BioXcel Therapeutics Inc (BTAI)

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Double bottom setup. $18.50 first target if it goes. 19M float with 20% short. GLTA $BTAI

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nice chart
broke through the downtrend

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blame H.C. Wainwright for Tuesday decline
They lowered the Buy from $134 to $110
At their conference Tuesday, management said expect revenue beginning in very early Q3. However Analyst expected revenue in Q2, although low.

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EMA Paediatric Investigation Plan modification approved this week

That should grease skids for EMA marketing authorization application for Igalmi in adults.

https://www.investorvillage.com/uploads/87669/files/agenda-pdco-agenda-May-2022-meeting.pdf

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BioXcel's Igalmi: Potential Market For Acute Agitation In Esquizofrenia And Bipolar Patients

https://seekingalpha.com/article/4512819-bioxcels-igalmi-potential-acute-agitation-esquizofrenia-bipolar

May 18, 2022 9:20 AM ETBioXcel Therapeutics, Inc. (BTAI)1 Comment3 Likes
Summary

BioXcel begins a new stage with IGALMI in the commercialization process.
With a current market cap of just $300 million, I think BioXcel offers an excellent investment opportunity right now.
I believe that BioXcel could reach a capitalization of between $1 billion and $1.5 billion without much trouble in the coming months.

BioXcel's Igalmi (dexmedetomidine oral film) was approved by the FDA on April 5 to treat acute agitation in patients with Schizophrenia and Bipolar syndrome. It is the first drug that BioXcel (NASDAQ:BTAI) manages to bring to market in its history. And most likely it will not be the only one, since the Company is currently conducting phase III trials with the same molecule (BXCL501) for another indication: Acute agitation in patients with Dementia and Alzheimer's, and the expectations are very good thanks to the very good results archived so far. As it is the first drug that BioXcel brings to the market, and there is no other similar drug to treat acute agitation in patients with Schizophrenia and Bipolar syndrome (there is only ADASUVE, but due to restrictive labeling, its sale potential is very limited), it is difficult to make a first estimate of the sales potential that IGALMI presents for this indication. In any case, we have some key data (number of annual attacks of agitation in this type of patient, the selling price of IGALMI, etc) thanks to which we can make a rough estimate of the revenue potential that IGALMI could have in the next years. What is interesting here is that, as I have already mentioned, the same drug is currently being tested for another indication (acute agitation in patients with Dementia and Alzheimer's), with exceptional results so far in terms of efficacy and safety profile, so if everything continues as planned (phase III top-line data are expected at the end of this year 2022), it would be expected to be approved for the first half of 2023. And the potential revenue for this last indication is between 4 and 6 times higher than the indication recently approved by the FDA.

What does this mean? Well, the initial sales of IGALMI in the coming quarters can give us an idea of the possible future revenue it will have once it is approved for the other indication (Dementia and Alzheimer's). In that sense, I think the first few quarters of sales growth will be slow, which is normal for any drug approved in its first few quarters, and within a few quarters is when I expect big sales growth.

BioXcel's share price has not stopped falling in recent weeks, practically at the same level as the entire Biotech sector. The inflation scenario and the latest rate hike by the Fed have made the markets nervous, reacting in a very exaggerated and bearish way. Many biotech companies are currently trading very undervalued. And it is precisely in this type of situation when you have to remain calm and take the opportunity to buy at really cheap prices knowing how to choose good companies with good fundamentals and a good cash position, because sooner or later purchases will return to the market, and these companies will be the ones that rise the most. BioXcel belongs to this group of companies.

The Company currently has a market capitalization of approximately $300 million. As we will see later, this capitalization implies a great undervaluation of BioXcel concerning IGALMI's revenue potential for the two indications that I have commented on previously. And all this without taking into account the other branch of its Pipeline: Oncology, with the candidate drug BXCL701, which is showing very promising efficacy in early phase trials to treat cancer resistant to first-line treatments. Therefore, I believe that BioXcel presents an unbeatable medium/long-term investment opportunity at current prices.
The potential market of IGALMI in Schizophrenia and bipolar Syndrome indication

BXCL501 will be marketed under the brand name IGALMI to treat acute agitation in patients with Schizophrenia and Bipolar syndrome. The initial date planned to start its commercialization is next May 24. The target will be patients who come to the hospital with agitation attacks. Subsequently, the Company plans to expand the use of IGALMI to other non-hospital settings. According to data provided by the Company, it is estimated that some 25 million attacks of agitation occur annually in patients of this type. Of all of them, about two-thirds are treated in hospitals. This gives us an initial patient target of around 16.5 million annually in the US.

What percentage of market penetration will IGALMI be able to take in the next 5 years?

This is a big question and difficult to answer. Currently, and as we have mentioned before, there is no drug specifically approved to treat this indication, except for ADASUVE, which, due to its restrictive labeling (many side effects), I practically do not consider to be a competitor for IGALMI. Until now, injectable or oral antipsychotics have been used to treat agitation in these patients, with many unpleasant side effects. There are also benzodiazepines (sedatives), which also have many side effects. Therefore, IGALMI is presented as a novel drug in this type of indication, highly effective and very safe, since it has practically no side effects. The FDA only recommends that its administration should be done under the supervision of a "health care provider", that is, any person in the health sector (doctors, nurses, caregivers, etc.), who can control blood pressure after administration. This is because a small percentage of patients in trials have experienced mild hypotension. The important thing here is that the FDA does not require the administration of IGALMI in a health facility, but rather that it can be administered even at home with the supervision of any health personnel, nurse, etc. This allows BioXcel to expand potential sales in the future. As it is the first drug to be commercialized by BioXcel, and as a small biotech company, without the commercial muscle of the big biopharmaceuticals, market penetration is expected to be slow and peak in the coming years. In my previous article, I estimated a maximum market penetration rate of 10%. I did this with a sale price of $150 per IGALMI film. We now know that BioXcel has lowered the selling price to $105 per film. Practically 33% lower than my first estimate. The Company argues in favor of this lower price that, after carrying out market studies, it is the best price to optimize sales. It is clear that the lower the price, the greater the demand. In fact, some analysts skeptical about IGALMI's commercial future argued that $150 was too expensive, since the alternative (antipsychotics and benzodiazepines can be found much cheaper). That's why I think the decision to lower the price is correct. In my estimation model of IGALMI's potential future revenues for this indication, I am going to increase the % of market penetration after the price reduction, up to 13%. I raise it by 30% (I calculated 10% initially) to compensate for the 33% reduction in the initial price of IGALMI.

So we have a peak annual potential revenue in the United States of:

16.6 millionX13%X$105=$226.59 million (This figure is based on very conservative numbers). Using a P/S ratio of 4 (before the interest rate increase I used to use a P/S ratio of 5, but I have now lowered it to 4 to reflect the greater future revenue discount due to higher rates), we get a value of $906.36 million.

This last figure would be an estimate only of the IGALMI value for the newly approved indication. As can be seen, a much higher value than BioXcel's current market capitalization (approximately $300 million). We will have to be attentive to the initial sales figures that will be reported from IGALMI during the second half of this year 2022. I expect slow (barring surprise) initial growth for later quarters this year 2022, and further sales growth for the next year 2023 once the commercial teams are up and running and Igalmi is better known.

For the other indication, Acute Agitation in Dementia and Alzheimer's patients, the expected revenue potential would be at least 4-5 times higher. This is because it is estimated that in the United States there are around 100 million attacks on this type of patient each year. And the figure continues to grow due to the high prevalence of Dementia and Alzheimer's in the most developed countries. Therefore, we would be talking about a peak potential annual revenue of approximately $1 billion. All this helps us to highlight the great potential for revaluation that BioXcel currently presents.
Risks

As with any biotech company, investors should consider some risks that could cause the share price to decline:

1- The Company intends to publish in the coming weeks the results of phase II of 40mg and 60mg to treat agitation in patients with Dementia and Alzheimer's. Although the expectations are very promising, there is always the risk that the results will not be as expected.

2- IGALMI's initial sales figures are lower than expected. This is the main risk I currently see. In any case, and as I have already mentioned, my very cautious estimate of maximum potential revenue is $226 million. And I have already commented that it would not be strange to see slow initial growth in sales, to then grow progressively at a higher rate once Igalmi will be best known.

3- Regarding a possible offering, I see it as very unlikely, after the agreement that the Company has recently signed with Qatar Investments under which BioXcel can use up to $260 million in the financing, which is added to the almost $200 million in cash that was reported in the last Q4 ER, allow the Company to finance its operations until at least 2024.
Conclusion

BioXcel begins a new stage with IGALMI in the commercialization process. My very conservative estimate of peak revenue for the indication of acute agitation in patients with Schizophrenia and Bipolar Syndrome is about 225 million dollars per year. For the other indication (Dementia and Alzheimer's) that figure should be 4 or 5 times higher due to the high prevalence of these diseases in more developed countries. For both indications, the annual peak revenue potential would be above $1.2 billion, which after applying a P/S ratio of 4x, would justify a long-term market capitalization of $4.8 billion. I believe that BioXcel could reach a capitalization of between $1 billion and $1.5 billion without much trouble in the coming months given the huge revenue potential of BXCL501 for both indications (acute agitation in patients with Schizophrenia+Bipolar disorder and Dementia+ Alzheimer's disease). With a current market cap of just $300 million, BioXcel offers an excellent investment opp

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$BTAI CG Target $75. Predicts Alzh Dementia irritability success. Sees successful Institutional launch. Increases peak sales estimate ~50% ($934MM from $627MM) TAKEOVER CANDIDATE given approved neurology product scarcity.

$BTAI CG Target $75. Predicts Alzh Dementia irritability success. Sees successful Institutional launch. Increases peak sales estimate ~50% ($934MM from $627MM) TAKEOVER CANDIDATE given approved neurology product scarcity. pic.twitter.com/rh9h7kjT8Q

— The Godfather Knows Best (@mojoblt) May 12, 2022

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BioXcel Therapeutics price target lowered to $71 from $125 at Truist

[realfast95]

Thanks for posting the transcript.
It appears that the pricing of $105 didn't go over well. I think it had $150 expectations.
So we may see a lot more lowering of targets from the analysts.

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Conference call transcript - pricing info

https://www.investorvillage.com/uploads/87669/files/BioXcel-CC-transcript-5-9-22.pdf

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Guggenheim maintained BTAI coverage with a Buy rating and $30 price target

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BioXcel Therapeutics Reports First Quarter 2022 Financial Results and Recent Operational Highlights
May 09 2022 - 07:00AM


BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a commercial-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced its financial results for the first quarter ended March 31, 2022 and provided an update on key strategic initiatives.

“2022 has already been a transformative year during which we have made monumental progress on our journey to become the leading AI-enabled neuroscience company. Our recent achievements across our clinical, business, and commercial priorities, highlighted by our first FDA approval of IGALMI, have positioned us to realize our 2022 goals and beyond,” said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. “Building on this momentum, we are excited to launch IGALMI, advance our proven technology, and continue delivering innovative medicines to patients and caregivers.”

Company Highlights

Neuroscience Franchise

IGALMI™ Approval and Commercial Launch

IGALMI was approved by the FDA on April 5, 2022 for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.1 Within these two patient populations in the U.S., up to 25 million agitation episodes occur each year.2-4

The Company is focused on the following key commercial launch activities to provide access to patients and caregivers:

Institutional Sales Force: Seasoned sales specialists were onboarded, undergoing training, and will be deployed for launch. The team has an average of over 21 years of industry experience, 14 years in hospital settings, and 8 product launches.
Launch meeting to be held in mid-May in preparation for national salesforce deployment on May 23rd across priority regions and customers.
Market Access Team: Currently engaging with group purchasing organizations (GPOs) and high value Integrated Delivery Networks (IDNs).
Trade Launch: Product load into distribution channels in Q3 2022.

Clinical Pipeline

BXCL501, a proprietary, sublingual film formulation of dexmedetomidine, is being investigated in multiple neuropsychiatric conditions. BXCL501 has received Breakthrough Therapy and Fast Track designation for the acute treatment of agitation associated with dementia.

Indication Expansion

Alzheimer’s Disease-related Agitation: TRANQUILITY program designed to maximize BXCL501 opportunity to treat Alzheimer’s Disease-related agitation. There are an estimated 100 million agitation episodes in Alzheimer’s patients occurring in the U.S. annually.5
TRANQUILITY II: First patient dosed; top-line data readout in Q4 2022/early Q1 2023.
TRANQUILITY III: Trial underway with enrollment initiating in 2H 2022.
Selection of 40 mcg and 60 mcg dosing regimens in pivotal trial supported by breakthrough designation from the FDA, along with positive efficacy, safety, and tolerability data observed in 100 patients in the Phase 1b/2 TRANQUILITY trial and a recent study of BXCL501 40 mcg.
Adjunctive Treatment for Major Depressive Disorder (MDD): Initiated Phase 1 multiple ascending dose trial in healthy volunteers.

Geographic Expansion

Marketing Authorization Application: Submission to the European Medicines Agency (EMA) for BXCL501 for acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults in 2Q 2022.
Japan Entry: Company exploring market entry strategies to expand access of IGALMI to patients in Japan.

OnkosXcel Therapeutics

Established OnkosXcel Therapeutics as a wholly owned subsidiary to focus on the sustained expansion and optimization of the Company’s immuno-oncology (I-O) franchise, including its most advanced I-O program, BXCL701. BXCL701 is an investigational, orally administered, systemic innate immune activator in development for the treatment of aggressive forms of prostate cancer and advanced solid tumors that are refractory or treatment naïve to checkpoint inhibitors.

Metastatic Castration-Resistant Prostate Cancer (mCRPC) Program: Following positive Phase 2 data for BXCL701 in combination with KEYTRUDA® (pembrolizumab) announced this past February, continued ongoing Phase 2 trial in mCRPC patients with either small cell neuroendocrine carcinoma (SCNC) or adenocarcinoma phenotype.
Expect to complete enrollment of 28-patient SCNC cohort in 2H 2022.
First patient enrolled in adenocarcinoma randomized trial expansion evaluating BXCL701 monotherapy vs. BXCL701-KEYTRUDA combination therapy.

Solid Tumors Program (Checkpoint Naïve and Refractory): Additional efficacy data from MD Anderson-led open-label Phase 2 basket trial of BXCL701 and KEYTRUDA is expected in 2H 2022.

Strategic Financing

Announced $260 Million Strategic Financing with Oaktree and Qatar Investment Authority: Full execution of this financing would extend the Company’s cash runway into 2025 to support the commercial launch of IGALMI and achieve key clinical and regulatory milestones.

First Quarter 2022 Financial Results

Research and Development Expenses: Research and development expenses were $18.6 million for the first quarter of 2022, compared to $14.7 million for the same period in 2021. The increased expenses were primarily attributable to clinical trial costs related to the Company’s TRANQUILITY program.

General and Administrative Expenses: General and administrative expenses were $12.9 million for the first quarter of 2022, as compared to $11.6 million for the same period in 2021. The increase was primarily due to personnel and costs related to the commercial launch readiness efforts for IGALMI in the U.S.

Net Loss: BioXcel Therapeutics reported a net loss of $31.5 million for the first quarter of 2022, compared to a net loss of $26.4 million for the same period in 2021.

As of March 31, 2022, cash and cash equivalents totaled approximately $200 million. This excludes contributions from the $260 million strategic financing announced in April. To date the Company has drawn $70M of the loan agreement and has met the milestone to receive $30M of the royalty financing which is expected to be drawn in the second quarter of 2022.

Conference Call

BioXcel Therapeutics will host a conference call and webcast May 9, 2022, at 8:30 a.m., ET, to discuss its first quarter 2022 financial results and provide an update on recent operational highlights. To access the call, please dial 877-407-5795 (domestic) and 201-689-8722 (international). A live webcast of the call will be available on the Investors section of the BioXcel website, www.bioxceltherapeutics.com, and a replay of the call will be available through August 9, 2022.

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BioXcel Therapeutics reports Q1 EPS ($1.12), consensus ($1.15)

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Presentation Details:

Event: BofA Securities 2022 Healthcare Conference*

Date: Thursday, May 12, 2022

Time: 11:00 AM ET / 8:00 AM PT

Event: UBS Global Healthcare Conference 2022*

Date: Monday, May 23, 2022

Time: 10:00 AM ET

Event: H.C. Wainwright Global Investment Conference

Date: Wednesday, May 25, 2022

Time: 3:00 PM ET

To access live webcasts of the fireside chats and presentation, and any accompanying presentation materials, please visit "News/Events" within the Investors & Media section of the Company's website at www.bioxceltherapeutics.com beginning 15 minutes prior to the start time of the presentation. A replay of the webcast will be available on the Company's website following the event.

*Fireside chat format

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BioXcel Therapeutics Announces First Patient Dosed in TRANQUILITY II Phase 3 Trial for Acute Treatment of Agitation in Patients with Alzheimer’s Disease
May 03 2022 - 07:00AM


BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a commercial-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced the first patient has been dosed in the Phase 3 TRANQUILITY II study of BXCL501, the Company’s proprietary, orally dissolving thin film formulation of dexmedetomidine, for the acute treatment of agitation in patients with Alzheimer’s disease (AD). The pivotal Phase 3 TRANQUILITY program includes two studies, TRANQUILITY II and TRANQUILITY III, which are designed to evaluate the safety and efficacy of BXCL501 in adults 65 years and older in assisted living or residential facilities and nursing homes.

“There are an estimated 100 million agitation episodes annually in the U.S. associated with Alzheimer’s disease1, which have a devastating impact on patients and their caregivers,” said Robert Risinger, M.D., Chief Medical Officer of BioXcel Therapeutics. “We believe the recent FDA approval of BXCL501 for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults has laid a strong foundation for pursuing this Alzheimer’s-related agitation program to potentially address this debilitating symptom for patients. Importantly, we are also expanding TRANQUILITY II to more than 10 clinical trial sites in the U.S. and with no current FDA approved treatments for agitation associated with this disease, we are making strong and swift efforts to potentially bring BXCL501 and its proven ability to address agitation to this large market.”

The Company’s decision to continue the evaluation of both the 40 and 60 mcg dosing regimens in the TRANQUILITY II and III pivotal trials is further supported by results from a recent 46 patient, multicenter, placebo-controlled study evaluating the efficacy, safety and tolerability of BXCL501 40 mcg dose in patients with agitation associated with dementia. Previously, BXCL501 was granted Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the acute treatment of agitation associated with dementia. BXCL501 demonstrated statistically significant reductions in agitation measures with both the 30 and 60 mcg doses as measured by multiple scales with no severe or serious adverse events.

[lettruthringout]

New journal publication

https://pubmed.ncbi.nlm.nih.gov/35477628/

Abstract
Episodes of acute agitation associated with psychiatric disorders are often managed in emergency and inpatient settings. These trials evaluated the efficacy, safety, and tolerability of dexmedetomidine orally dissolving film (ODF), an investigational treatment for acute agitation associated with schizophrenia (SERENITY I) or bipolar disorder (SERENITY II). Dexmedetomidine ODF is a highly selective agonist of alpha 2 adrenergic receptors that modulate norepinephrine release from the locus coeruleus. Two randomized, double-blind, placebo-controlled Phase 3 trials in 15 U.S. sites included participants aged 18 to 75 with acute agitation and a DSM-5 diagnosis of schizophrenia or schizoaffective disorder (Serenity I) or bipolar disorder I or II (Serenity II). Agitation was defined as ³14 on the Positive and Negative Syndrome Scale-Excited Component (PEC) at screening and baseline, and ³4 on at least 1 of the 5 PEC items (poor impulse control, tension, hostility, uncooperativeness, and excitement) at baseline. Randomization was 1:1:1 to dexmedetomidine ODF 120 or 180 mcg or matching placebo. All participants self-administered study drugs. For persistent or recurrent agitation after 2 hours, investigators could redose a half-dose. The primary endpoint was changed from baseline in PEC total at 2 hours. The secondary endpoint was the earliest time at which a statistically significant separation from placebo occurred.A total of 380 patients were randomized in each trial (N = 760). All doses of dexmedetomidine ODF met the primary endpoint of change from baseline in PEC at 2 hours vs placebo (P < .001). Statistically significant improvement in PEC occurred as early as 20 minutes with the 180 mcg dose in both trials. A second (half-strength) dose was given to 10 (4.0%) participants in the 180 mcg groups, 34 (13.3%) in the 120 mcg groups, and 58 (23.0%) in the placebo groups in Serenity 1 and Serenity 2. There were no drug-related serious or severe TEAEs in either trial. No participant was unarousable by the Agitation and Calmness Evaluation Scale. For dexmedetomidine 180 mcg, 120 mcg, and placebo, the incidence of TEAEs was 37.3%, 39.5%, and 15.1% in Serenity 1 and 35.7%, 34.9%, and 17.5% in Serenity 2. Somnolence was the most common TEAE in both trials (22% Serenity I; 21% Serenity 2). Of 110 somnolence reports, 75% were mild and 25% moderate. In 2 Phase 3 trials, the investigational treatment, dexmedetomidine ODF, effectively treated acute agitation associated with schizophrenia or bipolar disorder, with onset of action as early as 20 minutes at the 180 mcg dose. Both doses of dexmedetomidine ODF produced a calming effect without unarousable sedation. Mild or moderate somnolence was the most common AE. Dexmedetomidine ODF is a selective alpha-2 adrenergic receptor agonist that allows self-administration, making it a potential addition to noninvasive treatments for acute agitation associated with schizophrenia or bipolar disorder.

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associated with projects that were ended
Unfairly imo

https://www.evaluate.com/vantage/articles/news/deals/bad-day-molecular-partners

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article

https://psychnews.psychiatryonline.org/doi/10.1176/appi.pn.2022.05.5.10#.YmqRvVyReCk.twitter

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Earnings May 9th
BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a commercial-stage biopharmaceutical company utilizing artificial intelligence (AI) approaches to identify and develop transformative medicines in neuroscience and immuno-oncology, today announced that it will release its first quarter 2022 financial results on Monday, May 9, 2022 before the open of the U.S. financial markets. BioXcel Therapeutics’ management team will also host a conference call and webcast at 8:30 AM ET to discuss the Company’s financial results and to provide a general business update.
Conference Call & Webcast Details

Date/Time:
Domestic:
International:

Monday, May 9, 2022 at 8:30 AM Eastern Time
877-407-5795
201-689-8722

The webcast and the accompanying materials will be accessible* under "News/Events" on the Investors & Media page of the Company's website at www.bioxceltherapeutics.com.

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$BTAI Yesterday Canaccord Genuity reaffirmed their buy rating on shares of BTAI and $84 price target.

$BTAI Yesterday Canaccord Genuity reaffirmed their buy rating on shares of BTAI and $84 price target. pic.twitter.com/aTv3TF0PQB

— Antonio Costa (@ACInvestorBlog) April 26, 2022

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Chart
Bullish engulfing

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is it safe?

[lettruthringout]

EMA meeting this week for Igalmi PIP.

Discussions on Modification of an Agreed Paediatric Investigation Plan

https://www.ema.europa.eu/en/documents/agenda/agenda-pdco-agenda-19-22-april-2022-meeting_en.pdf

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BioXcel forms oncology subsidiary to free up neuroscience focus

https://www.thepharmaletter.com/article/bioxcel-forms-oncology-subsidiary-to-free-up-neuroscience-focus

At the same time as announcing strategic financing agreements worth $260 million, USA-based BioXcel Therapeutics (Nasdaq: BTAI) has revealed the formation of wholly-owned subsidiary OnkosXcel Therapeutics to develop transformative medicines in oncology.

OnkosXcel is focused on the sustained expansion and optimization of the oncology franchise, while providing maximum strategic and financial flexibility, and will progress the development of BXCL701, an…

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

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BioXcel Therapeutics Announces Formation of OnkosXcel Therapeutics to Develop Medicines Focused in Oncology
April 19 2022 - 07:05AM


BioXcel Therapeutics, Inc. (Nasdaq: BTAI) (the “Company” or “BioXcel Therapeutics”), a commercial-stage biopharmaceutical company utilizing artificial intelligence (AI) approaches to develop transformative medicines in neuroscience, today announced the formation of wholly-owned subsidiary OnkosXcel Therapeutics, Inc. (“OnkosXcel”) to develop transformative medicines in oncology.

OnkosXcel is focused on the sustained expansion and optimization of the oncology franchise, while providing maximum strategic and financial flexibility. OnkosXcel plans to progress the development of BXCL701, an investigational orally administered innate immune activator designed to initiate inflammation in the tumor microenvironment.

BXCL701 is being evaluated in combination with KEYTRUDA® (pembrolizumab) in an ongoing Phase 2 trial in metastatic castration-resistant prostate cancer (mCRPC) patients with either adenocarcinoma or small cell neuroendocrine carcinoma (SCNC) phenotype. Most recently, the Company announced positive efficacy and safety data at the 2022 ASCO Genitourinary Cancers Symposium, reinforcing the broad potential of BXCL701 to extend the activity of checkpoint inhibitor (CPI) therapy into “cold” tumor settings. BXCL701 is also being evaluated in combination with KEYTRUDA in advanced, “hot” and CPI-resistant tumors in an investigator-initiated, Phase 2 study led by MD Anderson Cancer Center, with additional efficacy data expected in the second half of 2022. BioXcel Therapeutics believes BXCL701 is one of the most advanced orally available, innate immune activators in the clinic and it has been evaluated in approximately 800 healthy subjects and cancer patients. OnkosXcel plans to explore the BXCL701 clinical development program in hematological malignancies and other solid tumors.

“We believe the formation of OnkosXcel will unlock significant value for both our neuroscience and immuno-oncology franchises and build a foundation for sustainable growth,” said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. “For BioXcel Therapeutics, this is the logical next step as we advance our five-year vision of becoming the premier AI-driven neuroscience company, exemplified by the recent FDA approval of IGALMI™ for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. For our immuno-oncology assets, we believe this new structure will sharpen our strategic focus and help us further maximize the value of our oncology portfolio with increased flexibility in the future.”

The Company plans to provide additional details regarding OnkosXcel in the second half of 2022.

[lettruthringout]

OnkosXcel Therapeutics subsidiary gives BioXcel more options

1) Sell OnkosXcel to suitor interested in cancer treatment franchise

2) Sell Igalmi franchise to suitor interested in schizophrenia/bi-polar/Alzheimer treatment

3) Sell OnkosXcel and Igalmi to different suitors

4) License Igalmi to Europe/Asian partners and focus on domestic market for both BXCL501 and BXCL701

-------------------------------------------------------------

From today's SEC filing

Notwithstanding the foregoing, the Credit Agreement permits OnkosXcel Therapeutics LLC (“OnkosXcel”), the Company’s subsidiary formed to develop BXCL701 and related assets (together with OnkosXcel Employee Holdings LLC and their respective subsidiaries, the “BXCL701 Subsidiaries”) to receive third-party investment or transfer all or substantially all of their assets to an unaffiliated third party, in each case subject to terms and conditions set forth in the Credit Agreement,

[Penny chatter]

This one is real wacky

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Up $1.53 on that news 15 minutes after financing was announced.

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BioXcel Therapeutics Announces $260 Million Strategic Financing with Oaktree and Qatar Investment Authority
April 19 2022 - 07:00AM


BioXcel Therapeutics, Inc. (Nasdaq: BTAI) (the “Company” or “BioXcel Therapeutics”), a commercial-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced strategic financing agreements with funds managed by Oaktree Capital Management, L.P. (“Oaktree”) and Qatar Investment Authority (“QIA”). Under the agreements, Oaktree and QIA will provide up to $260 million in gross funding to support the Company’s commercial activities of IGALMI™ (dexmedetomidine) sublingual film. In addition, the financing is intended to support the expansion of clinical development efforts of BXCL501, which includes a pivotal Phase 3 program for the acute treatment of agitation in patients with Alzheimer’s Disease (AD), and for the Company’s additional neuroscience and immuno-oncology clinical programs.

The long-term strategic financing process was led by Oaktree and is comprised of the following components:

Credit Agreement: Up to $135 million in a delayed draw term loan1
Revenue Interest Financing Agreement: Up to $120 million in a capped revenue interest on net sales of IGALMI and any other future BXCL501 products
Equity Investment: Up to $5 million purchase of BioXcel Therapeutics common stock

Under the agreement, BioXcel Therapeutics will receive $100 million in the first tranches of the strategic financing following approval by the U.S. Food and Drug Administration (FDA) of a New Drug Application (NDA) in respect of the use of the Company’s BXCL501 product for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. This condition was satisfied on April 5, 2022 with the FDA’s approval of IGALMI.

Key features of the financing include a credit facility with an interest-only period lasting through the duration of the facility of five years, which can be extended for an additional year at the Company’s option upon approval of BXCL501 by the FDA for the acute treatment of agitation associated with Alzheimer’s Disease. The credit facility includes substantial flexibility for future business development and monetization events, including BXCL701, the Company’s investigational, oral innate immunity activator. Under the terms of the revenue interest financing agreement, Oaktree and QIA will receive tiered revenue interest financing payments on U.S. net sales of IGALMI and any other future BXCL501 products up to a capped return. The revenue interest financing rate ranges from 0.375% to 7.750% of annual net sales of IGALMI and any other future BXCL501 products in the U.S. The total revenue interest financing payable by BioXcel Therapeutics to Oaktree and QIA has a cap at 1.75x of the amount funded, with the ability to redeem the revenue interest financing agreement at lower multiples within the first three years from funding. The strategic financing also includes a potential equity investment of up to $5 million for shares of the Company’s common stock, to be made at the option of Oaktree and QIA, while the credit agreement is outstanding at a price per share equal to a 10% premium over the stock’s 30-day volume weighted average price leading up to the exercise by Oaktree and/or QIA of such option.

Upon closing of this transaction, and together with the Company’s cash balance and anticipated business plan, BioXcel Therapeutics is expected to have a substantial multi-year working capital runway. Full execution of this financing would result in cash runway into 2025 for the Company.

“Following our recent approval of IGALMI and today’s financing announcement, we have never been in a better position to realize our vision of becoming the leading AI-enabled neuroscience company,” said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. “We are pleased to have strengthened our cash position with primarily non-dilutive capital as we prepare to launch IGALMI and progress our three-pillar portfolio growth strategy for this franchise, which includes pursuing additional indications, extending our geographical reach, and expanding the medical settings where IGALMI is offered. In parallel, we remain committed to advancing our additional neuroscience and immuno-oncology portfolio, including BXCL502 and BXCL701.”

“We are delighted to partner with BioXcel Therapeutics during this upcoming period of anticipated growth, highlighted by the recent approval and anticipated commercial launch of IGALMI as an acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults,” said Aman Kumar, Co-Portfolio Manager of Life Sciences Lending at Oaktree. “The Company has an exciting, AI-driven approach to drug discovery and development, and we look forward to funding the expansion of these efforts and assisting the Company in bringing new, innovative therapies to patients worldwide.”

Further information with respect to the strategic financing is set forth in a Form 8-K to be filed by BioXcel Therapeutics with the Securities and Exchange Commission (SEC).

[realfast95]

Chart for the day ending 4-18-22

[lettruthringout]

Psychiatrist. trashes the non-Igalmi anti-agitation pharmaceutical options

https://www.psychiatrictimes.com/view/treating-agitation-a-new-fda-approval

Dr Krystal is the Robert L. McNeil, Jr. professor of translational research; professor of psychiatry, neuroscience, and of psychology; and codirector at the Yale Center for Clinical Investigation. He also serves as chair and chief of psychiatry at Yale-New Haven Hospital. He is also the director of the NIAAA Center for the Translational Neuroscience of Alcoholism, and director of the clinical neuroscience division at the VA National Center for PTSD.

[lettruthringout]

EMA met February regarding BioXcel Paediatric Investigation Plan

https://www.investorvillage.com/uploads/87669/files/agenda-pdco-agenda-22-25-february-2022-meeting_en.pdf

[crudeoil24]

Wainwright is desperate for Buyers! Massive dilution in process.

BTAI

[crudeoil24]

Dilution SEC filing 3/10/22 > We may offer and sell up to $300,000,000.

[crudeoil24]

REVENUES >> Investors are forward looking! > $$$$$

Igalmi world-wide supply contract for ten years inked


ARx has agreed to exclusively manufacture and supply the Company with all of the Company’s worldwide supply of thin film formulation of dexmedetomidine to be used for the commercial supply of IGALMI

[crudeoil24]

Trading float is 19M.

[crudeoil24]

PT > $134.00

[realfast95]

HC Wainwright Adjusts Price Target on BioXcel Therapeutics to $134 From $130, Maintains Buy Rating
MT NEWSWIRES 5:24 AM ET 4/14/2022

(from someone's tweet, unconfirmed)

[realfast95]

correction. I meant that the sellers are lightning up. I don't know they are shorting.

[realfast95]

the pain is coming to an end, hopefully

midday 04/12/22



Volume is decreasing so the shorts are getting tired.
the bottom is the CCI and it's curling up

[realfast95]

analyst numbers (a few days old)

BioXcel Therapeutics, Inc. (NASDAQ:BTAI – Get Rating) – Equities research analysts at Truist Financial decreased their FY2023 earnings per share (EPS) estimates for shares of BioXcel Therapeutics in a note issued to investors on Wednesday, April 6th. Truist Financial analyst R. Karnauskas now anticipates that the company will post earnings per share of ($4.81) for the year, down from their previous forecast of $1.42. Truist Financial also issued estimates for BioXcel Therapeutics’ FY2024 earnings at ($0.18) EPS, FY2025 earnings at $5.27 EPS and FY2026 earnings at $9.67 EPS.

https://www.americanbankingnews.com/2022/04/11/fy2023-eps-estimates-for-bioxcel-therapeutics-inc-cut-by-analyst-nasdaqbtai.html

[lettruthringout]

And dexmedetomidine already approved in EU (IV)


https://www.ema.europa.eu/en/medicines/human/EPAR/dexdor

[lettruthringout]

Groundwork laid for IGALMI EMA submission

https://www.investorvillage.com/uploads/87669/files/EMA-decision-pediatric-investigation-plan.pdf

[lettruthringout]

Igalmi world-wide supply contract for ten years inked


ARx has agreed to exclusively manufacture and supply the Company with all of the Company’s worldwide supply of thin film formulation of dexmedetomidine to be used for the commercial supply of IGALMI

https://www.investorvillage.com/uploads/87669/files/Igalmi-supply.pdf

[realfast95]

Buffett probably already shorted the stock in anticipation of buying it next week from Jeffries

[lettruthringout]

Igalmi label is pretty broad

The Street was expecting it to be only approved for hospital use at best.

https://www.investorvillage.com/uploads/87669/files/Igalmi-label.pdf

[lettruthringout]

But most CEOs/Directors don't decide ..,

... to put 30% of the company's shares (8.5 million shares), that they own personally, on the market.

Most companies don't even do this type of registration

[medical veteran]

Realfast- Good stuff, thanks for the read!!! Patience with biotech, not easy, but, a must!!

[medical veteran]

Realfast- Good stuff, thanks for the read!!! Patience with biotech, not easy, but, a must!!

[realfast95]

Those shares registered by the CEO and a Director. They would still have to file form 4's. Most companies don't even do this type of registration and include them in company standard incentive filings. My guess is they will sell a million soon and hang on the rest since they have other milestones coming up.

[realfast95]

BioXcel Therapeutics: At A Turning Point After The Approval Of BXCL501
Apr. 08, 2022 4:59 PM ETBioXcel Therapeutics, Inc. (BTAI)

Summary

On April 6, BioXcel announced the FDA's approval of BXCL501 to treat acute agitation in patients with schizophrenia and bipolar syndrome.
In addition, the FDA approves it with very clean labeling.
BioXcel presents an excellent entry opportunity at current price levels.

Editor's note: This article was amended on 4/8/2022 to correct errors related to the FDA labeling and trial start date.

On April 6, BioXcel (NASDAQ:NASDAQ:BTAI) announced the FDA's approval of BXCL501 to treat acute agitation in patients with schizophrenia and bipolar syndrome. In addition, the FDA approves it with very clean labeling: There is no BLACK BOX, and it is only recommended that the administration of the drug should be done under the supervision of a health care provider, which means that the drug can be administered anywhere (even at home) as long as it is done under the supervision of a health care provider. This is very important because one of the bears' thesis is completely nullified: the approval will come with a strong restriction due to the drug administration would have to be carried out in hospital settings, which would greatly limit the future revenue potential. In this regard, Goldman Sachs analyst Corinne Jenkins double downgraded BioXcel last November based on this argument. Should Corina upgrade her BTAI valuation?

The approval marks BioXcel's move to a commercial-stage company for the first time in its history.

In addition, this approval is a very important milestone for the company, since it opens the door to future approvals of the same drug in other indications (Dementia & Alzheimer's, Depression, etc.) that are currently being tested. In fact, these indications present the greatest revenue potential. For this reason, I consider that BioXcel currently presents an excellent investment opportunity in the medium/long term.

Following approval, the share price surprisingly fell from $24.5 on the day of approval to $17 today (April 8). This behavior is normal in the Biotech sector (sell the news). But in BioXcel's case, and given that it's about to report phase II results in Dementia and Alzheimer's, and start phase III trials for this same indication, I don't think this drop will last long.

With a market capitalization of approximately $575 million, with the recent approval of BXCL501 to treat agitation in patients with schizophrenia and bipolar syndrome, and other indications to treat acute agitation (Dementia, Alzheimer's, Depression, etc.) are currently in the testing phase, and with cumulative revenue potential from all of these indications in the multi-billion dollar range, BioXcel presents an excellent entry opportunity at current price levels.
BXCL501: A drug with multi-million dollar future revenue potential

BXCL501 for acute agitation in patients with schizophrenia and bipolar syndrome

As we have already mentioned, BXCL501 has just been approved by the FDA to treat attacks of agitation in patients with schizophrenia and bipolar syndrome. Currently available drugs are limited to anxiolytics (benzodiazepines) which have some unpleasant side effects: high dependency rates, sedation, etc. On the other hand, there are antipsychotics, which also with many adverse effects. The only drug approved to specifically treat agitation in this type of patient is ADASUVE, from the Spanish company Ferrer. It was approved by the FDA in 2012, but has not had much commercial success due to hard labeling: it has a BLACK BOX with important safety warnings and it is specified that it can only be administered in hospital settings under the supervision of a doctor. This is due to the serious secondary effects that it presents in a high percentage of the population: Bronchospasms.

Therefore, IGALMI (trade name of BXCL501) does not face great competition in the agitation market for this type of patient.

As for the potential market, according to data reported by the company, it is estimated that some 25 million agitation episodes occur annually in the United States in patients of this group. Assuming a very conservative penetration rate of just 10%, IGALMI would be used 2.5 million times a year. The price at which the drug will be sold is not yet known, but there are some indications that the price of each IGALMI oral film could be around US$150 (competitor drug ADASUVE sells for US$150 per inhalation).

With these data, we can estimate a potential annual income of IGALMI of about $375 million.

The final price of IGALMI will probably be known in the next Q1 CC by next May.

The start of marketing will take place during this Q2, so we will have the first sales data during the second half of this year 2022. Because the first quarter of a drug's life is usually weak in sales, we will have to wait until early 2023 to see if IGALMI will be commercially successful. In my opinion, and as I said before, I think it will be successful and could easily reach 300 million dollars a year in a few years.

BXCL501 for acute agitation in patients with Dementia and Alzheimer's

The other indication for which BXCL501 is being tested is to treat acute agitation in patients with Dementia and Alzheimer's. BioXcel started phase III trials in December of the last year 2021. So far, the data obtained in the phase II trials are very promising: very good efficacy with few side effects.

The phase III trial is scheduled to last 12 weeks, so it is very likely that we will have the results in a few months. These results will be a great catalyst for BioXcel's stock price, and if they show good results in terms of efficacy and safety (which will most likely be the case), the approval of the drug by the FDA will be practically guaranteed (because the same drug has already been approved for another indication).

It is in this indication that the drug has the greatest revenue potential since it is estimated that in the United States some 100 million attacks of agitation occur annually in Dementia & Alzheimer's patients. In addition, the profile of patients with this type of pathology is usually over 65 years of age. This type of patient is very vulnerable to drug side effects, so the drugs available are very limited. In general, antipsychotics are discouraged due to the risk of death, and long-term use of benzodiazepines is not recommended.

Axsome Therapeutics (AXSM) is conducting Phase III trials of AXS-05 to treat chronic agitation in Alzheimer's patients. This candidate drug treats agitation from a different aspect than BXCL501: AXS-05 is given as a daily oral drug to prevent attacks, and BXCL501 is an oral drug used alone to reduce agitation after an attack. Furthermore, AXS-05 is only being tested in Alzheimer's patients, while BXCL501 is being tested in both Alzheimer's and Dementia patients. Personally, I believe that BXCL501 will be more commercially successful, once both are approved, than AXS-05, as it will only need to be administered a few times a month (depending on the patient's number of attacks), whereas AXS-05 will be administered every day. For an elderly patient who is likely to take many medications daily, it will be preferable to minimize the use of medication, so BXCL501 will be more attractive than AXS-05.

Therefore, BXCL501 can take a market niche with almost no competition in this group of patients.

Assuming a very conservative market penetration rate of 10%, BXCL501 could treat around 10 million cases of agitation annually for this group of patients in the United States. And assuming that the price is the same as AGALMI (we have estimated it at $150), we would have a potential annual revenue of around $1.5 billion.

Assuming that the phase III trials begin during the second half of this year, we would have the results at the end of this year 2022, or at the beginning of the next year 2023, and therefore, we could estimate that it would be approved in early 2024. The important thing here is that given the good results of efficacy and safety profile that have been shown in the last phase II trial, and after the recent approval of the same drug for the other indication, we can affirm that the approval of the drug for acute agitation in Dementia and Alzheimer's is practically guaranteed.

Another phase II trial is currently underway for this indication with two arms: (40 mcg and 60 mcg).

It is intended to report the results of this trial this summer. A good result (very likely) could be a good catalyst to cause a bullish momentum in the share price.

BXCL501 to treat agitation in Depression

The third indication for which BXCL501 is also being tested, in combination with antidepressant drugs, is depression. Here it is still in a very initial phase (it is intended to start phase II trials in the second half of this year). And here, as I have commented for the Dementia & Alzheimer's indication, the efficacy and safety of BXCL501 are almost guaranteed. This is because BXCL501 has already been tested in patients with the bipolar syndrome (it has just been approved for this indication). This type of patient presents depressive moments alternated with manic. And its efficacy and safety have already been demonstrated in both depressive and manic moments. Therefore, BXCL501 is likely to be effective in treating acute agitation in depressed patients.

Here the earning potential is huge, given the high prevalence of depression in most developed countries. Current therapies are based on the combination of new-generation antidepressants (serotonin reuptake inhibitors) in combination with anxiolytics (benzodiazepines). BXCL501 could be a good substitute for benzodiazepines for this type of patient.

Therefore, we can affirm that the potential revenue, estimated with caution, could be above $2 billion for the two indications:

(Schizophrenia&bipolar+Dementia&Alzheimer's).

At a P/E ratio of 5, it would justify a BTAI´s market cap of $10 billion.

BTAI currently only capitalizes $550 million. The enormous potential that BTAI currently has in the medium and long term is clearly appreciated.
Risks

Like all biotech, when investing in this type of company, several possible risks must be taken into account:

1- IGALMI's initial sales growth (for the first 3 quarters) may be slower than desired. This is normal at the beginning of the life of any drug, and above all, in the case of a Biotech with its first commercialized drug.

2- Possible offering risk. With a recently approved drug and several ongoing clinical trials, BioXcel will need a lot of funding in the coming months.

Regardless, as of September 30, 2021, cash and cash equivalents totaled approximately $252.9 million. This would be enough to finance the company's operations for at least another year.
Conclusion

On April 5, the FDA approved BXCL501 for the treatment of acute agitation in patients with schizophrenia and bipolar syndrome. In addition, the final labeling has been very favorable, since the administration of the drug is only recommended under the supervision of a healthcare professional, so it can be administered, even by oneself at home, under the supervision of a nurse. I believe that this approval is a very important milestone for BioXcel since it is not only the first drug that the company can sell, but it practically means that the approval of BXCL501 for the other indication (Dementia & Alzheimer's) is assured (Phase II results for this indication has been very good in terms of efficacy and safety).

The bearish reaction of the stock price after the approval is typical in the biotech sector (sell the news) and investors can take advantage by buying now at very cheap prices.

Phase II results are expected next summer to treat agitation in patients with Dementia and Alzheimer's. Two arms (40 mcg and 60 mcg) will be evaluated. A positive result (very likely) will be a good catalyst for the share price.

And it is expected that phase III trials data for this last indication will be reported in a few months.

With potential revenues for these two indications exceeding $2 billion and with a small current market capitalization of $500 million, BTAI's medium and long-term growth potential is immense.

To all this, we must add the other candidate drug BXCL701 (immuno-oncology), currently in phase II trials in patients with prostate cancer resistant to castration treatments.

My target price for the second half of this year or the beginning of the following year, 2023, is in the range of $60/$80.

https://seekingalpha.com/article/4500513-bioxcel-therapeutics-turning-point-after-bxcl501-approval