UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C., 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported):
(Exact name of registrant as specified in charter)
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
(Address of principal executive offices) (Zip Code)
(Registrant’s telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
(The Nasdaq Capital Market) | ||||
(The Nasdaq Capital Market) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging
growth company
If
an emerging growth company, indicate by check mart if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 8.01 Other Events.
On February 18, 2022, Jupiter Wellness, Inc. (the “Company”) issued a press release announcing that it completed recruitment for its clinical trial of JW-200 for the treatment of actinic keratosis, a common form of pre-cancerous growth that typically present as thick scaly lesions on sun-exposed skin. A copy of the press release is attached as Exhibit 99.1
Item 9.01 Financial Statements and Exhibits
Exhibits
Exhibit No. | Description | |
99.1 | Press Release dated February 18, 2022 | |
104 | Cover Page Interactive Data File (embedded with the Inline XBRL document) |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: February 18, 2022
JUPITER WELLNESS, INC. | ||
By: | /s/ Brian John | |
Brian John | ||
Chief Executive Officer |
Exhibit 99.1
Jupiter Wellness Completes Enrollment in Double-Blind Placebo-Controlled Clinical Trial of JW-200 for the Treatment of Actinic Keratosis
Data expected Q1 2022 on efficacy of JW-200 to clear AK lesions, a common form of pre-cancerous growth that left untreated can lead to cancer in up to 15% of patients
JUPITER, FL February 18, 2022 — Jupiter Wellness, Inc. (Nasdaq: JUPW) today announced it has completed recruitment in its clinical trial of JW-200 for the treatment of actinic keratosis (AK), a common form of pre-cancerous growths that typically present as thick scaly lesions on sun exposed skin. If left untreated, up to 15.1% of patients with 10 or more AK lesions will develop keratinocyte carcinoma.
The current standard of care for AK is surgical removal and/or medication. Treatments on the market include creams that may cause adverse side effects including intense local inflammation. Jupiter’s proprietary JW-200 is a dual mechanism of action cox 2 inhibitor comprised of cannabidiol and aspartame developed to offer rapid efficacy and relief in AK lesion clearance, as well as being a critical prophylactic treatment for skin cancer.
Approximately 100 patients with AK lesions on defined areas of either the face, scalp, arms, or hands were enrolled in the double-blind, randomized, placebo-controlled trial. The study measures the percentage of patients with complete clearance of AK following twice daily dosing of topical JW-200.
“We expect to report results in the next 30 days in this international study in Europe with a protocol similar to an FDA Phase 1/2. Should the study results prove favorable, Jupiter will be well positioned to launch an OTC product” stated Jupiter CEO Brian John.
An estimated 58 million Americans have one or more AK lesions. The skin cancer treatment market was worth $8.19 billion in 2019 and is growing at a CAGR of 7.5%, expected to reach $14.55 billion by 2027.
About Jupiter Wellness
Jupiter Wellness, Inc. (Nasdaq: JUPW) is a leading developer of pharmaceutical cannabinoids focused on skincare therapeutics and treatments. The Company’s product pipeline incorporates cannabidiol (CBD) to address indications including psoriasis, eczema, burns, herpes cold sores, and skin cancer. Jupiter generates revenue from a growing line of proprietary over-the-counter skincare products including its CaniSun™ sunscreen and other wellness brands sold through www.cbdcaring.com. For additional information, please visit www.jupiterwellness.com.
Jupiter Wellness Media Contact:
Phone: 561-244-7100
Email: info@JupiterWellness.com
Forward Looking Statements
This communication contains forward-looking statements regarding Jupiter Wellness, including, the anticipated timing of studies and the results and benefits thereof. You can generally identify forward-looking statements by the use of forward-looking terminology such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “explore,” “evaluate,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” or “will,” or the negative thereof or other variations thereon or comparable terminology. These forward-looking statements are based on each of the Company’s current plans, objectives, estimates, expectations, and intentions and inherently involve significant risks and uncertainties, many of which are beyond Jupiter Wellness’ control. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties and other risks and uncertainties affecting Jupiter Wellness and, including those described from time to time under the caption “Risk Factors” and elsewhere in Jupiter Wellness’ Securities and Exchange Commission (SEC) filings and reports, including Jupiter Wellness’ Annual Report on Form 10-K for the year ended December 31, 2020 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, and future filings and reports by Jupiter Wellness. Moreover, other risks and uncertainties of which the combined company is not currently aware may also affect each of the companies’ forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. Investors are cautioned that forward-looking statements are not guarantees of future performance. The forward-looking statements made in this communication are made only as of the date hereof or as of the dates indicated in the forward-looking statements and reflect the views stated therein with respect to future events at such dates, even if they are subsequently made available by Jupiter Wellness on its website or otherwise. Jupiter Wellness undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made.
1 |
"?\ ##/PF_Z!-_\ ^#"7_&C_ (89^$W_ $";_P#\&$O^-?0%,EE2 M")Y)'6.- 69V. H'4DUV?VICO^?TOO9YW]BY9_T#P_\ 4<+\*_@CX4^#4-_ M%X8M9[5+UE:837#2Y*],;CQUK3^)/PTT+XL>&SH7B*"6XTXS)/LAE:-MZYQR M.>YK(A^.W@^>ZC07TZ6LLGDQZ@]K(MJ[YQ@2D;>O?I7H .17)*O6=7V\I/G[ M]?O.^.%P\:/U>,%R;6MI]QX-9_L1_"JPNX+F'2KY98761"=0E."#D=Z]ZHI" M0H))P!U)IU\57Q-O;37#VT4GDR7\=I(UJCYQ@R@8ZUWL,R7$22Q.LD;@,KJ< M@@]"*U^NXI4_8NH^7:UW;[C'^SL%[7V_LH\][WLKW[W'UY7\>OB=XL^&>E:; M<^%?!EUXOEN)629;:.23R0!D$J@)Y]>E>J5RGC#XK>#_ !"9/$/B33M+(&? M*FG'FL/:,98_@*RPW\6+]GS^6NOW:FV,_@27M?9_WM-/OT/&OA3^T/\ $OQM MXZT[1]<^%>H:%I=P6$VH2VT\:P@*2"2Z@=0!CWKVSXC>(=4\)^"-7U?1=(EU M[5+2'S(-.A!+S'(& !R< DX'/%>">+?^"@?P_P!&+QZ+9ZEX@D4X#K%]GB/X MO\W_ ([7D'B3_@HIXHO=RZ+X=T_35_A>X=IF_H*^E_LC%XNK&I3PRA%=&WKZ MW=SY'^W<#@:,J57&.I)WLTDVM.EE;3<] _X:R^,'_1%=4_\ &[_ /B*0_M: M?%]>OP6U,?6QN_\ XBOG+7_VQ/BMKQ?_ (J5K!&_@LH4C _'!/ZUY]K'Q4\9 M:_G^T?%.L7:GJLE[(5_+.*^IIY%"7\2C!>CF_P#(^,J\23C_ L14?JH+]&? M85]^V;\4-,CWWGPDNK-!_%<6]S&/S*BN=N/^"BGB.TD*3>#+"-QU5KB0&OCJ M6>2=RTLC2,?XG8DU'7H0R# +XZ2^5_\ -GESXFS)_!6:]>5_^VH^G?B)^V7> M_P\=!U31;/1K42K<_:(IG 17/B/36SBZ4_13_A7'V5MIDN M/M5]/;_[EJ)/_9Q6Q!X?\-7! _X2O[-[W&FR ?\ CA:O1HX?#X.'LZ,6EY)O M_,^5Q]&MF^(^M8JI>5DMXK1#[C6;-R=LX/\ P$_X5EW-] _W9 ?P-='!\/=" MNU'D_$3P^K'^&XAO8C^9M\?K6G;? N>_&;/QOX)N2>BG6TA)_"55K5XFC'XG M;U37YH*64U%\"OZ.+_(S?A%\4[CX0^/+3Q/9V<6H2VZ.@@E8JK!ACJ*^BT_X M*-Z^[ +X.TXD]OM+UX@G[,7CN[&=/@T?5QV-AKME+G_R+534/V:?BAIN?-\% M:G+C_GU19_\ T66KRL11RK&SYZSC*6WQ?\$^FP=?.LNI>SP\9QC>_P /ZV9] M)Z?^W/X_U;'V#X:"^ST^S":3/_?(-:R_M%UAD?!C4B/:RN_P#XBOC'4/A? MXRT@$WOA/7+,+U:?3ID'YE:S8+_6]%D_ ,C\L5S_V)@)ZTH1?W M_P#R1VKB+,Z>E: /]'*_9?&.MQ;>BM>R,/R)(KK]+_:]^+&E[0/% *,YR>!SQ5:U^/?Q&F^+Z^&'^%^H1 MZ";_ .S'5S#-L$6?];OV[,8YZU\R:3^W]\2+':+N'2M04==]N4)_$&NUTG_@ MH]J2%1J?@ZUE' A]TT5\N^#?^"@?@37;N.WUK3]1\.ER!Y[@3PK_ +Q7Y@/^ FOI M?2=6LM=TVWU#3KJ*]L;A!)%<0.&1U/0@BOD,3@<3@VEB(.-_ZWV/N\'F.$QZ M;PU12MVW^[ QCGP^UUM(_9[U42MMN-&2^LFS_"R M.X4?DRU[37SIKA.F6_Q+\+@[?MVO6C1J/[MUL8X_(UR1UT.]G4_L_H/"GASQ M!H\YV#3)H[E@W99+=)#^NZMG]GJW"^POIAB?4YI[^3/ /M2_ MX0_6_B&%^1;WPY%*F.[C=#_(K7K'@;1_^$?\%Z%IF,&TL886'N$ /ZYIRVOW M!&Y39/N-]#3J;)]QOH:S*/.O@( ? DO'_,2O/_1S5Z/7A?PE\*^(M2\,7%QI M_BR;2[5M1N]MJEK&X4^:V>3SS7M]M&\5O$DDAFD5 &D(QN..3CWJI;B6Q+4= MQ_Q[R_[I_E4E1W'_ ![R_P"Z?Y5(SSO]GS_DF-E_U]77_H]Z](KS?]GS_DF- ME_U]77_H]Z](JI;L2V"N#^.O_)(O%/\ UYG^8KO*X/XZ_P#)(O%/_7F?YBB. MZ!['5^'/^1>TO_KUB_\ 0!6C6=X<_P"1>TO_ *]8O_0!6C4C"O(OV@M)773X M0TUAD7>HR0?0M;R ']:]=KS7XL_\C/\ #G_L.C_T4]5'<3V.<\;:PVO_ *T M"\D_UQN[!)0>H=9E5L_B#7MM?/7BK_B6>#_$^@MQ_9_B.UEB7_IE-.C@_F6' MX5]"TY;"05SWQ"_Y$77_ /KQF_\ 0#70USWQ"_Y$77_^O&;_ - -2MRB#X7 M?\*W\+\?\PVW_P#1:UU%>2_#/PCXE/A'PS=+XPG6S^QV\@L_LD> FU3LW=>G M&:]:IO<2"N1^+EO=77PP\41689KAM/E"JG4C:<@?AFNNIKE0IW$!>^>E):,9 MYF-,M_'/[/B6&B10W(NM%6*VB! 42B, #T!#C\Q7>>&[:XL_#NEV]W_Q]Q6L M4 Q1YO U[.#?6:#)TYV./-0?W,GD=J]@AF2 MXA26)UDBD4,KJ0138D/K,\3QSS>'-42VS]H:VD$>.N[:<5ITA( )) 'J M:D9YA\+[>T\0_ FSL+2..4M826LL)QQ-@AE;WSUS76_#K2KW0_ NAZ?J2[;Z MVM4BF7=NPPSWKA?$^CW_PCUF[\7>'XS<^'[E_,UC1T_A];B+W'<=Q7JFF: MC;ZQI]M?6D@FMKB-98Y%Z,I&0:MB1ROBWX:+XT+I?^(-:@M6_P"7?3[LVRX] M,H ?UK@HOV,_A8)FEGT2>]E8Y9[F[D=F/J237N%%=5/&XFBN6G4<5Y.WY'!5 MR_"5Y C_9D^%L73P5IA^J$_P!: M]/HH>.Q3WJR^]B678*.U&/\ X"O\CS0_LV?# _\ ,DZ5_P!^C_C5>;]EWX5S MC#>"M.'^ZK#^M>IT4EC<4MJLOO93R_!O>C'_ ,!7^1XM>_L=_">]4C_A%XX, M]X9G4_SKR[XM?LL? SX:Z$=6UZ_U'P_;2/Y<1CN&E>1\9VHF"2:^NJRO$?A; M2/%^G-8:UIMMJEFQSY-U&'4'U&>A]Q7;A\TQ5.: ,#\,XKC-1_X)Z_#ZYW&VU36[+/0+,C@?\ ?2&OOJ'$V 45 M&3E\U?\ (_,,3PAF4IN4%#Y.WYH_.VG1QM+(J(I=V. JC))K[KO_ /@G1X?_ M .77QAJ47_7:UCD_D5KF=8_X)^P::I>+QS*<=-VEC_X]7HPX@RZ>BJ?@_P#( M\J?"V:T]72_\FC_F?,$'PP\8SH)(?"^L2)U#I92$?F!5NWT3X@^'SN@L_$6G M$=XDGCQ^6*]GO?@WXG^'DF-,^(^I0A>@AB>-?R\XBD@^-7Q5\'D"+Q[<7R)P M%N[1)!^I-6\;.LOW/+)>?,OT9"RZG0?[_G@_+E?_ + J:-^VWXSLG6+6=*T7 M78_XBUN87/X@D?I7UE\.9/#_ ,5_!&GZ_=^%=,MVO$W&!X8YMO\ P(H,_E7A MXW&K")3Q6#C9]4U_DF?19=E\L;)PP>/FFM;--?\ MS1\(Z?^U5IUXP7Q+\+_ M IK"'[[V]H+>0_BHQ^E>M?#&3]G/XZ:G#HY\*MX7U^Y.(K1Y&59FZXCD4X) M]B 3VS7T]J7P(^'NK@BZ\':1)G^[;*G\L5%X6^ 'P]\%ZQ%JNC>%;"RU"(YC MN%0LR'U7).#7AULWP4Z;]C&=.?2TM+_?M\CZ/#Y'F%.K'ZQ.G5AUYHZV\G:] M_F>2:S_P3]^'5^&^Q7>K::3TV3B0#_OH5P>M?\$WXV).D^-'3T6\LPWZJP_E M7VQ17DT\\S&EM5;];/\ ,]NKPWE5;XJ"7I=?DSX*M_\ @G%XA:Y G\8::D&> M7CMI&;'T)'\Z^OO@U\+[;X/> +#PQ:WLVH1VQ=VN)^"S,VXX'89/ KMZ*RQF M;8O'P5.O*Z6NR1O@,DP.65'5PT+2:M>[>GS"O!_'^F.?V@_#UNJG[/JB07$F M.A:W,G)_!DKWBJTVFVEQ>PW'_M":>\_C M+PC"B$QZNXTR7']TRQOS^ ->\U5N],M+^6WEN;:*>2W?S(7D0$QMZKZ&K5#= MTD 4V3[C?0TZCK4C/(?@OXRT'2/!TUM?:S86=PNHW9:*>X1&&9FQP37JUAJ% MMJEJES9W$5U;ORLL+AE;Z$5CR_#[PS-(\DF@:<[N2S,ULA))ZGI6Q8:?;:7: MI;6=O':VZ<+%$H55^@%4VGJ)%BH[C_CWE_W3_*I*0@$$'D&I&>0? WQGH&D_ M#NUM;W6K"TN4N;K=%- MVUS%>6\<\$B30R*'21#E6!Z$'N*PW^ M'GAB1V9O#^FLS'))MDR3^5;EM;16=O'!!&L,,:A$C0850.@ JFTW<2):X/XZ M_P#)(O%/_7F?YBN\J"]LK?4;62VNH4N+>0;7BD4,K#T(-).SN,YCPWX\\-OH M^E6ZZ]IIG,$48B%TFXMM QC/7-==7/P_#_PS;RI+%H.G1R(P976V0%2.01Q7 M04.W005YI\7#CQ-\./\ L/+_ .BWKTNJ]UIUK?26\EQ;QS/;OYD3.H)C;^\/ M0T)V8,\&^/]C>*XGSM@UR&U3_>GM[N,C_R&[?E7T#5+4M$T_6# ;ZR@NS MV^(S1AMC>HST-7:;=TD%@KGOB%_R(NO_ /7C-_Z :Z&HYX([J%X9D66)P59& M&0P/4$4D,\^^''CWPU9^ /#D$^OZ;#-'I\"/&]T@92(QD$9X->A12I-ⅅ! MXW 964Y!!Z$5S_\ PKGPM_T+VF_^ J?X5T$4201)'&H2- %55& .@%#MT$A M]>=_'^TN[KX4ZT;..26:$1SE8L[MJR*6QCV!->B4C*&!! (/!![T)V=QGFOQ M#^('AG5?A)K=S%JEK=0WVG2QP1+("\DCH0BA>N[<1QVKJ_A]97&G>!?#]K=J MRW,-A"DBMU5@@R#]*CM_AOX6M-3&H0Z!81WH;>)E@7(/J/0UTE-M6LA!7*?% M:QN=2^&_B2VLU9[J2QE$:I]XG;T'O75TG6DM!GG&E?$+PY"F.[EU6U\E-. M\N6.20;PXCP4*GG.>,5I_!>RN-/^%WAV"Z1HIEM5.QQ@J#R ?PQ6A+\-O"TV >I_VA)H%@UYNW>:8%SGU]*Z0 * , = *;:Z"/__9 end
(MP>/,+H\D@M,42?W&S0A+U2,?TS&K9PJ:@F\39J
MY]%$=FXBI/$QGM#B:E$TS\DMWYISA?I%EKZ/0C\59BJ^B99@U5A@,(@,XA'3[D;E3"83'?(Z(;=2
M=AA8+R9)
;Q E'X()3$OR"P3/0=L@>A%OJ#HSE
7:7 VM/AE
MR/8,(J!SU=*M-LM6MXJ"(*#-F9&]*->BIM@#&E.6Q%&?!&=P#W&RXDB^V!UV[.5!W