternatives to JAK inhibitors, which carry black-box warnings and are today the only approved class of drugs to treat alopecia areata patients. This is the first study in which EQ101 has been tested in alopecia areata patients, where we are looking for signs of clinical activity above historically low observed placebo responses. We’re pleased to have completed enrollment of this study and look forward to announcing topline data in the second quarter this year."

"In addition to clinical execution, we have also focused efforts on advancing the rest of our novel multi-cytokine inhibitor programs," said Steve Connelly, chief scientific officer at Equillium. "EQ302, our first-in-class, bi-specific inhibitor of IL-15 and IL-21, is a second-generation peptide with improved potency that is orally deliverable and stable in the gut. We believe this represents a compelling product profile well positioned to target gastrointestinal indications including celiac disease, inflammatory bowel disease, and eosinophilic esophagitis. We look forward to advancing this program towards the clinic."

Option exercise payment is denominated in Japanese yen (5 billion) and subject to currency exchange rates at the time of payment.

Q4 2023 Highlights:

•
Presented positive data from the Phase 1b EQUALISE study of itolizumab in lupus nephritis patients at the annual meetings of both ASN and ACR. The presentations highlighted a well-tolerated safety profile and data that demonstrated high complete and partial response rates with rapid and deep reductions in urine protein creatinine ratios in highly proteinuric patients when itolizumab was added to mycophenolate mofetil and corticosteroids.

•
Hosted an Analyst & Investor Day featuring Arash Mostaghimi, MD, MPA, MPH, associate professor of dermatology at Harvard Medical School, that highlighted Equillium’s pipeline, the multi-cytokine platform and clinical-stage multi-cytokine inhibitors, with a focus on EQ101, currently in a Phase 2 clinical study for moderate to severe alopecia areata.

•
Announced a presentation at the 18th Annual Peptide Therapeutics Symposium highlighting EQ302, a first-in-class, second generation, orally deliverable multi-cytokine inhibitor targeting IL-15 and IL-21. The presentation outlined the origins of EQ302 from its parent peptide and data illustrating that adding hydrocarbon staples to the peptide conferred increased stability in the gastrointestinal tract while retaining its cytokine inhibitory properties.

Anticipated Upcoming Milestones:

•
EQ101: Phase 2 clinical study in subjects with moderate to severe alopecia areata – topline data anticipated in Q2 2024

•
Itolizumab: EQUALISE lupus nephritis topline data to Ono anticipated in the coming weeks; EQUATOR acute graft-versus-host disease interim review anticipated in Q3 2024

•
Ono option exercise decision anticipated in 2H 2024

Fourth Quarter and Full Year 2023 Financial Results

Revenue for the fourth quarter of 2023 was $9.2 million, compared with $15.8 million for the same period in 2022. For the full year of 2023, revenue was $36.1 million, compared with $15.8 million for the full year of 2022. Revenue in 2023 and 2022 consisted entirely of itolizumab development funding and amortization of the upfront payment from Ono resulting from the Asset Purchase Agreement with Ono executed in December 2022, which included such development funding retroactive to the beginning of the third quarter of 2022.

Research and development (R&D) expenses for the fourth quarter of 2023 were $9.2 million, compared with $8.5 million for the same period in 2022. For the full year of 2023, R&D expenses were $37.0 million, compared with $37.5 million for the full year of 2022. The nominal year-over-year decrease in R&D expenses was driven by a decrease in non-clinical research expenses and lower employee compensation and benefits, which were partially offset by increased clinical development expenses, primarily driven by the EQUATOR, EQ101 and EQ102 clinical studies.

General and administrative (G&A) expenses for the fourth quarter of 2023 were $3.2 million, compared with $5.2 million for the same period in 2022. For the full year of 2023, G&A expenses were $13.6 million, compared with $17.2 million for the full year of 2022. The year-over-year decrease was driven by decreased legal expenses primarily related to 2022 business development activities, lower employee compensation and benefits, and lower consulting and general overhead expenses, which were partially offset by greater audit and tax related professional fees.

Net loss for the fourth quarter of 2023 was $2.3 million, or $(0.07) per basic share and diluted share, compared with net income of $2.8 million, or $0.08 per basic and diluted share for the same period in 2022. Net loss for the full year of 2023 was $13.3 million, or $(0.38) per basic and diluted share, compared with a net loss of $62.4 million, or $(1.85) per basic and diluted share for the full year of 2022. The decrease in net loss for the full year of 2023 compared to the full year of 2022 was primarily due to lower operating expenses driven by the non-cash in-process R&D expense related to the acquisition of Bioniz Therapeutics, Inc. in 2022 and lower G&A expenses, greater revenue related to the Ono partnership, greater income on investments, and less interest expense due to the retirement of our former debt facility, which was partially offset by greater income tax expense.

Cash, cash equivalents and short-term investments totaled $40.9 million as of December 31, 2023, compared to $71.0 million as of December 31, 2022. Net cash used in operating activities in the fourth quarter was $5.7 million. Equillium believes that its cash, cash equivalents and short-term investments on the balance sheet as of December 31, 2023, will be sufficient to fund its currently planned operations into the second half of 2025, assuming no further repurchases under our stock repurchase program.

About Multi-Cytokine Platform and Multi-Cytokine Inhibitors EQ101 & EQ302

Our proprietary multi-cytokine platform generates rationally designed composite peptides that selectively block key cytokines at the shared receptor level targeting pathogenic cytokine redundancies and synergies while preserving non-pathogenic signaling. This approach is expected to avoid the broad immuno-suppression and off-target safety liabilities that may be associated with other therapeutic classes, such as Janus kinase inhibitors. Many immune-mediated diseases are driven by the same combination of dysregulated cytokines, and we believe identifying the key cytokines for these diseases will allow us to target and develop customized treatment strategies for multiple autoimmune and inflammatory diseases.

Current platform assets include EQ101, a clinical stage, first-in-class, selective, tri-specific inhibitor of IL-2, IL-9, and IL-15 for intravenous and subcutaneous delivery and EQ302, a preclinical stage, first-in-class, selective, bi-specific inhibitor of IL-15 and IL-21 for oral delivery.

About Itolizumab

Itolizumab is a clinical-stage, first-in-class anti-CD6 monoclonal antibody that selectively targets the CD6-ALCAM signaling pathway to downregulate pathogenic T effector cells while preserving T regulatory cells critical for maintaining a balanced immune response. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases.

On March 25, 2024 CureLab Oncologya clinical-stage biotech company, reported that it has been granted a patent in Canada for its novel biological agent, Elenagen, which has been shown to provide clinical benefits for cancer patients (Press release, CureLab Oncology, MAR 25, 2024, View Source [SID1234641406]). Elenagen belongs to a novel class of biological agents that use supercoiled circular DNA (plasmids) to increase anti-tumor immunity and boost the effectiveness of existing therapies.

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Elenagen has demonstrated a desirable safety profile and a statistically significant clinical benefit for cancer patients by enhancing the anti-cancer effects of chemotherapy. Experimental results also indicate mitigation of chronic inflammation, anti-aging effects, and stimulation of an immune response to a tumor. For example, in a recent study published in Frontiers in Oncology, a research team found that disease progression was significantly delayed in a group of stage III and IV platinum-resistant ovarian cancer patients who received gemcitabine in combination with Elenagen, compared to the group who received gemcitabine alone.

Elenagen addresses an urgent need in Canada

Cancer remains a significant health concern and a substantial economic burden in Canada. Recent studies indicate that in 2021, the total economic cost of cancer in Canada exceeded $26 billion, with a significant portion borne directly by patients and families. These rising costs highlight the urgent need for innovative solutions. The costs of cancer care are highest in the initial treatment period, emphasizing the critical need for advances in prevention and early detection, such as promising vaccine technologies. Elenagen has the potential to alleviate a portion of those costs, while also improving outcomes and quality of life for those affected by cancer.

"For too long, we’ve witnessed the devastating toll cancer takes on Canadian families. Elenagen represents a beacon of hope, moving us closer to a world where a cancer diagnosis doesn’t have to be a devastating sentence," said Alexander Shneider, Ph.D., founder and CEO of CureLab Oncology. "By mitigating the effects of cancer in Canada, we aim to alleviate substantial long-term healthcare costs and improve quality of life for countless patients."

A veterinary version of Elenagen called Elenavet, and the entire IP rights for cancer treatment in dogs, cats and horses has been exclusively licensed by CureLab Oncology to its sister company, CureLab Veterinary Inc. ElenaVet is a gene therapy that enhances the animal’s anticancer immune response. In comparative medicine studies, ElenaVet saved 10 out of 11 dogs with breast cancer and precluded or delayed the metastatic process in dogs with melanoma. Similar results were observed with cats.

About Elenagen
CureLab’s lead investigational compound is code-named Elenagen, an experimental DNA therapy that consists of a circular piece of DNA called a plasmid that includes a gene for a human protein called p62/SQSTM1. In clinical studies conducted ex-US, Elenagen demonstrated desirable safety profile and statistically significant clinical benefit for cancer patients by enhancing the anti-cancer effects of chemotherapy. Experimental results also indicate mitigation of chronic inflammation, anti-aging effects, and stimulation of an immune response to the tumor.

On March 25, 2024, BioXcel Therapeutics, Inc. (the "Company") reported to have entered into a Securities Purchase Agreement (the "Purchase Agreement") with the purchasers named therein (collectively, the "Purchasers") (, BioXcel Therapeutics, MAR 25, 2024, View Source [SID1234641404]). Pursuant to the Purchase Agreement, the Company agreed to issue and sell to the Purchasers in a registered direct offering (the "Offering") an aggregate of 3,054,609 shares (the "Shares") of common stock, par value $0.001 per share ("Common Stock"), and accompanying warrants (the "Accompanying Warrants") to purchase up to 3,054,609 shares of Common Stock at a combined offering price of $2.901 per Share and Accompanying Warrant and pre-funded warrants (the "Pre-Funded Warrants") to purchase up to 5,565,027 shares of Common Stock and Accompanying Warrants to purchase up to 5,565,027 shares of Common Stock, at a combined offering price of $2.900 per share underlying each Pre-Funded Warrant and Accompanying Warrant, which equals the offering price per Share and Accompanying Warrant less the $0.001 exercise price per share of the Pre-Funded Warrants, under an effective shelf registration statement on Form S-3 (File No. 333-275261) and a related prospectus supplement filed with the Securities and Exchange Commission ("SEC") on March 25, 2024 (the "Prospectus Supplement"). The closing of the Offering is expected to occur on or about March 27, 2024, subject to the satisfaction of customary closing conditions. The Pre-Funded Warrants and Accompanying Warrants are not listed on the Nasdaq Capital Market or any other securities exchange or trading system and the Company does not intend to list them.

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The Company expects to receive net proceeds from the Offering of approximately $24.9 million, after deducting estimated offering expenses payable by the Company, and excluding the proceeds, if any, from the exercise of the Pre-Funded Warrants and the Accompanying Warrants sold in the Offering. The Company intends to use the net proceeds from the Offering, together with its existing cash and cash equivalents, to fund planned clinical trials of BXCL501, commercialization activities for IGALMI and for working capital and other general corporate purposes.

The Purchase Agreement contains customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations of the Company and the Purchasers, including for liabilities under the Securities Act of 1933, as amended (the "Securities Act"), other obligations of the parties and termination provisions.

The Pre-Funded Warrants have an exercise price per share of Common Stock equal to $0.001 per share. The exercise price and the number of shares of Common Stock issuable upon exercise of the Pre-Funded Warrants are subject to appropriate adjustments in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the Common Stock. The Pre-Funded Warrants will be exercisable at any time after the date of issuance.

The Accompanying Warrants have an exercise price per share of Common Stock equal to $3.20 per share. The exercise price and the number of shares of Common Stock issuable upon exercise of the Accompanying Warrants are subject to appropriate adjustments in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the Common Stock. The Accompanying Warrants will be exercisable at any time after the date of issuance and will expire on the fifth anniversary of the date of issuance.

Under the terms of the Pre-Funded Warrants and the Accompanying Warrants, a holder will not be entitled to exercise any portion of any such warrant, if, upon giving effect to such exercise, the aggregate number of shares of Common Stock beneficially owned by the holder (together with its affiliates, any other persons acting as a group together with the holder or any of the holder’s affiliates) would exceed 9.99% or 4.99%, respectively, of the number of shares of Common Stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of such warrant, which percentage may be increased at the holder’s election upon 61 days’ notice to the Company subject to the terms of such warrants, provided that such percentage may not exceed 19.99%.

The foregoing descriptions of the Purchase Agreement, Pre-Funded Warrants and Accompanying Warrants are not complete and are qualified in their entirety by reference to the Purchase Agreement and forms of Pre-Funded Warrants and Accompanying Warrants, which are filed as Exhibits 10.1, 4.1 and 4.2, respectively, to this Current Report on Form 8-K (the "Form 8-K") and are incorporated by reference herein.

Latham & Watkins LLP, counsel to the Company, has issued an opinion to the Company, dated March 25, 2024, regarding the validity of the Shares, the Pre-Funded Warrants and the Accompanying Warrants to be issued and sold in the Offering and the shares of Common Stock issuable upon exercise of the Pre-Funded Warrants and the Accompanying Warrants, in each case in accordance with their respective terms. A copy of the opinion is filed as Exhibit 5.1 to this Form 8-K.

This Form 8-K shall not constitute an offer to sell or the solicitation of any offer to buy the securities discussed herein, nor shall there be any offer, solicitation or sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

On March 25, 2024 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported that the company will present at the H.C. Wainwright 2nd Annual Autoimmune & Inflammatory Disease Virtual Conference on Thursday, March 28, 2024, at 2:30 p.m. ET and the 23rd Annual Needham Virtual Healthcare Conference on Tuesday, April 9, 2024, at 10:15 a.m. ET (Press release, BioCryst Pharmaceuticals, MAR 25, 2024, View Source [SID1234641403]).

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Links to the live audio webcasts and replays of the presentations may be accessed in the Investors & Media section of BioCryst’s website at http://www.biocryst.com.