Factors Affecting Medication Adherence to Topical Acne Medications: a Single-center, Prospective Study Evaluating the Adherence and Patient Satisfaction to Single and Multiple Topical Acne Medications

Acne is a chronic condition that typically requires the use of multiple medications.1 Medication adherence is especially challenging for patients with chronic diseases and often decreases over time, especially for those using topical medications.1 Nonadherence can result in multiple negative effects including treatment failure, increased healthcare costs, and decreased quality of life. Primary nonadherence refers to problems acquiring and starting treatment. Challenges to this form of nonadherence include a lack of knowledge, misunderstanding of usage, poor communication with provider, increased cost, and fear of side effects.2 Secondary nonadherence refers to when the patient does not use the medication as prescribed. Hurdles to secondary nonadherence include delayed results, increased complexity of treatment plan, adverse effects, busy lifestyle, and inconvenience.2

Start Date01 Jul 2024

Sponsor / Collaborator

Wake Forest School of Medicine

[+1]

NCT05867654 / Not yet recruitingNot ApplicableIIT

Oral Versus Intravenous Antibiotics for the Management of the Osteomyelitis of the Jaws: An Open-Label Non-Inferiority Single-Arm Clinical Trial

The goal of this clinical trial is compare the efficacy of oral and IV antibiotics in the treatment of orofacial osteomyelitis. The main question it aims to answer is: Are oral antibiotics as effective as IV antibiotics in the treatment of orofacial osteomyelitis.
Participants, once diagnosed with osteomyelitis, will be started on oral antibiotics for their treatment. Participants will follow up with oral and maxillofacial surgery clinic accordingly and their progression and compliance will be monitored.

Start Date01 Mar 2024

Sponsor / Collaborator

University of Louisville

NCT05846399 / RecruitingPhase 4IIT

CAT BITE Antibiotic Prophylaxis and Durations for the Hand/Forearm (CATBITE): A Prospective, Randomized, Placebo-controlled, Double-blinded, Clinical Trial

Cat bites are puncture wounds that have the potential to seed bacteria deep within the joint capsule, periosteum, and bone. The hand is the most common site of bite injuries. Pasteurella multocida is the is the most common organism isolated from the mouths of cats that can cause infections after a bite. Prophylactic antibiotics are often recommended with amoxicillin-clavulanate for 3-5 days to decrease the incidence of developing an infection. However, only one randomized controlled clinical trial consisting of 12 patients has been performed to justify this course of treatment, raising the possibility that the use of antibiotics could be reduced or even eliminated. Investigators will compare different durations of prophylactic antibiotics and a placebo control for cat bites to the hand/forearm presenting to the Emergency Department, Urgent Care, Plastic Surgery Clinic using a randomized, controlled, double-blind clinical trial. Participants presenting to the University of Missouri Hospital Emergency Department, Missouri University (MU) Healthcare Urgent Care, Plastic Surgery Clinic over the next year will be offered the chance to enroll if they meet the inclusion/exclusion criteria. For inclusion, participants will be >18 years of age, have cat bites to the hand or distal to elbow, and present within 24 hours of the cat bite injury. Participants must not present with active local or systemic infections, have received antibiotics within the past 30 days, or be immunocompromised (primary and secondary immunodeficiencies). Participants will be randomized to one of three treatment arms (placebo; amoxicillin-clavulanate 1 day; amoxicillin-clavulanate 5 days). Outcomes are the development of an infection at the location of the cat bite and/or systemic infection, adverse effects of interventions, disability assessed by Quick Disabilities of Arm, Shoulder and Hand (QuickDASH) scores, and quality of life (QOL) assessed by HAND Questionnaire (HAND-Q) scores. Infection will be assessed at day 0, day 2, day 7+/-2, day 14+/-2, and day 30+/-2 by vital signs, laboratory values, physical examination and with an infrared and digital camera. All measures will be within the standard of care, apart from the infrared camera, QuickDASH, and HAND-Q scores. The anatomic locations of cat bites to the hand/forearm will be assessed for correlations with infections.

Start Date07 Sep 2023

Sponsor / Collaborator

University of Missouri

100 Clinical Results associated with Clindamycin Phosphate

100 Translational Medicine associated with Clindamycin Phosphate

100 Patents (Medical) associated with Clindamycin Phosphate

452

Literatures (Medical) associated with Clindamycin Phosphate

01 Feb 2024·Journal of drugs in dermatology : JDD

Benefit of Topical Combination Therapy for Acne: Analyzing Effect Size Using Number Needed to Treat

Article

Author: Callender, Valerie D ; Han, George ; Bhatia, Neal ; Feldman, Steven R ; Tyring, Stephen K ; Gold, Linda Stein ; Kircik, Leon H ; Zeichner, Joshua A

BACKGROUND:

Topical acne trials often are confounded by high vehicle response rates and differing outcome measures, making it difficult to compare treatments. Number needed to treat (NNT) can be a simple, clinically meaningful way to indirectly compare treatment options without head-to-head data. NNT is the number of patients who need to be treated with an intervention to observe one additional patient successfully achieving a desired outcome versus vehicle/placebo. While treatment attributes such as adverse events may not be captured, lower NNT is a good indicator of a more effective treatment.

METHODS:

Following a search of combination topical treatments for acne vulgaris, all treatments that reported pivotal trial efficacy data consistent with the 2018 FDA definition of success were included in NNT analyses. Results: Of 13 treatments, 7 reported 12-week treatment success rates in 11 phase 3 trials, with similar baseline demographics/disease severity. Treatment success ranged from 26.8% with tretinoin 0.1%/benzoyl peroxide (BPO) 3% cream to 50% with triple-combination clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel. NNTs for the triple-combination gel were 4 and 5 (from 2 pivotal trials). Adapalene 0.3%/BPO 2.5% gel had an NNT of 5. Tretinoin/BPO had the largest range between trials, with NNTs of 4 and 9. The other 4 treatments had NNTs ranging from 6 to 8.

CONCLUSION:

A comparison of combination topical acne treatment trial data, using the same treatment outcome and similar patient populations, resulted in triple-combination clindamycin phosphate/adapalene/BPO gel and adapalene/BPO gel having the most favorable NNTs.J Drugs Dermatol. 2024;23(2):42-49. doi:10.36849/JDD.7927.

26 Jan 2024·Medicine

Long-term debridement effect of denervated large sacrococcygeal pressure injury: A case report

Article

Author: Wu, Hai-Long ; Luo, Zong-Jian ; Lu, Yan

Rationale::

Complicated pressure injury in paraplegic patients is common and difficult to manage. Previous case studies have documented short-term management; however, little is known regarding suitable approaches to long-term clearing of extensive pressure injury in the sacrococcygeal area under denervation.

Patient concerns::

A 53-year-old man was bedridden for 1.5 years owing to cervical vertebral fracture-dislocation (C5–C6), resulting in extensive sacrococcygeal pressure injury.

Diagnoses::

On admission, he presented with the injury complicated by infection (stage IV necrosis), and his vital signs were unstable.

Interventions::

The infection was treated with a range of antibiotics, including clindamycin phosphate, metronidazole, cefoperazone sodium, and sulbactam sodium. Debridement of the pressure injury was performed, helping remove the necrotic tissue and stimulate tissue regeneration.

Outcomes::

The patient was discharged after 88 days of hospitalization. The extent of the pressure injury at discharge was reduced compared with that at admission. At 4-month follow-up, the injury was nearly healed, with no signs of any further complications.

Lessons::

This case study suggests that wound debridement is a cost-effective and clinically efficacious approach to long-term complicated pressure injury management.

31 Dec 2023·The Journal of dermatological treatment

Dermal sensitization, safety, and tolerability of triple-combination clindamycin phosphate 1.2%/benzoyl peroxide 3.1%/adapalene 0.15% gel from three clinical trials

Article

Author: Bhatia, Neal ; Tanghetti, Emil A ; Kircik, Leon H ; Stein Gold, Linda ; Draelos, Zoe D ; Zeichner, Joshua A ; Sugarman, Jeffrey L

BACKGROUND:

Using a three-pronged acne treatment approach-combining an antibiotic, antimicrobial agent, and retinoid-may provide greater efficacy than monad or dyad treatments. Herein are the dermal sensitization, irritation, safety, and tolerability results from phase 1 and 2 studies of fixed-dose clindamycin phosphate 1.2%/benzoyl peroxide (BPO) 3.1%/adapalene 0.15% (IDP-126) polymeric mesh gel.

METHODS:

Two phases 1, single-blind, vehicle-controlled dermal safety studies were conducted in healthy participants aged ≥18 years. One phase 2 (NCT03170388) double-blind, randomized, parallel-group, and vehicle-controlled study was conducted over 12 weeks in participants aged ≥9 years with moderate-to-severe acne.

RESULTS:

A total of 1,020 participants (IDP-126 gel, vehicle, or 1 of the 3 dyad gels [phase 2 only]) were included across the 3 studies (safety populations: n = 1,004). In the phase 1 studies, IDP-126 had no confirmed sensitization or contact dermatitis. IDP-126 (deemed "moderately irritating") was significantly less irritating than commercially available BPO 2.5%/adapalene 0.3% gel.

CONCLUSIONS:

The results from these three studies show that the triple-combination IDP-126 had a positive safety profile and was well tolerated in healthy participants and those with moderate-to-severe acne.

News (Medical) associated with Clindamycin Phosphate

09 May 2024

·www.globenewswire.com

XOMA Reports First Quarter 2024 Financial Results and Highlights Recent Activities

Earned $9 million milestone upon U.S. Food and Drug Administration’s approval of Day One’s OJEMDA™ (tovorafenib); XOMA is entitled to receive a mid-single digit royalty on OJEMDA™ sales Acquired Kinnate Pharmaceuticals, adding at least $9.5 million in non-dilutive capital to XOMA’s balance sheet Expanded the commercial royalty and milestone portfolio with the acquisitions of economic interests in DSUVIA® (sufentanil sublingual tablet) and XACIATO™ (clindamycin phosphate) vaginal gel 2%, as well as two Phase 3 assets Launched XOMA’s first stock repurchase program for up to $50 million EMERYVILLE, Calif., May 09, 2024 (GLOBE NEWSWIRE) -- XOMA Corporation (NASDAQ: XOMA), the biotech royalty aggregator, reported its first quarter 2024 financial results and highlighted recent activities. “We continue to build the foundation for accelerating value creation with a disciplined approach to capital deployment,” stated Owen Hughes, Chief Executive Officer of XOMA. “In recent months, we’ve completed the acquisition of Kinnate, acquired economic interests in two commercial assets, as well as in two first-in-class Phase 3 assets, and initiated our first share buyback program on the heels of securing the VABYSMO® royalty-backed loan with Blue Owl. Lastly, and most importantly, the FDA approved OJEMBA™ (tovorafenib), Day One Biopharmaceuticals’ type II RAF inhibitor for patients with relapsed or refractory pLGG harboring a BRAF fusion or rearrangement or BRAF V600 mutation, ushering in an important new treatment for children living with relapsed or refractory pLGG.” Key First Quarter Events PartnerEventTalpheraXOMA added another commercial asset to its royalty portfolio with an economic interest in DSUVIA®, which is marketed by Alora Pharmaceuticals. XOMA receives 100 percent of the DSUVIA® economics until a threshold is achieved; thereafter, XOMA retains the 15 percent royalty associated with DSUVIA® commercial sales. The 75 percent royalties from Department of Defense purchases and remaining milestone payments will be shared equally between XOMA and Talphera.Kinnate PharmaceuticalsXOMA initiated the acquisition of Kinnate Pharmaceuticals for $2.5879 in cash per share, plus a non-tradeable contingent value right (CVR) representing the right to receive 85 percent of the net proceeds from the out license or sale of Kinnate assets effected on or before April 2, 2025, and 100% of the net proceeds received from Pierre-Fabre.Zevra TherapeuticsU.S. Food and Drug Administration (FDA) accepted the arimoclomol NDA resubmission for review and set a Prescription Drug User Fee Act (PDUFA) action date of September 21, 2024. XOMA paid a $1 million milestone to LadRx based upon the achievement of this milestone.MedexusFDA approved the pediatric label expansion application for IXINITY® [coagulation factor IX (recombinant)].TakedaReported positive topline results from Phase 2 study evaluating mezagitamab (TAK-079), a potential best-in-class anti-CD38 monoclonal antibody for primary immune thrombocytopenia (ITP).iLG Chem (AVEO Oncology)Dosed the first patient in the ficlatuzumab Phase 3 study, resulting in a $1 million milestone payment to XOMA.CompugenReceived a $1 million milestone payment from Compugen. Subsequent Events PartnerEventDay One BiopharmaceuticalsFDA approved Day One’s OJEMDA™ (tovorafenib) for use in pediatric patients with pediatric low-grade glioma (pLGG). XOMA earned a $9 million milestone upon the approval and is entitled to receive mid-single digit royalties from OJEMDA sales.Daré BioscienceXOMA added economic interests to three best- or first-in-category assets to its portfolio. XACIATO™ vaginal gel 2% is commercially available and marketed by Organon. Bayer holds the U.S. rights to commercialize Ovaprene®, a hormone-free monthly intravaginal contraceptive, currently in Phase 3 clinical trials. XOMA also acquired a synthetic royalty in Sildenafil Cream, 3.6%, a Phase 3-ready asset for female sexual arousal disorder.RezoluteDosed first patient in its Phase 3 trial of RZ358; XOMA earned a $5.0 million milestone associated with the event. Anticipated 2024 Events of Note PartnerEventZevra TherapeuticsSeptember 21, 2024 – FDA PDUFA action date for arimoclomol NDATakedaIn its press release dated March 13, 2024, Takeda announced plans to initiate a global Phase 3 trial of mezagitamab in ITP in fiscal year 2024.ii First Quarter 2024 Financial Results XOMA recorded total revenues of $1.5 million for the first quarter of 2024, which included a $1.0 million milestone payment received from AVEO Oncology, as compared with $0.4 million in the first quarter of 2023. Research and development (R&D) expenses were $33,000 and $54,000, respectively, for the first quarters of 2024 and 2023. Upon closing the Kinnate merger in the second quarter of 2024, XOMA assumed operations of Kinnate’s pipeline, as well as ongoing Phase 1 study, and will incur increased R&D costs until winddown activities are complete. General and administrative (“G&A”) expenses were $8.5 million for the first quarter of 2024, compared to $6.2 million for the first quarter of 2023. The increase of $2.3 million was primarily due to a $1.3 million increase in stock-based compensation and a $0.7 million increase in consulting and legal expenses. The increase in stock-based compensation expenses was largely due to the appointment of Mr. Hughes as our full-time Chief Executive Officer in January 2024. In the first quarter of 2024, G&A expenses included $2.9 million in non-cash stock-based compensation expense, compared with $1.6 million in the first quarter of 2023. The increase in stock-based compensation expenses was largely due to the PSU grant associated with the appointment of Mr. Hughes as our full-time Chief Executive Officer in January 2024 combined with PSUs granted in May 2023. Interest expense in the first quarter of 2024 was $3.6 million, representing interest related to the Blue Owl Loan established in December 2023. The Company reported total other income, net, of $2.0 million in the first quarter of 2024, as compared to total other income, net, of $0.4 million in the corresponding period of 2023. The $1.6 million increase reflects a $1.3 million increase in investment income due to higher cash balances and higher market interest rates on our investments, as well as the change in the market price of Rezolute’s common stock. Net loss for the first quarter of 2024 was $8.6 million, compared to a net loss of $9.8 million for the first quarter of 2023. On March 31, 2024, XOMA had cash and cash equivalents of $142.4 million (including $6.2 million in restricted cash). On December 31, 2023, XOMA had cash and cash equivalents of $159.6 million (including $6.3 million in restricted cash). During the first quarter of 2024, XOMA received $9.8 million in cash from royalty and milestone payments and deployed $8 million to acquire new royalty and milestone economic interests. Net cash used in operating activities during the quarter was $4.9 million. On April 15, 2024, the Company paid a total of $1.4 million in cash dividends on the 8.625% Series A Cumulative Perpetual Preferred Stock (Nasdaq: XOMAP) and the 8.375% Series B Cumulative Perpetual Preferred Stock (Nasdaq: XOMAO). About XOMA CorporationXOMA is a biotechnology royalty aggregator playing a distinctive role in helping biotech companies achieve their goal of improving human health. XOMA acquires the potential future economics associated with pre-commercial and commercial therapeutic candidates that have been licensed to pharmaceutical or biotechnology companies. When XOMA acquires the future economics, the seller receives non-dilutive, non-recourse funding they can use to advance their internal drug candidate(s) or for general corporate purposes. The Company has an extensive and growing portfolio of assets (asset defined as the right to receive potential future economics associated with the advancement of an underlying therapeutic candidate). For more information about the Company and its portfolio, please visit www.xoma.com or follow the Company on LinkedIn. Forward-Looking Statements/Explanatory NotesCertain statements contained in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including statements regarding the timing and amount of potential commercial payments to XOMA and other developments related to VABYSMO® (faricimab-svoa), OJEMDA™ (tovorafenib), XACIATO™ (clindamycin phosphate) vaginal gel 2%, IXINITY® [coagulation factor IX (recombinant)], DSUVIA® (sufentanil sublingual tablet), and arimoclomol; the potential occurrences of the events listed under “Anticipated 2024 Events of Note”; the anticipated timings of regulatory filings and approvals related to assets in XOMA’s portfolio; and the potential of XOMA’s portfolio of partnered programs and licensed technologies generating substantial milestone and royalty proceeds over time. In some cases, you can identify such forward-looking statements by terminology such as “anticipate,” “intend,” “believe,” “estimate,” “plan,” “seek,” “project,” “expect,” “may,” “will”, “would,” “could” or “should,” the negative of these terms or similar expressions. These forward-looking statements are not a guarantee of XOMA’s performance, and you should not place undue reliance on such statements. These statements are based on assumptions that may not prove accurate, and actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry, including those related to the fact that our product candidates subject to out-license agreements are still being developed, and our licensees may require substantial funds to continue development which may not be available; we do not know whether there will be, or will continue to be, a viable market for the products in which we have an ownership or royalty interest; if the therapeutic product candidates to which we have a royalty interest do not receive regulatory approval, our third-party licensees will not be able to market them; and the impact to the global economy as a result of the COVID-19 pandemic. Other potential risks to XOMA meeting these expectations are described in more detail in XOMA's most recent filing on Form 10-Q and in other filings with the Securities and Exchange Commission. Consider such risks carefully when considering XOMA's prospects. Any forward-looking statement in this press release represents XOMA's beliefs and assumptions only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. XOMA disclaims any obligation to update any forward-looking statement, except as required by applicable law. EXPLANATORY NOTE: Any references to “portfolio” in this press release refer strictly to milestone and/or royalty rights associated with a basket of drug products in development. Any references to “assets” in this press release refer strictly to milestone and/or royalty rights associated with individual drug products in development. As of the date of this press release, the commercial assets in XOMA’s milestone and royalty portfolio are VABYSMO® (faricimab-svoa), OJEMDA™ (tovorafenib), XACIATO™ (clindamycin phosphate) vaginal gel 2%, IXINITY® [coagulation factor IX (recombinant)], and DSUVIA® (sufentanil sublingual tablet). All other assets in the milestone and royalty portfolio are investigational compounds. Efficacy and safety have not been established. There is no guarantee that any of the investigational compounds will become commercially available. XOMA CORPORATION CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, except share and per share amounts) March 31, December 31, 2024 2023 ASSETS(unaudited) Current assets: Cash and cash equivalents$136,225 $153,290 Short-term restricted cash 160 160 Short-term equity securities 413 161 Trade and other receivables, net 3 1,004 Short-term royalty and commercial payment receivables 9,819 14,215 Prepaid expenses and other current assets 270 483 Total current assets 146,890 169,313 Long-term restricted cash 6,016 6,100 Property and equipment, net 40 25 Operating lease right-of-use assets 364 378 Long-term royalty and commercial payment receivables 65,577 57,952 Other assets - long term 533 533 Total assets$219,420 $234,301 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable$1,515 $653 Accrued and other liabilities 1,299 2,768 Contingent consideration under RPAs, AAAs and CPPAs 3,000 7,000 Operating lease liabilities 55 54 Unearned revenue recognized under units-of-revenue method 2,159 2,113 Preferred stock dividend accrual 1,368 1,368 Current portion of long-term debt 6,144 5,543 Total current liabilities 15,540 19,499 Unearned revenue recognized under units-of-revenue method – long-term 6,692 7,228 Long-term operating lease liabilities 319 335 Long-term debt 114,528 118,518 Total liabilities 137,079 145,580 Stockholders’ equity: Preferred Stock, $0.05 par value, 1,000,000 shares authorized: 8.625% Series A cumulative, perpetual preferred stock, 984,000 shares issued and outstanding at March 31, 2024 and December 31, 2023 49 49 8.375% Series B cumulative, perpetual preferred stock, 1,600 shares issued and outstanding at March 31, 2024 and December 31, 2023 — — Convertible preferred stock, 5,003 issued and outstanding at March 31, 2024 and December 31, 2023 — — Common stock, $0.0075 par value, 277,333,332 shares authorized, 11,636,355 and 11,495,492 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively 87 86 Additional paid-in capital 1,314,036 1,311,809 Accumulated deficit (1,231,831) (1,223,223) Total stockholders’ equity 82,341 88,721 Total liabilities and stockholders’ equity$219,420 $234,301 XOMA CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (in thousands, except share and per share amounts) Three Months Ended March 31, 2024 2023 Revenues: Revenue from contracts with customers$1,000 $- Revenue recognized under units-of-revenue method 490 437 Total revenues 1,490 437 Operating expenses: Research and development 33 54 General and administrative 8,461 6,196 Arbitration settlement costs - 4,132 Amortization of intangible assets - 225 Total operating expenses 8,494 10,607 Loss from operations (7,004) (10,170) Other income (expense) Interest expense (3,551) - Other income (expense), net 1,960 357 Net loss and comprehensive loss$(8,595) $(9,813) Less: accumulated dividends on Series A and Series B preferred stock (1,368) (1,368) Net loss and comprehensive loss attributable to common stockholders, basic and diluted$(9,963) $(11,181) Basic and diluted net loss per share attributable to common stockholders$(0.86) $(0.98) Weighted average shares used in computing basic and diluted net loss per share attributable to common stockholders 11,580 11,460 XOMA CORPORATIONCONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS(in thousands) Three Months Ended March 31, 2024 2023 Cash flows from operating activities: Net loss$(8,595) $(9,813)Adjustments to reconcile net loss to net cash used in operating activities: Stock-based compensation expense 2,856 1,570 Common stock contribution to 401(k) 118 123 Amortization of intangible assets — 225 Depreciation 2 1 Accretion of long-term debt discount and debt issuance costs 306 — Non-cash lease expense 14 47 Change in fair value of equity securities (252) 24 Changes in assets and liabilities: Trade and other receivables, net 1,001 (5)Prepaid expenses and other assets 213 269 Accounts payable and accrued liabilities (105) 3,122 Operating lease liabilities (15) (50)Unearned revenue recognized under units-of-revenue method (490) (437) Net cash used in operating activities (4,947) (4,924) Cash flows from investing activities: Payments of consideration under RPAs, AAAs and CPPAs (15,000) (9,600)Receipts under RPAs, AAAs and CPPAs 7,771 2,366 Purchase of property and equipment (17) — Net cash used in investing activities (7,246) (7,234) Cash flows from financing activities: Principal payments – debt (3,616) — Debt issuance costs and loan fees paid in connection with long-term debt (581) — Payment of preferred stock dividends (1,368) (1,368)Repurchases of common stock (13) — Proceeds from exercise of options and other share-based compensation 1,956 — Taxes paid related to net share settlement of equity awards (1,334) — Net cash used in financing activities (4,956) (1,368) Net decrease in cash, cash equivalents and restricted cash (17,149) (13,526)Cash, cash equivalents and restricted cash at the beginning of the period 159,550 57,826 Cash, cash equivalents and restricted cash at the end of the period$142,401 $44,300 Supplemental Cash Flow Information: Cash paid for interest$3,780 $— Non-cash investing and financing activities: Accrual of contingent consideration under the Affitech CPPA$3,000 $— Preferred stock dividend accrual$1,368 $1,368 Investor contact: Media contact:Juliane SnowdenKathy VincentXOMAKV Consulting & Management+1-646-438-9754+1-310-403-8951juliane.snowden@xoma.comkathy@kathyvincent.com i https://www.takeda.com/newsroom/newsreleases/2024/takeda-announces-positive-topline-results-from-phase-2-study-evaluating-mezagitamab-TAK-079-a-potential-best-in-class-anti-CD38-monoclonal-antibody-for-primary-immune-thrombocytopenia/

Phase 3Drug ApprovalFinancial StatementPhase 1Clinical Result

30 Apr 2024

·www.globenewswire.com

Daré Bioscience Secures $22 Million in Non-Dilutive Strategic Royalty Financing to Advance Phase 3 First-in-Category Women’s Health Product Candidates through Key Catalysts

$22 million of non-dilutive capital at close provides significant capital to achieve objectives Upon achieving a pre-specified return threshold, XOMA will make upside-sharing milestone payments to Daré representing 50% of the future payments otherwise payable to XOMA Transaction allows Daré to focus on advancing Phase 3 first-in-category investigational products Ovaprene®, a potential first FDA-approved hormone-free intravaginal monthly contraceptive, and Sildenafil Cream, 3.6%, a potential first FDA-approved treatment for female sexual arousal disorder through key catalysts Previously announced royalty financing remains outstanding, bringing royalty-based capital committed to $34 million SAN DIEGO, April 30, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced it has closed a royalty monetization transaction with XOMA (US) LLC. Daré received $22 million in gross proceeds at close and, following a pre-specified total return to XOMA, XOMA will make upside-sharing milestone payments to Daré equal to 50% of all remaining cash flows sold to XOMA under the transaction. “This monetization of future net royalty and net milestone payments based on net sales of XACIATO™ (clindamycin phosphate) vaginal gel 2% under our license agreement with Organon, along with a low single digit minority interest in net payments related to future revenue from our Phase 3 candidates, Ovaprene and Sildenafil Cream, accelerates potential cash flows from the future commercial success of XACIATO and such product candidates, providing us with non-dilutive capital at an opportune time to drive shareholder value through the continued advancement of Ovaprene and Sildenafil Cream, both of which are first-in-category and represent large market opportunities,” said Sabrina Martucci Johnson, President and Chief Executive Officer of Daré Bioscience. “Importantly, this transaction ensures that Daré and our shareholders have the opportunity to participate meaningfully in XACIATO economics as commercialization progresses. The structure of these agreements also underscores the significant potential of Ovaprene and Sildenafil Cream, with Daré retaining the significant majority of future economics and the ability to achieve attractive margins through retained net sales and all commercial milestones. This transaction exemplifies our commitment to being creative, collaborative and opportunistic in seeking capital at an attractive cost to advance our potential first-in-category Phase 3 candidates to deliver value for all Daré stakeholders.” The transaction involves the sale of (a) the remaining royalties and potential milestones based on net sales of XACIATO payable to Daré under its global license agreement with Organon after deducting (i) all amounts due on such royalties and milestone payments to third-party licensors, and (ii) all payments owed by Daré under its existing royalty interest financing agreement with United in Endeavour, LLC, (b) 25% of the potential $20 million payment due to Daré under its license agreement with Bayer relating to Ovaprene, in the event Bayer, in its sole discretion, elects to make the payment1, and (c) a 4% synthetic royalty on net sales of Ovaprene and a 2% synthetic royalty on net sales of Sildenafil Cream, subject to an automatic decrease to 2.5% and 1.25%, respectively, as described below. Once XOMA achieves a pre-specified total return on its investment, XOMA will pay to Daré 50% of each successive $22 million that XOMA receives under the transaction agreements, and, once XOMA achieves another pre-specified total return on its investment, the synthetic royalty rates on net sales of Ovaprene and Sildenafil Cream will automatically decrease to 2.5% and 1.25%, respectively, which, after taking into account the $11 million payments to Daré after XOMA achieves the initial pre-specified total return, results in a lower effective royalty rate. TD Cowen, a division of TD Securities, acted as exclusive financial advisor to Daré Bioscience on the transaction. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. served as Daré’s legal advisor while XOMA was advised by Gibson, Dunn & Crutcher LLP. Additional information regarding the transaction is available in Daré’s Current Report on Form 8-K filed with the Securities and Exchange Commission today. 1 - Daré retains 75% of the potential $20 million payment and has no downstream obligations with respect to such payment. About Daré Bioscience Daré Bioscience is a biopharmaceutical company committed to advancing innovative products for women’s health. The company’s mission is to identify, develop and bring to market a diverse portfolio of differentiated therapies that prioritize women's health and well-being, expand treatment options, and improve outcomes, primarily in the areas of contraception, vaginal health, reproductive health, menopause, sexual health and fertility. The first FDA-approved product to emerge from Daré’s portfolio of women’s health product candidates is XACIATO™ (clindamycin phosphate) vaginal gel 2%, a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older, which is under a global license agreement with Organon. Organon commenced U.S. marketing of XACIATO in the fourth quarter of 2023. Daré’s portfolio also includes potential first-in-category candidates in clinical development: Ovaprene®, a novel, hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer; Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil, the active ingredient in Viagra®, to treat female sexual arousal disorder (FSAD); and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for menopausal hormone therapy. To learn more about XACIATO, Daré’s full portfolio of women’s health product candidates, and Daré’s mission to deliver differentiated therapies for women, please visit www.darebioscience.com. Daré Bioscience leadership has been named on the Medicine Maker’s Power List and Endpoints News’ Women in Biopharma 2022. In 2023, Daré's CEO was honored as one of Fierce Pharma’s Most Influential People in Biopharma for Daré’s contributions to innovation and advocacy in the women’s health space. Daré Bioscience placed #1 in the Small Company category of the San Diego Business Journal’s 2023 Best Places to Work Awards. Daré may announce material information about its finances, product and product candidates, clinical trials and other matters using the Investors section of its website (http://ir.darebioscience.com), SEC filings, press releases, public conference calls and webcasts. Daré will use these channels to distribute material information about the company and may also use social media to communicate important information about the company, its finances, product and product candidates, clinical trials and other matters. The information Daré posts on its investor relations website or through social media channels may be deemed to be material information. Daré encourages investors, the media, and others interested in the company to review the information Daré posts in the Investors section of its website and to follow these X (formerly Twitter) accounts: @SabrinaDareCEO and @DareBioscience. Any updates to the list of social media channels the company may use to communicate information will be posted in the Investors section of Daré’s website. Forward-Looking Statements Daré cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “objective,” or the negative version of these words and similar expressions. In this press release, forward-looking statements include, but are not limited to, statements relating to Daré’s use of proceeds from its transaction with XOMA, potential ongoing milestone payments from XOMA, the potential for lower effective synthetic royalty rates on net sales of Ovaprene and Sildenafil Cream, Daré’s expectation that proceeds from the transaction will provide sufficient capital to advance Ovaprene and Sildenafil Cream through key catalysts, the continued advancement of Ovaprene and Sildenafil Cream, the potential market opportunity for Ovaprene and Sildenafil Cream, if approved, and Daré’s ability to deliver value for all Daré stakeholders. In addition, as used in this press release, the description of a product candidate as “first-in-category” is a forward-looking statement relating to the potential of the candidate to represent a new category of product if it were to receive marketing approval for the indication for which Daré is developing it. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Daré’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, without limitation, risks and uncertainties related to: Daré’s ability to raise additional capital when and as needed to advance its product candidates, execute its business strategy and continue as a going concern; Daré’s ability to develop, obtain FDA or foreign regulatory approval for, and commercialize its product candidates and to do so on communicated timelines; failure or delay in starting, conducting and completing clinical trials of a product candidate; Daré’s ability to design and conduct successful clinical trials, to enroll a sufficient number of patients, to meet established clinical endpoints, to avoid undesirable side effects and other safety concerns, and to demonstrate sufficient safety and efficacy of its product candidates; Daré’s dependence on third parties to conduct clinical trials and manufacture and supply clinical trial material and commercial product; the risk that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; the risk that the FDA, other regulatory authorities, members of the scientific or medical communities or investors may not accept or agree with Daré’s interpretation of or conclusions regarding data from clinical studies of its product candidates; the risk that development of a product candidate requires more clinical or nonclinical studies than Daré anticipates; the loss of, or inability to attract, key personnel; the effects of macroeconomic conditions, geopolitical events, public health emergencies, and major disruptions in government operations on Daré’s operations, financial results and condition, and ability to achieve current plans and objectives; the risk that developments by competitors make Daré’s product or product candidates less competitive or obsolete; difficulties establishing and sustaining relationships with development and/or commercial collaborators; failure of Daré’s product or product candidates, if approved, to gain market acceptance or obtain adequate coverage or reimbursement from third-party payers; Daré’s ability to retain its licensed rights to develop and commercialize a product or product candidate; Daré’s ability to satisfy the monetary obligations and other requirements in connection with its exclusive, in-license agreements covering the critical patents and related intellectual property related to its product and product candidates; Daré’s ability to adequately protect or enforce its, or its licensor’s, intellectual property rights; the lack of patent protection for the active ingredients in certain of Daré’s product candidates which could expose its products to competition from other formulations using the same active ingredients; product liability claims; governmental investigations or actions relating to Daré’s product or product candidates or the business activities of Daré, its commercial collaborators or other third parties on which Daré relies; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; cybersecurity incidents or similar events that compromise Daré’s technology systems or those of third parties on which it relies and/or significantly disrupt Daré’s business; and disputes or other developments concerning Daré’s intellectual property rights. Daré’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of Daré’s risks and uncertainties, you are encouraged to review its documents filed with the SEC including Daré’s recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Daré undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. Contacts: Media and Investors on behalf of Daré Bioscience, Inc:Camilla White / Simona KormanikovaDentons Global AdvisorsDareBioscience@dentonsglobaladvisors.com / 1.212.466.6450 Source: Daré Bioscience, Inc.

License out/inPhase 3Drug Approval

30 Apr 2024

·www.globenewswire.com

XOMA Adds Economic Interests in Three First-in-Category Assets to its Royalty and Milestone Portfolio Including XACIATO™ (clindamycin phosphate) Vaginal Gel 2%

Organon, a global women’s healthcare company, initiated XACIATO™ commercial activities in the fourth quarter of 2023 XOMA further expands its late-stage portfolio with synthetic royalty and milestone interests in two additional women’s health assets: Ovaprene®, an investigational potential first-in-category Phase 3 hormone-free monthly intravaginal contraceptive, and Sildenafil Cream, 3.6%, a potential first-in-category Phase 3-ready candidate for female sexual arousal disorder Bayer HealthCare holds the exclusive rights to U.S. commercialization of Ovaprene® XOMA provided $22 million upfront as non-dilutive royalty capital solution to Daré Bioscience EMERYVILLE, Calif., April 30, 2024 (GLOBE NEWSWIRE) -- XOMA Corporation (NASDAQ: XOMA) announced today it has acquired an economic interest in three women’s health assets - XACIATO™ (clindamycin phosphate) vaginal gel 2%, Ovaprene®, and Sildenafil Cream, 3.6% - from Daré Bioscience, Inc., for an upfront payment of $22 million. XACIATO™ is approved by the U.S. Food and Drug Administration (FDA) for the treatment of bacterial vaginosis (BV) in females 12 years of age and older. In 2022, Daré entered into a license agreement with Organon, which initiated XACIATO™ commercial marketing activities in the fourth quarter of 2023. “XACIATO™, an important therapy, becomes the fifth commercial asset in XOMA’s royalty portfolio, and our royalty monetization transaction with Daré also adds two first-in-category Phase 3 royalty assets that have the potential to create additional value for our shareholders. Each of the three assets represents a meaningful advance in the women’s health category that has typically been under-represented and has significant growth potential,” stated Brad Sitko, Chief Investment Officer at XOMA. “XOMA structured an attractive, non-dilutive royalty capital solution that provides Daré with additional financial resources to advance its pipeline through key catalysts and aligns with its stockholders, enabling them to participate in the future value created by XACIATO™, Ovaprene®, and Sildenafil Cream.” Under the terms of the agreement, XOMA will receive the remaining royalties related to XACIATO™ not already included in Daré’s December 2023 royalty-backed financing agreement, which equates to low to high single-digit royalties on net sales. XOMA also is entitled to potential milestone payments based on the commercial success of XACIATO. Additionally, XOMA has acquired an interest in a potential milestone and a low single-digit synthetic royalty on Ovaprene®, as well as a low single-digit synthetic royalty on Sildenafil Cream, 3.6%. Upon achieving a pre-specified return threshold, XOMA will make upside-sharing milestone payments to Daré. AdvisorsGibson, Dunn & Crutcher LLP served as XOMA’s legal advisor, while Daré was advised by Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. TD Cowen, a division of TD Securities, acted as exclusive financial advisor to Daré. About XACIATO™ (clindamycin phosphate) vaginal gel 2%XACIATO vaginal gel is a prescription medicine used to treat bacterial vaginal infections in females 12 years of age and older, which is under a global license agreement with Organon. For more information, including important safety information, please visit www.xaciato.com. About Ovaprene®Ovaprene® is a novel investigational hormone-free monthly intravaginal contraceptive designed to be an easy-to use monthly option and prevent pregnancy by releasing a locally acting, non-hormonal agent, which impedes sperm motility, and physically blocks sperm from entering the cervical canal with its unique knitted polymer barrier. The novel combination of these complementary approaches has the potential to produce efficacy consistent with existing short-acting hormone birth control options (pills, patches, vaginal ring), without the use of hormones. U.S. commercial rights to Ovaprene® are under a license agreement with Bayer. About Sildenafil Cream, 3.6%Sildenafil, a phosphodiesterase-5 (PDE-5) inhibitor, is the active ingredient in a tablet for oral administration currently marketed under the brand name Viagra® for the treatment of erectile dysfunction in men. Sildenafil Cream is an investigational, proprietary cream formulation of sildenafil designed for topical administration to the vulvar-vaginal tissue on demand to increase genital blood flow and provide improvements in the female genital arousal response, while avoiding systemic side effects observed with oral formulations of sildenafil. About XOMA CorporationXOMA is a biotechnology royalty aggregator playing a distinctive role in helping biotech companies achieve their goal of improving human health. XOMA acquires the potential future economics associated with pre-commercial therapeutic candidates that have been licensed to pharmaceutical or biotechnology companies. When XOMA acquires the future economics, the seller receives non-dilutive, non-recourse funding they can use to advance their internal drug candidate(s) or for general corporate purposes. The Company has an extensive and growing portfolio of assets (asset defined as the right to receive potential future economics associated with the advancement of an underlying therapeutic candidate). For more information about the Company and its portfolio, please visit www.xoma.com or follow the Company on LinkedIn. Forward-Looking Statements/Explanatory NotesCertain statements contained in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including statements regarding the timing and amount of potential commercial payments to XOMA and other developments related to XACIATO™, Ovaprene®, and Sildenafil Cream, 3.6%. In some cases, you can identify such forward-looking statements by terminology such as “anticipate,” “intend,” “believe,” “estimate,” “plan,” “seek,” “project,” “expect,” “may,” “will,” “would,” “could” or “should,” the negative of these terms or similar expressions. These forward-looking statements are not a guarantee of XOMA’s performance, and you should not place undue reliance on such statements. These statements are based on assumptions that may not prove accurate, and actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry, including those related to the fact that our product candidates subject to out-license agreements are still being developed, and our licensees may require substantial funds to continue development which may not be available; we do not know whether there will be, or will continue to be, a viable market for the products in which we have an ownership or royalty interest; if the therapeutic product candidates to which we have a royalty interest do not receive regulatory approval, and our third-party licensees will not be able to market them. Other potential risks to XOMA meeting these expectations are described in more detail in XOMA's most recent filing on Form 10-K and in other filings with the Securities and Exchange Commission. Consider such risks carefully when considering XOMA's prospects. Any forward-looking statement in this press release represents XOMA's beliefs and assumptions only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. XOMA disclaims any obligation to update any forward-looking statement, except as required by applicable law. EXPLANATORY NOTE: Any references to “portfolio” in this press release refer strictly to milestone and/or royalty rights associated with a basket of drug products in development. Any references to “assets” in this press release refer strictly to milestone and/or royalty rights associated with individual drug products in development. As of the date of this press release, all assets in XOMA’s milestone and royalty portfolio, except VABYSMO® (faricimab), OJEMDA™ (tovorafenib), XACIATO™ (clindamycin phosphate) vaginal gel 2%, IXINITY® [coagulation factor IX (recombinant)], and DSUVIA® (sufentanil sublingual tablet), are investigational compounds. Efficacy and safety have not been established. There is no guarantee that any of the investigational compounds will become commercially available. XOMA Investor ContactXOMA Media ContactJuliane SnowdenKathy VincentXOMA CorporationKV Consulting & Management+1 646-438-9754+1 310-403-8951juliane.snowden@xoma.comkathy@kathyvincent.com

License out/inPhase 3Drug Approval

100 Deals associated with Clindamycin Phosphate

External Link

KEGG	Wiki	ATC	Drug Bank
D01073	Clindamycin Phosphate	G01AA10 J01FF01 D10AF01	-

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Anaerobic bacterial infection	US	Baxter Healthcare Corp.	20 Apr 2017
Bone and joint infections	US	Baxter Healthcare Corp.	20 Apr 2017
Gynecological infection	US	Baxter Healthcare Corp.	20 Apr 2017
Lower Respiratory Tract Infections	US	Baxter Healthcare Corp.	20 Apr 2017
Sepsis	US	Baxter Healthcare Corp.	20 Apr 2017
Skin and skin structure infections	US	Baxter Healthcare Corp.	20 Apr 2017
Pustular acne	JP	Sato Pharmaceutical Co., Ltd.	05 Jul 2002
Bacterial Vaginosis	US	Pfizer Inc.	11 Aug 1992
Acute Bronchitis	JP	Pfizer Japan, Inc.	04 Oct 1991
Hemorrhagic Septicemia	JP	Pfizer Japan, Inc.	04 Oct 1991
Laryngitis	JP	Pfizer Japan, Inc.	04 Oct 1991
Otitis Media	JP	Pfizer Japan, Inc.	04 Oct 1991
Pharyngitis	JP	Pfizer Japan, Inc.	04 Oct 1991
Pneumonia	JP	Pfizer Japan, Inc.	04 Oct 1991
Secondary infection	JP	Pfizer Japan, Inc.	04 Oct 1991
Sinusitis	JP	Pfizer Japan, Inc.	04 Oct 1991
Tonsillitis	JP	Pfizer Japan, Inc.	04 Oct 1991
Acne Vulgaris	US	Pfizer Inc.	07 Jan 1987
Bacterial Infections	CN	Hubei Huazhong Pharmaceutical Co. Ltd.	01 Jan 1984
Complicated skin and soft tissue infection	US	Pfizer Inc.	02 Oct 1972

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Pubmed	Phase 3	Acne Vulgaris	-	Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% gel (CAB)	jdqeyskhut(bpzuyqbzda) = Most TEAEs were of mild-moderate severity, and < 3% of CAB-treated participants discontinued study/treatment because of AEs urvkrptnks (erxuogjyuv ) View more	Positive	09 May 2024
				Vehicle gel
NCT04370548 (DARE-BVFREE, GlobeNewswire) Manual	Phase 3	Bacterial Vaginosis	307	DARE-BV1	exepahgckg(ovgoknsnkm) = phtfvatvbm emxzqrgyol (lfvnfusxcm ) View more	Positive	07 Dec 2020
				Placebo	exepahgckg(ovgoknsnkm) = vlrefcapre emxzqrgyol (lfvnfusxcm ) View more
NCT02168816 (CTgov)	Phase 2	Diabetic foot infection \| Osteomyelitis	30	piperacillin/tazobactam (Zosyn)+meropenem+aztreonam+metronidazole+cefepime+daptomycin+vancomycin (Intravenous Antibacterial Agent)	ufqufksjar(ykqxcusgej) = ewrqwmprjs ntxugmnzma (fpkgefykus, oqidxnwtle - uokzrlslok) View more	-	08 Jun 2018
				linezolid (Zyvox)+sulfamethoxazole+Clindesse+trimethoprim+clindamycin (Oral Antibacterial Agent)	ufqufksjar(ykqxcusgej) = tgceagthrm ntxugmnzma (fpkgefykus, sqleynnwmo - fpkwgtciyt) View more
NCT01915732 (CTgov)	Phase 3	Acne Vulgaris	1,018	Duac (Duac Once Daily Gel)	smnwsfmxhp(zoqikraqzt) = zmryclhdhp zwlpewqryb (pdlwevxzws, txchxsysec - kvzkgxznac) View more	-	25 Nov 2014
				Dalin+clindamycin phosphate+clindamycin (Dalin Gel)	smnwsfmxhp(zoqikraqzt) = jntzbemlsg zwlpewqryb (pdlwevxzws, hugjtefium - fmktbgmimh) View more
NCT01047189 (CTgov)	Phase 4	Acne Vulgaris	26	clindamycin phosphate+Ziana gel+tretinoin (Ziana Gel)	cvigokjoib(ngmtbyyxts) = eakgqpirqq twqnrrqxuw (uyocdrfvzb, dnaxirgpfd - davwoqmdqb) View more	-	17 Oct 2011
				Tretinoin+Clindamycin (Clindamycin Plus Tretinoin Applied Separately)	cvigokjoib(ngmtbyyxts) = bydynzaqzw twqnrrqxuw (uyocdrfvzb, akvlthpfrz - egbpzkjjdd) View more

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